• Abgenix Inc., of Fremont, Calif., plans to sell about $150 million in convertible senior notes due 2011 through a private placement. The company expects to provide an option for the initial purchasers to buy up to an additional $25 million in notes. Abgenix will use a portion of the proceeds to retire, from time to time, a portion of its outstanding convertible subordinated notes due March 15, 2007. The remaining proceeds will cover research and development costs, capital expenditures, working capital and other corporate purposes.
• Advancis Pharmaceutical Corp., of Germantown, Md., modified its existing collaboration with Par Pharmaceuticals Inc., of Spring Valley, N.J., to include a pulsatile version of the antibiotic combination amoxicillin/clavulanate for acute otitis media in children. Under the updated agreement, the companies have incorporated a Pulsys version of the combination product to their existing joint sales and marketing agreement for Amoxicillin Pulsys. A Phase II trial should begin in early 2006. Financial terms have not changed.
• Applied NeuroSolutions Inc., of Vernon Hills, Ill., signed a non-exclusive agreement with bioMerieux SA, of Marcy l'Etoile, France, to bring to worldwide markets a biologic test for the diagnosis of Alzheimer's disease. Milestones due Applied NeuroSolutions could be worth more than $5 million, plus what it termed substantial royalties. The agreement grants bioMerieux an option to further evaluate the technology before going forward; if it opts into the deal, bioMerieux would be financially responsible for obtaining regulatory approvals to develop and sell diagnostic tests for Alzheimer's disease using the technology.
• ArTec Inc., of Reno, Nev., said the protocol for a Phase Ib trial designed to evaluate the efficacy and safety of Tubercin in certain cancer patients has been finalized. The study is targeted at adults suffering from metastatic Stage IV melanoma who cannot be treated by surgery and will include about 30 people between the ages of 18 and 65. The study will evaluate the administration of Tubercin along and in conjunction with other established immunotherapy treatments.
• Axcan Pharma Inc., of Mont St.-Hilaire, Quebec, reported positive cardiac safety results of a high-dose study for ITAX (itopride hydrochloride). ITAX, at four times the intended therapeutic dose, had no clinically relevant effects on heart rate, cardiac conduction and cardiac repolarization. The company expects to execute a Phase III program to demonstrate the safety and effectiveness of ITAX in functional dyspepsia.
• Biomira Inc., of Edmonton, Alberta, completed its financing for $12.6 million with Rodman & Renshaw LLC acting as exclusive placement agent. The company expects to use the proceeds for the next phase of clinical testing of its BLP25 liposome vaccine to treat non-small-cell lung cancer, which recently had positive Phase IIb data reported. (See BioWorld Today, Dec. 6, 2004, and Dec. 9, 2004.)
• Biopure Corp., of Cambridge, Mass., closed a previously announced financing that raised $11.6 million. The company, which received net proceeds of $10.5 million, sold 40 million common shares at 29 cents apiece to institutional and individual investors, and also issued warrants to purchase 20 million more shares at an exercise price of 31 cents each. C.E. Unterberg, Towbin LLC acted as the offering's agent. (See BioWorld Today, Dec. 10, 2004.)
• Cell Therapeutics Europe Srl, a subsidiary of Cell Therapeutics Inc., of Seattle, gained an exclusive, worldwide license from the University of Vermont to a new class of platinum-containing cancer drug candidates, bisplatinum compounds. The agreement gives Cell Therapeutics development and commercialization rights to the compounds. At the same time, F. Hoffmann La Roche Ltd., of Basel, Switzerland, granted Cell Therapeutics a worldwide license for bisplatinum compounds under its patents. Both agreements foresee certain milestone payments and royalties on sales of the drugs, though specific financial terms were not disclosed.
• Chiron Corp., of Emeryville, Calif., said the FDA accepted the company's new drug application for Pulminiq (cyclosporine) inhalation solution. The NDA has been granted priority-review designation, which sets the action date six months from the Oct. 14 filing. Chiron is seeking approval for Pulminiq, in combination with standard immunosuppressive therapy, to increase survival and prevent chronic rejection in patients receiving allogeneic lung transplants. (See BioWorld Today, Oct. 15, 2004.)
• Ciphergen Diagnostics, a division of Ciphergen Biosystems Inc., of Fremont, Calif., said it is collaborating with the ADDNET consortium that is focused on creating a shift from biopsies for the diagnosis of kidney disease to advanced molecular diagnostics from patient urine. The ADDNET consortium consists of six participants from four countries and is led by Harry Holthofer at the University of Helsinki in Finland.
