The Food and Drug Administration's plans to streamline drug approval could fatten the bottom lines of biotech companies and lessen their dependence on corporate partners. "The reduced time will have significant implications for the way we capitalize these companies," said Richard Pops, president and chief executive officer of Alkermes Inc. of Cambridge, Mass. "One of the reasons we built these significant war chests was to endure the review period. This could change the whole burn rate scenario
Cytogen Corp. on Thursday said it has won market approval in the United Kingdom and the Netherlands for its monoclonal antibody-based cancer imaging agent for colorectal cancer. The company's OncoScint CR103 had received approvals in October for Germany and Luxembourg. OncoScint will be sold in Europe through EuroCetus, Cytogen Corp.'s exclusive marketing partner. The company estimates that 150,000 new cases of colorectal cancer were diagnosed in 1990 in Western Europe, and that countries in
MicroProbe Corp. has signed an agreement with Olympus Optical Co. Ltd. to jointly develop a diagnostic system based on MicroProbe's DNA probe technology. Both companies will contribute proprietary technology toward the development of an automated diagnostic system for the rapid identification of certain disease pathogens. Olympus of Tokyo will provide the bulk of the funding. No equity investment is involved. Others terms were not disclosed. The new diagnostic system will be based on one
American Biogenetic Sciences Inc. said Tuesday that it has received a notice of allowance from the Patent and Trademark Office for a composition of matter patent on its monoclonal antibody 45J. The 45J MAb is used in the company's first commercial product, Cadkit, a manual latex agglutination test that measures levels of fibrinogen in blood plasma. Several studies suggest that fibrinogen level may be superior to cholesterol as a predictor of cardiovascular events such as heart attack and stroke
Following are highlights of company presentations from this week's American Heart Association meeting in Anaheim, Calif. Centocor Inc. (NASDAQ:CNTO) The company presented data showing that its 7E3 anti-platelet monoclonal antibody, called CentoRx, appears to prevent complications seen with therapies for heart attacks. The antibody, which attaches to receptors on the surface of platelets and thereby prevents their aggregation into clots, performed well and with minimal side effects in patients
Schering-Plough and Bristol-Myers Squibb scientists have created a recombinant clot-busting chimera that links the clot- dissolving action of urokinase to a monoclonal antibody that targets the protein meshwork of clots. Limitations posed by existing recombinant clot-busters, such as t-PA, have prompted the use of recombinant technology to generate "hundreds of plasminogen activator mutants, which have produced, at best, only modest improvements in thrombolytic efficacy," the researchers noted
Elan Corp. plc of Ireland is testing a steroid as a possible therapeutic in AIDS. In preliminary clinical trials in San Francisco, the steroid dehydroepiandrosterone (DHEA) is being given to 23 HIV- infected men. The steroid, made by the adrenal gland, has been found at decreased levels in men who progressed to AIDS symptoms. A study reported in this month's issue of the Journal of Infectious Diseases found the statistical link between DHEA and disease progression. It is still unclear whether
A fourth set of human experiments have begun to transfer normal precursors of muscle into patients with Duchenne muscular dystrophy to see whether the transplant will form the protein missing in the genetic disease. A neurologist at Ohio State University has injected his first patient with myoblast cells taken from the boy's healthy brother. The study is being funded by $84,000 awarded by the Muscular Dystrophy Association and will test a total of 12 boys ages 5 to 9. Appearance of dystrophin
WASHINGTON -- The Food and Drug Administration on Wednesday said it will immediately begin to streamline the drug approval process, using reforms developed by the President's Council on Competitiveness. The recommendations, announced jointly on Wednesday by the top government officials from the Council, the Department of Health and Human Services and the FDA, promised a projected 45 percent reduction in approval time by 1994 for therapies against life-threatening diseases, and a 25 percent
Immune Response Corp., whose stock was pummeled after a Food and Drug Administration advisory committee recommended against use of CD4 cell counts as a primary end point in clinical studies of AIDS vaccines, on Wednesday said the recommendation wouldn't slow its pace of clinical development. The stock (NASDAQ:IMNR) lost $15.75 -- 25 percent of its value -- to close at $46 on Wednesday. Shares of other companies developing AIDS vaccines also declined slightly. Speculation that the committee on
