• Acacia Research Corp., of Newport, Calif., said its CombiMatrix group entered an agreement with Intel Corp., of Santa Clara, Calif., to work together on the feasibility of various projects using CombiMatrix's core technology. It is developing a platform technology to produce customizable active biochips, which are semiconductor-based tools for use in identifying and determining the roles of genes, gene mutations and proteins. Terms and conditions were not disclosed.

• Adolor Corp., of Exton, Pa., and GlaxoSmithKline plc, of London, said the FDA accepted for review the new drug application for Entereg (alvimopan). The FDA's acceptance triggered a $10 million milestone to Adolor from GSK. The Prescription Drug User Fee Act target action date is 10 months from the submission date, or April 25. Adolor completed the submission earlier this summer, seeking approval of Entereg for the management of postoperative ileus by accelerating time to recovery of gastrointestinal function following abdominal or pelvic surgeries. Adolor's stock (NASDAQ:ADLR) fell $1.53 Tuesday, or 12.2 percent, to close at $10.97. (See BioWorld Today, May 10, 2004.)

• BioDelivery Sciences International Inc., of Newark, N.J., will receive $2.5 million after agreeing to sell a royalty revenue stream related to a topical version of encochleated amphotericin B to Accentia Inc., of Tampa, Fla. Privately held Accentia is partly owned by Hopkins Capital Group LLC, which is partly owned and controlled by BioDelivery's chairman, president and CEO, Francis O'Donnell. Separately, BioDelivery entered an equity line of credit agreement in which Hopkins will invest up to $4 million in BioDelivery through March 31, 2006, in consideration of shares of a newly created class of Series B convertible preferred stock. To date, about $1.25 million has been drawn under the equity line agreement.

• Boston Life Sciences Inc., of Boston, named Peter Savas chairman and CEO. Prior to coming on board, he served as CEO of Aderis Pharmaceuticals Inc. BLSI is developing products for central nervous system diseases and cancer.

• Burzynski Research Institute, of Houston, said the FDA granted orphan drug designation for its drug candidates Antineoplastons A10 and AS2-1 for the treatment of brain stem glioma.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said it will start a Phase I trial of CAT-354, a human anti-IL-13 monoclonal antibody, for severe asthma, following recent approval from the Medicines and Healthcare Products Regulatory Agency. The trial will take place in the UK at the Matrix Drug Development Clinical Research Centre. Patient enrollment is expected to begin shortly, with results available during the second quarter.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said Phase II data showed Tostrelle (testosterone gel) 0.5 percent was safe, produced normal-range testosterone levels and a 65 percent improvement in the number of satisfying sexual events in postmenopausal women with low testosterone levels who were distressed by symptoms of sexual dysfunction. The results are similar to those demonstrated by other transdermal testosterone products to be clinically effective. Cellegy is stopping enrollment in its Phase II study and is beginning preparations for Phase III trials.

• Cellomics Inc., of Pittsburgh, named Shanghai AnXing Scientific Instrument & Materials Import & Export Co. Ltd., of Shanghai, China, its distribution partner in that territory. AnXing will provide sales, marketing, service and customer support for Cellomics' products for drug discovery and systems biology research.

• Corautus Genetics Inc., of Atlanta, began a Phase IIb trial to evaluate vascular endothelial growth factor-2 for the treatment of severe cardiovascular disease. Named Genasis (Genetic Angiogenic Stimulation Investigational Study), the randomized, double-blinded, dose-ranging and placebo-controlled study will enroll up to 404 patients with Class III or IV angina. The trial will evaluate the efficacy and safety of defined doses of VEGF-2 delivered percutaneously via Natick, Mass.-based Boston Scientific Corp.'s Stiletto endocardial direct-injection catheter system.

• CoTherix Inc., of South San Francisco, named Donald Santel CEO. Prevously president and chief operating officer, he will remain a board member. CoTherix also said the FDA accepted for review the new drug application for Ventavis inhalation solution, granting it priority-review status with an action data of Dec. 31, as well as orphan drug status for pulmonary arterial hypertension. Ventavis is an inhaled formulation of iloprost, a prostacyclin analogue.

