454 Life Sciences Corp., of Branford, Conn., a subsidiary of CuraGen Corp., announced a new method for the detection of cancer gene mutations present at extremely low levels. The research, done in collaboration with Dana Farber Cancer Center and Broad Institute, was published online in Nature Medicine. It describes how the 454 Sequencing method identifies rare cancer-associated genetic variations at the molecular level, possibly enabling the personalization of targeted therapies.
Aksys Ltd., of Lincolnshire, Ill., closed a financing with Durus Life Sciences Master Fund Ltd., which follows the $5 million bridge financing provided to the company in March. Under the financing, Aksys issued new shares of Series B preferred stock that are convertible into 5 million shares of common stock and warrants to buy 5 million shares of common stock in exchange for the cancellation of $5 million of existing subordinated promissory notes of the company held by Durus. At the closing, Durus provided about $15.9 million in senior debt to the company for a cash payment of about $1.5 million, the cancellation of about $9.3 million of existing subordinated promissory notes held by Durus and the rollover of the $5 million bridge financing into the senior debt. Durus also has made a $5 million line of credit available to Aksys. Joining the company s board are Douglass Given, Timothy Mayleben, Gretchen Piller and Leslie Lake.
ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, entered an alliance to use the molecular diagnostic services of MolecularMD Inc., of Menlo Park, Calif. The companies will work together to identify chronic myeloid leukemia patients with the T315I bcr-abl mutation who may be candidates for participation in ChemGenex s Phase II/III study of Ceflatonin. ChemGenex said T315I-expressing cells are resistant to the tyrosine kinase inhibitor Gleevec (imatinib, from Novartis AG), and patients who develop this mutation no longer respond to that treatment. In addition, preliminary data suggest that patients with the T315I point mutation also fail to respond to treatment with either of two second-generation tyrosine kinase inhibitors in clinical development.
Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, and BioSeek Inc., of Burlingame, Calif., entered a research collaboration agreement in which BioSeek will apply its BioMAP systems in an effort to characterize the mechanisms of action of the LSAIDs, Inflazyme s leukocyte selective anti-inflammatory drugs, that make up its respiratory program. Financial terms were not disclosed.
Johnson & Johnson, of New Brunswick, N.J., entered a definitive agreement to acquire Pfizer Consumer Healthcare, a unit of New York-based Pfizer Inc., for $16.6 billion in cash. J&J s board has given approval to the transaction, which is expected to close by the end of this year. Pfizer Consumer Healthcare s global business of personal care and over-the-counter products brought in $3.9 billion in sales in 2005.
Ligand Pharmaceuticals Inc., of San Diego, earned a milestone payment of an undisclosed amount because Wyeth, of Madison, N.J., filed a new drug application with the FDA for bazedoxifene, a selective estrogen receptor modulator (SERM) for postmenopausal osteoporosis therapy. Ligand is entitled to additional milestones upon regulatory submissions in other major markets, approval in the U.S. and other major markets, as well as royalty payments up to mid-single digits on net sales of bazedoxifene worldwide for any indication.
Medarex Inc., of Princeton, N.J., and Euroscreen SA, of Brussels, Belgium, completed a license and research agreement for the exclusive worldwide development and commercialization of antibody-based products against certain targets for various diseases, including inflammatory and autoimmune conditions. Medarex intends to use its UltiMAb technology to create antibodies to targets provided by Euroscreen. Medarex has rights to develop and commercialize antibody products against two undisclosed targets, and Euroscreen will receive an up-front payment and may receive milestone payments and royalties.
MorphoSys AG, of Munich, Germany, expanded its existing therapeutic antibody collaboration with Novartis AG, of Basel, Switzerland. The original collaboration provided for a three-year term with an option to extend. It now will continue through May 2011, and Novartis will have the option to receive access to the MorphoSys HuCAL GOLD library at an additional research site and will have access to certain technology for optimization of non-therapeutic antibodies. The agreement also provides for increased annual license fees. The companies signed the agreement in May 2004 to jointly develop therapeutics against a range of illnesses.
NexMed Inc., of East Windsor, N.J., said Schering AG, of Berlin, terminated its license, supply and distribution agreement for Alprox-TD, NexMed s topical treatment for erectile dysfunction. NexMed said that the product is no longer a strategic fit for Schering, which became marketing partner for Europe, Russia, the Middle East, South Africa, Australia and New Zealand in July 2004. NexMed has not received any milestone payments but is entitled to a €500,000 (US$629,046) termination fee from Schering. To date, Alprox-TD has completed two U.S. Phase III pivotal trials, involving more than 1,700 patients, and has shown statistically significant efficacy.
NovaScreen Biosciences Corp., of Hanover, Md., said it was selected by Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, to conduct a high-throughput screening campaign. The company will screen 500,000 compounds against an inflammatory target. The campaign combines NovaScreen s kinase profiling expertise with Caliper s LabChip 3000 microfluidic screening platform, which uses electrophoretic separation of assay components.
Slater Technology Fund, of Providence, R.I., said one of its portfolio companies, ProThera Biologics, was awarded $2.8 million in grants from the National Institutes of Health to pursue therapies for sepsis and anthrax intoxication. The company, which was founded in 2001, develops and commercializes integrated, protein-based therapeutics based on the natural serine protease inhibitors, called inter-alpha inhibitor proteins.
Tibotec Therapeutics, of Bridgewater, N.J., a division of Ortho Biotech Products LP, received accelerated approval from the FDA for the anti-HIV therapy Prezista (darunavir) tablets (previously called TMC114), which is designed to address treatment-resistant patients. The approval is based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the Power 1 and Power 2 studies. Longer-term data is required before the FDA can grant traditional approval. The product, which was developed by Tibotec Pharmaceuticals Ltd., of Cork, Ireland, and will be marketed by Tibotec Therapeutics, will be used in combination with other antiretroviral agents, including the fusion inhibitor Fuzeon (enfuvirtide), developed by Morrisville, N.C.-based Trimeris Inc. Data has shown that up to two-thirds of patients with extensive prior exposure to anti-HIV drugs achieved undetectable levels of virus when darunavir was used with Fuzeon, approved in March 2003. Tibotec submitted the new drug application for darunavir in December. (See BioWorld Today, Dec. 28, 2005.)