• BioMarin Pharmaceutical Inc., of Novato, Calif., said the FDA granted fast-track designation for Phenoptin (sapropterin dihydrochloride) for phenylketonuria. Phenoptin, an investigational oral small-molecule therapeutic, is in Phase III development.

• Biomira Inc., of Edmonton, Alberta, signed a letter of intent to amend its licensing agreement with Merck KGaA, of Darmstadt, Germany, for its BLP25 liposome vaccine in development to treat non-small-cell lung cancer. Changes call for Merck to take over costs and administrative responsibilities relating to the development and commercialization of the product, including the Phase III trial expected to start in mid-2006. In return, Biomira's co-promotion interest in U.S. sales will be converted to a specified royalty rate, which will be higher than what Merck agreed to pay in all markets outside of North America. The royalty rate for the rest of the world remains generally unchanged.

• BioMS Medical Corp., of Edmonton, Alberta, signed a letter of intent for global clinical research organization ICON plc to handle the company's ongoing pivotal Phase II/III trial for MBP8298 in multiple sclerosis. The trial is targeted to enroll up to 553 patients, who will be given either MBP8298 or placebo intravenously every six months for a period of two years.

• Callisto Pharmaceuticals Inc., of New York, signed an agreement with The University of Texas M.D. Anderson Cancer Center in Houston for the licensing of a new class of cancer drugs called Degrasyns for development of anticancer agents. Their effectiveness relates to their ability to selectively degrade key proteins that are involved in tumor cell proliferation and survival. Thus far, the company said, the degradation appears to be specific for C-MYC, BCR-ABL and JAK2.

• Cephalon Inc., of Frazer, Pa., said that it does not expect final action from the FDA on its pending new drug application for Sparlon (modafinil) tablets for the treatment of attention-deficit/hyperactivity disorder in children and adolescents until after the completion of several FDA advisory committee meetings. The first two panels, scheduled for Feb. 9 and March 22, will consider safety and risk management issues associated with products in the class of approved ADHD treatments.

• ConjuChem Inc., of Montreal, filed with the FDA a submission to initiate a Phase I/II trial for the treatment of Type II diabetes using the company's PC-DAC: Exendin-4 compound. Regulatory clearance is anticipated prior to the end of February with patient enrollment starting in March. Preliminary data are expected to be available at the end of the second quarter.

• Corautus Genetics Inc., of Atlanta, said its data safety monitoring committee recommended the continuation of GENASIS (Genetic Angiogenic Stimulation Investigational Study), a Phase IIb trial evaluating the safety and efficacy of Vascular Endothelial Growth Factor-2 to treat patients with severe angina. The planned interim safety analysis was conducted after the first 240 patients were treated in the trial. The trial will enroll 404 patients with Class III or IV angina who are not suitable candidates for traditional revascularization procedures.

• Cytogen Corp., of Princeton, N.J., filed a lawsuit against Advanced Magnetics Inc., of Cambridge, Mass., for breach of contract, fraud, unjust enrichment and breach of the implied covenant of good faith and fair dealing. The lawsuit, filed today in Massachusetts Superior Court, is in connection with the license agreement established between Cytogen and Advanced Magnetics in 2000, as amended, for both Combidex and ferumoxytol.

• Discovery Laboratories Inc., of Warrington, Pa., said the FDA granted fast-track status to Surfaxin for the prevention and treatment of bronchopulmonary dysplasia in premature infants. There are no approved drugs for BPD. Surfaxin has an approvable letter from the FDA for the prevention of respiratory distress syndrome in premature infants. Final approval is expected in April.

• Durect Corp., of Cupertino, Calif., plans to expand its worldwide development program for its postoperative pain relief depot, SABER-Bupivacaine, by initiating additional Phase II studies for soft tissue and orthopedic surgical procedures. Clinical studies will be conducted in the U.S. under the accepted investigational new drug application. A Phase III program is expected to begin in the second half of this year.

• ImmunoGen Inc., of Cambridge, Mass., saw its stock slip nearly 15 percent Thursday following the announcement that its partner, Millennium Pharmaceuticals Inc., also of Cambridge, is discontinuing development of MLN2701, an anti-PSMA antibody conjugated for the toxin DM1 due to toxicity issues. RBC Capital Markets in New York downgraded ImmunoGen's stock from "outperform" to "sector perform," and RBC analyst Jason Kantor wrote in a research note that the loss of an advanced product as one of the reasons for the downgrade. Shares of ImmunoGen (NASDAQ:IMGN) closed at $4.20 Thursday, down 82 cents. Millennium also said in its 2005 earnings call that it was dropping development of a second product, MLN1202 in rheumatoid arthritis. The company reported a net loss of $87.2 million, or 28 cents per share, for the full year ending Dec. 31. Its cash, cash equivalents and marketable securities totaled $645.6 million. Shares of Millennium (NASDAQ:MLNM) closed at $10.21 Thursday, down 10 cents.

• Intrabiotics Pharmaceuticals Inc., of Lafayette, Calif., said the court granted its motion to dismiss claims relating to a lawsuit filed in July 2004, alleging that the company failed to disclose and misrepresented several adverse facts concerning iseganan, a product to treat ventilator-related pneumonia. Safety issues prompted IntraBiotics to halt the late-stage program, causing the company's share value to fall by more than two-thirds. The company said it continues to believe the suit is without merit, though it is likely that litigation will continue through at least the end of 2006. (See BioWorld Today, June 24, 2004.)

• Nabi Biopharmaceuticals, of Rockville, Md., said it completed its Phase II dose-ranging study for NicVAX and plans to enter a full Phase II proof-of-concept study. Results showed that NicVAX was well tolerated. The vaccine used was manufactured with a lower level of adjuvant in an attempt to further optimize the formulation. NicVAX is being developed to treat nicotine addiction and prevent smoking relapse.

• NPS Pharmaceuticals Inc., of Salt Lake City, filed a shelf registration statement to permit the company, from time to time, to offer and sell securities under revised SEC regulations that took effect in December. NPS develops and commercializes small molecules and recombinant proteins as drugs.

• Rigel Pharmaceuticals Inc., of South San Francisco, said it will receive a $5 million milestone payment from Serono SA, of Geneva, triggered by the progress on the investigational new drug application for R763, for which Phase I trials in cancer patients should start later this year. R763 is an orally available multi-Aurora kinase inhibitor. Serono licensed development and commercialization rights to Rigel's Aurora kinase inhibitor program in October 2005.

• YM BioSciences Inc., of Mississauga, Ont., said its subsidiary, Delex Therapeutics Inc., enrolled the first patient for its randomized 120-patient Phase IIb trial for the treatment of moderate to severe acute pain with AeroLEF, a proprietary formulation of free and liposome-encapsulated nebulized fentanyl, which permits delivery through the lung. The trial is designed to evaluate multiple doses of AeroLEF for the management of pain in post-surgical patients following elective orthopedic surgeries. It will enroll 120 patients.

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