• Abgenix Inc., of Fremont, Calif., said it would receive a milestone payment from Amgen Inc., of Thousand Oaks, Calif., triggered after the latter began a pivotal trial of AMG 162. The fully human antibody was created using Abgenix's XenoMouse technology, which Amgen licensed through an April 1999 agreement. It is one of seven antibodies derived from XenoMouse technology in clinical trials, and the first product candidate from its technology out-licensing program to move into pivotal development. Patient dosing in the trial began last week. (See BioWorld Today, Aug. 11, 2004.)

• Alteon Inc., of Parsippany, N.J., said KPMG LLP resigned as its principal accountant. But the company added that KPMG noted that its resignation was not the result of any disagreements with Alteon on any matter of accounting principles or practices, financial statement disclosure or auditing scope or procedures. Simultaneous with the news, Alteon, which is developing drugs that reverse or slow down diseases of aging and complications of diabetes, reported the resignation of Robert deGroof as its senior vice president of scientific affairs.

• Antigenics Inc., of New York, filed a $100 million mixed shelf registration statement with the SEC. The company, whose pipeline includes therapeutics for cancer, said it would use any resulting funds for general corporate purposes.

• Auvation Ltd., of Aberdeen, Scotland, entered a collaboration with ExpressOn BioSystems Ltd., of Roslin, Scotland, to validate new molecular targets in tumor cells. Using its technology, Auvation has identified more than 20 tumor markers, to which ExpressOn will apply its array technology to determine regions on corresponding RNA molecules that are accessible to silencing reagents such as siRNA, antisense or ribozyme molecules. For its work, ExpressOn will receive an undisclosed up-front payment, followed by milestone payments on silencing reagents selected for clinical development.

• Bioheart Inc., of Weston, Fla., entered an agreement with the Powell Gene Therapy Center at the University of Florida in Gainesville to develop a second-generation stem cell recruiting myoblast technology that includes controlled release of angiogenic growth factors for improving blood supply. Bioheart is moving forward with additional comparative studies in animals and plans to be ready to submit an investigational new drug application to the FDA by the first quarter of next year, and the partners said they hope to begin Phase II trials next year. The technology is targeted at recovering scarred heart tissue damaged from a heart attack.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said Fredric Price resigned as chairman and CEO in order to relocate back to the East Coast. Board member Pierre Lapalme will assume the chairman's position, while Louis Drapeau, BioMarin's chief financial officer, was appointed acting CEO until a new one is named. The board has begun its search to fill the position. Jeffrey Cooper, the company's vice president and controller, was appointed acting chief financial officer.

• Biovation Ltd., of Aberdeen, Scotland, signed a research agreement to apply its immunogenicity assessment technologies to biopharmaceuticals designed by Pfizer Inc., of New York. Biovation, which will receive research revenues for its work, called the agreement an endorsement of the importance of T-cell epitopes in relation to prospective immunogenicity in patients.

• Cephalon Inc., of West Chester, Pa., completed its previously reported acquisition of all of the outstanding shares of CIMA Labs Inc., of Eden Prairie, Minn. As a result, CIMA is now a wholly owned subsidiary of Cephalon. The $515 million deal's closing follows a back-and-forth bidding war for CIMA, which originally was courted last summer by specialty pharmaceutical firm aaiPharma Inc., of Wilmington, N.C. Then Cephalon stepped in and upped the per-share offer for CIMA. Terms of the deal were worked out last fall. (See BioWorld Today, Nov. 5, 2003.)

• Erimos Pharmaceuticals LLC, of Raleigh, N.C., said Phase I results reported at the International Conference on Head and Neck Cancer in Washington showed EM-1421-IT appeared to be tolerable and not associated with systemic side effects. Use of the small molecule produced visible tumor necrosis in five of six patients with refractory head and neck tumors completing three doses of the drug.

• Genelabs Technologies Inc., of Redwood City, Calif., completed the treatment phase of Study GL02-01, a confirmatory Phase III trial designed to measure the effect of Prestara on the bone mineral density of women with systemic lupus erythematosus who are receiving glucocorticoids. It was conducted to address the key contingency raised in an approvable letter issued in 2002 by the FDA in response to a new drug application on the drug. Its primary endpoint is bone mineral density at the lumbar spine, and enrolled 155 women who were treated for six months with either 200 mg per day of Prestara or a placebo. Genelabs, which said it remains on track to report data next quarter, disclosed the trial's design nearly two years ago, about two months after receiving the approvable letter. (See BioWorld Today, Sept. 3, 2002, and Nov. 18, 2002.)

