• Access Pharmaceuticals Inc., of Dallas, received FDA approval to market MuGard as an oral rinse for managing oral mucositis, a side effect that afflicts many cancer patients undergoing radiation and chemotherapy. The company, which estimated that the product would operate in a U.S. market that exceeds $1 billion, is seeking partners for that territory and abroad.

• Affymetrix Inc., of Santa Clara, Calif., signed a development and marketing deal granting Sysmex Corp., of Kobe, Japan, exclusive rights to distribute Affymetrix's diagnostic microarray products and instrumentation in Japan with the opportunity to expand into certain Asia Pacific countries. In addition, the companies signed a Powered by Affymetrix agreements, which gives Sysmex nonexclusive access to Affymetrix' microarray technology to develop and market in vitro tests on a worldwide basis. Financial terms were not disclosed.

• Elusys Therapeutics Inc., of Pine Brook, N.J., extended its Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases, a relationship that's already led to an anthrax therapeutic, Anthim, that's in the final stages of clinical development. Going forward, both parties will continue to perform collaborative research to develop therapeutics against anthrax and other unspecified biowarfare agents using Elusys' HP Antibody technology, as well as against other emerging infections.

• Endotherm GmbH, of Saarbruecken, Germany, entered a collaboration with PharmaInformatic, of Emden, Germany, to develop and optimize new antiviral agents. PharmaInformatic will use its cheminformatics systems to predict antiviral and pharmacokinetic properties of compounds based on computer calculations, and promising candidates will be identified and directly synthesized by Endotherm. Further terms of the deal were not disclosed.

• GPC Biotech AG, of Martinsried, Germany, said Waltham, Mass.-based Spectrum Pharmaceuticals Inc., its partner for satraplatin, filed a demand for arbitration and statement of claim with the American Arbitration Association to resolve a dispute under the companies' co-development and license agreement for satraplatin. In its allegations, Spectrum claims it is entitled to a payment of €9 million (US$12 million) in connection with a reimbursement for past development expenses, and alleges that GPC has not used "commercially reasonable efforts" to gain regulatory approval of the drug and to promote satraplatin in Japan. In response, GPC said Spectrum's claims are "made in bad faith," and are without merit, and the company intends to seek an affirmative declaration that it has not defaulted on any material obligation under the license agreement. The companies have worked together since October 2002, when Spectrum licensed satraplatin, a third-generation platinum analogue, to GPC for development against cancer. (See BioWorld Today, Oct, 2002.)

• Graffinity Pharmaceuticals GmbH, of Heidelberg, Germany, said its partner, Ingelheim, Germany-based Boehringer Ingelheim Pharmaceuticals Inc., decided to exercise options in the companies' original agreement to significantly increase the number of targets screened by Graffinity. Under the terms, Graffinity will receive additional technology access fees for the generation of multiple small-molecule hit series against drug targets from different therapeutic areas. Financial terms were not disclosed.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said the FDA accepted for review its new drug application for Sanctura XR (trospium chloride), a once-daily formulation of Sanctura, for overactive bladder, and the PDUFA data is Aug. 13. The NDA, submitted in October, includes results from the company's Phase III program, as well as results of additional Phase I and Phase II studies.

• Pozen Inc., of Chapel Hill, N.C., said the FDA completed its initial review of the company's response to the June 8 approvable letter for Trexima, and requested additional analyses and supporting information relating to the data submitted in the November response. Pozen expects to prepare and submit the revised response before year end. Trexima, which combines sumatriptan with naproxen sodium in a single tablet, is designed to treat migraine.

• Trana Discovery Inc., of Cary, N.C., and Southern Research Institute in Birmingham, Ala., agreed to collaborate on research that could lead to the discovery of new classes of drugs for HIV patients. Under the agreement, Trana will screen Southern Research's collection of nucleosides to identify anti-infective compounds. Financial terms were not disclosed.

• Vion Pharmaceuticals Inc., of New Haven, Conn., entered a manufacturing agreement for its lead anticancer agent, Cloretazine (VNP40101M), with Ben Venue Laboratories, a division of Boehringer Ingelheim GmbH, of Ingelheim, Germany. The alkylating agent is being evaluated in a Phase III trial in combination with cytarabine in relapsed acute myelogenous leukemia and a pivotal Phase II trial as a single agent in elderly patients with previously untreated, de novo, poor-risk acute myelogenous leukemia. Ben Venue will manufacture finished drug product. Financial terms were not disclosed.