• Acologix Inc., of Hayward, Calif., and Tokyo-based Toray Industries Inc. entered a collaboration and license agreement for Toray's TRK-820 in North America and Europe. Acologix gains an exclusive license to develop and commercialize the drug in North America, and to co-develop it with Toray in Europe, where Acologix retains a commercialization option. TRK-820 is a highly selective kappa opioid receptor agonist that has completed Phase II studies to treat uremic pruritus, a severe itching condition in dialysis patients. A Phase III study is expected to begin in Europe later this year.

• Allos Therapeutics Inc., of Westminster, Colo., and Loures, Portugal-based Hovione entered a long-term manufacturing agreement for the supply of Efaproxyn bulk drug substance, efaproxiral sodium. The drug is the subject of a confirmatory Phase III trial designed to compare the effect of whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn in women with brain metastases originating from breast cancer.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., signed an amendment to its agreements with Garching Innovation GmbH, the licensing agent for the Max Planck Society in Germany. The amendment reinforces Alnylam's continued exclusivity for the "Tuschl II" patent application, and improves the operating flexibility for the company's subsidiary, Alnylam Europe AG. The patent is required for development and commercialization of RNAi therapeutics.

• Corixa Corp., of Seattle, and GlaxoSmithKline plc, of London, reported that the waiting period imposed by the Hart-Scott-Rodino Act in connection with the proposed acquisition of Corixa by GSK expired on June 13. The transaction remains subject to various closing conditions, including the approval of Corixa's stockholders. (See BioWorld Today, May 3, 2005.)

• Encysive Pharmaceuticals Inc., of Houston, said it plans to market Thelin (sitaxsentan), an endothelin receptor antagonist, directly in Europe. The company has said it would market the product itself in the U.S., but previously had remained noncommittal to plans for a European partner. Encysive submitted the new drug application to the FDA in May for Thelin to treat pulmonary arterial hypertension. It expects to file for European approval in the third quarter. Also, it said the SEC declared effective its registration statement pertaining to the resale of up to $130 million in 2.5 percent convertible senior notes due 2012. (See BioWorld Today, May 26, 2005.)

• Genentech Inc., of South San Francisco, said its board has authorized the extension of its current stock repurchase program for the repurchase of up to an additional $2 billion in stock for $4 billion through June 30, 2006. The board also amended the current repurchase program by increasing the maximum number of shares that can be purchased from 50 million to 80 million shares. As of May 31, Genentech has purchased about 29 million shares of its stock for about $1.5 billion.

• Generex Biotechnology Corp., of Toronto, entered a product licensing and distribution agreement in which MedGen Corp. will apply to the Lebanese Ministry of Public Health for approval of the oral insulin buccal spray formulation Oral-lyn. Generex has granted to MedGen a license to market, promote, distribute and sell Oral-lyn in Lebanon following registration. MedGen has paid an up-front license fee to Generex and has obligations to purchase minimum periodic quantities of Oral-lyn from Generex.

• GenoMed Inc., of St. Louis, said it has successfully treated its first patient this summer with presumed West Nile virus encephalitis. The patient, a 17-year-old woman in Philadelphia, was agitated with a fever for three days and became delirious despite antiviral medications. After two doses of GenoMed's protocol, 12 hours apart, the patient's mental state has improved markedly, according to her mother.

• Gentium SpA, of Villa Guardia, Como, Italy, priced its initial public offer of 2.4 million American depository shares at $9 each, raising $21.6 million. The shares represent 2.4 million of Gentium's ordinary shares. Its lead product, defibrotide, is set to enter Phase III testing in the U.S. and Europe to treat veno-occlusive disease. Underwriters have an overallotment option for up to 360,000 additional ADSs, which will be listed on the American Stock Exchange under the symbol "GNT."

• Harvard-Partners Center for Genetics and Genomics, of Boston, said its researchers have developed a rapid, high-throughput screening technology for identifying disease-related genes, and are applying it to discover a new gene associated with colon cancer.

• Ipsat Therapies, of Helsinki, Finland, said Tekes, the Finnish National Technology Agency, will provide €3 million (US$3.6 million) in funding to support Ipsat's development, focusing on its lead product, P1A, through Phase IIb studies. P1A is a recombinant enzyme for the prevention of microflora gut disturbance and antibiotic-associated diarrhea and preservation of colonization resistance.

