• A.P. Pharma Inc., of Redwood City, Calif., initiated a Phase II program in cancer patients with its lead product candidate, APF530, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting. APF530 was developed using the company's Biochronomer bioerodible drug delivery system with granisetron, one of a class of 5-HT3 antagonists, and is designed to provide therapeutic levels of the drug for four or five days of relief following a single subcutaneous injection. The trial will enroll patients undergoing moderately emetogenic chemotherapy, and the primary endpoints will be determining pharmacokinetics, safety and tolerability.

• Actimis Pharmaceuticals Inc., of San Diego, announced a $6 million private placement of its Series A stock to fund development of small-molecule therapeutics for severe respiratory, inflammatory and autoimmune diseases, as well as chronic obstructive pulmonary disease, inflammatory dermatoses, inflammatory bowel disease and rheumatoid arthritis. Actimis is a start-up spun out from Bayer HealthCare AG, of Leverkusen, Germany, in November, and was assigned five preclinical research programs. The financing was led by Sanderling Ventures and included Mitsui & Co. Venture Partners.

• Argonaut Technologies Inc., of Redwood City, Calif., filed an application to have its common stock traded on the Nasdaq SmallCap Market as its price has remained below the Nasdaq National Market's minimum $1 per share requirement. Argonaut also filed its annual report with the SEC, which contained an Ernst & Young LLP "going concern" opinion. The company has entered an agreement with Biotage AB, of Uppsala, Sweden, for the sale of its assets.

• BioTime Inc., of Berkeley, Calif., received notice that it does not meet certain listing standards of the American Stock Exchange. The company has shareholder equity of less than $6 million and has incurred losses during the last five fiscal years. The exchange has filed with the SEC to delist BioTime common stock and warrants. The company has appealed and requested a hearing.

• Commonwealth Biotechnologies Inc., of Richmond, Va., said delayed work pertaining to assay of human clinical trial samples will get under way in May. The contract was awarded to the company last July and all run-up work was completed by August. The clinical trial program, as well as $730,000 in payments to CBI, were delayed while the sponsor dealt with regulatory issues.

• Depomed Inc., of Menlo Park, Calif., entered an agreement with Ridgefield, Conn.-based Boehringer Ingelheim Pharmaceuticals Inc., the U.S. unit of Germany-based Boehringer Ingelheim GmbH, to develop a controlled-release form of an undisclosed pharmaceutical compound. Boehringer Ingelheim will reimburse Depomed for costs and out-of-pocket expenditures. Based on the outcome of the formulation work and pharmacokinetic studies, Boehringer Ingelheim might choose to advance the formulation and enter a license agreement with Depomed.

• Endovasc Inc., of Montgomery, Texas, said its board authorized the purchase of up to 50 percent of the outstanding shares of the company's common stock and up to 100 percent of the outstanding shares of Series NDC common stock. Any purchases of the shares will be made through a program of open-market purchases. The buyback plan was authorized because the company said the shares are trading at a discount.

• Generex Biotechnology Corp., of Toronto, said the first patients had received a therapeutic vaccine developed by its wholly owned subsidiary, Antigen Express, as part of the company's Phase I trial of AE37, a compound designed to stimulate an immune response against the tumor-causing gene HER-2/neu that occurs in a significant percentage of patients with breast and other cancers. The trial will include between 16 and 24 patients, and is designed to evaluate the safety of AE37, as well as the level and longevity of specific T-cell stimulation induced by the drug.

• Genta Inc., of Berkeley Heights, N.J., announced the publication of a clinical pharmacologic study using Genasense (oblimersen sodium) Injection, the company's lead cancer compound, in patients with acute myelocytic leukemia. In the study, data showed a correlation between the levels of Genasense achieved within cancer cells and a decrease in Bcl-2, the molecular target of Genasense therapy. An abstract of the report appears in the current issue of Clinical Cancer Research.

