• Abbott Laboratories, of Abbott Park, Ill., said it simultaneously submitted a supplemental biologics license application to the FDA and a marketing authorization application to the European Medicines Agency seeking approval to market Humira (adalimumab) for psoriatic arthritis. The filings are based on two placebo-controlled studies, including data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), a Phase III trial showing patients on Humira achieved significant improvement in both arthritic and psoriatic signs and symptoms. The product already is approved in both the U.S. and Europe for moderate to severe rheumatoid arthritis.

• Abgenix Inc., of Fremont, Calif., priced its previously announced convertible senior notes due 2011 for $225 million. The company also has granted the initial purchasers an option to purchase up to an additional $75 million principal amount of notes. Abgenix intends to use a portion of the proceeds to retire, from time to time, a portion of its outstanding convertible subordinated notes due March 15, 2007.

• Acusphere Inc., of Watertown, Mass., has enrolled 300 patients in its Phase III program for AI-700, a cardiovascular drug designed to enable ultrasounds to compete more effectively with nuclear stress tests to detect coronary heart disease. The AI-700 Phase III program includes a pilot phase for training of new clinical sites and two simultaneous pivotal trials. The company estimates that it will enroll about 600 patients in the Phase III program and complete enrollment in the second half of 2005.

• Allos Therapeutics Inc., of Westminster, Colo., acquired an exclusive worldwide license from the University of Colorado Health Sciences Center, the University of Salford and Cancer Research Technology to develop and commercialize RHI, a chemotherapeutic agent. The compound is being investigated in a Phase I trial sponsored by Cancer Research UK. RHI is a targeted cytotoxic prodrug that is bioactivated by the enzyme DT-diaphorase.

• Avanir Pharmaceuticals Inc., of San Diego, began submitting a rolling new drug application to the FDA for approval of Neurodex for pseudobulbar affect. The agency indicated that the product should qualify for a priority review when the submission is complete. The company, which four months ago said it planned to begin its submission by the end of this year upon reporting positive Phase III results, expects to complete its submission in the first half of next year. Separately, Avanir said an article published in the Dec. 16, 2004, issue of the Journal of Medicinal Chemistry detailed the activity of AVP 13358 against critical targets in the allergy cascade. The report was titled "Novel 2-(substituted phenyl) Benzimidazole Derivatives with Potent Activity Against IgE, Cytokines and CD23 for the Treatment of Allergy and Asthma." (See BioWorld Today, Aug. 25, 2004.)

• AVAX Technologies Inc., of Philadelphia, received FDA approval to begin a clinical trial of its autologous, hapten-modified melanoma vaccine, M-Vax. It is expected to begin enrollment in the beginning of next year. A maximum of 56 patients with Stage III or IV melanoma will be assigned in a double-blinded design to one of four vaccine dosage groups, including one with a zero-cell dose. They will be evaluated for safety and for the development of an immune response to autologous melanoma cells, as measured by delayed-type hypersensitivity, and the trial will determine whether M-Vax is bio-equivalent to the original autologous, hapten-modified vaccine.

• Avigen Inc., of Alameda, Calif., said the first patient was treated in a Phase I/II trial using AV201, the company's gene-therapy drug candidate for the treatment of severe Parkinson's disease. Significantly reduced levels of dopamine in the brain is a fundamental characteristic of the disease, the company said, and Avigen's AV201 is designed to restore normal levels of dopamine.

• Barrier Therapeutics Inc., of Princeton, N.J., announced positive results from a confirmatory Phase III trial of Sebazole for seborrheic dermatitis. The data confirm findings from two other Phase IIIs reported in January. The topical formulation consists of 2 percent ketoconazole in a waterless gel for once-daily application. Of 459 subjects tested at 24 U.S. sites, 25.8 percent of Sebazole-treated patients reached the primary endpoint, compared to 13.9 patients treated with the gel alone (p=0.001). The endpoint was the proportion of patients with a reduction in signs and symptoms at day 28, or 14 days after the two-week treatment period, as well as the investigator's global assessment. The mean change from baseline for scaling, the secondary endpoint, was better in treated patients and redness and itching was better, though not statistically significant. The company plans to file a new drug application by mid-2005.

