Affymetrix Inc., of Santa Clara, Calif., and Monsanto Co., of St. Louis, entered a custom supply agreement for Affymetrix’s GeneChip technology, which Monsanto will use in its research to improve food quality while enhancing crop yield and reducing the need for chemical inputs. Both companies have collaborated to create a single microarray representing the Arabidopsis genome. Monsanto will use this proprietary microarray as part of its high-throughput discovery program. Financial details were not disclosed.
AlphaRx Inc., of Richmond Hill, Ontario, signed a letter of intent to acquire all the stock of an undisclosed privately held U.S. pharmaceutical manufacturing company with more than 200 vitamin and mineral supplements in its product line. Financial details were not disclosed.
Amaxa GmbH, of Cologne, Germany, released its Cell Line Optimization Nucleofector Kit. Amaxa said it is closing the gap between standard cell lines and primary cells with its Nucleofector technology, which can be used for the range of cells used in laboratory work.
ARC Pharmaceuticals Inc., of Vancouver, British Columbia, completed a private offering of common shares with gross proceeds of $550,000. Investors include company founders, employees and a group of private investors. ARC combines polymeric drug delivery systems with antisense oligonucleotides and small-molecule therapeutics to provide treatments for cancer and inflammatory diseases. Proceeds will be used to build ARC’s intellectual property portfolio and advance the company’s research and development programs.
Atrix Laboratories Inc., of Fort Collins, Colo., called for the redemption of its remaining 7 percent convertible subordinated notes due 2004. The redemption date has been set for May 15. This action will clear $2.9 million in debt remaining from Atrix’s public offering of $50 million in convertible subordinate notes issued November 1997. The notes will be redeemed at 102.25 percent of the outstanding principal amount of the notes plus accrued interest through the day prior to the date of redemption. The notes called for redemption may be converted into shares of common stock at a conversion price of $19 per share.
Avicena Group Inc., of San Francisco, received orphan drug designation from the FDA for creatine to treat patients with amyotrophic lateral sclerosis. The company plans to submit an investigational new drug application this year. Initial results suggest that creatine can slow the disease’s progression and help maintain patient quality of life, the company said. Creatine is an element in cellular energy production and modulation.
Biacore International AB, of Uppsala, Sweden, said the U.S. Court of Appeals for the Federal Circuit affirmed the judgment that was appealed in April, which granted a permanent injunction preventing Thermo BioAnalysis Corp., of Helsinki, Finland, from infringing Biacore’s patent. The court awarded damages in favor of Biacore to be calculated based upon a royalty rate of 40 percent of the price of each IAsys biosensor sold by Thermo since July 1995, plus interest. Biacore expects to receive approximately $1.7 million in damages from Thermo.
Biogen Inc., of Cambridge, Mass., and the Massachusetts Institute of Technology’s Biological Engineering Division established a fellowship program designed to train scientists for careers in the biotechnology industry, with special emphasis in the area of toxicology. Each year, two MIT doctoral candidates will be selected as Biogen Fellows, and will participate in an internship at Biogen. Biogen will contribute $50,000 annually for the fellowships, which will last two to three years.
British Biotech plc, of Oxford, UK, received FDA approval to test the novel thrombolytic agent BB-10153 in heart attack patients. The Phase II trial will be conducted by the U.S.-based Thrombolysis in Myocardial Infarction Study Group in suitable heart attack patients, initially at two U.S. hospitals. The study is designed to test the ability of BB-10153, given at doses between 1 mg/kg and 5 mg/kg, to dissolve clots and restore blood flow in the coronary arteries of heart attack patients and to determine the safety of the treatment, especially with respect to bleeding. BB-10153 will be administered within six hours after clinical symptoms appear.
Cellegy Pharmaceuticals Inc., of South San Francisco, began a Phase II/III trial with Tostrelle (testosterone gel) for the treatment of sexual dysfunction in menopausal women. The trial has a planned enrollment of about 120 subjects. Prior trials demonstrated that bioavailable testosterone levels, similar to those in young women, could be achieved in women on various forms of hormone replacement therapy, without significant adverse events.
Celltech Group plc, of Slough, UK, and BioReliance Corp., of Rockville, Md., entered a multiyear manufacturing agreement in which BioReliance will manufacture and supply clinical-grade antibody fragment-based drugs to Celltech. The contract provides for BioReliance to support three product candidates in 2002, plus a minimum of two additional candidates in earlier stages of development during 2003. BioReliance will provide technology transfer, scale-up, GMP manufacturing and quality control testing services at its wholly owned subsidiary, BioReliance Manufacturing GmbH in Heidelberg, Germany.
