Amylin Tries To Distance Itself From Novo Nordisk Drug
April 06 2009 - 3:13PM
Dow Jones News
Amylin Pharmaceuticals Inc. (AMLN) said Monday that its diabetes
drug Byetta doesn't share a connection to thyroid cancer risk seen
in potential competitor, Novo Nordisk A/S's (NVO) Liraglutide - a
concern that contributed to Amylin losing $1.7 billion in market
value last week.
Despite belonging to the same class of drugs, the San
Diego-based Amylin stressed that the two drugs are distinctly
different molecules and that data already show Byetta doesn't carry
similar risk.
Separately, the company said it remains on track to file a
longer-acting version, in development with Byetta partner Eli Lilly
& Co (LLY) and Alkermes Inc. (ALKS), and that the Food and Drug
Administration should agree to key Byetta label changes soon.
Amylin's attempt to clear the air comes as its shares dropped
19% last week and are down 72% in the last 12 months. They recently
traded Monday down 3.6% to $9.33.
Last week, an FDA panel came to a split vote on whether the
occurrence of a type of thyroid cancer in rodent studies permitted
marketing of once-daily Liraglutide. A panel member, and
subsequently some Wall Street analysts, raised concerns that the
cancer risk could be present in the currently marketed twice-daily
Byetta, or the once-weekly version in development.
"This is not a problem with Byetta," said Orville Kolterman,
head of research and development at Amylin. He noted that the FDA
itself made that statement following the panel meeting.
He added that the company looked for similar effects in both
versions of Byetta, but only saw abnormal amount of those thyroid
cancers in female rats at very high doses.
In Liraglutide, the higher risk was seen in both rats and mice,
and across multiple dosages.
Separately, Kolterman said, Amylin remains on track to file for
marketing approval of the longer-acting version, called Byetta LAR,
by the end of June.
The launch and timing of that new drug, which Lazard Capital
Markets expects to have $1.8 billion in sales as soon as 2012, is
seen as vital to the unprofitable Amylin as sales growth of Byetta
rapidly decelerate.
Though it wasn't a topic at the Liraglutide advisory meeting,
both versions of Byetta continue to be overshadowed by concerns
that they increase the risk of pancreatitis, an inflammation of the
pancreas.
The FDA is expected to approve Byetta for use as a monotherapy,
but that decision has been delayed for months by ongoing
discussions for increased label warnings about pancreatic
risks.
"We have had extensive discussions with the FDA regarding the
pancreatitis issue," Kolterman said. "Based on those discussions,
we believe that resolution of that issue is imminent and will be
forthcoming shortly."
Kolterman pointed to data that show that pancreatitis occurs
more often in the type-2 diabetes patients and findings from an
insurance company database to show that neither Byetta nor Merck
& Co.'s (MRK) Januvia increased pancreatitis risk.
Despite the company's efforts, data released Monday from IMS
Health Inc. (IMS) and cited by multiple Wall Street analysts show
that total Byetta prescriptions for the week ended March 27 fell
14% from a year ago.
The bigger worry for investors is that FDA concern about
pancreatic side effects related to the longer-acting version, which
remains in the body longer, could delay the drug's launch.
"We have not had an indication from the agency of a concern
about LAR," Kolterman said. "But I just need to caution that they
could have concerns and they haven't been expressed yet."
Any questions from regulators will likely come as they review
the application, and Kolterman said he believes the company can
address any issues with the data it continues to collect on the
drugs.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053;
thomas.gryta@dowjones.com