• Affinium Pharmaceuticals Inc., of Toronto, executed a two-year $4.8 million research contract with the Defense Threat Reduction Agency, a unit of the U.S. Department of Defense, to fund preclinical studies of selected compounds from Affinium's fatty acid biosynthesis inhibitor portfolio. The compounds have demonstrated potential as therapeutics to treat diseases caused by serious pathogens including Francisella tularensis, a potential biological warfare and bioterrorism agent.

• Alkermes Inc., of Cambridge, Mass., and Indevus Pharmaceuticals Inc., of Lexington, Mass, entered a joint collaboration for the development of ALKS 27, an inhaled formulation of trospium chloride, in chronic obstructive pulmonary disease (COPD). The deal follows the completion of feasibility work and preclinical studies, as well as a Phase I trial in healthy volunteers that showed, in preliminary data, that the product was well tolerated over a wide dose range. Alkermes and Indevus plan to begin a Phase IIa study in the first half of this year to evaluate ALKS 27, administered once daily, in COPD patients, and pending results, plan to engage a partner for further development. Under collaboration terms, the companies are sharing equally all costs of development and commercial returns on a worldwide basis.

• AVEO Pharmaceuticals Inc., of Cambridge, Mass., acquired an exclusive license from Tokyo-based Kirin Brewery Co. Ltd. to develop and commercialize Kirin's once-a-day, oral VEGF receptor inhibitor, KRN951, in all territories outside of Asia. KRN951 is in a 30-patient Phase I trial in solid tumors and AVEO expects to begin Phase II studies by mid-2007, with an initial focus on renal-cell carcinoma. Financial terms were not disclosed.

• CODA Genomics Inc., of Laguna Hills, Calif., and Integrated Genomics, of Chicago, entered a collaboration to apply CODA's Translation Engineering protein expression technology to the Integrated Genomics' Pichia yeast expression system to provide enhanced genes for protein expression. Financial terms were not disclosed.

• DOR BioPharma Inc., of Miami, received $3 million under a non-binding letter of intent with Gaithersburg, Md.-based Sigma-Tau Pharmaceuticals Inc., which grants Sigma-Tau an exclusive right to negotiate for a possible business transaction or strategic alliance regarding orBec (oral beclomethasone dipropionate) and other pipeline compounds until March 1. Sigma-Tau has purchased about 4 million shares worth $1 million of DOR's common stock, and has paid DOR an additional $2 million in cash, which will be deducted from up-front payments due to DOR if a commercialization agreement is reached between the parties. If no agreement is reached, DOR will return the $2 million to Sigma-Tau. OrBec is designed to treat the gastrointestinal manifestation of graft-vs.-host disease. Separately, Sigma-Aldrich granted New York-based Pfizer Inc. a worldwide nonexclusive research license to use DNA-directed RNAi technology. Financial terms were not disclosed.

• Elusys Therapeutics Inc., of Pine Brook, N.J., entered an exclusive research and license agreement with New York-based Pfizer Inc. to develop infectious disease drugs using Elusys' HP Antibody technology. The collaboration includes ETI-211, an HP antibody for methicillin-resistant Staphylococcus aureus infections, in addition to research in other indications. Terms call for Elusys to receive an up-front equity investment, research and development funding, and near-term research milestones. Elusys also granted Pfizer an option to acquire exclusive rights to products developed under the agreement, in exchange for clinical and sales milestones and royalties. Specific financial details were not disclosed.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., entered an agreement with Deerfield, Ill.-based Ovation Pharmaceuticals Inc. for the supply of the active ingredient in Enzon's Oncaspar, a form of L-asparaginase enhanced with Enzon's PEGylation technology for acute lymphoblastic leukemia. The existing agreement expired at the end of 2006, and the new agreement extends through 2009. Under the terms, Enzon will make an up-front payment for a nonexclusive license to Ovation's cell line.

• ImClone Systems Inc., of New York, began a Phase I trial of IMC-3G3, its fully human IgG1 monoclonal antibody targeting the platelet-derived growth factor receptor alpha (PDGFR[alpha]), in patients with solid tumors. The study is designed to establish the product's safety profile and evaluate the pharmacokinetics and pharmacodynamics of the new antibody administered weekly by intravenous infusion. It's expected to enroll about 30 to 40 patients.

• ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., and GenPhar Inc., of Charleston, S.C., began their first study of Viprovex (Homspera) to explore its adjuvant capabilities in a pandemic influenza vaccine. Homspera is the company's generic name to describe the synthetic peptide Sar9, Met (O2)11-Substance P, an analog of the naturally occurring human neuropeptide Substance P that's found throughout the human body.

• Inhibitex Inc., of Atlanta, granted 3M Health Care, of St. Paul, Minn., an exclusive global license to use Clumping Factor A, an MSCRAMM protein, in the development of diagnostic products in return for license fees, milestone payments, research and development support and royalties. The royalties will kick in once product sales exceed $4 million in cash considerations over the next five years. 3M also received a license to use additional MSCRAMM protein targets for the development of other diagnostic products.

• Light Sciences Oncology Inc., of Seattle, purchased the assets of its former parent company, Light Sciences LLC, through the issuance of common stock to extend intellectual property rights for its Light Infusion Therapy (Litx). LSO now owns IP covering LEDs and the use of LEDs to activate a photo-sensitive compound therapeutically, and will no longer have to pay licensing fees to Light Sciences LLC. Financial terms were not disclosed.

