• A.P. Pharma Inc., of Redwood City, Calif., said the multicenter Phase II study of APF112 to treat post-surgical pain is continuing to enroll patients. Recruitment in the first part of the study was slower than anticipated due to concerns that APF112 might interfere with the standard inguinal hernia repair surgery. Once clinical investigators completed several procedures using APF112, enrollment in the study increased, A.P. Pharma said.

• Aerogen Inc., of Mountain View, Calif., raised gross proceeds of $505,133 after closing a convertible debt financing with the Carpenter Family Trust, the trustees of which are Aerogen's chairman and CEO, Jane Shaw, and her husband, Peter Carpenter. Aerogen issued a secured convertible debenture with a face amount of $500,000, which bears annual interest at 10 percent and is due March 1. The conversion price of the debenture is about $3.04, which is equal to the five-day trailing average of the daily closing price of Aerogen's common stock.

• Antigenics Inc., of New York, said it plans to publicly offer about 5 million common shares pursuant to its existing shelf registration statement. UBS Securities LLC is acting as the offering's sole bookrunning manager, along with co-managers Needham & Co. Inc. and Ryan Beck & Co. Inc. Antigenics would grant the underwriters an overallotment option to purchase an additional 750,000 shares within 30 days after close.

• ArQule Inc., of Woburn, Mass., received a milestone payment from Wyeth Pharmaceuticals, a unit of Wyeth, of Madison, N.J. The milestone stems from Wyeth's investigational new drug application for a women's health compound, which was discovered through a collaborative program with ArQule, a five-year, $28 million agreement that involved access to ArQule's Mapping Array and Directed Array programs. (See BioWorld Today, July 11, 1997.)

• Atrix Laboratories Inc., of Fort Collins, Col., said that MediGene AG, of Martinsried, Germany, received marketing authorization in Germany for the company's three-month prostate cancer drug, Eligard. Last month, the company received approval in Germany for Eligard 7.5 mg dosed once monthly.

• AVI BioPharma Inc., of Portland, Ore., said positive results reported at the Midwinter Conference of Immunologists in Pacific Grove, Calif., demonstrate the therapeutic manipulation of the immune system using its Neugene antisense compounds. The study represents an approach to specific immunotherapy by clonally deleting activated lymphocytes responding to transplanted tissue. Neugene antisense drugs targeting an inhibitor of programmed cell death, or apoptosis, resulted in the elimination of the responding immune cells and acceptance of the transplant.

• Cephalon Inc., of West Chester, Pa., and CIMA Labs Inc., of Eden Prairie, Minn., said the Federal Trade Commission requested additional information pertaining to their pending merger, extending the waiting period during which the FTC is permitted to review the proposed transaction. The companies expect to close the $515 million transaction upon completion of the clearance process and the satisfaction of all other closing conditions contained in the merger agreement. Separately, Cephalon received FDA approval to market Provigil (modafinil [C-IV]) tablets to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder. The wake-promoting agent initially received approval in 1998 for improving wakefulness in patients with narcolepsy. (See BioWorld Today, Nov. 5, 2003.)

• Children's Hospital of Philadelphia researchers published findings in last month's issue of the Journal of Thoracic and Cardiovascular Surgery showing that children carrying the epsilon2 version of the apolipoprotein E (APOE) gene were significantly more likely to have worse neurodevelopmental outcomes at age 1, compared to children who also underwent surgery but did not have the epsilon2 gene variant. The epsilon2 gene variant may decrease the ability of neurons to repair themselves following open-heart surgery, with the result that children score lower in developmental evaluations of psychomotor skills. The variant occurs in about 8 percent of the population.

• ExonHit Therapeutics SA, of Paris, received recommendation by an independent data safety monitoring board to continue its clinical trial of Ikomio, a potential treatment for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The board said interim data raised no safety concerns, clearing the trial to proceed to its planned conclusion later this year. Survival is the primary endpoint of the 400-patient, double-blinded, randomized, placebo-controlled study. Ikomio or placebo is administered in addition to Rilutek (riluzole, Aventis SA), currently the sole approved drug for ALS. Ikomio appears well tolerated and does not alter the safety profile of Rilutek.

