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British Biotech Drops One Marimastat Study
LONDON — British Biotech plc announced last week that it will axe one of the 11 pivotal studies of its oral anticancer therapy, marimastat, prompting a fall of 5 pence in the share price, to 30 pence. The company, based in Oxford, dropped the European Phase III monotherapy trial in ovarian cancer following a review of the trials program, but stressed that the decision was not related to any problems of safety or efficacy. A trial of marimastat in combination with chemotherapy in ovarian cancerBioWorld International | Wednesday, December 23, 1998 -
Australian Food Industry Assails Labeling Decision
SYDNEY — The Australian food industry has attacked a decision, taken jointly by the governments of both Australia and New Zealand, to require consumer warnings on all package labels for food containing genetically altered material. At present, a warning is required if the product is significantly different in some way, perhaps by taste or smell, from a similar product that is produced by conventional means. But the new decision, announced in mid-December — after a joint meeting of healthBioWorld International | Wednesday, December 23, 1998 -
Mologen, Virbac Enter Agreement For Vaccines
HAMBURG, Germany — Only a half-year after its founding, Mologen Holding AG, of Berlin, reported several partnerships with pharmaceutical companies. Virbac, a French veterinary vaccine producer, will obtain two exclusive licenses for the use of Mologen's proprietary MIDGE DNA vaccine technology. In addition, Mologen has agreed on research collaborations with German and international companies to establish its proprietary MIDGE-technology in clinical studies targeting infectious diseases andBioWorld International | Wednesday, December 23, 1998 -
Oxford BioMedica, RPR In £11 million Deal
LONDON — Oxford BioMedica has become the first U.K. gene therapy company to agree to a significant commercial deal, with the signing of an exclusive license with Rhone-Poulenc Rorer (RPR) Gencell, worth up to £11 million (US$18.4 million), if all milestones are reached. The license covers the use of the Hypoxia Response Element (HRE), a control mechanism designed to turn genes off or on in response to oxygen levels in the body, in RPR's cardiovascular gene therapy products. Under the terms ofBioWorld International | Wednesday, December 23, 1998 -
Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: November 1998
Company** Product Description Indication Type Action (Date) CANCER Aphton Corp. and Gastrim- Vaccine for treating Pancreatic cancer Initiated Phase III trials in Pasteur Merieux mune cancers driven by hor- Canada (11/19) Connaught Canada mone gastrin; consists (unit of Rhone-Poulenc of synthetic peptides SA; NYSE: RP; France) bound to carrier Diatide Inc. and NeoTect Small molecule synthetic In vivo imaging agent for Nycomed submitted marketBioWorld Insight | Monday, December 21, 1998 -
FDA Submissions, Approvals And Other Actions: November 1998
Company** Product Description Indication Type Action (Date) CANCER AltaRex Corp. OvaRex Anti-idiotype induction Late-stage ovarian cancer Filed IND for 2nd Phase IIb (Canada) therapy-based vaccine; in patients with elevated trial (11/4) consists of modified serum CA125 levels who murine monoclonal anti- have completed 1st-line body that binds to CA125 treatments cancer antigen OvaRex Anti-idiotype induction Recurrent ovarian cancerBioWorld Insight | Monday, December 21, 1998 -
New Therapies For Hepatitis Reach The Market
By Jennifer Van Brunt Editor Regulatory agencies around the globe are setting records for the rate at which they are beginning to approve new drugs for treating two of the world's most insidious and prevalent diseases infections caused by hepatitis viruses B and C. Taken together, or individually, these two viruses pose a major threat. They have already infected hundreds of millions of individuals worldwide. An approved therapy for hepatitis B and C viruses has been available for someBioWorld Insight | Monday, December 21, 1998 -
GPC, Byk Gulden Enter Deal For Genomic Targets
ByLudger Wess BioWorld International Correspondent HAMBURG, Germany - Genome Pharmaceuticals Corp. AG (GPC), of Martinsried, Germany, announced a collaboration with Altana subsidiary Byk Gulden, of Konstanz, Germany, to identify new genomic targets for the control of Helicobacter and Chlamydia infections. The collaboration is the biggest alliance between a German pharmaceutical and a German biotechnology company so far. GPC is already one of Germany's record-breaking bio tech companiesBioWorld International | Wednesday, December 16, 1998 -
Vanguard Quits Dialysis Drug, Pairs With 3M For Hepatitis C
ByNuala Moran BioWorld International Correspondent LONDON - Shares in Vanguard Medica Ltd. fell by 20 percent last week to #1.58 (US$2.67) after the company said it was stopping development of VML 252 for the treatment of elevated blood phosphate levels in dialysis patients. The fall came despite the simultaneous announcement of a collaboration deal with 3M Pharmaceu ticals to evaluate a potential treatment for hepatitis C, under which Vanguard stands to earn up to US$25 million in milestonesBioWorld International | Wednesday, December 16, 1998 -
Teva Likely To Appeal Court's Fluoxetine Ruling
ByRachelle H.B. Fishman BioWorld International Correspondent TEL AVIV, Israel - Teva Pharmaceutical Industries Ltd. said it will probably appeal the Tel Aviv District Court decision made in favor of Eli Lilly and Co., of Indianapolis, regarding Teva's alleged patent infringement of fluoxetine (the active ingredient in Prozac). The appeal must be filed within 45 days of the court ruling. The court's decision relates to Teva's initiation of small-scale production in the early 1990s, which itBioWorld International | Wednesday, December 16, 1998 -
