WASHINGTON -- Sen. Howard Metzenbaum, author of legislation to limit revenues for orphan drugs, has come under increasing industry allegations that the lawmaker is using distorted statistics to support his bill. The Ohio Democrat has used revenue and expense data to support his contention that pharmaceutical and biotechnology companies are reaping exorbitant profits on drugs that have been awarded orphan status to treat rare diseases. Several companies, however, contend that Metzenbaum's
Glycomed Inc. has signed an agreement with the University of Washington giving Glycomed an option to an exclusive license for a drug delivery system to treat diseases of the heart and blood vessels, the company said Tuesday. The system uses a polymer impregnated with a drug to prevent grafted arteries from reclosing following coronary artery bypass surgery. The degradable polymer is placed outside the rejoined blood vessels during surgery for localized delivery of the drug over time. The
Genetics Institute Inc. and American Home Products Corp. said Tuesday that they have formed a collaboration to discover and develop new small molecule drugs. GI (NASDAQ:GENIZ) of Cambridge, Mass., will receive funding over the next several years, and the companies will share marketing rights for any resulting products. Further terms weren't disclosed. AHP owns 60 percent of GI. In the first phase, the companies will focus on blocking cellular adhesion proteins with small molecules. The
WASHINGTON -- At a contentious Senate hearing on Tuesday, FDA Commissioner David Kessler expressed opposition to proposed amendments to the Orphan Drug Act that would withdraw orphan status from drugs that exceed $200 million in sales. "A sales cap provision is both bad policy and unadministerable," Kessler told the Senate Committee on Labor and Human Resources. "I don't think we know enough about the market forces to be certain that whatever adjustments we make will not have a negative effect
The Liposome Co. on Tuesday said it has started an expanded Phase II trial of TLC G-65, a liposomal form of the antibiotic gentamicin, in AIDS patients with Mycobacterium avium- intracellulare. MAI is an opportunistic infection that affects about 30 percent to 50 percent of AIDS patients. MAI infections reside within macrophages, which normally engulf and kill pathogens. Most conventional antibiotics can't penetrate macrophages in sufficient concentrations to kill MAI. But liposomes are
Xoma Corp. on Tuesday was issued a composition of matter and methods of use patent for reagents that link monoclonal antibodies and cell-killing toxins. U.S. Patent No. 5,093,475 covers Substituted 2-Iminothiolanes (X2IT) reagents that are used in the Berkeley, Calif., company's first immunoconjugate product, CD5 Plus. The patent also covers other proteins that could be linked to MAbs using this family of linkers, said Patrick Scannon, president. Scannon said he knew of no other companies
Xoma Corp. responded bluntly on Monday to a prominent market analyst's negative assessment of its E5 treatment for gram-negative sepsis, which has been waiting for a final FDA review since September. Investors pushed down Xoma shares $2 to $22.50 after Oppenheimer & Co. analyst Jeffrey Casdin reported that his review of mortality data for the drug led him to conclude that "there is no hope for any approval of E5." In response, Xoma President Pat Scannon called Casdin's approach "scientifically
Xoma Corp. and Ribi ImmunoChem Research Inc. on Monday presented data on two competing approaches to treating gram- negative sepsis. Xoma's bactericidal/permeability increasing protein (BPI) kills most gram-negative bacteria and inhibits the release of tumor necrosis factor and other cytokines in whole blood, according to data presented in Colorado on Monday at the Keystone Symposium on Recognition of Endotoxin in Biologic Systems. Pat Scannon, Xoma president, said BPI could work
Vical Inc. has raised $9.5 million in an oversubscribed round of venture financing, the gene therapy company said Monday. The round was led by Venrock Associates, which, along with U.S. Venture Partners, Grace Horn Ventures and Sorrento Associates, is making its first investment in Vical. Previous investors participating in the round were Hillman Ventures, Morgenthaler Ventures, Sanderling Venture Partners, Security Pacific Capital and Sutter Hill Ventures. The money will be used to develop
Mycogen Corp. stock gained $1.50 on Monday after the company announced that its scientists have discovered diverse strains of the Bacillus thuringiensis bacterium that expand the range of pests that can be treated by Bt-based products. Leo Kim, executive vice president of research and chief technical officer, said the discoveries offer the prospect of Bt products controlling a number of pests that plague animals and humans, including the common adult house fly, flatworms and protozoa. The
California Biotechnology Inc. said Monday that it has changed its name to Scios Inc. Effective immediately, the Mountain View, Calif., company's stock will trade on NASDAQ under the symbol "SCIO." The company's old symbol was "CBIO." Scios is developing products to treat cardiopulmonary disease and metabolic disorders and for tissue repair. (c) 1997 American Health Consultants. All rights reserved.