• GeneThera Inc., of Wheat Ridge, Colo., and UTEK Corp., of Plant City, Fla., signed a strategic alliance agreement to have UTEK find partners for GeneThera's technology in the U.S. and the UK. GeneThera has developed a system for the collection of blood and the testing of live cattle for mad cow disease.

• GenoMed Inc., of St. Louis, launched a free clinical trial for anyone with the common cold. GenoMed said it has genomic epidemiologic evidence that autoimmune diseases, such as allergic sinusitis, are associated with overactivity of angiotensin I-converting enzyme, or ACE. The company has been accumulating clinical evidence that blocking the major product of ACE, which is a small, eight-amino-acid hormone named angiotensin II, can decrease inflammation in a number of diseases, including viral diseases.

• GTC Biotherapeutics Inc., of Framingham, Mass., applied for European marketing approval for ATryn, its recombinant antithrombin product. The application seeks review through the centralized European procedure to market ATryn for patients with hereditary antithrombin deficiency, with an indication for prophylaxis of deep-vein thrombosis and thromboembolism in clinical risk situations such as surgical procedures or during labor and delivery.

• Health Discovery Corp., of Waco, Texas, signed its second biomarker and pathway discovery agreement with the University of Texas M.D. Anderson Cancer Center in Houston. The school granted the company a first option to obtain an exclusive worldwide royalty-bearing commercial license to commercialize any discovered prostate cancer biomarkers or pathways identified by the company using its Fractal Genomics Modeling techniques.

• Hemispherx Biopharma Inc., of Philadelphia, said results from an independent preclinical study published in this month's issue of Antimicrobial Agents and Chemotherapy suggested that Ampligen was effective in treating Coxsackie virus. Treatment in an animal model with the experimental compound decreased inflamed foci by about 98 percent and was 10 times superior to recombinant interferon (rIFN) and 15 times better than pegylated interferon (PEG-IFN), the standards of care for several human viral infections. Viral concentrations in the heart were decreased more than 99 percent by Ampligen and serial EKGs evidenced improved cardiac performance.

• Immtech International Inc., of Vernon Hills, Ill., completed a $5 million private placement financing. The offering of 200,000 Series D convertible preferred shares at $25 per unit was fully subscribed by private investors. In addition, Immtech received the first payment of $668,000 of a multimillion-dollar contract from Medicines for Malaria Venture (MMV) to develop a new malarial drug with MMV and a scientific consortium. The initial payment is for the company's DB289 Phase IIa malaria trial in Thailand, the cost of drug manufacture and the research to evaluate potential drug combinations to complement the activities identified in the Phase IIa trial. MMV will fund the complete clinical development of DB289 as a malarial drug, subject to milestone achievements.

• Immunomedics Inc., of Morris Plains, N.J., reported Phase II results at the GI Cancer Symposium of the American Society of Clinical Oncology in San Francisco, showing positive safety findings, an overall median survival of 54.2 months and a median disease-free survival of 18.4 months from a study involving 19 evaluable patients who had their liver metastases from colorectal cancer surgically removed. The study sought to determine the safety and efficacy of the company's humanized monoclonal antibody against a carcinoembryonic antigen called labetuzumab, labeled with therapeutic amounts of iodine-131 and given after attempted surgery of liver metastases.

• Ingenuity Systems, of Mountain View, Calif., said that Wyeth, of Madison, N.J., purchased its Ingenuity Pathways Analysis for use across the drug discovery and development chain. The technology is designed to enable biologists to explore, understand and discover therapeutically relevant networks significant to experiment results.

• Introgen Therapeutics Inc., of Austin, Texas, said findings from combination therapy with its cancer drug Advexin and conventional radiation were detailed at last week's Oncologic Interventional Radiology Symposium. In one Phase II study of patients with non-small-cell lung cancer, about 60 percent of their primary tumors regressed or disappeared after the combination therapy. Also, such therapy did not appear to increase the side effects caused by radiation treatment. Advexin remains in Phase III trials, and Introgen plans to submit a marketing application to the FDA later this year for head and neck cancer.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said findings from the first two Phase I and Phase I/II trials of NX-1207 confirmed a positive safety profile of the benign prostatic hyperplasia drug candidate. Most of the patients also had rapid improvement in their symptoms. Clinical improvement in both trials reached statistical significance, the company said, adding that the results will be sufficient to advance NX-1207 to a pivotal Phase II study.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., said it plans to publicly offer 3.5 million common shares pursuant to an effective registration statement. The company also intends to grant the offering's underwriters an option to purchase up to an additional 525,000 shares, all of which are being sold by Onyx. Morgan Stanley & Co. Inc., together with Piper Jaffray & Co., SG Cowen Securities Corp. and Leerink Swann & Co., are acting as the underwriters. Morgan Stanley will serve as the sole bookrunner.

