Miles Inc. announced late Thursday that FDA has given its pharmaceutical division marketing clearance for its recombinant Factor VIII product Kogenate (anti-hemophilic factor recombinant) to treat hemophilia A, a chronic bleeding disorder. Genentech Inc. (NYSE:GNE) of South San Francisco, Calif., originally cloned the Factor VIII gene and licensed it to Miles in 1984 as part of a collaborative agreement. "Miles acquired the rights to use the gene and develop a manufacturing process to produce
CAMBRIDGE, Mass. -- Public outrage last year over the humongous pay, perks, bonuses and stock options showered on top company executives in corporate America stirred the Security and Exchange Commission last October to issue tougher "Revised Executive Compensation Proxy Rules" for 1993. At a two-hour breakfast roundtable here on Wednesday for some 190 regional biotechnology executives and financiers, Larry S. Schumer, human resource advisory manager of Coopers & Lybrand's Boston office, took
Medicis Pharmaceutical Corp. of New York has acquired a 75 percent interest in privately held Genetic MediSyn Corp., an antisense company. Genetic MediSyn of Columbia, Md., was formed in July 1991 as a wholly owned subsidiary of 6-year-old, privately held Synthecell Corp., also of Columbia. Medicis, which pursues skin condition treatments, exchanged 1.27 million shares of its class A common stock in the acquisition. Medicis has 50 million shares outstanding, a spokeswoman told BioWorld, and
Vestar Inc. announced Wednesday that it has filed a new drug application (NDA) with the FDA for DaunoXome, its liposomal formulation of the anti-cancer drug daunorubicin, for treating AIDS-related Kaposi's sarcoma (KS). This is the first NDA filed in the U.S. on a liposomal drug, the San Dimas, Calif., company (NASDAQ:VSTR) said. It may also be one of the few NDAs filed in the U.S. on the basis of Phase II clinical trial data. "We believe the data will be acceptable to FDA and see no reason to
WASHINGTON, D.C. -- For the second time this week, a congressional committee has slammed the pharmaceutical industry for the high cost of drugs. But George Rathmann, president and chief executive officer of Icos Corp. of Seattle, representing the biotechnology trade associations, said biotechnology companies should be treated differently from the pharmaceutical industry. "Unlike established pharmaceutical companies," Rathmann stated in prepared testimony, "most ... do not currently have
AT Biochem, a division of Applied Technology Genetics Corp. (ATGC), agreed to supply Roche Molecular Systems Inc. of Branchburg, N.J., with custom components for Roche's DNA- based human identity and parental testing kits, the Malvern, Pa., company announced. Roche Molecular Systems' marketing partner, Perkin-Elmer of Norwalk, Conn., will sell the material under the GeneAmp trademark for polymerase chain reaction (PCR)-based products. ATGC has optimized the GeneAmp gels and loading buffers
Alpha 1 Biomedicals Inc. (NASDAQ:ALBM) has revised certain terms of its Class B warrants. The changes are a reduction in the exercise price to $10 per share, a reduction to $19 of the exercise price, and a reduction to $25 of the redemption trigger price of the Class C warrants that are issuable upon the exercise of the Class B warrants and an extension to March 9, 1993, of the redemption date for the Class B warrants. For each Class B warrant exercised, holders will receive one share of common
BioCryst Pharmaceuticals Inc., a privately held biopharmaceutical company that uses structure-based drug design, has been granted its fifth U.S. composition-of-matter patent for compounds that inhibit modification of nucleotides. The compounds target purine nucleoside phosphorylase, which attaches phosphates to RNA. This enzyme's involvement in regulation of T cell function has been demonstrated in preclinical studies and is being tested in clinical trials. BioCryst received its four earlier
Belmac Corp. (ASE:BLM) announced last week that it has completed Phase I trials in the U.S. on its transdermal anti- hemorrhoidal patch, Alphanon. Alphanon is a formulation of camphor that acts as an anti- inflammatory and vasorelaxant. The patch has been co- developed by Belmac of Tampa, Fla., and Alza Corp. of Palo Alto, Calif. Recognizing that Phase II and III trials "will require substantial sums and several years of testing," the company is considering several options as to how to conduct
NeoRx Corp. announced Tuesday that its "pretargeting" method for radioactive monoclonal antibody-based cancer therapy works in mice. The Seattle company (NASDAQ:NERX) reported these findings to its shareholders at last week's annual gathering. Not only did the pretargeting approach cause complete tumor regressions, but it also apparently cured chemotherapy-resistant human lung cancer tumors in mice. Monoclonal antibodies tagged with tissue-damaging radioactivity or toxin molecules are
Spectral Diagnostics Inc. signed an exclusive option agreement with The Johns Hopkins University School of Medicine of Baltimore for exclusive licensing of cDNA clones coding for human cardiac Troponin I. The agreement was made in preparation for the Toronto company's second generation of cardiac prognosis tests. During the option period, Spectral Diagnostics (NASDAQ:DIAGF) will evaluate the suitability of the clones for use in manufacturing of scale-up quanities of recombinant Troponin I
