• Alba Therapeutics Corp., of Baltimore, was awarded multiple grants from state and federal agencies to continue its work on the zonulin pathway. Zonulin is a signaling protein that transiently and reversibly opens the tight junctions between the cells of epithelial and endothelial tissues. Funding from the Maryland Industrial Partnerships program will be applied toward completing zonulin receptor cloning and characterization work currently under way at the University of Maryland School of Medicine. A Small Business Innovation Research grant from the National Institute of Diabetes, Digestive and Kidney Diseases, part of the National Institutes of Health in Bethesda, Md., was awarded to support development of Alba’s lead molecule, AT-1001, for Type I diabetes.

• Bioheart Inc., of Sunrise, Fla., which develops cell therapies for heart repair, announced a patent licensing agreement with Cleveland Clinic to further develop its cell-based technology. The deal gives Bioheart worldwide exclusive rights to five pending U.S. patent applications and corresponding foreign filings related to the repair of scarred heart tissue damaged from a heart attack. The patents pending cover methods of repairing damaged heart tissue by transplanting muscle stem cells that express therapeutic proteins capable of recruiting other stem cells within a patient’s own body to the cell transplanted area.

• Biosite Inc., of San Diego, and Five Prime Therapeutics Inc., of San Francisco, entered a collaboration to evaluate disease targets for potential commercialization of diagnostic and therapeutic products. Specifically, Five Prime will provide Biosite access to selected functional disease targets for use in developing diagnostics. In exchange, Biosite will provide Five Prime with Omniclonal antibodies for selected targets to accelerate Five Prime’s therapeutic research efforts. Biosite said its antibody development process generates diverse libraries of Omniclonal antibodies with high affinity and low cross-reactivity. Financial terms were not disclosed.

• Cellectis SA, of Romainville, France, entered a collaboration to allow Celonic GmbH, of Jülich, Germany, to use its Meganuclease Recombination System technology to develop next-generation I-SceI meganuclease-tagged host cell lines for biopharmaceuticals production. Cellectis noted that meganuclease technologies have been used in academic research for more than a decade, and is now becoming central for contract manufacturing of biopharmaceuticals and therapeutic proteins to allow for better control in generating stable producer cell lines. Financial terms were not disclosed.

• Cerimon Pharmaceuticals Inc., of South San Francisco, licensed exclusive worldwide rights to develop and commercialize Simulect (basiliximab) for inflammatory bowel disease from Novartis Pharma AG, of Basel, Switzerland. The monoclonal antibody, currently marketed by Novartis for the prevention of organ rejection in renal transplant recipients, selectively blocks the receptor for interleukin-2 to inhibit T-lymphocyte activation involved in serious immune-related disease. Cerimon will be responsible for the development and marketing of Simulect for injection in inflammatory bowel disease, while Novartis will continue to market it in the transplantation indications. Assuming expanded approval, Cerimon will market Simulect and share revenue from net sales in this field with Novartis. Cerimon also stands to receive performance-based milestone payments, although more specific financial terms were not disclosed.

• FibroGen Inc., of South San Francisco, said a single dose of FG-4539, its novel small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase for ischemic disease, was neuroprotective and significantly reduced brain tissue damage in a preclinical model of permanent ischemic stroke. The potency of FG-4539 and the window of therapeutic opportunity observed following permanent middle cerebral artery occlusion compare favorably to results from the model reported for the most promising neuroprotective therapies currently in development. The data were presented at the International Stroke Conference 2006 in Kissimmee, Fla.

• IDM Pharma Inc., of San Diego, granted an exclusive license to its immune system stimulator Junovan to Genesis Pharma SA, of Athens, for the southeast European countries of Greece, Cyprus, Bulgaria, Croatia, the former Yugoslavian Republic Of Macedonia, Romania and Slovenia. In exchange, IDM will receive an undisclosed up-front license fee and milestone payments on reaching certain sales levels in that territory. The product, designed to destroy cancer cells by activating a patient’s macrophages, has orphan drug status in both the U.S. and Europe, areas where IDM Pharma expects to receive approval next year.

