• Acadia Pharmaceuticals Inc., of San Diego, said Allergan Inc., of Irvine, Calif., filed an investigational new drug application covering a small-molecule drug candidate to treat neuropathic pain, triggering a milestone payment to Acadia. The companies have an ongoing collaboration focused on treatments for neuropathic pain. Allergan is responsible for clinical development and has worldwide rights to commercialize products that result from the collaboration. Acadia is entitled to receive milestones and royalties.

• Altana AG, of Bad Homburg, Germany, and the Sanofi-Aventis Group, of Paris, received an approvable letter from the FDA for Alvesco (ciclesonide) for persistent asthma in adults, adolescents and children 4 years of age and older. Aventis said it already is working with the agency to address clinical data requests outlined in the letter. Aventis and Altana in 2001 signed an agreement to jointly develop and market Alvesco in the U.S.

• Arena Pharmaceuticals Inc., of San Diego, achieved a preclinical development milestone under its collaboration with Whitehouse Station, N.J.-based Merck & Co. Inc. The milestone triggered a $1 million payment to Arena. The companies entered the collaboration in October 2002 to focus on GPCR targets and to identify compounds that play a role in preventing and controlling particular cardiovascular diseases. Earlier this month, Merck extended the collaboration through October 2007.

• Axonyx Inc., of New York, said it formalized an existing arrangement with a consulting firm, Pharmaceutical Special Projects Group LLC, under a multiyear retainer agreement. Axonyx's lead compound, Phenserine, is a dual-action acetylcholinesterase and beta-APP inhibitor in Phase III trials for mild to moderate Alzheimer's disease. Pharmaceutical Special Projects has been assisting the company with all aspects of Phenserine's development program, and next will aid in the regulatory registration process.

• Bioenvision Inc., of New York, filed a shelf registration statement with the SEC for the proposed offering of up to $90 million of common stock, from time to time. If consummated, proceeds would be used primarily for the launch of clofarabine in the European market and to expand the existing sales and marketing infrastructure for that clofarabine and Modrenal.

• Biovitrum AB, of Stockholm, Sweden, entered a multiyear drug discovery and development alliance with Pharmacopeia Drug Discovery Inc., of Princeton, N.J., to identify and optimize small-molecule lead compounds to advance into preclinical development for multiple targets within the metabolic disease area. Biovitrum will access Pharmacopeia's drug discovery assets, including its multimillion-compound collection of drug-like small molecules and its drug discovery know-how to identify and optimize leads. In return, Pharmacopeia will receive some initial funding and could secure a greater return upon the achievement of preclinical and clinical milestones. Pharmacopeia also would receive royalties. Biovitrum is responsible for development and retains all marketing rights.

• Chiron Corp., of Emeryville, Calif., granted to F. Hoffmann-La Roche Ltd., of Basel, Switzerland, a nonexclusive license for the research, development and commercialization of small-molecule therapeutics against hepatitis C virus drug targets. Roche would pay Chiron up-front license fees, milestone payments and royalties on products. Specific financial terms and details of the license were not disclosed.

• CuraGen Corp., of New Haven, Conn., and Bayer Pharmaceuticals Corp., of West Haven, Conn., advanced into preclinical development a new orally active small molecule for the management of Type II diabetes. The companies' collaboration aims to identify and develop drugs targeted at the treatment of diabetes and obesity. CuraGen also said CG53135 moved into a Phase II trial for the prevention of oral mucositis in cancer patients undergoing bone marrow transplantation, and that CR002 will soon begin a Phase I trial in IgA nephropathy.

• CytoGenix Inc., of Houston, said a preclinical proof-of-concept study demonstrated that its antimicrobial compound CY401 is active against vancomycin-resistant Staphylococcus aureus (VRSA). Specifically, the lab study showed that CY401 inhibits growth of VRSA.

• Durect Corp., of Cupertino, Calif., initiated a Phase II study for its post-operative pain-relief depot, a sustained-release formulation of a local anesthetic using the company's Saber drug delivery system. Saber-bupivacaine is designed to be administered via injection around an incision site following surgery.

