• Advion BioSciences Inc., of Ithaca, N.Y., signed a $9 million, three-year contract to provide bioanalytical services to an unnamed, top-10 pharmaceutical company, it said. Advion will provide scientists and instrumentation to support the client's bioanalytical method development, method validation and sample analysis programs. The agreement also provides the client an option to increase its level of committed resources during the life of the contract and to secure resources at a time when outsourcing is a strategic imperative for the drug development industry, the company said.

• Agilent Technologies Inc., of Palo Alto, Calif., entered an agreement to integrate some of its networked data systems with instruments belonging to Bayer AG, of Leverkusen, Germany. More specifically, they will work to develop and market the integration of the Covin Instruments logistics solution from Bayer Business Services with Agilent's ChemStation and Cerity NDS for pharmaceutical quality assurance and quality control.

• Amgen Inc., of Thousand Oaks, Calif., provided financial guidance for next year, including adjusted earnings per share that will range between $2.30 and $2.40, driven by sales, and total revenue ranging between $9.7 billion and $10.4 billion. Amgen, which announced a $5 billion stock-repurchase plan, said that its 2003 adjusted earnings per share is expected to be in the middle of its guidance range of $1.85 and $1.95, with expected sales in all franchises to be in the middle or high end of guidance ranges.

• Arena Pharmaceuticals Inc., of San Diego, expects to initiate Phase I trials during the first quarter of 2004 for its obesity compound, APD356. Meanwhile, as part of its transition to a development company, Arena intends to restructure certain operations forcing it to reduce staff by 9 percent, or 30 people. Also, 12 scientists will be transferred from research activities to development-oriented activities. Arena internally discovered APD356, a highly selective 5HT2C agonist that has been shown to reduce body weight and food intake in animal models of obesity. Targeting the 5HT2C receptor is proposed to regulate body weight by regulating satiety.

• Atrix Laboratories Inc., of Fort Collins, Colo., reported its Japanese licensee, Sosei Co. Ltd., of Tokyo, entered a co-promotion agreement with Nippon Organon KK, of Tokyo, for Eligard products (leuprolide acetate for injectable suspension, known as SOT-375 in Japan) in Japan for the treatment of advanced prostate cancer. SOT-375 is a formulation of Eligard 7.5 mg, a once-a-month prostate cancer product. Atrix also reported Mayne Pharmaceutical, of Melbourne, Australia, Atrix's licensee, received marketing approval for Eligard one-, three- and four-month prostate cancer products in Australia.

• BioPoint Solutions Inc., of Danvers, Mass., reported its official company launch. BioPoint is a provider of technology solutions and professional services for the biopharma industry. Its sole focus is to enable biotech and pharmaceutical companies to meet their growing data management, tracking and regulatory compliance needs.

• Celsion Corp., of Columbia, Md., established a joint venture to develop its technologies and distribute its products in China with Asia Pacific Life Sciences Group Ltd., a group of Hong Kong-based investors. Over the last several years, the company said it has built a network of China-based scientists and clinicians in the field of heat-based therapies for cancer care. Shorter term, Celsion added that a pre-market approval of its Microfocus BPH 800 Microwave Urethroplasty System would be expedited in China once it is approved by the FDA. Separately, Celsion raised $4 million in a private placement of its common stock and associated warrants. The company sold 4.5 million units consisting of one share of common stock and a warrant to purchase 0.30 shares of common stock exercisable at $1.25 per share (representing 30 percent warrant coverage) at a price of 88 cents per unit to institutions and individual investors. Investors from Asia Pacific Life Sciences led the group. Proceeds will be used to continue development of the company's heat-activated liposomes and Cancer Repair Inhibitor technologies and for working capital and general corporate purposes through the end of 2004.

• ComGenex Inc., of Budapest, Hungary, developed an integrated chemical genomics screening platform based on its combinatorial chemistry, QSAR, molecular modeling, affinity labeling and microfabricated devices. The platforms include PhotoMics technology, which enables covalent labeling to reduce complexity of the proteome and to find disease-specific diagnostic markers, and LibrArrays, chemical microarrays allowing rapid non-covalent affinity profiling.

• Depomed Inc., of Menlo Park, Calif., reported the approval of its application to list its stock on Nasdaq. Depomed's stock will trade at the opening of trading today, under the ticker symbol "DEPO." Depomed uses its Gastric Retention System to develop oral products and improved formulations of existing oral drugs.

