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NEWS ARCHIVE 2008 - 2018

 

moksha8 Mexico will commercialize Duaklir and Eklira, the Astra Zeneca treatments indicated for Chronic Obstructive Pulmonary Disease

December 11th 2018

 

moksha8 Mexico and Astra Zeneca, a leading pharmaceutical company in respiratory therapies, have signed an agreement under which moksha8 Mexico will assume responsibility for promoting and distributing Duaklir and Eklira (aclidinium bromide/formoterol fumarate dihydrate 400/12 μg) in the Mexican territory. Duaklir and Eklira are indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 300 million people worldwide and is predicted to be the third leading cause of death by 2030*.

 

The PLATINO study described the epidemiology of COPD in five major Latin American cities. This population-based study reported crude prevalence rates of COPD of 7.8% in Mexico City**.

 

Approximately 90 per cent of COPD patients experience symptoms such as breathlessness and coughing during at least one part of the day and Eklira /Duaklir provides patients with a safe, effective way to improve breathlessness and lung function to these patients.

 

Joel Barlan, moksha8 CEO said: “This strategic partnership will strengthen our pharmaceutical business, accelerating the build of our pipeline and our presence in the respiratory area. Also, we are pleased to continue providing such excellent products for all COPD patients in Mexico.”

 

This agreement represents an immediate opportunity for moksha 8 to build its respiratory portfolio and presence, and these products will add new revenue growth.

*World Health Organization. Burden of COPD.

**Chronic obstructive pulmonary disease in five Latin American cities (the PLATINO study): a prevalence study. Lancet 2005; 366: 1875–1881

 

 

Montreux Partners Portfolio Company Moksha8 Announces The Appointment Of Mariano Garcia-Valiño To Its Board Of Directors

Berwin, Pennsylvania, USA, December 10th 2018

 

moksha8, a specialty pharmaceutical company, announces the appointment of Mariano Garcia-Valiño as a Board Member and Chairman of its Compensation and Business Development Committees.

 

Mariano has been active at the intersection of healthcare, deal-making and entrepreneurship for over 25 years, experiencing the space from many different angles, be it by building and operating companies, leading M&A and licensing transactions, working for some of the premier players in the business or managing investments for professional equity firms.

 

Recently, Mariano stepped down as CEO of Biotoscana Investments (BR:GBIO33), a company he architected, launched and took public in a transaction that was the largest healthcare IPO in the Americas in 2017 and the region’s first cross-border IPO in a decade.   Under his leadership, the company acquired, merged and transformed several local pharmaceutical players into a streamlined 10-country leading specialty player and closed licensing deals for over 40 novel compounds with some of the premier players in the world.

 

“We are very excited to have Mariano join our Board”, said Daniel K. Turner III, Founding Partner of Montreux.  “He brings invaluable experience in building Latin-American platforms and a unique track record in licensing and M&A. We believe he will be instrumental in taking Moksha8 to the next level”.

 

“I am very excited to work with the team at Montreux and Moksha8, whom I have known for several years and with whom we share a passion for building great businesses”, said Mr. Garcia-Valiño.   “Mariano is joining at a pivotal time”, added Joel Barlan, CEO of Moksha8.  “The company is leaving its start-up phase and prepared for accelerated development.   We believe Moksha8 will benefit highly from his experience”.

 

Mr. Garcia-Valiño holds an Engineering degree from Universidad de Buenos Aires and an MBA from the Harvard Business School.  He is based in Montevideo, Uruguay.

 

moksha8 Pharmaceuticals and CHEPLAPHARM enter into a strategic partnership to distribute Questran® in Mexico and Brazil

October 31st, 2018

 

moksha8 Pharmaceuticals and the German pharmaceutical company CHEPLAPHARM Arzneimittel GmbH have signed an agreement on the basis of which moksha8 will commercialize and promote Questran® in Mexico and Brazil.

 

Questran® (Cholestyramine) is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low-density lipoprotein [LDL] cholesterol).

 

High level of cholesterol increases the risks of heart disease and stroke. Globally, a third of ischaemic heart disease is attributable to high cholesterol. Overall, hypercholesterolemia is estimated to cause 2.6 million deaths. Prevalence for high cholesterol among adults is 39% worldwide (37% for males and 40% for females) - the highest prevalence according to WHO is found in Europe (54% for both sexes), followed by the Americas (48% for both sexes).

 

In Latin America, lipid abnormalities have a high prevalence and this is related to multiple causes: Genetic load and epigenetic modifications combined with a sedentary lifestyle and an inadequate nutrition*.

 

Questran® (Cholestyramine) has proven efficacy, if used along with a proper diet to lower cholesterol in the blood. Lowering cholesterol helps decrease the risk for strokes and heart attacks.

 

Since last year, with the distribution agreement for Dilatrend® in Mexico, moksha8 and CHEPLAPHARM have established a great partnership and, due to the positive results achieved, the companies decided to expand their commercial relationship in the Latin American country.

 

With this agreement, moksha8 Pharmaceuticals continues with its global diversification strategy and is increasing its cardiology portfolio. In Mexico, Questran® is the second product in the cardiology line and in the case of Brazil, Questran® will be the therapy with which the subsidiary will enter into this therapeutic area.

 

moksha8 is committed to work hard to maximize the product value of Questran® and to further contribute to hypercholesterolemia treatments in the Latin American region.

 

* World Health Organization/cholesterol, 2011

 

moksha8 Brazil announces a strategic alliance with HRA Pharma to commercialize Lysodren as the first step to build an Oncology line in this Market

March 26th, 2018

 

moksha8 Brazil has entered into a Promotion and Distribution Agreement with HRA Pharma to commercialize Lysodren in Brazil as the first step to build an Oncology line in this country. Lysodren (mitotane tablets) is an oral chemotherapeutic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma and until now the only product available in the market for this type of cancer.

 

Adrenocortical carcinoma (ACC) is a rare and aggressive tumor which peaks in incidence during the first and fifth decades of life. ACC has an estimated worldwide annual incidence of 2 cases per million overall. The highest reported annual incidence of pediatric ACC in the world occurs in Southern Brazil (3.4 per million) and is 10-15-fold higher compared to the United States (U.S.), where the annual incidence of pediatric ACC is 0.2-0.3 cases per million*.

 

With this alliance and the new addition to its portfolio, moksha8 expects higher revenue growth and this expansion into the Oncology therapeutic area allows it to achieve a greater presence in the markets in which it operates.

 

The deal is also relevant for moksha8 because with it, the company continues its philosophy to bring innovative treatments to improving the health and quality of life to patients around the world, especially with rare and aggressive disease as adrenal cortical carcinoma.

 

HRA Pharm, a fast growing, innovative healthcare company with headquarters in Paris, France, affirmed that this partnership allows them to expand the international reach of its Endocrinology and Rare Disease Division in different markets such as Europe, United States, Canada, Brazil and South Korea and strengthens its position as a key player in Adrenal Cortical Carcinoma.

 

The companies expect strong results and a possible expansion of the relationship in the South America Country.

 

 

*Adrenocortical Carcinoma in Adults and Children: A Population-Based Outcomes Study involving 1,623 Patients from the Surveillance, Epidemiology, and End Result (SEER) Database (1973-2012)

Remedy Publications LLC   Published 06 May, 2016

 

moksha8 Pharmaceuticals and Daewoong Pharmaceuticals sign exclusive licensing agreement to commercialize Nabota (botulinum toxin) in Brazil

January 29th, 2018

 

moksha8 Pharmaceuticals, announced today that it has entered into an exclusive licensing agreement with Daewoong Pharmaceuticals to commercialize botulinum toxin product Nabota in Brazil, the largest economy in Latin America.

 

“We are honored to be partnering with Daewoong Pharmaceuticals, one of the leading research- based companies in the world, in order to help expand the usage of Nabota in Latin America", said Joel Barlan.

 

Under the new agreement, moksha8 will be responsible for marketing authorizations, market access, commercialization, distribution throughout Brazil.

 

moksha8 Brazil will adopt a two-track marketing strategy for Nabota, the company will be in charge of Nabota applied to medical conditions while cosmetic use will be taken care of by GC Aesthetic Brazil, the leading pure play female Aesthetic company.

 

moksha8 Attains Brainsway Regulatory Approval for Marketing Deep TMS in Mexico

September 20th, 2016

 

Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced that it has received local regulatory approval for the marketing and distribution of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in Mexico. The company entered an exclusive distribution and marketing agreement with Moksha8, a leading specialty pharmaceutical company in Latin America, who has exclusive rights to distribute Deep TMS in Mexico.