• Crucell NV, of Leiden, the Netherlands, and contract manufacturer DSM Biologics, of Sittard, the Netherlands, signed a PER.C6 deal with MorphoSys AG, of Munich, Germany. MorphoSys gains rights to use the technology in its antibody research programs, and an option to license it for antibody production. Crucell and DSM will get an up-front payment and annual maintenance fees.

• Cytovax Biotechnologies Inc., of Edmonton, Alberta, named Graham Strachan chairman. He has been a company director since April 1998, and is replacing Robert Fildes. Cytovax is developing approaches to combat infectious diseases.

• Dharmacon Inc., of Lafayette, Colo., entered an agreement to supply custom siRNA reagents to the genomics research operations at Wyeth Pharmaceuticals, of Madison, N.J. Dharmacon will supply SMARTpool reagents and individual SMARTselection-designed duplexes covering 800 gene targets. The reagents will be used by Wyeth to support and accelerate its genomic-based drug development research. The agreement expands and extends the relationship between Dharmacon and Wyeth based on the success of a previous supply agreement.

• Diagnostic Products Corp., of Los Angeles, and Compugen Ltd., of Tel Aviv, entered a collaboration for the development and commercialization of diagnostic products, with an anticipated focus in the cancer and cardiovascular fields. Terms of the agreement allow Diagnostic Products to develop and commercialize immunoassay and nucleic acid-based diagnostic products based on Compugen-discovered biomarkers, including certain biomarker candidates already discovered by Compugen, as well as additional candidates arising out of the collaboration.

• Diversa Corp., of San Diego, was awarded a three-year grant by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in Bethesda, Md., for the discovery and development of antibodies to diagnose and treat severe acute respiratory syndrome. Diversa will apply its OmniMab antibody program to screen more than 1 billion fully human antibodies against targets associated with the SARS coronavirus. The U.S. Army Medical Research Institute of Infectious Diseases then will test antibody candidates selected and optimized by Diversa for their ability to neutralize live SARS coronavirus. NIAID recommended about $1.9 million in total funding, of which $1 million was awarded for the project's first year.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., appointed William Heiden president and CEO and a member of the board. Heiden most recently was president and chief operating officer of Praecis Pharmaceuticals Inc. Elixir is focused on discovering and developing new drugs for metabolic disorders.

• Entropin Inc., of Indio, Calif., said in vitro studies found several formulations that improve the delivery of ENT-103 into human skin and penetration of the pain product through the skin. A second series of studies to find a formulation for clinical studies is under way, with data likely available later this month. Separately, Entropin said a state court dismissed a securities class-action lawsuit last month, though shortly after the plaintiffs filed a notice of appeal. Entropin also said it learned a complaint was filed in a federal district court, but it has yet to be served.

• EPIX Medical Inc., of Cambridge, Mass., changed its name to EPIX Pharmaceuticals Inc. to better reflect its focus on developing pharmaceutical products. EPIX continues to trade on the Nasdaq National Market under the ticker symbol "EPIX." EPIX discovers and develops pharmaceuticals for imaging.

• Evotec OAI AG, of Hamburg, Germany, and Evotec Neurosciences GmbH formed a three-year research collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to identify and develop small-molecule therapeutics acting on selected G protein-coupled receptors. The companies initially will focus on central nervous system diseases. Boehringer Ingelheim will have global rights to the development, manufacturing and commercialization of the compounds identified. Boehringer Ingelheim will make research payments, additional discovery and development payments, and royalty payments to Evotec.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, secured a sterols sales agreement for $24.4 million over a three-year period beginning in January 2005. The agreement is between Forbes' manufacturing joint venture, Phyto-Source LP, of Pasadena, Texas, and an ingredient company.

