• Accelrys Inc., of San Diego, signed a definitive agreement for a $21.5 million merger between one of its wholly owned subsidiaries with SciTegic Inc., also of San Diego. At closing, SciTegic shareholders will receive $12.25 million in cash and about 1 million Accelrys common shares in exchange for their shares, as well as 334,324 additional Accelrys shares over the next two years, subject to certain conditions. SciTegic's two founders will become Accelrys employees after the merger. Expected to close this month, the deal remains subject to the approval of the shareholders of SciTegic, which offers workflow software to the research science market. SciTegic will become a wholly owned subsidiary of Accelrys, a provider of software for computation, simulation, and the management and mining of scientific data.

• Altana AG, of Bad Homburg, Germany, said that regulatory authorities in Brazil and Mexico have granted marketing approval for Alvesco, an inhaled corticosteroid. The Brazilian and Mexican authorities have approved Alvesco to treat all severity grades of asthma at doses of 80 mcg to 640 mcg.

• Amarillo Biosciences Inc., of Amarillo, Texas, agreed to license rights to oral, low-dose interferon-alpha to Nobel Ilac Sanatii Ve Ticaret A/S, of Istanbul, Turkey. The license covers use of the drug for Behcet's disease in a territory with a population of about 365 million. The area includes Turkey, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Macedonia, Russia, Saudi Arabia, Tajikistan, Uzbekistan and Yugoslavia. Both companies will conduct studies in the disease in Turkey under an investigational new drug application submitted by Amarillo to the FDA. Amarillo will seek U.S. approval and will own rights to the drug. Nobel could seek regulatory clearance in each country of the territory.

• Anadys Pharmaceuticals Inc., of San Diego, and LG Life Sciences Ltd., of Seoul, South Korea, said the first two cohorts have completed enrollment in a Phase II trial of ANA380 in patients with lamivudine-resistant hepatitis B virus infection. ANA380 is an antiviral compound that has exhibited activity against HBV.

• CeMines Inc., of Golden, Colo., completed an expansion of its business operations, which required relocation of its headquarters and BioSystems Division to a larger facility in Golden. The new facility should allow CeMines to achieve greater operational scale.

• Chiron Corp., of Emeryville, Calif., filed a registration statement with the SEC for the resale of $385 million in 2.75 percent convertible debentures due 2034 and the shares of its common stock issuable upon conversion of the debentures. The debentures originally were issued in a private placement in June. Chiron will not receive proceeds from any resale by the security holders of the debentures or the shares.

• Coley Pharmaceutical Group Inc., of Wellesley, Mass., received a $5 million milestone payment from Paris-based Sanofi-Aventis for the initiation of a Phase I study of CpG-based TLR Therapeutics in allergic respiratory disease. The trial will test dose and safety in normal healthy volunteers. Each of the TLR Therapeutics acts through the Toll-like receptor 9 pathway, targeting and modulating immune responses. Coley and Aventis entered their $260 million collaboration in August 2001. Aventis has exclusive, worldwide rights to develop TLR Therapeutics in specific respiratory conditions.

• Crucell NV, of Leiden, the Netherlands, and the International AIDS Vaccine Initiative signed an exclusive license agreement to develop an AIDS vaccine based on Crucell's AdVac technology. Crucell expects to receive development funding, and up-front, annual and milestone payments, as well as royalties on future HIV vaccine sales.

• Cyntellect Inc., of San Diego, said it will receive about $1.5 million under a Phase II Small Business Innovation Research grant for the continued development of RNA interference applications on its LEAP platform. The grant will fund further development of Cyntellect's LEAP-enabled LaserFect technology for the delivery of siRNA into cells that typically are refractory to standard transfection techniques.

• Diversa Corp., of San Diego, identified several lead protein therapeutic candidates in its research and product development agreement with Basel, Switzerland-based Syngenta AG, resulting in milestone payments of $300,000 from Syngenta. The companies, which initiated their collaboration in February 2003, will begin early preclinical studies of the candidates. Diversa is entitled to receive a minimum of $118 million in research and development funding over the initial seven-year term and is eligible for milestone payments and royalties for product development and commercialization.

• DOV Pharmaceutical Inc., of Hackensack, N.J., received government antitrust clearance to close its potential $455 million licensing agreement with Merck & Co. Inc., of Whitehouse Station, N.J. Under the agreement, Merck licensed exclusive worldwide rights to a Phase I product called DOV 21,947 in all therapeutic indications. Merck also licensed exclusive worldwide rights to DOV 216,303 for depression, anxiety and addiction, while DOV retained rights to the compound for other indications. The deal was reported last month. (See BioWorld Today, Aug, 9, 2004.)

• Eurand International SpA, of Milan, Italy, entered a feasibility agreement for the development of a modified-release formulation of Zanidip (lercanidipine), a calcium channel blocker for hypertension from Recordati SpA, also of Milan. Eurand will apply its Diffucaps technology to develop the formulation. Financial terms were not disclosed.