• Elan Corp. plc, of Dublin, Ireland, reached an agreement to settle a consolidated class-action lawsuit filed in early 2002, and has reached a provisional agreement to settle the investigation by the SEC's Division of Enforcement. The provisional settlement is subject to approval by SEC commissioners and will conclude all aspects of the investigation. Under the settlement, all claims will be dismissed with no admission of wrongdoing and a cash payment will be made to class members of $75 million. Elan will pay a civil penalty of $15 million. It will not be required to restate or adjust its historical financial results or information. The SEC probe into Elan's accounting practices began in February 2002 and resulted in the company's downsizing from a larger specialty pharmaceutical company to a smaller biotech company. (See BioWorld Today, Feb. 11, 2002, and June 18, 2004.)

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said data from two trials presented this week at the American Society of Anesthesiologists' annual meeting in Las Vegas support the safety and efficacy of DepoDur (morphine sulfate extended-release liposome injection) CII, a single-dose epidural injection designed to improve post-operative pain control. DepoDur, approved in May, will be commercially available in the U.S. by the end of this year.

• Galileo Genomics Inc., of Montreal, completed a panel of about 80,700 single nucleotide polymorphisms covering 99.8 percent of the sequenced genome at a density optimized for the Quebec French Canadian Founder Population. The panel, known as the Quebec Linkage Disequilibrium Map, is suitable for cost-effective genome-wide scans in heritable diseases to discover the common causative genes. The QLDM is based on the first completed genome-wide evaluation of genetic sharing in any population, the company said.

• Genetronics Biomedical Corp., of San Diego, said Vical Inc., of San Diego, exercised its option to establish an exclusive worldwide license and supply agreement to use and purchase Genetronics' MedPulser DNA Delivery System in conjunction with Vical's DNA delivery technology for a solid-tumor application and HIV. The agreement broadens the initial option and license agreement established in October 2003. Vical conducted preclinical studies using Genetronics' electroporation technology and has decided to advance a compound into clinical testing. Vical has rights to use the technology with an option to extend the agreement to include a limited number of additional products. Genetronics will receive an up-front payment and potential milestone payments and royalties.

• Hybridon Inc., of Cambridge, Mass., began patient enrollment in a Phase II trial of IMOxine (HYB2055) in renal-cell carcinoma. IMOxine is a second-generation immunomodulatory oligonucleotide that functions as an agonist of TLR9, a Toll-like receptor in certain cells of the immune system.

• Immunetrics Inc., of Pittsburgh, said a class of drugs designed to treat severe sepsis would achieve higher efficacy under conditions specified by a novel in silico model of inflammation, according to an article in the current edition of Critical Care Medicine. The computer model was developed by a University of Pittsburgh team and is being commercialized by Immunetrics. The article describes a computer-based trial of 1,000 virtual patients with randomized bacterial loads submitted to a neutralizing antibody directed at tumor necrosis factor. The trial found that the greatest benefit was obtained using low doses of anti-TNF therapy for 48 hours.

• Inhibitex Inc., of Atlanta, entered an agreement with Dyax Corp., of Cambridge, Mass., for the discovery, development and commercialization of products for the prevention or treatment of enterococcal infections. Using Dyax's phage display technology, the companies will discover fully human monoclonal antibodies targeted against Inhibitex's MSCRAMM proteins expressed by enterococci. Terms call for the partners to jointly develop product candidates and to equally share research and development costs, commercialization rights and profits. On Tuesday, Inhibitex's stock (NASDAQ:INHX) gained $1.05, or 17.9 percent, to close at $6.93.

• Insmed Inc., of Richmond, Va., said that the Committee for Orphan Medicinal Products of the European Agency for the Evaluation of Medicinal Products approved the company's application for orphan drug designation in Europe for SomatoKine for the treatment of insulin resistance.

• Kosan Biosciences Inc., of Hayward, Calif., said the FDA granted its cancer compound, 17-allylamino-17-demethoxy-geldanamycin, or 17-AAG, an analogue of the polyketide geldanamycin, orphan drug status for the treatment of chronic myelogenous leukemia. The drug is being evaluated for the treatment of multiple cancer indications in Phase I and II trials including a Phase Ib trial with Gleevec (Novartis AG) as a combination therapy in CML.

• NascaCell IP GmbH, of Munich, Germany, entered an agreement to grant exclusive rights to GE Healthcare Amersham Biosciences KK, of Tokyo, to distribute NascaCell's aptamers in Japan for target validation and drug discovery applications. GE Healthcare will initiate and negotiate agreements with prospective customers for aptamers and related services. NascaCell labeled the agreement part of its business strategy to make aptamers available to the life science industry. Financial terms were not disclosed.

