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Non-U.S. Clinical Trials, Regulatory Submissions, Recommendations And Approvals: June 1998
Company** Product Description Indication Type Action/Date CANCER Cel-Sci Corp. Multikine Natural mixture of Treatment of head and Results of small trial human cytokines, neck cancer prior to conducted in Israel pre- including interleukin-2 surgery or radiation sented at 1998 Interna- therapy tional Head And Neck Cancer Congress in Hong Kong (6/8) Cytogen Corp. Quadramet Samarium-153 EDTMP Relief of bone pain in Approved for marketing (intravenous radio- patients withBioWorld Insight | Monday, July 13, 1998 -
Other News To Note
* Antisoma plc, of London, received approval from the U.K. Medicines Control Agency to start pivotal Phase III trials of Theragyn for the treatment of ovarian cancer. This follows approvals from the FDA and elsewhere in Europe for the same Phase III program. Theragyn, licensed from the London-based Imperial Cancer Research Fund (ICRF), is a murine monoclonal antibody directed against polymorphic epithelial mucin, a protein produced in an abnormal form by more than 90 percent of ovarian cancersBioWorld International | Wednesday, July 8, 1998 -
Oxford Molecular Invests £2.5M In MicroGenics For Antibiotics
LONDON - Drug discovery services company Oxford Molecular Group (OMG) plc has agreed to invest up to £2.5 million in MicroGenics Ltd., an Oxford University spin-off, with the aim of eventually turning it into a subsidiary. MicroGenics was formed by Jeff Errington, professor of microbiology at Oxford, in the U.K., to develop screening systems for novel antibiotics based on his research into bacterial cell division and spore formation. OMG is paying £500,000 for 19.99 percent of the ordinaryBioWorld International | Wednesday, July 8, 1998 -
UK Aims To Keep Lead In Cloning With PPL Grant
LONDON - The U.K. government awarded a grant of £600,000 to PPL Therapeutics plc and the Roslin Institute for research to protect the U.K.'s lead in cloning by nuclear transfer. The grant, to be matched by £600,000 of funding from PPL itself, will be spent on a three-year project to improve the precision of genetic modification using nuclear transfer. The aim is to develop techniques for removing, as well as replacing, genes, and thus to produce proteins it was not previously possible toBioWorld International | Wednesday, July 8, 1998 -
Circadian Spin-Off To Target Anti-Obesity Drug In US Trials
SYDNEY - A biotechnology group in Melbourne plans to raise about A$10 million by floating off in a separate one-project company an anti-fat treatment that has shown considerable promise in trials with mice. The money raised in the float of the new company, to be called Metabolic Pharmaceuticals Ltd., will be used for human trials in the U.S. of the treatment - a reengineered fragment of the human growth hormone that can be taken orally. To remain under the control of its parent, MelbourneBioWorld International | Wednesday, July 8, 1998 -
European Union Takes Action On Policy Failings By States
BRUSSELS, Belgium - The European Commission (EC) has decided to take Portugal to the European Union's highest tribunal, the European Court of Justice, for failure to respect rules on biotechnology. Portugal has not properly implemented the 1990 policies on contained use and deliberate release of genetically modified organisms, EC officials said, and despite repeated warnings has not changed its national laws sufficiently. The laws should have been in force by October 1991. The EC also issuedBioWorld International | Wednesday, July 8, 1998 -
German Firm Opens Virtual Lab With A Click Of The Mouse
HAMBURG, Germany - Interactiva Biotechnologie GmbH, a genomics company that bills itself as a virtual laboratory, has entered an exclusive agreement with Swedish research centers covering the analysis of single nucleotide polymorphisms. Interactiva, of Ulm, Germany, was founded three years ago by Flavio Ortigao, a bioinformatics specialist at the University of Ulm. Ortigao had the idea of creating a company based on the vast opportunities of the Internet and supplies of custom-made bio-organicBioWorld International | Wednesday, July 8, 1998 -
