• Affymetrix Inc., of Santa Clara, Calif., released genotype data for 120,000 validated SNPs selected from both public SNP databases and a SNP database developed by Perlegen Sciences Inc., of Mountain View, Calif. Affymetrix, which said the data were generated using its GeneChip DNA analysis technology, called it the first significant SNP database freely available that includes genotype data and allele frequencies for SNPs distributed across the human genome. The 120,000 validated, genome-wide SNPs were genotyped in the same set of individuals.

• Avant Immunotherapeutics Inc., of Needham, Mass., filed a shelf registration with the SEC to allow Avant to sell from time to time up to 15 million shares of its common stock, warrants to purchase up to 2.25 million shares of common stock or a combination of those securities. Avant focuses on products that harness the human immune system.

• AVI BioPharma Inc., of Portland, Ore., initiated a Phase I study of oral dosing of its Neugene antisense drug, AVI-4557, which targets the metabolic enzyme cytochrome P450. Cytochrome P450 is a liver enzyme responsible for the metabolism of about half of currently marketed drugs. AVI-4557 has been shown in previous clinical studies to inhibit the metabolism of two FDA-approved drugs metabolized by P450, the anti-anxiety agent buspirone and the anesthetic midazolam.

• Cephalon Inc., of West Chester, Pa., received German and Irish regulatory authorization to market modafinil tablets in those countries for excessive daytime sleepiness associated with obstructive sleep apnea/hypopnea syndrome. Both approvals include the adjunctive use of modafinil in patients who are receiving adequate treatment for their condition with standard therapy continuous positive airway pressure. Modafinil, which is marketed as Vigil in Germany and Provigil in Ireland, is the first in a new class of wake-promoting agents believed to work selectively through the sleep/wake centers to activate the cortex of the brain, Cephalon said. The drug is approved in more than 20 countries.

• Encysive Pharmaceuticals Inc., of Houston, said its majority-owned German affiliate, Revotar Biopharmaceuticals AG, began two Phase IIa trials of bimosiamose for psoriasis and atopic dermatitis. In both double-blinded, placebo- and standard drug-controlled studies, a new topical formulation of the small-molecule selectin antagonist will be used. Revotar also is evaluating bimosiamose in asthma.

• Exelixis Inc., of South San Francisco, reported that CEO George Scangos executed a sale of 77,120 shares of Exelixis common stock directly to the company at a purchase price of $7.80 per share. The purpose of the sale was to repay a loan and advances extended by the company to Scangos in 1998, 2000 and 2001. The price was determined on the basis of the 20-day average trading price of Exelixis stock.

• Exten Industries, of Warwick, R.I., said its wholly owned subsidiary MultiCell Technologies Inc., is scheduled to launch its immortalized human hepatic cell lines with its new distribution partner, XenoTech LLC, at the 12th annual meeting of the International Society for the Study of Xenobiotics. The meeting was scheduled to begin Oct. 12 and continue through Thursday in Providence, R.I. The deal is expected to mean more than $18 million for MultiCell over the next seven years. (See BioWorld Today, Aug. 21, 2003.)

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said it plans to file for European approval for StaphVAX by the end of next year. The company also entered a 10-year manufacturing agreement with Cambrex Bio Science Baltimore Inc., a subsidiary of Cambrex Corp., of East Rutherford, N.J., which will produce the investigational vaccine being developed to prevent S. aureus bloodstream infections. The manufacturing pact means the end of a similar agreement with Dow Biopharmaceutical Contract Manufacturing Services, for which Nabi will write off about $14 million in costs capitalized in prior periods relating to the right to manufacture StaphVAX in Dow's facility. Nabi added that it continues to target its FDA filing during the fourth quarter of 2005.

• Novavax Inc., of Columbia, Md., and King Pharmaceuticals Inc., of Bristol, Tenn., received FDA approval for Estrasorb (estradiol topical emulsion) in estrogen therapy. More specifically, it was approved for short-term use to reduce moderate to severe vasomotor symptoms, commonly called hot flashes, in menopausal women. The partners expect to launch the drug early next year through a combined sales force. They will co-promote Estrasorb in the U.S. and Puerto Rico, and will share equally gross profits from net sales within these territories and associated costs of promotion. King also has an exclusive license from Novavax to promote, market, distribute and sell the drug worldwide, except in the U.S. and Puerto Rico. Novavax will receive a royalty on net sales of Estrasorb outside of the U.S. and Puerto Rico.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said Phase II data reported at the International Society for Anesthetic Pharmacology meeting in San Francisco showed that the investigational drug methylnaltrexone relieved opioid-induced urinary retention. Inability to urinate is prevalent in men receiving opioid pain therapy after surgery and might require the insertion of a catheter into the bladder. Progenics noted that the drug was able to restore bladder function without reversing the central nervous system effects of the opioid, unlike a standard opioid-receptor antagonist. Methylnaltrexone also is in a Phase II trial to evaluate its ability to relieve post-operative ileus.

• Stanford University in Palo Alto, Calif., said its medical center received an $8 million grant from the National Human Genome Research Institute of the National Institutes of Health in Bethesda, Md., to boost the efforts of its human genome researchers. The funds went to eight different research groups using various techniques to analyze small portions of the human genome. Results from the work will guide future experiments involving the entire sequence.

• The BioBalance Corp., of New York, a wholly owned subsidiary of New York Health Care, released the results of a controlled study in which a formulation containing its biotherapeutic agent, Probactrix, reduced mortality rates and incidence of diarrhea as compared to antibiotics in piglets. The studies showed a decrease of 6.6 percent in mortality rates in the Probactrix group, compared with the antibiotic control group (p<0.01). Antibiotics included gentamycin and advocin.

• Transkaryotic Therapies Inc., of Cambridge, Mass., said the European Patent Office invalidated a patent owned by Applied Research Systems ARS Holdings NV, a wholly owned subsidiary of Serono SA, of Geneva. The board of appeals ruled that Serono's claims failed for lack of enablement. In February, Serono brought suit against TKT in the district court at The Hague in the Netherlands, claiming that TKT's activities relating to Replagal (agalsidase alfa) infringe European Patent No. 0 505 500. The court proceedings are stayed, pending the outcome of the appeal by Serono. TKT said it would move to dismiss the case, adding that it expects to "prevail promptly."

No Comments