• Accelrys Inc., of San Diego, formed an exclusive agreement with Boston University to distribute two new software methods for studying protein-protein docking, ZDOCK and RDOCK. The algorithms help scientists understand the action of proteins by predicting the manner in which two proteins will interact at the atomic level. The methods are designed to help scientists prioritize in silico which interactions to study further.

• Actelion Ltd., of Basel, Switzerland, and Celltech Group plc, of Slough, UK, modified their license agreement covering Zavesca (miglustat), which is approved for Type I Gaucher's disease in the European Union, U.S., Canada and Israel. Actelion will manage the ongoing or planned clinical trials in the approved indication and trials exploring Zavesca in other glycolipid storage disorders. It also will be responsible for all regulatory and marketing activities, while Celltech will handle manufacturing and receive undisclosed royalties on sales.

• Affymetrix Inc., of Santa Clara, Calif., said scientists at the European Society of Human Genetics Meeting 2004 presented a series of studies using GeneChip Mapping 10K Arrays to identify mutations in certain cancers and developmental disorders. The microarrays enable scientists to genotype and characterize chromosomal abnormalities, including amplifications and deletions in tumors. GeneChip array-based genotyping has strengthened the ability to identify cancer-causing genes, and molecular rearrangements that correlate with clinical outcomes, researchers said.

• Allos Therapeutics Inc., of Westminster, Colo., assigned new global trade names to its lead therapeutic efaproxiral, formerly known as RSR13. It will be marketed in the U.S. as Efaproxyn and outside the U.S. as Revaproxyn. Earlier this month, Allos received an approvable letter from the FDA for Efaproxyn to treat patients with brain metastases originating from breast cancer. The company needs to complete its ongoing Phase III trial and submit the results as an NDA amendment before final approval can be granted. The company also filed for approval in Europe earlier this month. (See BioWorld Today, June 3, 2004.)

• Aphton Corp., of Miami, selected Insegia as the trade name for G17DT, Aphton's product designed to reduce tumor growth and extend survival rates of patients with gastrointestinal cancers. Insegia targets the hormone gastrin 17 to treat gastrointestinal cancers, including pancreatic, gastric, esophageal and colorectal cancer.

• Basilea Pharmaceutica AG, of Basel, Switzerland, received a second fast-track designation from the FDA for its broad-spectrum, first-in-class antibiotic BAL5788. The additional designation covers hospital-acquired pneumonia including ventilator-associated pneumonia due to suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). BAL5788 is a broad-spectrum cephalosporin antibiotic and has a combination of features resulting in bactericidal activity toward MRSA and penicillin-resistant Streptococcus pneumoniae, in addition to a broad-spectrum profile toward other Gram-positive and Gram-negative pathogens.

• CIMA Labs Inc., of Eden Prairie, Minn., said its stockholders voted to approve the company's merger with Cephalon Inc., of West Chester, Pa. About 99.4 percent of stockholders voted in favor of the merger. Cephalon will acquire all of CIMA's outstanding shares for $34 per share in cash. Cephalon announced its plans last November to acquire CIMA for $515 million. (See BioWorld Today, Nov. 5, 2003.)

• Cougar Biotechnology Inc., of Los Angeles, licensed the worldwide, exclusive rights to Emory University's intellectual property portfolio for noscapine and analogues of noscapine. Emory professors discovered that noscapine, an opium alkaloid that has been used as an anti-tussive agent in Japan, Sweden and South Africa, has antitumor activity against solid murine lymphoid tumors and against human breast and bladder tumors implanted in nude mice. Emory received an up-front payment and could receive milestone payments as compounds progress through clinical development. It also would receive a royalty on sales. Cougar would sponsor additional preclinical research studies performed at Emory.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said the June 15, 2004, issue of Clinical Infectious Diseases includes data from two Phase III trials of Cubicin (daptomycin for injection), which received FDA approval in September for complicated skin and skin-structure infections caused by certain Gram-positive organisms. Among the findings were data showing that both studies met pre-defined statistical criteria of noninferiority across all efficacy populations. Also, Cubicin demonstrated comparable efficacy to comparator against methicillin-susceptible Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.

• Curis Inc., of Cambridge, Mass., said the recent issue of Proceedings of the National Academy of Science contains an article that describes the use of a small-molecule Hedgehog signaling pathway agonist to promote the generation of new motoneurons. The report states that isolated stem cells can be converted into motoneurons when the cells are exposed to a Hedgehog agonist and another compound called retinoic acid. Curis said Hedgehog pathway agonists might have therapeutic potential when used directly to promote the development of new neurons in the body. The company entered an agreement in January to license Hedgehog pathway agonist technologies to Wyeth Pharmaceuticals, a division of Madison, N.J.-based Wyeth, on an exclusive worldwide, royalty-bearing basis.