• Bavarian Nordic A/S, of Copenhagen, Denmark, set up a U.S. holding company, Bavarian Nordic Inc., based in Delaware to serve as a legal entity for future activities in the U.S., as well as an operating company, BN ImmunoTherapeutics Inc., for cancer research and development. The latter will be based in Palo Alto, Calif., and initially will focus on breast, prostate and colon cancer. Bavarian Nordic initially will invest DKK26 million (US$4.6 million). Both units will operate as wholly owned subsidiaries of Bavarian Nordic, which said it decided to resume work with cancer vaccines following recent progress.

• Bioaccelerate Inc., of New York, said its development partner, Australian Cancer Technology, of Sydney, Australia, initiated a Phase II trial of RP101 for the treatment of metastatic pancreatic cancer. The study will include 22 patients. RP101 is an antiviral drug marketed in some European countries including Germany for herpes zoster.

• Biopure Corp., of Cambridge, Mass., said that on Wednesday it received a notice from the Nasdaq National Market providing the company with an additional 180 calendar days, or until June 13, to regain compliance with the daily minimum bid price requirement for continued listing. To regain compliance, the bid price of Biopure's common stock must close at $1 a share or more for a minimum of 10 consecutive business days. If the company does not regain compliance, it faces delisting.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, said all resolutions were passed at its general meeting. The company applied to the UK Listing Authority and the London Stock Exchange for about 10.2 million new shares in relation to a subscription by AstraZeneca plc, of London, to be admitted to the official list and to be admitted to trading on the market. It is expected that admission of the new shares will become effective and dealings in them will begin today.

• Cell Therapeutics Inc., of Seattle, updated its clinical development of Xyotax, including survival estimates for its STELLAR 3 and 4 trials in non-small-cell lung cancer, at the Wachovia Capital Markets Ten for 05 Biotechnology Conference in New York. The company, which already has extended timelines for releasing the pivotal trial data due to higher than historically predicted survival rates, said that at the current rate the trials would not reach the 311 deaths required for data analysis until early next month for STELLAR 3, and in February for STELLAR 4. As of last week, 281 deaths had been reported in STELLAR 3 and 222 events among 388 patients who received Xyotax at the 175-mg/m2 dose or control in STELLAR 4.

• Cephalon Inc., of West Chester, Pa., completed its offer to exchange its outstanding zero coupon convertible subordinated notes due 2033, first putable June 15, 2008, and zero coupon convertible subordinated notes due 2033, first putable June 15, 2010, for an equal amount of zero coupon convertible subordinated notes due 2033, first putable June 15, 2008, and zero coupon convertible subordinated notes due 2033, first putable June 15, 2010. About 96.5 percent of the old 2008 notes and 98.7 percent of the old 2010 notes were validly tendered and not withdrawn pursuant to the exchange offer, and Cephalon will issue a like principal amount of the new 2008 notes and new 2010 notes.

• ChemDiv Inc., of San Diego, signed an agreement with Entercel Ltd., of Austin, Texas. Entercel will have access to ChemDiv's compound collection as well as bioscreening, assay development, hit-to-lead and medicinal chemistry services. The agreement is designed to enhance Entercel's existing technology platform and allow the application of targeted bio-screening and extended biology and chemistry services from ChemDiv to their agricultural discovery programs.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, has entered an agreement with New York-based Pfizer Inc. to develop cell lines using the ACE (Artificial Chromosome Expression) System for production of Pfizer's recombinant proteins. The companies will work to engineer cell lines specific for the expression of a Pfizer protein using the ACE System. Pfizer, which will fund the collaboration, will evaluate the performance of the engineered cell lines.

• Competitive Technologies Inc., of Fairfield, Conn., and Abbott Laboratories, of Abbott Park, Ill., said a homocysteine patent license has been granted to Abbott under CTT's U.S. patent and its foreign counterparts relating to homocysteine medical tests. Abbott will pay sales-based royalties on assays, but CTT will relieve current Abbott customers from royalty obligations.

• ConjuChem Inc., of Montreal, announced that results from a Phase II trial of DAC:GLP-1 to treat Type II diabetes, in combination with Metformin, showed significantly reduced blood glucose levels in patients who were on oral diabetic medications though not on glycemic control. The company also reported positive initial results from an ongoing Phase I program evaluating new diluents for DAC:GLP-1, which are being developed to enhance the drug's tolerability profile and dosing convenience.

