• Amgen Inc., of Thousand Oaks, Calif., and Wyeth of Madison, N.J., Pharmaceuticals, a division of Wyeth, said the FDA approved an expanded indication for Enbrel (etanercept) as a treatment to improve physical function in patients with moderately to severely active rheumatoid arthritis (RA). The drug already is approved to reduce signs and symptoms and inhibit structural damage in patients with moderately to severely active RA. It also is approved to reduce the signs and symptoms of active arthritis in patients with psoriatic arthritis; to reduce the signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to disease-modifying medicines; and to treat active ankylosing spondylitis. Enbrel is designed to act by binding tumor necrosis factor.

• Biogen Inc., of Cambridge, Mass., said the FDA approved its large-scale manufacturing plant for Amevive (alefacept). Located in Research Triangle Park, N.C., the facility will be used for commercial production of the chronic plaque psoriasis drug as well as future products, courtesy of its 90,000 liters of bioreactor capacity. Biogen, which broke ground on the 250,000-square-foot plant in 1999, said it completed construction of the $173 million facility ahead of schedule. Amevive was approved early this year. (See BioWorld Today, Feb. 3, 2003.)

• BioTransplant Inc., of Medford, Mass., reported that the U.S. Bankruptcy Court in Boston approved the sale of its Eligix HDM Cell Separation System to Miltenyi Biotec GmbH, of Bergisch Gladbach, Germany. The company expects to consummate the transaction within 10 business days, subject to the satisfactory completion of customary closing conditions by both parties. Miltenyi will acquire all intellectual property and physical assets associated with the Eligix business in exchange for an up-front payment of $450,000 and royalties of 4 to 10 percent.

• Cytogen Corp., of Princeton, N.J., completed the reacquisition of marketing rights held by Berlex Laboratories Inc., the U.S. affiliate of Schering AG, of Berlin, to Quadramet in North and Latin America in exchange for an up-front payment of $8 million and royalties. Quadramet is a skeletal targeting therapeutic radiopharmaceutical for the relief of pain due to bone metastases arising from prostate, breast, multiple myeloma and other types of cancer. In 2002, Berlex recorded Quadramet sales of about $7.36 million, for which Cytogen recorded $1.84 million in royalties. The deal was announced in June. (See BioWorld Today, June 17, 2003.)

• Evotec Neurosciences GmbH, of Hamburg, Germany, and Takeda Chemical Industries Ltd., of Osaka, Japan, formed a four-year collaboration in the area of Alzheimer's disease. The companies aim to identify and validate targets relating to different aspects of the causes and progression of Alzheimer's disease, with the goal of developing small-molecule therapeutics. Evotec will grant Takeda access to its database of Alzheimer's disease-related targets, and will validate selected target candidates. Takeda will make payments to Evotec Neurosciences of up to 120 million covering database access fees, research funding and milestone payments relating to the selection of targets for further drug discovery. Milestones also would be payable as compounds are developed.

• eXegenics Inc., of Dallas, said it would review an increased tender offer from EI Acquisition Inc. and Foundation Growth Investments LLC, of Chicago, as part of their unsolicited offer to acquire all of the outstanding common stock and Series A convertible preferred stock of eXegenics. AVI BioPharma Inc., of Portland, Ore., has made an all-stock offer for eXegenic originally valued at $11 million based on the price of its shares at the time, but the unsolicited bid group called its cash offer higher than the value of AVI's, adding that AVI's stock has lost almost 20 percent of its value since the merger was first reported. The amended offer, which expires Aug. 15, increases the purchase price from 37 cents per share to 51 cents. eXegenics said it would evaluate the amended offer and eventually advise its stockholders of its response. In the meantime, eXegenics asked its stockholders to defer on any decisions as to both offers. (See BioWorld Today, July 17, 2003.)

• Genentech Inc., of South San Francisco, and Xoma Ltd., of Berkeley, Calif., said the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will review their biologics license application for Raptiva for moderate to severe psoriasis in adults on Sept. 9. The BLA was filed in December and includes data from more than 2,700 patients. (See BioWorld Today, Dec. 27, 2002.)

• GPC Biotech AG, of Martinsried, Germany, provided an update on the development of its fully human oncology monoclonal antibody, 1D09C3. The company reported a number of achievements, including consistent in vivo efficacy results in various lymphoid tumor animal models, production of sufficient quantities of GMP-quality material for Phase I/II trials and identification of an appropriate administration schedule. The company expects to initiate clinical trials in the second half of 2004.

• ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said an arbitrator ruled that it and its subsidiary, Ribapharm Inc., were entitled to receive past royalties for sales of ribavirin under an indigent care program prior to 2002 from Schering-Plough Corp., of Kenilworth, N.J. The arbitrator also decided that neither ICN nor Ribapharm would be entitled to receive future royalty payments under the Schering indigent care program as currently structured. ICN said the amount awarded about equals what it and Ribapharm received and recorded to date, meaning that the royalty will have little impact on its or Ribapharm's financial results.

• Invitrogen Corp., of Carlsbad, Calif., said it completed the private placement of $325 million of 2 percent senior convertible notes due 2023. The initial buyers have a 13-day option to purchase up to $48.75 million worth of the notes. The sale replaces its cash needs relative to its $325 million acquisition of Molecular Probes Inc., of Eugene, Ore. (See BioWorld Today, July 3, 2003, and July 30, 2003.)

• MorphoSys AG, of Munich, Germany, reported the achievement of the third milestone in its therapeutic antibody collaboration with Centocor Inc., of Malvern, Pa. The milestone is based on the delivery by MorphoSys of antibodies against an undisclosed Centocor target involved in inflammatory diseases. In achieving the current milestone, MorphoSys delivered several engineered antibodies against the target molecule from Centocor. Financial terms relating to the milestone were not disclosed.

• Rigel Pharmaceuticals Inc., of South San Francisco, completed its stockholder rights offering, raising about $9.3 million. All validly exercised subscription rights, both basic and over-subscription rights, were accepted by the company. Rigel issued about 1.6 million shares of its common stock in the rights offering, which concluded July 25. Each stockholder received one basic subscription right to purchase 0.4508 of a share of Rigel common stock for each share owned as of the record date, April 29 (adjusted for the 1-for-9 reverse split completed on June 25). The subscription price of each share purchased was $5.76 per share. The rights were related to the company's $46 million financing in April. (See BioWorld Today, May 1, 2003.)

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., filed a registration statement with the SEC for the public offering of 6 million shares. Underwriters will have an option to purchase up to an additional 900,000 shares from the company to cover overallotments, if any. SciClone focuses on developing and commercializing therapeutics to treat diseases.

• Ventana Medical Systems Inc., of Tucson, Ariz., signed a license and development agreement with ILEX Oncology Inc., of San Antonio, that exclusively sublicenses to Ventana diagnostic rights to develop and commercialize immunohistochemistry tests to detect the presence of the CD52 antigen in tissue. ILEX Oncology previously reported the signing of a letter of intent with Ventana to sublicense the rights on Dec. 9.

• Zen-Bio Inc., of Research Triangle Park, N.C., said it would sell liver cells for research. The company, which already sells fat cells, said the human hepatocytes are isolated from non-transplantable donor tissue.