¿ Abgenix Inc., of Fremont, Calif., submitted an investigational new drug application to the FDA to initiate a Phase IIa trial of ABX-IL8 in patients with chronic obstructive pulmonary disease. ABX-IL8 is the company¿s lead fully human monoclonal antibody generated with XenoMouse technology that blocks the activity of interleukin-8, a chemokine involved in inflammatory diseases. The trial will be a double-blind, placebo-controlled safety and efficacy study involving 150 patients at approximately 15 sites in the U.S. Results of the trial are expected in the first quarter of 2003.
¿ Alliance Pharmaceutical Corp., of San Diego, said it won a favorable final judgment from the U.S. Patent and Trademark Office¿s board of patent appeals and interferences regarding claims in U.S. Patent No. 5,558,854, owned by Nycomed Imaging AS, of London. The judgment determined claims made in the Nycomed patent with respect to microbubbles that contain perfluorohexane gas are invalid and therefore unpatentable.
¿ Amgen Inc., of Thousand Oaks, Calif., submitted a biologics license application supplement to the FDA for Aranesp (darbepoetin alfa), for the treatment of cancer patients suffering from anemia associated with certain types of chemotherapy. On Tuesday, the FDA approved Aranesp for the treatment of anemia associated with chronic renal failure, including patients both on and off dialysis. At that time the company said the sNDA was imminent. (See BioWorld Today, Oct. 19, 2001.)
¿ Atrix Laboratories Inc., of Fort Collins, Colo., presented Phase III data on its Leuprogel Three-Month Depot prostate cancer treatment at the Eighth Annual CaP CURE Scientific Retreat. The company said it achieved testosterone levels below the generally accepted level of 50 ng/dl and a majority of patients met the standard of 20 ng/dl. Atrix is in late-stage development for one-, three- and four-month sustained release of leuprolide acetate using its Atrigel depot drug delivery system. Separately, the company said it raised $110,000 for the American Disaster Relief Fund to assist families of the victims from the Sept. 11 terrorist attacks. The contribution consists of donations from the company and individual employees.
¿ Biotechnology Industry Organization (BIO), of Washington, named Iowa Gov. Tom Vilsack as Governor of the Year for his support of the industry¿s economic growth and agricultural biotechnology research. In May 2000 Vilsack helped create the Governors¿ Biotechnology Partnership, a bipartisan coalition of governors serving as a clearinghouse for biotechnology information. Starting with only 13 members, the group now enjoys participation from more than half of the nation¿s governors. The success of the coalition is due in part to Vilsack¿s dedication to the biotechnology industry, BIO said.
¿ Chiron Corp., of Emeryville, Calif., on Aug. 17 filed a Form S-3 registration statement with the SEC for the resale of liquid yield option notes (LYONs) issued by the company on June 12 and the common stock into which the LYONs are convertible. On Sept. 10, the SEC declared the amended Form S-3 effective.
¿ Collateral Therapeutics Inc., of San Diego, said its board adopted a shareholders rights plan in which preferred stock purchase rights will be distributed as a dividend at the rate of one right for each share of common stock held at the close of business on Oct. 1. The rights would be exercisable on the 10th day following a person or group acquiring 20 percent or more of the company¿s common stock.
¿ Corvas International Inc., of San Diego, and Dyax Corp., of Cambridge, Mass., formed a collaboration to develop novel cancer therapeutics focused on serine protease inhibitors. The companies will assume joint development of any product candidates that may be identified and will share commercialization rights and profits from any marketed products. Dyax will use its phage display technology to identify small proteins, peptides and antibodies that bind to two serine protease targets isolated and characterized by Corvas. Corvas will apply its expertise in target validation and preclinical biology.
¿ Echelon Research Laboratories Inc., of Salt Lake City, said the it was awarded a Small Business Innovation Research Phase I grant from the National Institutes of Health to develop methods for screening small molecules as potential anticancer drugs. Colin Ferguson is the principal investigator for the project, and other scientists and technicians at Echelon and at the University of Utah will support him in this effort.
¿ Eli Lilly and Co., of Indianapolis, formed Lilly BioVentures, a venture capital group. The group plans to invest $75 million in early stage biotech companies. Specifically, it will make initial investments of up to $5 million in companies developing platform technologies aimed at improving and accelerating drug discovery and development and emerging or novel technologies in the biotechnology or biopharmaceutical fields.