BioChem, SmithKline Sign Deal For Nasal Flu Vaccine
ByJames Etheridge BioWorld International Correspondent PARIS - BioChem Pharma, of Laval, Quebec, has signed a worldwide development, production and marketing agreement with SmithKline Beecham plc, of London, for an influenza vaccine using the nasal delivery system of the French company Biovector Therapeutics. Under the agreement, which confirms a letter of intent concluded between the two companies in June, SmithKline Beecham Biologicals, of Rixensart, Belgium, will manufacture the vaccineBioWorld International | Wednesday, December 16, 1998 -
Start-Up Wilex Targeting Tumor-Metastasis Enzymes
ByLudger Wess BioWorld International Correspondent HAMBURG, Germany - With a new strategy, Wilex Biotechnologie GmbH, of Munich, Germany, is attempting to develop therapeutics to block tumor cell invasion and metastasis in patients afflicted with breast, ovarian and gastrointestinal cancers. Clinical trials are expected to start in 1999. Wilex is a spin-off of a clinical research group of the Women's Clinic at Technische Universitdt M|nchen. The group, led by Henner Graeff, was established inBioWorld International | Wednesday, December 16, 1998 -
Vaxis Aims For Share Of Impotence Market
ByPeter Winter BioWorld International Correspondent KINGSTON, Ontario - Male erectile dysfunction (MED) is one of the largest growing markets for pharmaceuticals. Current estimates indicate that 66 million men worldwide suffer from some degree of MED, and by 2002 the market is expected to be worth approximately US$5 billion. However, the sexual-dysfunction market is still at a comparatively early stage, and estimates indicate that less than 5 percent of men with erectile dysfunction areBioWorld International | Wednesday, December 16, 1998 -
Amrad Wins A$24.6M Grant For R&D From Government
ByMark Lawson BioWorld International Correspondent SYDNEY, Australia - Melbourne-based Amrad Ltd. has emerged as a major winner from a change in government policy for supporting research and development by gaining a A$24.6 million (US$15.2 million) grant. The Australian government announced on Friday that Amrad will be given the money over a five-year period, and the news pushed the company's share price up A$0.12 to A$1.52. Also, earlier last week, Amrad received a query from the AustralianBioWorld International | Wednesday, December 16, 1998 -
OGS, Quintiles Team Up In Proteomics Agreement
ByNuala Moran BioWorld International Correspondent LONDON - Oxford GlycoSciences plc (OGS) has agreed on a deal in which Quintiles Transnational Corp., a clinical services company, will test the use of OGS' proteomics technology in the preclinical drug development process and in clinical research. "The intention is to apply proteomics as a parallel and additional way of screening compounds in preclinical development," said Michael Kranda, CEO of Oxford Glyco Sciences. With technologies suchBioWorld International | Wednesday, December 16, 1998 -
Celltech Says Data Positive In Pivotal Leukemia Study
ByNuala Moran BioWorld International Correspondent LONDON - Celltech plc said it expects to file for approval of its lead product, CMA 676, in mid-1999, following further promising results in a pivotal U.S. study involving first-relapse patients suffering from acute myeloid leukemia. The company also said it is on track to file for approval of CDP 571, a humanized anti-TNF alpha antibody, for the treatment of Crohn's disease in 2000. If the two registrations take place, Celltech will move intoBioWorld International | Wednesday, December 16, 1998 -
New Cervical Smear Test Proves Superior In Studies
BySharon Kingman BioWorld International Correspondent LONDON - The efficiency and accuracy of cervical screening programs could be greatly boosted by a new cervical smear test developed by scientists in the U.K. Preliminary studies suggest the new test can detect some abnormal smears that are missed by conventional screening methods. The new method may also hasten the day when smears can be read by machines. The test, which uses antibodies to proteins found only in dividing cells, is beingBioWorld International | Wednesday, December 16, 1998 -
Elan 'Replenishes Coffers' With US$750M Placement
By Cormac Sheridan BioWorld International Correspondent DUBLIN, Ireland - Elan Corp. has raised gross proceeds of US$750 million in a zero coupon exchangeable subordinated notes offering to U.S. institutions. Merrill Lynch & Co. Inc., of New York, underwrote the placement, which closed Monday. The financing will be sufficient to take Dublin-based Elan to its US$1 billion revenue target, said company chairman and CEO Donal Geaney. Elan, which reported US$171 million in revenue for the thirdBioWorld International | Wednesday, December 16, 1998 -
Cardiovascular Gene Therapy Enters The Clinic
By Jennifer Van Brunt Editor The earliest clinical trial results of a radical new method of treating cardiovascular disease have not only demonstrated that the technique is safe -- a critical parameter -- but they also indicate that it may be efficacious. For the first time, the theoretical promise of using gene therapy to treat serious heart problems -- including peripheral vascular disease and coronary artery disease -- has gained a practical footing. In a report to cardiologists attendingBioWorld Insight | Monday, December 14, 1998 -
Clinical Trial Update: November 1998
Company** Product Description Indication Status (Date) CANCER Aronex Atragen Liposomal formulation of Hormone-refractory Initiated Phase II trial (11/30) Pharmaceuticals all-trans retinoic acid; prostate cancer Inc. induces tumor cells to differentiate into mature normal cells (injection) Biomira Inc. Theratope Synthetic, carbohydrate- Metastatic breast cancer Announced results of bridging (Canada) and vaccine based vaccine (mimic ofBioWorld Insight | Monday, December 14, 1998
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