• Alteon Inc., of Parsippany, N.J., said the FDA is maintaining the clinical hold previously placed on the company's Phase IIa study of alagebrium in diabetic patients with erectile dysfunction due to changes in the livers of rats during preclinical testing. Alteon submitted in June preclinical toxicity data supporting the company's view that liver alternations were related to the male rat metabolism and not the genotoxic pathways. The company also provided additional data in August. After reviewing that information, the FDA decided to maintain the clinical hold, it said. (See BioWorld Today, June 13, 2005.)

• Avalon Pharmaceuticals Inc., of Germantown, Md., said the investigational new drug submission for AVN944 was cleared by the FDA. The allowance permits Avalon to initiate a Phase I trial in patients with advanced hematological malignancies. AVN944 is an oral, small-molecule inhibitor of the enzyme inosine monophosphate dhydrogenase.

• Axordia Ltd., of Sheffield, UK, a stem cell research company, signed an exclusive agreement with Chemicon International Inc., a subsidiary of Serologicals Corp., of Atlanta, to co-develop new antibody markers from Axordia's human embryonic stem cell lines. Axordia will contribute expertise and materials for antibody generation and antibody characterization, and Chemicon will commercialize the new antibody research tools arising from the collaboration. Financial terms were not disclosed.

• BioDelivery Sciences International Inc., of Morrisville, N.C., priced a public offering of 4.4 million shares of its common stock, anticipated to raise gross proceeds of $8.8 million for the company. The public price per share for the offering was $2. BioDelivery is using its licensed and patented drug delivery technologies to develop and commercialize new formulations of therapeutics to target such areas as pain, anxiety, nausea, vomiting and infections.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said results of its 276-patient Phase III study (ACT 3) in atrial arrhythmia achieved its primary endpoint, showing that of the 170 patients with recent-onset atrial fibrillation, 52 percent of those receiving an intravenous dose of RSD1235 converted to normal heart rhythm, compared to 4 percent of placebo patients. Data also showed that the recent-onset patients who converted to normal heart rhythm within 90 minutes had a median time to conversion of about eight minutes from the initiation of dosing. The company said the results are consistent with those reported following an earlier pivotal Phase III study, Act 1, reported in December. Shares of Cardiome (NASDAQ:CRME) gained $1.09 Friday, or 14.2 percent, to close at $8.79. (See BioWorld Today, Dec. 21, 2004.)

• Epigenomics AG, of Berlin, extended its existing agreement with Roche Diagnostics, of Pleasanton, Calif., to continue the research and development part of the collaboration for at least six months, with an option to prolong it for an additional 18 months. Financial terms were not disclosed. The collaboration involves the development of five cancer diagnostics: screenings for colon, prostate and breast cancers; a test to determine how aggressively prostate cancer is growing; and a pharmacodiagnostic test to predict the probability of relapse in breast cancer patients undergoing treatment with tamoxifen.

• Guilford Pharmaceuticals Inc., of Baltimore, said its stockholders approved the merger transaction pursuant to which Guilford will become a wholly owned subsidiary of MGI Pharma Inc., of Bloomington, Minn., an oncology and acute care-focused biopharmaceutical company. The transaction is expected to be completed Oct. 3. Under the terms of the transaction, each share of Guilford stock will be exchanged for $1.12 in cash and 0.1103 of a share of MGI Pharma common stock. (See BioWorld Today, July 22, 2005.)

• InSite Vision Inc., of Alameda, Calif., completed enrollment for one of its two Phase III studies of AzaSite in bacterial conjunctivitis. The study was a randomized, double-blind, active-controlled study. The randomized patients were treated for five days with either AzaSite or tobramycin ophthalmic solution. The goal of the study was to show equivalent efficacy between AzaSite and tobramycin-treated patients.

• MediciNova Inc., of San Diego, said Takashi Kiyoizumi will resign as president and CEO, effective immediately. The company announced that Chief Business Officer Brian Anderson has left, as well. MediciNova's executive chairman, Yuichi Iwaki, will serve as acting CEO.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., said results of its immunogenicity study of StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) in patients undergoing orthopedic surgery with a prosthetic device implant demonstrated that 94 percent of patients achieve antibody levels above the estimated protective levels. The company also said it is continuing to compile data from the confirmatory Phase III trial for the prevention of S. aureus bloodstream infections in patients with end-stage renal disease and expects to release top-line data in late October or early November. Nabi anticipates filing a biologics license application for StaphVAX in the fourth quarter.

