• Acadia Pharmaceuticals Inc., of San Diego, achieved a milestone in its collaboration with Allergan Inc., of Irvine, Calif., to discover, develop and commercialize selective muscarinic drugs for the treatment of glaucoma. The milestone was triggered by Allergan's selection of a compound for further development and commercialization. The program comes from Acadia's discovery of chemical leads that selectively target the muscarinic receptor responsible for the lowering of intraocular pressure, while avoiding interaction with other targets believed to cause side effects.

• Access Pharmaceuticals Inc., of Dallas, formed a licensing agreement with Wyeth Consumer Healthcare, a division of Wyeth, of Madison, N.J., which gains North American rights to develop and market an over-the-counter product using Access' OraDisc technology. The agreement covers marketing rights in the U.S., Canada and Mexico, with an option to extend the rights worldwide. Wyeth will pay Access an up-front licensing fee, and Access is entitled to milestone payments. Wyeth will purchase the finished product from Access for sale in the territories. The OraDisc technology overcomes problems associated with products applied to the mucous membrane, including localizing the release of the drug at the desired site, Access said.

• Advancis Pharmaceutical Corp., of Germantown, Md., achieved the first milestone in a collaboration with GlaxoSmithKline plc, of London. As a result, Advancis received a payment of $3 million from GSK, bringing the total payments received under the collaboration to $8 million. Advancis and GSK entered into a licensing agreement in which Advancis licensed patents and Pulsys technology for use with a major GSK product.

• Amylin Pharmaceuticals Inc., of San Diego, said Swiss authorities will not approve Symlin based on data it has received. The Swiss Agency for Therapeutic Products said it requires additional clinical information demonstrating the benefits relative to risks associated with adverse events, such as nausea and hypoglycemia. Amylin submitted the application in August 2001 and submitted a response to inquiries last March. Swiss regulatory procedure does not permit another supplemental submission; therefore, Amylin has withdrawn its application.

• Antares Pharma Inc., of Exton, Pa., signed a development and licensing option agreement with ProSkelia SAS, of Paris, for the development and future licensing of products using Antares Pharma's ATD gel technology. The products will contain an undisclosed ProSkelia compound in clinical development, and will use the ATD gel technology for delivery. Financial terms were not disclosed.

• AspenBio Inc., of Castle Rock, Colo., completed a private placement of about 1.1 shares of stock at $1 per share. Placement agent for the transaction was Berry Shino Securities. AspenBio is focused on the creation of patentable products and has a core antigen business.

• AstraZeneca Inc., of Wilmington, Del., said Phase II data on Iressa, published this week in the Journal of Clinical Oncology, showed that none of the glioblastoma patients had either complete response or partial response. In total, 51 out of 53 patients eventually developed progressive disease. The median duration of event-free survival was 8.1 weeks, while the median overall survival time was 39.4 weeks. Adverse events included skin reactions and diarrhea.

• Atrix Laboratories Inc., of Fort Collins, Colo., said its partner, Pfizer Inc., of New York, completed initial clinical testing of CP-533,536 and is advancing the product into additional clinical testing. The compound was formulated with the Atrigel sustained-release drug delivery system, and Atrix continues to support its development through production of clinical supplies and consultation.

• BioMimetic Pharmaceuticals Inc., of Franklin, Tenn., formed a worldwide strategic alliance with Luitpold Pharmaceuticals Inc., a subsidiary of Tokyo-based Sankyo Co. Ltd., to research, develop, market and manufacture the periodontal product GEM 21S. The alliance is expected to generate $150 million in revenues for BioMimetic, which will cover research and development expenses, marketing assistance and milestone payments. BioMimetic also will receive a low double-digit royalty on sales.

• Biopure Corp., of Cambridge, Mass., met with the FDA to discuss the biologics license application for Hemopure to treat acutely anemic orthopedic surgery patients and to eliminate or reduce allogeneic red-blood-cell transfusions in those patients. The FDA expressed safety and efficacy concerns about the BLA but agreed to continue discussions. It also asked Biopure to provide results of three preclinical studies, which could take about six months to complete. Once the FDA reviews the studies, as well as Biopure's responses to issues raised by the FDA, the agency will determine whether additional clinical trials are required. Class-action lawsuits were filed against the company on Thursday by stockholders who purchased the company's stock between March 17 and Dec. 24, alleging the company failed to disclose FDA safety concerns to the investing public. The lawsuits also state that the company conducted at least two offerings of stock during that time, with insiders selling hundreds of thousands of shares at inflated prices.