• NeoRx Corp., of Seattle, filed an investigational new drug application with the FDA for a Phase II trial of NX 473, its next-generation platinum product candidate, in patients with small-cell lung cancer. The randomized trial proposes to enroll 120 patients with SCLC that are refractory or resistant to previous platinum therapy to examine the impact of treatment with NX 473 on clinical response. NX 473 was developed to overcome the limitations of existing platinum compounds, including platinum resistance and toxicities to the kidney and peripheral nervous system.

• Newron Pharmaceuticals SpA, of Milan, Italy, reported positive Phase II results from a study that assessed ralfinamide's tolerability and preliminary efficacy in patients suffering from neuropathic pain. More specifically, the primary efficacy measure, pain Visual Analogue Scale, showed a statistically significant improvement of 26 percent vs. baseline. Patients were enrolled if they were affected by neuropathic pain induced by one of the following causes: traumatic or ischemic nerve roots disease, nerve roots compression in spine disease, post herpetic neuropathy, diabetic neuropathy, nerve entrapment, traumatic mononeuropathy and polyneuropathy.

• Novartis AG, of Basel, Switzerland, and Orion Pharma, a division of Espoo, Finland-based Orion Corp., launched a study in Parkinson's disease, called STRIDE-PD (Stalevo Reduction in Dyskinesia Evaluation), which will investigate if the optimized levodopa medication Stalevo delays the onset of motor complications in comparison with the traditional formulation of levodopa/carbidopa. The trial will enroll about 740 patients at 70 centers in 14 countries. Patient recruitment started in September and will last about 12 months. Initial study results are expected in 2007. Stalevo was developed by Orion Pharma and is marketed by Novartis and Orion.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said it concluded a meeting with the FDA regarding its investigational new drug application for Tarvacin. In response to requests from the agency during the meeting, the company said it would provide additional information and might alter some aspects of its planned clinical study. A formal information request from the meeting will be sent to Peregrine within the next 30 days. Tarvacin is a chimeric monoclonal antibody being developed as a cancer agent. On Tuesday, Peregrine's stock (NASDAQ:PPHM) dropped 15 cents, or 11.5 percent, to close at $1.16.

• Perlegen Sciences Inc., of Mountain View, Calif., was awarded a $13.2 million contract by the National Institute of Environmental Health Sciences in Bethesda, Md., to identify sequence variation in inbred mouse strains. Perlegen will use Affymetrix Inc.'s whole-wafer, high-density, oligonucleotide array technology to identify single nucleotide polymorphism and other genetic differences among the strains.

• Procyon Biopharma Inc., of Montreal, identified the PSP94 (prostate secretory protein of 94 amino acids) binding protein, which is a crucial part of the company's assay development technology for prostate cancer diagnosis and prognosis. Procyon's scientists have demonstrated that pre-treatment blood measurements of bound and free PSP94 can separate prostate cancer patients treated with curative intent radiotherapy into good and bad prognostic groups. Recent company findings have been accepted for publication in the Biochemical Journal and are available online.

• ProCyte Corp., of Redmond, Wash., completed the sale of its former contract manufacturing assets to ICOS Corp., of Bothell, Wash., for $900,000 in a cash transaction. ICOS took possession of the assets, as well as ProCyte's former contract manufacturing facility. ProCyte amended its existing lease to relinquish its leasehold rights and obligations related to the portion of space being taken by ICOS and ICOS, in turn, entered a multiyear lease for the same space. ProCyte will continue to occupy about 14,000 square feet of its existing facility for its dermatology, cosmetic surgery and spa business.

• Protein Design Labs Inc., of Fremont, Calif., entered an agreement to access San Diego-based Cyntellect Inc.'s Cell Xpress service. The service allows customers to leverage high-throughput LEAP (Laser Enabled Analysis and Processing) technology to provide visually documented cloning of the highest secreting recombinant cells for therapeutic monoclonal antibody and protein production. Financial terms were not disclosed.

• Repligen Corp., of Waltham, Mass., said preclinical data reported at the Society for Neuroscience meeting in San Diego indicate that RG2417 has anti-anxiety properties in animal models and might have activity in anxiety disorders. RG2417, a formulation of the nucleoside uridine, is in development for neuropsychiatric disorders and neurodegenerative diseases. The company previously reported Phase I results showing the safety of a prodrug of uridine and early evidence of its clinical effect in treating bipolar disorder and major depression.