 

“At least 15 million Mexicans suffer from a mental illness, many of whom do not have access to quality care,” said David Zacut, chief executive officer of Brainsway. “Our technology has been well-received globally, and we are confident that together with Moksha8 we will be able to provide hope to the people of Mexico.”

 

moksha8 entered an exclusive distribution and marketing agreement in Mexico for VESANOID® a CHEPLAPHARM product
September 14th, 2016

 

moksha8 and CHEPLAPHARM, a family owned pharmaceutical company based in Germany, have recently stepped up their relationship, signing a licensing deal that will see moksha8 take responsibility for the import, distribution, marketing and sale of VESANOID® in Mexico.

 

VESANOID® contains the ingredient Tretinoin and is applied in the treatment of a special form of leukemia, the Acute Promyelocytic Leukemia (APL) which is a subtype of the Acute Myeloid Leukemia (AML)

 

Brainsway joins Mexico through an exclusive distribution deal with moksha8

December 8th, 2015

 

Brainsway LTD (TASE: BRIN), leader in non-invasive brain stimulation, is pleased to announce a new alliance with moksha8, a leading company in the marketing of medicines for the CNS in Latin America, for the exclusive distribution of Transcranial Magnetic Stimulation Deep in Mexico. Moksha8 intends to register and start the marketing of several Deep EMT devices in 2016 and has already committed to launch 10 devices in the next 12 months.

 

“Brainsway is excited to announce this new alliance. I am sure that with Brainsway technology and the presence of moksha8 in the Mexican market, we will have a great success opening a new horizon for Deep EMT technology. We hope to be able to make the treatment affordable for the majority of patients suffering from major depression in Mexico, who are desperately seeking new solutions. The agreement reflects Brainsway’s strategy to expand its facilities, “said Dr. Guy Ezekiel, President and CEO of Brainsway.

 

Mexico is a highly promising market for Brainsway Deep EMT, since no other EMT device has been approved in this country. Under this agreement, moksha8 will promote registration, medical education and in-sales activities related to Deep EMT in Mexico.

 

“We are excited to bring the Deep EMT to Mexico. It is a perfect complement to our portfolio of CNS drugs, since the need for an effective and non-invasive solution for patients with depression is enormous, “said Joel Barlan, CEO of moksha8. “Brainsway technology is an innovative solution eagerly awaited.”

 

About Brainsway

 

Braisnway is a leading company dedicated to the development of treatments for brain disorders. Brainsway Deep TMS (Transcranial Magnetic Stimulation) effectively treats non-invasive depression, avoiding side effects, and is effective for patients resistant to treatment of depression. Brainsway’s technology was approved by the FDA for the treatment of patients with depression who did not respond to several pharmacological treatments in the depressive episode. Brainsway Deep EMT was enthusiastically received by the international academic community, with 60 clinical trials in various institutions globally. For more information, please visit www.brainsway.com

 

Forest Laboratories and moksha8 Form Broad Strategic Alliance for Latin America

October 22th, 2012

 

Forest Laboratories, Inc.(NYSE: FRX), an international pharmaceutical company, and moksha8, a leader in the commercialization of CNS medicines in Latin America, today announced that they have entered into a broad strategic alliance that will provide Forest with a commercial footprint in Latin America and give moksha8 access to Viibryd® and potentially other Forest products for the Latin American market.

 

The alliance includes an exclusive license from Forest to moksha8 to commercialize Viibryd®, and potentially other Forest products, in Latin America. In addition, Forest will provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals. At the conclusion of this two-year period, Forest will have the option to acquire moksha8 in a merger transaction. The moksha8 shareholders will also have a put option at such time, provided that moksha8 has achieved certain business objectives.

 

In connection with the alliance, moksha8 has expanded its license arrangement with Watson Pharmaceuticals, Inc. (NYSE: WPI), to extend moksha8’s rights to commercialize a portfolio of Watson CNS branded generic products in Brazil and Mexico and has bought out Watson’s minority equity position in moksha8. Other financial terms were not disclosed.

 

David Solomon, Senior Vice President of Corporate Development and Strategic Planning of Forest Laboratories Inc. said, “We are pleased to enter into this transaction with moksha8, which provides Forest access in a risk controlled manner to a high quality commercial operation in Latin America, one of the largest and fastest growing pharmaceutical markets in the world. Moksha8 is uniquely positioned to commercialize novel products such as Viibryd® in Latin America, and Forest will augment the moksha8 pipeline through our broad global partner network and business development reach. This alliance will in time contribute important incremental profits and growth to Forest and is consistent with Forest’s strategy to improve returns on our product investments through fiscally responsible international expansion. We are also pleased with the agreement between moksha8 and Watson, as Watson’s high quality branded generic products are complementary to Viibryd® and the other novel brands Forest expects to provide to moksha8.”

 

The CEO of moksha8 said “Forest has built one of the strongest proprietary drug pipelines in the industry and we are excited to partner with Forest to commercialize these products in the fast growth markets of Latin America. We are also very pleased to build on our successful partnership with Watson, which has one of the strongest branded generics portfolios in the industry and with whom we have rapidly become a market leader in the area of branded generic CNS medicines in Brazil.”

 

Fred Wilkinson, President Global Brands and Biosimilars of Watson said “We are pleased to be able to expand on our successful partnership with moksha8 in commercializing branded generic CNS products in Brazil and Mexico. We are also pleased with the alliance between moksha8 and Forest which will provide moksha8 with novel brands that are complementary to our branded generic CNS products.” Today, the Latin America pharmaceutical market is USD $67 billion with a CAGR of over 14% over the last 5 years. Brazil ad Mexico account for two thirds of the Latin America market value. The CNS market in Latin America is estimated to be approximately USD $6 billion.

 

About Viibryd®

 

Viibryd® is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd® was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd® is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd® antidepressant effect are unknown. Viibryd® is not yet approved in Brazil or Mexico and regulatory submission of Viibryd® in these countries is expected in Forest’s next fiscal year.

 

Forest will manufacture and supply Viibryd® to moksha8, under its license from Merck-Serono, and moksha8 will have exclusive rights to market, sell and distribute Viibryd® in Latin America.

 

About Forest Laboratories

 

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

 

moksha8 and Watson Pharmaceuticals launch Kitapen® for schizophrenia and bipolar disease.

April 11th, 2011

 

Six months after establishing a partnership to commercialize high quality branded generics in Latin America, moksha8 and U.S. generics leader Watson Pharmaceuticals, have launched Kitapen®, the first and only branded generic of quetiapine available in the Brazilian market. The drug was approved by ANVISA for the treatment of schizophrenia and bipolar disorder.

 

The launch of Kitapen® strengthens moksha8’s leadership position in the commercialization of high quality CNS medicines in Latin America. “This partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders, including depression, anxiety, bipolar and schizophrenia,” stated moksha8’s CEO.

 

Kitapen® is classified as a branded generic product with demonstrated bioequivalence to the reference compound quetiapine and is more affordable for patients. Bioequivalence studies are designed to demonstrate that the generic product has the same efficacy, safety and quality as the reference product. Kitapen® is priced at approximately 50% of the price of the reference product and is manufactured in Canada where it is also approved and marketed for the treatment of schizophrenia and bipolar disorder.

 

“Drug therapy has a fundamental function in controlling both diseases and is crucial to restore quality of life of these patients. For most of them, this treatment, combined with psychosocial strategies, allows the reintegration into family, society and work,” says Dr. L. Alcioly T. Lacey, one of the founders of the Synapse Institute of Clinical Neurosciences. Several studies, for example, show that 50% of schizophrenic patients are hospitalized only once, and in 60% of these cases, with an appropriate treatment, they are able to achieve a social and professional reintegration.

 

In addition to Kitapen®, under its alliance with Watson, moksha8 currently commercializes Carbolim® (lithium) to treat bipolar disorder, Vicodil® (paracetamol and codeine) for moderate to severe pain and Fatig®, a multi-vitamin. Moksha8 is planning to launch three to four additional products in Brazil in 2011. These anticipated product launches will be high-quality affordable medicines to address significant mental health indications affecting a growing number of Brazilians, such as Alzheimer’s disease, bipolar disorder, schizophrenia and depression.

 

Schizophrenia and bipolar disorder affect over 2 million people in Brazil. Throughout the country, over 23 million people suffer from some kind of mental disorder. Providing safe effective medicines at an affordable price may help improve the lives of millions of people that would not otherwise be able to positively contribute to society.

 

Kitapen® (quetiapine) is part of a drug group known as atypical or second generation antipsychotics, which have a better tolerability (fewer side effects) compared to first-generation antipsychotics. Quetiapine is used to treat the symptoms of schizophrenia and is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine works by changing the activity of certain natural substances in the brain.

