David R. Burt, President and CEO of Ergo Science Corporation Becomes Part-time President and CEO of NAHC, Inc.Business/Technology Editors BOSTON--(BUSINESS WIRE)--June 2, 2000 Ergo Latin, therefore; hence; because. ergo (air-go) conj. Latin for therefore, often used in legal writings. Its most famous use was in "Cogito, ergo sum:" "I think, therefore I am" principle by French philosopher Rene Descartes (1596-1650). Science Corporation (Nasdaq:ERGO) today announced that David R. Burt, President and Chief Executive Officer has taken on the additional responsibility of part-time President and Chief Executive Officer of NAHC NAHC National Association for Home Care and Hospice NAHC Native American Heritage Commission NAHC National Association of Housing Cooperatives NAHC North American Hunting Club NAHC National AIDS Housing Coalition NAHC National Advisory Health Council , Inc. (OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. : NAHC), formerly NovaCare, Inc. Mr. Burt will split his time equally between Ergo Science and NAHC. Ergo Science Background Ergo Science Corporation is a biopharmaceutical company developing a novel treatment for metabolic disorders. In 1997, the Company filed with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ERGOSET(R) tablets to treat Type 2 diabetes type 2 diabetes n. See diabetes mellitus. , and the FDA accepted the NDA for filing. On May 14, 1998, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA found that there was not sufficient evidence to recommend for approval the Company's NDA for ERGOSET(R) tablets for Type 2 diabetes. On November 20, 1998, the Company received a letter from the Division of Metabolic and Endocrine Drug Products at the FDA stating that its NDA for ERGOSET(R) tablets for the treatment of Type 2 diabetes is not approvable. The Company appealed the letter within the Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. and provided additional safety data. On October 21, 1999, the Company announced that it received a letter from the Office of Drug Evaluation II, Center for Drug Evaluation and Research at the FDA, stating that its NDA for ERGOSET(R) tablets to treat Type 2 diabetes is approvable. However, before ERGOSET(R) tablets can be approved by FDA for marketing, it will be necessary for Ergo Science to address FDA concerns relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the clinical safety of ERGOSET(R) tablets and other issues, including biopharmaceutics, pharmacology and toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. . In its letter, FDA stated that ERGOSET(R) tablets are effective in the treatment of Type 2 diabetes as adjunctive therapy adjunctive therapy Medtalk A therapeutic maneuver(s) with an ancillary role in treating a disease by ↓ M&M, but not part of the immediate therapy required to stabilize the Pt. Cf Adjuvant therapy. with sulfonylureas. The letter also stated, however, that data submitted by the Company, including epidemiology data recently developed by the Company, did not adequately overcome FDA's concerns about the possible increased risk of a serious adverse event with the use of ERGOSET(R) tablets in Type 2 diabetes patients. To address this outstanding safety concern, the FDA has recommended that a "large, simple" placebo-controlled study be undertaken to evaluate whether treatment with ERGOSET(R) tablets is associated with an increase in the specified serious adverse event. In the letter, FDA does not provide specifics about the size and scope of such a clinical trial. The resolution of this safety concern must be sufficient to support approval in light of a treatment effect which FDA characterized as small. After the Company finalizes with FDA the requirements for the safety study, the Company will determine whether to proceed with its ERGOSET(R) program. NAHC Background NAHC, Inc., formerly NovaCare, Inc. is currently working under a Restructuring Plan approved by stockholders on September 21, 1999, where the company may reinvest re·in·vest tr.v. re·in·vest·ed, re·in·vest·ing, re·in·vests To invest (capital or earnings) again, especially to invest (income from securities or funds) in additional shares. the net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). from its recently completed divestitures in a new business or businesses, subject to stockholder approval. If the company is unable, or chooses not to reinvest in a new business, the Plan authorizes the Board to liquidate To pay and settle the amount of a debt; to convert assets to cash; to aggregate the assets of an insolvent enterprise and calculate its liabilities in order to settle with the debtors and the creditors and apportion the remaining assets, if any, among the stockholders or owners of the the company and distribute any remaining excess cash to stockholders on or after December 31, 2000, unless the Board chooses to liquidate at an earlier date. This discussion contains forward-looking statements. Forward-looking statements reflect Ergo Science's current views with respect to future events. Actual results may vary materially and adversely from those anticipated, believed, assumed, estimated or otherwise indicated. Important factors that could affect actual results include, without limitation, (1) an "approvable" letter does not mean that a product will be approved, particularly where, as here, it is necessary to satisfy FDA (prior to approval) that there is not an increased risk of a serious adverse event, (2) the clinical trial to assess safety recommended by FDA may involve a relatively high number of patients and may require substantial resources and take years to complete, (3) Until the size and scope of the safety trial are determined by FDA, an assessment of the advisability of any such trial cannot be made, (4) Ergo Science may not have sufficient resources for such a safety trial or decide that undertaking such a trial is not in the Company's best interests. (5) Ergo Science may not be able to attract a partner to assist in undertaking such a safety trial, (6) data obtained from clinical trials are subject to varying interpretations, and there can be no assurance that the FDA (or an FDA panel of experts) will agree with Ergo Science's assessment of current or future clinical trial results, (7) uncertainty related to the scientific development of a new medical therapy, (8) competition in the anti-diabetic market is intense; other products have been recently approved for these indications and other companies are developing competing products, (9) the need for additional funding, (10) there can be no assurance that Ergo Science will be able to establish corporate alliances to market ERGOSET(R) tablets, if approved for commercial marketing, and assist with development of product candidates, (11) there can be no assurance that Ergo Science's formulation of bromocriptine mesylate bromocriptine mesylate (brō´mōkrip´tēn mes´ilāt´), n brand name: Parlodel; drug class: dopamine receptor agonist, ovulation stimulant; action: , if approved for commercial marketing, will be successful in the marketplace, or that Ergo Science will receive any profits from its sale, and (12) the uncertainty relating to patent protection in the pharmaceutical and biotechnology industries. Further information and additional important factors are set forth in reports and other filings of Ergo Science with the Securities and Exchange Commission, including, without limitation, the 1999 Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. , generally under the section entitled "Risk Factors." Ergo Science does not undertake to update any forward-looking statement that may be made from time to time by or on behalf of Ergo Science. |
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