• aaiPharma Inc., of Wilmington, N.C., said it would not file its 2003 Form 10-K within the previously provided 15-day extension period, resulting in a default under its senior secured credit facility. Nasdaq notified aaiPharma that the delay means it is not in compliance with listing rules and its common stock is subject to delisting on April 8, unless the company requests a hearing pursuant to Nasdaq rules. AaiPharma acknowledged that it might receive a subpoena from the SEC and/or the U.S. Attorney's Office relating to unusual pharmaceutical product sales activities in the second half of last year, which the company is looking. AaiPharma's stock (NASDAQ:AAII) dropped $1.55 Wednesday, or 19 percent, to close at $6.63.

• Accelrys Inc., of San Diego, released two new products, including Topkat 6.2, a software tool for predicting the toxicity of potential drug compounds. It also released its Accord Chemistry Software Development Kit 6.0, the latest version of the company's programmers' toolkit for chemical data-management applications. Accelrys is a wholly owned subsidiary of Pharmacopeia Inc., of Princeton, N.J.

• AEterna Laboratories Inc., of Quebec City, Quebec, adopted a shareholder rights plan to provide adequate time for its board and shareholders to assess any unsolicited takeover bids, sufficient time to explore and develop alternatives for maximizing shareholder value if a bid is made, and give shareholders an equal opportunity to participate in a bid. The company said it is not adopting the plan in response to any specific proposal.

• Affymetrix Inc., of Santa Clara, Calif., said a team of researchers from SUNY Upstate Medical University in Syracuse, N.Y., the Department of Veterans Affairs in Washington, the University of Coimbra in Portugal, and the Broad Institute and the Whitehead Institute, both at the Massachusetts Institute of Technology in Cambridge discovered new evidence for whole-genome linkage in bipolar disorder. The study on the psychiatric disease is one of the first published using the GeneChip Mapping 10K Array. The study will be published in next month's issue of the American Journal of Human Genetics.

• Agendia BV, of Amsterdam, the Netherlands, closed a Series A financing round led by Gilde Investment Management, of Utrecht, the Netherlands. Global Life Science Ventures and AXA Private Equity Venture Funds also participated. The company will use funds to market its microarray-based breast cancer test and to develop microarray-based diagnostic tests for other cancers based on gene expression profiles. Agendia is a pharmacogenomics company founded by scientists from the Netherlands Cancer Institute in Amsterdam. Wim van Harten and Pieter van der Meer, of Gilde Investment Management, are joining the company's board. The amount raised in the financing was not disclosed.

• Amylin Pharmaceuticals Inc., of San Diego, plans to privately place $150 million of convertible senior notes. The notes, due in 2011, would be convertible into shares of Amylin common stock. Amylin intends to use the net proceeds to continue research and development, fund operating expenses, establish manufacturing sources and inventory, pursue regulatory approvals and expand its commercialization capabilities.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said Boston Scientific Corp., of Natick, Mass., concluded enrollment in its Taxus V de novo lesion clinical trial. It expands on the Taxus IV trial, which established the safety and efficacy of the Taxus Express(2) paclitaxel-eluting stent system, to which Angiotech contributed the drug. Final results are expected early next year.

• Avanir Pharmaceuticals Inc., of San Diego, completed patient enrollment in its second pivotal Phase III trial evaluating Neurodex for the treatment of pseudobulbar affect (PBA) in patients with neurological disorders. The trial, which exceeded its patient enrollment goal, is being conducted in patients suffering from multiple sclerosis who also have PBA. The primary endpoint is the change in a subject's score on the CNS-Lability Scale compared to a baseline score prior to treatment. Results of a previous Phase III study of PBA in patients with amyotrophic lateral sclerosis were positive, with statistical significance achieved in the primary and all secondary endpoints. (See BioWorld Today, Nov. 20, 2002.)

• Bionomics Ltd., of Adelaide, Australia, and Southern Cross University in Lismore, Australia, established a collaboration to discover new drugs targeting epilepsy and anxiety. Under the terms, SCU will provide Bionomics with extracts from its collection of Australian-based natural products, together with expertise in natural products chemistry. Bionomics will screen for activity against biological targets associated with the two indications, and will use SCU's natural products library and chemistry know-how to support its drug discovery program.

