SciClone Pharmaceuticals announced Tuesday that it has begun a multicenter Phase III trial in Mexico with 100 patients to evaluate thymosin alpha 1 in the treatment of hepatitis B. Phillip Vander Werf, president and chief operating officer of the San Mateo, Calif., company, told BioWorld that SciClone has also begun enrolling patients for a planned 150-patient Phase III trial in Taiwan. "We're expecting to be on the market in 1994 in Mexico and Taiwan," said Vander Werf. Thymosin has shown
Procyte Corp. (NASDAQ:PRCY) of Kirkland, Wash., announced Tuesday that it has filed with the Securities and Exchange Commission for an offering of 2 million shares of common stock with an overallotment option of 300,000 shares. The offering will be co-managed by William Blair & Co. and Dain Bosworth Inc. This is the company's third round of public financing. Procyte went public in November 1989, raising $9.3 million. It raised another $7.1 million from a secondary offering completed last May
Genelabs Technologies Inc. announced Monday that it has signed a non-exclusive worldwide licensing agreement with Abbott Laboratories (NYSE:ABT) under which Abbott will develop and commercialize products for diagnosing and screening hepatitis X virus (HXV). The hepatitis X virus, as yet uncharacterized, is believed to cause those transfusion-transmitted cases of hepatitis not caused by hepatitis B or C virus. To date, five viruses that cause hepatitis, dubbed A-E, have been isolated and
MedImmune Inc. announced Monday that it has filed a product license application (PLA) with FDA for Respivir, its polyclonal antibody product for prevention of respiratory syncytial virus (RSV) disease in children. The Gaithersburg, Md., company (NASDAQ:MEDI) completed an efficacy trial for the product last April. The trial, begun in 1989 and conducted at five centers in the U.S., is the basis of the PLA. No trial results have been made public. The first presentation of data is scheduled for May
The U.S. Patent and Trademark Office (PTO) last week awarded three patents for transgenic mice -- numbers 5,175,383, 5,175,384 and 5,175,385 -- to Harvard University, GenPharm International and Ohio University, in that order. That makes the Harvard mouse the second-ever patented animal. The first, patented in 1988, was the "Harvard oncomouse," which Philip Leder, chairman of genetics at Harvard Medical School and a senior investigator of the Howard Hughes Medical Institute, engineered to grow
Gensia Pharmaceuticals Inc. announced Monday that it submitted on schedule a new drug application (NDA) to FDA on Dec. 30 for use of its purine-based drug, Arasine, in patients undergoing coronary artery bypass graft (CABG) surgery. The San Diego company also announced that it will file for regulatory approval of Arasine in the European Community in mid-January and for Canadian approval by March. The NDA for Arasine is based on data from three clinical trials -- one Phase II trial and two
Univax Biologics Inc. announced Monday that it has filed with the Securities and Exchange Commission (SEC) for a secondary offering of 2.5 million shares of common stock, with an overallottment option of 375,000 shares. Managing underwriters for the offering are Prudential Securities Inc. and Montgomery Securities. Univax completed an initial public offering last February, grossing $48 million with 4 million shares at $12 per share. After the IPO, the company (NASDAQ:UNVX) had 11,074,103 shares
Repligen Corp. announced Monday that Swiss pharmaceutical giant Sandoz Ltd. has bought out Repligen's interest in their joint venture and purchased $4 million of common stock in the Cambridge, Mass., biotech company (NASDAQ:RGEN). This stock purchase -- of 320,000 shares at $12.50 per share -- was made by Sandoz's subsidiary, Sandoz Pharma Ltd., in conjunction with the acquisition of the joint venture. Sandoz's U.S. subsidiary, Sandoz. Corp., bought Repligen's 40 percent interest in the
Published Dec. 9 and16 (EPO) Dec. 10 (WO) Dec. 16 (GB) Bayer AG Plant-parasite EPO 516 958 Leverkusen, Germany resistance CaffeoylGcoAG3-OGmethyltransferase gene isolated from a plant; its use for engineering increased resistance to parasites by crop plants. Baylor College of Charcot-Marie- WO 92/21694 Medicine, Houston Tooth diagnosis A peripheral myelin protein, PMP-22; DNA sequences encoding it; probe, primers for detecting CMT-type neuropathies. Behringwerke AG Tetravalent EPO 517 024
The FDA issued several approvals in the last week of 1992. On Thursday, the agency approved marketing of Tilade, nedocromil sodium, a new class of anti-inflammatory drug, for the preventive management of asthma. Developed by Fisons Pharmaceuticals of Ipswich, England, the drug is a non-steroid, inhaled, anti-inflammatory agent. On Wednesday, SmithKline Beecham announced FDA approval to market Paxil, paroxetine hydrochloride, a selective serotonin re-uptake inhibitor, for the treatment of
Genetic Therapy Inc. (NASDAQ:GTII) of Gaithersburg, Md., said it filed with the U.S. Securities and Exchange Commission (SEC) for a public offering of 2 million common shares. Smith Barney and Montgomery Securities are underwriters for the offering. Proceeds will be used mainly to fund the company's research and development activities. (c) 1997 American Health Consultants. All rights reserved.
