• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said a preliminary analysis of the virologic data from a Phase II trial indicated that intramuscular peramivir demonstrated statistically significant reductions in influenza virus shedding in both active treatment groups when compared with placebo, with greater reductions in the 300-mg group (p<0.001). Based on the clinical results and virologic data, the firm said it believes that a single intramuscular dose of 300-mg peramivir, an antiviral agent that inhibits influenza viral neuraminidase, an enzyme essential for the spread of influenza virus within the host, can be a potentially clinically effective dose. BioCryst said it is planning to initiate a Phase II clinical trial that will evaluate the 300-mg dose and a higher dose of peramivir later this year. The firm said that it will not continue to pursue a pivotal Phase III program for intramuscular peramivir in the current influenza season. The company noted that the key elements of its $102.6 million contract with the Department of Health and Human Services remain the same, but the development plan for peramivir has changed from that outlined in its original proposal. HHS has indicated that it will fund certain elements of the revised program, including the ongoing Phase II I.V. study in hospitalized subjects, planning and conduct of the planned Phase II intramuscular study, manufacturing and toxicology, the firm said.
• BioSeek Inc., of Burlingame, Calif., said it has partnered with Dainippon Sumitomo Pharma Co., of Japan, to develop drug candidates to treat inflammation and metabolic disorders. Under the collaboration, BioSeek will apply its BioMAP systems, a series of human primary cell-based assay systems designed to replicate the intricate cell and pathway interactions present in human disease biology, to support compound differentiation, lead development and drug candidate selection activities for DSP's discovery programs in inflammation and metabolic diseases.
• Cangene Corp., of Toronto, said the FDA approved Accretropin (somatropin [rDNA origin] injection, its recombinant human growth hormone, for treating pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone or treatment of short stature associated with Turner syndrome in pediatric patients whose epiphyses are not closed. Accretropin was submitted as a 505(b) application. The product was developed in collaboration with Apotex Group, of Weston, Ontario, Cangene's majority shareholder, and Apotex retains marketing rights.
• Celgene International Sarl, of Boudry, Switzerland, said the European Committee for Medicinal Products for Human Use issued a negative opinion for Lenalidomide for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a 5q deletion. Celgene said the CHMP concluded that the drug had shown efficacy in that patient group, but was not convinced that the safety data were sufficient. The company plans to apply for a re-examination of the CHMP opinion in accordance with EMEA procedures. In Canada, the drug gained conditional marketing approval for patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with the 5q deletion. Revlimid (lenalidomide) previously gained FDA approval in that same indication. Celgene also reported that, in Australia, Revlimid received marketing approval for use in combination with dexamethasone in multiple myeloma patients whose diseases have progressed after one therapy.
• Cephalon Inc., of Frazer, Pa., said the European Committee for Medicinal Products for Human Use issued a positive opinion regarding Effentora, the company's fentanyl buccal tablet pain medication. The company submitted the application in March for breakthrough pain in adult cancer patients who are receiving maintenance opioid therapy for chronic cancer pain. The CHMP recommendation will be forwarded to the European Commission for final marketing approval, expected to occur within two to three months.
• Clinical Data Inc., of Newton, Mass., and Affymetrix Inc., of Santa Clara, Calif., have entered into a marketing agreement for a new drug metabolism service using the Affymetrix Drug Metabolizing Enzymes and Transporter Early Access solution. Cogenics and Epidauros Biotechnologie AG, both subsidiaries of Clinical Data Inc., will offer the DMET services globally, with limited exclusivity in Europe.
• Emergent BioSolutions, of Rockville, Md., and Ninebio Sdn. Bhd., of Putrajaya, Malaysia, have formed a joint venture in Malaysia to create a biologics infrastructure and supply biodefense countermeasures, including BioThrax (anthrax vaccine absorbed), and other medical and complementary products and services to the government of Malaysia. The venture also will seek to supply products and services to other member countries of the Organization of the Islamic Conference and other countries within Asia.
• EPIX Pharmaceuticals Inc., of Lexington, Mass., has received a $1.25 million milestone payment from Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation. The milestone stems from completion of the development of a validated model of a full-length Cystic Fibrosis Transmembrane Conductance Regulator ion channel protein. It is the fourth milestone payment under a research, development and commercialization agreement between EPIX and CFFT signed in 2005 that focuses on discovering potential drug therapies targeting the CFTR ion channel.
• Forbes Medi-Tech Inc., of Vancouver, British Columbia, has requested a hearing with Nasdaq to discuss the company's failure to maintain a $1 minimum listing price. Forbes said it is in the process of a corporate reorganization designed to regain compliance.
• Genaera Corp., of Plymouth Meeting, Pa., said preclinical data showed that four weekly treatments of trodusquemine (MSI-1436), the firm's lead drug candidate for the treatment of Type II diabetes and obesity, administered to diet-induced obese mice resulted in significant reductions in plasma insulin levels. Additionally, hyperglycemic (Ob/Ob) mice treated with weekly doses of trodusquemine for 122 days demonstrated that the significant improvements in glucose tolerance, as measured by oral glucose tolerance testing, can be sustained during long periods of therapy. Researchers concluded that the antidiabetic properties of trodusquemine, a centrally and peripherally acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B, included improved insulin sensitivity, lowering of plasma insulin levels and durable improvements in fasting blood glucose and glucose tolerance.
• GenVec Inc., of Gaithersburg, Md., has entered into a manufacturing development agreement with Cobra Biomanufacturing Plc, of Keele, UK, for TNFerade, an adenovector. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers. The agreement will cover technology transfer, scale-up and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra's facility in Oxford, UK.