• Cryo-Cell International Inc., of Oldsmar, Fla., said on Dec. 14 the District Court for the District of Delaware issued an order on a final judgment in the company's favor in a patent-infringement suit filed by PharmaStem Therapeutics Inc., of Wayne, Pa. The suit was filed in 2002 against Cryo-Cell and other cord blood banking companies. The ruling reverses a 2003 jury verdict of patent infringement and a damages award.

• Cryptome Pharmaceuticals Ltd., of Sydney, Australia, said that it is initiating a program to apply its Cryptomics drug discovery platform to the field of neuroinflammatory diseases. Cryptomics is a systematic approach to the identification of protein fragments with previously undiscovered therapeutic activities.

• CV Therapeutics Inc., of Palo Alto, Calif., and Solvay Pharmaceuticals Inc., of Marietta, Ga., said a steering committee stopped the ASCOT study due to benefits observed in the amlodipine plus perindopril arm of the study. Labeled the Anglo-Scandinavian Cardiac Outcomes Trial, it was comparing the combination use of perindopril, their partnered angiotensin-converting enzyme inhibitor, and amlodipine, a calcium channel blocker, to a treatment regimen with the beta blocker atenolol and the diuretic bendroflumethiazide.

• Cytokinetics Inc., of South San Francisco, and GlaxoSmithKline plc, of London, began a Phase II trial of SB-715992, a small-molecule inhibitor of kinesin spindle protein. The 35-patient study will evaluate an 18-mg/m2 dose given every three weeks as second-line treatment of advanced ovarian cancer patients previously treated with a platinum and taxane-based regimen. Response rate is the primary endpoint in the third Phase II trial of SB-715992 in solid-tumor cancers. Trials in non-small-cell lung and breast cancer are ongoing, in addition to two GSK-sponsored Phase Ib trials and others supported by the National Cancer Institute.

• Cytomics Systems, of Paris, reported favorable preclinical results showing that use of its nosocomial fungal infection treatment resulted in a complete cure in mice infected with a pathogenic fungus. There were no undesirable side effects. The company identified the molecules used in the tests with its high-throughput screening system, UbiScreen.

• Diatos SA, of Paris, reported the positive review and regulatory clearance of its lead drug's investigational new drug application by the ethics committee of Toulouse 1 (France). AFSSAPS, the French health products safety agency, was notified and the company will conduct Phase I studies beginning in early 2005. The trials primarily will study the safety and pharmacokinetics of DTS-201, a doxorubicin prodrug that can be delivered selectively to tumors, in patients with advanced or metastatic solid tumors.

• DOV Pharmaceuticals Inc., of Hackensack, N.J., said it commenced a private offering of up to $65 million in convertible subordinated debentures due 2025 and expects to grant initial purchasers an option to purchase up to $15 million more. The company plans to allocate proceeds to working capital, research and development, capital expenditures and potential acquisitions or other investments.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., secured an exclusive license to intellectual property from the regents of the University of California on work led by Eric Verdin with SirT2 and SirT3, members of the sirtuin family of deacetylases, also known as Class III HDACs. In addition, Verdin joined the company's scientific advisory board. Elixir already holds a license to the related Sir2, a gene identified in yeast believed to control lifespan, metabolism and resistance to stress, and SirT1 from MIT.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application for XL880, an orally administered small molecule for cancer. In preclinical studies it demonstrated potent inhibition of the Met and VEGFR2 receptor tyrosine kinases, which play synergistic roles in promoting tumor growth and angiogenesis. Pending clearance by the FDA, the company plans to begin a Phase I trial next quarter.

• First Genetic Trust, of Chicago, said the FDA, Vanderbilt University Medical Center and London-based GlaxoSmithKline plc will participate in a post-marketing research effort using FGT's enTRUST genetic banking and research technology to understand the genetic basis of drug-induced Long QT. A similar study is being conducted at the St. Michael's Hospital of Toronto.