• Cell Therapeutics Inc., of Seattle, reported preclinical data at the International Symposium on Polymer Therapeutics in Cardiff, Wales, showing that Xyotax patients have about 100 times less free paclitaxel in their bloodstream than patients receiving an equivalent dose of marketed paclitaxel products. The product, in Phase III development for non-small-cell lung cancer and entering Phase III for ovarian cancer, links paclitaxel to a water soluble, biodegradable, polyglutamate polymer. Separate preclinical data reported on CT-2106 show early evidence of antitumor activity and predictable toxicity for the polymer-linked camptothecin, which is expected to enter Phase II trials this year.

• Cellegy Pharmaceuticals Inc., of South San Francisco, completed patient testing in the U.S. and Europe in its Phase III trial of Cellegesic, nitroglycerin ointment, to treat pain associated with chronic anal fissures. The company expects to release study results next month.

• Celltech Group plc, of Slough, UK, achieved a milestone in its agreement with Amgen Inc., of Thousand Oaks, Calif., for the research, development and global commercialization of treatments for osteoporosis using Celltech's antibody fragment technology, which aims to identify antibody fragments against sclerostin, a protein discovered by Celltech. Sclerostin is involved in the regulation of bone deposition, and it is believed that by inhibiting the protein, bone loss in osteoporosis patients might be reversed.

• Celsion Corp., of Columbia, Md., reported plans to undertake clinical trials to treat liver cancer. On Dec. 22, Celsion filed an investigational new drug application with the FDA for the use of ThermaDox, Celsion's temperature-sensitive liposomal formulation, which encapsulates doxorubicin. The Phase I study will be conducted at the National Institutes of Health Clinical Center in Bethesda, Md.

• Chiron Corp., of Emeryville, Calif., said it decided to expand its program evaluating the efficacy of Proleukin interleukin-2 and rituximab in patients with low-grade non-Hodgkin's lymphoma. Chiron will increase enrollment in its Phase II study, expecting to complete the enrollment this year. The study so far has evaluated 29 patients.

• Connetics Corp., of Palo Alto, Calif., completed enrollment in its two Phase III trials for Velac gel, a first-in-class combination of 1 percent clindamycin and 0.025 percent tretinoin, for the treatment of acne. The trials include an aggregate of 2,218 patients who will be treated for 12 weeks at 37 centers. Connetics anticipates data from the trial will be available in the second quarter.

• Corautus Genetics Inc., of Atlanta, signed a manufacturing agreement with Qiagen NV, of Venlo, the Netherlands, and Strathmann Biotech AG, of Hamburg, Germany, to produce VEGF-2 plasmid for Phase III trials and future commercial use. The VEGF-2 plasmid will be produced at Strathmann's facility in Dengelsberg, Germany.

• Covalent Group Inc., of Wayne, Pa., signed a $1.1 million contract with DynPort Vaccine Co. LLC, of Frederick, Md., for a Phase I study in the development of a recombinant vaccine designed to provide protection against botulinum neurotoxin. At the same time, the company said it formed a global counter-bioterrorism initiative to focus on the development of vaccines against biologic agents with potential military and terrorism applications.

• Dharmacon Inc., of Lafayette, Colo., and the University of Massachusetts Medical School in Worcester, Mass., entered a collaboration to use RNA interference to study obesity and diabetes. Dharmacon will design and supply siRNA reagents for studies that will be used to assess several thousand gene targets over a three-year period. UMMS will share study data with Dharmacon to provide the company with evidence of the effectiveness of Dharmacon's siRNA technologies. Financial terms of the agreement were not disclosed.

• Diversa Corp., of San Diego, was awarded $2.3 million from the U.S. Department of Defense's Chemical and Biological Defense Initiatives Fund to support the first year of a potential multiyear biodefense project. Diversa plans to work with Agentase LLC and Life Science Research Israel Ltd. to develop an environmentally benign, enzyme-based system that is capable of decontaminating a spectrum of both chemical and biological warfare agents. Diversa will apply its discovery and evolution technologies to identify and optimize enzyme leads demonstrating active decontamination against a range of chemical and biological warfare agents.

• Favrille Inc., of San Diego, completed enrollment for its Phase II trial with its lead investigational agent, FavId. The agent is under development for follicular B-cell lymphoma following cytoreductive therapy with Rituxan. The trial includes 90 evaluable patients with follicular non-Hodgkin's lymphoma. It is designed to evaluate the ability of patients to mount an immune response to their tumor and the potential for FavId to enhance the response rate or prolong the time to progression following Rituxan treatment.

