• Aastrom Biosciences Inc., of Ann Arbor, Mich., said a Nasdaq listing qualifications panel granted it a 90-day grace period for compliance with the $1 minimum bid price requirement. Aastrom will maintain its listing under the symbol "ASTM" on the Nasdaq SmallCap Market until May 23. If at any time before that date the bid price closes at or above $1 for a minimum of 10 consecutive trading days, or such other length of time as Nasdaq may require, the market will provide written notification of compliance.

• Advanced Cell Technology Inc., of Worcester, Mass., said judgment was awarded in its favor in a patent interference with Infigen Inc., of Deforest, Wis. The U.S. Patent and Trademark Office's Board of Patent Appeals and Interferences turned back Infigen's challenge of U.S. Patent Nos. 5,945,577; 6,215,041; and 6,235,969 assigned to the University of Massachusetts in Amherst and licensed exclusively to Advanced Cell Technology. The patents cover the use of any proliferating somatic cell for the cloning of nonhuman animals.

• Amgen Inc., of Thousand Oaks, Calif., said researchers presented positive Phase III data from a study of Enbrel (etanercept) in psoriasis patients during the American Academy of Dermatology meeting in San Francisco. The 652-patient trial showed that 49 percent of patients treated with 50 mg twice weekly achieved at least a 75 percent improvement, compared to placebo after three months. Nearly 60 percent achieved at least a 75 percent improvement after six months. Among patients receiving 25 mg twice weekly, 34 percent achieved at least a 75 percent improvement after three months and 44 percent improved after six months. (See BioWorld Today, Jan. 21, 2003.)

• Celgene Corp., of Warren, N.J., reported data at the American Pain Society meeting in Chicago from the first pilot, open-label trials of Thalomid (thalidomide) in complex regional pain syndrome (CRPS). The studies, begun after a clinical observation of a patient being treated with Thalomid in a multiple myeloma trial, showed reduction of at least two points in visual analogue scale scores in seven of eight patients at one center and four of six at another. At their outset, the two trials recruited nine and 12 patients, respectively. A third site that began with 13 patients revealed a reduction in CRPS symptoms in the three that continued for three months. Adverse events, which included rash and somnolence, resulted in the other 10 dropping from the study, as did various CRPS symptoms. Celgene said patients who experienced a reduction in their CRPS symptoms usually experienced the therapeutic effect within four to six weeks of starting Thalomid, and none that completed three months of therapy developed peripheral neuropathy, a side effect.

• Centocor Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., presented positive Phase II data from a study of Remicade (infliximab) in psoriasis patients during the American Academy of Dermatology meeting in San Francisco. The multicenter, randomized, double-blind, placebo-controlled, 249-patient trial showed that at the 10th week, 88 percent and 72 percent of patients treated with 5 mg/kg and 3 mg/kg of Remicade, respectively, experienced a greater than or equal to 75 percent improvement from baseline in Psoriasis Area Severity Index (PASI) score, compared to 6 percent of placebo patients. Among the 5 mg/kg group, nearly half achieved a greater than or equal to 75 percent PASI score improvement as early as the fourth week, and 58 percent achieved 90 percent PASI score improvement in the 10th week.

• CIMA Labs Inc., of Eden Prairie, Minn., filed a patent infringement complaint in U.S. District Court for the District of Minnesota against KV Pharmaceutical Co., of St. Louis, and its wholly owned subsidiary, Ethex Corp. CIMA alleges infringement of its U.S. Patent No. 6,024,981, titled "Rapidly Dissolving Robust Dosage Form." KV Pharmaceutical labeled the patent infringement claim "baseless and without merit."

• Cypress Bioscience Inc., of San Diego, reported at the American Pain Society meeting in Chicago that its lead candidate, milnacipran, was shown to statistically improve a number of primary and secondary hallmark symptoms of fibromyalgia syndrome, including occurrence/intensity of pain and overall well being. The trial showed that milnacipran patients randomized to the twice-daily dosing group showed statistically significant improvement in pain, compared to placebo. Further, 37 percent reported at least a 50 percent reduction in pain intensity, compared to 14 percent of placebo patients, a statistically significant difference (p=0.0395, intent-to-treat analysis).