• Inspire Pharmaceuticals Inc., of Durham, N.C., acquired certain exclusive rights to an intranasal dosage form of epinastine in the U.S. and Canada for rhinitis via a development and license agreement with Boehringer Ingelheim International GmbH, of Ingelheim, Germany. Upon regulatory approvals, Inspire would have exclusive marketing and sales responsibility in the U.S. and Canada, while Boehringer Ingelheim has retained the rights to develop and commercialize intranasal epinastine elsewhere, based on any future results of Inspire’s intranasal epinastine development program. Inspire is paying Boehringer Ingelheim an up-front license fee of an undisclosed amount, will fund all development activities and pay single-digit royalties on net sales of the product, if approved. Inspire will not owe any additional milestone payments under the agreement. If Boehringer Ingelheim commercializes Inspire’s intranasal epinastine product outside of the U.S. and Canada, it will pay royalties to Inspire on net sales. Boehringer Ingelheim will supply Inspire with active drug substance pursuant to a separate commercial supply agreement.

• MaxThera Inc., of Beverly, Mass., was awarded a $600,000 Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases through January 2008 to support its ongoing efforts to design and develop antibiotics for treating potentially lethal infections that are complicated by antibiotic resistance. At the end of Phase I funding, the company is eligible to submit a Phase II application for up to $1 million per year for three years.

• Monogram Biosciences Inc., of South San Francisco, said it is collaborating with Whitehouse Station, N.J.-based Merck & Co. Inc. by providing its PhenoSense and GeneSeq testing technologies for use in Phase III trials of MK-0518, Merck’s HIV-1 integrase inhibitor. Monogram’s technology will be used to evaluate drug resistance. Financial terms were not disclosed.

• MorphoSys AG, of Munich, Germany, said its division named Antibodies by Design entered a co-marketing agreement with Chimera Biotec GmbH, of Dortmund, Germany, for the co-marketing of the rapid generation of monoclonal antibodies by AD and Chimera’s complementary Imperacer assay technology for ultra-sensitive antigen detection. Each partner will offer the services of the other to its customers throughout the worldwide market.

• MuriGen Therapeutics Inc., of Victoria, Australia, and Zenyth Therapeutics Ltd., of Melbourne, Australia, are collaborating to co-develop a new class of drugs that target arthritis and other inflammatory diseases. The deal aims to work on proteins that inhibit the activity of the cytokine granulocyte colony stimulating factor or its receptor.

• Senetek plc, of Napa, Calif., out-licensed North American rights to its erectile dysfunction drug treatment Invicorp to Plethora Solutions Holdings plc, of London. Plethora is assuming full responsibility for the regulatory process and for establishing the injectable therapy’s market presence, and is granted options on additional non-North American markets outside of Europe. Senetek will receive royalties on net sales of Invicorp, a combination of phentolamine mesylate and vasoactive intestinal polypeptide, plus predetermined milestone payments upon achievement of regulatory approvals and cumulative net sales targets. More specific financial terms were not disclosed.

• Supernus Pharmaceuticals Inc., of Rockville, Md., received a $17.5 million investment from New Enterprise Associates in Baltimore, following an earlier investment round from a month ago. Newly formed Supernus is essentially continuing the business of the former Shire Laboratories Inc., a subsidiary dissolved by Shire plc, of Chineham, UK. Last month, the specialty pharmaceutical company acquired the assets of Shire Labs and closed an initial equity sale. (See BioWorld Today, Jan. 13, 2006.)

• VaxGen Inc., of Brisbane, Calif., entered an agreement with Becton, Dickinson and Co., of Franklin Lakes, N.J., to evaluate the potential advantages of using BD’s Micro Injection technology to dermally deliver VaxGen’s recombinant anthrax vaccine candidate. A Phase I trial will use BD’s microneedle technology with VaxGen’s anthrax vaccine to compare the safety and effectiveness of dermal injection vs. traditional intramuscular administration of the vaccine. Funding will be provided through BD’s research contract with the Department of Defense.

• Viragen Inc., of Plantation, Fla., and its majority-owned subsidiary, Viragen International, Inc., today announced that the Swedish Medical Products Agency approved Multiferon (multi-subtype, natural human alpha interferon) for the first-line adjuvant treatment of high-risk (Stage IIb to Stage III) malignant melanoma following dacarbazine, after surgical removal of tumors. Viragen officially will launch the drug in the new indication this month.

• Ziopharm Oncology Inc., of New York, presented preclinical data showing ZIO-201, the active metabolite of ifosfamide, may be less likely to kill normal kidney cells than the other metabolites of both cyclophosphamide and ifosfamide, and could be a substitute for those drugs in blood cell and bone marrow transplant conditioning regimens. The data were presented at the 2006 Bone Marrow Transplant Meetings in Honolulu.

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