• Gene Logic Inc., of Gaithersburg, Md., said that Sumitomo Pharmaceuticals Co. Ltd., of Tokyo, renewed its agreement with Gene Logic for three years to use Gene Logic's information services in Sumitomo's pharmaceutical research and development programs. Sumitomo will retain access to the comprehensive gene expression data in Gene Logic's BioExpress database. In addition, it will obtain limited-seat access to the newer Ascenta system as an additional research tool. Financial details of the renewal agreement were not disclosed.

• GenVec Inc., of Gaithersburg, Md., entered a research collaboration with Cordis Corp., of Miami Lakes, Fla., to study the clinical benefit of Biobypass in a procedure involving guided delivery of the angiogenic agent directly into targeted regions of the heart in severe coronary artery disease patients using the Cordis Nogastar Mapping Catheter and Myostar Injection Catheter. The randomized, double-blinded, placebo-controlled, Europe-based study is expected to enroll up to 125 patients. Both parties will collaborate on regulatory matters and share clinical trial costs, and will retain all rights to their respective products. Cordis is a unit of Johnson & Johnson, of New Brunswick, N.J.

• GlycoGenesys Inc., of Boston, entered definitive agreements to raise about $4.3 million in proceeds from institutional and accredited investors. The company will issue about 3.5 million shares of common stock at $1.25 per share and issue warrants to purchase 962,500 shares of common stock at an exercise price per share of $2.70, exercisable for a period of five years. In addition, the company will issue warrants to purchase about 1.4 million and 340,000 shares of common stock at $1.25 and $1.47 per share respectively, each exercisable for a period ending 60 days following the effectiveness of a shelf registration.

• Hemispherx Biopharma Inc., of Philadelphia, said it is accelerating its experimental severe acute respiratory syndrome treatment, including preparation of the clinical investigator's brochure and related packaging/labeling materials. The company plans to pursue clinical activities surrounding Oral Alferon, which is believed to work by stimulating an immune cascade, enabling or bolstering immune defenses against various viral strains and subtypes. In December, the company reported the beginning of a strategic program with Aplicare Inc., of Branford, Conn., to package more than 100,000 sachets of its experimental immunotherapeutic Alferon LDO as a topically applied antiviral for SARS.

• Human Genome Sciences Inc., of Rockville, Md., began dosing patients in a Phase II trial of LymphoStat-B (human monoclonal antibody to B-lymphocyte stimulator, BlyS) for the treatment of rheumatoid arthritis. The trial will evaluate LymphoStat-B in about 230 patients with active rheumatoid arthritis who have failed prior therapy.

• Ingenium Pharmaceuticals AG, of Munich, Germany, and the University of Cambridge in the UK are part of an international consortium of academic and industry participants that will receive €11.7 million over five years as part of a European community Sixth Framework grant to discover genetic targets for obesity. The funding will support the discovery of four to five drug targets for the treatment and prevention of obesity and its complications, including Type II diabetes.

• Insmed Inc., of Richmond, Va., and the University of Rochester School of Medicine in New York initiated a collaboration to explore the efficacy of Insmed's rhIGF-I/rhIGFBP-3 (SomatoKine) to treat myotonic dystrophy. The university will receive up to $1 million in federal funding through the Bethesda, Md.-based National Institutes of Health for five years, and up to $500,000 per year from the Muscular Dystrophy Association for three years, for a total of up to $6.5 million.

• InterMune Inc., of Brisbane, Calif., said the New England Journal of Medicine published previously reported results of its first Phase III trial of Actimmune (interferon gamma-1b) for idiopathic pulmonary fibrosis. The company said the data warranted further investigation of the product, and, as such, formed the basis for its recently initiated 600-patient trial called INSPIRE, a randomized, double-blinded, placebo-controlled, pivotal study that enrolled its first patient last month. Actimmune already is approved for chronic granulomatous disease and severe malignant osteopetrosis. InterMune's stock (NASDAQ:ITMN) dropped $2.50 Thursday, or 10.2 percent, to close at $22.05.

• Invitrogen Corp., of Carlsbad, Calif., said that Baseball Acquisition Corp., its wholly owned subsidiary, began a cash tender offer for all of the outstanding shares of BioReliance Corp., of Rockville, Md., for $48 per share. BioReliance advised Invitrogen that the BioReliance board approved the acquisition and recommends that BioReliance stockholders accept the tender offer.

• Merial Ltd., of Duluth, Ga., released its Recombitek equine vaccine for West Nile virus. The product uses recombinant DNA technology to stimulate a multifaceted immune response demonstrated against natural mosquito challenge of the virus.

