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ARIAD Files for EU Approval of Lung Cancer Drug Brigatinib
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ARIAD Pharmaceuticals, Inc. announced the submission of a Marketing Authorisation Application (MAA) for its experimental ALK inhibitor, brigatinib, with the European Medicines Agency (EMA). ARIAD is looking to get brigatinib approved for the treatment of adult patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to Pfizer Inc.'s (PFE - Free Report) Xalkori (crizotinib).
Brigatinib is the most advanced candidate in the company’s pipeline. The company completed the submission of a rolling NDA in the U.S. for brigatinib in Aug 2016. The application was accepted for review in Oct 2016 with a PDUFA date of Apr 29, 2017. Upon approval, ARIAD expects to launch the product in 2017.
We note that brigatinib enjoys Breakthrough Therapy status in the U.S. for the treatment of patients with ALK+ NSCLC whose tumors are resistant to Xalkori. Brigatinib also has Orphan Drug status in the U.S. for this indication.
Shares of ARIAD have significantly outperformed the Zacks classified Medical-Drugs industry in the last six months. The stock gained 137.7% during the period, while the industry registered a decline of 4.7%.
Coming back to the latest news, the MAA submission was supported by data from a phase I/II and pivotal phase II study, ALTA, on brigatinib. With a median follow-up of 11 months, data demonstrated that 55% of patients under a 180-mg regimen with a seven-day lead-in at 90 mg, witnessed an investigator-assessed confirmed objective response – the primary endpoint of the study. In addition, median progression-free survival exceeded one year (15.6 months) in this arm.
Meanwhile, the company initiated a first-line phase III study (ALTA1L) comparing the efficacy and safety of brigatinib with Xalkori in patients with locally advanced or metastatic ALK+ NSCLC who have not previously been treated with an ALK inhibitor.
According to the American Cancer Society, NSCLC accounts for approximately 80% to 85% of the estimated 222,500 new cases of lung cancer in the U.S. diagnosed each year. Hence, approval of this drug will offer the company huge market opportunity in the near term.
We are encouraged by the company’s progress with brigatinib. Currently, ARIAD has only one marketed product in its kitty – Iclusig for leukemia. If brigatinib is finally approved, it could become a two-product commercial company by early 2017.
We remind the investors that in Jan 2017, ARIAD announced a definitive agreement to be acquired by Japan’s Takeda Pharmaceutical Company Limited for approximately $5.2 billion. Under the acquisition deal, Takeda will add ARIAD’s sole marketed product, Iclusig, to its portfolio.
Eli Lilly’s earnings estimates increased from $3.99 to $4.11 for 2016 and from $4.31 to $4.37 for 2017 over the last 60 days. Its share price increased 5.8% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
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ARIAD Files for EU Approval of Lung Cancer Drug Brigatinib
ARIAD Pharmaceuticals, Inc. announced the submission of a Marketing Authorisation Application (MAA) for its experimental ALK inhibitor, brigatinib, with the European Medicines Agency (EMA). ARIAD is looking to get brigatinib approved for the treatment of adult patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to Pfizer Inc.'s (PFE - Free Report) Xalkori (crizotinib).
Brigatinib is the most advanced candidate in the company’s pipeline. The company completed the submission of a rolling NDA in the U.S. for brigatinib in Aug 2016. The application was accepted for review in Oct 2016 with a PDUFA date of Apr 29, 2017. Upon approval, ARIAD expects to launch the product in 2017.
We note that brigatinib enjoys Breakthrough Therapy status in the U.S. for the treatment of patients with ALK+ NSCLC whose tumors are resistant to Xalkori. Brigatinib also has Orphan Drug status in the U.S. for this indication.
Shares of ARIAD have significantly outperformed the Zacks classified Medical-Drugs industry in the last six months. The stock gained 137.7% during the period, while the industry registered a decline of 4.7%.
Coming back to the latest news, the MAA submission was supported by data from a phase I/II and pivotal phase II study, ALTA, on brigatinib. With a median follow-up of 11 months, data demonstrated that 55% of patients under a 180-mg regimen with a seven-day lead-in at 90 mg, witnessed an investigator-assessed confirmed objective response – the primary endpoint of the study. In addition, median progression-free survival exceeded one year (15.6 months) in this arm.
Meanwhile, the company initiated a first-line phase III study (ALTA1L) comparing the efficacy and safety of brigatinib with Xalkori in patients with locally advanced or metastatic ALK+ NSCLC who have not previously been treated with an ALK inhibitor.
According to the American Cancer Society, NSCLC accounts for approximately 80% to 85% of the estimated 222,500 new cases of lung cancer in the U.S. diagnosed each year. Hence, approval of this drug will offer the company huge market opportunity in the near term.
We are encouraged by the company’s progress with brigatinib. Currently, ARIAD has only one marketed product in its kitty – Iclusig for leukemia. If brigatinib is finally approved, it could become a two-product commercial company by early 2017.
We remind the investors that in Jan 2017, ARIAD announced a definitive agreement to be acquired by Japan’s Takeda Pharmaceutical Company Limited for approximately $5.2 billion. Under the acquisition deal, Takeda will add ARIAD’s sole marketed product, Iclusig, to its portfolio.
ARIAD Pharmaceuticals, Inc. Price
ARIAD Pharmaceuticals, Inc. Price | ARIAD Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
ARIAD currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Eli Lilly and Company (LLY - Free Report) and Enzo Biochem, Inc. (ENZ - Free Report) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Eli Lilly’s earnings estimates increased from $3.99 to $4.11 for 2016 and from $4.31 to $4.37 for 2017 over the last 60 days. Its share price increased 5.8% year to date.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
Just Released – Driverless Cars: Your Roadmap to Mega-Profits Today
In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>