• Amgen Inc., of Thousand Oaks, Calif., and Serono SA, of Geneva, signed an agreement that allows Serono to sell Novantrone (mitoxantrone for injection concentrate) in the U.S. Novantrone is approved for secondary progressive, progressive relapsing and worsening relapsing-remitting multiple sclerosis, as well as for certain forms of cancer in the U.S. Financial terms were not disclosed. Amgen acquired Novantrone through its acquisition of Immunex Corp., completed in July. The product had U.S. sales last year of $71 million. The acquisition of Immunex by Amgen was originally announced in December and was valued at $16 billion. (See BioWorld Today, Dec. 18, 2001.)

• AtheroGenics Inc., of Atlanta, filed with the SEC a shelf registration statement to permit the firm to offer and sell up to $75 million of common stock. AtheroGenics said it plans to use net proceeds from subsequent offerings for research and development activities, including clinical trials, general corporate purposes and potential acquisitions of technologies or companies.

• Biomira Inc., of Edmonton, Alberta, completed enrollment of the planned 166 patients in its Phase IIb trial of BLP25 liposomal vaccine. There are now 168 patients enrolled in the trial, which began in August 2000. The controlled, randomized study involves patients with non-small-cell lung cancer. All were required to be stable or responding following completion of their first-line standard chemotherapy for treatment of the disease. Objectives of the trial are to measure the safety and potential survival benefit of BLP25.

• Cell Therapeutics Inc., of Seattle, said it earned a $3 million milestone in connection with the acceptance by regulatory authorities of Tokyo-based Chugai Pharmaceutical Co. Ltd.'s investigational new drug application to initiate trials of Xyotax in Japan. Xyotax links paclitaxel to a biodegradable polyglutamate polymer and is designed to affect tumors.

• Cytos Biotechnology AG, of Zurich, Switzerland, and Medarex Inc., of Princeton, N.J., entered into a research, development and license agreement to develop immunology drug targets. Medarex will acquire the exclusive rights to develop and commercialize monoclonal antibody therapeutics against the collaboration targets discovered using Cytos' DELphi protein discovery technology. Medarex also receives a first right of negotiation for use of those targets in small-molecule drug discovery and as protein therapeutics. Cytos will receive precommercial payments and milestones, as well as royalties on commercial sales, if any, of resulting Medarex products.

• DepoMed Inc., of Menlo Park, Calif., reported results from a Phase I trial comparing its internally developed, extended-release dosage form, Furosemide GR, with the currently marketed immediate-release furosemide formulation. Furosemide is a loop diuretic anti-hypertensive drug, currently sold by Aventis SA, of Paris, as Laxis and as a generic product by other pharmaceutical companies. With the GR tablet, diuresis was extended with less urgency, and the total urinary volumes and the total amounts of sodium excreted were nearly identical to the immediate release product.

• EntreMed Inc., of Rockville, Md., began its ENMD 0995 clinical trial program for the treatment of patients with multiple myeloma. In the open-labeled Phase I study at the Mayo Clinic in Rochester, Minn., ENMD, a derivative of thalidomide, will be administered orally once daily to patients. The trial will evaluate the safety and pharmacokinetics of ENMD 0995, as well as tumor response.

• Essential Therapeutics Inc., of Waltham, Mass., entered into separate conversion agreements with certain holders of its outstanding shares of Series B preferred stock. Each outstanding share of Series B preferred stock will convert into the number of shares of common stock obtained by dividing the aggregate stated value of the outstanding Series B preferred stock, plus any accrued and unpaid dividends, by a per share conversion price of 75 cents. The outstanding Series B preferred stock has an aggregate value of $60 million. If the conversion is consummated, the company will issue 80 million new shares of common stock in exchange for the conversion of all 60,000 shares of Series B stock outstanding. The conversion is part of the company's plan to achieve compliance with the Nasdaq National Market System. Its stock (NASDAQ:ETRX) fell 40 cents Wednesday, or 38.5 percent, to close at 64 cents.

• Genmab A/S, of Copenhagen, Denmark, gave a strategic update of its finances and strategy. It said it obtained access to manufacturing resources through relationships with manufacturing partners and because building a facility would require a significant commitment of fixed costs, it postponed indefinitely plans to build a manufacturing facility in Hillerod, north of Copenhagen. Genmab focuses on human antibodies and has products in development for cancer, rheumatoid arthritis and other inflammatory conditions.

• Guidant Corp., of Indianapolis, and Genzyme Biosurgery, a division of Genzyme Corp., of Cambridge, Mass., entered a cross-license agreement related to certain patents for products used in "off-pump" or beating-heart cardiac bypass surgery. Genzyme will make a one-time license fee payment and pay ongoing royalties. Guidant also will obtain a license to certain Genzyme patents subject to certain provisions in the agreement. Financial details were not disclosed.

• Hungarian Biotechnology Association in Budapest said the European Association for Bioindustries, or EuropaBio, elected it as a member. EuropaBio will provide a platform for the Hungarian Biotechnology Association to represent the Hungarian bioscience industry through membership and participation in the work of the Emerging Enterprises Board and the National Associations Council.