• Kalypsys Inc., of San Diego, and NovImmune SA, of Geneva, formed a collaboration to accelerate the discovery and development of new drugs for autoimmune and inflammatory diseases. The companies will work to find small-molecule modulators of the major histocompatibility complex II in patients with the diseases. Financial terms were not disclosed.

• MedImmune Inc., of Gaithersburg, Md., said it met the primary endpoint in a Phase III study evaluating the immunogenicity of two different formulations of its live, attenuated intranasal influenza vaccine. Preliminary results indicate that the approved formulation, FluMist, and the investigational, next-generation refrigerator stable formulation, CAIV-T (cold adapted influenza vaccine, trivalent), produced similar immune responses. Final results will be submitted later this year to the FDA.

• Metabolon Inc., of Research Triangle Park, N.C., was awarded a contract from the National Institute of Mental Health to identify biomarkers occurring in women affected by premenstrual dysphoric disorder. Metabolon scientists will compare samples from women with PMDD to samples from normal healthy women under controlled hormonal conditions. Metabolon will analyze the data to identify biomarkers that indicate a metabolic difference between the two groups.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the New England Journal of Medicine published results from two clinical trials this week. The first reports Phase III results showing Velcade was superior in survival, time to disease progression and response rates compared to standard of care, high-dose dexamethasone, in patients with relapsed multiple myeloma. Results from the second study, a randomized Phase I trial of MLN02 in patients with ulcerative colitis, demonstrated statistically significant improvements in remission rates in patients compared to placebo.

• Nonlinear Dynamics Ltd., of Newcastle-upon-Tyne, UK, said the Australian Proteome Analysis Facility Ltd. has purchased two full licenses of Progenesis Discovery v2005, Nonlinear's flagship product. The product is a 2D gel image analysis platform that uses statistically driven proteomics and tools for data analysis.

• OrthoLogic Corp., of Tempe, Ariz., reported the publication of a key preclinical study in support of the ongoing Chrysalin fracture repair program. The study was published in the current volume of the Journal of Orthopaedic Research. Chrysalin (TP508) is a 23-amino-acid peptide that represents the receptor-binding domain of the human thrombin molecule.

• Power3 Medical Products Inc., of The Woodlands, Texas, received notification from Nasdaq that its common stock will be delisted from the Over-the-Counter Bulletin Board because it failed to satisfy listing rules requiring it to be current and complete with its SEC reporting obligations. The company has not filed its Form 10-K for the period ended Dec. 31. It expects to file it by the end of this month. Power3 expects to reapply for re-quotation of its common stock on the OTCBB.

• Prana Biotechnology Ltd., of Melbourne, Australia, said it will continue to develop PBT2 for Alzheimer's disease, and is confident it will not present impurity problems found in PTB1. The company began Phase I trials of PBT2 in March, and it continues to be focused on developing and commercializing a range of metal-protein attenuating compounds to treat neurodegenerative diseases. In other news, Jonas Alsenas has stepped down as Prana's CEO and director to pursue other opportunities. Geoffrey Kempler will re-assume the positions of executive chairman and CEO until a successor is found.

• Quark Biotech Inc., of Fremont, Calif., said findings were presented from a study that outline the role of the hypoxia inducible gene RTP801 in cigarette smoking-induced pulmonary injury/inflammation at the annual Aspen Lung Conference in Colorado. The study was conducted in wild-type mice and in mice where expression of RTP801 was suppressed either genetically, or by instillation with anti-RTP801 siRNA. Quark discovered RTP801 in 1997.

• Resverlogix Corp., of Calgary, Alberta, said its board has authorized the company to purchase for cancellation up to 250,000 common shares representing about 1 percent of the 23.4 million currently issued and outstanding common shares. The company's lead technology Nexvas applies advanced medical research to develop therapies that increase high-density lipoprotein to treat cardiovascular diseases.

• Speedel Group, of Basel, Switzerland, developed next generation renin inhibitors for the treatment of cardiovascular and metabolic diseases, triggering a milestone payment. Working together with Locus Pharmaceuticals Inc., of Blue Bell, Pa., under a collaboration initiated in 2003, Speedel produced a series of lead compounds (SPP800 series) for which it has filed a patent application.

• Vical Inc., of San Diego, received about $12.1 million in production orders for multiple clinical lots of DNA vaccines against HIV for the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. The orders came under a subcontract managed by SAIC-Frederick Inc., of Frederick, Md. Production is scheduled to begin in the second half of 2005, with shipments anticipated in 2005 and 2006 in support of planned Phase II studies.