• Helix BioMedix Inc., of Bothell, Wash., is extending the expiration date of its tender offer to exchange warrants described in its March 1 announcement until 9 a.m. EST May 31. Following the expiration of the exchange offer and subject to the terms of the exchange offer, Helix BioMedix will accept all existing warrant shares validly tendered and not withdrawn prior to the expiration of the exchange offer and will issue for exchange unregistered shares of common stock. Helix BioMedix focuses on developing small proteins called bioactive peptides for antimicrobial and wound-healing uses.

• ImmunoGen Inc., of Cambridge, Mass., reported that Genentech Inc., of South San Francisco, licensed exclusive rights to use ImmunoGen's tumor-activated prodrug technology with therapeutic antibodies to an undisclosed target. The license is in addition to the existing agreement between the companies that grants Genentech exclusive rights to use ImmunoGen's technology with therapeutic antibodies to HER2. The agreement stems from a 2000 agreement between the companies.

• Isotechnika Inc., of Edmonton, Alberta, received a "no objection" letter from Health Canada for the commencement of a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247. The randomized, open-label trial will include about 332 newly transplanted kidney patients. The primary endpoint is defined as non-inferiority in biopsy-proven acute rejection episodes with patients receiving ISA247 for six months, compared to tacrolimus.

• Large Scale Biology Corp., of Vacaville, Calif., entered a multiyear agreement with EMD Biosciences Inc., of San Diego, under which LSBC will manufacture and supply one of its protein products for distribution by EMD. LSBC's plant-based biomanufacturing platform can produce commercial quantities of a range of pharmaceutical ingredients, industrial proteins and R&D reagents. Terms of the agreement were not disclosed.

• Martek Biosciences Corp., of Columbia, Md., watched its shares plunge 45.9 percent Thursday following news that its third-quarter and full-year revenues will be materially lower than what it had forecast. The shares (NASDAQ:MATK) fell $27.59, to close at $32.49. The decrease in expected sales primarily is due to reduced customer demand caused by the build-up of inventory by large customers to protect themselves from supply shortages, it said. The company, which markets nutritional oils and supplements, as well as fluorescent markers, is estimating third-quarter revenues of between $38 million and $42 million, and full-year revenues between $220 million and $240 million.

• Migenix Inc., of Vancouver, British Columbia, received a letter of authorization from Health Canada to begin a Phase I/II trial with MX-4509 to treat neurodegenerative diseases. The study will assess the effect of MX-4509 on oxidative stress markers, as well as the safety and tolerability of the compound in 14 patients with mild to moderate Alzheimer's disease. The study should begin in the middle of this year.

• Neose Technologies Inc., of Horsham, Pa., and BioGeneriX AG, of Mannheim, Germany, entered a research, license and option agreement to use Neose's GlycoPEGylation technology to develop a long-acting, next-generation version of a marketed therapeutic protein. Neose will receive further up-front and research payments, and could receive milestone payments totaling up to $61.5 million, as well as royalties. Earlier this year, the companies announced a supply and option agreement for the protein. (See BioWorld Today, Feb. 1, 2005.)

• OpGen Inc., of Madison, Wis., signed an exclusive distribution agreement with the Japanese company M&S Instruments Inc. The agreement will provide Japan's life sciences researchers with access to Optical Mapping, OpGen's whole-genome analysis system. Financial terms were not disclosed.

• Point Therapeutics Inc., of Boston, achieved the desired tumor response criteria with its lead compound, talabostat, in its Phase II non-small-cell lung cancer trial. The trial was intended to evaluate talabostat in combination with docetaxel in patients with Stage IIIb/IV NSCLC who have failed a platinum-based therapy. The company said it plans to use the results to design a Phase III pivotal program to begin later this year. Talabostat (PT-100) is a small-molecule, orally-active drug developed to inhibit the growth of malignant tumors and to accelerate the reconstitution of the hematopoietic system.