• Genentech Inc., of South San Francisco, and the FDA issued an Avastin-related drug warning that there is evidence of an increased risk of serious arterial thromboembolic events, including cerebrovascular accident, myocardial infarctions, transient ischemic attacks and angina related to use of the anti-angiogenesis product. There also is an increase in the risk of fatal arterial thrombotic events. In randomized, active-controlled studies conducted in metastatic colorectal cancer patients, the risk of a serious arterial thrombotic event was about twofold higher in patients receiving 5-FU-based chemotherapy plus Avastin, with an estimated overall rate of up to 5 percent. A revised package insert containing more detailed information on the clotting events is in development. Other adverse events reported in clinical trials included hypertension and a potential for increased gastrointestinal perforations. Genentech markets the product in the U.S., while ex-U.S. rights belong to F. Hoffmann-La Roche Ltd., of Basel, Switzerland. It was approved earlier this year. (See BioWorld Today, Feb. 27, 2004.)

• Genmab A/S, of Copenhagen, Denmark, began a Phase II study of HuMax-CD4 for refractory or relapsed non-cutaneous T-cell lymphoma. The international multicenter trial is expected to include about 20 patients who will receive 980 mg of HuMax-CD4 once weekly for 12 weeks. They will be followed until disease progression. The study's primary endpoint is objective tumor response from start of treatment to week 18.

• Illumina Inc., of San Diego, said it would generate more than 25 million mouse genotypes for The Wellcome Trust Centre for Human Genetics at Oxford University in the UK under a fast-track services agreement signed between the organizations. Wellcome Trust-funded researchers will use single nucleotide polymorphism variants to search for quantitative trait loci that contribute to variation across a range of physiological and behavioral traits that are relevant to human disease, including diabetes, obesity, asthma, anxiety and depression. The Wellcome Trust will publish genotyping results and make the information freely available to other researchers and to the public.

• Karo Bio AB, of Huddinge, Sweden, said its board decided to issue up to 11.3 million new shares, with preferential rights for existing shareholders. If fully subscribed, the rights issue will raise about SEK96 million (US$12.9 million). Each three shares entitle their holder to subscribe two new shares at SEK8.50 apiece. A consortium of existing and new shareholders secured 85 percent of the rights issue through guarantees and letters of intent. The nuclear receptor drug discovery company noted that its current cash would last only through the first quarter of next year. The deal remains subject to approval at a special general meeting on Aug. 30.

• Lorus Therapeutics Inc., of Toronto, said findings from an ongoing Phase II trial, reported at the International Congress on Kidney and Bladder Cancer in Orlando, Fla., demonstrated that GTI-2040 is well tolerated in combination with capecitabine. The results stem from the dose-escalation stage of the trial, which is evaluating the antisense drug combined with capecitabine for metastatic kidney cancer. Data also showed no need to reduce the starting capecitabine dose, up to and including the target GTI-2040 dose that was previously established as a monotherapy in Phase I. Lorus said the study's efficacy stage is nearing completion.

• MediGene AG, of Martinsried, Germany, acquired the anticancer drug candidates and the EndoTAG platform technology of Munich Biotech AG, of Munich, Germany. The deal expands MediGene's pipeline, in particular through the acquisition of MBT-0206, an anti-angiogenesis drug candidate that has completed several Phase I trials in different cancer indications in more than 120 patients. A syndicate of existing investors in the insolvent Munich Biotech are contributing its major assets and is investing EUR4 million toward the further development of the products and technology at MediGene. In return, the syndicate will receive EUR12.5 million in MediGene shares, which after the transaction will correspond to a 12.7 percent share of MediGene. The newly issued shares are subject to a 12-month lockup period. As MBT-0206's development progresses, MediGene will make milestone payments, starting with Phase III. MediGene also is hiring key Munich Biotech employees, but will not assume any liabilities of the company.

• Medivir AB, of Huddinge, Sweden, and Novartis AG, of Basel, Switzerland, said they resolved the issue of partly overlapping patents in the U.S. relating to the Medivir ME-609 project by means of a free, two-way license agreement. The agreement gives Medivir exclusive rights to topical combination products containing the antiviral agent acyclovir, such as ME-609, or omaciclovir (H2G), Medivir's antiviral substance. Novartis was granted a nonexclusive license to certain antiviral combination products such as penciclovir, while Medivir will retain the exclusive rights to its formulation patent relating to combinations containing penciclovir. In countries outside the U.S., including the European Union, they said there is no conflict between the patents.

• Pro-Pharmaceuticals Inc., of Newton, Mass., raised about $6 million in gross proceeds through a private placement of about 2 million common shares at $3 apiece to new and existing institutional investors. They also will receive five-year warrants to purchase about 2 million more shares at an exercise price of $4.20. The cancer drug developer said it would use proceeds for general corporate purposes, including clinical trials and research and development. Rodman & Renshaw acted as the transaction's placement agent.

• Syrrx Inc., of San Diego, received its second and third success-based milestone payments from Biogen Idec Inc., of Cambridge, Mass. In the collaboration, Syrrx applies its high-throughput crystallization of proteins across multiple Biogen Idec drug targets. Financial terms were not disclosed, but with the payments complete, the nine-month-old collaboration has closed.

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