Euro Officials Face Challenge To Improve Biotech Image
BRUSSELS, Belgium - Martin Bangemann, European commissioner for industry, said the European Commission (EC) and other political authorities face a major challenge in convincing the public that "opportunities of biotechnology are immense - both in economic and in social terms." Bangemann made his comments at a pharmaceutical industry conference in Berlin late last month, locating his remarks firmly in the context of the current widespread negative sentiment toward biotechnology in Europe. "WeBioWorld International | Wednesday, July 8, 1998 -
Parasite Study Shows Importance Of Controlling Immune Response
Perhaps the only aspects of tropical diseases that might be considered entertaining are the names they collect. Mal morado, volvulosis, Robles' disease and river blindness, for instance, all describe a single parasitic infection formally known as onchocerciasis. The cause of this nonfatal, chronic infection is the round worm Onchocerca volvulus. Spread by blood-sucking female blackflies, river blindness can produce symptoms that range from rashes to skin atrophy to blindness. EighteenBioWorld International | Wednesday, July 8, 1998 -
TAB Raises US$3M To Regroup; Ends Sepsis Trial To Cut Costs
LONDON - Therapeutic Antibodies Inc. (TAB) raised US$3.2 million in interim funding as the first stage of re-financing the company and said it will cut costs by ending a clinical trial of its CytoTAb antitumor necrosis factor (TNF) antibody in the treatment of sepsis. The US$3.2 million, raised in a private placement, will fund TAB to the end of 1998. It involved short-term interest-bearing notes with warrants. The notes carry a 15 percent coupon and are repayable in 180 days. The five-yearBioWorld International | Wednesday, July 8, 1998 -
Venture Capital, PIPE/Reg. S And Corporate Investments In Biotechnology Companies: June 1998
I. FINANCING OF PRIVATE BIOTECHNOLOGY COMPANIES: $75.6M Company Location Date Amt. (M) Investors Argonex Inc. Charlottesville, Va. 6/2 $7.5 Argonex raised $7.5M from lead investor (1st round) Healthcare Ventures LLC and other (un- named) venture capital investors Atugen Biotech- Berlin 6/16 $7 Atugen Biotechnology was formed by nology GmbH Ribozyme Pharmaceuticals Inc.; invest- (start-up funding) ments of $50M over the next 5 years will come from the private sector, led byBioWorld Insight | Monday, July 6, 1998 -
Other Financings Of Public Biotechnology Companies: June 1998
Company Type Of Number Of Amount Investors; Placement Agents; (Symbol) Financing Shares, Units Raised (M) Details (Date) Or Warrants (M) Access Private 0.95S $2.9 Access raised $2.9M in the 1st closing of a Pharmaceuticals placement private placement of $7.8M total; the com- Inc. (OTC Bulletin pany sold 0.95M shares of unregistered Board:AXCS) common stock at $3.053 each to undis- closed investors; the company will register the stock for resale; Sunrise Securities CorpBioWorld Insight | Monday, July 6, 1998 -
Public Financing Of Biotechnology: June 1998
I. COMMENCED TRADING IN JUNE Company Date Date Shares/ Price Gross Net Shares Fully Lead (Symbol) Filed Comm. Units Per Share/ (M) (M) Out Dil. Underwriters (M) Unit (M) (M) INITIAL OFFERINGS Chemunex SA* 2/27 6/15 4.5S $2.48 $11.2 $9.9E 30.1 31.3 NI; MR Ophidian 8/8; 5/7 1.75U $6.10 $10.7 $8.9 9.0 10.0 DC; SCT Pharmaceuticals 3/4 Inc. (OPHD)** TOTAL: $11.2M NOTES: * Chemunex SA came public on Le Nouveau Marche. There were 6.35M shares sold in the offering; ofBioWorld Insight | Monday, July 6, 1998 -
Biotech Stocks Flounder In Wake Of Uncertainty
