In a press release this morning, the company claims that the lawsuit is based upon the false claim that "...defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered..." regarding the Ampligen(R) (Poly I : Poly C12U) investigational product. That claim is irrefutably false.You can read the complete press release here.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) relating to the Company’s Biologics License Application (BLA) requesting the approval of raxibacumab for use in the treatment of inhalational anthrax. The FDA issues Complete Response Letters to request additional information needed to complete the review of a BLA.
“We have responded to all of FDA’s previous questions. We plan to address the current questions as well,” said Sally D. Bolmer, Ph.D., R.A.C, Senior Vice President, Development and Regulatory Affairs, HGS. “In certain respects, the Complete Response Letter appears to be inconsistent with the FDA’s published final rule governing the development of new drugs when human efficacy studies are not ethical or feasible.”
James H. Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS, and leader of the Company’s raxibacumab program with the U.S. Government, said, “It is unfortunate that it was not possible to resolve these questions before the PDUFA date passed. However, HGS has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under our contract with BARDA, so it is currently available in the Stockpile for use in the event of an emergency while we complete our discussions with the FDA.”
Raxibacumab represents a new way to address the anthrax threat.
Bad news for Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today. The company announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.
"We are disappointed that the trial did not meet the primary endpoint. The data indicates that more patients on the best supportive care arm received chemotherapy following progression than those on the picoplatin arm, and we believe that this may have been a significant factor contributing to the trial outcome, as picoplatin appeared to demonstrate a trend toward a survival advantage. Based on these findings and other analyses, we are contacting the FDA today to request a meeting to discuss a regulatory path forward. We look forward to presenting the full SPEAR efficacy and safety data at an upcoming medical conference early next year," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We believe that the SPEAR data, coupled with efficacy and safety data from more than 1,100 cancer patients treated with picoplatin and the proof-of-concept data from our trials in colorectal, prostate and ovarian cancers, support our continued partnering effort. Our focus will be on the regulatory pathway for picoplatin, partnering activities, and realigning the use of resources for these objectives."
Novavax, Inc. (Nasdaq: NVAX) announced today that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico. An independent data and safety monitoring board has reviewed preliminary safety data from the first half of this cohort and recommended that this first stage continue as planned.
"We are encouraged by the recommendation of the data and safety monitoring board to continue the trial and plan to begin subjects' enrollment in the second phase of the study as soon as possible," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "This pivotal trial is advancing rapidly toward completion with the ability to evaluate results early next year. If our findings are positive, Novavax and our partners plan to seek immediate approval to market our VLP-based 2009 H1N1 VLP pandemic influenza vaccine in Mexico, which currently faces a critical shortage of H1N1 influenza vaccine."
The company has gone outside the country to look for ways to monetize their VLP vaccine technology after the CDC and other US regulators announced that they wanted to stay with older and proven technologies to continue making vaccines.
CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that on November 13, 2009, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate EXALGOTM (hydromorphone HCl extended release) tablets, seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA). In these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA).