• Embrex Inc., of Research Triangle Park, N.C., filed a federal suit against two companies it claims have breached two of its patents. Embrex said an in ovo injection device designed by Breuil SA, of Landivisiau, France, and New Tech Solutions Inc., of Gainesville, Ga., violates U.S. Patent Nos. 5,745,228 and 5,900,929. Embrex is seeking injunctive relief and monetary damages for the alleged infringements and is demanding a jury trial.

• Esperion Therapeutics Inc., of Ann Arbor, Mich., completed a second Phase I study of ETC-642 (RLT peptide), a candidate for treatment of patients with acute coronary syndromes. The Phase I study of 20 patients with stable cardiovascular disease was designed to determine the maximum tolerated dose for single intravenous infusions of ETC-642. In an earlier Phase I, there was evidence of cholesterol mobilization at dose levels of 3 mg/kg and higher of ETC-642. In the second trial, patients received one of three dose levels (10, 20 or 30 mg/kg) of drug or placebo. Results of both studies provided evidence of safety and tolerability for single infusions of ETC-642 at the dose levels tested. At 30 mg/kg, investigators observed evidence of asymptomatic elevations of liver function tests in a single patient, suggesting the identification of a maximum dose.

The Forsyth Institute in Boston said its researchers published findings in next month's issue of the Journal of Bone and Mineral Research showing that a potassium channel blocker compound found in scorpion venom can inhibit bone loss, as demonstrated in a model of advanced periodontal disease. The researchers added that their discovery also suggests the compound might be useful in treating osteoarthritis and rheumatoid arthritis.

• Galapagos Genomics NV, of Mechelen, Belgium, entered a target discovery collaboration with Bayer HealthCare AG, a unit of Bayer AG, of Leverkusen, Germany, in which Galapagos will couple its disease biology knowledge with its SilenceSelect and FLeXSelect target discovery collections to identify and validate undisclosed druggable targets. Bayer has the exclusive right to select validated targets for drug development in return for up-front payments, research funding and milestones. Further financial terms were not disclosed.

• Genentech Inc., of South San Francisco, entered a long-term manufacturing agreement with Lonza Group Ltd., of Basel, Switzerland, which will manufacture commercial quantities of Rituxan (rituximab) for Genentech. Lonza will use its production facility in Portsmouth, N.H. Financial terms were not disclosed.

• Genmab A/S, of Copenhagen, Denmark, entered a research collaboration with Sanquin Blood Supply Foundation in Amsterdam, the Netherlands, to develop a potential improvement in the treatment for hemophilia patients who are not able to respond adequately to standard therapy with Factor VIII. Sanquin discovered a method of preventing inhibitory antibodies from binding to Factor VIII, which replaces the missing clotting product. Genmab will support a limited research program at Sanquin to further validate the approach. The agreement includes an option for Genmab to license Sanquin's technology on specified terms.

• HMGene Inc., of Piscataway, N.J., entered a drug discovery and development agreement with Suntory Pharmaceutical Research Laboratories LLC, of Cambridge, Mass., to pursue one of HMGene's obesity targets. The privately held company said several targets identified by its Adiposense technology can be modulated either to prevent fat deposition or to increase fat mobilization by stimulating its breakdown from fat depots. Financial terms were not disclosed.

• Insmed Inc., of Richmond, Va., received FDA orphan drug designation for rhIGF-I/rhIGFBP-3 (also called SomatoKine), a candidate to treat extreme insulin resistance. The investigational drug is a delivery composition of insulin-like growth factor-I (IGF-I). It is administered as a once-daily subcutaneous injection and is designed to restore IGF-I levels to more normal ranges in metabolic and anabolic disorders where IGF deficiency exists.

• Isolagen Inc., of Houston, said it developed a new cell-culturing system and automated manufacturing system that permit a fully automated cell-harvesting process in a closed-loop sterile system, compared to the existing process of separating cells using centrifuge technology. The technology was developed through a collaboration with Applikon Biotechnology Inc., of Foster City, Calif., which uses sound waves to separate cells from culture medium in bioreactors for both research and production.

• Kibow Biotech Inc., of Philadelphia, reported contingency grant funding of $600,000 from the Industrial Credit and Investment Corp. of India bank for the program of Technology Development and Commercialization, created under the authority of the U.S. Agency for International Development for India. The funding is aimed to help complete the funding needs toward nutraceutical product development, specifically for the direct or indirect technology or intellectual property transfer of Kibow's gut-based uremia therapy to India when completed.