• Human Genome Sciences Inc., of Rockville, Md., began dosing patients in a Phase II trial of HGS-ETR1 (agonistic human monoclonal antibody to trail receptor) in patients with advanced non-small-cell lung cancer. The trial will evaluate HGS-ETR1 in patients with relapsed or refractory NSCLC. The primary objective is to evaluate tumor response. HGS also said it began dosing patients in a Phase Ib trial of HGS-ETR1 to evaluate it in combination with paclitaxel and carboplatin in patients with advanced solid malignancies.

• Interleukin Genetics Inc., of Waltham, Mass., and collaborators reported findings in this week's Journal of Physiology showing that specific interleukin-1 (IL-1) gene variations modify the body's response to exercise. The study showed that some individuals have a significantly greater inflammatory response to exercise than others, and that the inflammatory response difference appears to be associated with IL-1 gene variations. The research was done with the University of Arkansas for Medical Sciences and the Central Arkansas Veterans Health Care System.

• INYX Inc., of New York, said it raised about $7.4 million in gross proceeds through two private placements of stock and warrants to accredited investors. The specialty pharmaceutical company, which is focused on aerosol drug delivery technologies and products, sold about 9.2 million common shares and issued five-year warrants, with exercise prices ranging from $1 to $1.11 per share, to purchase an equal amount of shares.

• Jerini AG, of Berlin, began its U.S. and Canadian pivotal registration study with Icatibant in a subcutaneous formulation for hereditary angioedema. The final protocol for a European multicenter pivotal registration study will be submitted this month. Icatibant has orphan drug status in the U.S. and Europe for hereditary angioedema, and fast-track designation from the FDA in the indication. Icatibant is a peptidomimetic bradykinin B2 receptor antagonist.

• MicroIslet Inc., of San Diego, said positive preclinical data from a study at the Scripps Research Institute will be presented this week at the International Congress of the Transplantation Society in Vienna, Austria. The presentation is based on work from MicroIslet's laboratories and data from its ongoing preclinical study. Results show that microencapsulated porcine islets were able to maintain normal blood glucose levels for up to 250 days in mice with a normal immune system, without the need for immunosuppression.

• Mirus Bio Corp., of Madison, Wis., entered an agreement with Genzyme Corp., of Cambridge, Mass., covering research applications of Mirus' hydrodynamic gene delivery technology. Genzyme will have the nonexclusive right to use a range of Mirus technologies in its research programs, including its Pathway protocol, a method to deliver genes to muscle via the bloodstream. Financial terms were not disclosed.

• NicOx SA, of Sophia-Antipolis, France, started a clinical study to evaluate the effects of HCT 3012 and rofecoxib on arterial blood pressure in patients with mild essential hypertension. The study aims to confirm pivotal Phase II data in osteoarthritis patients suggesting that HCT 3012 decreased systolic blood pressure, while rofecoxib tended to raise systolic blood pressure. The study will be conducted at the University of Pennsylvania and will involve 50 hypertensive patients treated for six weeks with each of the trial medications. Results are expected in the first quarter.

• Novo Nordisk A/S, of Bagsvaerd, Denmark, said it would appeal two U.S. District Court rulings against the validity and enforceability of its patent that covers recombinant human growth hormone, the active ingredient in the company's Norditropin (somatropin [rDNA origin] for injection) product. The decisions prevent Novo from barring Teva Pharmaceuticals Ltd., of Jerusalem, and its licensor, Savient Pharmaceuticals Inc., of East Brunswick, N.J., from marketing human growth hormone in the U.S.

• Nymox Pharmaceutical Corp., of Maywood, N.J., said one-year follow-up Phase II results of NX-1207 indicated statistically significant symptomatic improvement in benign prostatic hyperplasia patients. Clinical improvement was measured at 30 days and at 12 months. The mean American Urological Association symptom score in treated patients showed an 8.8 point improvement, compared to controls. The score includes data on sensations of incomplete emptying of the bladder, the need to urinate frequently, urgency, urination during sleep and other measures.