• PharmaNetics Inc., of Raleigh, N.C., said a federal circuit court would hold a hearing in March in New Bern, N.C., relating to the company's lawsuit against Aventis Pharmaceuticals Inc., a subsidiary of Aventis SA, of Strasbourg, France. PharmaNetics also said it is reducing its work force by an additional 17 people to 38 employees.

• PhenoMed Sdn Bhd, of Kuala Lumpur, Malaysia, began clinical trials for infectious diseases, such as avian flu. The company's partner, GenoMed Inc., of St. Louis, believes it has discovered a way to accomplish the equivalent of vaccination against all viruses. The method involves blocking angiotensin II, which is being studied by the National Institute of Allergy and Infectious Diseases in Bethesda, Md., to test the company's compounds against influenza and severe acute respiratory syndrome.

• Protein Design Labs Inc., of Fremont, Calif., received payments in excess of $2 million related to the exercise of licenses under the company's antibody-humanization patents for Xolair and Raptiva antibody products belonging to Genentech Inc., of South San Francisco. Each party may obtain nonexclusive licenses under the other company's patents or applications subject to certain conditions such as a license fee of up to $1 million per antibody.

• QLT Inc., of Vancouver, British Columbia, said its registration statement was declared effective with respect to the resale of its $172.5 million worth of 3 percent convertible senior notes due 2023, as well as the common shares issuable thereunder. QLT, which will not receive any proceeds from the resale of the notes and underlying common shares, specializes in the development of therapies to treat cancer, eye diseases and niche areas for which treatments can be marketed by a specialty sales force.

• The Quigley Corp., of Doylestown, Pa., said its compound QR-435 has shown virucidal and virtustatic activity against the 3B strain of HIV Type I (HIV-1) in an in vitro study. The independent study was conducted by Retroscreen Virology Ltd., an affiliate of the University of London. Based on the results, the company plans to proceed to a confirmatory in vitro study with additional dilution levels to fully explore the capabilities of QR-435.

• Ricerca Biosciences LLC, of Concord, Ohio, and the Cleveland Clinic entered an agreement to collaborate on the initial development of a targeted drug therapy that uses cobalamin, or vitamin B12, as the carrier of a cancer-killing agent. The parties jointly will conduct preclinical testing and toxicology studies of the vitamin B12 compound and eventually apply to begin a Phase I trial of the candidate. They plan to partner the compound for later-stage development and marketing.

• Rigel Pharmaceuticals Inc., of South San Francisco, reported positive clinical safety data from a Phase I trial of R803, indicating that the investigational hepatitis C virus drug is well tolerated. There were no notable adverse effects in the dose levels that the company plans to use moving forward. Rigel plans to launch a Phase I/II efficacy trial in the U.S. next quarter to monitor viral clearance and safety over several days of drug administration.

• Sanofi-Synthelabo SA, of Paris, said it is making a $60 billion share and cash offer to take over all the shares of Aventis SA, of Strasbourg, France. The offer includes a 15.2 percent premium based on the average share price over the month ended Jan. 21, valuing each Aventis share at €60.43. Sanofi, which has unanimous approval from its board members, filed necessary documents in Paris and will file additional documents in the coming days in the U.S. and Germany. Sanofi said completion of the transaction would create the largest pharmaceutical group in Europe and third biggest in the world, with pro forma 2002 consolidated sales of €25 billion in core business and a direct presence in all major world markets. The combined entity's headquarters would be in Paris.

• United Therapeutics Corp., of Silver Spring, Md., completed a study in normal volunteers establishing the bioequivalence of Remodulin when delivered intravenously instead of subcutaneously. Remodulin is approved by the FDA as a subcutaneous therapy to treat pulmonary arterial hypertension. The company expects to file a supplemental new drug application within 30 days.

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