 

Watson, moksha8 Form Marketing Partnership for Brazil and Mexico.

October 4th, 2010

 

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Moksha8, based in Sao Paulo, Brazil, today announced that they have entered into an agreement that will expand Watson’s commercial presence in Latin America’s two largest markets, Brazil and Mexico.

 

“This unique partnership further demonstrates our commitment to expand our global footprint through creative business solutions that maximize the commercial opportunities for our current portfolio of brands and branded generics, establish the foundation for future growth in high value and expanding markets, and creates immediate value for both partners,” said Paul Bisaro, Watson’s President and Chief Executive Officer.

 

“The management team of Moksha8, has a proven track record of effectively commercializing products within the brand and branded generic markets of Mexico and Brazil. This agreement, which provides Watson with an initial equity position, enables us to help fund Moksha8’s expansion and to share in their continued success. The partnership complements Watson’s existing commercial operations in Brazil, while establishing an expanded longer-term strategy to grow our presence in Brazil, establish our presence in Mexico and develop a pan- Latin American growth strategy,” Bisaro continued.

 

“The addition of Watson to our current business expands our existing portfolio and pipeline of high quality products for the Latin America market,”” said the Chief Executive Officer of Moksha8. “Further, this partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders including depression, anxiety and schizophrenia.”

 

Watson will manufacture and supply select products to Moksha8, which will have exclusive rights to market, sell and distribute these products in Brazil and Mexico. Moksha8 and Watson have initially identified approximately one dozen product candidates, with the opportunity to expand the commercialization and marketing agreement to include additional products in the future. Watson will continue to own all marketing authorizations, and Moksha8 will be responsible for sales, marketing and commercialization expenses.

 

moksha8 and BioCryst Gain Approval for the Importation and Use of Peramivir in Mexico for the Treatment of H1N1 Influenza

January 13th, 2010

 

moksha8 and BioCryst today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) antiviral that is currently available under an Emergency Use Authorization in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.

 

“Rapidly bringing important novel products to patients in need in Mexico and Brazil is core to our vision,” said the Head of moksha8 in Mexico. “The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government’s commitment to public health. We look forward to bringing this potentially life saving drug to as many patients as possible.”

 

“We are pleased that the Mexican government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. “The relationship between BioCryst and moksha8, established only three months ago, is producing the near-term results we desired. We are prepared to respond to any peramivir order we may receive under this authorization from Mexico.”

 

“Peramivir is an important part of our influenza preparedness program,” said Miguel Angel Toscana, Federal Commissioner of COFEPRIS (Mexico’s Federal Commission for the Protection against Sanitary Risk). “Approval of peramivir importation will help our mission of protecting our nation.”

 

The 2009 H1N1 influenza A virus is a new influenza virus and one to which most people have no or little immunity and, therefore, this virus could cause more infections than are seen with seasonal flu. The severity of the disease ranges from very mild symptoms to severe illnesses that can result in death.

 

About Peramivir

 

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in over 1800 patients with complicated and uncomplicated influenza. In November 2009, Shionogi & Co., Ltd. filed for regulatory approval in Japan.

 

About BioCryst

 

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company’s Web site at www.biocryst.com.

 

moksha8 Expands Alliance with Roche to Commercialize $200 Million of Products in Brazil and Mexico

May 20th, 2009

 

moksha8, Inc. announced today that it has expanded its strategic partnership with Roche to commercialize an additional portfolio of products in Mexico currently generating sales of $140 million USD. moksha8 will commercialize products in three therapeutic areas, CNS disease, anti-infectives, and inflammation. The product portfolio consists of well-known brands including Rivotril®, Rocephin® and Bactrim®

 

“moksha8 has produced strong results for Roche in Brazil and we are delighted to expand our relationship to include Mexico as a key country in Latin America” said Ernest Egli, President of Roche Latin America. “moksha8 brings strong commercial capabilities and innovative marketing to our CNS, anti-infectives and inflammation franchises. We look forward to continuing this valuable relationship.”

 

“moksha8 has established a broad footprint in Latin America with leading products that are cornerstones of medical care,”” said the CEO of moksha8. “We look forward to continuing our strong relationship with Roche and driving value from this important portfolio of products. We are now firmly positioned as the leading partner of choice for pharmaceutical and biotechnology companies looking to generate value across Latin America.”

 

In just over a year, moksha8 has grown its commercial organization to over 200 employees in Brazil and Mexico and a portfolio of products with sales of $200 million USD. moksha8 is uniquely positioned as the leading specialty pharmaceutical company in Latin America with a strong presence in CNS, anti-infectives and inflammation.

 

moksha8 Launches Broad Product Portfolio in Key Emerging Markets, Strategic Alliances with Roche and Pfizer Provide Portfolio of Over 20 Products

April 16th, 2008

 

moksha8, Inc. announced today strategic partnerships with Roche and Pfizer, the launch of over twenty products and establishment of its Latin America headquarters in Sao Paulo, Brazil. moksha8 is committed to providing the highest quality medicine to the fastest growing markets of the world, with an initial focus on Asia, Latin America and Eastern Europe.

 

In February 2008, moksha8 established strategic alliances with Roche and Pfizer in four therapeutic areas, CNS disease, anti-infectives, cardiovascular disease and pain management. The initial Roche and Pfizer portfolios consist of more than 20 products, including Neurontin®, Lexotan®, Zoloft®, and Bactrim®

 

moksha8 has established its Latin American headquarters in Sao Paulo, Brazil and has built a fully integrated sales and marketing team to drive the launch and commercialization of this comprehensive first line of products. Current annual sales of these products in Brazil are estimated to be over $80 million USD.

 

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NEWS ARCHIVE 2016 - 2008

 

moksha8 entered an exclusive distribution and marketing agreement in Mexico for VESANOID® a CHEPLAPHARM product
September 14th, 2016

 

moksha8 and CHEPLAPHARM, a family owned pharmaceutical company based in Germany, have recently stepped up their relationship, signing a licensing deal that will see moksha8 take responsibility for the import, distribution, marketing and sale of VESANOID® in Mexico.

 

VESANOID® contains the ingredient Tretinoin and is applied in the treatment of a special form of leukemia, the Acute Promyelocytic Leukemia (APL) which is a subtype of the Acute Myeloid Leukemia (AML)

 

moksha8 Attains Brainsway Regulatory Approval for Marketing Deep TMS in Mexico

September 20th, 2016

 

Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced that it has received local regulatory approval for the marketing and distribution of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in Mexico. The company entered an exclusive distribution and marketing agreement with Moksha8, a leading specialty pharmaceutical company in Latin America, who has exclusive rights to distribute Deep TMS in Mexico.

 

“At least 15 million Mexicans suffer from a mental illness, many of whom do not have access to quality care,” said David Zacut, chief executive officer of Brainsway. “Our technology has been well-received globally, and we are confident that together with Moksha8 we will be able to provide hope to the people of Mexico.”

 

Brainsway joins Mexico through an exclusive distribution deal with moksha8

December 8th, 2015

 

Brainsway LTD (TASE: BRIN), leader in non-invasive brain stimulation, is pleased to announce a new alliance with moksha8, a leading company in the marketing of medicines for the CNS in Latin America, for the exclusive distribution of Transcranial Magnetic Stimulation Deep in Mexico. Moksha8 intends to register and start the marketing of several Deep EMT devices in 2016 and has already committed to launch 10 devices in the next 12 months.

 

“Brainsway is excited to announce this new alliance. I am sure that with Brainsway technology and the presence of moksha8 in the Mexican market, we will have a great success opening a new horizon for Deep EMT technology. We hope to be able to make the treatment affordable for the majority of patients suffering from major depression in Mexico, who are desperately seeking new solutions. The agreement reflects Brainsway’s strategy to expand its facilities, “said Dr. Guy Ezekiel, President and CEO of Brainsway.

 

Mexico is a highly promising market for Brainsway Deep EMT, since no other EMT device has been approved in this country. Under this agreement, moksha8 will promote registration, medical education and in-sales activities related to Deep EMT in Mexico.

 

“We are excited to bring the Deep EMT to Mexico. It is a perfect complement to our portfolio of CNS drugs, since the need for an effective and non-invasive solution for patients with depression is enormous, “said Joel Barlan, CEO of moksha8. “Brainsway technology is an innovative solution eagerly awaited.”