Imre Corp. said that FDA has granted the company "restricted approval" of its Prosorba column treatment for immune thrombocytopenic purpura (ITP) patients. The treatment will be available to patients who are "critically in need." The company is still awaiting formal FDA approval of its new manufacturing facility. According to company spokeswoman Lois Yoshida, Imre (NASDAQ:IMRE) of Seattle asked FDA to conduct a manufacturing inspection of its new facility in May, but FDA did not review the
Macronex Inc. said it has received two Phase I small business innovation research (SBIR) grants from the National Institute of Allergy and Infectious Diseases of the National Institute of Health. One grant will be used to conduct preclinical studies of a class of proprietary peptides and proteins that the Research Triangle Park, N.C., company is developing as immunoregulating agents with potential applications in the treatment of inflammatory and autoimmune conditions and graft rejection, said
Cytogen Corp. announced Wednesday that FDA approved the first monoclonal antibody (MAb)-based imaging agent for marketing in the U.S. The product, OncoScint CR/OV, allows physicians to visualize the extent and location of malignancies in patients with known colorectal or ovarian cancer in whom recurrent or metastatic disease is suspected. The agent may provide earlier diagnosis of small tumor deposits in the abdominal cavity in patients with recurrent ovarian cancer, growths that are often
Ten years since the orphan drug legislation was passed, FDA has finally issued official regulations. For companies developing or producing orphan drugs, it will be business as usual. For example, there will remain no profit limit on orphan drugs, nor will licenses be revoked if new indications are approved. One biotech company representative, who requested anonymity, said the regulations governing what constitutes a "same drug" as one already marketed are virtually identical to interim
Orphan drugs share in common only one major characteristic: They are intended to treat conditions or diseases with patient populations no greater than 200,000. Some drugs are granted that status while still in clinical trials. Others don't get the nod until they are approved for marketing. Sometimes it's a race between competing products. Some are monoclonal antibodies, while others are hormones, enzymes or amino acids. Listed below is a sample -- not intended to be comprehensive -- of the
Advanced Tissue Sciences Inc. (NASDAQ:ATIS) of La Jolla, Calif., and Cell Genesys Inc. of Foster City, Calif., announced today that they have signed a collaborative agreement to explore the development of a universal full-thickness skin replacement product. The research agreement involves evaluating ATS's dermal tissue engineering technology in universal epidermal skin cells engineered by Cell Genesys' gene targeting technology. Gene targeting allows precise and permanent activation or
Enzon Inc. announced Wednesday that it has filed a registration statement with the Securities and Exchange Commission for a proposed public offering of 3 million shares of common stock. Enzon also filed for an additional 450,000 shares to cover over- allotments. The offering is being managed by Prudential Securities. The Plainfield, N.J., company (NASDAQ:ENZN) said it will use the proceeds for research and development, selling, general and administrative purposes, and acquisition of plant and
Scios Nova Inc. announced Tuesday that it has begun a multicenter Phase III clinical trial of Auriculin -- atrial natriuretic peptide (ANP) -- for treating acute kidney failure. Auriculin is generally regarded as the Mountain View, Calif., company's lead product. The study will be conducted at 35 centers and will include 500 patients, treated on a one-time basis in a hospital setting. "We are targeting people who have developed acute renal failure in response to a specific insult, usually an
Bristol-Myers Squibb Co. announced Tuesday that it has received final FDA clearance to market its anti-cancer drug Taxol in the U.S. Company officials said the drug will be commercially available within the next two weeks. FDA approved Taxol for the treatment of women with ovarian cancer whose first-line or subsequent chemotherapy has failed. Ovarian cancer is diagnosed in 21,000 women and claims 13,000 lives each year. The drug is to be administered intravenously at a recommended dose of
SciClone Pharmaceuticals announced Tuesday that it has begun a multicenter Phase III trial in Mexico with 100 patients to evaluate thymosin alpha 1 in the treatment of hepatitis B. Phillip Vander Werf, president and chief operating officer of the San Mateo, Calif., company, told BioWorld that SciClone has also begun enrolling patients for a planned 150-patient Phase III trial in Taiwan. "We're expecting to be on the market in 1994 in Mexico and Taiwan," said Vander Werf. Thymosin has shown