• Alba Therapeutics Corp., of Indianapolis, was incorporated as a Delaware corporation that will develop and commercialize synthetic peptide therapeutics and drug delivery adjuvants with a focus on immunomodulation and inflammation, as applied to specialty pharmaceutical markets. The company's founding management team includes Blake Paterson as CEO. The management team and advisory board have been involved in the development of more than 10 therapeutic macromolecules, 10 small-molecule pharmaceuticals and 10 drug launches over the past 20 years.

• Avant Immunotherapeutics Inc., of Needham, Mass., said Phase II data reported at the International Conference on Vaccines for Enteric Diseases in Montego Bay, Jamaica, showed that its CholeraGarde vaccine was well tolerated and there were no reports of diarrhea. Previously released findings showed that more than 70 percent of vaccinated adults responded with a favorable immune response against cholera. Another presentation described the status of VibrioVec strains that vector protective antigen from Bacillus anthracis, the anthrax organism, and SalmoVec strains that vector a fusion of protective antigens (F1- V) from the plague organism Yersinia pestis. Separate preclinical data showed that a plague-directed bacterial vaccine candidate was well tolerated in mice and elicited high antibody titers against plague antigens.

• Biovail Corp., of Toronto, and Depomed Inc., of Menlo Park, Calif., submitted a new drug application to the FDA for 500-mg and 1,000-mg tablets of Glumetza, once daily, extended-release formulations of metformin. The submission occurred simultaneous with Biovail and Depomed amending their license agreement to cover both dosage strengths. The 500-mg dosage strength was developed using Depomed's Gastric Retention drug delivery technology and the 1,000-dosage strength was developed by Biovail's Smartcoat delivery technology. Depomed conducted two double-blind Phase III trials for its 500-mg dose in more than 1,000 patients with Type II diabetes.

• Cangene Corp., of Toronto, said it will partner with Defence R&D Canada on two new projects as part of the Chemical, Biological, Radiological and Nuclear Research & Technology Initiative, a Canadian government biodefense plan. Cangene and the University of British Columbia will collaborate with Defence R&D Canada to identify structural information about the anthrax antigen to allow development of diagnostic tests and anti-infective treatments. In partnership with Health Canada, the second project will tap Cangene's knowledge in developing antibody-based therapeutics to investigate potential new treatments for smallpox exposure. Cangene has two such projects already under way.

• Cel-Sci Corp., of Vienna, Va., signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center of the U.S. Navy to jointly evaluate CEL-1000 with new adjuvants against several species of malaria-causing Plasmodium. The initial tests will be conducted in mice. Once the optimal combination has been determined, the product might be further tested in primates with a species of Plasmodium that causes malaria in humans. CEL-1000 is a small peptide that has induced protective responses upon challenge in animals against malaria, herpes simplex and cancer.

• Elan Corp. plc, of Dublin, Ireland, completed its sale of Zonegran (zonisamide) to Eisai Co. Ltd., of Tokyo. In exchange for about $130 million, Eisai acquired exclusive North American and European manufacturing, development and marketing rights to the drug, which was developed and marketed by Elan for the adjunctive treatment of partial seizures in adult epilepsy.

• Gamida-Cell Ltd., of Jerusalem, said preclinical results showed that the injection of expanded populations of human stem cells improves cardiac function in animals that have suffered a heart attack. Another preclinical study found that expanded populations of stem cells derived from bone marrow might provide an alternative treatment source for patients with cardiac ischemia. The company also said the copper-chelation capacity of certain compounds together with the chemical structure adopted by the molecule in the presence of copper are important factors in determining their capacity to enhance the self-renewal of stem cells.

• Genmab A/S, of Copenhagen, Denmark, said that 55 percent of higher-dose patients in the primary indication achieved at least a partial response in HuMax-CD4 Phase II cutaneous T-cell lymphoma studies (CTCLs). The higher-dose levels in the study were 560 mg and 980 mg weekly for up to 17 weeks. Those patients all were treated for mycosis fungoides (MF), which comprise 75 percent of CTCLs. Fourteen early stage MF patients were treated at the 560-mg dose level, and seven of them achieved at least a partial response, or more than 50 percent composite assessment score reduction for at least four weeks, including two who obtained a complete response.

• GenVec Inc., of Gaithersburg, Md., said Phase I interim results of AdPEDF in patients with severe wet age-related macular degeneration demonstrated the product was well tolerated at all dose levels and exhibited no dose-limiting toxicities or drug-related serious adverse events. A total of 24 patients have received a single intravitreal injection of AdPEDF, and dose escalation from the initial dose has increased by 3,000-fold. Investigators also observed positive changes in visual acuity and retinal appearance at the higher-dose levels.