Celltech Pharmaceuticals Inc., of Rochester, N.Y., received an approvable letter from the FDA for its supplemental new drug application for Metadate CD extended-release capsules, 20 mg, to include sprinkling in its labeling. Metadate is a once-daily buiphasic methylphenidate formulation indicated for the treatment of ADHD symptoms in patients 6 years of age and older.
Corixa Corp., of Seattle, and GlaxoSmithKline plc, of London, said Corixa notified the FDA that it intends to amend its biologics license application for Bexxar, an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin’s lymphoma. The company also said it formally requested a meeting with the FDA to discuss the complete review letter and potential next steps regarding the application. A meeting is expected to occur within 45 days. (See BioWorld Today, March 14, 2002.)
Cortex Pharmaceuticals Inc., of Irvine, Calif., reported it was notified that the Cortex-funded project “Ampakine modulation of brain neurotrophin expression: a novel therapeutic strategy,” was recommended for extended funding under the University of California BioSTAR project. Cortex President and CEO Vincent Simmon said he expects the extension to provide roughly $193,000 for two years. Research has demonstrated that Ampakine compounds can increase the production of neurotrophin brain-derived neurotrophic factor and nerve growth factor in areas of the brain involved in memory and cognition, relevant in Alzheimer’s disease.
Cypress Bioscience Inc., of San Diego, received stockholder approval to sell up to about 6.9 shares of common stock and warrants to purchase up to about 3.4 shares of common stock, for a total of up to $17 million, to institutional and other accredited investors. When the financing closes later this week, Cypress will have about 13.2 million shares of common stock outstanding. The financing was announced in February. (See BioWorld Today, Feb. 22, 2002.)
CytoGenix Inc., of Houston, received a Small Business Technology Transfer Research Phase I grant from the National Institutes of Health, of Bethesda, Md., to test the company’s single-stranded DNA expression systems in a transgenic mouse model. The grant will support research at CytoGenix and in the laboratory of a collaborator at Yale University to develop a mouse model producing triplex-forming oligonucleotides using ssDNA expression systems.
Cytovax Biotechnologies Inc., of Edmonton, Alberta, entered an agreement for a private placement with a syndicate of agents co-led by Dlouhy Merchant Group Inc. and First Associates Investments Inc., and including Sprott Securities Inc. As part of an overall C$10 million (US$6.3 million) private placement of up to about 3.3 million shares at $3 per share, the agents have undertaken to market, on a best-efforts basis, up to about 2.7 shares for total gross proceeds of up to $8 million. The company also agreed to grant up to 186,667 agents’ compensation warrants exercisable for up to two years from closing at $3 per common share.
DepoMed Inc., of Menlo Park, Calif., filed and served a complaint against Bristol-Myers Squibb Co., of New York, in the U.S. District Court for the Northern District of California for infringement of DepoMed’s U.S. Patent No. 6,340,475, issued Jan. 22. The patent, titled “Extending the Duration of Drug Release Within the Stomach During the Fed Mode,” covers DepoMed’s technology for the controlled delivery of a range of drugs from a gastric retained polymer matrix tablet to maximize therapeutic benefits. The complaint alleges infringement by Bristol-Myers Squibb’s once-a-day Glucophage XR tablet, as well as other matters set forth in the complaint.
Digital Gene Technologies Inc., of La Jolla, Calif., entered a collaboration with the Howard Hughes Medical Institute and the Salk Institute for Biological Sciences to apply DGT’s patented TOGA gene expression profiling technology in an investigation of retinoid receptor signaling. The TOGA-based analyses will include studies on retinoid receptor-deficient mice to understand the role of vitamin A in the synaptic changes that occur in the brain during learning and memory, among other things.
F. Hoffmann-La Roche Ltd., of Basel, Switzerland, spun out biotech firm BioXell, of Milan, Italy. MPM Capital LP, of Boston, invested more than $10 million in the company. Hoffman-La Roche, Index Ventures and Life Sciences Partners also financed BioXell. BioXell is led by CEO Francesco Sinigaglia, previously scientific director of Roche Milano Ricerche, a Roche research center in Milan with a focus on chronic inflammatory diseases and autoimmunity. BioXell will focus on therapeutics to treat and/or prevent immune disorders and other diseases.