• NeoPharm Inc., of Lake Forest, Ill., said it plans to offer 3.5 million common shares through an underwritten public offering under its existing shelf registration statement. The company also intends to grant a 525,000-share overallotment option to its underwriters. NeoPharm is selling all the shares. UBS Securities LLC is acting as the offering's sole book-running manager, with co-management from Robert W. Baird & Co. Inc., First Albany Capital Inc. and JMP Securities LLC. NeoPharm's stock (NASDAQ:NEOL) dropped $2.11 Thursday, or 11.8 percent, to close at $15.82.

• Neurion Pharmaceuticals Inc., of Pasadena, Calif., agreed with New York-based Pfizer Inc. to renew and expand a research collaboration initiated in December 2002, which will now continue through this year and include modeling of drug binding to the HERG potassium ion channel. It also will involve new evaluation of Pfizer compounds using Neurion's NP2 technology.

• NicOx SA, of Sophia Antipolis, France, said NCX 4016 reached its primary efficacy endpoint in a Phase IIa study in patients with symptomatic peripheral arterial obstructive disease. NCX 4016 is a nitric oxide-donating derivative of aspirin in development for the prevention and treatment of cardiovascular diseases. The study, conducted in Italy, showed NCX 4016 had statistical significance in reversing endothelium dysfunction induced by physical exercise.

• NitroMed Inc., of Bedford, Mass., received a $3 million up-front payment after extending its exclusive worldwide research, licensing and commercialization agreement with Boston Scientific Corp., of Natick, Mass., for the development of nitric oxide-coated stents to complement the latter's paclitaxel-coated stent. Both companies will continue to develop and advance nitric oxide-releasing compounds that can be incorporated onto stents to treat a variety of vascular diseases. The extension continues the research and development collaboration through 2005, building on the original 2001 agreement. Terms include milestone payments as well as royalties on any resulting product sales. Prior to the extension, NitroMed received $1.5 million in research and development funding and $4 million in equity investments from Boston Scientific.

• NV Organon, of Oss, the Netherlands, and Paris-based Sanofi-Synthelabo SA agreed to revise the terms of their collaboration on antithrombotic Arixtra and certain other oligosaccharides. Organon will transfer to Sanofi its remaining rights for Arixtra and its development obligations for Arixtra and other oligosaccharides in exchange for revenues based on future sales.

• Perlegen Sciences Inc., of Mountain View, Calif., entered a collaboration with Pfizer Inc., of New York, to analyze drug response in patients with major depression. Perlegen will use its technology to genotype single nucleotide polymorphisms in clinical samples to identify genetic markers associated with drug response. Both parties will share resulting therapeutic and diagnostic rights. Pfizer will provide research funding support to Perlegen, in addition to undisclosed milestone payments and licensing terms.

• Pro-Pharmaceuticals Inc., of Newton, Mass., initiated a Phase II study of its lead carbohydrate compound, Davant, with 5-Fluorourcil (5-FU) in refractory colorectal cancer patients. The trial is part of an open-label, single-dose study in patients with metastatic colorectal cancer who have failed standard surgical, radiation and chemotherapeutic regimens. The study will evaluate the efficacy and safety of intravenous Davant in combination with 5-FU when administered in monthly cycles as the third-line therapy for metastatic colorectal cancer.

• Sepracor Inc., of Marlborough, Mass., extended until Feb. 6 its overallotment option connected to its private placement in December of $200 million of 0 percent Series A convertible subordinated notes due 2008, and $400 million of Series B notes due 2010. The purchasers had until Jan. 7 to buy up to an additional $50 million in Series A notes and $100 million in Series B notes.

• Targeted Genetics Corp., of Seattle, was granted a three-year extension in its collaboration with the International AIDS Vaccine Initiative (IAVI) and Columbus Children's Research Institute at Children's Hospital in Ohio to develop an AIDS vaccine. The company will receive up to $10.7 million in funding this year. It will support manufacturing of clinical supply costs, as well as preclinical studies. IAVI will fund clinical trials of tgAACO9, a recombinant adeno-associated virus-based AIDS vaccine candidate, which is in a Phase I study.

• Third Wave Technologies Inc., of Madison, Wis., extended its multiyear partnership with BML Inc., of Tokyo, a clinical reference lab, for a minimum of one year. The companies will continue their collaboration to commercialize molecular diagnostic tests for infectious disease, genetic testing and pharmacogenomics. Third Wave and BML in December 2000 entered a development and commercialization agreement.

• Unigene Laboratories Inc., of Fairfield, N.J., received an approvable letter from the FDA for Fortical, its calcitonin nasal spray for the treatment of osteoporosis. Upsher-Smith Laboratories Inc., of Plymouth, Minn., will market the product once it's approved. The company's stock (OTC BB:UGNE) rose 9 cents Thursday, or 13.2 percent, to close at 77 cents.

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