• Protemix Corp., of Auckland, New Zealand, said a study published in Diabetes showed that abnormal levels of oxidized copper accumulate in people with Type II diabetes, which it said should be eliminated to reduce the incidence of heart disease. Trientine, developed by Protemix as Laszarin, extracts oxidized copper, which then is excreted in the patient's urine.

• Quark Biotech Inc., of Fremont, Calif., said a study suggested that the hypoxia-inducible gene RTP801 might serve an important role in the pathogenesis of early diabetic retinal disease. The study reveals that the knockout of the gene ameliorates diabetes-induced retinal vascular permeability (RVP) and electroretinogram abnormalities in an animal model. Data show that in the diabetic mouse, knockout of RTP801 reduced RVP by 80 percent, resulting in a 140 percent RVP suppression. Full findings will be presented at the Association for Research in Vision and Ophthalmology annual conference in May in Fort Lauderdale, Fla.

• Santarus Inc., of San Diego, submitted a new drug application for Zegerid (omeprazole) capsules 40 mg and 20 mg to the FDA. The company is seeking approval of the capsules as the first immediate-release proton pump inhibitor in a capsule formulation to treat heartburn and other symptoms associated with gastroesophageal reflux disease, erosive esophagitis, duodenal ulcers and gastric ulcers. The company is marketing Zegerid powder for oral suspension 40 mg and 20 mg.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., appointed Ira Lawrence president and CEO, effective June 1. He also will join the company's board. Before joining SciClone, Lawrence served as senior vice president of research and development at Astellas Pharma U.S. Inc., the U.S. subsidiary of Japanese-based Astellas Pharma Inc.

• Seattle Genetics Inc., of Bothell, Wash., entered an antibody-drug conjugate collaboration with MedImmune Inc., of Gaithersburg, Md. MedImmune will pay an up-front fee of $2 million for rights to use Seattle Genetics' ADC technology with antibodies against a single tumor target that MedImmune has selected. MedImmune also has an option to pay an additional fee to access the ADC technology for a second antibody program. MedImmune also will make milestone payments and pay royalties on net sales of any resulting products and is responsible for research, product development, manufacturing and commercialization of all products under the collaboration. Seattle Genetics will receive material supply and annual maintenance fees as well as research support payments for any assistance provided to MedImmune in developing ADC products.

• SkinMedica Inc., of Carlsbad, Calif., filed for its initial public offering. All the shares to be offered will be newly issued shares. SkinMedica is a specialty pharmaceutical company focused on developing, acquiring and commercializing products that treat dermatologic conditions and diseases, as well as improve the appearance of skin, the company said.

• SkyePharma plc, of London, entered an amendment agreement with GlaxoSmithKline plc, of London, regarding Paxil. GSK will make a one-time payment of about $10 million. In addition, SkyePharma also will be entitled to an increase in the royalty rate from 3 percent to 4 percent on actual net sales of Paxil CR, with effect from March 4. Since GSK has been unable to supply Paxil in the U.S. since that time, GSK also agreed to pay SkyePharma the same level of royalty on GSK's budgeted sales of Paxil CR from March 4 while the product remains off the market, subject to other terms of the agreement. In March 1996, SkyePharma entered a license agreement with SmithKline Beecham, now part of GSK, for the development, manufacture and marketing of a modified-release version of Paxil.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said a fire that originated on the roof occurred Wednesday afternoon at its Cambridge-based manufacturing facility. The company manufactures bulk drug substance of its protein products, Replagal, iduronate-2-sulfatase and gene-activated glucocerebrosidase, at the facility, but does not expect any interruption with commercial and clinical supply due to existing inventory levels. TKT temporarily has suspended production at the facility. All employees were safely evacuated.

• ViRexx Medical Corp., of Edmonton, Alberta, completed a development agreement with Protein Sciences Corp., of Meriden, Conn., for the manufacture of ViRexx's lead Chimigen vaccine, HepaVaxx B. The vaccine is being developed to treat patients chronically infected with hepatitis B virus. The product is on track to start a Phase I trial in the third quarter.