• Geron Corp., of Menlo Park, Calif., said Kirin Brewery Co. Ltd., of Tokyo, filed a lawsuit against Geron in the U.S. District Court for the Northern District of California, alleging interference with contracts and interference with Kirin's prospective business advantage concerning Geron's acquisition of rights to develop cancer vaccines from Merix Bioscience Inc., of Durham, N.C. Geron is focused on developing and commercializing therapeutic and diagnostic products for cancer based on its telomerase technology and cell-based therapeutics using its human embryonic stem cell technology. The company in March broadened its long-standing relationship by agreeing to use Merix's platform technology in cancer vaccines that have telomerase as an antigen. (See BioWorld Today, March 11, 2004.)

• Inverness Medical Innovations Inc., of Waltham, Mass., gained rights to a biomarker technology from Roche Diagnostics, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Through its Inverness Medical Switzerland GmbH subsidiary, Inverness exercised an option for a nonexclusive license under the patent rights of Roche Diagnostics relating to the development, manufacture and marketing of immunoassays that detect a key marker of congestive heart failure, NT-proBNP. The option rights were granted as part of a settlement last year that stemmed from litigation relating to Inverness's rapid assay lateral flow patents.

• Kos Pharmaceuticals Inc., of Miami, received final regulatory approval from Germany's Federal Institute for Drugs and Mechanical Devices to market Niaspan (extended-release niacin) in that country. Niaspan, developed and manufactured by Kos, is indicated in the German label for use as an adjunct to diet to decrease total and LDL-C, ApoB and triglyceride levels, and to increase HDL-C. Niaspan has been on the market in the U.S. since 1997.

• Large Scale Biology Corp., of Vacaville, Calif., said its wholly owned subsidiary, Eclipse Diagnostics Inc., and researchers at Wake Forest University Baptist Medical Center have reported the presence of distinct proteomic signatures in blood serum from multiple sclerosis patients. The discovery was made using Large Scale's BAMF (biomarker amplification filter) technology for the early diagnosis of life-threatening diseases.

• Medmark Inc., of Pittsburgh, raised $28 million through an equity investment from LLR Partners Inc. and Quaker BioVentures Inc. Prior to the transaction, Medmark was majority owned by a health insurance company called Highmark Inc., which formed Medmark to help contain rising prescription drug costs for specialty pharmaceuticals and provide better care for its members. Medmark supplies specialty drugs, supplies and services for patients with diseases such as hepatitis C, multiple sclerosis and respiratory synctial virus. The company said it would use a portion of its new funding to provide its services to other health insurance companies across the country.

• Ortec International Inc., of New York, entered an agreement to collaborate in the development of human embryonic stem cell-derived cell therapy products from ES Cell International Pte. Ltd., of Singapore. Ortec will supply ESI with human skin cells generated from cell lines developed and manufactured by Ortec for use in its OrCel tissue-engineered product. In exchange, Ortec will receive an up-front payment and be entitled to milestone payments, as well as royalties.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said that The Foundation Fighting Blindness in Owings Mill, Md., agreed to perform preclinical proof-of-principle studies using Peregrine's Vascular Targeting Agent technology platform for use in ocular diseases. The preclinical studies will be carried out at the Johns Hopkins University School of Medicine's Wilmer Eye Institute in Baltimore.

• Prana Biotechnology Ltd., of Melbourne, Australia, entered definitive agreements with new institutional investors for the purchase of $20 million of securities through the sale of 4 million American depository receipts (ADRs) at $5 per receipt. The agreements also involve the acquisition by the investors of five-year warrants to purchase an additional 3 million ADRs at an exercise price of $8 per each. If exercised, those warrants would raise an additional $24 million for the company. The transaction is expected to close upon shareholder approval. The placements were made to institutional and professional investors in the U.S. led by OrbiMed Advisors and Xmark Funds.

• Protein Sciences Corp., of Meriden, Conn., said a Phase IIb trial of FluBlOk met its two primary endpoints. The double-blinded trial compared three different doses of FluBlOk, its protein-based influenza vaccine that is produced using cell culture, with a standard dose of a licensed egg-grown influenza vaccine. Data showed that FluBlOk was safe and statistically more immunogenic against the H3 influenza strain when administered at higher doses than the current licensed influenza vaccine. The trial was sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., and conducted in 399 elderly subjects.

• responsif GmbH, of Erlangen, Germany, said findings published in the Journal of Biological Chemistry showed that small molecules and proteins can be ferried into living cells via a new technique making use of artificial capsoids. The scientists produced a capsoid protein, a viral coat protein found on the surface of the murine polyoma virus, and an anchor protein, which was taken from the inner part of the viral capsoid, to which various substances can be coupled. The researchers demonstrated that, under suitable conditions, complete protein capsoids will form in the reaction mixture and envelop the active substances. The resulting viral capsules contain up to an average of 64 polypeptides.

