• Applied Genetics Inc. Dermatics, of Freeport, N.Y., said an investor, Olecranon, has purchased all of the company's shares held by Elan Corp. plc, of Dublin, Ireland, in an all-cash transaction. The shares comprise more than 10 percent of AGI's Class A common stock. AGI Dermatics focuses on products for aging and cancer prevention, which are based on the company's liposomes for skin-drug delivery technology.

• Celgene Corp., of Summit, N.J., said results of a Phase I/II trial evaluating Revlimid (lenalidomide) therapy for myelodysplastic syndrome showed that 24 of the 36 evaluable patients achieved an erythroid response to the drug, defined by at least a 50 percent decrease in transfusions or an increase in hemoglobin of 1 g/dl. Twenty-one of those patients achieved a major erythroid response, defined as freedom from the need for transfusion or a sustained increase in hemoglobin levels of more than 2 g/dl. Study results were published in the New England Journal of Medicine. Celgene is evaluating Revlimid, an immunomodulatory drug, for indications in hematology and oncology, and plans to submit a new drug application this quarter.

• Cephalon Inc., of West Chester, Pa., said that its Phase III studies of 150- and 250-milligram daily doses of Nuvigil (armodafinil) in patients suffering from excessive sleepiness associated with narcolepsy, shift-work sleep disorder or obstructive sleep apnea/hypoapnea syndrome show that the medication significantly improves wakefulness and overall clinical condition of patients as compared to placebo. Nuvigil is a single-isomer of the active pharmaceutical ingredient contained in Provigil.

• Durect Corp., of Cupertino, Calif., completed dosing in a Phase I pharmacokinetic study of its Transdur-based sufentanil patch, designed to provide extended pain relief for up to seven days. The company also announced the completion of dosing in the first cohort of the ongoing Phase II study of its Saber-based post-operative pain-relief depot product, Bupivacaine, and is enrolling patients in the second cohort.

• Emergent Technologies Inc., of Austin, Texas, formed a new biotech company, Auxano Biologics Ltd., to commercialize patented technology using Substance P for wound-healing applications. Emergent said the technology is designed to promote healing and to treat chronic wounds, such as diabetic ulcers. Emergent is a venture capital firm that specializes in forming, funding and managing biotech companies.

• Eximias Pharmaceutical Corp., of Berwyn, Pa., named Gail Schulze president and chief executive officer, as the company prepares to complete its pivotal Phase III study with Thymita (nolatrexed dihydrochloride), an investigational product to treat inoperable primary liver cancer. Before joining Eximias, Schulze served as chief offering officer of Aventis Behring and was a founding officer and corporate vice president for Allegiance Healthcare.

• Generex Biotechnology Corp., of Toronto, said its wholly owned subsidiary, Antigen Express, established collaborations with Emory University and the Imperial College of London to develop a smallpox vaccine based on Antigen Express's technology using modified peptide antigens to stimulate immunity. Antigen Express, acquired by Generex in August 2003, has a core technology platform that comprises immunotherapeutics for treating malignant, infectious, allergic and autoimmune diseases.

• IDEA AG, of Munich, Germany, began a clinical Phase II study of IDEA-070 to treat various inflammatory skin diseases. The goal of the double-blind, placebo-controlled study is to identify dermatological diseases that might benefit from topical treatment of the product. IDEA-070 will be further tested in a Phase III program focusing on certain conditions, such as atopic eczema, dishydrotic hand eczema, plaque-type psoriasis, seborrheic eczema and acne vulgaris.

• ImmunoGen Inc., of Cambridge, Mass., said its partner, Ingelheim, Germany-based Boehringer Ingelheim GmbH, decided to discontinue its development of bivatuzumab mertansine, but is retaining the right to use ImmunoGen's DM1 Tumor-Activated Prodrug technology for a different antigen target. The company said development of bivatuzumab mertansine - consisting of Boehringer's anti-CD44v6 antibody, bivatuzumab, and ImmunoGen's DM1 cytotoxic agent - was stopped due to the occurrence of skin toxicity in Phase I trials in patients with advanced carcinoma. Under the companies' 2001 agreement, Boehringer had the right to use the DM1 technology to target a different antigen if it chose to discontinue the anti-CD44v6 compound at an early stage.