• Cellegy Pharmaceuticals Inc., of South San Francisco, filed for an extension from the SEC for its annual report on Form 10-K for the year ended Dec. 31. The company changed its independent auditors during the fourth quarter and recently announced a restatement of its financial statements for 2002 and the first three quarters of 2003.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said its independent auditor removed a going-concern qualification from a report for fiscal year 2003. The company operates as a life sciences contract research organization and biotechnology firm.

• Epimmune Inc., of San Diego, received a two-year Phase I grant for a potential $600,000 from the National Cancer Institute in Bethesda, Md., to define and conduct preclinical testing of a multi-epitope clinical candidate vaccine for ovarian and breast cancer. The company will collaborate with the University of Washington to design a vaccine to induce helper-T-cell responses against multiple tumor-associated antigens in order to prevent or delay disease recurrence following surgery and chemotherapy.

• First Horizon Pharmaceuticals Corp., of Alpharetta, Ga., registered with the SEC for security holders to sell up to $150 million worth of 1.75 percent convertible notes. The sales are being registered pursuant to an agreement with the initial purchasers of the notes; the company will not receive proceeds from such sales.

• Gastrotech Pharma A/S, of Copenhagen, Denmark, entered an agreement with Eli Lilly and Co., of Indianapolis, to continue the development of peptides that treat irritable bowel syndrome (IBS) and functional dyspepsia. Gastrotech will continue the ongoing double-blind, placebo-controlled Phase II trial of a glucagon-like peptide-1 (GLP-1) analogue in IBS patients with moderate to severe pain, in five medical centers in Sweden and Denmark. Lilly will manufacture the compound and has an option to further develop and commercialize products under the agreement. Specific financial terms were not disclosed, but Gastrotech could receive milestone payments and royalties.

• Genentech Inc., of South San Francisco, broke ground on a new manufacturing facility at its existing site in Vacaville, Calif. The three new buildings will total 380,000 square feet, which when combined with the existing 427,000-square-foot manufacturing facility, will make it the largest biotechnology manufacturing facility in the world, the company said.

• Genomics Collaborative Inc., of Cambridge, Mass., and Celestar-Lexico Sciences Inc., of Westwood, Mass., entered a partnership to create a profile of genes expressed in human breast cancer, using Celestar's Large-scale in situ Hybridization (LisH) technology, and leveraging GCI's Global Repository of human biological samples in DNA, serum and tissue. The partnership aims to document differences in gene expression between human breast cancer and normal breast tissue samples by applying the LisH technology to a sample of well-annotated tissue samples provided by GCI.

• GenVec Inc., of Gaithersburg, Md., entered a two-year collaborative research, development and supply agreement with PATH's Malaria Vaccine Initiative (MVI). MVI will provide GenVec up to $2.5 million for the production and evaluation of adenovirus vectors containing genes for up to five malaria antigens. Under a separate agreement with the U.S. Naval Medical Research Center (NMRC), GenVec will receive optimized malaria genes to be used in the adenovector vaccines. NMRC will compare the effects of those vaccines alone and in combination in animal models.

• ILEX Oncology Inc., of San Antonio, submitted the final section of its new drug application to the FDA for clofarabine to treat refractory or relapsed acute leukemia in children. Clofarabine received fast-track status in September. Pivotal Phase II data showed an overall response rate of 29 percent for clofarabine in heavily pretreated children with acute myelogenous leukemia or acute lymphoblastic leukemia. ILEX submitted the first part of the rolling NDA in October. (See BioWorld Today, Oct. 23, 2003.)

• InterMune Inc., of Brisbane, Calif., said it would focus on hepatology and pulmonology as part of a new strategy and corporate realignment initiative. As part of that effort, the company is planning to begin a Phase III trial of a combination of Infergen and ribavirin in hepatitis C virus nonresponders in the first half of this year. Among its non-core assets, InterMune said it would seek another company to assume future development responsibilities for oritavancin, a hospital-based glycopeptide antibiotic agent, and divest its Amphotec antifungal agent. While oncology is no longer a core area, the company decided to maintain control of Actimmune rights in oncology.