• Generex Biotechnology Corp., of Toronto, said its Antigen Express subsidiary made progress in its work with academic collaborators in Rome and London. Hybrid peptides, which include antigenic epitopes that appear to trigger diabetes, were studied against patients' lymphocytes. The studies might lead to a diagnostic kit to identify people in the earliest stage of the autoimmune process leading to Type I diabetes mellitus. The company said those patients are candidates for insulin supplementation with its transmucosal, needle-less RapidMist Oralin method.

• Genmab A/S, of Copenhagen, Denmark, reached two milestones in its collaboration with Basel, Switzerland-based F. Hoffmann-La Roche Ltd., as proof of concept has been established for two human antibodies generated by Genmab. They are the third and fourth antibodies in the collaboration to reach that stage. Under the agreement, Genmab is creating human antibodies to disease targets identified by Roche, and receives milestone and royalty payments based on successful products. If all goals are reached, the value of the collaboration to Genmab could be $100 million, plus royalties.

• GenOway, of Lyon, France, completed a €4 million fund raising (US$4.9 million). CDC Enterprises Innovation, of Paris, led the round, and Siparex Ventures, the venture capital subsidiary of Sigefi Private Equity, also participated. The money raised will support the development of custom transgenic mice and rats and the launching of mice and rat models.

• Guilford Pharmaceuticals Inc., of Baltimore, said its Gliadel Wafer (polifeprosan 20 with carmustine implant) received extended marketing authorization in Europe to include use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Under the mutual-recognition procedure, Gliadel Wafer was approved in France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and the UK. It previously was authorized for use only in recurrent surgery for glioblastoma multiforme.

• Halozyme Therapeutics Inc., of San Diego, filed for FDA approval of Cumulase for use in treating oocytes to facilitate certain in vitro fertilization procedures. The company said Cumulase, an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase), is the first and only synthetic alternative to impure slaughterhouse-derived enzymes currently used in IVF procedures.

• HistoRx Inc., of New Haven, Conn., raised $1.5 million in a Series A financing. Proceeds will be used to initiate commercialization of a new molecular-based imaging technology developed at Yale University for tissue and tissue microarrays called AQUA (Automated Quantitative Analysis). The microarrays enable researchers to identify relationships between protein expression and therapeutic response that were undetectable using conventional methods of pathology analysis. Navigator Technology Ventures served as lead investor. Other investors were Genentech Inc., Sachem Ventures LLC and Marnat Investments.

• ICN Canada Ltd., of Montreal, changed its name to Valeant Canada Ltd. to reflect its transformation into an integrated, global specialty pharmaceutical company. The name change was implemented worldwide.

• Medarex Inc., of Princeton, N.J., said its licensing partner, Eli Lilly and Co., of Indianapolis, began a Phase I trial of an antibody that was developed using Medarex's UltiMAb technology. Medarex expects to receive milestone payments and royalties on sales resulting from the development of the product. Medarex focuses on therapies for cancer, inflammation, and autoimmune and infectious diseases.

• MIV Therapeutics Inc., of Vancouver, British Columbia, completed in vivo safety studies on its biocompatible hydroxyapatite nanofilm coating, designated for passive application on cardiovascular stents and other implantable medical devices. The study showed that the stent coating is safe and did not cause any adverse arterial response.

• NuGEN Technologies Inc., of San Carlos, Calif., launched its Ovation RNA Amplification System, which is the third product in the Ovation family and is designed to enable life scientists to analyze small samples of gene-expression experiments, particularly those based on real-time quantitative PCR, the company said.

• Orphan Medical Inc., of Minneapolis, said Phase IIIb results showed that Xyrem (sodium oxybate) monotherapy is effective in the treatment of excessive daytime sleepiness associated with narcolepsy, as measured by objective response in the Maintenance of Wakefulness Test. The combined use of Xyrem and Provigil (modafinil, Cephalon Inc.) showed a greater response than either agent alone. The data follow findings reported in June showing that the addition of Xyrem to stimulants or wakefulness-promoting drugs resulted in a statistically significant improvement in excessive daytime sleepiness. The company plans to file a supplemental new drug application incorporating the results of both trials with the FDA by the end of the year. Xyrem is approved for cataplexy associated with narcolepsy.

• OxiGene Inc., of Waltham, Mass., said that its lead compound, Combrestatin A4 Prodrug (CA4P), will enter a Phase I cervical cancer trial in combination with cisplatin, a primary chemotherapeutic treatment for cervical cancer. In the dose-escalating trial, CA4P, a vascular targeting agent, will be involved in six concurrent human oncology trials in seven tumor types in the U.S. and Europe.