• Genmab A/S, of Copenhagen, Denmark, said that HuMax-CD20 was designated a fast-track product by the FDA. The designation covers patients with chronic lymphocytic leukemia who have failed fludarabine therapy. That patient group includes those who are refractory to available treatment. HuMax-CD20 is in two Phase I/II studies to treat CLL and non-Hodgkin's lymphoma.

• Icoria Inc., of Research Triangle Park, N.C., said its application to transfer the listing of its common stock from the Nasdaq National Market to the Nasdaq SmallCap Market was approved. The transfer is effective at the opening of business today. Icoria is focused on the application of systems biology to identify biomarkers for drug discovery and development, diagnostics and to develop agrichemicals. Icoria's stock (NASDAQ: ICOR) fell 18 cents Thursday, or 23.1 percent, to close at 60 cents.

• Inspire Pharmaceuticals Inc., of Durham, N.C., began a Phase I study of INS50589 Cardiovascular after filing an investigational new drug application with the FDA. In addition to safety and tolerability, the double-blinded, placebo-controlled trial is designed to assess the compound's pharmacokinetics and biological activity using various platelet function tests.

• Labopharm Inc., of Laval, Quebec, finalized a special protocol assessment agreement with the FDA for its ongoing Phase III trial of its once-daily formulation of tramadol. The company noted that should the study achieve desired results, it would be considered a positive pivotal trial in its new drug application. It is testing Labopharm's product vs. placebo over a 12-week period in more than 500 patients with osteoarthritis of the knee. Enrollment is proceeding on schedule, and data are to be reported and an NDA submitted during the second half of next year.

• MacroPore Biosurgery Inc., of San Diego, and The University of Giessen in Germany said findings published in this month's issue of the Journal of Cranio-Maxillofacial Surgery detailed a case report on the use of adipose-derived stem cells to treat a damaged region in a skull of a 7-year-old following a severe head injury that occurred a year earlier. The cells were harvested using a protocol developed by the company, and three months following the treatment, CT-scan analysis showed signs of new bone formation and near complete calvarial continuity around the area of the skull trauma.

• Merck KGaA, of Darmstadt, Germany, said it plans to acquire the Lumitec OLED R&D project from Schott AG, of Mainz, Germany. All 20 employees involved with the project have been offered positions at Merck, which expects the transaction, including an unlimited exclusive license for the business-related patents and associated assets, to be completed in early January. The Lumitec OLED (organic light-emitting diode) project involves indium tin oxide-coated glass substrates owned by a Merck subsidiary.

• MicroIslet Inc., of San Diego, reported an expanded research collaboration with the University of Alberta at Edmonton in the area of human islet-cell transplantation therapies for treatment of insulin-dependent diabetes. MicroIslet and University of Alberta scientists will conduct animal studies using MicroIslet's technologies for encapsulating islet cells that have been isolated from human cadavers.

• Nanogen Inc., of San Diego, said its stockholders approved the issuance of common shares pursuant to a merger agreement with Epoch Biosciences Inc., of Bothell, Wash. They also approved an amendment to increase the number of authorized shares to 135 million. Epoch stockholders also adopted and approved the merger agreement, and both companies expect to close the merger today. Epoch's stock was expected to cease trading on the Nasdaq exchange at the close of trading Thursday. The companies agreed three months ago to a $58 million stock deal to combine Nanogen's diagnostic products with Epoch's genomic analysis products. (See BioWorld Today, Sept. 9, 2004.)

• Orphan Medical Inc. of Minneapolis, announced that patient enrollment has been completed for its trial assessing Xyrem (sodium oxbate) oral solution for the treatment of fibromyalgia syndrome. Patients will complete a three-month trial with an active eight-week treatment period. The company also is expected to submit a supplemental new drug application in late December or January seeking to expand the Xyrem label to treat narcolepsy.

• OxiGene Inc., of Waltham, Mass., began a Phase II trial of its lead compound, Combretastatin A4 Prodrug (CA4P), in combination with carboplatin and paclitaxel. The company is advancing CA4P into the study with chemotherapy ahead of schedule based on positive results from an ongoing Phase I/II trial in the UK, in which CA4P was administered to patients with either carboplatin or paclitaxel. The new study represents the seventh clinical trial of CA4P in oncology. OxiGene expects to complete enrollment late next year, and then move forward into a Phase II/III trial in a specific cancer indication.