 

About Brainsway

 

Braisnway is a leading company dedicated to the development of treatments for brain disorders. Brainsway Deep TMS (Transcranial Magnetic Stimulation) effectively treats non-invasive depression, avoiding side effects, and is effective for patients resistant to treatment of depression. Brainsway’s technology was approved by the FDA for the treatment of patients with depression who did not respond to several pharmacological treatments in the depressive episode. Brainsway Deep EMT was enthusiastically received by the international academic community, with 60 clinical trials in various institutions globally. For more information, please visit www.brainsway.com

 

Forest Laboratories and moksha8 Form Broad Strategic Alliance for Latin America

October 22th, 2012

 

Forest Laboratories, Inc.(NYSE: FRX), an international pharmaceutical company, and moksha8, a leader in the commercialization of CNS medicines in Latin America, today announced that they have entered into a broad strategic alliance that will provide Forest with a commercial footprint in Latin America and give moksha8 access to Viibryd® and potentially other Forest products for the Latin American market.

 

The alliance includes an exclusive license from Forest to moksha8 to commercialize Viibryd®, and potentially other Forest products, in Latin America. In addition, Forest will provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals. At the conclusion of this two-year period, Forest will have the option to acquire moksha8 in a merger transaction. The moksha8 shareholders will also have a put option at such time, provided that moksha8 has achieved certain business objectives.

 

In connection with the alliance, moksha8 has expanded its license arrangement with Watson Pharmaceuticals, Inc. (NYSE: WPI), to extend moksha8’s rights to commercialize a portfolio of Watson CNS branded generic products in Brazil and Mexico and has bought out Watson’s minority equity position in moksha8. Other financial terms were not disclosed.

 

David Solomon, Senior Vice President of Corporate Development and Strategic Planning of Forest Laboratories Inc. said, “We are pleased to enter into this transaction with moksha8, which provides Forest access in a risk controlled manner to a high quality commercial operation in Latin America, one of the largest and fastest growing pharmaceutical markets in the world. Moksha8 is uniquely positioned to commercialize novel products such as Viibryd® in Latin America, and Forest will augment the moksha8 pipeline through our broad global partner network and business development reach. This alliance will in time contribute important incremental profits and growth to Forest and is consistent with Forest’s strategy to improve returns on our product investments through fiscally responsible international expansion. We are also pleased with the agreement between moksha8 and Watson, as Watson’s high quality branded generic products are complementary to Viibryd® and the other novel brands Forest expects to provide to moksha8.”

 

The CEO of moksha8 said “Forest has built one of the strongest proprietary drug pipelines in the industry and we are excited to partner with Forest to commercialize these products in the fast growth markets of Latin America. We are also very pleased to build on our successful partnership with Watson, which has one of the strongest branded generics portfolios in the industry and with whom we have rapidly become a market leader in the area of branded generic CNS medicines in Brazil.”

 

Fred Wilkinson, President Global Brands and Biosimilars of Watson said “We are pleased to be able to expand on our successful partnership with moksha8 in commercializing branded generic CNS products in Brazil and Mexico. We are also pleased with the alliance between moksha8 and Forest which will provide moksha8 with novel brands that are complementary to our branded generic CNS products.” Today, the Latin America pharmaceutical market is USD $67 billion with a CAGR of over 14% over the last 5 years. Brazil ad Mexico account for two thirds of the Latin America market value. The CNS market in Latin America is estimated to be approximately USD $6 billion.

 

About Viibryd®

 

Viibryd® is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd® was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd® is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd® antidepressant effect are unknown. Viibryd® is not yet approved in Brazil or Mexico and regulatory submission of Viibryd® in these countries is expected in Forest’s next fiscal year.

 

Forest will manufacture and supply Viibryd® to moksha8, under its license from Merck-Serono, and moksha8 will have exclusive rights to market, sell and distribute Viibryd® in Latin America.

 

About Forest Laboratories

 

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

 

moksha8 and Watson Pharmaceuticals launch Kitapen® for schizophrenia and bipolar disease.

April 11th, 2011

 

Six months after establishing a partnership to commercialize high quality branded generics in Latin America, moksha8 and U.S. generics leader Watson Pharmaceuticals, have launched Kitapen®, the first and only branded generic of quetiapine available in the Brazilian market. The drug was approved by ANVISA for the treatment of schizophrenia and bipolar disorder.

 

The launch of Kitapen® strengthens moksha8’s leadership position in the commercialization of high quality CNS medicines in Latin America. “This partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders, including depression, anxiety, bipolar and schizophrenia,” stated moksha8’s CEO.

 

Kitapen® is classified as a branded generic product with demonstrated bioequivalence to the reference compound quetiapine and is more affordable for patients. Bioequivalence studies are designed to demonstrate that the generic product has the same efficacy, safety and quality as the reference product. Kitapen® is priced at approximately 50% of the price of the reference product and is manufactured in Canada where it is also approved and marketed for the treatment of schizophrenia and bipolar disorder.

 

“Drug therapy has a fundamental function in controlling both diseases and is crucial to restore quality of life of these patients. For most of them, this treatment, combined with psychosocial strategies, allows the reintegration into family, society and work,” says Dr. L. Alcioly T. Lacey, one of the founders of the Synapse Institute of Clinical Neurosciences. Several studies, for example, show that 50% of schizophrenic patients are hospitalized only once, and in 60% of these cases, with an appropriate treatment, they are able to achieve a social and professional reintegration.

 

In addition to Kitapen®, under its alliance with Watson, moksha8 currently commercializes Carbolim® (lithium) to treat bipolar disorder, Vicodil® (paracetamol and codeine) for moderate to severe pain and Fatig®, a multi-vitamin. Moksha8 is planning to launch three to four additional products in Brazil in 2011. These anticipated product launches will be high-quality affordable medicines to address significant mental health indications affecting a growing number of Brazilians, such as Alzheimer’s disease, bipolar disorder, schizophrenia and depression.

 

Schizophrenia and bipolar disorder affect over 2 million people in Brazil. Throughout the country, over 23 million people suffer from some kind of mental disorder. Providing safe effective medicines at an affordable price may help improve the lives of millions of people that would not otherwise be able to positively contribute to society.

 

Kitapen® (quetiapine) is part of a drug group known as atypical or second generation antipsychotics, which have a better tolerability (fewer side effects) compared to first-generation antipsychotics. Quetiapine is used to treat the symptoms of schizophrenia and is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine works by changing the activity of certain natural substances in the brain.

 

Watson, moksha8 Form Marketing Partnership for Brazil and Mexico.

October 4th, 2010

 

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Moksha8, based in Sao Paulo, Brazil, today announced that they have entered into an agreement that will expand Watson’s commercial presence in Latin America’s two largest markets, Brazil and Mexico.

 

“This unique partnership further demonstrates our commitment to expand our global footprint through creative business solutions that maximize the commercial opportunities for our current portfolio of brands and branded generics, establish the foundation for future growth in high value and expanding markets, and creates immediate value for both partners,” said Paul Bisaro, Watson’s President and Chief Executive Officer.

 

“The management team of Moksha8, has a proven track record of effectively commercializing products within the brand and branded generic markets of Mexico and Brazil. This agreement, which provides Watson with an initial equity position, enables us to help fund Moksha8’s expansion and to share in their continued success. The partnership complements Watson’s existing commercial operations in Brazil, while establishing an expanded longer-term strategy to grow our presence in Brazil, establish our presence in Mexico and develop a pan- Latin American growth strategy,” Bisaro continued.

 

“The addition of Watson to our current business expands our existing portfolio and pipeline of high quality products for the Latin America market,”” said the Chief Executive Officer of Moksha8. “Further, this partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders including depression, anxiety and schizophrenia.”

 

Watson will manufacture and supply select products to Moksha8, which will have exclusive rights to market, sell and distribute these products in Brazil and Mexico. Moksha8 and Watson have initially identified approximately one dozen product candidates, with the opportunity to expand the commercialization and marketing agreement to include additional products in the future. Watson will continue to own all marketing authorizations, and Moksha8 will be responsible for sales, marketing and commercialization expenses.

 

moksha8 and BioCryst Gain Approval for the Importation and Use of Peramivir in Mexico for the Treatment of H1N1 Influenza

January 13th, 2010

 

moksha8 and BioCryst today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) antiviral that is currently available under an Emergency Use Authorization in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.

 

“Rapidly bringing important novel products to patients in need in Mexico and Brazil is core to our vision,” said the Head of moksha8 in Mexico. “The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government’s commitment to public health. We look forward to bringing this potentially life saving drug to as many patients as possible.”

 

“We are pleased that the Mexican government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. “The relationship between BioCryst and moksha8, established only three months ago, is producing the near-term results we desired. We are prepared to respond to any peramivir order we may receive under this authorization from Mexico.”

