• A.P. Pharma Inc., of Redwood City, Calif., reported that its executives met with FDA officials to review the company's proposal to proceed with the clinical development of its lead product, APF-112. The action plans agreed to at the meeting will be implemented immediately and, assuming that the preclinical testing proceeds as planned, the company expects to submit a new Phase II protocol for APF 112 to the FDA by the middle of 2003. APF112 is a biochronomer-based product containing mepivacaine that is designed to provide 24 to 36 hours of pain relief following certain surgical procedures. The initial clinical target for APF112 will be pain relief following abdominal surgery.

• American Pharmaceutical Partners, of Los Angeles, reported that patient enrollment was completed in a pivotal Phase III trial evaluating ABI-007, a next generation nanoparticle paclitaxel, in patients with metastatic breast cancer. A total of 460 patients with first- and second-line metastastic breast cancer were enrolled in the multicenter trial. The study is designed to compare the safety and efficacy of ABI-007 to Taxol.

• Aphton Corp., of Miami, sold 1.5 million shares of registered common stock at about $2.37 each for gross proceeds of about $3.6 million. The transaction is scheduled to close Friday. Aphton said it would use the proceeds for general corporate purposes, including funding ongoing clinical trials and operations while Aphton negotiates with one or more potential partners to structure a worldwide agreement. Life Science Group Inc. acted as placement agent.

• Aventis SA, of Strasbourg, France, said its chemotherapeutic agent, Taxotere for Injection Concentrate, was approved by the FDA as first-line therapy in patients with unresectable locally advanced or metastatic non-small-cell lung cancer in combination with cisplatin, in patients who have not received prior chemotherapy. With the approval, Taxotere is the only agent indicated both for patients with newly diagnosed NSCLC, in combination with cisplatin, and for those with previously treated advanced NSCLC, as a single agent.

• Becton, Dickinson and Co., of Franklin Lakes, N.J., said its unit, BD Biosciences, entered a collaboration with the International AIDS Vaccine Initiative. The collaboration is designed to provide and validate technology for IAVI-sponsored vaccine development and testing programs.

• Bionomics Ltd., of Adelaide, Australia, reported publication of a study in the Proceedings of the National Academy of Science regarding a gene that causes epilepsy and also validates a component of Bionomics' ionX discovery platform. The company said the findings reveal fundamental molecular deficits in epilepsy patients, also showing that the gene is not fully responsive to current epilepsy drugs.

• British Biotech plc, of Oxford, UK, received notice indicating that it has failed to comply with the minimum $1 bid price requirement for continued listing in the Nasdaq market with respect to its ADS. British Biotech's ADS are now subject to delisting. As a result, British Biotech decided to amend the ratio of its ADS to its ordinary shares from 1-for-10 to 1-for-40 and has set Dec. 16 as the effective date for the ratio change. Its stock (NASDAQ:BBIOY) fell 16 cents Tuesday, or 24 percent, to close at 51 cents.

• CeMines Inc., of Evergreen, Colo., entered a pilot program with CePeP AB, of Stockholm, Sweden, in which CeMines will provide CePeP with information regarding transcription factors involved in the proliferation of several cancer types. CePeP will design and provide CeMines with cell-penetrating peptides that CeMines will evaluate to determine the possibility of using them to manipulate the aforementioned transcription factors and deliver a targeted treatment into a cancerous tumor. Financial terms were not disclosed.

• Cephalon Inc., of West Chester, Pa., received marketing approval from the UK regulatory agency to expand the label of Provigil (modafinil) to treat excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome. The 200 mg tablet also was approved, in addition to the 100 mg dosage currently available in the UK.

• Columbia Laboratories Inc., of Livingston, New Jersey, reported the submission of an application for marketing approval to the United Kingdom Medicines Control Agency for Striant (testosterone buccal bioadhesive product). The submission is based on the new drug application filed in August, which the FDA accepted for review in October. Approval of Striant in the UK is anticipated in the second half of 2003, with mutual recognition files to be submitted in all other countries within six months of the approval, the company said.

• Cytos Biotechnology AG, of Zurich, Switzerland, said an initial round of immunization with its first Immunodrug product in a Phase I study with 24 healthy volunteers was well tolerated. Only three subjects reported a mild local irritation, including some itching at the site of injection. No systemic side effects were reported. The study is designed to compare subcutaneous vs. intramuscular administration and different doses.