• Pain Therapeutics Inc., of South San Francisco, completed enrollment in a Phase III study of more than 700 patients with severe low-back pain. The study compares oxycodone against the pain relief drug Oxytrex with the primary endpoint of analgesic efficacy. The company expects to announce results in the first quarter. A second Phase III trial of Oxytrex will enroll more than 700 patients with moderate to severe osteoarthritic pain. It began in March and continues to enroll patients at more than 40 centers. Results are expected in the second quarter of 2005.

• PediaMed Pharmaceuticals Inc., of Florence, Ky., said it acquired Protein Therapeutics Inc., of Tucson, Ariz. The purchase includes an investigational immunoglobulin drug that is entering Phase II trials for gastrointestinal dysfunction in autistic children. Protein Therapeutics was developing therapies for immunological diseases. Financial terms were not disclosed.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., received $1.5 million from Defiante Farmaceutica Lda, a wholly owned subsidiary of the Italian pharmaceutical group Sigma Tau SpA, of Rome, in connection with the exercise of warrants associated with its June 2003 purchase of RegeneRx common stock. Defiante purchased about 1.4 million shares of RegeneRx stock for about $1 a share. There were no placement fees associated with the transaction.

• Sangart Inc., of San Diego, started a Phase II trial involving Hemospan, a hemoglobin-based oxygen carrier designed to serve as an alternative for blood transfusions. The trial will include 90 patients undergoing elective orthopedic surgeries at six hospitals in Sweden. Sangart also said it received a $1.3 million joint grant for its oxygen carrier research from the National Heart Lung and Blood Institute of the National Institutes of Health and the U.S. Army Medical Research and Material Command.

• Senomyx Inc., of La Jolla, Calif., said its scientists discovered that the human sweet taste receptor contains multiple binding sites for sweeteners and sweet taste inhibitors. A binding site for sweet taste modulators was identified in the related umami receptor, which mediates the savory taste of monosodium glutamate. The results were published in the Sept. 7, 2004, early edition of the Proceedings of the National Academy of Sciences.

• The Immune Response Corp., of Carlsbad, Calif., and San Diego-based NovaRx Corp. signed a licensing agreement to transfer from Immune Response to NovaRx all of the in-licensed development and marketing rights of the Sidney Kimmel Cancer Center's patent portfolio for cancer cell lines. NovaRx agreed to pay about $1 million, including an up-front fee and a final payment due by August 2007. Immune Response first licensed the cancer cell vaccine technology in 1994.

• Third Wave Technologies Inc., of Madison, Wis., said its Invader hepatitis C virus genotyping reagents were being used by TriCore Reference Laboratories, of Albuquerque, N.M. TriCore, which has used the reagents to develop assays that identify the six genotypes of the virus, operates a laboratory network in the Southwest.

• Tripos Inc., of St. Louis, released its SarNavigator 1.5, a research application designed to allow scientists to analyze the quantities of chemical and biological data that comprise the results of real or virtual high-throughput screening.

• Valentis Inc., of Burlingame, Calif., received a $1 million license fee in its deal with Schering AG, of Berlin. The fee resulted from Schering's decision to use certain Valentis technologies in an additional product development program. In December 2002, Valentis and Schering signed a multiproduct license and option agreement to develop and commercialize products using Valentis' Pinc polymer-based gene delivery system and the GeneSwitch gene-regulation technologies. Schering has exclusive worldwide rights to the Pinc and GeneSwitch technologies in up to two Schering genes, as well as an option for nonexclusive rights to the Pinc technology for a third gene. (See BioWorld Today, Dec. 23, 2002.)

• Valera Pharmaceuticals Inc., of Cranbury, N.J., began patient enrollment in a Phase III trial of a one-year implant for the hormonal treatment of central precocious puberty, an affliction characterized by the early onset of sexual development in pre-adolescents. The pivotal study will test VP 002, a product that uses the company's Hydron drug delivery platform, to provide the continuous administration of a controlled dose of histrelin, a synthetic nonapeptide agonist of the naturally occurring gonadotropin-releasing hormone. Formerly known as Hydro Med Sciences, Valera raised $11.5 million two weeks ago and disclosed at the time its near-term plans to begin the trial. (See BioWorld Today, Aug. 24, 2004.)

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