• Affectis Pharmaceuticals AG, of Munich, Germany, closed a €4 million (US$5.2 million) Series B financing round led by EMBL Ventures, of Heidelberg, Germany. The company said proceeds will be used to advance its drug development programs into the clinic for the treatment of depression. Affectis' lead candidate addresses an ion channel associated with depression that has been validated as a possible target to act faster than existing antidepressants with fewer side effects. Along with the financing, Christof Antz, managing partner of EMBL Ventures, will join Affectis' board.

• Affymetrix Inc., of Santa Clara, Calif., launched the GeneChip Globin-Reduction kits and associated protocol developed in conjunction with PreAnalytiX, of Hombrechton, Switzerland, a joint venture between Qiagen NV, of Venlo, the Netherlands, and Becton, Dickinson & Co., of Franklin Lakes, N.J. The kits optimize the PreAnalytiX PAXgene Blood RNA System for use with Affymetrix GeneChip technology and improve gene-expression profile results of cellular RNA extracted from whole blood.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and Benitec Ltd., of St. Lucia, Australia, formed a licensing agreement covering intellectual property in RNA interference. Alnylam will provide Benitec and its licensees an option to nonexclusively license Alnylam-controlled IP. Once Benitec exercises the option, Alnylam would receive license fees and potential milestone payments and royalties. Benitec also will provide Alnylam with reciprocal options under reciprocal terms to nonexclusively license Benitec IP for expressed RNAi and synthetic siRNAs.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., and Oscient Pharmaceuticals Corp., of Waltham, Mass., signed a two-year co-promotion partnership to promote Testim 1 percent testosterone gel to treat hypogonadism in the U.S. Oscient will promote Testim to primary care physicians, while Auxilium will continue to promote Testim to urologists, endocrinologists and select primary care physicians. Both companies will share profits from primary care sales above a predetermined baseline after marketing expenses are reimbursed.

• Avanir Pharmaceuticals Inc., of San Diego, completed its previously announced sale of about 7.8 million shares of Class A common stock in a registered direct offering at $2.20 per share, raising gross proceeds of about $17.1 million and net proceeds of about $15.8 million. The company said funds will be used for general corporate purposes, including the Phase III trial for Neurodex in neuropathic pain, along with research and development activities for other products in the pipeline. Part of the funds also could go toward pre-launch activities for Neurodex, for which Avanir is completing a rolling new drug application. (See BioWorld Today, April 8, 2005.)

• Bioaccelerate Holdings Inc., of New York, and Symbollon Pharmaceuticals Inc., of Framingham, Mass., formed an exclusive worldwide license and co-marketing agreement for IoGen, an oral form of Symbollon's iodine technology to treat cyclic mastalgia. Bioaccelerate will fund ongoing Phase III development of the product and will cover the commercialization expenses. Symbollon will oversee future clinical development efforts, and the parties will share any net profits upon commercialization.

• Celgene Corp., of San Diego, said human placenta-derived stem cells that are pluripotent can be isolated with a perfusion technology from placenta to be available for potential treatment applications. Results of the study, presented at the International Conference on Stem Cells Research and Therapeutics in San Diego, showed that through the perfusion process, mononucleated cells could be obtained, purified and cultured, and within two to four weeks, adherent cells with fibroblast-like morphology could be grown from the placenta perfusate culture.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, and Tripos Inc., of St. Louis, reached milestones in their joint research partnership on catechol-O-methyltransferase (COMT) inhibitors and entered a new agreement to continue their collaboration. Terms of the agreements were not disclosed. The companies have identified several series of compounds active against the target COMT.

• CombinatoRx Inc., of Boston, was awarded a cooperative research grant of up to $4.4 million by the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health in Bethesda, Md. The objective of CombinatoRx's research is to discover combinations of approved small-molecule drugs that interact synergistically to block the adverse effects of anthrax lethal toxin.

