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Glaxo's Nucala Suffers Regulatory Setback, Gets CRL for COPD
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GlaxoSmithKline plc (GSK - Free Report) announced that the FDA has issued a complete response letter (CRL) to its supplemental biologics license application (sBLA) for label expansion of its asthma drug, Nucala for a new indication — eosinophilic chronic obstructive pulmonary disease (COPD).
Glaxo was looking to get Nucala approved as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in COPD patients guided by blood eosinophil counts.
The CRL was not exactly a surprise as in July an FDA advisory committee had voted against recommending approval of Nucala for COPD. The committee recommended that the risk-benefit profile of Nucala, demonstrated in studies, was not adequate to support its approval. Glaxo informed that the FDA has sought more information before giving an approval.
Nucala is already approved for the treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). It is being evaluated in late-stage studies for nasal polyps.
Glaxo’s shares have outperformed the industry, rising 11.6% compared with a 4.6% increase for the industry.
Nucala and Glaxo’s other new products like inhaled Ellipta portfolio (COPD and asthma), Tivicay and Triumeq (HIV) and Menveo, Bexsero (meningitis vaccines) are all doing well and represent significant commercial opportunity. These new products generated 22% of Glaxo’s Pharmaceuticals and Vaccine sales in 2016 and 30% in 2017 and continue to boost revenues in 2018.
However, Glaxo’s older inhaled respiratory products, particularly Seretide/Advair, are facing competitive and continued pricing pressure, thus hurting sales. Also, continued transition to newer products is affecting sales of Advair. The drug is also expected to face generic competition in the United States this year, which will further hurt sales.
It is noteworthy here, however, that three companies Mylan , Hikma Pharmaceuticals and Novartis (NVS - Free Report) , which are trying to bring a generic version of Advair, have received a CRL from the FDA, thereby delaying the entry of generics in the U.S. market.
Lilly’s earnings estimates increased 6% for 2018 and 3.6% for 2019 over the last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 10.15%. The company’s shares have increased 26.8% year to date.
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Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
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Glaxo's Nucala Suffers Regulatory Setback, Gets CRL for COPD
GlaxoSmithKline plc (GSK - Free Report) announced that the FDA has issued a complete response letter (CRL) to its supplemental biologics license application (sBLA) for label expansion of its asthma drug, Nucala for a new indication — eosinophilic chronic obstructive pulmonary disease (COPD).
Glaxo was looking to get Nucala approved as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in COPD patients guided by blood eosinophil counts.
The CRL was not exactly a surprise as in July an FDA advisory committee had voted against recommending approval of Nucala for COPD. The committee recommended that the risk-benefit profile of Nucala, demonstrated in studies, was not adequate to support its approval. Glaxo informed that the FDA has sought more information before giving an approval.
Nucala is already approved for the treatment of severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). It is being evaluated in late-stage studies for nasal polyps.
Glaxo’s shares have outperformed the industry, rising 11.6% compared with a 4.6% increase for the industry.
Nucala and Glaxo’s other new products like inhaled Ellipta portfolio (COPD and asthma), Tivicay and Triumeq (HIV) and Menveo, Bexsero (meningitis vaccines) are all doing well and represent significant commercial opportunity. These new products generated 22% of Glaxo’s Pharmaceuticals and Vaccine sales in 2016 and 30% in 2017 and continue to boost revenues in 2018.
However, Glaxo’s older inhaled respiratory products, particularly Seretide/Advair, are facing competitive and continued pricing pressure, thus hurting sales. Also, continued transition to newer products is affecting sales of Advair. The drug is also expected to face generic competition in the United States this year, which will further hurt sales.
It is noteworthy here, however, that three companies Mylan , Hikma Pharmaceuticals and Novartis (NVS - Free Report) , which are trying to bring a generic version of Advair, have received a CRL from the FDA, thereby delaying the entry of generics in the U.S. market.
Glaxo currently carries a Zacks Rank #3 (Hold). A better-ranked large-cap drug stock is Eli Lilly & Company (LLY - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lilly’s earnings estimates increased 6% for 2018 and 3.6% for 2019 over the last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 10.15%. The company’s shares have increased 26.8% year to date.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>