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Allergan's Uterine Fibroids Candidate Positive in Phase III
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Allergan Plc and European specialty pharma company Gedeon Richter reported encouraging results from a phase III study on their pipeline candidate, ulipristal acetate, a selective progesterone receptor modulator (SPRM), in women with abnormal bleeding due to uterine fibroids.
Venus II, the second of two pivotal phase III studies on ulipristal acetate assessed the efficacy and safety of ulipristal acetate.
Allergan’s share price has declined 26.4% in the past one year, which compares favorably with the Zacks classified Medical-Generics Drugs industry’s fall of 32.6%.
Coming back to Venus II, 432 patients were enrolled in the trial, of which 162 patients were randomized to receive ulipristal acetate 5 mg, 157 patients received ulipristal acetate 10 mg, and the remaining 113 were given placebo. The study met all the co-primary and secondary endpoints, with both the ulipristal treatment arms – 5 and 10 mg – achieving statistically significant results over placebo.
The co-primary efficacy endpoints were percentage of patients with the absence of uterine bleeding and the time to absence of bleeding on treatment during Treatment Course One (12-week duration). About 54.8% of the patients treated with 10 mg and 42% treated with ulipristal acetate 5 mg achieved absence of bleeding compared to none on placebo.
The most common adverse events on ulipristal acetate treatment included hot flush, headache, fatigue, nausea and headache.
The company expects to submit an NDA for the candidate in the second half of 2017.
We remind investors that Venus I, one of the two pivotal phase III clinical trials, also met all the co-primary and secondary endpoints and achieved statistically significant results.
Meanwhile, biopharmaceutical company AbbVie (ABBV - Free Report) also has a pipeline candidate, elagolix, for the treatment of women with uterine fibroids. The candidate is currently in a phase III trial for the same and has bright prospects.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 35.3% in the past one year.
Enzo Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 48.7% in the past year.
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>
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Allergan's Uterine Fibroids Candidate Positive in Phase III
Allergan Plc and European specialty pharma company Gedeon Richter reported encouraging results from a phase III study on their pipeline candidate, ulipristal acetate, a selective progesterone receptor modulator (SPRM), in women with abnormal bleeding due to uterine fibroids.
Venus II, the second of two pivotal phase III studies on ulipristal acetate assessed the efficacy and safety of ulipristal acetate.
Allergan’s share price has declined 26.4% in the past one year, which compares favorably with the Zacks classified Medical-Generics Drugs industry’s fall of 32.6%.
Coming back to Venus II, 432 patients were enrolled in the trial, of which 162 patients were randomized to receive ulipristal acetate 5 mg, 157 patients received ulipristal acetate 10 mg, and the remaining 113 were given placebo. The study met all the co-primary and secondary endpoints, with both the ulipristal treatment arms – 5 and 10 mg – achieving statistically significant results over placebo.
The co-primary efficacy endpoints were percentage of patients with the absence of uterine bleeding and the time to absence of bleeding on treatment during Treatment Course One (12-week duration). About 54.8% of the patients treated with 10 mg and 42% treated with ulipristal acetate 5 mg achieved absence of bleeding compared to none on placebo.
The most common adverse events on ulipristal acetate treatment included hot flush, headache, fatigue, nausea and headache.
The company expects to submit an NDA for the candidate in the second half of 2017.
We remind investors that Venus I, one of the two pivotal phase III clinical trials, also met all the co-primary and secondary endpoints and achieved statistically significant results.
Meanwhile, biopharmaceutical company AbbVie (ABBV - Free Report) also has a pipeline candidate, elagolix, for the treatment of women with uterine fibroids. The candidate is currently in a phase III trial for the same and has bright prospects.
Zacks Rank & Key Picks
Allergan currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) and Enzo Biochem, Inc. (ENZ - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 35.3% in the past one year.
Enzo Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 48.7% in the past year.
Allergan PLC. Price
Allergan PLC. Price | Allergan PLC. Quote
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>