• Agile Therapeutics Inc., of West Conshohocken, Pa., completed a round of financing of $4.5 million, bringing its total raised to date to $20 million. The Hillman Co., TL Ventures and PA Early Stage Partners participated in the round. Agile also announced a new CEO and president, Thomas Rossi, and named women's health care expert Al Altomari a member of its board. The company's lead product, a transdermal contraceptive patch, is in Phase II testing.

• Agilent Technologies Inc., of Palo Alto, Calif., and Rosetta Biosoftware, of Seattle, today said that Agilent - the exclusive distributor of the Rosetta Resolver and Rosetta Luminator gene-expression data-analysis systems - increased its commitment to the Rosetta platforms. Agilent will provide those and other informatics products to address existing and emerging life science applications. Financial terms were not disclosed.

• Applera Corp., of Norwalk, Conn., said Michael Hunkapiller, senior vice president and president of its Applied Biosystems Group, retired. The company promoted Catherine Burzik, formerly executive vice president and chief operating officer of Applied Biosystems, to the position vacated by Hunkapiller. Applied Biosystems develops and markets instrument-based systems, consumables, software and services.

• Genmab A/S, of Copenhagen, Denmark, said the FDA labeled HuMax-CD4 an orphan drug for mycosis fungoides, which constitutes 75 percent of all cutaneous T-cell lymphomas. The human antibody, which targets the CD4 receptor on T lymphocytes, has the same designation in Europe. The company has run two Phase II studies using HuMax-CD4 to treat cutaneous T-cell lymphomas, one in early stage patients and the other in patients with advanced disease, both of which achieved positive results. It said planning for a pivotal study in mycosis fungoides patients is under way.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., launched Sanctura (trospium chloride tablets) in collaboration with Odyssey Pharmaceuticals, a subsidiary of Pliva d.d., of Zagreb, Croatia. The product recently received FDA approval for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. Indevus and Odyssey hired and trained a 480-person sales force to launch the product to primary-care physicians, urology specialists, obstetricians and gynecologists. (See BioWorld Today, June 1, 2004.)

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said results of its Phase IV study of Visicol for chronic constipation were accepted for publication by Clinical Therapeutics and would be published this fall. The company said the results support additional studies to obtain a labeled constipation indication for the product, which is approved for bowel cleansing prior to colonoscopy. Visicol is being tested for use as a laxative in treating patients with constipation.

• LifeSpan BioSciences Inc., of Seattle, formed a $2 million agreement with an undisclosed international pharmaceutical company for a subscription to LifeSpan's DrugTarget Database. The database is a resource for human protein-localization data for drug targets in eight gene families. The database provides subscribers with information on protein expression in 75 human tissues and diseases at the cellular level. The subscriber will nominate 50 additional genes for study and inclusion in the expanded database over a two-year period.

• PARI GmbH, of Starnberg, Germany, said its inhaled cyclosporine product received European orphan designation. The company plans to develop it to minimize the risk of graft rejection in lung transplants. It is the first drug the company will privately develop in conjunction with its eFlow aerosol-delivery platform.

• Pharming Group NV, of Leiden, the Netherlands, acquired the patent portfolio of PPL Therapeutics Ltd., of Edinburgh, UK. Pharming obtained patents and licenses on various products and technologies, including the production and purification of recombinant human fibrinogen and recombinant tissue-sealant compositions. In addition, it obtained access to processes and know-how for the large-scale, GMP-grade purification of recombinant human fibrinogen. Pharming also acquired patents on the production of recombinant protein products and production technology patents for proteins, fusion proteins, as well as peptides. Pharming also has taken over certain product and technology licenses that PPL had obtained from third parties. PPL recently decided to restructure its commercial focus following a sale of the company. Financial terms were not disclosed.

• Sanofi-Aventis, of Paris, was formed following the closure of the merger of Sanofi-Synthelabo SA, of Paris, and Aventis SA, of Strasbourg, France. The deal closed Friday following the settlement of the tender offers, after which Sanofi-Synthelabo controls Aventis with about 95.5 percent of the share capital.

• Transition Therapeutics Inc., of Toronto, agreed to license its Islet Neogenesis Therapy for diabetes to Novo Nordisk A/S, of Bagsvaerd, Denmark. Designed to regenerate insulin-producing cells in the body, the technology is in development for Type I and II insulin-dependent diabetes. The agreement includes an equity investment of C$6 million (US$4.6 million), up-front payments and development milestones potentially totaling up to $48 million, as well as additional commercial milestones and royalties. Transition said in June that Novo might exercise its option to license the technology, months after Novo first entered an option agreement with Transition. (See BioWorld Today, Nov. 10, 2003.)

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