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 The Indianapolis drugmaker said tanezumab, given by injection every
eight weeks, could be a far more effective and appropriate
alternative for chronic pain than opioids, without their abuse
potential.
"Opioids cause addiction and (overdoses) that are killing more
people than traffic accidents," Jan Lundberg, Lilly's research
chief, said in an interview. "If our medicine proves effective and
safe, that would be a huge opportunity."
Pfizer and Lilly, in a $1.8 billion deal, agreed in 2013 to jointly
develop and sell tanezumab for several pain-related conditions, with
the companies equally sharing development expenses and future sales.
Tanezumab has proven in large trials conducted by Pfizer more
effective than oxycodone, a widely used opioid, and naproxen, the
active ingredient of over-the-counter painkiller Aleve.
It blocks Nerve Growth Factor (NGF), a protein involved in growth of
nerve cells. U.S. regulators in 2012 put a hold on trials of
medicines targeting the protein due to concerns they could worsen
osteoarthritis in a small percentage of patients.
But the agency lifted the hold last year after new data suggested
such risk could be greatly reduced by using lower drug doses and
taking other precautions.
Opioids caused 18,893 overdose deaths in the United States in 2014,
according to the American Society of Addiction Medicine. Another
10,574 overdose deaths were due to heroin, it said, an illegal
opioid to which abusers of prescription opioids often turn because
of its far-cheaper price.
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Andrew Ahn, chief scientific officer of pain research at Lilly, said
opioids are effective against acute pain. But he said they have
limited and decreasing effectiveness against chronic pain. Even so,
he noted many doctors prescribe opioids for patients with long-term
back pain, osteoarthritis and cancer.
"So they chase relief with higher and higher doses until they stop
breathing," he said on the sidelines of a company meeting in New
York with industry analysts and fund managers.
Although well tolerated so far, some patients taking tanezumab have
developed swelling of the extremities and other side effects.
Morningstar analyst Damien Conover said tanezumab, if approved,
could generate annual sales of $1 billion. But he said the earlier
FDA safety concerns have dampened enthusiasm for the emerging new
class of drugs.
(Reporting by Ransdell Pierson; Editing by Cynthia Osterman)
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