To all:
As an investor in the British Biotech, Senetek, I have been following your discussion of the fortunes and follies of Vivus, Viagra, and Zonagen with keen interest. How about adding to your debate a consideration of the competitive merits of Senetek's Invicorp? Yes, it's an injectable, but an injectable with a difference. As far as injectables go, Senetek appears to have the best and most effective combination of drug and delivery system. They already have filed three PLA applications in Europe, and will be filing a NDA for the U.S. later this year or early next year.
A recent press release:
<< Senetek Seeking Approval to Market its INVICORP Erectile Dysfunction Therapy in Switzerland, South Africa and New Zealand
NEW YORK, Sept. 18 /PRNewswire/ -- Senetek PLC (Nasdaq: SNTKY) announced today that it has filed three additional Product Licensing Applications (PLAs) with the appropriate regulatory agencies seeking approval to market in Switzerland, South Africa and New Zealand its new drug therapy for treating moderate-to-severe, organic-based erectile dysfunction (ED) in males -- INVICORP(TM), a unique combination therapy administered with a proprietary state-of-the-art autoinjector.
In April of this year, Senetek announced that it had filed its first PLA -- with England's Medicines Control Agency (MCA) -- for approval to market INVICORP. In addition, in July, Senetek announced it had filed its second and third PLAs with the appropriate regulatory authorities in Denmark and Ireland. These submission are a part of the Company's pan-European approval strategy for INVICORP.
INVICORP is an injectable formulation of vasoactive intestinal polypeptide (VIP) in combination with phentolamine mesylate. An extensive body of clinical data includes more than 15,000 intracavernous injections of INVICORP (VIP/phentolamine) in a population of 718 male patients followed up for up to six years. Patients' etiology was predominantly non-psychogenic. Efficacy of greater than 80 percent has been reported from multiple sites, and the placebo-controlled study was highly statistically significant. Discontinuation for adverse events has been reported only in 12 patients (1.7 percent).
A novel autoinjector has been developed for use with INVICORP. The device is small (5.75" x 0.50"), utilizes an ultrafine 29-gauge needle that is not visible to the patient prior to injection, and contains a single dose of INVICORP. Following activation, a controlled delivery of 0.35ml occurs in 3-5 seconds, following which the autoinjector is totally disposable. Drug reconstitution is not necessary, and the possibility of dosing errors and contamination is virtually eliminated.
Senetek PLC is a biotechnology company providing solutions for aging- related health problems.
Visit Senetek's Web site on the Internet senetekplc.com
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