FDA Notifies Zonagen That Additional Two-Year Animal Study is Required to Lift Clinical Hold On VASOMAX.Business Editors & Health/Medical Writers THE WOODLANDS, Texas--(BUSINESS WIRE)--November 19, 2002 Zonagen, Inc. (Nasdaq:ZONA)(PCX (1) A bitmapped graphics file format that handles monochrome, 2-bit, 4-bit, 8-bit and 24-bit color and uses RLE to achieve compression ratios of approximately 1.1:1 to 1.5:1. Images with large blocks of solid colors compress best under the RLE method. See PC Paintbrush. :ZNG ZNG Zbor Nacionalne Garde (Croatian National Guard) ) announced today that it has been notified by the Division of Reproductive and Urologic Drug Products of the 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. that an additional two-year rodent study will be required in order to lift the clinical hold on VASOMAX(R). The FDA made the decision following a meeting between Zonagen and the full Cancer Assessment Committee of the FDA held on October 21, 2002. In that meeting, Zonagen consultants presented data that suggests phentolamine phentolamine a potent a-adrenergic blocking agent; it blocks the hypertensive action of epinephrine and norepinephrine and most responses of smooth muscles that involve a-adrenergic cell receptors. neither initiates nor promotes brown fat proliferations (hibernomas) in the rat. However the FDA opined that the mechanistic study did not demonstrate a clear positive response in young animals YOUNG ANIMALS. It is a rule that the young of domestic or tame animals belong to the owner of the dam or mother, according to the maxim Partus sequitur ventrem. Dig. 6, 1, 5, 2; Inst. 2, 1, 9. without a response in older animals or provide any explanation for the hibernomas seen in the earlier study. They further noted that no markers of hibernoma formation, which could be monitored in humans, were identified. The FDA summarized its position by stating that in order to remove the clinical hold, results showing no drug related hibernoma formation in a two-year carcinogenicity carcinogenicity /car·ci·no·ge·nic·i·ty/ (kahr?si-no-je-nis´i-te) the ability or tendency to produce cancer. carcinogenicity the ability or tendency to produce cancer. study in mice or rats should be submitted. Joseph Podolski, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Zonagen, noted, "We are disappointed in the Committee's decision. We remain convinced that VASOMAX(R) does not pose a safety risk to humans. Nevertheless, we do not presently plan to conduct another two-year study." On October 29, 2002, Zonagen announced its merger agreement with Lavipharm. The consummation of the merger is conditioned upon customary closing conditions, including the approval of Zonagen's stockholders. The combined company will change its name to Lavipharm. It is anticipated that after the merger Lavipharm will focus on development of its drug formulation and drug delivery technologies. About Zonagen Zonagen is engaged in the development of pharmaceutical products for the reproductive system reproductive system, in animals, the anatomical organs concerned with production of offspring. In humans and other mammals the female reproductive system produces the female reproductive cells (the eggs, or ova) and contains an organ in which development of the fetus , including sexual dysfunction sexual dysfunction Inability to experience arousal or achieve sexual satisfaction under ordinary circumstances, as a result of psychological or physiological problems. , vaccine adjuvants, products for fertility and female health as well as urological applications, specifically prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . For more information, visit Zonagen's web site at http://www.zonagen.com. About Lavipharm Lavipharm is an innovative drug formulation and drug delivery company. Lavipharm combines proprietary particle engineering, solubilization and formulation technologies with its expertise in drug delivery to improve pharmaceutical and OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). products and drug candidates developed by other companies. Lavipharm applies its technologies to drugs in the early stage of development including small molecules, peptides and proteins, and to drugs that are currently marketed but have not performed to their full market potential. Lavipharm's technologies can further enhance the value of currently marketed drugs by attempting to improve their pharmaco-kinetic profile, and thereby potentially improving patient compliance and/or extending patent protection. By developing creative solutions to enhance delivery of drug molecules, Lavipharm also assists its customer base in differentiating their products from those of the competition. By improving existing products in less time, at a potentially lower risk of failure, and at potentially lower costs than required to develop new chemical entities, Lavipharm believes it can add scientific and commercial value to pharmaceutical company products, both in the short and longer term. For more information, visit Lavipharm's website at http://www.lavipharm.com. Any statements that are not historical facts contained in this release, such as approval of the transaction with Lavipharm, are forward-looking statements that involve risks and uncertainties, including but not limited to those relating to approval of the merger and related transactions with Lavipharm by Zonagen's stockholders and other risks identified in Zonagen's Annual Report on Form 10-K for the year ended December 31, 2001, as filed with the Securities and Exchange Commission (SEC). These documents are available on request from Zonagen or at www.sec.gov. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. |
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