• Alliance Pharmaceutical Corp., of San Diego, said its wholly owned subsidiary, PFC Therapeutics LLC, agreed to modify its exclusivity agreement with LEO Pharma A/S, of Ballerup, Denmark, related to the development and marketing of Oxygent in Europe and Canada. The amendment extends the deadline for LEO to complete due diligence, from March 1 to 60 days following PFC's submission to LEO of results of a proof-of-concept study in surgery patients. Oxygent is a synthetic oxygen therapeutic being developed to help avoid red-blood-cell transfusions during surgery.

• Amgen Inc., of Thousand Oaks, Calif., said its paying agent, LaSalle Bank National Association, reported that about $1.59 billion in aggregate principal amount at maturity of its liquid yield option notes (LYONs) due 2032 were validly surrendered for purchase and not withdrawn. Amgen said it purchased those LYONs, leaving about $2.36 billion in principal outstanding. The holders' option to surrender the notes for repurchase expired March 1 at 5 p.m. The purchase price was $738.68 in cash per $1,000 in principal amount at maturity, and the aggregate purchase price for all notes validly surrendered and not withdrawn totaled about $1.17 billion. The company has paid the aggregate purchase price in cash from existing cash balances.

• Bionomics Ltd., of Adelaide, Australia, completed the acquisition of the French central nervous system business Neurofit for €1.25 million (US$1.6 million) in cash and shares. The acquisition includes intellectual property rights to Bionomics for the Parkinson's disease animal model developed by the Institut Pasteur. Bionomics said it intends to grow Neurofit's revenues while using the French company's CNS knowledge to enhance its development programs.

• BioSeek Inc., of Burlingame, Calif., received a milestone payment in its collaboration with Dynavax Technologies Corp., of Berkeley, Calif. BioSeek used its BioMAP Systems to characterize the biological activity of a new family of TNF-alpha inhibitors, known as thiazolopyrimidines, on which Dynavax is conducting research for chronic inflammatory diseases. BioSeek is eligible for additional milestone payments and royalties on future product sales, though specific financial terms were not disclosed.

• CepTor Corp., of Hunt Valley, Md., granted an exclusive 15-year license to JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan, to develop and commercialize its muscular dystrophy product, Myodur, in the Pacific Rim, which includes Japan, South Korea, China, Taiwan and Singapore. The licensing agreement provides for equity payments and milestone payments, as well as double-digit royalties to CepTor from product sales. CepTor said it is moving Myodur into Phase I/II trials for Duchenne's muscular dystrophy.

• Cresset BioMolecular Discovery Ltd., of Hertfordshire, UK, agreed to collaborate with Royston, UK-based Pharmagene plc to find leads against one of Pharmagene's drug discovery targets. Cresset will use its computational field technology to generate electrostatic and surface-property molecular fields for known active compounds against Pharmagene's target, and then use them to create templates for identifying active compounds. Financial details were not disclosed.

• CytoGenix Inc., of Houston, said an animal study demonstrated that Simplivir (CY301) reduced the size of herpes skin lesions compared to placebo. In the study, Simplivir was applied to the herpes-infected skin of guinea pigs twice daily for three days. The company said results showed a reduction in the total lesion area, as well as a reduction in the amount of herpes virus observed. CytoGenix said it expects to move into additional studies to optimize dosage levels and timing of therapy.

• Forest Laboratories Inc., of New York, said the FDA issued a second non-approvable letter for Lexapro in the indication of panic disorder. The company said the letter was pursuant to its response to the first non-approvable letter that raised issues relating to methods and statistical analyses performed for the two placebo-controlled trials of the SSRI antidepressant. Forest is reviewing the letter to determine the appropriate action. Lexapro is indicated for the treatment of major depressive disorder and for generalized anxiety disorder in adults.

• GenVec Inc., of Gaithersburg, Md., began a Phase IIb trial of its Biobypass angiogen for the treatment of severe coronary artery disease. Dubbed NOVA (NOGA Delivery of VEGF for Angina), the randomized, placebo-controlled study is designed to evaluate the product's effects on exercise tolerance, heart function, symptoms and quality of life in about 129 patients suffering from moderate to severe chest pain due to advanced coronary artery disease. The company expects about 15 centers in Europe and Israel to participate in the study, which is being conducted under a collaboration with the cardiology division of Cordis Corp., a unit of Johnson & Johnson, of New Brunswick, N.J.

• Millenia Hope Inc., of Montreal, said it is finalizing its sponsorship of an anti-malarial study to start this year. The company said it would be a first-in-man study based on its newly acquired therapeutic molecule, Tranex18, and it will focus on developing the molecule for treating malaria and other diseases, with specific emphasis on the drug-resistance mechanism in chloroquine-resistant Plasmodium falciparum.

• Neurocrine Biosciences Inc., of San Diego, reported Phase I results showing that NBI-56418 was safe and well tolerated in 60 healthy premenopausal women, and the drug demonstrated a dose-dependent suppression of estradiol that was observed throughout the duration of dosing. NBI-56418 is an orally active, gonadotropin-releasing hormone receptor antagonist. Based on the data, the company selected doses for a Phase II study evaluating the small molecule in patients with endometriosis. It is expected to begin next quarter.

