Flemington Pharmaceutical Announces Agreement With Altana.FLEMINGTON, N.J.--(BUSINESS WIRE)--February 18, 1998--Flemington Pharmaceutical Corporation ("Flemington" or the "Company")(OTCBB OTCBB See OTC Bulletin Board (OTCBB). :"FLEM") today announced that it has entered into an Agreement with Altana, Inc. of Melville, N.Y. ("Altana"), for the development and marketing of a topical ointment product for the treatment, and immediate relief from the effects, of acute poison ivy poison ivy, poison oak, and poison sumac, woody vines and trailing or erect shrubs of the family Anacardiaceae (sumac family), native to North America. inflammation (the "Product"). Flemington has a patent application pending for the Product. Under the terms of the Agreement, Flemington will conduct a small pilot study, at Flemington's expense, to validate the efficacy of the Product. This pilot study should be completed during the summer of 1998. If Altana is satisfied with the results of the pilot study, Flemington will proceed to conduct clinical trials and file 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 ) with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) seeking approval for the Product. The clinical trials and the filing of the NDA will be carried out by Flemington and will be funded by Altana. Upon authorizing the project to proceed, Altana will begin making milestone payments to Flemington, plus, following FDA approval of the Product, paying a royalty on Altana's sales. Altana is the United States subsidiary of Altana, AG, a world-wide pharmaceutical company headquartered in Germany. Altana specializes in the manufacture and marketing of topical pharmaceutical and over-the-counter products, including its Savage(R) and Fougera(R) brands. Flemington is engaged in the development of novel application drug delivery systems for presently marketed prescription and over-the-counter drugs. The novel delivery systems include lingual lingual /lin·gual/ (ling´gwal) 1. pertaining to or near the tongue. 2. in dental anatomy, facing the tongue or oral cavity. lin·gual adj. 1. sprays and soft gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid. bite capsules. The company believes that these delivery systems offer (i) improved drug safety by reducing the required dosage, therefore, reducing side effects Side effects Effects of a proposed project on other parts of the firm. (ii) improved dosage reliability; (iii) improved patient convenience and compliance; and (iv) enhanced dosage reliability. The company plans to develop such products through collaborate arrangements with major pharmaceutical companies. For further information, contact Robert F. Schaul, Esq., the company's General Counsel, at 908/782-3431. NOTE: Except for historical information contained herein, this document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements involve known and unknown risks and uncertainties that may cause the company's actual results or outcomes to be materially different from those anticipated and discussed herein. Further, the company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the company's control. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's Prospectus, dated Nov. 19, 1997, filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, readers are urged to carefully read all cautionary statements contained in that filing with the Securities and Exchange Commission. CONTACT: Robert F. Schaul, Esq. 908/782-3431 |
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