UPDATE: Lilly, Amylin, Alkermes Diabetes Drug Gets EU Backing
April 15 2011 - 11:32AM
Dow Jones News
An injectable once-weekly diabetes drug, Bydureon, being
developed by Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc.
(AMLN) and Alkermes Inc. (ALKS) obtained a key recommendation that
should lead to European regulatory approval.
The Committee for Medicinal Products for Human Use, known as
CHMP, of the European Medicines Agency recommended the approval of
Bydureon. The opinion will be forwarded to the European Commission
for ratification, something that is highly likely and should occur
within two to three months.
The opinion is a positive development for the companies, which
are still hoping to get approval in the U.S. after a rejection of
the drug last year.
The news sent Amylin shares up 13% to $12.67 on heavy volume.
Shares of Alkermes rose 3.5% to $13.88, and Lilly added 25 cents to
$36.
If approved, Lilly will market the drug overseas and will pay
Amylin an undisclosed royalty. Alkermes will collect an 8% royalty
on global sales.
Bydureon is a long-acting version of Byetta, a twice daily drug
from Lilly and Amylin that was approved in 2005.
The FDA declined to approve Bydureon early last year and made
the same move in October, asking for more clinical data. The
companies expect to submit that data and re-apply for approval in
the second half of the year with a projected six-month review.
The initial FDA delays came from requests on details that didn't
require additional studies. But the latest rejection requested a QT
study, which aims to determine potential heart arrhythmia caused by
a drug.
The European decision won't directly impact the FDA review, but
Deutsche Bank analyst Robyn Karnauskas believes the CHMP
recomendation "suggests they view Bydureon safe enough for use and
the U.S. may likely follow." Furthermore, she believes that the
European launch will provide some insight on how Bydureon will fare
in the U.S. if approved.
Lazard Capital Markets analyst William Tanner disagrees about
reading too much into the decision and warns about Bydureon's
prospects, citing competition from other drugs and continued
concerns about its safety.
"We view the EU approval as no indication of whether the FDA
will ultimately approve Bydureon," he said. He projects Amylin
getting a royalty on European sales of $52 million in 2016, based
on sales of $605 million in the region.
The success of Bydureon is key to the future of Amylin, which
hasn't reported a profit since going public in 1992. The drug would
be a positive development for Lilly, a company looking for new
drugs to offset looming generic competition to its top
products.
Last month, Bydureon suffered a setback as it failed to prove as
effective as a once daily treatment. In a study, it failed to
reduce blood-sugar levels as well as Victoza, made by Novo Nordisk
A/S (NVO, NOVO-B.KO). Victoza is already on the market and is in
the same class of drugs as Byetta and Bydureon, but is taken once
daily.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Oct 2024 to Nov 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Nov 2023 to Nov 2024