Epitope Inc. said Wednesday that the Food and Drug Administration has asked for more information relating to its application for premarket approval of its OraSure oral specimen collection device. The announcement was made after the close of the stock market. Epitope shares (AMEX:EPT) closed down 88 cents at $22.88. The Beaverton, Ore., company in May filed for permission to market OraSure for use in the detection of antibodies to the AIDS virus. A company spokeswoman said the FDA's request
Incstar Corp. on Wednesday said it has completed a North American distribution agreement for certain of Centocor Inc.'s tumor marker immunodiagnostic tests. The agreement grants Incstar (AMEX:ISR) of Stillwater, Minn., semi-exclusive sales and marketing rights to Centocor's CA 125 RIA Serum Tumor Marker kit and other kits receiving regulatory approval, in exchange for cash payments totaling $2.7 million over the next two years. CA 125 is sold in the United States as an ovarian cancer test
CytRx Corp. said Wednesday that 6 million of its 7.5 million class A warrants, which expired on Monday, have been converted. The Norcross, Ga., company also said that the underwriter of its 1986 initial public offering exercised its remaining unit purchase option for 100,000 units, priced at $6 per unit. The units consisted of three shares of common stock and three class A warrants. The class A warrants entitled the holder to purchase for $3.25 one share of common stock and one class B warrant
WASHINGTON -- The following is a summary of the changes that will be instituted by the Food and Drug Administration to speed up drug approvals. The first three reforms, which increase the number of people involved in drug approvals, are intended to reduce the backlog of drug reviews at the agency. External Review Outside experts will be contracted to conduct clinical reviews for drugs where the backlog is greatest -- most likely allergy/pulmonary, analgesics, anti-inflammatory, and anti
Time savings, in months, under planned changes in FDA drug approval process. Source: Council on Competitiveness. Preclinical Testing Current Duration: 18 Accelerated Approval Drugs New Time: 15 Months Saved: 3 All Other Drugs (Non-accelerated) New Time: 15 Months Saved: 3 Major Reasons for Savings: International harmonization, computerized data IND Approval Current Duration: 1 Accelerated Approval Drugs New Time: 1 Months Saved: 0 All Other Drugs (Non-accelerated) New Time: 1 Months
BETHESDA, Md. -- The Vaccines and Related Biological Products advisory committee unanimously recommended Tuesday that the Food and Drug Administration not use CD4 cell counts as a primary end point in clinical studies of AIDS therapeutics. CD4 receptors on T cells are the primary target of HIV 1, and a decrease in the number of T cells with CD4 receptors gives an early indication that a patient may develop AIDS. The committee unanimously recommended that some clinical end point be made primary
Alza Corp. shares slipped $1.13 on Tuesday, closing at $81.13, after the company said it would take $100 million in one-time charges against earnings in the fourth quarter of 1991. The charges relate to Alza's decision, also announced Tuesday, to exercise its option to acquire all 3.2 million shares outstanding of its Bio-Electro Systems Inc. spinoff and to restructure an acquisition from On-Site Therapeutics. Alza also said its board has approved a 2-for-1 split of Alza's class A common stock
Phyton Catalytic Inc. has formed a collaborative research and development partnership with Bristol-Myers Squibb to develop a plant cell tissue culture process for the production of the anti-cancer drug taxol. Terms of the annually renewable contract were not disclosed in Tuesday's announcement. For the most part, said Phyton President Rus Howard, "Bristol-Myers will provide funds and we will provide technology." He added: "They're looking at us for more than just taxol. They're looking at us to
Vertex Pharmaceuticals Inc. said Tuesday it has filed for a 2 million-share public stock offering. Of the shares to be offered, 1.6 million will be sold in the United States and the remaining 400,000 will be offered abroad. In July, Vertex raised $27 million in a 3 million-share initial public offering priced at $9. The company had proposed a $13- to-$15 price range, but reduced the price due to market conditions. Vertex stock (NASDAQ:VRTX) closed at $14.50, down 63 cents. Prior to the
Following are highlights of two company presentations at this week's 21st Annual Meeting of the Society of Neuroscience in New Orleans. Sibia Inc. Company researchers have cloned genes encoding a newly isolated brain-specific form of a voltage-dependent calcium channel. VDCCs regulate the flow of calcium ions into electrically excitable cells, such as nerve cells in the brain and muscle cells in the heart and skeletal muscles. The function of the newly cloned gene is as yet unknown, but "we
The Food and Drug Administration's plans to streamline drug approval could fatten the bottom lines of biotech companies and lessen their dependence on corporate partners. "The reduced time will have significant implications for the way we capitalize these companies," said Richard Pops, president and chief executive officer of Alkermes Inc. of Cambridge, Mass. "One of the reasons we built these significant war chests was to endure the review period. This could change the whole burn rate scenario