• Genelabs Technologies Inc., of Redwood City, Calif., reported preclinical data on its antifungal compound, GL48656, at the Focus on Fungal Infections conference. Findings showed that GL48656 is fungicidal in vitro against various species of pathogenic fungi. Also in a mouse model of systemic aspergillosis, the compound produced a significant increase in survival at doses as low as 1 mg/kg compared to untreated controls. Genelabs' stock (NASDAQ:GNLB) rose 9 cents Friday to close at $1.31.

• Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif., reported positive Phase III data from a study of Raptiva (efalizumab) in psoriasis patients during the American Academy of Dermatology meeting in San Francisco. Results from the 556-patient study showed that after 12 weeks of Raptiva therapy, 98 of 369 study patients (27 percent) demonstrated 75 percent or greater Psoriasis Area and Severity Index score improvement, vs. 8 of 187 (4 percent) of placebo patients. But 216 of Raptiva patients (59 percent) achieved 50 percent or greater PASI score improvement, vs. 26 in the placebo group (14 percent). The partners called the results consistent with data obtained from previous Phase III studies, adding that they were included as part of a biologics license application filed with the FDA late last year. Partner Serono SA, of Geneva, filed for approval in Europe in February. (See BioWorld Today, Dec. 27, 2002.)

• Generex Biotechnology Corp., of Toronto, said the appellate division of the New York Supreme Court denied a motion for re-argument of the Oct. 29, 2002, decision, or for leave to appeal to the Court of Appeals, a motion filed by Sands Brothers & Co. Ltd. On Oct. 29, the appellate division issued a decision and order affirming a lower court's order vacating a New York Stock Exchange arbitration panel's award granting Sands warrants for about 1.5 million Generex shares. The decision and order modified the lower court's order by remanding the issue of damages to a new panel of arbitrators, expressly limiting that issue to reliance damages which are not to include an award of lost profits.

• Ligand Pharmaceuticals Inc., of San Diego, received a $1.5 million milestone payment from Eli Lilly and Co., of Indianapolis, which advanced into Phase II studies LY818, an oral, once-daily peroxisome proliferation activated receptor (PPAR) modulator for Type II diabetes and metabolic diseases. LY818 was discovered through an ongoing research collaboration that began in 1997. Ligand receives research and milestone funding from Lilly, which also is responsible for the development and registration of any resulting products. Lilly retains exclusive worldwide marketing rights to resulting products, and would pay Ligand royalties on sales. The agreement also has advanced two other PPAR modulators into clinical studies.

• Medi-Hut Co. Inc., of Wall Township, N.J., named David LaVance CEO and chairman, and also appointed Thomas Gifford chief financial officer and a board member. At the same time, Medi-Hut terminated three officers - Joseph Sanpietro Sr., Vincent Sanpietro and Laurence Simon - as well as Joseph Sanpietro Jr., who also was an employee. The company plans to reissue more accurate financial results from the past two years, calling the prior reports unreliable for investors and shareholders. At 10:07 a.m., Nasdaq halted trading of the company's securities (NASDAQ:MHUTE), which had fallen 13 cents Friday, or 12 percent, to close at 96 cents.

• Orchid BioSciences Inc., of Princeton, N.J., said it received from Nasdaq an exception to the market's shareholder approval requirements in connection with a proposed private financing of up to $16 million. Orchid intends to sell up to 1,600 shares of newly issued convertible preferred stock, each convertible into about 22,222 common shares. Each preferred share, which will cost $10,000, would include a warrant to purchase about 6,667 common shares. The preferred shares will be convertible into common stock at a per-share conversion price of 45 cents, and the warrants will be exercisable at 45 cents apiece.

• Organon International, a unit of Akzo Nobel NV, of Arnhem, the Netherlands, named Toon Wilderbeek president. He succeeds Hans Vemer, effective April 1. Wilderbeek, who will be assisted by Vemer during the transition, will conduct his business unit management responsibilities from Organon's Roseland, N.J., headquarters while maintaining his membership status on Akzo Nobel's board.

• The Senate Health, Education, Labor and Pensions Committee unanimously approved President Bush's Project BioShield, a plan to develop and make available modern, effective countermeasures against biological and other dangerous agents. Under the Department of Homeland Security, Bush proposes spending $6 billion over 10 years to fund the project, which gives federal health officials the authority to stockpile treatments against biological weapons without congressional approval. (See BioWorld Today, Feb. 4, 2003, and March 7, 2003.)