Syntro Corp., which is developing genetically engineered vaccines for the animal health market, on Monday said it has filed for a secondary offering of 3 million shares of common stock. Last month, Syntro (NASDAQ:SYNT), Hoechst-Roussel Agri-Vet Co. and Hoechst Veterinar GmbH said they signed a letter of intent to collaborate on the development of cattle and equine vaccines based on Syntro's viral vector technology. The Hoechst companies will fund the multiyear development program, which is
Organogenesis Inc. has presented data showing that two of its human skin equivalents perform similarly to human skin in toxicology testing. Testskin LSE incorporates both the dermal and epidermal layers of skin, including the stratum corneum of the epidermal layer. The stratum corneum reproduces the barrier function of skin, preventing pathogens from entering the system. According to the Cambridge, Mass., company (AMEX:ORG), Testskin performs like human skin in evaluating the penetration and
Canguard Health Technologies on Monday said it has filed a motion to dismiss a patent infringement suit filed in Canadian Federal Court by Deprenyl Research Ltd. and Chinoin Pharmaceutical and Chemical Works Co. Ltd. The dispute involves Canguard's development of a generic based on l-deprenyl, called Parkinyl. Chinoin, a Hungarian company, licensed Canadian rights to its production patent on l-deprenyl to Deprenyl Research. Deprenyl calls its version Eldepryl. The drug is a treatment for late
Researchers have published findings documenting biochemical changes in the brains of Alzheimer's victims that may prove to be particular to the disease. The scientists, reporting in the March 1 issue of the Proceedings of the National Academy of Sciences, presented evidence for abnormal metabolism of the lipids in nerve cell membranes in Alzheimer's cases. In brains from people who died with the disease, the cell membrane ingredients choline and ethanolamine were depleted 30 percent to 50
GenDerm Corp., which develops and markets products to control pain and treat skin and allergic disorders, has filed for an initial public offering of 2.6 million shares of common stock with a proposed price of $12 to $14 a share. Of the shares being offered, 900,000 would be sold by selling stockholders, including the founder, Dr. Joel Bernstein, and certain venture investors. GenDerm's core technologies are focused on neuropeptide- active compounds and histamine antagonists. Neuropeptide
CellPro Inc. was to announce today that its Ceprate SC Stem Cell Concentration System will be used in a gene therapy trial designed to cure adenosine deaminase deficiency. The trial, approved last month by the Recombinant DNA Advisory Committee of the National Institutes of Health, will purify stem cells from the peripheral blood of patients using the CellPro system. Ceprate concentrates stem cells using monoclonal antibodies that bind to stem cells bearing the CD34 marker molecule. Those stem
British Bio-technology Group plc said Friday that it has completed Phase I testing of its AIDS immunotherapeutic in healthy, HIV-negative male volunteers. Multinational Phase II trials of the drug, which is designed to delay the onset and/or slow the progression of AIDS, will begin later this year, said Anne McBride, a spokeswoman for the Oxford-based company. Phase I subjects showed no significant adverse reactions, and the vaccination produced the predicted cellular and antibody immune
Biotechnology companies tracked by BioWorld raised $309.1 million through public offerings in February, bringing to $995.8 million the total raised in the public markets this year. Univax Biologics Inc. and EcoScience Corp. raised $76.6 million in initial public offerings in February, bringing the total IPO funds raised by 11 companies this year to $481.8 million. Seven companies have filed for offerings that would be worth about $231 million if completed. Six companies raised $232.5 million
Scientists at Bio-Rad Pty. Ltd. in Victoria, Australia, and collaborators showed that a porphyrin compound can sensitize otherwise incurable brain cancer to radiation and chemotherapy. Brain tumors called high-grade gliomas kill 10,000 Americans annually. In lab mice, the Australians and colleagues at the University of California, San Francisco, combined two sensitizing treatments, light sensitization by porphyrin (PDT) and neutron capture by boron. The boronated protoporphyrin selectively
WASHINGTON -- Sen. Howard Metzenbaum, author of legislation to limit revenues for orphan drugs, has come under increasing industry allegations that the lawmaker is using distorted statistics to support his bill. The Ohio Democrat has used revenue and expense data to support his contention that pharmaceutical and biotechnology companies are reaping exorbitant profits on drugs that have been awarded orphan status to treat rare diseases. Several companies, however, contend that Metzenbaum's