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Santarus, Inc. (Nasdaq: SNTS) $3.17, and Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
The safety and efficacy of RHUCIN for the treatment of HAE attacks were evaluated in two randomized placebo-controlled studies and are supported by four open label treatment studies. Both placebo-controlled clinical studies showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms at RHUCIN dosage strengths of 50 U/kg and 100 U/kg compared to placebo. In October 2010, Pharming received Marketing Authorization for RUCONEST™ (RHUCIN in non-European countries) for the treatment of acute HAE in the European Union. Pharming has updated the clinical dataset reviewed and approved by the European Medicines Agency with additional patient data and analyses. In total, the BLA dossier includes nine clinical studies covering 714 administrations in 190 subjects.
What They Do: Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists.
MannKind Corporation (Nasdaq: MNKD) $7.97. Today announced that it was informed on December 27, 2010 by the U.S. Food & Drug Administration (FDA) that the agency will not be able to complete the review of the New Drug Application (NDA) for AFREZZA (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. The FDA stated that it will require approximately four additional weeks to complete its review of the NDA.
What They Do: MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer.
Sinovac Biotech Ltd. (Nasdaq: SVA) $4.50. Today announcedannounced that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). According to the approval document, Sinovac is required to conduct each phase of the human clinical trials in accordance with SFDA requirements, to conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and to conduct efficacy study in the phase III clinical trial. Sinovac filed in late December 2009 with the SFDA the application to commence human clinical trials for its inactivated EV71 vaccine.
What They Do: Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza.
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