• Ligand Pharmaceuticals Inc., of San Diego, agreed with the FDA to a final statistical plan for its two pivotal Phase III studies of Targretin capsules to treat advanced non-small-cell lung cancer. The company modified its original plan for the randomized SPIRIT I and II studies being conducted at 265 sites worldwide. The studies are designed to evaluate whether adding Targretin to front-line cisplatin/vinorelbine and carboplatin/paclitaxel chemotherapy extends the survival of patients. The primary endpoint for both studies is overall survival. Enrollment was completed for the studies last fall. Ligand also announced its plans to expand its combined Avinza primary-care sales force calls with NV Organon, of Oss, the Netherlands, by more than 50 percent to establish a specific targeted sales force effort. The companies want to cover the long-term care and hospice segment of the sustained-release opioid pain market. The partners expect to increase the drug's year-end, five-year market share target to 15 percent of overall sustained-release opioid prescriptions.

• MediGene AG, of Martinsried, Germany, said a Phase III trial of Polyphenon E Ointment for genital warts produced statistically significant results as more than 500 patients showed a high and lasting efficacy of the drug with low systemic adverse reactions. About 53 percent treated with 15 percent Polyphenon E Ointment showed complete clearance of all external genital warts. Results of the European trial, along with data from an ongoing Phase III study in the U.S., will be prerequisites for the company's application for approval. MediGene said pooled results from both trials are expected at the end of this year.

• Miravant Medical Technologies Inc., of Santa Barbara, Calif., submitted a new drug application to the FDA seeking approval of SnET2-PDT as a photodynamic therapy treatment for wet age-related macular degeneration (AMD). The submission is based on data from two randomized, placebo-controlled, parallel-group Phase III studies conducted at 60 U.S. ophthalmology centers. SnET2-PDT was designated a fast-track product by the FDA, and Miravant is requesting priority review status for the drug. As a part of the submission, a premarket approval application was submitted for the light device used to activate SnET2 during the ocular PDT procedure.

• Misonix Inc., of Farmingdale, N.Y., launched the Sonablate 500 in Western Europe, Eastern Europe and Russia, for the treatment of prostate cancer, enlarged prostate and other prostatic tumors. The product launch occurred in conjunction with the release of new data at the European Urology Association meeting in Vienna, Austria. The report, which was sponsored by Misonix, includes data showing that the Sonablate 500 is 88 percent effective in producing prostate-specific antigen measurements below 1.0 within one year following treatment using the Sonablate 500. Misonix has exclusive distribution rights for the product, which is licensed from Focus Surgery Inc., of Indianapolis.

• MWG Biotech AG, of Ebersberg, Germany, entered a supply agreement to allow Government Scientific Source Inc., of Vienna, Va., to distribute all products from MWG's four business units to U.S. federal customers. MWG provides technologies, instruments, products and services to pharma, biotechnology, diagnostics and agrobio businesses, while Government Scientific is a certified distributor of scientific equipment and supplies to federal, state and municipal government laboratories. Financial and other details were not disclosed.

• NexMed Inc., of Robbinsville, N.J., entered an agreement with a Japanese pharmaceutical company whereby NexMed will provide contract development services for a topical product to treat a form of herpes. NexMed received up-front funding and is eligible to receive additional payments upon the achievement of certain development milestones, including the successful filing of an investigational new drug application and the completion of a single U.S.-based Phase IIa study.

• Orchid BioSciences Inc., of Princeton, N.J., implemented a 1-for-5 reverse split of the company's common stock. Stockholders approved the split in February, and the board authorized it in March. Orchid's stock began trading on a split-adjusted basis Wednesday.

• PharmaNetics Inc., of Raleigh, N.C., said it is filing for an extension with the SEC for filing its 2003 annual report on Form 10-K. The company, which said it expects to file on or before April 14, is winding down its operations in preparation for the sale of its intellectual property and residual assets. As part of that process, PharmaNetics has decided to license or sell its intellectual property to a company potentially capable of selling the coagulation tests as part of a critical-care test menu. At the same time, the company said it expects a verdict before the end of this month in its lawsuit against Aventis Pharmaceuticals Inc., a wholly owned subsidiary of Aventis SA, of Strasbourg, France. The suit alleges that Aventis breached its contractual obligations to co-market and co-label PharmaNetics' rapid bedside test for monitoring Lovenox (enoxaparin sodium) in certain cardiology indications.

