Old 1995 10k stuff......
LIDAKOL: Company scientists have developed a therapeutic compound,
n-docosanol, trademarked under the name LIDAKOL, which has demonstrated anti-viral and anti-inflammatory properties. The Company has been focusing on approval for LIDAKOL as a topical treatment for oral herpes infections. During fiscal 1995, a Phase 3 clinical trial of LIDAKOL as a topical treatment for oral herpes was completed in Europe by Yamanouchi, the Company's licensing partner in Europe. In this double blind study, LIDAKOL was compared to acyclovir (Zovirax(R)) 5% cream in over 300 patients initiating treatment at
early stage of a recurrent herpes episode. Results of this trial demonstrated that LIDAKOL showed statistically comparable therapeutic efficacy to Zovirax 5% cream, a product which is approved by European regulatory authorities as a treatment for this indication. Zovirax 5% cream is not available in the U.S. and Zovirax ointment, which is available in the U.S., has not been approved by the FDA for use as a treatment for recurrent oral herpes. Demonstrating comparable efficacy to an approved product is a requirement for obtaining
regulatory approval in most major European countries ("European Regulatory Approval"). Results of this trial will be used by Yamanouchi, along with results from the U.S./Canada placebo controlled trials described below, for submission to the appropriate regulatory agencies for marketing approval in Europe as clear efficacy versus placebo is also a requirement for European Regulatory Approval. Demonstrating comparative efficacy to an approved product is not a requirement for approval in the United States where only efficacy versus placebo is relevant.
In November 1994, the Company initiated two double-blind placebo controlled Phase 3 clinical trials in sites in both the U.S. and Canada. These trials were designed to evaluate LIDAKOL versus placebo in patients with both early and late stage episodes of oral herpes. In April 1995, a third Phase 3 trial was initiated in the U.S. evaluating LIDAKOL versus placebo in only early stage patients. In aggregate these three trials include over 1,000 patients at
25 clinical sites in the U.S. and Canada. If the results of these
placebo-controlled trials demonstrate that using LIDAKOL results in a
statistically and clinically significant reduction in the average healing time of the herpes episode, such results will be submitted to the FDA in an NDA for marketing approval in the U.S. and to the Health Protection Branch in a New Drug Submission ("NDS") for marketing approval in Canada. Results of these trials are expected to be available in the first calendar quarter of 1996. See "Business-General".
>>>>>>>>>>>>> During fiscal 1994, the Company was advised by the FDA that it may be required to undertake certain carcinogenicity studies for topical LIDAKOL prior to the submission of an NDA. During fiscal 1995, the Company filed a response to the FDA setting forth the Company's position that the carcinogenicity studies should not be required and the Company was subsequently notified by the FDA that such carcinogenicity studies would not be required<<<<<<<<<<.
The Company is also investigating the possibility of initiating additional clinical trials for other topical indications of LIDAKOL which may include therapeutic use in genital herpes, shingles, burns, wound healing, fungal infections and other skin conditions, although no specific plan has been established for initiation of such trials. In addition, the Company has preliminary data indicating that the topical formulation of LIDAKOL might be beneficial in preventing sexually transmitted HIV.
The Company is also developing LIDAKOL for systemic (internally administered) anti-viral and anti-inflammatory use. Preclinical studies indicate that systemically formulated LIDAKOL inhibits viral replication of certain lipid-enveloped viruses.
Several medically significant diseases are caused by these viruses which include herpes, shingles, cytomegalovirus (CMV),
influenza, respiratory syncytial virus (RSV), hepatitis and HIV.
Patents covering medical and veterinary uses of the topical and systemic formulations of LIDAKOL have been issued to LIDAK in the U.S. and Europe. The Company has additional foreign patent
applications pending covering topical and systemic uses of LIDAKOL and has been granted rights under certain United States and foreign patents and patent applications relating to LIDAKOL held by a third party. See "Patents and Proprietary Rights."
OVER THE COUNTER.......appears right.....IMO.
luis |
