MEXICO CITY and BIRMINGHAM, Ala., Jan. 12 /PRNewswire-FirstCall/ -- 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 Ayse Kocak, 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.
In September 2009, moksha8 signed a binding letter of intent to exclusively represent BioCryst and its anti-viral peramivir for influenza stockpiling opportunities, as well as for marketing and distribution of peramivir for seasonal influenza upon local regulatory approval, in certain Latin American countries, including Brazil and Mexico.
moksha8 also announced that it has raised $25 million in a Series C financing led by Montreux Equity Partners. Existing investor TPG Biotechnology and CEO, Simba Gill, also participated in the financing.
moksha8 has established broad commercial operations in Mexico and Brazil, the two largest pharmaceutical markets in Latin America. Together they represent 75% of a $30 billion market in Latin America. The Company is currently commercializing approximately $200 million of products in the infections disease, central nervous system and inflammation therapeutic areas under partnerships with Roche and Pfizer. Products in the Company's portfolio include key brands such as Rocephin®, Bactrim®, Lexotan®, Rivotril® as well as UnaSyn® and Vibramycin®.
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.
moksha8 was founded in December 2006 by Simba Gill and TPG Biotechnology, and has raised significant financing from top-tier private equity and venture capital firms, including TPG Biotechnology, Montreux Equity Partners and Votorantim Novos Negocios, the venture capital and private equity arm of Votorantim, one of Brazil's largest privately held conglomerates. moksha8 is uniquely positioned as the partner of choice for both pharmaceutical and biotechnology companies seeking to capture value from their products in high growth emerging markets. moksha8 has established commercial operations in key geographies in Latin America including Sao Paulo and Mexico City. moksha8 provides the highest quality medicines to the fastest growing markets of the world.
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.