Biotech Values

[DewDiligence]

MNT’s PurTox Hits Phase-3 Endpoints With Ease

[PurTox is a type-A botulinum toxin similar to Botox that may have an advantage relative to Botox in dispersion characteristics. This randomized and blinded study, the first of three phase-3 trials to support a BLA, tested a single dose vs placebo for treatment of brow furrow and hit every efficacy endpoint with p<=0.0001. In other words, the drug clearly works and the only regulatory issue will be safety. A second phase-3 trial is testing multiple doses over a six-month period and a third phase-3 trial is an open-label safety study. Enrollment in all of these studies has been extremely fast.]

http://biz.yahoo.com/bw/081001/20081001005424.html

›Wednesday October 1, 9:00 am ET

SANTA BARBARA, Calif.--(BUSINESS WIRE)--Mentor Corporation (NYSE:MNT - News), a leading supplier of medical products for the global aesthetic market, today announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox®) for the reduction of glabellar rhytides (frown lines). This newly completed study involved 400 subjects at ten investigational sites in the United States. Subjects received a single treatment with PurTox or placebo.

Using a validated 4-point photo scale as a reference, reduction in line severity was scored by subjects, investigators, and independent reviewers at time points through six months. Satisfaction with treatment outcome was measured using a standard global satisfaction assessment tool and safety was assessed by adverse event tracking. The results for the primary efficacy endpoint and for each of the eight secondary efficacy endpoints were all highly significant (p<=0.0001 in each case). For each of these endpoints, the findings were indicative of a substantial treatment effect. In addition, a very large percentage of subjects expressed a high degree of satisfaction with the treatment outcome.

Data from the three Phase 3 studies will be used to support the filing of a BLA (Biologics License Application) with the U.S. Food and Drug Administration. The remaining two Phase 3 studies for this indication have completed enrollment and are currently in the follow-up stage.

About Mentor Corporation

Mentor is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve their quality of life. The Company's website is www.mentorcorp.com.‹