• PharmAthene Inc., of Annapolis, Md., filed an investigational new drug application with the FDA to begin clinical trials of ToxBlox, a protein being developed as a therapeutic agent to combat the effects of anthrax toxin. The company plans to begin a placebo-controlled, dose-escalation Phase I trial to evaluate the product's safety, tolerability and pharmacokinetics in healthy adult volunteers. PharmAthene also noted that it has completed process development activities in the ToxBlox manufacturing process and is producing commercial quantities in compliance with good manufacturing regulations.

• Renovis Inc., of South San Francisco, restated its net loss per common share amounts for the full years ended Dec. 31, 2001, 2002 and 2003. For 2001, the loss should have been $36.28, followed by $41.94 and $87.93 for the subsequent two years, respectively. Renovis determined that the shares used to compute basic and diluted net loss per common share should be revised to exclude certain shares that were subject to repurchase by the company during the periods presented.

• Sequenom Inc., of San Diego, said its MassArray system was used to identify a genetic association to diabetes. Researchers, including those from the National Institutes of Health, used DNA sample pools of affected and healthy individuals to show that the HNF4A gene has a genetic association to adult-onset diabetes. They found that DNA pools could be used effectively to estimate differences in single nucleotide polymorphism allele frequencies.

• Serono Inc., of Rockland, Mass., said data published in the Journal of AIDS showed that Serostim improves lean body mass and physical performance in patients with HIV-associated wasting. The condition is a metabolic disorder that causes the loss of lean body mass and can lead to infection. The randomized, double blind, placebo-controlled study confirmed the efficacy, safety and tolerability of Serostim, treating 757 patients in the U.S., Europe and other international sites. Serostim met its primary endpoint of cycle work output, and it showed greater improvement for the secondary endpoint of change in lean body mass as compared to placebo. While pain increased according to the dose received, the pain did not interfere with the subjects' normal work.

• The Genetics Co. Inc., of Zurich-Schlieren, Switzerland, entered a research collaboration to use structural biology tools belonging to Morphochem AG, of Munich, Germany, to support the ß-Secretase program of The Genetics Co. More specifically, Morphochem will apply its protein expression, purification, crystallization and structure determination capabilities (all part of its MOREsystem) to generate biostructural information for further optimization of inhibitor compounds against ß-Secretase identified by The Genetics Co. as potential new therapeutic agents for Alzheimer's disease. Financial terms were not disclosed.

• Tibotec Pharmaceuticals Ltd., a subsidiary of Johnson & Johnson, of New Brunswick, N.J., entered an agreement to allow the International Partnership for Microbicides (IPM) in London to develop TMC120 as an HIV microbicide. Tibotec, which is providing a royalty-free license to IPM to develop, manufacture and distribute the compound in resource-poor countries, has advanced a TMC120-containing gel into Phase I testing. IPM will assume responsibility for development of the compound, a non-nucleoside reverse transcriptase inhibitor. IPM will look to develop other formulations with TMC120, both alone and in combination with other active ingredients. Tibotec will fund the compound through Phase II testing and will remain active as a scientific adviser.

• United Therapeutics Corp., of Silver Spring, Md., said its intravenous Remodulin supplemental new drug application was accepted for review by the FDA. The sNDA was submitted on Jan. 30 to add the intravenous route of delivery to the Remodulin label for the treatment of patients with pulmonary arterial hypertension. The FDA has until Nov. 30 to issue an action letter for the sNDA.

• Vical Inc., of San Diego, began a Phase I trial of its immunotherapeutic vaccine for cytomegalovirus. The initial trial will test the vaccine for safety and immune responses in healthy volunteers, in preparation for planned trials in hematopoietic cell transplant patients. No other CMV vaccine is approved or in late-stage clinical development, the company said.

• YM BioSciences Inc., of Mississauga, Ontario, dosed the first patient in its Phase III registration trial of tesmilifene for breast cancer. The 700-patient international study is designed to compare the overall survival differential resulting from the combination of tesmilifene with epirubicin and cyclophosphamide against the use of epirubicin and cyclophosphamide alone in women with metastatic breast cancer. The company said it expects to complete enrollment in about 18 months. A prior Phase III trial in 305 women showed that overall survival in women on the combination of tesmilifene with anthracycline was greater than 50 percent longer than for women treated with anthracycline alone. YM received FDA clearance to begin the latest study last spring. (See BioWorld Today, March 5, 2003.)