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Pfizer's Chantix Fails in Phase IV Study in Young Smokers
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Pfizer Inc. (PFE - Free Report) announced that its smoking cessation drug, Chantix (varenicline) failed in a phase IV study, evaluating it in adolescent smokers. The study was being conducted as a regulatory post marketing commitment in smokers aged 12 to 16 years in the United States and 12 to 17 years in Europe.
The complete study results are expected to be presented at an upcoming scientific congress and will be published later in a peer-reviewed medical journal.
Chantix is already on the market as a prescription drug for helping adults aged 18 and over, along with counseling, to stop smoking.
Shares of the company were down 3.1% on Mar 23. Meanwhile, Pfizer’s shares have declined 4.8% so far this year, compared with the industry’s decline of 5.8% in that period.
The dose ranging multi-centre phase IV study evaluated Chantix for smoking cessation in nicotine dependent adolescents in combination with age-appropriate counselling. The study evaluated two dosages of the drug – 0.5 mg once and twice daily.
Chantix failed to meet the primary endpoint of the four-week continuous abstinence rate compared to placebo at weeks 9 through 12.
The adverse events observed in the study were similar to those seen in an earlier study conducted in adult smokers.
Pfizer is planning to submit data from this study to the FDA for pediatric exclusivity determination. Pediatric exclusivity is granted for six months in return for conducting studies in pediatric patients. With the failure of the study on young smokers, it is unlikely to receive the exclusivity.
In another setback for Pfizer, GlaxoSmithKline (GSK - Free Report) terminated talks to buy the former’s consumer healthcare business. Last week, England-based Reckitt Benckiser also announced to drop its buyout plans for the segment.
Horizon Pharma’s earnings estimates increased from $1.30 to $1.43 for 2018 and from $1.54 to $1.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Lilly’s earnings per share estimates increased $4.84 to $4.85 for 2018 and from $5.26 to $5.29 for 2019 over the last 30 days. The company delivered a positive earnings surprise in all the four trailing quarters with an average beat of 4.08%. The company’s shares have increased 23% so far this year.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
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Pfizer's Chantix Fails in Phase IV Study in Young Smokers
Pfizer Inc. (PFE - Free Report) announced that its smoking cessation drug, Chantix (varenicline) failed in a phase IV study, evaluating it in adolescent smokers. The study was being conducted as a regulatory post marketing commitment in smokers aged 12 to 16 years in the United States and 12 to 17 years in Europe.
The complete study results are expected to be presented at an upcoming scientific congress and will be published later in a peer-reviewed medical journal.
Chantix is already on the market as a prescription drug for helping adults aged 18 and over, along with counseling, to stop smoking.
Shares of the company were down 3.1% on Mar 23. Meanwhile, Pfizer’s shares have declined 4.8% so far this year, compared with the industry’s decline of 5.8% in that period.
The dose ranging multi-centre phase IV study evaluated Chantix for smoking cessation in nicotine dependent adolescents in combination with age-appropriate counselling. The study evaluated two dosages of the drug – 0.5 mg once and twice daily.
Chantix failed to meet the primary endpoint of the four-week continuous abstinence rate compared to placebo at weeks 9 through 12.
The adverse events observed in the study were similar to those seen in an earlier study conducted in adult smokers.
Pfizer is planning to submit data from this study to the FDA for pediatric exclusivity determination. Pediatric exclusivity is granted for six months in return for conducting studies in pediatric patients. With the failure of the study on young smokers, it is unlikely to receive the exclusivity.
In another setback for Pfizer, GlaxoSmithKline (GSK - Free Report) terminated talks to buy the former’s consumer healthcare business. Last week, England-based Reckitt Benckiser also announced to drop its buyout plans for the segment.
Pfizer Inc. Price
Pfizer Inc. Price | Pfizer Inc. Quote
Zacks Rank & Other Key Picks
Pfizer currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the health care sector include Horizon Pharma Public Limited Company and Eli Lilly and Company (LLY - Free Report) . Both the stocks carry a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Horizon Pharma’s earnings estimates increased from $1.30 to $1.43 for 2018 and from $1.54 to $1.77 for 2019 over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 68.92%.
Lilly’s earnings per share estimates increased $4.84 to $4.85 for 2018 and from $5.26 to $5.29 for 2019 over the last 30 days. The company delivered a positive earnings surprise in all the four trailing quarters with an average beat of 4.08%. The company’s shares have increased 23% so far this year.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>