* Affymetrix Inc., of Santa Clara, Calif., enered into a three-year Easy Access-Silver agreement with Eli Lilly and Co., of Indianapolis, under which Lilly will gain broad access to Affymetrix's GeneChip arrays, instrumentation and software to monitor gene expression in research and development activities. The Easy Access-Silver package is a volume discount pricing agreement designed for large research organizations.

* Anergen Inc., of Redwood City, Calif., entered a license agreement with Sunol Molecular Corp., of Miami, as the result of a research collaboration formed last year to explore using Sunol's recombinant expression technology for producing the human major histocompatibility complex (MHC) molecules that form the basis of Anergen's platform technology. The license agreement includes rights to single chain, recombinant forms of MHC class II molecules, coupled with an auto-antigenic peptide.

* Hoffmann La-Roche Inc., of Nutley, N.J., received marketing clearance from the FDA for a new formulation of CellCept (mycophenolate mofetil), an immunosuppressive agent. The new formulation is intravenous, to be used in kidney and heart transplant patients immediately after surgery. Roche is a subsidiary of F. Hoffmann-La Roche AG, of Basel, Switzerland.

* Immune Response Corp., of Carlsbad, Calif., presented results of an exploratory Phase II, double-blind trial involving 84 patients with moderate to severe psoriasis. The nine-arm, placebo-controlled clinical trial was designed to test the company's potential T cell receptor peptide therapeutic vaccine using different adjuvants and routes of administration. Results showed patients improved when given intramuscular injections of the peptides along with Incomplete Freund's adjuvant, as compared to all other treatment groups.

* Immunomedics Inc., of Morris Plains, N.J., entered an agreement with Syncor International Inc., of Chatsworth, Calif., whereby Syncor will help distribute CEA-Scan (arcitumomab), a nuclear imaging agent used in the treatment of colorectal cancer. The agreement calls for Syncor to make CEA-Scan available to its hospital and clinic accounts across the U.S., supported by Immunomedics' sales and technical teams. CEA-Scan "lights up" otherwise invisible, metastasized cancers on hospital gamma-camera computers.

* Inhale Therapeutic Systems Inc., of San Carlos, Calif., said preliminary results from a Phase IIb trial showed patients with Type II diabetes can markedly improve glycemic control without insulin injections by combining Inhale's pulmonary insulin with oral diabetes agents. Results were collected from 56 of 69 outpatients in an ongoing, three-month trial conducted by Inhale's collaborator, Pfizer Inc., of New York. Hemoglobin A1c levels were lowered an average of 2.3 percentage points in the group using pulmonary delivery, while those using oral agents alone showed little change.

* Oncor Inc., of Gaithersburg, Md., received a letter from the American Stock Exchange (AMEX), expressing the exchange's plan to delist the company. Oncor's history of losses and other related factors have caused the company to fall below certain guidelines required for listing. The company intends to appeal the delisting action.

* Texas Biotechnology Corp., of Houston, said results from a Phase IIa study of TBC1269, a selectin inhibitor for the treatment of asthma, showed statistically significant improvement over placebo in patients with mild to moderate asthma. Results were measured by reduction in eosinophil recruitment, which improves asthmatic response.

* Zonagen Inc., of The Woodlands, Texas, reported that its worldwide marketing partner for the impotence drug Vasomax, Schering-Plough Corp., of Madison, N.J., filed a marketing authorization application with the Medicines Control Agency of the U.K. If Schering-Plough wins that approval, the company will file applications in all other European Union countries under a mutual recognition procedure. Vasomax is a rapidly disintegrating oral formulation of phentolamine mesylate, which works as a short-term alpha-adrenergic blocker. Zonagen filed a new drug application for the product with the FDA in July.

No Comments