December 10, 2009 - Troy, Michigan, USA
MPR to Administer the Emergency Use of Peramivir Under Special Regulatory Approvals in Selected Countries
MPR Inc. announced to several MOH in MENA and Gulf region the availability of Peramivir to treat H1N1 flu vaccine under emergency use and special process approval. MPR, in collaboration with BioCryst Pharmaceutical Inc. and several regulatory agencies, is making the drug available for the treatment of H1N1 during the flu season.
The shipping and use of Peramivir will follow a special approval and handling process considering that the drug is still not yet approved for commercialization. Several countries in the MENA region have no special regulations regarding emergency use, however, with the assistance of medical experts and regulatory bodies in USA and other regions, the administration of the drug will be managed within special guidelines.
Also, with the approval of MOH in each country, direct orders to local hospitals or medical cities could be coordinated. MPR Inc. has initiated an awareness campaign with leading academic institutions about the drug and its use.
Peramivir is a potent, intravenously administered anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, Peramivir 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 1,800 patients with complicated and uncomplicated influenza. On October 23, 2009, BioCryst announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for i.v. Peramivir in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
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 forcutaneous 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. The company's strategic alliances with the U.S. Department of Health and Human Services, Shionogi & Co., Ltd., Green Cross Corporation and Mundipharma International Holdings Limited validate its scientific foundation and the utility of its product candidates.