Regeneron CEO says Amgen not putting patients first in patent dispute

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By Bill Berkrot

<span class="articleLocation”>Regeneron Pharmaceuticals Chief
Executive Len Schleifer on Monday ripped into Amgen Inc for its insistence on blocking sales of a rival Regeneron
cholesterol drug while the appeals process in a patent
infringement case plays out.

A federal judge last week handed Regeneron and its partner
Sanofi a stunning setback by banning sales of their
LDL-lowering medicine Praluent, finding it infringed patents
held by Amgen on its Repatha cholesterol drug.

Regeneron and Sanofi were given 30 days before the ban takes
effect to give them time to appeal. That was extended to 45 days
on Monday.

Speaking at the annual JP Morgan Healthcare Conference in
San Francisco, Schleifer said Amgen had refused a request to
delay any ban of Praluent sales until the appeal is heard, even
though the judge in her ruling had said competition among the
two drugs was in the public interest.

“If they really cared about patients they wouldn’t rip this
drug from patients,” the outspoken Schleifer said.

“To say that you cannot wait, is that putting patients
first? It’s no small wonder that our industry isn’t beloved,” he
continued.

“If this industry is to survive, we have got to do the right
thing by patients … and still adequately reward our
investors,” Schleifer said.

Earlier at the conference, Amgen CEO Robert Bradway
reiterated that his company intended to defend its patents. He
declined to say whether Amgen would consider a settlement in the
case.

Amgen did not immediately respond to a request for comment
on Schleifer’s statements.

The expensive injectable drugs from both companies
dramatically lower “bad” LDL cholesterol by blocking a protein
called PCSK9. Both companies are expecting data this year that
is likely to show that the drugs also cut the risk of heart
attacks and deaths.

Amgen’s Bradway said he does not expect that data to be
added to the Repatha label until 2018, and Amgen would not be
allowed to promote those heart benefits until they are in the
label.

Without proof that the drugs prevent heart attacks, health
insurers have been denying payment for three quarters of Repatha
prescriptions written, Amgen said.

The drug had just $40 million in third quarter sales. Amgen
said if all Repatha prescriptions written had been filled it
would be well on its way to being a $1 billion drug.

Regeneron has run into similar resistance to Praluent with
insurers refusing to pay for it.



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