• Saegis Pharmaceuticals Inc., of Half Moon Bay, Calif., said Phase II results of its lead product SGS742 demonstrated improvement in cognition in patients with mild cognitive impairment. The company in-licensed SGS742, an orally active, selective GABAB receptor antagonist, from Novartis Pharma AG, of Basel, Switzerland, in 2001. In the Phase II study, 110 patients were randomized to receive either SGS742 or placebo daily for eight weeks. While there was no improvement of cognitive performance in the Hopkins Verbal Learning Test-Revised endpoint, significant improvements and positive trends were seen in additional endpoints assessing memory, attention and psychomotor speed. Saegis plans to pursue additional clinical development of SGS742 for Alzheimer's disease.

• The San Luigi Gonzaga Hospital in Torino, Italy, said its researchers reported findings at the American Academy of Neurology meeting in San Francisco showing that increasing the dose of Betaferon (interferon beta-1b, from Chiron Corp. and Berlex Laboratories Inc.) significantly improves the response of multiple sclerosis patients who exhibit persisting signs of disease activity with the standard dose. Patients who switched to 375 mcg of Betaferon every other day were 72 percent less at risk for active disease than those who continued on Betaferon 250 mcg every other day, and the proportion who were free of active disease on monthly magnetic resonance imaging scans was nearly double that of the 250-mcg-treated group.

• Serono SA, of Geneva, and Pfizer Inc., of New York, said long-term data support early treatment with high-dose, high-frequency Rebif in reducing the long-term accumulation of brain lesion volume in patients with relapsing-remitting multiple sclerosis. As measured by magnetic resonance imaging, the study showed Rebif 44 mcg continued to have an impact in reducing the accumulation of MS lesion volume in patients after seven to eight years of follow-up. Rebif (interferon beta-1a) was approved in the U.S. in 2002 and in Europe in 1998.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said data reported at the American Academy of Neurology meeting in San Francisco showed that relapsing-remitting multiple sclerosis patients who remained on Copaxone (glatiramer acetate injection) therapy for an average of 10 years experienced significantly less progression of disability than patients who withdrew from the open-label follow-up study. More than 90 percent of those still on Copaxone did not show evidence of disease progression to a six on the Expanded Disability Status Scale, while 50 percent of those who withdrew from Copaxone therapy after an average of four-and-a-half years progressed to that score. Separate data showed that treatment with Copaxone might provide beneficial effects in patients with primary progressive multiple sclerosis. In a post-hoc analysis of all available data from an intention-to-treat cohort, men treated with Copaxone were found to have significantly slower rates of progression of the disease than those treated with placebo.

• Theratechnologies Inc., of Montreal, said its subsidiary Celmed BioSciences is in discussions for a possible transaction with San Diego-based NewBiotics Inc. Further details are undisclosed. Theratechnologies focuses on the discovery and development of therapeutic products in the field of endocrinology and metabolism. Celmed develops photodynamic-based cancer therapies.

• Transgenomic Inc., of Omaha, Neb., agreed to provide additional quantities of modified nucleic acid building-block compounds to Geron Corp., of Menlo Park, Calif., under terms of multiple new addendums to an existing supply agreement. The compounds will be used in the synthesis of Geron's cancer drug, GRN163L, a thio-phosphoramidate oligonucleotide. Product shipments began in the first quarter and should continue through the third quarter.

• Tranzyme Pharma, of Research Triangle Park, N.C., achieved its interim milestone in a project funded by The Institute for the Study of Aging (ISOA) in New York. The company was awarded a grant by ISOA in March 2003 to develop in vitro and in vivo models of Alzheimer's disease. In conjunction with reaching the interim milestone, Tranzyme received the final tranche of the $500,000 award. Tranzyme is applying its gene delivery and expression system to create neuronal cell lines expressing AD-related genes for use in high-throughput assays of beta-amyloid production.

• VaxGen Inc., of Brisbane, Calif., submitted a proposal to the U.S. Department of Health and Human Services describing its plan to provide up to 75 million doses of its recombinant anthrax vaccine to the U.S. strategic national stockpile of biodefense products. HHS plans to award purchase contracts for such a vaccine in August. To date, VaxGen has received two contracts valued at more than $100 million from the National Institute of Allergy and Infectious Diseases to develop its anthrax vaccine.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said findings to be reported at the European Congress of Clinical Microbiology and Infectious Diseases meeting in Prague, Czech Republic, point to the effectiveness of its two late-stage lead candidates, anidulafungin and dalbavancin. In vitro data demonstrated anidulafungin's superior potency vs. existing agents against a range of Candida species; a series of pharmacokinetic studies demonstrated that anidulafungin can be used in patients with potentially complicating conditions without drug-drug interactions or hepatic toxicity; results of a Phase I trial evaluating co-administration of anidulafungin and voriconazole showed no sign of drug-drug interactions and the regimen was well tolerated; and positive data from a previously reported Phase II trial demonstrated the superior efficacy of once-weekly dalbavancin vs. vancomycin twice daily for catheter-related bloodstream infections.