• Crucell NV, of Leiden, the Netherlands, said that Merck & Co. Inc., of Whitehouse Station, N.J., has met a clinical development milestone in connection with the PER.C6 technology licensed to Merck for its investigational HIV vaccine program.
• DOV Pharmaceutical Inc., of Hackensack, N.J., began the fourth of seven Phase III trials to evaluate the long-term safety of bicifadine in patients with chronic lower back pain. It will enroll about 1,550 patients with chronic lower back pain, 1,050 of whom will be entered directly into this study and randomized to receive either 400 mg of bicifadine twice daily or any appropriate pharmacological analgesic treatment. In addition, the trial will enroll about 500 patients who will have completed 12 weeks of treatment in either an ongoing or a confirmatory Phase III chronic lower back pain trial, currently planned for the second half of next year. The patients will receive 400 mg of bicifadine twice daily. The study's safety objective is part of an FDA-approved path toward an eventual regulatory filing. The pivotal program's first study got under way three months ago. (See BioWorld Today, Sept. 27, 2004.)
• Halozyme Therapeutics Inc., of San Diego, said holders exercised warrants from the first tranche of a January financing to purchase about 1.6 million shares of its common stock for total cash proceeds of $2.75 million. The company plans to redeem 611,399 warrants not exercised with the call for $0.01 a share, or $6,114. Halozyme develops and commercializes recombinant human enzymes.
• Illumina Inc., of San Diego, said that it has synthesized and began shipping a new Oligator mouse genome oligo set for spotted gene-expression arrays. The new MEEBO (Mouse Exonic Evidence-Based Oligonucleotide) set is designed for the study of mouse transcription and alternative splicing patterns, allowing interrogation of nearly 25,000 mouse genes.
• Lipomics Technologies Inc., of West Sacramento, Calif., signed an agreement with the nonprofit organization Cure Autism Now for a new biomarker study in children with autism and related disorders. Building on previous research, privately held Lipomics will produce lipomic profiles of children with autism, their siblings and age-matched controls to identify metabolic signatures of the disorder. Samples analyzed in the study will be collected by Cure Autism Now's DNA repository, the Autism Genetic Resource Exchange.
• Medarex Inc., of Princeton, N.J., is calling for redemption on Jan. 14 of all of its outstanding 4.25 percent convertible senior notes due Aug. 10, 2010, issued on July 23, 2003, and Jan. 30, 2004. The aggregate principal amount outstanding is about $147 million. Prior to Jan. 13, holders can elect to convert notes into common stock at $6.72 per share, or about 149 shares per $1,000 in notes, plus a make-whole payment of about $85 per that $1,000. Cash will be paid in lieu of shares. Holders also can choose to have their notes redeemed at a price equal to $1,000 per $1,000 in notes, plus the make-whole payment. Notes not converted by Jan. 13 automatically will be redeemed on Jan. 14 and interest will no longer accrue. Upon completion of the redemption, Medarex said its long-term debt position would be reduced by about $147 million. The company expects to record a non-operating charge of about $12.5 million for the fourth quarter to the make-whole payment.
• NicOx SA, of Sophia-Antipolis, France, said it completed an end-of-Phase II meeting with the FDA and plans to move HCT 3012 into Phase III for osteoarthritis as a result. The company's Phase II program included more than 2,700 patients and demonstrated the product was a potent and safe anti-inflammatory with the potential for improved cardiovascular safety over NSAIDS and COX-2-selective NSAIDs. Later stages of development are scheduled to start in the second half of next year, subject to a further meeting on manufacturing and formulation with the FDA planned for next quarter.
• PerkinElmer Inc., of Boston, and Procognia Ltd., of Maidenhead, UK, entered an exclusive distribution and co-marketing agreement to deliver a product for high-throughput and high-resolution analysis of the glycosylation of proteins. To that end, Procognia's U-c fingerprint lectin array-based platform is being combined with PerkinElmer's instrumentation, the Protein Array Workstation and the ProScanArray HT.
• Pharmos Corp., of Iselin, N.J., said its previous marketing partner, Bausch & Lomb, of Rochester, N.Y., received FDA approval for Zylet as an opthalmic anti-inflammatory/antiobiotic combination product. The product is part of the lotepredenol etabonate business acquired by Bausch & Lomb from Pharmos in 2001. Zylet is a combination of anti-inflammatory and antibiotic components (0.5 percent lotepredenol etabonate and 0.3 percent tobramycin) to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and in which superficial bacterial ocular infection or a risk of infection exists. Pharmos expects to receive within six months a milestone payment for the approval.