• Pervasis Therapeutics Inc., of Cambridge, Mass., secured $12 million in Series B financing to fund continued development of its first product, a combination device for patients with vascular disease. The round was led by new investor Lexington, Mass.-based Highland Capital Partners, with support from founding investors Waltham, Mass.-based Polaris Venture Partners and Cambridge, Mass.-based Flagship Venture Partners. Pervasis is focused on creating biologically active vascular technologies to treat cardiovascular disease by combining cell biology, drug delivery and biomaterials. In addition to its financing, the company recently named Steve Bollinger president and chief operating officer; and Beverly Huss senior adviser. Duke Collier and Peter Barton Hutt joined the company's board.

• Provid Pharmaceuticals Inc., of North Brunswick, N.J., was awarded a $750,000 Phase II SBIR grant by the National Cancer Institute in Bethesda, Md. The NCI and Provid will collaborate on a number of oncology targets over the next two years. Provid will apply its hypothesis-driven drug discovery chemistry to translate the assay hits into viable drug candidate leads for applications in cancer therapy. Those projects emerged from the efforts of the Developmental Therapeutics Program Screening Technologies branch at NCI, where small-molecule assay hits have been identified and are ready for medicinal chemistry validation and optimization.

• PSMA Development Co. LLC, a joint venture of Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., reported positive preclinical findings of its prostate cancer drug, prostate-specific membrane antigen antibody-drug conjugate. The findings were reported Friday at the 12th annual Prostate Cancer Foundation Scientific Retreat. Progenics also reported that it has reached the target enrollment of patients in the second pivotal Phase III trial of methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced medicinal illness. The company expects to report results for the 130-patient, double-blind, randomized, placebo-controlled study during the first quarter of 2006.

• Renovis Inc., of South San Francisco, closed a public offering of 4 million shares of common stock sold at $13.50 per share, raising net proceeds of $50.8 million. The company has granted underwriters a 30-day option to purchase up to 600,000 additional shares to cover overallotments. Proceeds will go toward research and development, including clinical trials for future product candidates, and working capital and other general expenses. (See BioWorld Today, Sept. 26, 2005.)

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., and InKine Pharmaceuticals Co. Inc., of Blue Bell, Pa., said stockholders of both companies approved the previously announced merger. Salix announced plans in June to acquire InKine in an all-stock transaction valued at $190 million. The acquisition will provide Salix, a gastroenterology company, with InKine's marketed bowel-cleansing product, Visicol, as well as a second bowel-cleansing agent, INKP-102, which has been submitted for FDA approval. InKine shareholders will receive newly issued shares of Salix common stock for InKine shares based on an exchange ratio of 0.1737 of a share of Salix stock for each InKine share. InKine will continue as a wholly owned subsidiary of Salix. (See BioWorld Today, June 27, 2005.)

• Sepracor Inc., of Marlborough, Mass., said results from its Phase IIIb/IV study evaluating Lunesta brand eszopiclone for the treatment of insomnia in perimenopausal and menopausal women showed that nightly use of the drug resulted in statistically significant improvement from baseline compared with placebo in patient-reported measures of sleep latency, wake time after sleep onset and total sleep time. In the six-week, 410-patient study, patients treated with Lunesta also demonstrated significant improvements in additional sleep measures and measures of daytime function over placebo, and was well tolerated during the treatment period. The results were presented at the North American Menopause Society's annual meeting in San Diego.

• Stratagene Corp., of La Jolla, Calif., said that an injunction was granted by the U.S. District Court for the Western District of Wisconsin that enjoins Stratagene from manufacturing, selling and offering for sale its FullVelocity QPCR and its FullVelocity QRT-PCR products. On Aug. 31, the jury in the case determined that patents 6,090,543 and 6,348,314 from Third Wave Technology Inc., of Madison, Wis., are valid and that two FullVelocity products infringed those patents. In other news, ThirdWave responded to a lawsuit filed against it by Innogenetics NV, of Ghent, Belgium, that alleges Third Wave is infringing one of Innogenetics' hepatitis C virus patents. Innogenetics also filed a similar suit against Abbott Laboratories, of Abbott Park, Ill.

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