¿ Genetronics Biomedical Corp., of San Diego, appointed Avtar Dhillon president and CEO. Dhillon replaces Grant Denison, who remains on the company¿s board and had served as president and CEO on an interim basis. Dhillon most recently was vice president of MDS Capital Corp., of Toronto, a venture capital firm focused exclusively on health care and life sciences companies. Genetronics Biomedical specializes in targeted intracellular delivery of large-molecule therapeutics.
¿ Human Genome Sciences Inc., of Rockville, Md., completed patient enrollment in two Phase II trials evaluating mirostipen (myeloid progenitor inhibitory factor ¿ MPIF) as a treatment for chemotherapy-induced neutropenia and thrombocytopenia. The double-blind, placebo-controlled, dose-escalation Phase IIa trials are being conducted at several sites in the United States. Results from the approximately 100 patients are expected in spring 2002.
¿ Genta Inc., of Berkeley Heights, N.J., said it received notice from the FDA that Genasense, its lead anticancer compound, has been granted fast-track designation for multiple myeloma. Genasense previously had received such designation for treatment of malignant melanoma. The company has randomized Phase III clinical trials ongoing in both diseases at multiple sites in the U.S., Canada and Europe. Separately, the company said it received notices of approvability from the European Agency for the Evaluation of Medicinal Products for the designation of Genasense as an orphan drug for the treatment of both multiple myeloma and chronic lymphocytic leukemia.
¿ Hybrigen Inc., of Dallas, and Bionomics Ltd., of Adelaide, Australia, signed a letter of intent to negotiate the terms of a collaboration to discover drug targets in breast cancer. The program will be based on genes identified and patented by Bionomics, focused initially on the TSG18 and BNO1 genes. TSG18 is being studied as a breast cancer tumor suppressor gene; BNO1 has been shown to induce programmed cell death in breast cancer cells. The companies would co-own the drug targets developed in this program.
¿ Ilex Oncology Inc., of San Antonio, said it appointed Jeffrey Buchalter president. Buchalter has more than 20 years of pharmaceutical experience and has held key positions at a number of multinational pharmaceutical companies, including American Home Products Corp. and Schering-Plough Corp. He will assume the role of president from Ilex co-founder Richard Love, who continues as CEO.
¿ Inex Pharmaceuticals Corp., of Vancouver, British Columbia, said promising preclinical data on its early stage OligoVax therapeutic vaccine platform were published in the September 2001 issue of The Journal of Pharmacology and Experimental Therapeutics. Peter Cullis, Inex¿s senior vice president of research, said that short sequences of DNA called oligonucleotides are known to stimulate the immune system and may have the potential to treat a number of diseases.
¿ Infigen Inc., of DeForest, Wis., said a Wisconsin court approved the company¿s restraining order against Pharming Holding NV, of Leiden, the Netherlands, and its subsidiaries. The injunction constrains Pharming from selling or transferring transgenic cattle created by Infigen during their multiyear agreement. The injunction followed an announcement by Pharming that the firm had entered receivership. Infigen and Pharming formed a strategic partnership in early 1998. The collaboration focused on the use of Infigen¿s and Pharming¿s technologies in the cattle biopharmaceutical field, aimed primarily at the production of human therapeutics from the milk of transgenic cattle.
¿ InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said it expects revenues for the third quarter of 2001 to be in the range of $900,000 to $1.2 million, which includes $500,000 of licensing fees. The revenue shortfall relative to recent analyst expectations is due to lower than expected IMS prescription trends. The company expects a net loss per share of 14 cents to 16 cents for the third quarter. InKine¿s stock (NASDAQ:INKP) fell 81 cents Thursday, or 41 percent, to close at $1.16.
¿ Lexicon Genetics Inc., of The Woodlands, Texas, and Deltagen Inc., of Redwood City, Calif., reported the settlement of Lexicon¿s patent infringement litigation against Deltagen. Deltagen will obtain a commercial license under the patents covering Lexicon¿s gene targeting technologies. Lexicon will receive a subscription to Deltagen¿s DeltaBase database of mammalian genes and their in vivo functions, and all of the claims and counterclaims in the litigation will be dismissed with prejudice. Lexicon will have the opportunity to receive payments for Deltagen¿s fee-for-service generation of knockouts. Deltagen will have the opportunity to receive milestone and royalty payments for potential therapeutic and diagnostic products developed from drug targets in DeltaBase. Neither company will pay subscription or license fees.
¿ Myriad Genetics Inc., of Salt Lake City, released preclinical data on its lead anti-HIV compound, MPI-49839. MPI-49839, which is designed to inhibit HIV replication and the virus¿ invasion of normal cell processes, was shown to have strong anti-HIV activity without harming human cell survival. The company said it plans to file an investigational new drug application with the FDA this fiscal year.