• La Jolla Pharmaceutical Co., of San Diego, submitted a new drug application to the FDA for Riquent, a candidate for the treatment of patients with lupus (systemic lupus erythematosus, or SLE) at risk of renal disease. Riquent is designed to reduce the levels of antibodies to double-stranded DNA, which are believed to be responsible for lupus renal disease, a primary cause of sickness and death in lupus patients. Riquent has received orphan status in the U.S. and Europe. The evidence supporting the safety and effectiveness of Riquent is derived from 12 clinical trials involving about 900 patients and subjects conducted over a period of about 10 years. The company said in May it planned to file the NDA. (See BioWorld Today, May 6, 2003.)

• Micrologix Biotech Inc., of Vancouver, British Columbia, said MBI-2401, the lead development candidate from its lipopeptide program, advanced into preclinical development activities related to an eventual investigational new drug application. The selected compound is intended to be an intravenous product for the treatment of hospital-acquired Gram-positive infections. The company plans to begin clinical development of the systemic antibacterial agent in early 2005.

• Morphotek Inc., of Exton, Pa., said Abgenix Inc., of Fremont, Calif., confirmed the development of an antibody-producing cell line from their research collaboration. The development triggers an undisclosed milestone payment to Morphotek. The cell line comes from a research program employing Morphotek's Morphodoma technology, a process that evolves lead mammalian cell lines to generate subclones yielding protein products with enhanced therapeutic efficacy and/or genetically enhanced cells exhibiting high titers of protein for scaleable manufacturing.

• NanoBio Corp., of Ann Arbor, Mich., will use a $3.2 million contract by the U.S. Department of Defense to support the development of antimicrobial nanoemulsions. The award will help fund clinical trials to confirm the safety of those nanoemulsions for human topical use. Applications of the nanoemulsion technology that are of interest to the DOD include the decontamination of infectious agents on humans and the prevention of infectious disease following a bioterrorism attack.

• Nautilus Biotech, of Evry, France, received an undisclosed milestone payment from Aventis Pasteur, of Lyon, France, after developing a number of cell clones that have shown significant improvement of virus yield. Some of the clones are now progressing into further development at Aventis Pasteur, the vaccines business of Aventis SA, of Strasbourg, France.

• PharmaNetics Inc., of Raleigh, N.C., said that, due to continued legal action against Aventis SA, of Strasbourg, France, it is seeking strategic alternatives, including the sale of the manufacturing operations. The company also reported that, if a buyer for the operations is not identified, it plans to terminate its distribution agreement with Bayer Diagnostics, of Tarrytown, N.Y. PharmaNetics said it has had discussions with potential purchasers and is optimistic about the consummation of an agreement. PharmaNetics notified Bayer in writing of its intent to terminate its agreement.

• Pheromone Sciences Corp., of Toronto, said its shareholder rights offering, which expired Dec. 12, has not raised the minimum gross proceeds of $285,000. Therefore, the company will not accept subscriptions to acquire common shares pursuant to the exercise of rights and will return any subscription funds received to subscribers without interest. The company intends to scale down operations to conserve cash while it pursues other financing options. Pheromone Sciences' work focuses on licensing and commercializing its Fertility Monitor product.

• Prana Biotechnology Ltd., of Melbourne, Australia, released results from a pilot Phase II trial showing that treatment with its drug, PBT-1 (clioquinol), for Alzheimer's disease slowed progression of cognitive decline in a group of patients with moderate to severe disease. The findings were published in the Dec. 15, 2003, issue of Archives of Neurology. When compared to patients treated with placebo, those receiving PBT-1 experienced improved cognitive performance, together with a significant lowering in the plasma of the key marker of Alzheimer's, the amyloid beta protein. The study enrolled 36 patients. PBT-1 is a chemical that binds zinc and copper and has been shown to lower the levels of amyloid beta and the associated toxicity in the brains of transgenic mice.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said collaborators at the National Institutes of Health in Bethesda, Md., published findings in this month's online issue of Federation of American Societies for Experimental Biology showing that Thymosin Beta 4 (TB4), which promotes tissue growth and wound repair, can also stimulate hair growth in laboratory animals. The researchers concluded that TB4, the company's lead therapy, exerts a profound hair-promoting effect through a combined action on several critical events in hair follicle growth. Evidence suggests that it does this by promoting the migration of stem cells to the base of the follicles, among other events.

