moksha8 receives approval to import and use peramivir in patients with H1N1 influenza A in Mexico

Jan 13 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 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.