• Phytopharm plc, of Godmanchester, UK, granted an exclusive global license to its Hoodia gordonii extract to Unilever plc, of London. Terms call for Unilever to commit to initial payments of about $12.5 million out of a potential $40 million in payments to Phytopharm. The companies will collaborate on safety and efficacy studies to bring anti-obesity products to market. Unilever also will manage a separate agronomy program, and will support international patents for the products. Phytopharm will receive an undisclosed royalty on sales of all products containing the extract. The company's stock (LSE:PYM) rose 23 pence, or 10.7 percent, to close at £2.39 (US$1.95).
• Power3 Medical Products Inc., of The Woodlands, Texas, received additional blood samples from Mercy Women's Center in Oklahoma City to continue testing to identify and track protein biomarkers for the early indication of breast cancer in blood serum. The parties have been collecting blood samples during the past year from women undergoing MRI of the breast. The database now is the largest collection of samples tied to MRI in the country, the company said.
• QLT Inc., of Vancouver, British Columbia, received FDA approval for Eligard 45 mg (leuprolide acetate for injectable suspension) six-month formulation for the palliative treatment of prostate cancer. The approval came about two months ahead of the customary 12-month review period, the company said, similar to the time frame for other Eligard product approvals. Eligard depot, which lowers testosterone levels in the blood, belongs to the luteinizing hormone-releasing hormone agonist class. The product already is approved for one- (7.5 mg), three- (22.5 mg) and four-month (30 mg) depots.
• Sangamo BioSciences Inc., of Richmond, Calif., said its research agreement with LifeScan Inc., a Johnson & Johnson company, has been expanded to include additional gene targets important in diabetes. The agreement provides LifeScan with additional access to Sangamo's zinc finger DNA-binding proteins for use in an ongoing program to develop therapeutic cell lines as a treatment for diabetes. Financial terms were not disclosed.
• Sequenom Inc., of San Diego, said findings published in the Dec. 15, 2004, issue of Cancer Research detail its discovery of common genetic variations in intercellular adhesion molecule (ICAM) genes. The study, titled "Large-scale association study identifies ICAM gene region as breast and prostate cancer susceptibility locus," reports that individuals with a deleterious version of the ICAM gene region have a 40 percent higher risk of developing breast or prostate cancer compared to those without it. On Wednesday, the company's stock (NASDAQ:SQNM) spiked 46.9 percent, or 52 cents, to close at $1.63.
• SinusPharma Inc., of Carpinteria, Calif., initiated a Phase II trial of SPRC-AB01, a formulation of an antibiotic for nasal inhalation. The study will test the safety and efficacy of different doses in chronic rhinosinusitis patients who have had sinus surgery but continue to have bacterial infections. The patients will be randomized to receive placebo or one of two dosages of active treatment. Endpoints will include both patient- and physician-assessed reductions in signs and symptoms of disease, as well as microbiological outcomes.
• SuperArray Bioscience Corp., of Frederick, Md., released a pair of products for PCR-based gene-expression analysis: RT2 Real-Time and RT2 End-Point PCR. The gene-expression assay kits are designed for either real-time or end-point PCR applications, and the entire product line offers primer sets for every gene in the human, mouse and rat genomes and several PCR master mixes accommodating different PCR instruments.
• VaxGen Inc., of Brisbane, Calif., said the restatement of the company's recent financial statements is expected to increase revenues by about $16 million for the two-year period ended Dec. 31. The company and its independent auditors have been reauditing the company's financial statements in order to apply a more appropriate policy for recognizing revenue from certain existing government contracts. The reaudit likely will have to reflect Celltrion Inc.'s financial results. VaxGen is a minority shareholder in the South Korea-based corporation. The reaudit should not affect previously reported cash balances and it does not apply to the $877.5 million government contract awarded to VaxGen for 75 million doses of anthrax vaccine. (See BioWorld Today, Nov. 23, 2004.)
• Vion Pharmaceuticals Inc., of New Haven, Conn., said the Phase II trial of Triapine in combination with gemcitabine in pancreatic cancer showed an objective response rate of 11 percent, median progression-free survival of 4.7 months and median survival of 7.1 months. The first patients were enrolled in May 2003 and accrual is closed with 60 patients. Further data will be presented in January at the American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium.
• Xtrana Inc., of Broomfield, Colo., and Alpha Innotech Corp., of San Leandro, Calif., entered a definitive agreement for Alpha to merge with a wholly owned subsidiary of Xtrana in a reverse-merger transaction. Security holders of Alpha will receive shares of Xtrana common stock, and all outstanding Alpha stock options and warrants will be converted into options and warrants to purchase Xtrana common stock. Xtrana stockholders will hold about 17 percent and Alpha stockholders will hold about 83 percent of the combined company. Upon completion, Xtrana plans to change its name to Alpha Innotech.