¿ Orion Genomics LLC, of St. Louis; NC+ Hybrids, of Lincoln, Neb.; and SolviGen LLC, of St. Louis, said their consortium received a five-year, $7.5 million matching grant from the U.S. Department of Energy, Office of Industrial Technologies, Industries of the Future, to improve sorghum for the production of a portfolio of bio-based products including ethanol, organic acids and other basic carbon molecules for industrial uses.
¿ Pharmacopeia Inc., of Princeton, N.J., said its board authorized a stock repurchase program under which Pharmacopeia may purchase $16 million of its stock in the open market. Share purchases may be made at prevailing prices beginning immediately and the purchases will be funded from available working capital, the company said. Repurchased shares may be used for ongoing stock issuances.
¿ Rosetta Inpharmatics Inc., of Kirkland, Wash., said it created a separate business unit called Rosetta Biosoftware, which will produce and market bioinformatics software solutions for life sciences research. It will continue to develop new versions of Rosetta Inpharmatics¿ flagship software product, the Rosetta Revolver gene expression data analysis system.
¿ Scios Inc., of Sunnyvale, Calif., said it will repurchase up to $10 million of its common stock. The repurchases will be made through open-market transactions at the discretion of management and as market conditions warrant. As of June 30, Scios had $164 million in cash and marketable securities.
¿ Sequenom Inc., of San Diego, said it completed its merger with Gemini Genomics plc, of Cambridge, UK, in a stock-for-stock exchange initially valued at $238 million. The combined company retains the name Sequenom. In aggregate, Sequenom issued approximately 12.9 million shares. Sequenom also assumed all outstanding options and warrants of Gemini, which as a result have become options and warrants to purchase an aggregate of 1.5 million shares of Sequenom. (See BioWorld Today, May 30, 2001.)
¿ SIGA Technologies Inc., of New York, received $1,159,500 from a private placement of 409,636 shares of common stock and warrants to purchase 307,226 shares of common stock to a group of investors, including members of the company¿s board. The common stock was placed at $2.75 to $3.07 per share. The warrants are exercisable at $3.552 per share, which represents a 20 percent premium at the time the transaction was completed.
¿ Structural GenomiX Inc., of San Diego, signed a multimillion-dollar agreement with Compaq Computer Corp., of Houston, to develop SGX¿s structural informatics systems. SGX will purchase a complete Compaq technology solution. The technology and services provided by Compaq will assist SGX and its partners in target identification and validation, lead selection and screening, and optimization of compounds for binding and selectivity.
¿ The Institute for Systems Biology, of Seattle, received a $828,500 grant from the M.J. Murdock Charitable Trust for acquiring equipment for its protein research. The grant will enable the purchase of robotics workstations for preparing and processing protein samples and mass spectrometers for measuring them. The institute is a nonprofit research entity devoted to systems biology.
¿ Tranzyme Inc., of Birmingham, Ala., and Active Pass Pharmaceuticals Inc., of Vancouver, British Columbia, entered a collaboration in the areas of gene expression and drug discovery. This alliance will use Tranzyme¿s TexT (Tranz Expression Technology) in support of the ABC transporter chemogenomic program at Active Pass. Active Pass will provide multiple sets of ABC transporter gene sequences, a family of molecular pumps found in the membranes of all cells. Tranzyme will deliver these genes into mammalian cells and express and purify the proteins using its gene expression technology. Financial terms were not disclosed.
¿ Tripos Inc., of St. Louis, signed a multiyear, multimillion-dollar agreement with AstraZeneca plc, of London, to provide the Sybyl suite of in silico drug discovery technologies to the pharmaceutical company¿s life scientists worldwide. Tripos will provide its discovery software technologies for lead identification and optimization. The relationship will enable searching of databases to locate possible drug candidates, perform virtual testing of candidates and guide scientists seeking to improve the effectiveness of the best candidates.
¿ VaxGen Inc., of Brisbane, Calif., appointed Lance Gordon CEO. Gordon has more than 20 years in the vaccine industry. He was CEO and president of OraVax Inc. from 1990 to 1999 and also invented a vaccine for childhood meningitis.
¿ ViroLogic Inc., of South San Francisco, entered an agreement with Triangle Pharmaceuticals Inc., of Durham, N.C., to assist in clinical evaluation of new anti-HIV agents being developed by Triangle. Triangle will use ViroLogic¿s PhenoSense HIV phenotypic drug resistance assay to evaluate the effectiveness of its investigational nucleoside reverse transcriptase inhibitors.