Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the FDA accepted and designated for priority review the supplemental biologics license application for Tysabri (natalizumab) to treat multiple sclerosis. The sBLA includes final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with Avonex (interferon beta-1a) in multiple sclerosis, as well as an integrated safety assessment, and a revised label and risk management plan. Tysabri was pulled from the market in February based on reports of progressive multifocal leukoencephalopathy. (See BioWorld Today, March 1, 2005.)
Chiron Corp., of Emeryville, Calif., and Cubist Pharmaceuticals Inc., of Lexington, Mass., reported that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has issued a positive opinion recommending approval of Chiron's marketing authorization application for Cubicin. Cubicin is an I.V. antibiotic being evaluated by the EMEA for the treatment of complicated skin and soft-tissue infections caused by Gram-positive bacteria.
Computer Sciences Corp., of El Segundo, Calif., reported that DVC LLC, a unit of Computer Sciences, vaccinated all volunteers in a Phase I trial for its recombinant plaque vaccine candidate rF1V. The trial is evaluating safety, tolerability and immunogenicity of the plague vaccine candidate in 44 healthy volunteers between the ages of 18 and 40. Long-term safety evaluation is under way and will be completed in early 2006.
CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, updated interim Phase I data on PXD101, a small-molecule histone deacetylase inhibitor being developed for solid and hematologic tumors. Data suggest PXD101 is well tolerated following intravenous administration and might have potential antitumor activity. Results were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.
Cytokinetics Inc., of South San Francisco, said data from Phase Ib combination clinical trials and nonclinical studies of ispinesib (SB-715992) were presented at the 2005 AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia. Clinical data showed that the combination of ispinesib with docetaxel has an acceptable tolerability profile on a once-every-21-day schedule, and the combination of ispinesib and capecitabine appears to have an acceptable tolerability profile on the study's treatment schedule.
GlaxoSmithKline plc, of Research Triangle Park, N.C., and Vertex Pharmaceuticals Inc., of Cambridge, Mass., said that the FDA approved GSK's application to add clinical data to the prescribing information for Lexiva (fosamprenavir calcium), an HIV protease inhibitor. The newly added information shows that simultaneous administration of Lexiva in combination with esomeprazole does not result in lowering of blood levels for Lexiva.
Independent Research Network, of New York, appointed the first seven members to its Research Independence Council, a joint venture created by Nasdaq and Reuters in June to act as an intermediary for under-followed public companies seeking to have their equity securities covered by analysts. Members are: Stephen Balog, general partner of Cedar Creek Management in Summit, N.J.; Michael Gorin, retired vice chairman and chief financial officer of Long-Island, N.Y.-based Aeroflex Inc.; Jack Kaplan, adjunct professor of Entrepreneurial Studies at Columbia Business School; A. Michael Lipper, president of Lipper Advisory Services; David Mangum, executive vice president and chief financial officer of CheckFree Corp.; Jay Ritter, the Joe Cordell professor of finance at the University of Florida's Warrington College of Business; and Margaret Wyrwas, senior managing director of corporate communications and investor relations at Knight Capital Group, of Jersey City, N.J.
Ligand Pharmaceuticals Inc., of San Diego, said its board and management believe that, while operational actions should translate into improved shareholder value, they will initiate an external process of exploring strategic alternatives. The company has engaged UBS Investment Bank as its financial adviser in the process. The company recently filed its Form 10-K for fiscal year 2004, restating audited results for 2003 and 2002 and selected financial data for 2001 and 2000. The company develops drugs that address cancer, pain, skin diseases, hormone-related disease, osteoporosis, metabolic disorders, and cardiovascular and inflammatory diseases.
Neurochem Inc., of Montreal, closed the sale and leaseback transaction for its campus located in Laval, Quebec, including its head office and research facility, with an affiliate of Alexandria Real Estate Equities Inc. The transaction generated gross proceeds to Neurochem of C$32 million (US$26.9 million) and net proceeds of about C$22 million after repayment of the related debt in the amount of about C$9.8 million, as well as transaction expenses.
Neurologix Inc., of Fort Lee, N.J., reported findings from preclinical studies, showing that the gene XIAP (X-linked inhibitor of apoptosis) might prevent the progression of Huntington's disease. Neurologix scientists demonstrated that a mutated form of the gene delivered by an adeno-associated virus vector, introduced using standard neurosurgical techniques, improved motor deficits associated with the disease. The data were presented during the 35th annual meeting of the Society for Neuroscience in Washington.
Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said data showing that cholesterol-lowering drugs like statins were found to slow the progression of Alzheimer's disease in a three-year study conducted at the University of Lille and the University Hospital in Lille in France. Nymox holds U.S. and global patent rights for the use of statins in the prevention and treatment of Alzheimer's disease.
Reliant Pharmaceuticals Inc., of Liberty Corner, N.J., withdrew its initial public offering due to unfavorable market conditions. In May, it filed to raise $300 million in an IPO. Founded in 1999, the company is focused on cardiovascular drugs. (See BioWorld Today, May 24, 2005.)
ReNeuron Group plc, of Guildford, UK, generated provisional preclinical data indicating that its lead ReN001 cell line for stroke does not form tumors following implantation. The ability to demonstrate a lack of tumorigenicity in vivo is one of the principal safety hurdles that must be overcome before regulatory authorities will allow the company to begin human clinical trials.
Solbec Pharmaceuticals Ltd., of Perth Australia, reported receipt of a Capital Access Grant from the Western Australia Department of Industry and Resources to assist in securing further funding for Coramsine's Phase II cancer tri als. Solbec will direct the A$23,000 (US$16,841) grant funding, on a dollar-for-dollar basis, toward securing further funding for Coramsine's Phase II cancer trials.
Spectrum Pharmaceuticals Inc., of Irvine, Calif., said data from a study on SPI-1620 showed that animals treated with the drug followed by treatment with paclitaxel 15 minutes later had better efficacy when compared to control animals in terms of tumor volume, progression and complete regression. The study demonstrates that SPI-1620 could be used as a tumor selective vasodilator to enhance delivery and efficacy of paclitaxel and other chemotherapeutic agents. Results were presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.