Tags: Cancer | lung | cancer | drug | FDA | fast-track | keytruda

FDA Fast-Tracks Lung Cancer Drug

Monday, 27 Oct 2014 12:40 PM


Merck & Co., the second-biggest U.S. drugmaker, beat analyst earnings estimates and said it won a “breakthrough” designation from regulators that would bring its most promising oncology drug to lung cancer patients faster.
Profit excluding one-time items of 90 cents a share beat by 2 cents the average of 17 analysts’ estimates compiled by Bloomberg. Third-quarter net income fell to $895 million, or 31 cents a share, from $1.12 billion, or 38 cents, a year earlier, the company said in a statement today.
Keytruda, the drugmaker’s new cancer medicine, was approved for use in melanoma in September and Merck said 900 patients were treated with it last month. The U.S. Food and Drug Administration today awarded the therapy a “breakthrough” designation for a form of lung cancer, which could speed approval for use in those patients.
“Keytruda demand looks strong and obviously the breakthrough designation is a huge positive for Merck going forward,” said Tony Butler, an analyst at Guggenheim Securities LLC, in a telephone interview. “They’re doing a great job on the oncology front.”
Merck has cut jobs and overhauled its research operations to focus on its cancer pipeline. Keytruda, its flagship new medicine, is part of a new generation of oncology treatments that use the body’s own immune system to attack and destroy tumors. Merck is competing against Bristol-Myers Squibb Co., AstraZeneca Plc and others to dominate that market.
Moneymakers
Bristol-Myers’s drug Opdivo received breakthrough designation from the FDA in September, following the approval of Keytruda. “Merck has kind of been playing catch up, but let’s be fair they’ve got the first product on the market,” Butler said. “You’ve got to give them credit, they pulled ahead.”
The new cancer drugs should be lucrative for their makers - - Keytruda will cost about $12,500 a month. By 2017, analysts project the drug’s sales to be $1.8 billion.
Merck narrowed its adjusted adjusted earnings forecast for the year to $3.46 to $3.50 a share, from a prior forecast of $3.43 to $3.53. It also cut the top end of its sales forecast by $400 million to $42.8 billion.
The company’s drug sales fell 4 percent to $9.13 billion. Gardasil, a vaccine for human papillomavirus, declined 11 percent on lower use from the U.S. public sector. Cholesterol drugs Zetia and Vytorin fell 3 percent in the quarter on weaker U.S. sales.
Merck’s animal health business’ sales rose 11 percent to $885 million, which the company attributed to growth across all species.
 

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Merck Co., the second-biggest U.S. drugmaker, beat analyst earnings estimates and said it won a "breakthrough" designation from regulators that would bring its most promising oncology drug to lung cancer patients faster. Profit excluding one-time items of 90 cents a share...
lung, cancer, drug, FDA, fast-track, keytruda
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2014-40-27
Monday, 27 Oct 2014 12:40 PM
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