 

“Peramivir is an important part of our influenza preparedness program,” said Miguel Angel Toscana, Federal Commissioner of COFEPRIS (Mexico’s Federal Commission for the Protection against Sanitary Risk). “Approval of peramivir importation will help our mission of protecting our nation.”

 

The 2009 H1N1 influenza A virus is a new influenza virus and one to which most people have no or little immunity and, therefore, this virus could cause more infections than are seen with seasonal flu. The severity of the disease ranges from very mild symptoms to severe illnesses that can result in death.

 

About Peramivir

 

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in over 1800 patients with complicated and uncomplicated influenza. In November 2009, Shionogi & Co., Ltd. filed for regulatory approval in Japan.

 

About BioCryst

 

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company’s Web site at www.biocryst.com.

 

moksha8 Expands Alliance with Roche to Commercialize $200 Million of Products in Brazil and Mexico

May 20th, 2009

 

moksha8, Inc. announced today that it has expanded its strategic partnership with Roche to commercialize an additional portfolio of products in Mexico currently generating sales of $140 million USD. moksha8 will commercialize products in three therapeutic areas, CNS disease, anti-infectives, and inflammation. The product portfolio consists of well-known brands including Rivotril®, Rocephin® and Bactrim®

 

“moksha8 has produced strong results for Roche in Brazil and we are delighted to expand our relationship to include Mexico as a key country in Latin America” said Ernest Egli, President of Roche Latin America. “moksha8 brings strong commercial capabilities and innovative marketing to our CNS, anti-infectives and inflammation franchises. We look forward to continuing this valuable relationship.”

 

“moksha8 has established a broad footprint in Latin America with leading products that are cornerstones of medical care,”” said the CEO of moksha8. “We look forward to continuing our strong relationship with Roche and driving value from this important portfolio of products. We are now firmly positioned as the leading partner of choice for pharmaceutical and biotechnology companies looking to generate value across Latin America.”

 

In just over a year, moksha8 has grown its commercial organization to over 200 employees in Brazil and Mexico and a portfolio of products with sales of $200 million USD. moksha8 is uniquely positioned as the leading specialty pharmaceutical company in Latin America with a strong presence in CNS, anti-infectives and inflammation.

 

moksha8 Launches Broad Product Portfolio in Key Emerging Markets, Strategic Alliances with Roche and Pfizer Provide Portfolio of Over 20 Products

April 16th, 2008

 

moksha8, Inc. announced today strategic partnerships with Roche and Pfizer, the launch of over twenty products and establishment of its Latin America headquarters in Sao Paulo, Brazil. moksha8 is committed to providing the highest quality medicine to the fastest growing markets of the world, with an initial focus on Asia, Latin America and Eastern Europe.

 

In February 2008, moksha8 established strategic alliances with Roche and Pfizer in four therapeutic areas, CNS disease, anti-infectives, cardiovascular disease and pain management. The initial Roche and Pfizer portfolios consist of more than 20 products, including Neurontin®, Lexotan®, Zoloft®, and Bactrim®

 

moksha8 has established its Latin American headquarters in Sao Paulo, Brazil and has built a fully integrated sales and marketing team to drive the launch and commercialization of this comprehensive first line of products. Current annual sales of these products in Brazil are estimated to be over $80 million USD.

 

NEWS ARCHIVE 2016 - 2008

 

moksha8 entered an exclusive distribution and marketing agreement in Mexico for VESANOID® a CHEPLAPHARM product
September 14th, 2016

 

moksha8 and CHEPLAPHARM, a family owned pharmaceutical company based in Germany, have recently stepped up their relationship, signing a licensing deal that will see moksha8 take responsibility for the import, distribution, marketing and sale of VESANOID® in Mexico.

 

VESANOID® contains the ingredient Tretinoin and is applied in the treatment of a special form of leukemia, the Acute Promyelocytic Leukemia (APL) which is a subtype of the Acute Myeloid Leukemia (AML)

 

moksha8 Attains Brainsway Regulatory Approval for Marketing Deep TMS in Mexico

September 20th, 2016

 

Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced that it has received local regulatory approval for the marketing and distribution of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in Mexico. The company entered an exclusive distribution and marketing agreement with Moksha8, a leading specialty pharmaceutical company in Latin America, who has exclusive rights to distribute Deep TMS in Mexico.

 

“At least 15 million Mexicans suffer from a mental illness, many of whom do not have access to quality care,” said David Zacut, chief executive officer of Brainsway. “Our technology has been well-received globally, and we are confident that together with Moksha8 we will be able to provide hope to the people of Mexico.”

 

Brainsway joins Mexico through an exclusive distribution deal with moksha8

December 8th, 2015

 

Brainsway LTD (TASE: BRIN), leader in non-invasive brain stimulation, is pleased to announce a new alliance with moksha8, a leading company in the marketing of medicines for the CNS in Latin America, for the exclusive distribution of Transcranial Magnetic Stimulation Deep in Mexico. Moksha8 intends to register and start the marketing of several Deep EMT devices in 2016 and has already committed to launch 10 devices in the next 12 months.

 

“Brainsway is excited to announce this new alliance. I am sure that with Brainsway technology and the presence of moksha8 in the Mexican market, we will have a great success opening a new horizon for Deep EMT technology. We hope to be able to make the treatment affordable for the majority of patients suffering from major depression in Mexico, who are desperately seeking new solutions. The agreement reflects Brainsway’s strategy to expand its facilities, “said Dr. Guy Ezekiel, President and CEO of Brainsway.

 

Mexico is a highly promising market for Brainsway Deep EMT, since no other EMT device has been approved in this country. Under this agreement, moksha8 will promote registration, medical education and in-sales activities related to Deep EMT in Mexico.

 

“We are excited to bring the Deep EMT to Mexico. It is a perfect complement to our portfolio of CNS drugs, since the need for an effective and non-invasive solution for patients with depression is enormous, “said Joel Barlan, CEO of moksha8. “Brainsway technology is an innovative solution eagerly awaited.”

 

About Brainsway

 

Braisnway is a leading company dedicated to the development of treatments for brain disorders. Brainsway Deep TMS (Transcranial Magnetic Stimulation) effectively treats non-invasive depression, avoiding side effects, and is effective for patients resistant to treatment of depression. Brainsway’s technology was approved by the FDA for the treatment of patients with depression who did not respond to several pharmacological treatments in the depressive episode. Brainsway Deep EMT was enthusiastically received by the international academic community, with 60 clinical trials in various institutions globally. For more information, please visit www.brainsway.com

 

Forest Laboratories and moksha8 Form Broad Strategic Alliance for Latin America

October 22th, 2012

 

Forest Laboratories, Inc.(NYSE: FRX), an international pharmaceutical company, and moksha8, a leader in the commercialization of CNS medicines in Latin America, today announced that they have entered into a broad strategic alliance that will provide Forest with a commercial footprint in Latin America and give moksha8 access to Viibryd® and potentially other Forest products for the Latin American market.

 

The alliance includes an exclusive license from Forest to moksha8 to commercialize Viibryd®, and potentially other Forest products, in Latin America. In addition, Forest will provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals. At the conclusion of this two-year period, Forest will have the option to acquire moksha8 in a merger transaction. The moksha8 shareholders will also have a put option at such time, provided that moksha8 has achieved certain business objectives.

 

In connection with the alliance, moksha8 has expanded its license arrangement with Watson Pharmaceuticals, Inc. (NYSE: WPI), to extend moksha8’s rights to commercialize a portfolio of Watson CNS branded generic products in Brazil and Mexico and has bought out Watson’s minority equity position in moksha8. Other financial terms were not disclosed.

 

David Solomon, Senior Vice President of Corporate Development and Strategic Planning of Forest Laboratories Inc. said, “We are pleased to enter into this transaction with moksha8, which provides Forest access in a risk controlled manner to a high quality commercial operation in Latin America, one of the largest and fastest growing pharmaceutical markets in the world. Moksha8 is uniquely positioned to commercialize novel products such as Viibryd® in Latin America, and Forest will augment the moksha8 pipeline through our broad global partner network and business development reach. This alliance will in time contribute important incremental profits and growth to Forest and is consistent with Forest’s strategy to improve returns on our product investments through fiscally responsible international expansion. We are also pleased with the agreement between moksha8 and Watson, as Watson’s high quality branded generic products are complementary to Viibryd® and the other novel brands Forest expects to provide to moksha8.”

 

The CEO of moksha8 said “Forest has built one of the strongest proprietary drug pipelines in the industry and we are excited to partner with Forest to commercialize these products in the fast growth markets of Latin America. We are also very pleased to build on our successful partnership with Watson, which has one of the strongest branded generics portfolios in the industry and with whom we have rapidly become a market leader in the area of branded generic CNS medicines in Brazil.”

