Regeneron CEO says Amgen not putting patients first in patent dispute

[January 10, 2017]  By Bill Berkrot

(Reuters) - 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.

Sanofi and Regeneron had no right to sell Praluent, Amgen said in an emailed statement.

Amgen also said the companies were afforded a full and fair opportunity to challenge the validity of Amgen's patents at trial and the jury determined Amgen's patents to be valid.

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.

(Reporting by Bill Berkrot; Editing by Leslie Adler and Sunil Nair)

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