• DOR BioPharma Inc., of Miami, and Thomas Jefferson University in Philadelphia entered a Cooperative Research and Development Agreement with the U.S. Army's Medical Research Institute of Infectious Diseases (USAMRIID) to advance the development of DOR's mucosally delivered vaccine for botulinum toxin. USAMRIID will supply antigens and critical testing reagents and methodologies, while DOR and Jefferson will be responsible for developing and testing formulations suitable for mucosal delivery. The mucosally delivered vaccine previously demonstrated 100 percent protection against botulinum toxin in animal models.

• Emisphere Technologies Inc., of Tarrytown, N.Y., initiated a trial as part of its oral heparin program, to select an oral form of unfractionated heparin, an antithrombotic/anticoagulant, for use in late-stage clinical trials. The study, conducted in 15 healthy volunteers, is designed to determine the dosage most comparable to the liquid heparin formulation previously tested by Emisphere in a 2002 Phase III trial.

• EntreMed Inc., of Rockville, Md., named James Burns president and CEO. Most recently, he was at the specialty pharmaceutical company he co-founded, MedPointe Pharmaceuticals Inc., of Somerset, N.J. EntreMed primarily is developing cancer therapeutics.

• Genaera Corp., of Plymouth Meeting, Pa., reported the opening of enrollment for the second and largest of its Phase II trials of its small-molecule, systemically administered, anti-angiogenic drug, squalamine, for the treatment of wet age-related macular degeneration (AMD). The study is designed to evaluate squalamine as first-line therapy in 100 patients with AMD over a two-year period.

• Generex Biotechnology Corp., of Toronto, presented two posters at the Endocrine Society's 86th annual meeting on Wednesday in New Orleans. The first poster was "Addition of Oralin to Metformin Mono Therapy to Improve Mealtime Hyperglycemia and Overall Glycemic Control in Subjects with Type 2 Diabetes." The second poster, "Beneficial Effects of Addition of Oral Spray Insulin (Oralin) on Insulin Secretion and Metabolic Control in Subjects with Type 2 Diabetes Mellitus Sub-optimally Controlled on Oral Hypoglycemic Agents," will be presented today.

• Genzyme Corp., of Cambridge, Mass., said data reported at this week's Endocrine Society meeting in New Orleans showed that Thyrogen (thyrotropin alfa for injection) met a study's primary endpoint as a therapy for the ablation of thyroid tumor remnants in patients who have thyroid cancer tumors. Its use was shown to be similar to withdrawal from thyroid hormone in achieving ablation of remnant tissue, and significantly reduced the side effects of thyroid hormone withdrawal by allowing patients to remain on hormone therapy. On the market since 1998 as a diagnostic to manage patients being followed for the recurrence of well-differentiated thyroid cancer, Genzyme said it would file in Europe on data from the 63-patient study and continue regulatory discussions in the U.S.

• ImmuneRegen BioSciences, of Scottsdale, Ariz., a wholly owned subsidiary of IR BioSciences Holdings Inc., will award a grant to the University of Arizona College of Medicine in Tucson, to begin a study to test whether Homspera has efficacy as a treatment for gamma radiation by direct muscle injection at the same success level as aerosol administration. The study was requested by the FDA in a meeting with the company executives and scientists in the spring. ImmuneRegen said the FDA is interested in potentially using Homspera as a countermeasure against acute radiation exposure by either military personnel or emergency first responders.

• Immuno-Designed Molecules SA, of Paris, postponed its proposed initial public offering. The company, which is developing inmmunotherapeutic products to treat and control cancer, said current market conditions influenced its decision to pull out of its listing on the Nouveau Marche.

• Isolagen Inc., of Houston, completed the sale of 7 million shares of its common stock underwritten by CIBC World Markets Corp. The company also reported that the underwriters exercised the overallotment option in full, resulting in the sale and issuance of 200,000 shares by the company and 850,000 shares by certain selling shareholders. The gross proceeds to the company, including the 200,000 shares issued by the company upon exercise of the overallotment option, is $61.2 million. (See BioWorld Today, June 11, 2004.)

• Labopharm Inc., of Laval, Quebec, entered an agreement with Debiopharm SA, of Lausanne, Switzerland, to conduct research on the oral delivery of a current intravenous cancer drug using Labopharm's polymeric nano-delivery systems technology to address the delivery challenges of water-insoluble compounds, and, potentially, proteins and peptides. The systems are composed of block co-polymers developed specifically for delivery of water-insoluble compounds and poorly bioavailable compounds.