• Depomed Inc., of Menlo Park, Calif., and Biovail Corp., of Toronto, said a response has been submitted to the FDA regarding an outstanding inquiry on the new drug application for Glumetza, a once-daily, extended-release formulation of metformin hydrochloride for the treatment of Type II diabetes. The FDA issued an approvable letter for the drug last month, pending the resolution of an issue related to finalizing a manufacturing specification. The companies expect a 60-day review process and, if approved, Depomed stands to receive a $25 million milestone payment from Biovail. (See BioWorld Today, March 2, 2005.)

• Insmed Inc., of Richmond, Va., received priority-review notification from the FDA for the new drug application for SomatoKine (mecasermin rinfabate). The user-fee goal date is July 3. The FDA previously granted SomatoKine orphan drug designation. The product is a delivery composition of insulin-like growth factor-I and its principal binding protein, IGFBP-3. Insmed submitted the NDA in January. (See BioWorld Today, Jan. 5, 2005.)

• KineMed Inc., of Emeryville, Calif., signed a compound evaluation agreement with Sosei Co. Ltd., of Tokyo. KineMed will screen numerous molecules provided by the library of Sosei's Drug Reprofiling Platform using KineMed's in vivo KineMarker Assays. The compounds have completed preclinical development and most have advanced through Phase I or Phase II testing. KineMed will use its assays to determine whether any of the compounds have potential indications other than those for which they originally were developed.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., presented positive results for Velcade in treating patients across the multiple myeloma treatment paradigm at the 10th annual International Myeloma Workshop in Sydney, Australia. Data regarding the use of Velcade as a single agent and in combination with standard and emerging MM therapies were reported, showing Velcade induced higher response rates in earlier lines of therapy. Velcade (bortezomib) is approved in the U.S. for the treatment of patients who have received at least one prior therapy.

• MultiCell Technologies Inc., of Warwick, R.I., will relocate its offices and laboratory into facilities in Lincoln, R.I., upgrading the company's research capabilities and bringing certain functions in-house. MultiCell is expanding a number of its existing research programs and developing new cell-based technologies for liver support and liver tissue regeneration, it said. The company has signed a three-year lease with CytoTherapies Inc., now StemCell Inc., which vacated the location when it relocated to California.

• Musculoskeletal Transplant Foundation, of Edison, N.J., signed two agreements with Israeli company ProChon Biotech Ltd. The agreements include an equity investment agreement and a research collaboration to develop products combining ProChon's growth factor and cell technology with MTF's allograft and tissue materials. MTF will provide funding for research and development and will have exclusive worldwide rights to supply and distribute the finished products.

• Myriad Genetics Inc., of Salt Lake City, said its board elected John Henderson chairman, to succeed Dale Stringfellow, who recently died of cancer. Henderson, who has been a director of Myriad since March 2004, worked for New York-based Pfizer Inc. for 25 years, where he served most recently as a vice president in Pfizer's pharmaceuticals group.

• Nonlinear Dynamics Ltd., of Newcastle Upon Tyne, UK, undertook a large-scale development program to evolve a new biomarker discovery product range. The program will seek the launch of multiple biomarker products to form a solution for the analysis of mass spectrometry and capillary electrophoresis trace data.

• Perlegen Sciences Inc., of Mountain View, Calif., and Mitsubishi Pharma Corp., of Osaka, Japan, formed a licensing agreement for the late-stage development and commercialization of MCC-555 to treat diabetes and other metabolic disorders. Perlegen will have exclusive worldwide rights, excluding Asia, to develop and commercialize MCC-555, and Mitsubishi will receive up-front cash payments, as well as potential milestone payments. Mitsubishi also gains an exclusive license to use Perlegen-identified predictive genetic markers for use with the therapeutic in Asia. The companies will receive reciprocal royalties.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., said that Kenilworth, N.J.-based Schering-Plough Corp. is beginning preclinical development of a small-molecule drug candidate identified as part of the companies' collaboration targeting inflammatory disease. That triggers an undisclosed cash milestone payment from Schering-Plough. Pharmacopeia could receive additional milestone payments as the compound progresses through clinical development, as well as royalties. The collaboration, signed in 1998, has yielded a total of five development candidates, two of which have moved into Phase I trials.

