• Align Pharmaceuticals Inc., of Cary, N.C., signed a three-year agreement for Saddle River, N.J.-based PDI Inc. to assist with commercialization of three oncology products: Numoisyn Lozenges and Numoisyn Liquid for xerostomia caused by radiation therapy or Sjogren's syndrome, and Xclair to treat symptoms of radiation dermatitis. PDI initially will provide a sales team of 40 field representatives. Financial terms were not disclosed.

• Biofusion plc, of Sheffield, UK, invested £420,000 (US$741,219) in Axordia Ltd., also of Sheffield, one of the UK's stem cell research companies and part of the Biofusion portfolio. The investment, which will be provided as a convertible loan stock, will be in two tranches - £280,000 invested now and £140,000 payable after July. Biofusion will receive 5 percent of ordinary shares in Axordia, which will take its total holding to about 36 percent.

• Cellegy Pharmaceuticals Inc., of Huntingdon Valley, Pa., renegotiated its European Union license and distribution agreement for its product, Tostrex, with ProStrakan Group plc, of Galashiels, UK. Tostrex is a 2 percent topical testosterone gel indicated to treat male hypogonadism. In December 2004, it was approved for sale in Sweden. Under terms of the amended agreement, ProStrakan will assume responsibility for all manufacturing and other product support functions and will purchase the product directly from the manufacturer rather than from Cellegy, which will continue to receive milestones and royalties as set forth in the original agreement. Tostrex, which is known as Fortigel in the U.S., was launched in Sweden in September.

• Cellzome AG, of Heidelberg, Germany, and the European Molecular Biology Laboratory (EMBL) said results of the first genome-wide screen for protein complexes were published in Nature, and describe the characterization of nearly 500 complexes in the model organism, S. cerevisiae, more than half of which have never been described before. The work is intended to enable the elucidation of the molecular basis of health and disease, and allow for the identification of the most appropriate targets for drug discovery.

• Cobra Biomanufacturing plc, of Keele, UK, entered an agreement with Debiopharm SA, of Lausanne, Switzerland, for the manufacture of the biopharmaceutical protein huTNFa Kinoid. The agreement includes process development and supply of material for clinical trials. The new agreement replaces a prior manufacturing deals with Neovacs SA, which has licensed to program to Debiopharm.

• DOR BioPharma Inc., of Miami, said an analysis of the survival benefit of orBec (oral beclomethasone dipropionate) in gastrointestinal graft-vs.-host disease, conducted in response to an FDA request, suggests that the day-200, post-transplant survival results from the Phase II study are in concordance with the about 70 percent reduction in mortality at day-200 post-transplant data in a 129-patient Phase III trial. The agency asked for the analysis because survival data from the earlier Phase II study had not been analyzed previously. Results from DOR's pivotal study, first reported at the end of 2004, showed that five deaths (8 percent) were reported among patients treated with orBec, as opposed to 16 deaths (24 percent) in the placebo arm. The company's stock (AMEX:DOR) gained 5 cents Friday, or 21 percent, to close at 37 cents. (See BioWorld Today, Jan. 5, 2005.)

• Gentium SpA, of Villa Guardia, Italy, started a Phase II/III trial with Defibrotide, a single-stranded DNA that protects the vascular endothelial cells, to prevent veno-occlusive disease (VOD), a complication of bone marrow and stem cell transplantation (SCT), in pediatric patients. The study will include 270 patients undergoing SCT at 30 clinical sites in Europe and Israel.

• Inspire Pharmaceuticals Inc., of Durham, N.C., discontinued two Phase II pilot trials of denufosol tetrasodium intravitreal injection (INS3727 ophthalmic) in macular edema after data from the first trial, involving 12 patients with persistent macular edema associated with uveitis, failed to demonstrate improvement in either reduction of retinal thickness or improvement in visual acuity. The second trial was targeted to enroll 15 patients with persistent macular edema following cataract surgery, but the company stopped the study before any patients could enroll. The company has no plans to conduct any further studies of denufosol in retinal disease.

• NitroMed Inc., of Lexington, Mass., modified its agreement with Publicis Selling Solutions, of Lawrenceville, N.J., to now staff 144 of the original 195 BiDil (isosorbide dinitrate/hydralazine hydrochloride) sales territories. BiDil was launched in July 2005 using a cardiovascular sales force hired for NitroMed through Publicis. The reduction of staffed territories is the company's first step in its plan to hire 140 to 155 of its own sales representatives by the third quarter.

• Norwood Immunology Ltd., of Melbourne, Australia, a subsidiary of Norwood Abbey Ltd., entered a call option to acquire all of the share capital of Netherlands-based Bestewil Holding Ltd., the 100 percent owner of Virosome Biologicals Ltd., which is developing and commercializing a platform-enabling technology for vaccines. The technology is based on the combination of an adjuvant with virosomes and achieves a significantly enhanced immune response to an antigen challenge. If the option is called, the transaction will be worth €25 million (US$30.3 million), subject to certain milestones.

• Orion Genomics, of St. Louis, initiated a collaboration with researchers at the University of Glasgow in Scotland to discover epigenetic biomarkers for the development of cancer screening tests at an early stage. They also would provide personalized information about how tumors are most effectively treated. Scientists at Orion and the university will use Orion's methylation technologies.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., said the FDA accepted for filing the company's supplemental new drug application for marketing approval of Factive (gemifloxacin mesylate) tablets (320 mg once daily) for the five-day treatment of mild to moderate community-acquired pneumonia (CAP). The FDA has refused to accept the sNDA filing for the five-day treatment of acute bacterial sinusitis, saying the drug did not exhibit an acceptable risk vs. benefit profile given the potential risk of rash in those patients. It is expected to act on the filing for the CAP indication by the end of September. Factive is approved for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and the seven-day treatment of mild to moderate CAP.

• ProIX Pharmaceuticals Corp., of Tucson, Ariz., enrolled the first patient in a Phase Ib trial to study PX-12, a thioredoxin inhibitor, in patients with advanced gastrointestinal cancers. This trial is designed to evaluate PX-12 as a 24-hour infusion every two weeks.

• Solexa Inc., of Hayward, Calif., completed the second closing of a private placement for about $40 million following approval at a special meeting of its stockholders. The transaction represents the final closing of a $65 million financing with a group of institutional investors announced in November. Solexa sold 6.1 million shares at $6.50 per share and issued warrants for the purchase of an additional 2.2 million shares at $7.50 per share at the second closing. The financing resulted in net proceeds of $61 million. (See BioWorld Today, Nov. 22, 2005.)

• SuperGen Inc., of Dublin, Calif., withdrew its marketing authorization application for Orathecin (rubitecan) capsules from the European Medicines Agency. The drug, an orally active camptothecin and a topoisomerase I inhibitor, is being developed to treat pancreatic cancer in patients who have failed at least one prior chemotherapy regimen. Orathecin is in an ongoing Phase II trial in the U.S. in combination with gemcitabine as a first-line therapy for advanced pancreatic cancer patients who have not undergone chemotherapy. SuperGen intends to make a decision on Orathecin based on a review of the trial's interim results.

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