Genaissance Pharmaceuticals Inc., of New Haven, Conn., said an initial analysis of the Strength I identified a number of statistically significant associations that link specific genetic markers to changes in LDL cholesterol, HDL cholesterol and triglycerides in patients taking cholesterol medications known as statins. Clinical associations were found with genetic markers from several families of genes in different biochemical pathways. The Strength I study, initiated in April 2001, evaluated two doses of simfvastatin, atorvastatin and pravastatin in more than 500 patients. The findings included the analysis of 100 genes Genaissance identified as having a potential role in predicting patient response to statin therapy.
Gilead Sciences Inc., of Foster City, Calif., submitted a marketing authorization application to the European Medicines Evaluation Agency for adefovir dipivoxil 10 mg. Gilead is seeking an indication for the treatment of patients with chronic hepatitis B, including treatment-na ve and treatment-experienced patients. The application is supported by data from Phase III studies in hepatitis B “e” antigen-positive patients, “e” antigen-negative patients and chronic hepatitis B patients with lamivudine-resistant HBV. Gilead filed a new drug application with the FDA last week. (See BioWorld Today, March 25, 2002.)
Hemosol Inc., of Toronto, received clearance from the FDA to begin a Phase II trial of its flagship product, Hemolink, as a treatment for chemotherapy-induced anemia. The single-blind, dose-comparison study will evaluate the safety and tolerability of a short course of Hemolink in 50 patients with lung or ovarian cancer who are being treated with erythropoietin for chemotherapy-induced anemia. The multicenter study will be led by investigators at Duke University and is expected to begin enrolling patients in June.
ID Biomedical Corp., of Vancouver, British Columbia, received a $2.5 million milestone payment from Takara Biomedical Group, a wholly owned subsidiary of Takara Shuzo Co. Ltd., of Tokyo. The payment was earned after Takara successfully developed a nucleic acid test incorporating ID’s Cycling Probe technology. ID’s lead vaccine products, FluINsure and StreptAvax, are in clinical development.
IDEC Pharmaceuticals Corp., of San Diego, said Zevalin (ibritumomab tiuxetan) is commercially available nationwide. IDEC, which on Feb. 19 received FDA approval to market Zevalin, will begin fulfilling orders Thursday. Zevalin, the first radioimmunotherapy to receive FDA approval, is indicated for the treatment of relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin’s lymphoma (NHL), including patients with Rituxan (Rituximab) refractory follicular NHL. (See BioWorld Today, Feb. 21, 2002.)
InforMax Inc., of Bethesda, Md., licensed the GenoMax enterprise informatics system to serve the analysis and data management needs of researchers at Johns Hopkins University School of Medicine in Baltimore. Researchers at the school’s microarray core facility will use the GenoMax solution for molecular biological research.
NeuroMed Technologies Inc., of Vancouver, British Columbia, closed a second tranche financing of C$8.6 million (US$5.4 million), having successfully met all required milestones. Including this most recent tranche, total funds raised since inception exceed C$25 million. NeuroMed will use this additional capital to advance its development programs in pain and accelerate other products in the pipeline. Major investors in the round included GrowthWorks Capital, MDS Capital, RBC Capital Partners, Trian Equities, Business Development Bank of Canada, Pictet & Cie, Kinetic Capital, as well as private individual investors.
Oncolytics Biotech Inc., of Calgary, Alberta, reported the publication of a research paper titled “Reovirus Oncolysis of Human Breast Cancer,” in Human Gene Therapy. The paper examined the use of the reovirus as a treatment for breast cancer in animal models. Oncolytics is developing a formulation of the human reovirus Reolysin as a potential therapeutic against Ras-activated cancers. The study examined two animal models of breast cancer to demonstrate the effectiveness of the reovirus in causing tumor regression.
ViroLogic Inc., of South San Francisco, closed a transaction to sell newly designated shares of 6 percent convertible preferred stock to several large investors in a private placement resulting in gross proceeds of $10 million. ViroLogic plans to use the funds to support and enhance ongoing commercial activities, accelerate research and development of new products, and for general administrative expenses, capital expenditures and working capital. ViroLogic develops and markets drug resistance assays that allow physicians to measure the level of clinically significant HIV drug resistance.