Biotechnology stocks took a breather on Tuesday after the feeding frenzy following Synergen Inc.'s (NASDAQ:SYGN) announcement of disappointing preliminary Phase III results for its lead compound, Antril. The indexes and some of the hardest-hit stocks even staged modest comebacks. The AMEX Biotechnology Stock Index gained 1.16 points to 114.57 and the Chicago Board Options Exchange Biotechnology Index picked up 2.01 points, closing at 104.38. Synergen gained $1.25 a share, to $14.75; Amgen Inc
Vestar Inc. (NASDAQ:VSTR) announced that its licensee, Fujisawa USA Inc., has filed an investigational new drug (IND) application with FDA for AmBisome, Vestar's liposomal formulation of the anti-fungal drug amphotericin B, for patients with systemic fungal infections. "This IND filing represents the first step in the clinical evaluation of this product in the U.S.," said Roger Crossley, president and chief executive officer of the San Dimas, Calif., company. AmBisome already has marketing
HemaCare Corp. announced that it has acquired an exclusive license in the U.S. to passive hyperimmune therapy (PHT), a method for treating AIDS, from Medicorp. Inc. of Montreal. Under the terms of the agreement, which replaces and expands the original 1989 license between the two companies, HemaCare (NASDAQ:HEMA) of Los Angeles has paid Medicorp a cash fee and has granted warrants to purchase HemaCare common stock. HemaCare's license was originally only for California. The patented technology
DeKalb Genetics Corp. is releasing 25 new corn, soybean and sorghum products for sale to farmers in the company's most extensive product introduction in recent years. The new products include 13 new corn hybrids, the product line that accounts for most of DeKalb's (NASDAQ:SEEDB) seed sales and the largest portion of its $34 million seed research budget. However, Thomas Rauman, chief financial officer, told BioWorld, these varieties are not from the division's genetic transformation program
Bio-Technology General Corp. announced Tuesday it has received $2.4 million resulting from the exercise of warrants held by David Blech, a major investor and a director of the New York-based company. These warrants were issued to Blech in February 1990 in connection with a private placement of stock and warrants that generated $3.1 million for the company at that time. During 1992, the company received an additional $2.4 million from the exercise of warrants held by other investors and issued
Betting on a totally mouse-free, "primatized" human monoclonal antibody, SmithKline Beecham (SKB) has upped its ante in Idec Pharmaceutical Corp. by another $20 million. This latest wager raises the pharmaceutical giant's stake in Idec's potential therapy for autoimmune diseases to more than $50 million. Under the amended agreement, Idec (NASDAQ:IDPH) of La Jolla, Calif., announced Monday that besides the additional milestone payments, SKB will pay the company royalties on sales of the anti-CD4
Epitope Inc. (ASE:EPT) announced at its shareholders' meeting Monday several new marketing and manufacturing pacts for its OraSure oral specimen collection device. The Portland, Ore., company has established a joint venture in the People's Republic of China (PRC), has agreed to supply OraSure to a U.S. insurance testing laboratory and has appointed a company to manufacture OraSure in the United Kingdom. Epitope and China National Biological Products Corp., a marketing arm of the Chinese
The biotechnology stock indexes followed Synergen Inc.'s (NASDAQ:SYGN) precipitous decline on Monday with large drops of their own. The AMEX Biotechnology Stock Index fell 15.72 points to 113.41, while the Chicago Board Option Exchange Biotechnology Index lost 17.05 points, closing at 102.37. The two indexes have lost 23 percent and 27 percent, respectively, since Feb. 1. Among individual issues, Chiron Corp. (CHIR) lost $5.13 a share to close at 45.63; Idexx Laboratories Corp. (IDXX) fell $4
WASHINGTON, D.C. -- Rep. Ron Wyden, D-Ore., announced Monday that he will introduce next week legislation to require companies seeking partnerships with the government to compete for subsidies on the basis of the price they intend to charge for resulting drug therapies. The bill would also direct the National Institutes of Health to co-license multiple companies as research and development partners to foster competition. Wyden announced the legislation at a meeting of Rep. Henry Waxman's, D
Miles Inc. announced late Thursday that FDA has given its pharmaceutical division marketing clearance for its recombinant Factor VIII product Kogenate (anti-hemophilic factor recombinant) to treat hemophilia A, a chronic bleeding disorder. Genentech Inc. (NYSE:GNE) of South San Francisco, Calif., originally cloned the Factor VIII gene and licensed it to Miles in 1984 as part of a collaborative agreement. "Miles acquired the rights to use the gene and develop a manufacturing process to produce