• Isotechnika Inc., of Edmonton, Alberta, said it reached the original target enrollment of 400 moderate to severe psoriasis patients for its Canadian Phase III trial of ISA247. The company plans to raise the total enrollment by another 80 patients. The trial began in December and is being conducted at 32 centers across Canada. Patients will be randomized between three doses of ISA247 and placebo.

• LAB International Inc., of Laval, Quebec, acquired Scantox Biologisk Laboratorium, of Lille Skensved, Denmark, for C$6.1 million (US$4.9 million). About 90 percent of the purchase price will be paid on closing, with the remaining portion payable by March 31, 2006, subject to post-closing adjustments. LAB Research will operate contract research facilities in Denmark, Hungary, the U.S. and Canada.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., delayed the pricing of its initial public offering and entered discussions with an undisclosed pharmaceutical company regarding the potential acquisition of Peninsula. Peninsula expects to execute a definitive agreement related to the potential transaction. Peninsula is focused on developing and commercializing antibiotics to treat infections.

• Qiagen GmbH, of Venlo, the Netherlands, entered a manufacturing and supply agreement with Roche Molecular Systems, of Pleasanton, Calif., which will market Qiagen's media sample-preparation kits under its AmpiLute trademark. The customized kit will incorporate a specific version of Qiagen's QIAamp technology to purify DNA from specimens stored in liquid cytology media.

• Shire Pharmaceuticals Group plc, of Basingstoke, UK, said that Health Canada requested the suspension of sales of Shire's attention deficit hyperactivity disorder treatment, Adderall, in Canada, following the agency's interpretation of adverse event data as part of routine label updating. Shire said that while the company is complying with the request, it disagrees with the conclusions drawn by Health Canada. The interpretation of the same data by the FDA led to a revised U.S. label for Adderall XR in September, clarifying that the drug generally should not be used in children or adults with structural cardiac abnormalities, Shire said. The company's stock (NASDAQ:SHPGY) fell $3.84 Thursday, or 10.8 percent, to close at $31.80.

• The Immune Response Corp., of Carlsbad, Calif., named Robert Knowling chairman. Knowling is known for his career in telecommunications, including positions with Indiana Bell and Ameritech. James Glavin, who has served as chairman since 1993, will leave the board later this year.

• ViRexx Medical Corp., of Edmonton, Alberta, said its product called OvaRex MAb (oregovomab) is being studied by Northwest Cancer Specialists, of Portland, Ore., to determine the extent of remission in advanced ovarian cancer patients who have a favorable response to surgery and chemotherapy. Researchers are assessing survival, quality of life, immune response and safety. ViRexx gained the product through its October acquisition of AltaRex Medical Corp., also of Edmonton.

• WellGen Inc., of New Brunswick, N.J., signed a research contract and licensing agreement with HMGene Inc., of Piscataway, N.J., to identify natural, bioactive compounds to target weight loss and obesity control. Terms of the agreement call for HMGene to screen WellGen's bioactive compounds against a panel of genes involved in adipocyte development. Financial terms were not disclosed. WellGen, which uses nutrigenomics to discover and develop products, said it initiated two trials this year for bioactives that target genes involved in colon cancer and arthritis.

• XenoPort Inc., of Santa Clara, Calif., initiated a Phase IIb trial with XP13512, designed to treat restless legs syndrome, to assess the efficacy of two doses administered once a day for 14 days. The company expects to complete the trial later this year. XP13512 is a Transported Prodrug of gabapentin.

• ZymoGenetics Inc., of Seattle, reported positive results from its Phase II studies of recombinant human Thrombin (rhThrombin), and said it plans to move forward with a Phase III program. The Phase II study results showed rhThrombin was safe and well tolerated, and the company reported that its drug plus gelatin sponge was found to be superior to placebo and gelatin sponge in all indications, according to estimates for time to hemostasis. About 130 patients undergoing certain surgical procedures participated in the trials. ZymoGenetics is developing rhThrombin for the control of bleeding during surgery.

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