• Immtech International Inc., of Vernon Hills, Ill., completed Phase IIa trials of its first compound, DB289, for the treatment of African sleeping sickness (trypanosomiasis). Initial trial results showed the DB289 was well tolerated and about 95 percent of the patients treated were cured, Immtech said. Data for 5 percent of the patients were not confirmed due to civil war unrest in Angola.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reported the results of a special meeting of stockholders Monday. The stockholders approved four proposals, including the terms of ISTA's private placement of $40 million of its common stock at 38 cents a share and warrants exercisable for $6 million of stock to investors at 38 cents a share. It also approved an amendment to ISTA's current amended and restated certificate of incorporation to effect a reverse stock split of not less than 1-for-7 and not more than 1-for-10.

• Kaleidos Pharma Inc., of Seattle, entered a collaboration with the Division of AIDS at the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md. The NIH will conduct a nonhuman primate study to evaluate the potential of Kaleidos' transforming growth factor alpha compound to increase CD4 T-cell counts in rhesus monkeys infected with simian immunodeficiency virus, the ape or monkey equivalent of HIV. Kaleidos said the collaboration follows promising findings showing elevation of CD4 T-cell counts in response to TGF alpha in a rhesus monkey study conducted at the University of Washington in Seattle.

• Keryx Biopharmaceuticals Inc., of Cambridge Mass., said it designed a Subpart H development plan in collaboration with the FDA for KRX-101, Keryx's fast-track investigational drug for the treatment of diabetic nephropathy. Subpart H allows for the use of surrogate endpoints in pivotal Phase III trials to support new drug development approval, with confirmatory studies completed post-approval. The Subpart H clinical development plan was submitted to the FDA as a special protocol assessment in September.

• The National Institutes of Health in Bethesda, Md., said a vaccine developed by scientists from the Dale and Betty Bumpers Vaccine Research Center at its division, the National Institute of Allergy and Infectious Diseases, is in tests directed at the three most globally important HIV subtypes. The trial might help develop a globally effective HIV vaccine, the institute said. The product is a DNA vaccine.

• OraPharma Inc., of Warminster, Penn., signed a definitive agreement to be acquired by Johnson & Johnson, of New Brunswick, N.J., for about $85 million. OraPharma shareholders will receive $7.41 for each outstanding share, and the transaction is expected to close in the first quarter of 2003, subject to closing conditions and regulatory approvals. OraPharma's product, Arestin, is a locally administered, time-released antibiotic encapsulated in microspheres designed to combat periodontal disease. OraPharma also has a program to treat oral mucositis, and a next-generation periodontal therapeutic. OraPharma's stock (NASDAQ:OPHM) gained $2.71 Wednesday, or 59.7 percent, to close at $7.25.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said researchers at the University of Texas Southwestern Medical Center at Dallas characterized and defined anionic phospholipids as potential markers for tumor blood vessels. Researchers developed monoclonal antibodies that target anionic phospholipids to be used as potential vascular targeting agents. The study appears in the November issue of Cancer Research.

• Photogen Technologies Inc., of New Hope, Pa., said its therapeutic business was transferred to its five founding scientists in exchange for their majority ownership of Photogen. The resulting business, renamed Valley Pharmaceuticals, will merge with Provectus Pharmaceuticals Inc., of Knoxville, Tenn. The therapeutic business consists of a number of technologies, including prescription drugs for dermatology and oncology, medical and research laser technologies and biotechnology methods.

• SURG II Inc., of Minneapolis, said it entered an agreement with Chiral Quest LLC, of State College, Pa., in which the companies will complete a stock-for-LLC unit exchange, after which Chiral Quest stockholders receive about two-thirds of the merged company. The company will be renamed Chiral Quest Inc. and an application will be filed to trade under the OTCBB symbol CQST. Chiral Quest is a chemistry research and drug development company focused on commercializing solutions to improve the processes for the pharmaceutical, biotechnology and fine chemical industries. Financial details of the merger were not disclosed.

• Tm Bioscience Corp., of Toronto, and MDS Capital Corp., reported the closing of a debt financing with Canadian Medical Discoveries Fund Inc. for the principal amount of C$4.67 million (US$2.96 million). The loan has a term of 39 months, with payments of interest only during the first three months, followed by equal payments of principal and interest during the subsequent 36 months.

• Valentis Inc., of Burlingame, Calif., said the Nasdaq Listing Qualifications Panel will continue to list its securities on Nasdaq while Valentis executes a plan to re-establish compliance with the market's continued listing criteria. Valentis added that its Series A preferred stockholders voted to convert all outstanding shares of Series A preferred stock to common stock and to waive certain rights with respect to the Series A Preferred Stock. The conversion, along with a proposal to affect a reverse split of common stock, is subject to shareholder approval.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., published the first 3-dimensional atomic structure of Aurora-2, a protein kinase implicated in the growth of cancer cells. Vertex scientists are using Aurora-2 kinase structural information to design and optimize small-molecule inhibitors of that and related kinase enzymes. The structural determination was published in the Nov. 8, 2002, issue of the Journal of Biological Chemistry. The company also said it advanced a small-molecule Aurora kinase inhibitor, VX-528, into preclinical development. It is the first drug candidate to be taken into formal development as part of Vertex's collaboration with Novartis AG, of Basel, Switzerland.