 

Fred Wilkinson, President Global Brands and Biosimilars of Watson said “We are pleased to be able to expand on our successful partnership with moksha8 in commercializing branded generic CNS products in Brazil and Mexico. We are also pleased with the alliance between moksha8 and Forest which will provide moksha8 with novel brands that are complementary to our branded generic CNS products.” Today, the Latin America pharmaceutical market is USD $67 billion with a CAGR of over 14% over the last 5 years. Brazil ad Mexico account for two thirds of the Latin America market value. The CNS market in Latin America is estimated to be approximately USD $6 billion.

 

About Viibryd®

 

Viibryd® is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd® was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd® is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd® antidepressant effect are unknown. Viibryd® is not yet approved in Brazil or Mexico and regulatory submission of Viibryd® in these countries is expected in Forest’s next fiscal year.

 

Forest will manufacture and supply Viibryd® to moksha8, under its license from Merck-Serono, and moksha8 will have exclusive rights to market, sell and distribute Viibryd® in Latin America.

 

About Forest Laboratories

 

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

 

moksha8 and Watson Pharmaceuticals launch Kitapen® for schizophrenia and bipolar disease.

April 11th, 2011

 

Six months after establishing a partnership to commercialize high quality branded generics in Latin America, moksha8 and U.S. generics leader Watson Pharmaceuticals, have launched Kitapen®, the first and only branded generic of quetiapine available in the Brazilian market. The drug was approved by ANVISA for the treatment of schizophrenia and bipolar disorder.

 

The launch of Kitapen® strengthens moksha8’s leadership position in the commercialization of high quality CNS medicines in Latin America. “This partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders, including depression, anxiety, bipolar and schizophrenia,” stated moksha8’s CEO.

 

Kitapen® is classified as a branded generic product with demonstrated bioequivalence to the reference compound quetiapine and is more affordable for patients. Bioequivalence studies are designed to demonstrate that the generic product has the same efficacy, safety and quality as the reference product. Kitapen® is priced at approximately 50% of the price of the reference product and is manufactured in Canada where it is also approved and marketed for the treatment of schizophrenia and bipolar disorder.

 

“Drug therapy has a fundamental function in controlling both diseases and is crucial to restore quality of life of these patients. For most of them, this treatment, combined with psychosocial strategies, allows the reintegration into family, society and work,” says Dr. L. Alcioly T. Lacey, one of the founders of the Synapse Institute of Clinical Neurosciences. Several studies, for example, show that 50% of schizophrenic patients are hospitalized only once, and in 60% of these cases, with an appropriate treatment, they are able to achieve a social and professional reintegration.

 

In addition to Kitapen®, under its alliance with Watson, moksha8 currently commercializes Carbolim® (lithium) to treat bipolar disorder, Vicodil® (paracetamol and codeine) for moderate to severe pain and Fatig®, a multi-vitamin. Moksha8 is planning to launch three to four additional products in Brazil in 2011. These anticipated product launches will be high-quality affordable medicines to address significant mental health indications affecting a growing number of Brazilians, such as Alzheimer’s disease, bipolar disorder, schizophrenia and depression.

 

Schizophrenia and bipolar disorder affect over 2 million people in Brazil. Throughout the country, over 23 million people suffer from some kind of mental disorder. Providing safe effective medicines at an affordable price may help improve the lives of millions of people that would not otherwise be able to positively contribute to society.

 

Kitapen® (quetiapine) is part of a drug group known as atypical or second generation antipsychotics, which have a better tolerability (fewer side effects) compared to first-generation antipsychotics. Quetiapine is used to treat the symptoms of schizophrenia and is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine works by changing the activity of certain natural substances in the brain.

 

Watson, moksha8 Form Marketing Partnership for Brazil and Mexico.

October 4th, 2010

 

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Moksha8, based in Sao Paulo, Brazil, today announced that they have entered into an agreement that will expand Watson’s commercial presence in Latin America’s two largest markets, Brazil and Mexico.

 

“This unique partnership further demonstrates our commitment to expand our global footprint through creative business solutions that maximize the commercial opportunities for our current portfolio of brands and branded generics, establish the foundation for future growth in high value and expanding markets, and creates immediate value for both partners,” said Paul Bisaro, Watson’s President and Chief Executive Officer.

 

“The management team of Moksha8, has a proven track record of effectively commercializing products within the brand and branded generic markets of Mexico and Brazil. This agreement, which provides Watson with an initial equity position, enables us to help fund Moksha8’s expansion and to share in their continued success. The partnership complements Watson’s existing commercial operations in Brazil, while establishing an expanded longer-term strategy to grow our presence in Brazil, establish our presence in Mexico and develop a pan- Latin American growth strategy,” Bisaro continued.

 

“The addition of Watson to our current business expands our existing portfolio and pipeline of high quality products for the Latin America market,”” said the Chief Executive Officer of Moksha8. “Further, this partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders including depression, anxiety and schizophrenia.”

 

Watson will manufacture and supply select products to Moksha8, which will have exclusive rights to market, sell and distribute these products in Brazil and Mexico. Moksha8 and Watson have initially identified approximately one dozen product candidates, with the opportunity to expand the commercialization and marketing agreement to include additional products in the future. Watson will continue to own all marketing authorizations, and Moksha8 will be responsible for sales, marketing and commercialization expenses.

 

moksha8 and BioCryst Gain Approval for the Importation and Use of Peramivir in Mexico for the Treatment of H1N1 Influenza

January 13th, 2010

 

moksha8 and BioCryst today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) antiviral that is currently available under an Emergency Use Authorization in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.

 

“Rapidly bringing important novel products to patients in need in Mexico and Brazil is core to our vision,” said the Head of moksha8 in Mexico. “The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government’s commitment to public health. We look forward to bringing this potentially life saving drug to as many patients as possible.”

 

“We are pleased that the Mexican government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. “The relationship between BioCryst and moksha8, established only three months ago, is producing the near-term results we desired. We are prepared to respond to any peramivir order we may receive under this authorization from Mexico.”

 

“Peramivir is an important part of our influenza preparedness program,” said Miguel Angel Toscana, Federal Commissioner of COFEPRIS (Mexico’s Federal Commission for the Protection against Sanitary Risk). “Approval of peramivir importation will help our mission of protecting our nation.”

 

The 2009 H1N1 influenza A virus is a new influenza virus and one to which most people have no or little immunity and, therefore, this virus could cause more infections than are seen with seasonal flu. The severity of the disease ranges from very mild symptoms to severe illnesses that can result in death.

 

About Peramivir

 

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in over 1800 patients with complicated and uncomplicated influenza. In November 2009, Shionogi & Co., Ltd. filed for regulatory approval in Japan.

 

About BioCryst

 

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company’s Web site at www.biocryst.com.

 

moksha8 Expands Alliance with Roche to Commercialize $200 Million of Products in Brazil and Mexico

May 20th, 2009

 

moksha8, Inc. announced today that it has expanded its strategic partnership with Roche to commercialize an additional portfolio of products in Mexico currently generating sales of $140 million USD. moksha8 will commercialize products in three therapeutic areas, CNS disease, anti-infectives, and inflammation. The product portfolio consists of well-known brands including Rivotril®, Rocephin® and Bactrim®

 

“moksha8 has produced strong results for Roche in Brazil and we are delighted to expand our relationship to include Mexico as a key country in Latin America” said Ernest Egli, President of Roche Latin America. “moksha8 brings strong commercial capabilities and innovative marketing to our CNS, anti-infectives and inflammation franchises. We look forward to continuing this valuable relationship.”

 

“moksha8 has established a broad footprint in Latin America with leading products that are cornerstones of medical care,”” said the CEO of moksha8. “We look forward to continuing our strong relationship with Roche and driving value from this important portfolio of products. We are now firmly positioned as the leading partner of choice for pharmaceutical and biotechnology companies looking to generate value across Latin America.”

 

In just over a year, moksha8 has grown its commercial organization to over 200 employees in Brazil and Mexico and a portfolio of products with sales of $200 million USD. moksha8 is uniquely positioned as the leading specialty pharmaceutical company in Latin America with a strong presence in CNS, anti-infectives and inflammation.

 

moksha8 Launches Broad Product Portfolio in Key Emerging Markets, Strategic Alliances with Roche and Pfizer Provide Portfolio of Over 20 Products

April 16th, 2008

 

moksha8, Inc. announced today strategic partnerships with Roche and Pfizer, the launch of over twenty products and establishment of its Latin America headquarters in Sao Paulo, Brazil. moksha8 is committed to providing the highest quality medicine to the fastest growing markets of the world, with an initial focus on Asia, Latin America and Eastern Europe.