• Sanguine Corp., of Pasadena, Calif., said that its synthetic red blood substitute, PHER-02, is being tested in various phases of animal toxicity trials being conducted by three medical schools in the U.S. and Canada. The focus of studies with PHER-02 is its effectiveness in perfusion for pancreas preservation for transplantation. The schools include the University of Chicago, the University of Maryland and the University of Alberta in Canada.

• Sequenom Inc., of San Diego, formed a joint working group with Siemens Medical Solutions of Siemens AG, of Erlangen, Germany, to explore the requirements for next-generation molecular diagnostics platforms. Siemens will purchase four MassArray Compact systems, and the companies will work to execute a functional-requirement analysis.

• Targeted Molecular Diagnostics LLC, of Westmont, Ill., added to its service offerings gene sequencing in either paraffin-embedded blocks or frozen tissue samples. The laboratory will prepare DNA, design PCR primers specific for the exons (or other regions) of the gene of interest, amplify the DNA in a series of nested PCR reactions and sequence the second-round PCR products bi-directionally to identify mutations.

• Transave Inc., of Monmouth Junction, N.J., said the FDA approved its investigational new drug application for SLIT Cisplatin. The company said it would begin the first of several planned Phase I/II trials by the end of the year. The product is being developed for initial therapeutic indications for bronchoalveolar carcinoma and recurrent metastatic lung tumors in osteosarcoma patients. A Phase I/II escalating-dose study in end-stage lung cancer patients is nearing completion in Europe, and to date, SLIT (Sustained-Release Lipid Inhaled Targeting) Cisplatin has been well tolerated with no evidence of systemic toxicities. In addition, some patients have shown stable, non-progressive disease.

• TransTech Pharma Inc., of High Point, N.C., achieved a milestone in its five-year research collaboration with Bagsvaerd, Denmark-based Novo Nordisk A/S, which began in July 2001. The collaboration is based on TransTech's TTP Translational Technology for small-molecule drug discovery in combination with Novo's biological targets. The technology has been applied to biological targets and produced small-molecule drug candidates to treat diabetes, cancer, inflammation, Alzheimer's disease and thrombosis.

• The University of Wisconsin at Madison said findings reported at the Society for Neuroscience meeting in San Diego detailed its researchers' identification of a protein in the brain that halts the progression of Alzheimer's disease in human brain tissue. The protein, known as transthyretin, protects brain cells from gradual deterioration by blocking another toxic protein that contributes to the disease process. The National Institute of Environmental Health Sciences, a component of the National Institutes of Health in Bethesda, Md., provided $1.25 million for the study.

• Vasogen Inc., of Toronto, said preclinical data reported at the Society for Neuroscience meeting in San Diego demonstrated the ability of VP025 to provide a significant neuroprotective effect in a model of Parkinson's disease. Specifically, pretreatment with VP025 significantly (p<0.001) reduced movement abnormalities seven days after 6-hydroxydopamine was administered to initiate nerve damage, and the protective effect continued until the end of the three-week study. VP025 also significantly attenuated both the reduction in dopamine (p<0.05) and the loss of dopaminergic neurons (p<0.05), factors that mediate behavioral changes in the model, as well as in Parkinson's disease.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said a pilot Phase II study of VX-385 (640385) began under the watch of GlaxoSmithKline plc, of London. The trial will enroll about 30 HIV patients who will receive the protease inhibitor for up to 48 weeks to assess its safety, efficacy and clinical activity. In connection with the start of the study, Vertex said it expects to recognize as revenue a milestone payment this quarter.

• VION Pharmaceuticals Inc., of New Haven, Conn., was granted orphan drug designation from the FDA for Cloretazine (VNP0101M) in acute myelogenous leukemia. Cloretazine is a sulfonylhydrazine alkylating agent that is being evaluated by the company in a Phase II trial for acute myelogenous leukemia. The company plans to begin a Phase III trial of Cloretazine in combination with Ara-C in relapsed acute myelogenous leukemia no later than the first quarter of 2005.

• Yaupon Therapeutics Inc., of Philadelphia, initiated a Phase I trial for lobeline in methamphetamine addiction. The company also said it intends to begin Phase II/III trials of a new topical agent, Clearazide, for the treatment of cutaneous T-cell lymphoma. Lobeline is derived from a natural product with a history of safety in human use, the company said.