DeCode Genetics, the groundbreaking Icelandic firm that sought to use the genetics of the island nation’s population to develop new diagnostics and therapeutics, said it will for bankruptcy. DeCode filed for relief under Chapter 11 of the United States Bankruptcy Code with the United States Bankruptcy Court for the District of Delaware to facilitate the sale of substantially all of its assets. The company said in recent months it explored multiple restructuring alternatives, including the sale of specific portions of its operations, the sale or license of its drug discovery programs, the restructuring of its outstanding convertible notes and the obtaining of new equity financing. As a result of these efforts, it has entered into an asset purchase agreement with Saga Investments to sell its Iceland-based subsidiary Islensk Erfdagreining, and its drug discovery and development programs. The agreement is subject to a number of contingencies, including a competitive bidding procedure and court approval in accordance with bankruptcy law.

 

Berkeley Heights, New Jersey-based Genta announced a restructuring that includes a reduction in workforce and re-ordering of clinical development priorities. The decision follows the recent release of top-line results from a late-stage clinical trail of the company’s lead compound Genasense in patients with advanced melanoma that showed the experimental drug failed to meet its primary endpoint. The restructuring has reduced the workforce by approximately 30 percent, which is estimated to reduce annualized payroll costs by approximately 25 percent. Together with other initiatives, the company estimates that reduced expenses will yield sufficient cash to continue operations into the second quarter of 2010.

 

Poinard Pharmaceuticals said a late-stage pivotal trial of its platinum-based chemotherapeutic agent picoplatin in the second-line treatment of small cell lung cancer failed to meet its primary endpoint of overall survival. The news sent shares of the South San Francisco-based company plummeting more than 75 percent. 

 

The U.S. Food and Drug Administration notified Genzyme that it would not approve its application to begin marketing Lumizyme for the treatment of the rare, progressive and debilitating muscle condition known as Pompe disease. In a complete response letter from the FDA, the agency said that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved. Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy, the product label, and post-marketing requirements, have been satisfactorily addressed. The FDA completed its five-week inspection of the Allston plant November 13, and provided the company with notification about remaining deficiencies, which are mainly related to the fill/finish capabilities at the facility.  

 

The U.S. Food and Drug Administration told Human Genome Sciences that it would not approve its application to begin marketing its monoclonal antibody treatment for inhaled anthrax without additional information it said it needed to complete its review. “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,” says Sally Bolmer, senior vice president of development and regulatory affairs for HGS. The company has delivered 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile under a contract with Biomedical Advanced Research and Development Authority or BARDA. Those doses are currently available in the stockpile for use in the event of an emergency while the company completes its discussions with the FDA. Raxibacumab represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective. Raxibacumab is a first-in-class treatment for anthrax, and the first procurement under Project BioShield of a product discovered and developed after the September 11, 2001 terrorist attacks.

 

The U.S. Food and Drug Administration notified Genentech and Biogen Idec that it would not approve their application to expand the indications for Rituxan in combination with fludarabine and cyclophosphamide to treat chronic lymphocytic leukemia, the most common adult leukemia. The FDA in its complete response letter did not request any new data to complete its review of these applications. Genentech and Biogen Idec say they will continue final label discussions with the FDA and are committed to making Rituxan in combination with FC an FDA-approved option for people with CLL. Rituxan received FDA approval for rheumatoid arthritis in February 2006 and is currently indicated in combination with methotrexate for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had inadequate response to one or more tumor necrosis factor antagonist therapies.

 

A U.S. Food and Drug Administration advisory panel said Protein Sciences experimental flu vaccine FluBlok should not be approved without additional data to prove the vaccine’s safety, Bloomberg reported. FluBlok is produced in caterpillar ovary cells in just two months. The 6-to-5 vote found the clinical trials were not large enough to establish its safety. Nevertheless, nine of the 11 members of the panels found that the Meriden, Connecticut-based company’s vaccine was as effective as licensed vaccines in adults ages 18 to 49.

 

Covidien and Neuromed Pharmaceuticals said the U.S. Food and Drug Administration has extended its expected date on a decision on whether or not to approve its application to begin marketing Exalgo (hydromorphone HCl extended-release) by three months to February 22, 2010. The delay is due to supplemental information the companies supplied to the agency, which the agency said constitutes a major amendment to the application. The companies are seeking approval for Exalgo as a once daily administration 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.

 

The U.S. Food and Drug Administration has recommended Cerus use more stringent safety margins in its late-stage trial design for its Intercept Blood System for platelets. The FDA's Blood Products Advisory Committee recommendations may require a clinical trial with a larger number of patients than Cerus had proposed. The company said it will take at least 12 months to complete the clinical trial preparations and partnering arrangements necessary for commencement of the potential trial. The proposed phase 3 clinical trial is designed as a randomized, double-blinded, non-inferiority trial to assess the hemostatic efficacy and safety of routine use of Intercept-treated platelets compared to platelets prepared with conventional processes. The proposed primary efficacy endpoint is number of days of Grade 2 bleeding, and the proposed primary safety endpoint is the incidence of acute lung injury. The Intercept Blood System for platelets is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood.

 

Brussels-based UCB said it would eliminate more than 200 jobs at sites in the United Kingdom and Belgium as part of an effort to achieve sustainable growth. As part of reorganization the company will eliminate 174 positions in its Braine-l'Alleud site in Belgium and 44 positions in its Slough site in the United Kingdom. UCB says it will adopt its NewMedicines division at both sites. It will also streamline manufacturing support services, industrial development and some administrative functions at the Braine’ l’Alleud site. UCB NewMedicines is UCB’s externally networked organization established to secure the future pipeline and deliver UCB's products of the future.