• Liponex Inc., of Ottawa, is amending a Phase I/II trial of CRD5 by suspending patient treatment at the highest dose level of 5 g per day because of gastrointestinal adverse events. Patients receiving 1-g and 3-g doses will continue to do so, as per the established protocol. More than 50 dyslipidemic patients have been enrolled to date, and treatment remains ongoing. The primary endpoints are safety and a measure of serum HDL increases, with triglyceride and LDL reductions as secondary endpoints. The company expects to report results by the end of this quarter.

• Medarex Inc., of Princeton, N.J., received a milestone payment from ImClone Systems Inc., of New York, following the acceptance of an investigational new drug application by the FDA for IMC-3G3, a fully human antibody that targets platelet-derived growth factor receptor alpha to treat cancer. The product was developed using Medarex's UltiMAb technology and is the second antibody derived from the technology that is in clinical development by ImClone. Medarex may receive milestone payments and royalties if the product progresses and reaches the market.

• Medivir AB, of Huddinge, Sweden, filed an application to begin a Phase I study in Europe of MIV-701, an inhibitor of cathepsin K that could benefit osteoporosis, osteoarthritis, rheumatoid arthritis, Paget's disease and certain tumors causing bone metastases. The trials are expected to start this quarter.

• Neosil Inc., of Emeryville, Calif., said Phase IIa data demonstrated that its lead product, NEOSH101, increased hair growth significantly in men diagnosed with androgenetic alopecia compared to placebo. Hair growth was measured using a photographic, computer-based analysis for up to 24 weeks after initiation of therapy, and a 4.8 percent increase in total hair count ( p=0.04) and 3.7 percent increase in cumulative hair thickness (p=0.02) were observed, with peak effects occurring eight weeks following the second treatment cycle.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., granted commercialization rights to Factive (gemifloxacin) in Europe to Menarini Group, of Italy, in exchange for undisclosed up-front and milestone payments. Menarini will pursue European regulatory approval in coordination with Oscient, with Oscient reimbursing Menarini for regulatory expenses up to an agreed limit. Additional terms were not disclosed. Oscient recently licensed Factive commercialization rights in North American and Europe from Seoul, South Korea-based LG Life Sciences Ltd.

• Phase Bioscience Inc., of Durham, N.C., raised the first tranche in a Series B financing from Johnson & Johnson Development Corp. The amount of the funding was not disclosed, though the company said it plans to use the money to further its purification and drug delivery technologies. Carol Marino, of JJDC joined Phase's board.

• Protherics plc, of London, completed its previously announced acquisition of MacroMed Inc., of Sandy, Utah, in an all-share transaction valued at about $25 million. The deal gives Protherics access to MacroMed's lead product, OncoGel, a sustained-release formulation of paclitaxel that is in Phase II development for local administration in esophageal and brain cancers.

• Schwarz Pharma AG, of Monheim, Germany, said pivotal Phase III data published in the journal Neurology showed positive results for its once-daily dopamine agonist, rotigotine, in early stage Parkinson's disease. Specifically, the transdermal drug significantly improved patients' symptoms through six months of therapy as measured by parts II and III of the Unified Parkinson Disease Rating Scale, compared to placebo. A decrease in those scores signifies symptom improvement, and patients in the rotigotine group had a mean decrease of 3.98 +/- 0.707, while the placebo group had a mean increase of 1.31 +/- 0.956 (p<0.0001).

• Sound Pharmaceuticals Inc., of Seattle, completed Phase I testing of SPI-1005, an oral compound in development for the prevention and treatment of noise-induced hearing loss. Results from this 32-patient study will be reported at next month's meeting of the Association for Research in Otolaryngology in Denver, along with the protocol for a Phase II study in 80 noise-exposed volunteers.

• Synosis Therapeutics, of San Francisco, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, formed a partnership that could lead to the development of treatments for schizophrenia, cognitive disorders, Parkinson's disease, drug dependency and pain. It centers on five drug candidates that Synosis will acquire from Roche, including four Phase I molecules that target the central nervous system. Roche had shelved the compounds when reprioritizing its focus. Under terms of the deal, Synosis will be responsible for clinical development and, in some cases, commercialization of the drugs. Roche has retained the right to opt-in to two particular programs.

• Vical Inc., of San Diego, said a pivotal Phase III trial is under way to test its Allovectin-7 cancer immunotherapeutic as first-line therapy in chemotherapy-naive patients with recurrent Stage III or IV metastatic melanoma. The head-to-head superiority study against first-line chemotherapy will be conducted by AnGes MG Inc., of Osaka, Japan, through a collaborative agreement. About 375 patients will be randomized on a 2:1 basis, meaning about 250 will be receive Allovectin-7 and the other 125 will be treated with their physician's choice of either dacarbazine or temozolomide. The primary endpoint is a comparison of objective response rates at six months or more after randomization, and the study also will evaluate safety and tolerability as well as survival. Called AIMM (Allovectin-7 Immunotherapeutic for Metastatic Melanoma), it is being conducted under a special protocol assessment from the FDA.

• Victory Pharma Inc., of San Diego, said the FDA cleared its investigational new drug application to evaluate MGX-006 for various nausea and vomiting conditions. The product is a new formulation of a currently marketed agent indicated for these problems, and the company said it's scheduled to enter pivotal trials this year.