• Pieris Proteolab AG, of Freising, Germany, signed an agreement with the biopharmaceutical unit of Syngenta AG, of Basel, Switzerland, to develop an anticalin-based drug for an indication with high unmet medical need. Anticalins are engineered receptor proteins with antibody-like functions. Pieris will be responsible for research and for providing active biopharmaceuticals, while Syngenta will be responsible for preclinical and clinical development and commercialization. Neither the specific indication nor the financial terms were disclosed.

• Questcor Pharmaceuticals Inc., of Union City, Calif., announced a new business strategy that will focus exclusively on developing and commercializing products that treat diseases and disorders of the central nervous system. The company said it initially will focus its sales and marketing resources on promoting H.P. Acthar Gel (repository corticotrophin injection). The announcement was made during the American Academy of Neurology meeting in Miami.

• Seattle Genetics Inc., of Bothell, Wash., entered a license agreement with Fremont, Calif.-based Protein Design Labs Inc. for exclusive rights to PDL's anti-CD33 program for both unconjugated antibody and antibody-drug conjugate applications. Under the license agreement, Seattle Genetics receives rights, patents and patent applications, as well as supplies of clinical-grade materials and a nonexclusive CD33 license under PDL's antibody humanization patents. PDL will receive an up-front fee, progress-dependent milestone payments and royalties on net sales of any resulting products. In addition, Seattle Genetics agreed to reduce the royalties payable by PDL with respect to a limited number of products that PDL might develop under the existing ADC collaboration between the companies. Further financial details were not disclosed.

• Senesco Technologies Inc., of New Brunswick, N.J., and Rahan Meristem Ltd., of Israel, announced that field trials of Senesco/Rahan banana plants have shown increased tolerance to the Black Sigatoka disease, as measured on an index of tolerance. Those field data corroborate earlier findings that the Factor 5A technology confers resistance to fungal pathogens by preventing premature plant cell death. In addition to the banana disease tolerance data, the companies previously showed both an increase in banana fruit shelf life and increase in growth rates of banana plants in field trials.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., launched a multicenter Phase II trial to evaluate SPI-153 in benign prostatic hypertrophy. The trial is designed to evaluate both objective parameters, such as improvement in urine flow and shrinkage of prostate volume, as well as various symptoms of BPH over a period of several months. SPI-153 is a fourth-generation luteinizing hormone-releasing hormone, also known as a gonadotropin-releasing hormone antagonist.

• Vectura Group plc, of Chippenham, UK, and Arakis Ltd., of Little Chesterford, UK, signed a global development and commercialization agreement with Novartis AG, of Basel, Switzerland, for their collaborative product AD 237, a once-daily, long-acting antimuscarinic agent for the treatment of chronic obstructive pulmonary disease. Novartis will be responsible for developing AD 237 both as a monotherapy and in combination with QAB149, its long-acting beta2 agonist in Phase II development.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said a Phase I trial of its cancer agent Cloretazine (VNP40101M) in pediatric brain tumors has been initiated by the Pediatric Brain Tumor Consortium. The trial will evaluate the maximum tolerated dose and dose-limiting toxicities of the drug, administered for five consecutive days every six weeks in children with recurrent, progressive or refractory primary brain tumors. Vion said Cloretazine is an alkylating agent that has shown promising activity in preclinical studies in brain tumor xenografts.

• Xenova Group plc, of Slough, UK, entered a licensing agreement for the glioblastoma multiforme treatment TransMID with PharmaEngine Inc., of Taipei, Taiwan, for the Chinese and South Korean markets. Xenova will receive an up-front payment, milestone payments and royalties on potential future sales. Xenova also retains manufacturing rights, while PharmaEngine will hold exclusive rights to develop, market and sell TransMID in China and South Korea.