• DepoMed Inc., of Menlo Park, Calif., settled its litigation with Bristol-Myers Squibb Co., of New York, in connection with a lawsuit filed on Jan. 27 by DepoMed. As reported on Nov. 11, the parties had signed an agreement in principle that included a one-time, $18 million payment to be made by Bristol-Myers to DepoMed. Both parties have released all lawsuit claims against each other and granted to each other a limited nonexclusive royalty-free license. Under the final agreement, the $18 million was paid Monday. The complaint alleged patent infringement by Bristol-Myers Squibb's once-a-day Glucophage XR tablet.

• Dimethaid Research Inc., of Toronto, said it received an approvable letter from Health Canada for Pennsaid, its first commercial product using its patented transcellular technology. Pennsaid is a topical solution for treating the symptoms of osteoarthritis of the knee.

• Entelos Inc., of Foster City, Calif., and NV Organon, of Oss, the Netherlands, extended their collaboration to expand their research program in rheumatoid arthritis using the Entelos rheumatoid arthritis PhysioLab technology. Organon will provide up-front fees, milestones and royalties on the sale of immunological and inflammatory drugs. Organon also will participate in and provide funding for the development of the next generation of the technology. Specific financial details were not disclosed.

• EntreMed Inc., of Rockville, Md., received notice that Celgene Corp., of Warren, N.J., initiated further legal action pertaining to the intellectual property patents of EntreMed's thalidomide analogue, ENMD 0995. EntreMed said Celgene submitted a brief in opposition to EntreMed's request that the U.S. District Court for the District of Columbia dismiss a lawsuit filed by Celgene against the U.S. Patent and Trademark Office and EntreMed seeking to block the issuance of patent applications protecting ENMD 0995. The candidate, which last month entered Phase I trials, was designated by the FDA an orphan drug to treat multiple myeloma.

• Genetronics Inc., of San Diego, extended a collaborative agreement with Chiron Corp., of Emeryville, Calif., to conduct experiments using Genetronics' Electroporation technology to test an HIV DNA vaccine. Chiron now plans to include more advanced studies in large animals as a prelude to possible future clinical development of a DNA vaccine for HIV. Both parties are continuing a collaborative relationship that explores electroporation-assisted delivery of a second DNA vaccine for an unnamed target indication. Financial terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, said its HuMax-TAC antibody program against the interleukin-2 receptor target, also known as TAC, is under way for use to treat organ transplant rejection. Genmab identified a lead candidate in the program that the company said appears to be superior to at least one antibody product currently on the market when tested in vitro. HuMax-TAC showed superior inhibition of IL-2 binding to the IL-2 receptor and also blocked the proliferation of activated T cells that express the receptor and play a role in inflammation. Other potential indications include graft vs. host disease, T-cell leukemia, Hodgkin's disease and autoimmune diseases.

• Heska Corp., of Fort Collins, Colo., entered an agreement with Pharmacia Diagnostics, a unit of Pharmacia Corp., of Peapack, N.J., which acquired a worldwide exclusive license to develop and commercialize Heska's recombinant allergen intellectual property for human allergy diagnostic use. The license covers a range of unnamed recombinant allergens. Heska will receive license fees, and could receive milestone payments and royalties. Specific financial terms were not disclosed.

• ICOS Corp., of Bothell, Wash., and Eli Lilly and Co., of Indianapolis, reported at the Congress of the European Society of Sexual and Impotence Research in Hamburg, Germany, clinical data on Cialis (tadalafil), a PDE5 inhibitor designed to treat erectile dysfunction. New data were presented from a study involving 268 men randomized with either 5 mg or 10 mg Cialis or placebo taken daily for 12 weeks. Improved erections were reported by 84 percent of men taking 10 mg Cialis and 80 percent of men taking 5 mg Cialis compared with 28 percent of men taking placebo. Findings from other studies show that neither 10 mg nor 20 mg Cialis had any clinically significant effects on blood pressure or heart rate in healthy subjects, compared to placebo. In addition, the incidence of heart attack in Cialis-treated patients across all studies (involving more than 4,000 patients) was no higher than in those receiving placebo. Lilly ICOS LLC, a joint venture between ICOS and Lilly, said it plans to launch Cialis, which last month received European authorization, during the first half of next year.

• Illumina Inc., of San Diego, signed a commercial agreement with Cold Spring Harbor Laboratory in Cold Spring Harbor, N.Y., to provide nearly 100,000 longmer oligonucleotides (oligos) for a large-scale study designed to determine the mechanism of RNA interference (RNAi). Illumina said it is working with investigators to validate oligo design integrity and provide fast turnaround from its Oligator high-throughput DNA synthesis facility to meet the study's compressed schedule.