• Geron Corp., of Menlo Park, Calif., and Sienna Cancer Diagnostics, of Melbourne, Australia, have signed a licensing agreement giving Sienna access to patents and information related to the detection or measurement of telomerase activity. Under the terms of the license, Sienna gains worldwide exclusive rights within a defined field to Geron-controlled intellectual property to detect telomerase activity for the cancer in vitro diagnostics market. In exchange, Geron received an undisclosed equity interest in Sienna and is entitled to receive royalties on future product sales.
• Insmed Inc., of Richmond, Va., provided a positive update of the Iplex Expanded Access Program in Italy for the treatment of amyotrophic lateral sclerosis. The program has grown to include 15 physicians and approximately 70 subjects. Thus far, the company said, Iplex appears to be safe and well tolerated; no one has dropped out of the study for reasons related to the treatment.
• Labopharm Inc., of Laval, Quebec, said its appeal submitted through the agency's formal dispute resolution process about an approvable letter for the company's once-daily tramadol formulation was unsuccessful. However, John Jenkins, director of the FDA's Office of New Drugs, suggested that an additional statistical analysis of existing data potentially could satisfy the agency's requirements, the company said, noting that the statistical method proposed for the analysis is different from that previously requested by the FDA in its the May 2007 approvable letter. Jenkins also recommended that Labopharm meet with the agency prior to any resubmission, the firm said.
• Oculus Innovative Sciences Inc., of Petaluma, Calif., said the U.S. District Court for the Northern District of California has awarded damages of $6.6 million to Oculus Innovative Sciences, of Petaluma, Calif., and entered judgment against defendant Nofil Corp., finding Nofil liable for breach of contract and misappropriation of Oculus' intellectual property rights related to its Microcyn Technology. On Nov. 15, 2007, the court issued a permanent injunction barring Nofil from using Oculus' intellectual property and from manufacturing product using the Microcyn Technology. The court also ordered an accounting and disgorgement of profits to Oculus based on Nofil's wrongful conduct.
• PharmatrophiX Inc., of Chapel Hill, N.C., received a $300,000 founder's grant from the Alzheimer's Drug Discovery Foundation in New York for its work to develop drugs for preventing neuronal degeneration and improve brain function. The start-up firm is working on a series of small-molecule compounds called "neurotrophin mimetics," which are designed to mimic the function of neurotrophins, naturally occurring proteins that are responsible for development, health and survival of neurons.
• Pharmion Corp., of Boulder, Colo., said the European Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Thalidomide Pharmion in combination with melphalan and prednisone as a first-line treatment in untreated multiple myeloma patients who either are 65 years and older or are ineligible for high-dose chemotherapy. That opinion will be forwarded to the European Commission, which generally follows the recommendation of CHMP and is expected to issue a decision within two to three months. Pharmion, which gained rights to the drug from Summit, N.J.-based Celgene Corp., submitted the marketing application in January 2007. Thalidomide Pharmion has received orphan drug designation in the European Union for multiple myeloma, which would guarantee 10 years of marketing exclusivity upon approval.
• Quantum Genomics Corp., of Jersey City, N.J., said it is partnering with Inserm, the French national institute for health and medical research and Universities Paris Descartes and Paris XII Val-de-Marne, to co-develop QGC002, a recombinant protein, as a treatment for stroke and cardiac ischemia. Under the terms of the agreement, QGC is retaining the right to acquire the intellectual property generated by Inserm and to "exploit associated know-how," the company said. QGC will fund and conduct preclinical development and drug manufacturing, whereas Inserm's teams will handle pharmacological studies in relevant animal models of the targeted diseases. QGC is aiming to initiate a regulatory preclinical development phase in 2009, the firm noted.
• Samaritan Pharmaceuticals Inc., of Las Vegas, agreed to nonexclusively license six of its Alzheimer's drugs to CHDI Foundation Inc., a nonprofit organization aimed at discovering and developing Huntington's disease drugs, which will evaluate them over an 18-month period as possible HD therapeutics. The drugs are designed as SP-233, Sp-sc4, Sp-sc7, Sp-04, Sp-04m and Sp-08. Under the agreement, CHDI will pay for the cost of that evaluation, and Samaritan retains all rights to the compounds.
• Serenex Inc., of Durham, N.C., signed a materials cooperative research and development agreement with the National Cancer Institute to assess the company's oral, small-molecule heat-shock protein 90 (Hsp90) inhibitor, SNX-5422, in non-small-cell lung cancer. The product, which emerged from Serenex's Hsp90 platform technology, is in Phase I testing in cancer.
• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., announced that one of its new chemical entities, which is structurally unrelated to and 1,000 times more potent than resveratrol, reduces fat, boosts exercise endurance and improves insulin sensitivity in mice on a high-fat diet. Data being presented this weekend at a scientific meeting will show that mice on a high-fat diet treated with one of Sirtris' new chemical entities remained lean while consuming the same number of calories as the untreated mice. Mice on the highest dose had no weight gain over 13 weeks, and in exercise testing, ran more than 1,600 meters before tiring, while the untreated mice tired at roughly 800 meters.
• StemCells Inc., of Palo Alto, Calif., said it is collaborating with the Oregon Health & Science University (OHSU) Casey Eye Institute to evaluate HuCNS-SC (purified human neural stem cells) as a potential treatment for retinal degeneration, a leading cause of blindness. Under the partnership, the parties will evaluate engraftment and function of HuCNS-SC cells in the same rat model preparatory to planned clinical trials. The research, expected to be concluded by year-end, will be conducted at OHSU.