 

In February 2008, moksha8 established strategic alliances with Roche and Pfizer in four therapeutic areas, CNS disease, anti-infectives, cardiovascular disease and pain management. The initial Roche and Pfizer portfolios consist of more than 20 products, including Neurontin®, Lexotan®, Zoloft®, and Bactrim®

 

moksha8 has established its Latin American headquarters in Sao Paulo, Brazil and has built a fully integrated sales and marketing team to drive the launch and commercialization of this comprehensive first line of products. Current annual sales of these products in Brazil are estimated to be over $80 million USD.

 

NEWS ARCHIVE 2016 - 2008

 

moksha8 entered an exclusive distribution and marketing agreement in Mexico for VESANOID® a CHEPLAPHARM product
September 14th, 2016

 

moksha8 and CHEPLAPHARM, a family owned pharmaceutical company based in Germany, have recently stepped up their relationship, signing a licensing deal that will see moksha8 take responsibility for the import, distribution, marketing and sale of VESANOID® in Mexico.

 

VESANOID® contains the ingredient Tretinoin and is applied in the treatment of a special form of leukemia, the Acute Promyelocytic Leukemia (APL) which is a subtype of the Acute Myeloid Leukemia (AML)

 

moksha8 Attains Brainsway Regulatory Approval for Marketing Deep TMS in Mexico

September 20th, 2016

 

Brainsway Ltd. (TASE:BRIN), the leader in the development of advanced noninvasive treatments for brain disorders, announced that it has received local regulatory approval for the marketing and distribution of Brainsway Deep TMS (Transcranial Magnetic Stimulation) in Mexico. The company entered an exclusive distribution and marketing agreement with Moksha8, a leading specialty pharmaceutical company in Latin America, who has exclusive rights to distribute Deep TMS in Mexico.

 

“At least 15 million Mexicans suffer from a mental illness, many of whom do not have access to quality care,” said David Zacut, chief executive officer of Brainsway. “Our technology has been well-received globally, and we are confident that together with Moksha8 we will be able to provide hope to the people of Mexico.”

 

Brainsway joins Mexico through an exclusive distribution deal with moksha8

December 8th, 2015

 

Brainsway LTD (TASE: BRIN), leader in non-invasive brain stimulation, is pleased to announce a new alliance with moksha8, a leading company in the marketing of medicines for the CNS in Latin America, for the exclusive distribution of Transcranial Magnetic Stimulation Deep in Mexico. Moksha8 intends to register and start the marketing of several Deep EMT devices in 2016 and has already committed to launch 10 devices in the next 12 months.

 

“Brainsway is excited to announce this new alliance. I am sure that with Brainsway technology and the presence of moksha8 in the Mexican market, we will have a great success opening a new horizon for Deep EMT technology. We hope to be able to make the treatment affordable for the majority of patients suffering from major depression in Mexico, who are desperately seeking new solutions. The agreement reflects Brainsway’s strategy to expand its facilities, “said Dr. Guy Ezekiel, President and CEO of Brainsway.

 

Mexico is a highly promising market for Brainsway Deep EMT, since no other EMT device has been approved in this country. Under this agreement, moksha8 will promote registration, medical education and in-sales activities related to Deep EMT in Mexico.

 

“We are excited to bring the Deep EMT to Mexico. It is a perfect complement to our portfolio of CNS drugs, since the need for an effective and non-invasive solution for patients with depression is enormous, “said Joel Barlan, CEO of moksha8. “Brainsway technology is an innovative solution eagerly awaited.”

 

About Brainsway

 

Braisnway is a leading company dedicated to the development of treatments for brain disorders. Brainsway Deep TMS (Transcranial Magnetic Stimulation) effectively treats non-invasive depression, avoiding side effects, and is effective for patients resistant to treatment of depression. Brainsway’s technology was approved by the FDA for the treatment of patients with depression who did not respond to several pharmacological treatments in the depressive episode. Brainsway Deep EMT was enthusiastically received by the international academic community, with 60 clinical trials in various institutions globally. For more information, please visit www.brainsway.com

 

Forest Laboratories and moksha8 Form Broad Strategic Alliance for Latin America

October 22th, 2012

 

Forest Laboratories, Inc.(NYSE: FRX), an international pharmaceutical company, and moksha8, a leader in the commercialization of CNS medicines in Latin America, today announced that they have entered into a broad strategic alliance that will provide Forest with a commercial footprint in Latin America and give moksha8 access to Viibryd® and potentially other Forest products for the Latin American market.

 

The alliance includes an exclusive license from Forest to moksha8 to commercialize Viibryd®, and potentially other Forest products, in Latin America. In addition, Forest will provide up to $125 million in financing to moksha8 in several tranches over a two-year period, conditioned upon moksha8 achieving certain business goals. At the conclusion of this two-year period, Forest will have the option to acquire moksha8 in a merger transaction. The moksha8 shareholders will also have a put option at such time, provided that moksha8 has achieved certain business objectives.

 

In connection with the alliance, moksha8 has expanded its license arrangement with Watson Pharmaceuticals, Inc. (NYSE: WPI), to extend moksha8’s rights to commercialize a portfolio of Watson CNS branded generic products in Brazil and Mexico and has bought out Watson’s minority equity position in moksha8. Other financial terms were not disclosed.

 

David Solomon, Senior Vice President of Corporate Development and Strategic Planning of Forest Laboratories Inc. said, “We are pleased to enter into this transaction with moksha8, which provides Forest access in a risk controlled manner to a high quality commercial operation in Latin America, one of the largest and fastest growing pharmaceutical markets in the world. Moksha8 is uniquely positioned to commercialize novel products such as Viibryd® in Latin America, and Forest will augment the moksha8 pipeline through our broad global partner network and business development reach. This alliance will in time contribute important incremental profits and growth to Forest and is consistent with Forest’s strategy to improve returns on our product investments through fiscally responsible international expansion. We are also pleased with the agreement between moksha8 and Watson, as Watson’s high quality branded generic products are complementary to Viibryd® and the other novel brands Forest expects to provide to moksha8.”

 

The CEO of moksha8 said “Forest has built one of the strongest proprietary drug pipelines in the industry and we are excited to partner with Forest to commercialize these products in the fast growth markets of Latin America. We are also very pleased to build on our successful partnership with Watson, which has one of the strongest branded generics portfolios in the industry and with whom we have rapidly become a market leader in the area of branded generic CNS medicines in Brazil.”

 

Fred Wilkinson, President Global Brands and Biosimilars of Watson said “We are pleased to be able to expand on our successful partnership with moksha8 in commercializing branded generic CNS products in Brazil and Mexico. We are also pleased with the alliance between moksha8 and Forest which will provide moksha8 with novel brands that are complementary to our branded generic CNS products.” Today, the Latin America pharmaceutical market is USD $67 billion with a CAGR of over 14% over the last 5 years. Brazil ad Mexico account for two thirds of the Latin America market value. The CNS market in Latin America is estimated to be approximately USD $6 billion.

 

About Viibryd®

 

Viibryd® is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd® was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd® is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd® antidepressant effect are unknown. Viibryd® is not yet approved in Brazil or Mexico and regulatory submission of Viibryd® in these countries is expected in Forest’s next fiscal year.

 

Forest will manufacture and supply Viibryd® to moksha8, under its license from Merck-Serono, and moksha8 will have exclusive rights to market, sell and distribute Viibryd® in Latin America.

 

About Forest Laboratories

 

Forest Laboratories’ (NYSE: FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States have yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective, respiratory, gastrointestinal and pain management medicine. Forest’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more, visit www.FRX.com.

 

moksha8 and Watson Pharmaceuticals launch Kitapen® for schizophrenia and bipolar disease.

April 11th, 2011

 

Six months after establishing a partnership to commercialize high quality branded generics in Latin America, moksha8 and U.S. generics leader Watson Pharmaceuticals, have launched Kitapen®, the first and only branded generic of quetiapine available in the Brazilian market. The drug was approved by ANVISA for the treatment of schizophrenia and bipolar disorder.

 

The launch of Kitapen® strengthens moksha8’s leadership position in the commercialization of high quality CNS medicines in Latin America. “This partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders, including depression, anxiety, bipolar and schizophrenia,” stated moksha8’s CEO.

 

Kitapen® is classified as a branded generic product with demonstrated bioequivalence to the reference compound quetiapine and is more affordable for patients. Bioequivalence studies are designed to demonstrate that the generic product has the same efficacy, safety and quality as the reference product. Kitapen® is priced at approximately 50% of the price of the reference product and is manufactured in Canada where it is also approved and marketed for the treatment of schizophrenia and bipolar disorder.

