• Adolor Corp., of Exton, Pa., initiated study 29CL227, a Phase II trial of its sterile lidocaine patch intended for the treatment of post-surgical incisional pain. Top-line results are expected during the first half of 2006. The company also intends to conduct additional studies in hernia repair surgery and other procedures to support product registration.

• Alkermes Inc., of Cambridge, Mass., said that its partner, Janssen-Cilag SpA, of Italy, received approval from the Italian Regulatory Authorities to market Risperdal Consta (risperidone) long-acting injection, an atypical antipsychotic medication for the treatment of schizophrenia. Alkermes expects its partner to launch the product in Italy before the end of the year. Risperdal Consta is a long-acting injectable form of risperidone that was developed utilizing Alkermes' Medisorb drug-delivery technology.

• Biopure Corp., of Cambridge, Mass., said the SEC filed a civil injunctive proceeding against the company, along with two former officers and one current officer, alleging that the company should have disclosed in April 2003 that the FDA put on hold a proposed clinical trial of Hemopure, an oxygen therapeutic to treat trauma patients in the hospital setting. The SEC's suit stated that, when the agency communicated the hold, it asked questions described as "safety concerns." Biopure said it intends to seek dismissal of the SEC's claims, arguing that it was not required to disclose the trial's hold status, and that the in-hospital treatment indication for the product had not been a planned indication with regard to commercial development. Biopure's stock (NASDAQ:BPUR) fell 16 cents Thursday, or 12.4 percent, to close at $1.13.

• Debiopharm SA, of Lausanne, Switzerland, announced the integration of its fully owned affiliate Debiovision, formerly known as H3 Pharma, into the Debio Group, following the purchase of all outstanding shares of H3 Pharma in May 2005. Debiovision will focus on the development and worldwide registration of specialty pharmaceuticals.

• EntreMed Inc., of Rockville, Md., entered a Cooperative Research and Development Agreement with the National Cancer Institute to evaluate the role of HIF-1alpha inhibition in cancer. Under the terms of the three-year agreement, the NCI's Developmental Therapeutics Program Screening Technologies Branch and EntreMed will investigate the mechanism of action of the company's lead compound, 2-methoxyestradiol (2ME2), and a second-generation analogue of 2ME2, ENMD-1198, which are designed to inhibit tumor hypoxia factor-1 alpha in human cell lines.

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., named Michael Astrue, the former president and CEO of Transkaryotic Therapies, as interim CEO. Astrue will help the company to execute its business plan in the imaging field and pursue opportunities to grow beyond imaging. He also will assist the board in its search for a permanent CEO. Astrue succeeds Michael Webb, who will remain as a consultant.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, reported the results from the two preclinical studies involving the company's cholesterol-lowering drug, FM-VP4. The first study was designed to assess the effects of Forbes' cholesterol-lowering drug candidate in combination with Simvastatin, or Zocor, from Merck and Co. Inc., of Whitehouse Station, N.J. The second study was to determine if FM-VP4 decreased body weight in a mouse model fed a high-fat diet. The results illustrated that a combination of Zocor and FM-VP4 reduced total plasma cholesterol, LDL cholesterol, total plasma triglycerides and the LDL cholesterol/HDL ratio more than either Zocor or FM-VP4 alone.

• Genaera Corp., of Plymouth Meeting, Pa., closed its previously announced direct offering to sell 11.4 million shares of common stock for aggregate proceeds of $24.5 million. Investors also received warrants to purchase about 3.4 million shares. The company initiated a Phase III trial earlier this year to evaluate its lead drug, Evizon, in patients with wet age-related macular degeneration, and a second trial is expected to begin by the end of the year. (See BioWorld Today, Sept. 13, 2005.)

• Genzyme Corp., of Cambridge, Mass., started a clinical trial evaluating the safety and efficacy of Myozyme (alglucosidase alfa) in patients with late-onset Pompe disease. The randomized, double-blind, placebo-controlled study will enroll at least 72 patients. The company already has submitted European and U.S. marketing applications for Myozyme, and regulatory action is expected in early 2006. Genzyme expects to submit marketing applications in Japan and several other countries by the end of the year.

• ImClone Systems Inc., of New York, and Bristol-Myers Squibb Canada, of Montreal, said Erbitux (cetuximab) injection was approved by Health Canada's Biologics and Genetic Therapies Directorate as a treatment for metastatic colorectal cancer. It was authorized for use in combination with irinotecan in the treatment of patients with epidermal growth factor receptor-expressing cancer who are refractory to other irinotecan-based chemotherapy treatments and as a single agent for patients who are intolerant to irinotecan.

• Microbia Inc., of Cambridge, Mass., started Phase I testing of MD-0727, a cholesterol absorption inhibitor under investigation to treat hypercholesterolemia. It is the first molecule to enter clinical testing from Microbia's cardiovascular research program. The objectives of the program are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of MD-0727 in healthy volunteers.