• ProMetic Life Sciences Inc., of Montreal, will receive a $5 million license fee after agreeing to partner its Enabling Technology with a newly formed private Tunisian company called BioMena SA. It was founded to manufacture biopharmaceuticals for the treatment of anemia, cancer, hepatitis and multiple sclerosis, and sell them in the Middle East, North Africa and select European markets.

• Santhera Pharmaceuticals AG, of Liestal, Switzerland, raised an additional €7 million (US$9.3 million) from existing and new investors, adding to €7 million it raised earlier this year upon its formation. That increased the full-year amount raised by the company, including its predecessor organizations Graffinity Pharmaceuticals AG and MyoContract AG, to €27 million. Santhera plans to use the latest capital to advance the preclinical and clinical development of therapies for neuromuscular and metabolic diseases. The second closing was subscribed by a syndicate led by NGN Capital, and also included Altana Innovationsfond GmbH, Heidelberg Innovation and a private investor.

• Senesco Technologies Inc., of New Brunswick, N.J., will conduct two preclinical studies of its technologies. The first, to be conducted at the Mayo Clinic, will investigate Factor 5A in multiple myeloma in mice. The second, at the University of Virginia, will test Senesco's inhibitor of eukaryotic initiation Factor 5A in an in vivo animal model of sepsis for its ability to ameliorate harmful effects to organs.

• Sinovac Biotech Ltd., of Beijing, signed an avian flu vaccine co-development agreement with the China Centre of Disease Control and Prevention, which will be responsible for surveillance of influenza prevalence, a molecular epidemiology study of the virus strain, guidance and establishment of the avian flu vaccine development strategy, plus participation in avian flu vaccine research and development and the design of a technical roadmap. Sinovac is responsible for avian flu vaccine research and development, vaccine application and production. The Chinese CDC is responsible for conducting several tests, including genome analysis on the virus strains used in the vaccine research and development, antigen analysis and immunization protection analysis, among others. The parties intend to apply for government funding, and longer term, all commercial rights will be owned by Sinovac.

• Symyx Technologies Inc. of Santa Clara, Calif., agreed to a five-year alliance with Dow Chemical Co., of Midland, Mich., to enhance research and development activity within Dow with high-throughput experimentation technologies and informatics solutions provided by Symyx. Symyx will perform research, develop and provide research tools and license software, and Dow will pay $120 million over the five-year period. Symyx expects about 40 percent of that to be for services, 30 percent for product revenue and 30 percent license revenue. Also, Symyx will receive royalties on sales of products.

• Tanox Inc., of Houston, executed an agreement with Biogen Idec Inc., of Cambridge, Mass., for the lease of a biologics manufacturing facility in San Diego and to acquire certain manufacturing assets to expand the company's antibody production capacity. The transaction comprises manufacturing equipment with a 5,500-liter production capacity and assumption of a long-term lease on the 76,000-square-foot building housing the equipment. Tanox will pay about $5.5 million for manufacturing equipment, associated documentation and furniture and fixtures. The building lease extends through October 2011, with two five-year extension options.

• The Medicines Co., of Parsippany, N.J., released primary results of the ESCAPE-1 trial of Clevelox (clevidipine), an intravenous blood pressure control agent in Phase III development, and reported that the results met trial objectives. Pre-operative cardiac patients treated with Clevelox showed at least a 15 percent reduction in blood pressure 92.5 percent of the time.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and GlaxoSmithKline plc, of London, said results presented at the Frontiers in Drug Development for Antiretroviral Therapies conference show Lexiva plus ritonavir dosed once daily led to sustained viral suppression and safety over 120 weeks. The findings came from study APV30005, which enrolled 211 patients who completed 48 weeks of treatment in the SOLO study evaluating the protease inhibitor in combination with abacavir and lamivudine twice daily.

• Vivus Inc., of Mountain View, Calif., said the FDA completed a special protocol assessment on the design of its pivotal Phase III trial to be conducted to support the registration of Evamist (estradiol metered-dose transdermal spray) for the treatment of vasomotor symptoms associated with menopause. The product is a small, hand-held spray that is designed to provide a convenient means to deliver a pre-set dose of estradiol via the skin.

No Comments