SENETEK ANNOUNCES PARTNERSHIP WITH AKORN INC. FOR ADVANCED DRUG DELIVERY SYSTEM FOR INVICORP(TM)
NAPA, Calif., Mar 28, 2000 /PRNewswire via COMTEX/ -- Senetek PLC(Nasdaq: SNTKY), today announced that the Company has entered into a partnership with Akorn, Inc. for the manufacture of pre-filled drug delivery cartridges for the administration of Invicorp(TM) utilizing the Autoject(R)Mini. Senetek has recently acquired exclusive rights to the Autoject(R)Mini, a state-of-the-art drug delivery device developed by Owen Mumford, for use with the Company's Erectile Dysfunction treatment.
Akorn Inc., is a premier specialty pharmaceutical company that manufactures injectable sterile pharmaceutical products and provides contract manufacturing to leaders in the industry. The Company's pharmaceutical outsourcing division has been in operation for more than 50 years and is committed to developing long-term strategic alliances with their clients, while providing world-class, full-service pharmaceutical development and analytical, microbiological and manufacturing services. Utilizing their advanced sterile manufacturing capabilities, the company will provide and fill a universal drug closure container system for Senetek's premier Erectile Dysfunction(ED) treatment, Invicorp(TM). This self-contained cartridge allows for simple and effortless loading into the Autoject(R)Mini, a re-useable automatic drug delivery device, for Invicorp(TM) users.
The Autoject(R)Mini with Akorn's supply of a universal drug closure container system combine for an ideal, user-friendly delivery of the Invicorp(TM) product. This advanced delivery system further enhances Invicorp's(TM) advantages as a leading treatment for ED. In clinical trials Invicorp(TM) has demonstrated an 81% overall efficacy without the common side affects associated with other therapies. Delivered through this new technology, Invicorp(TM) is made even more convenient, as well as extremely cost competitive, while remaining easy to use and
essentially painless.
Glenn Wickes, Vice President of Operations for Akorn Inc. and lead project coordinator for this joint effort, has extensive experience in the biopharmaceutical industry with special emphasis on the development of injectable products. He has developed numerous new proprietary drug delivery enhancements and is the key inventor for several drug delivery related patents.
Frank Massino, Chairman and CEO of Senetek stated, "This partnership with Akorn for the supply of the universal drug closure container system marks an important milestone in establishing an outstanding means by which to deliver our premier ED therapy. Glenn Wickes and the expert team at Akorn, Inc. provide an assurance of the highest possible standards in the manufacture and timely supply of this product."
This partnership with Akorn, Inc. as a supplier in the new drug delivery system completes the enhanced positioning of Invicorp(TM) for its targeted market. In addition, Senetek is simultaneously moving forward with plans to broaden its coverage of the market with a topical administration of Invicorp(TM) for both ED and Female Sexual Dysfunction.
Invicorp(TM) is currently approved in Denmark and New Zealand. Senetek has received conditional approval for Invicorp(TM) from the United Kingdom's Medicines Control Agency (MCA). On January 28, 2000 the Company filed an amendment with the Agency that addresses each issue cited in the conditional approval.
Late last year, the FDA and the MCA placed a temporary hold on all clinical trials involving phentolamine mesylate, a compound used in low concentration in Invicorp(TM). Senetek has hired an independent expert clinical pharmacotoxicologist firm, Soteros Ltd., to review the matter. Their findings conclude that phentolamine mesylate's carcinogenicity found in animal models has no relevance as an indicator of carcinogenic risk in humans. This information along with an extensive review of all prior company studies and the medical literature supporting the efficacy and safety of phentolamine mesylate were included in the recent amendment to the MCA. Named patient supplies of Invicorp(TM) are currently sold in Denmark and the United Kingdom.
Senetek, PLC is a science-driven biotechnology company providing solutions to aging-related healthcare problems in the form of biopharmaceuticals, drug delivery systems and skincare.
www.senetekplc.com
THE SAFE HARBOR STATEMENT UNDER PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. This press release contains forward-looking statements that involve risks and uncertainties including the risks detailed from time to time in the Company's Securities and Exchange Commission
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