• Merrion Pharmaceuticals Inc., established its headquarters in Wilmington, N.C. It plans to develop oral drugs and seek collaboration and licensing opportunities with pharmaceutical and biotechnology partners. Merrion was founded by Growcorp, an Irish life sciences venture capital group, to enable the acquisition of a portfolio of drug delivery assets from Elan Corp. plc, of Dublin, Ireland.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said Phase I results reported at the Endocrine Society meeting in New Orleans showed that its PYY3-36 nasal spray appears safe, well tolerated and shows evidence of reducing caloric intake. To date, more than 60 subjects have received treatment and more than 900 doses have been administered in the program, which is designed to deliver the appetite-regulating hormone PYY directly to the bloodstream through the nasal mucosa.

• OSI Pharmaceuticals Inc., of Melville, N.Y., and Genentech Inc., of South San Francisco, entered two agreements detailing their roles in the future promotion, marketing and manufacturing of Tarceva (erlotinib HCl), an investigational cancer drug under FDA review. Genentech will continue to be responsible for the marketing, launch and promotion of Tarceva, while OSI will assist with the promotion by providing at least 25 percent of the combined U.S. sales force. The companies will continue to share responsibility for ongoing development after launch. OSI is responsible for obtaining the current approval by the FDA and is working to complete the new drug application this summer. OSI also will handle commercial manufacturing and supply of Tarceva in the U.S. market. The agreements amend a 2001 deal between the companies. (See BioWorld Today, Jan. 9, 2001.)

• Pharmacyclics Inc., of Sunnyvale, Calif., is enrolling patients in a multicenter Phase II trial of Xcytrin (motexafin gadolinium) injection to treat patients with recurrent low-grade non-Hodgkin's lymphoma. The trial will study the efficacy and safety of Xcytrin used as a single agent in 35 to 40 patients with low-grade NHL, who experienced relapse after prior therapy with Rituxan. They will receive Xcytrin intravenously each day for three days every two weeks until disease progression. Xcytrin is in a randomized Phase III trial comparing the effects of whole-brain radiation therapy (WBRT) alone to that of WBRT plus Xcytrin to treat brain metastases in patients with non-small-cell lung cancer.

• Sepracor Inc., of Marlborough, Mass., resubmitted its new drug application to the FDA for Estorra to treat insomnia, answering all of the agency's questions, it said. The FDA issued an approvable letter for the therapy in February. It has not requested additional clinical or preclinical trials for approval. The NDA contains a total of 24 clinical trials, involving more than 2,700 subjects. Sepracor expects the FDA's review to take about six months. The company ended a co-promotion deal with the Ross Products division of Abbott Laboratories, of Abbott Park, Ill., for the asthma therapy Xopenex earlier this year, as it prepared to triple its in-house sales force to launch Estorra. (See BioWorld Today, March 26, 2004.)

• Tercica Inc., of South San Francisco, said detailed Phase III results on its recombinant human insulin-like growth factor-1 (rhIGF-1) product would be reported Friday at the Endocrine Society meeting in New Orleans. Findings include positive efficacy and safety results on rhIGF-1's use in treating severe short stature caused by insulin-like growth factor-1 deficiency (IGFD) due to growth hormone insensitivity (GHI). Specific results demonstrated a statistically significant increase (p<0.001) in growth rate over an eight-year period in response to therapy, achieving the study's primary endpoint. Long-term treatment resulted in an average threefold increase in growth rate in the first year of therapy, and a twofold increase in growth rate over an eight-year period. Compared to pretreatment growth patterns, children gained, on average, an additional inch per year for each year of therapy during the eight-year period. The multicenter, open-label study included 65 children. Of them, 54 had been treated with rhIGF-1 for a minimum of one year. Tercica acquired the product through a licensing arrangement with Genentech Inc., of South San Francisco. Tercica has said it plans to file a new drug application with the FDA early next year after validating a production process with a contract manufacturer. Its stock (NASDAQ:TRCA) rose 7 cents Wednesday to close at $9.96.

• Vasogen Inc., of Toronto, said a Phase III trial of Celacade (immune modulation therapy) for peripheral arterial disease would take a bit longer than first planned. Enrollment in the 500-patient study, labeled SIMPADICO, is expected to be complete by the end of this year, rather than next quarter as previously projected. It is expected to complete its primary endpoint - the change in maximal treadmill walking distance over six months - during the second quarter of next year. Vasogen said its previous guidance for completing the 2,000-patient ACCLAIM trial of Celacade in chronic heart failure remains unchanged, concluding when a minimum of 701 outcome events have occurred and all patients have been followed for at least six months.

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