• Peninsula Pharmaceuticals Inc., of Alameda, Calif., said that Dennis Podlesak joined as president and CEO. Podlesak previously was senior vice president of a North American business unit of Novartis, as well as a member of its executive committee and global leadership team. Paul Truex, Peninsula's former CEO, will continue at the company as executive vice president of business development. Peninsula is focused on antibiotics to treat infection.

• Predix Pharmaceuticals Inc., of Woburn, Mass., reported that its investigational drug, PRX-00023, showed clear induction of surrogate biomarkers and was well tolerated in single and multiple doses among volunteers in two Phase I studies. PRX-00023 is a serotonin 1A receptor agonist intended to treat neuropsychiatric disorders. The company is planning to initiate Phase II trials for anxiety and depression. PRX-00023 is designed to selectively interact with the 5HT1A receptor in the brain.

• Quorex Pharmaceuticals Inc., of San Diego, appointed Thomas Bologna president and CEO. Prior to joining Quorex, Bologna served as chairman, president and CEO of Ostex International Inc. Quorex is focused on drugs to treat bacterial infections.

• Sangamo BioSciences Inc., of Richmond, Calif., said it is on track to file an investigational new drug application before the end of the year for SB 509, a product from its ZFP technology, for diabetic neuropathy. The company said cellular studies have demonstrated that SB 509 protects neuronal cells, and in a rat model of diabetic neuropathy, a single treatment improved sensory and motor nerve conduction. Sangamo also is using its ZFP technology to recreate a mutation that results in a non-functional form of the CCR5 protein, making individuals resistant to HIV infection, in an attempt to protect cells against HIV infection.

• Scios Inc., of Fremont, Calif., said data from the world's largest heart failure registry, known as ADHERE, reported at the Heart Failure Society of America meeting in Toronto, identified clinical indicators that might be used to predict mortality risk in heart failure patients. The analysis compared differences in clinical characteristics between patients classified as higher- and lower-risk, as previously delineated by classification and regression tree analysis. Heart failure patients determined to have high risk of mortality were identified with blood urea nitrogen greater than or equal to 43 mg/dL, systolic blood pressure less than 115 mm Hg, and serum creatinine greater than or equal to 2.75 mg/dL (20.5 percent average mortality rate, n=1,202). Heart failure patients determined to have low risk of mortality (2.2 percent average mortality rate, n=41,609) were identified with blood urea nitrogen less than 43 mg/dL and systolic blood pressure greater than or equal to 115 mm Hg. Heart failure patients with intermediate risk of mortality (6.75 percent average mortality rate, n=22,369) had less than three of the high-risk markers and differed from the low-risk group by at least one marker. Scios is a unit of Johnson & Johnson, of New Brunswick, N.J.

• SIGA Technologies Inc., of New York, secured $4 million in government funding after being designated a prime contractor by the U.S. Air Force Surgeon General's office to create systems for the rational development of vaccines and therapeutics against potential agents of biological terrorism. The company's program will complement ongoing Air Force bioterrorism countermeasure research into developing detection and diagnostics capabilities. The funding will support technology platform development using new methods such as genetic engineering to create safer non-infectious vaccines that can be administered without injections. SIGA's stock (NASDAQ:SIGA) gained 7 cents Tuesday to close at $1.51.

• The Immune Response Corp., of Carlsbad, Calif., said interim results from an ongoing multicenter Phase II study conducted in Italy showed that Remune induces HIV-specific immunity in drug-na ve patients. Researchers hope that enhanced immunity may delay disease progression. The final analysis of the trial is expected at the end of the year. The multicenter, single-blind, randomized study is investigating 50 subjects over 28 weeks following treatment.

• Velcera Pharmaceuticals Inc., of Langhorne, Pa., gained an exclusive worldwide license to lingual spray drug delivery technology from NovaDel Pharma Inc., of Flemington, N.J. Privately held Velcera is a newly formed animal health company, and believes use of the spray technology would simplify pet-owner administration of medicines. For its part, NovaDel received an equity stake in Velcera along with an up-front cash technology fee, and will receive milestone payments for each product developed by Velcera, as well as potential royalties. Products will be formulated in NovaDel labs at Velcera's expense, and Velcera will fund all development and regulatory activities. Resulting Velcera products will be manufactured by NovaDel.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said that six holders of its existing 5 percent convertible subordinated notes due 2007 have agreed to exchange about $79.3 million in aggregate principal amount of the notes for the same amount in newly issued 5.75 percent convertible senior subordinated notes due 2011. The senior subordinated notes will be issued through a private offering to qualified institutional buyers. The notes are identical in terms to the notes issued by Vertex in February, and they will be convertible into Vertex common stock at $14.94 per share.

• Zonagen Inc., of The Woodlands, Texas, said that all 30 patients were enrolled and have completed initial dosing and safety assessment in the company's study of Progenta as an oral treatment for women with uterine fibroids. The company said it might have reportable data by the end of the year.

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