Needham & Company Maintains a 'Hold' on Watson Pharmaceuticals (WPI); Path to Near-Term PROCHIEVE Approval Appears Cloudy as Efficacy Fails to Meet FDA Threshold
Tweet
Share
E-mailGet Alerts WPI Hot Sheet
Price: $85.73 --0%
Rating Summary:
13 Buy, 4 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
13 Buy, 4 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Join SI Premium – FREE
Needham & Company maintains a 'Hold' on Watson Pharmaceuticals (NYSE: WPI).
Needham analyst says, "In the sponsor presentation by Watson/Columbia, the phase 3 pivotal study demonstrated that Prochieve led to a statistically significant (p=0.022) reduction in preterm birth in women with a short cervix. The same data under FDA analysis, which adjusted for additional heterogeneities (incl. region, marternal age, cervical length, race and BMI) came short of statistical significance (p=0.058) and thus was deemed inadequate to support efficacy for the proposed indication. While most panel members acknowledged that Prochieve likely led to some benefit in reducing preterm birth, they did not believe the efficacy data met the standard for FDA approval. Given that the sponsors had relied on data from one single pivotal trial (vs. the usual two confirmatory trials), the FDA, as well as many panel members, indicated their preference for a higher level of statistical significance (p<0.01 of p<0.05). Other panelists indicated their preference for statistically significant efficacy in two independent trials. The FDA and the panel also raised the issue of the lack of treatment efficacy in the small subgroup of U.S. patients. The FDA will make a decision on the approvability of Prochieve (PDUFA is 2/26/12) taking in consideration the AdCom’s vote and comments. Given the background documents and the panel outcome, a first-pass approval appears remote."
For an analyst ratings summary and ratings history on Watson Pharmaceuticals click here. For more ratings news on Watson Pharmaceuticals click here.
Shares of Watson Pharmaceuticals closed at $58.14 yesterday.
Needham analyst says, "In the sponsor presentation by Watson/Columbia, the phase 3 pivotal study demonstrated that Prochieve led to a statistically significant (p=0.022) reduction in preterm birth in women with a short cervix. The same data under FDA analysis, which adjusted for additional heterogeneities (incl. region, marternal age, cervical length, race and BMI) came short of statistical significance (p=0.058) and thus was deemed inadequate to support efficacy for the proposed indication. While most panel members acknowledged that Prochieve likely led to some benefit in reducing preterm birth, they did not believe the efficacy data met the standard for FDA approval. Given that the sponsors had relied on data from one single pivotal trial (vs. the usual two confirmatory trials), the FDA, as well as many panel members, indicated their preference for a higher level of statistical significance (p<0.01 of p<0.05). Other panelists indicated their preference for statistically significant efficacy in two independent trials. The FDA and the panel also raised the issue of the lack of treatment efficacy in the small subgroup of U.S. patients. The FDA will make a decision on the approvability of Prochieve (PDUFA is 2/26/12) taking in consideration the AdCom’s vote and comments. Given the background documents and the panel outcome, a first-pass approval appears remote."
For an analyst ratings summary and ratings history on Watson Pharmaceuticals click here. For more ratings news on Watson Pharmaceuticals click here.
Shares of Watson Pharmaceuticals closed at $58.14 yesterday.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Coherent (COHR) PT Raised to $420 at Needham
- Globant S.A. (GLOB) PT Lowered to $45 at Needham
- Freedom Broker Upgrades Serve Robotics (SERV) to Buy
Create E-mail Alert Related Categories
Analyst CommentsRelated Entities
Needham & CompanySign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