 

“Drug therapy has a fundamental function in controlling both diseases and is crucial to restore quality of life of these patients. For most of them, this treatment, combined with psychosocial strategies, allows the reintegration into family, society and work,” says Dr. L. Alcioly T. Lacey, one of the founders of the Synapse Institute of Clinical Neurosciences. Several studies, for example, show that 50% of schizophrenic patients are hospitalized only once, and in 60% of these cases, with an appropriate treatment, they are able to achieve a social and professional reintegration.

 

In addition to Kitapen®, under its alliance with Watson, moksha8 currently commercializes Carbolim® (lithium) to treat bipolar disorder, Vicodil® (paracetamol and codeine) for moderate to severe pain and Fatig®, a multi-vitamin. Moksha8 is planning to launch three to four additional products in Brazil in 2011. These anticipated product launches will be high-quality affordable medicines to address significant mental health indications affecting a growing number of Brazilians, such as Alzheimer’s disease, bipolar disorder, schizophrenia and depression.

 

Schizophrenia and bipolar disorder affect over 2 million people in Brazil. Throughout the country, over 23 million people suffer from some kind of mental disorder. Providing safe effective medicines at an affordable price may help improve the lives of millions of people that would not otherwise be able to positively contribute to society.

 

Kitapen® (quetiapine) is part of a drug group known as atypical or second generation antipsychotics, which have a better tolerability (fewer side effects) compared to first-generation antipsychotics. Quetiapine is used to treat the symptoms of schizophrenia and is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine works by changing the activity of certain natural substances in the brain.

 

Watson, moksha8 Form Marketing Partnership for Brazil and Mexico.

October 4th, 2010

 

Watson Pharmaceuticals, Inc. (NYSE: WPI) and Moksha8, based in Sao Paulo, Brazil, today announced that they have entered into an agreement that will expand Watson’s commercial presence in Latin America’s two largest markets, Brazil and Mexico.

 

“This unique partnership further demonstrates our commitment to expand our global footprint through creative business solutions that maximize the commercial opportunities for our current portfolio of brands and branded generics, establish the foundation for future growth in high value and expanding markets, and creates immediate value for both partners,” said Paul Bisaro, Watson’s President and Chief Executive Officer.

 

“The management team of Moksha8, has a proven track record of effectively commercializing products within the brand and branded generic markets of Mexico and Brazil. This agreement, which provides Watson with an initial equity position, enables us to help fund Moksha8’s expansion and to share in their continued success. The partnership complements Watson’s existing commercial operations in Brazil, while establishing an expanded longer-term strategy to grow our presence in Brazil, establish our presence in Mexico and develop a pan- Latin American growth strategy,” Bisaro continued.

 

“The addition of Watson to our current business expands our existing portfolio and pipeline of high quality products for the Latin America market,”” said the Chief Executive Officer of Moksha8. “Further, this partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders including depression, anxiety and schizophrenia.”

 

Watson will manufacture and supply select products to Moksha8, which will have exclusive rights to market, sell and distribute these products in Brazil and Mexico. Moksha8 and Watson have initially identified approximately one dozen product candidates, with the opportunity to expand the commercialization and marketing agreement to include additional products in the future. Watson will continue to own all marketing authorizations, and Moksha8 will be responsible for sales, marketing and commercialization expenses.

 

moksha8 and BioCryst Gain Approval for the Importation and Use of Peramivir in Mexico for the Treatment of H1N1 Influenza

January 13th, 2010

 

moksha8 and BioCryst today announced that moksha8 has been granted approval from COFEPRIS (The Federal Commission for the Protection against Sanitary Risk) in Mexico for the importation and use of peramivir in patients with influenza associated with the 2009 H1N1 influenza A strain. moksha8 has also filed for regulatory approval of peramivir in Brazil. Peramivir is the only intravenous (i.v.) antiviral that is currently available under an Emergency Use Authorization in the U.S. in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza A infection who are admitted to a hospital.

 

“Rapidly bringing important novel products to patients in need in Mexico and Brazil is core to our vision,” said the Head of moksha8 in Mexico. “The rapid approval of peramivir for importation and use is a strong validation of the Mexican Government’s commitment to public health. We look forward to bringing this potentially life saving drug to as many patients as possible.”

 

“We are pleased that the Mexican government has authorized the use of peramivir to treat its citizens who are infected with 2009 H1N1 influenza A,” said Jon P. Stonehouse, President and Chief Executive Officer of BioCryst Pharmaceuticals. “The relationship between BioCryst and moksha8, established only three months ago, is producing the near-term results we desired. We are prepared to respond to any peramivir order we may receive under this authorization from Mexico.”

 

“Peramivir is an important part of our influenza preparedness program,” said Miguel Angel Toscana, Federal Commissioner of COFEPRIS (Mexico’s Federal Commission for the Protection against Sanitary Risk). “Approval of peramivir importation will help our mission of protecting our nation.”

 

The 2009 H1N1 influenza A virus is a new influenza virus and one to which most people have no or little immunity and, therefore, this virus could cause more infections than are seen with seasonal flu. The severity of the disease ranges from very mild symptoms to severe illnesses that can result in death.

 

About Peramivir

 

Peramivir is an anti-viral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in over 1800 patients with complicated and uncomplicated influenza. In November 2009, Shionogi & Co., Ltd. filed for regulatory approval in Japan.

 

About BioCryst

 

BioCryst Pharmaceuticals designs, optimizes and develops novel small-molecule pharmaceuticals that block key enzymes involved in infectious diseases, cancer and inflammatory diseases. BioCryst has progressed two novel compounds into late-stage pivotal clinical trials; peramivir, an anti-viral for influenza, and forodesine, a purine nucleoside phosphorylase (PNP) inhibitor for cutaneous T-cell lymphoma (CTCL). Utilizing crystallography and structure-based drug design, BioCryst continues to discover additional compounds and to progress others through pre-clinical and early development to address the unmet medical needs of patients and physicians. For more information, please visit the Company’s Web site at www.biocryst.com.

 

moksha8 Expands Alliance with Roche to Commercialize $200 Million of Products in Brazil and Mexico

May 20th, 2009

 

moksha8, Inc. announced today that it has expanded its strategic partnership with Roche to commercialize an additional portfolio of products in Mexico currently generating sales of $140 million USD. moksha8 will commercialize products in three therapeutic areas, CNS disease, anti-infectives, and inflammation. The product portfolio consists of well-known brands including Rivotril®, Rocephin® and Bactrim®

 

“moksha8 has produced strong results for Roche in Brazil and we are delighted to expand our relationship to include Mexico as a key country in Latin America” said Ernest Egli, President of Roche Latin America. “moksha8 brings strong commercial capabilities and innovative marketing to our CNS, anti-infectives and inflammation franchises. We look forward to continuing this valuable relationship.”

 

“moksha8 has established a broad footprint in Latin America with leading products that are cornerstones of medical care,”” said the CEO of moksha8. “We look forward to continuing our strong relationship with Roche and driving value from this important portfolio of products. We are now firmly positioned as the leading partner of choice for pharmaceutical and biotechnology companies looking to generate value across Latin America.”

 

In just over a year, moksha8 has grown its commercial organization to over 200 employees in Brazil and Mexico and a portfolio of products with sales of $200 million USD. moksha8 is uniquely positioned as the leading specialty pharmaceutical company in Latin America with a strong presence in CNS, anti-infectives and inflammation.

 

moksha8 Launches Broad Product Portfolio in Key Emerging Markets, Strategic Alliances with Roche and Pfizer Provide Portfolio of Over 20 Products

April 16th, 2008

 

moksha8, Inc. announced today strategic partnerships with Roche and Pfizer, the launch of over twenty products and establishment of its Latin America headquarters in Sao Paulo, Brazil. moksha8 is committed to providing the highest quality medicine to the fastest growing markets of the world, with an initial focus on Asia, Latin America and Eastern Europe.

 

In February 2008, moksha8 established strategic alliances with Roche and Pfizer in four therapeutic areas, CNS disease, anti-infectives, cardiovascular disease and pain management. The initial Roche and Pfizer portfolios consist of more than 20 products, including Neurontin®, Lexotan®, Zoloft®, and Bactrim®

 

moksha8 has established its Latin American headquarters in Sao Paulo, Brazil and has built a fully integrated sales and marketing team to drive the launch and commercialization of this comprehensive first line of products. Current annual sales of these products in Brazil are estimated to be over $80 million USD.

 

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