• ID Biomedical Corp., of Vancouver, British Columbia, reported positive results from two Phase II trials of FluINsure, its intranasally delivered influenza vaccine. ID said results of the ongoing, randomized, double-blind and concurrent placebo-controlled studies, which enrolled 99 healthy adult subjects, continued to exhibit a favorable safety and tolerability profile with no serious adverse events and only mild and transient nasal stuffiness and/or runny nose being associated with the active vaccine when compared to a placebo nasal spray. Statistically significant increases in serum hemagglutination-inhibiting antibodies were induced by all regimens tested, including both one- and two-dose regimens, 28 days after immunization.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said treatment with IP 751 (previously known as CT-3), an anti-inflammatory and analgesic synthetic cannabinoid compound, significantly reduced the degree of neuropathic pain in a Phase II trial. The 21 patients in the trial all had chronic pain syndromes as a result of previous spinal or peripheral nerve injuries. The degree of pain, as shown by visual analogue scores, decreased significantly during treatment periods (p<0.05).

• Medarex Inc., of Princeton, N.J., said its licensee, Novartis Pharma AG, of Basel, Switzerland, began Phase I trials with a fully human antibody product candidate for the treatment of autoimmune disease. The antibody product was developed using Medarex's UltiMAb Human Antibody Development System. Medarex would receive milestone payments and royalties on any commercial sales .

• Neurotech SA, of Paris, reported publication of preclinical efficacy studies in the journal Investigative Ophthalmology & Visual Science relating to its Encapsulated Cell Technology to treat chronic ophthalmic diseases. Findings showed the technology delivers the natural neuroprotective protein CNTF in the eye over an extended period of time and protects the retina from degeneration. The neuroprotective effect is dose-dependent with greater protection observed with higher doses. In addition, the implanted capsules were well tolerated and retained their function during the implant period.

• NM Rothschild Ltd., of Perth, Australia, said it agreed to a management buyout of its bioscience funds management by GBS Venture Partners, formerly known as Rothschild Bioscience Managers Ltd., for an undisclosed amount. Rothschild said the move reflects its decision to shift its private equity activities away from seed and early stage capital.

• Oncologic Inc., of Richmond, Calif., appointed as its chairman Winston Salser, the founding president of Amgen Inc., of Thousand Oaks, Calif. Salser succeeds William Gibson, the managing partner of Oncologic's principal investor, CR Ventures, of San Francisco. Gibson, who served as chairman since Oncologic's inception, will remain as a member of its board.

• Oncolytics Biotech Inc., of Calgary, Alberta, entered an agreement with Canaccord Capital Corp., of Vancouver, British Columbia, to issue up to 750,000 units for C$2 apiece, resulting in up to C$1.5 million (US$963,710) in proceeds to be used by Oncolytics for general corporate purposes. Each unit consists of one common share and one-half of one common share purchase warrant. Each whole common share purchase warrant would entitle the holder to acquire one common share in the capital of Oncolytics upon payment of C$3 per share until 18 months following closing. The common shares in the private placement, expected to close Dec. 11, will be subject to a four-month hold provision.

• PrimaBioMed Ltd., of Victoria, Australia, said its Panvax Ltd. subsidiary entered a collaboration with the Institute Pasteur in Paris to develop Panvax's DCtag antigen delivery technology in combination with the institute's malaria proteins. Initial studies will be undertaken in mouse models with the human malaria parasite Plasmodium falciparum and results are expected to be available within 12 months. Financial terms were not disclosed.

• Remedyne Corp., of Santa Barbara, Calif., obtained an exclusive worldwide license from The Regents of the University of California to the patent rights covering a key immune stimulating technology that primes the immune system against diseases such as cancer, or other viral and bacterial pathogens. The technology was originally developed at the University of California at Berkeley. Financial terms were not disclosed.

• Scil Technology Holding GmbH, of Martinsried, Germany, said its unit, Scil Proteins, and its Affilines technology demonstrated a proof of principle following a study that shows it is possible to generate customized proteins based on an Affilines scaffold that displays binding properties against predefined target molecules. Scil also received state-sponsored funding in Germany to further its Affilines technology and develop processes for recombinant therapeutic protein production at industrial scale. Separately, the Scil Biomedicals unit said a series of preclinical studies demonstrated its bone regeneration material, MD05, to be at least equivalent to autogenous bone. Scil said MD05 also was shown to be significantly superior to the synthetic bone substitute beta-tricalcium phosphate.

• Tripos Inc., of St. Louis, released the latest version of its computational platform for drug design and discovery, Sybyl 6.9/Unity 4.4. The technology provides upgrades that design practical combinatorial libraries and streamline optimization of lead compounds within a protein active site, among other capabilities, the company said.