• Repligen Corp., of Waltham, Mass., said it would release top-line Phase III results related to its study of secretin for autism sometime during the week of Jan. 5, affirming previous guidance. The study will remain blinded through the end of the year.

• Sepracor Inc., of Marlborough, Mass., reported that on Friday, it closed its sale of $600 million aggregate principal amount 0 percent convertible senior subordinated notes, including $200 million of 0 percent Series A convertible senior notes due 2008 and $400 million of 0 percent Series B notes due 2010. The initial purchasers have the option to purchase up to an additional $50 million principal amount of Series A notes and/or up to $100 million principal amount of Series B notes. The conversion rate is equivalent to a conversion price of about $31.89 per share, subject to adjustment.

• Sequenom Inc., of San Diego, said its Gene Expression Analysis technology would be used by the Institute for Genomic Research in Rockville, Md., and the University of Michigan Medical Center in Ann Arbor. The institute will use Sequenom's analysis application on the recently introduced MassARRAY Compact system to assess the functional implications of genetic polymorphisms on gene expression. The university purchased Sequenom's analysis application with the company's MassARRAY 7K flagship system for low-copy-number gene detection and quantitation.

• Structural GenomiX Inc., of San Diego, and UroGene SA, of Evry, France, formed a joint research and development collaboration for the discovery and clinical development of drugs for the treatment of urological cancers. SGX and UroGene will develop small-molecule inhibitors against urological cancer kinase targets. The SGX FAST lead discovery technology will be combined with UroGene's expertise in target validation and clinical studies for urological indications to focus initially on the development of drugs for bladder cancer.

• Therion Biologics Corp., of Cambridge, Mass., licensed from Biogen IDEC Inc., of Cambridge, Mass., patent rights relating to Lymphocyte Function Associated Antigen-3. LFA-3 is a component of Tricom, Therion's co-stimulatory system for optimizing immune response against tumor cells. Therion gains a nonexclusive license under the LFA-3 patent rights to develop, manufacture and commercialize oncology product candidates incorporating LFA-3. Tricom, which stands for Triad of Co-stimulatory Molecules, uses three co-stimulatory molecules to enhance antigen presentation and activation of immune responses critical for tumor destruction. Therion said Tricom is an integral component of Therion's lead cancer vaccine candidates, Prostvac-VF and Panvac-VF, currently in clinical investigation for the treatment of metastatic prostate cancer and pancreatic cancer, respectively.

• TransForm Pharmaceuticals Inc., of Lexington, Mass., entered an agreement with Johnson & Johnson Pharmaceutical Research & Development LLC, of La Jolla, Calif., covering topiramate, an anti-epileptic drug marketed by Ortho-McNeil Pharmaceutical Inc., also a Johnson & Johnson company. TransForm was granted a patent on a salt form of topiramate in May 2003, based on work it had done to improve the compound's solubility. Under the current agreement, TransForm is assigning all rights to its topiramate patent to J&JPRD in exchange for up-front payments, milestones and royalties.

• V.I. Technologies Inc., of Watertown, Mass., reported that funding was completed on the private placement of equity securities that the company had previously reported on Dec. 5. Several new investors were added to the original group bringing the total amount raised to $4 million, up from $3.4 million previously reported. Vitex entered agreements to sell about 4.4 million shares of its common stock to institutional investors at a negotiated price of 90 cents per share for gross proceeds of about $4 million. The investors also received a five-month option to purchase about 1.1 million additional shares at 90 cents per share and four-year warrants to purchase about 1.8 million shares, exercisable for cash only, at $1.32 per share.

• Xcellerex LLC, of Marlborough, Mass., completed an undisclosed initial round of private financing. The company is using the funds for licensing manufacturing technology, acquiring laboratory and manufacturing equipment and hiring trained staff. The company recently established new corporate headquarters and a manufacturing facility in Marlborough. Xcellerex's technology platform consists of BioMax for high-speed manufacturing process optimization and FlexMax, the company's modular biologics manufacturing platform.

• Zeptosens AG, of Witterswil, Switzerland, said a blinded study using its planar waveguide-based microarray technology with Quantum Resonance Interferometry signal processing software from ViaLogy Corp., of Pasadena, Calif., demonstrated results better than currently available commercial microarray systems. The study documented a 50-fold improvement in limit of quantitation and a 10-fold reduction in data variance starting from Zeptosens' SensiChip system.

No Comments