• New River Pharmaceuticals Inc., of Radford, Va., said its lead drug, NRP104, for attention deficit hyperactivity disorder met its primary endpoint in a Phase II study. The company said patients receiving the drug showed a statistically significant improvement, according to the SKAMP-Deportment rating scale, the primary efficacy endpoint, as compared to those receiving placebo. The therapeutic effects also indicated drug action duration of 12 hours. Results were presented Tuesday at the Wells Fargo Securities Healthcare Conference.

• Nutra Pharma Corp., of Boynton Beach, Fla., said contract researcher Eno Research and Development Inc. completed the analysis of a series of microarray studies with RPI-78M in the gene expression of cells from multiple sclerosis patients. RPI-78M is the lead drug candidate of Nutra's minority holding, ReceptoPharm Inc., and is being studied in preclinical assays for its efficacy in treating MS. Eno analyzed immune cells and brain lesions of MS patients, with and without the addition of RPI-78M, to measure changes in gene expression. After statistical evaluation of the data, researchers reported finding more than 60 genes with significant changes in expression compared to the control, and said at least 30 might have a specific role in the progression and symptoms of the disease.

• Oxford BioMedica plc, of Oxford, UK, reported positive results from three ongoing Phase II trials of TroVax, its lead cancer immunotherapy, in the treatment of metastatic colorectal cancer. In two trials using the drug in a first-line setting in combination with chemotherapy, primary endpoints of safety and immunological responses were achieved. All 25 patients evaluable for immunological response mounted responses to the 5T4 tumor antigen, and 18 of 19 patients evaluable for tumor responses responded to treatment. Analysis of the first evaluable patients in the third Phase II trial showed that all patients mounted an immune response against the target tumor antigen.

• Procyon Biopharma Inc., of Montreal, entered a licensing and distribution agreement with Medicorp Inc., also of Montreal, to allow Medicorp exclusive worldwide rights to develop, manufacture and commercialize PSP94-based test kits for research purposes, as well as rights to sublicense for clinical diagnostic applications. The companies will share revenue generated from product sales, as well as revenues from up-front, milestone and royalty payments from sublicensing agreements.

• Sinovac Biotech Ltd., of Beijing, extended the expiration date of warrants issued in the private placement that closed Feb. 24 until April 30, in order to raise additional capital. The exercise price of the warrants, starting at $1.70 per share, will increase 5 cents each month beginning March 15. To date, Sinovac has received proceeds of more than $3.4 million, and could receive up to an additional $3.7 million if the remaining outstanding warrants are exercised. The company said it anticipates proceeds to help fund the construction of influenza vaccine production facilities.

• Speedel Group, of Basel, Switzerland, said Phase IIb data showed that all dose groups of SPP301 showed a statistically significant decrease in the albumin excretion rate compared to placebo, the primary endpoint of the 286-patient diabetic nephropathy study. The decrease was greater in the two higher dose groups compared to the two lower dose groups. Also, the drug reduced proteinuria by more than 30 percent on top of standard treatment for 55 percent of patients across all dose groups. In Phase IIa, clinically relevant efficacy with SPP301 was seen after four weeks of treatment. Speedel plans to advance SPP301, a once-a-day oral endothelin A receptor antagonist, into Phase III in the second half of this year.

• Targent Inc., of Princeton, N.J., said the FDA authorized the transfer of two orphan drug designations to its lead oncology candidate, Isovorin (L-leucovorin), for the treatment of colon cancer with 5-fluorouracil and for use in conjunction with methotrexate for osteosarcoma. Isovorin already is on the market in many European Union countries and in Japan.

• Techne Corp., of Minneapolis, repurchased about 2.9 million shares for $100 million. The buyback represents about 7 percent of its outstanding common stock. The company has two operating subsidiaries: Research and Diagnostic Systems Inc., a manufacturer of biological products, and R&D Systems Europe Ltd., a distributor of biotechnology products.

• Theravance Inc., of South San Francisco, said a paper describing the multifunctional mechanism of action of its lead product, telavancin, was published in the March 2005 issue of Antimicrobial Agents and Chemotherapy. The paper states that the activity of telavancin, a bactericidal injectable antibiotic, results from interaction with D-Ala-D-Ala-containing peptidoglycan intermediates that leads, at submicromolar concentrations, to inhibition of the transglycosylation step of peptidoglycan synthesis during cell-wall synthesis. Researchers said the mechanism of action provides for the pharmacodynamic activity and low potential for resistance to the drug. Telavancin is in Phase III studies to compare its efficacy to vancomycin in hospital-acquired pneumonia and complicated skin and skin-structure infections.

• UCB Group SA, of Brussels, Belgium, and ChemBridge Corp., of San Diego, agreed to a collaboration that will advance UCB's drug discovery efforts, based on multiple discovery chemistry projects by ChemBridge scientists funded by UCB. UCB said it will provide validated drug targets and use ChemBridge's expertise in discovery chemistry to push its lead-generation process in neurological diseases. Further details and financial terms were not disclosed.

• Valeant Pharmaceuticals International, of Costa Mesa, Calif., completed its acquisition of San Diego-based Xcel Pharmaceuticals Inc., following the early termination by the U.S. Federal Trade Commission of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976. Valeant said the acquisition is expected to expand its U.S. business by $60 million from in-market products and help grow its neurology franchise. The $280 million acquisition was announced last month. (See BioWorld Today, Feb. 4, 2005.)