By Jennifer Van Brunt Editor Today's initial public offerings (IPO) market for new companies is downright terrible. That sentiment seems to be the general consensus among market watchers, analysts and chief executives across broad sectors of the economy. Biotechnology companies have certainly been affected, but so have firms that specialize in other businesses — from building products and insulation to theme parks. The general underlying factor that seems to tie all these sectors togetherBioWorld Insight | Monday, July 6, 1998 -
Money Raised By Biotech In 1998: January June
TYPE OF JAN. FEB. MARCH APRIL MAY JUNE TOTAL FINANCING $(M) $(M) $(M) $(M) $(M) $(M) $(M) Public offering 65.1 86.6 267.8 183.3 45.7 31.9 680.4 Private rounds 72.9 112.3 103.0 109.1 85.9 75.6 558.8 PIPE/Reg. S 0 0 0 0 0 19.0 19.0 Public/other 170.7 839.1 323.5 170.0 443.9 133.0 2,080.2 Milestone payments 23.2 24.8 11.5 12.0 39.2 52.8 163.5 and equity investments from corporate partners TOTAL ($M): $331.9 $1,062.8 $705.8 $474.4 $614.7 $312.3 $3,501.9BioWorld Insight | Monday, July 6, 1998 -
Israeli PM Backs Participation In European R&D Program
JERUSALEM - Israeli Prime Minister Benjamin Netanyahu authorized state participation in the European Union's fifth Research and Technological Development framework during a meeting with an interministerial committee including representatives from the ministries of Industry and Trade, Finance and Science and the Council of Higher Education. All members of the committee endorsed participation except Finance Minister Yaakov Neeman, who said the $160 million participation fee for the four-yearBioWorld International | Wednesday, July 1, 1998 -
Cerep Licenses Gene Profile System From Xenometrix
PARIS - Drug discovery company Cerep SA has concluded a licensing agreement with Xenometrix Inc., a U.S.-based firm that has developed proprietary technologies in the areas of gene expression profiling and gene toxicity. The deal gives Cerep, of Paris, a nonexclusive license to Boulder, Colo.-based Xenometrix's gene profiling system as well as limited rights to sublicense it. The system, which is already patent-protected in Europe and for which a patent is due to be granted shortly in the UBioWorld International | Wednesday, July 1, 1998 -
Enzacta Takes Different Approach To Cancer Chemotherapies
LONDON - The U.K.'s latest start-up, Enzacta Ltd., raised £2 million for the discovery and development of targeted chemotherapies for cancer. The company said it has an integrated technology base, or "toolkit," for targeting agents, enzymes, clearance agents and drugs. Its lead program is expected to enter clinical trials later this year. Jon Dickens, Enzacta CEO, told BioWorld International, "Our focus is on the discovery and development of therapies which have site-specific effects. WeBioWorld International | Wednesday, July 1, 1998 -
Peptech Shares Fluctuate With Veterinary Drug Approval
SYDNEY - The share price of Peptech Ltd. has had a wild ride since Peptech became the first Australian biotechnology company to receive U.S. clearance for a drug. Peptech Managing Director Michael Cohen said the Sydney-based company won FDA approval for its Ovuplant implant, used primarily to increase fertility rates in horses. Peptech's stock price already had moved up from around A$0.22 a share to nearly A$0.40 in early June, as the market assessed the company's chances of having the horseBioWorld International | Wednesday, July 1, 1998 -
Public Urges French Officials To Monitor Transgenic Plants
PARIS - The French government has been urged by a panel of 14 members of the general public to be extremely vigilant about the cultivation of transgenic plants and their use in the production of food. The panel, scientifically selected to be representative of the French population, spent two days late last month listening to the views of researchers, farmers, seed companies, environmentalists, consumer associations and lawyers. The 15-page report it produced was not a unanimous document, andBioWorld International | Wednesday, July 1, 1998
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