May 6 Merck & Co said on Tuesday it plans to
seek marketing approvals this year for an osteoporosis drug and
a product to reverse the effects of anesthesia that have long
been delayed by safety concerns.
The No. 2 U.S. drugmaker will seek approval in the second
half of the year for odanacatib, its experimental treatment for
osteoporosis in postmenopausal women, and will seek approval in
2014 for sugammadex, meant to reverse the effects of muscle
relaxants after surgery.
Merck shares were down 2 percent at $57.50 in morning
trading on the New York Stock Exchange.
The company is counting on odanacatib, sugammadex and other
experimental drugs, including promising treatments for hepatitis
C and cancer, to boost its earnings growth following generic
competition for its Singulair asthma treatment and other brands.
But Merck research chief, Roger Perlmutter, in a company
meeting with investors in Boston to review research projects,
said a numerically higher incidence of stroke and atrial
fibrillation - a type of irregular heartbeat most common in the
elderly - was seen in patients taking odanacatib than those
taking placebos in studies.
Perlmutter also said a type of skin thickening and itching
called morphea was seen in 0.2 percent of patients taking
odanacatib. He said 0.1 percent of patients had fractures in the
shaft of the femur, or thigh bone, a greater incidence than seen
in the placebo group.
ISI Group analyst Mark Schoenebaum said the half-day Merck
research meeting had been relatively uneventful, except for news
that Merck would seek approval this year for odanacatib.
"That's an upside surprise," he said in a research note.
"But the news was tempered perhaps by their disclosure that
there was a numerical imbalance in atrial fibrillation and
stroke" and there were skin issues.
Analysts at Cowen and Co have predicted that odanacatib, if
approved, could reap Merck annual sales of $1 billion by 2020.
Odanacatib works through a new mechanism of action, by
blocking a protein called cathespin K, and would compete with
widely used older drugs called bisphosphonates that include
Merck's own Fosamax.
Bisphosphonates, leading treatments for osteoporosis, have
raised concern because of rare cases of disintegration of jaw
bone as well as femur fractures. Merck said the jaw condition
had not been seen with odanacatib.
Merck last year said it was delaying its application for
odanacatib because it needed additional data from a clinical
As for sugammadex, the FDA declined to approve the
injectable product in 2008, citing concerns about its possible
association with allergic reactions and bleeding.
Sugammadex has already been approved in more than 50
countries, where it is sold under the brand name Bridion. It
generated worldwide sales of $73 million in the first quarter.
But analysts believe the medicine, if approved in the United
States, could generate annual sales of $500 million or more.
Earlier on Tuesday, Merck said it would sell its consumer
healthcare business for $14.2 billion to Germany's Bayer AG
, adding to a string of major cross-border deals in
the healthcare industry.
Merck's consumer brands include Dr Scholl foot care,
Coppertone sunscreen and its Claritin allergy medicine. They
were acquired from Merck's 2009 purchase of U.S. drugmaker
In addition, Bayer agreed to sell to Merck some rights to
its Adempas drug against high blood pressure in the lung, and
other experimental cardiovascular drugs, saying it needed a
As part of that alliance, Merck will pay up to $2.1 billion,
including $1.1 billion in milestone payments contingent on
Merck said it is selling off the consumer products to
increase its focus on developing more-lucrative prescription
(Editing by Bernadette Baum)