• Morphotek Inc., of Exton, Pa., was awarded a $6.3 million challenge grant from the Defense Advanced Research Projects Agency to apply its morphogenics technology to develop cell lines suitable for the scaleable manufacturing of biologic-based anti-biowarfare therapies. The cell lines will enable the agency to produce large quantities of biologic therapeutics in response to mass pathogen exposure, as well as for generating a drug stockpile.

• NicOx SA, of Sophia Antipolis, France, expanded its existing collaboration with Grupo Ferrer Internacional SA, of Barcelona, Spain, for the research, development and marketing of nitric oxide-donating corticosteroids in dermatology. NicOx is eligible to receive additional milestone payments, commercial success fees and royalties in return for granting Ferrer an option on the U.S. development and marketing rights to any products that result from the collaboration.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said its UK subsidiary, Prosidion, presented preclinical research showing that its DPIV inhibitor, PSN9301, increased blood glucose clearance to a similar degree as Metformin in rat models, and its combination with Metformin further improved glucose homeostasis compared to either drug given alone. Those data were presented during the European Association for the Study of Diabetes 41st annual meeting in Athens, Greece. PSN9301 is being evaluated in ongoing Phase II trials in Type II diabetic patients.

• Oxis International Inc., of Portland, Ore., said its shares have been listed for trading on the Frankfurt Stock Exchange under the symbol "OXI." Oxis focuses on developing technologies and products to research, diagnose, treat and prevent diseases associated with damage from free radical and reactive oxygen species.

• PharmaMar SA, of Madrid, Spain, started a program of combination studies with Aplidin (plitidepsin), the company's marine-derived antitumor agent, originally isolated from the tunicate Aplidium albicans. The first study is a Phase I/II trial of Aplidin in combination with DTIC, the standard agent for metastatic malignant melanoma. A second study will assess the compound when administered with carboplatin in patients with advanced solid and hematological tumors.

• Serologicals Corp., of Atlanta, said its wholly-owned subsidiary, Celliance, is offering a new line of peptones under the brand name of LucraTone. The products will be launched in the bioprocessing market and are critical components in cell culture and fermentation.

• Starpharma Holdings Ltd., of Melbourne, Australia, said Dimerix Bioscience Pty. Ltd., of Perth, Australia, closed its Series A financing, led by venture capital firm Foundation Capital, of Menlo Park, Calif., and supported by Western Australia-based Murdoch Westscheme Enterprise Partnership fund. Proceeds will be used to advance the development of the company's compounds targeting chronic gut disorders. Dimerix's compounds, which are being developed in a joint venture with Starpharma, are based on Starpharma's dendrimer nanostructures designed to enable the activation of multiple receptor sites on the cell surface. Following the financing, Starpharma holds 22 percent of Dimerix.

• Synthetech Inc., of Albany, Ore., received notification from Nasdaq SmallCap Market that it has not regained compliance with the bid price requirements for continued listing during a 180-day grace period, and its securities are subject to delisting. They will be delisted at the opening of business on Sept. 22. Synthetech, which specializes in organic synthesis, biocatalysts and chiral technologies, will request a hearing before a panel that will stay the delisting pending the panel's decision.

• Tm Bioscience Corp., of Toronto, said that Genzyme Genetics, a division of Genzyme Corp., of Cambridge, Mass., launched an upgraded CFplus cystic fibrosis (CF) mutation analysis, which now includes testing for 97 mutations. Genzyme Genetics' new CFplus assay incorporates technology from Tm Bioscience which was developed in a collaborative effort.

• Vical Inc., of San Diego, was awarded a two-year, $2.9 million challenge grant from the National Institutes of Health's Institute of Allergy and Infectious Diseases. Funding under the grant will be released in stages contingent upon the achievement of development milestones, and would support the development of a DNA vaccine against naturally emerging or weaponized strains of avian influenza. The goal is to design a vaccine that could be developed and manufactured quickly and safely, without handling the infectious organism, and stockpiled longer than conventional vaccines.

• ZioPharm Inc., of New York, and EasyWeb Inc., of Englewood, Colo., completed their previously reported merger. Jonathan Lewis will serve as CEO and board member of ZioPharm Oncology, along with the remainder of the former board of ZioPharm. The company is in Phase I studies for two product candidates known as ZIO-101 and ZIO-201. ZIO-101 is the first of a new class of organic arsenicals. ZIO-201 is a formulation of isophosphoramide mustard, the active metabolite of ifosfamide.

• Zonagen Inc., of The Woodlands, Texas, said a study of its lead product, Proellex, in cyomolgus monkeys showed that Proellex and mifepristone suppressed progesterone's effects on tissues without any suppression of estrogen's effects, compared to Lupron (gonadotropin-releasing hormone agonist, TAP Pharmaceuticals Inc.), which suppresses both hormonal activities and potentially leads to adverse effects on bone. Proellex also showed an antiproliferative response in the uterine lining, and was apoptotic in the breast. Those data were presented at the 9th World Congress on Endometriosis in Maastricht, the Netherlands. Zonagen is planning upcoming trials of the drug in humans for uterine fibroids in the U.S. and for endometriosis in Europe, and is anticipating data from the trials in mid-2006.

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