FDA Rejects 2nd Teva Citizen Petition Against Generic Copaxone
13 Mai 2010 - 3:43PM
Dow Jones News
The Food and Drug Administration has again denied Teva
Pharmaceutical Industries Ltd.'s (TEVA) citizen's petition asking
the agency to block approval of a generic version of its Copaxone
multiple sclerosis treatment.
The Israeli drug giant filed the letter in November after its
initial attempt failed earlier in 2009. The FDA rejected the second
petition for the same reason as the first, because it would be
"premature and inappropriate" to grant Teva's requests, but gave a
detailed response that rejects many of the company's arguments
against the generic approval.
Momenta Pharmaceuticals Inc. (MNTA) and Mylan Inc. (MYL) have
both filed to produce generic versions of Copaxone, a process that
is likely to span years. The drug, one of the world's best selling
MS treatments and a key component of Teva's business, was approved
in 1996. In 2009, it racked up sales of $2.8 billion.
Teva has sued both companies. That triggered an automatic
30-month stay on FDA approval, which is required by a
generics-related law, meaning no generic version of Copaxone can
enter the U.S. market until early 2011.
The rejection letter is dated Tuesday, but was posted on a
government website Wednesday.
The Copaxone battle is notable because it pits the world's
largest generics company, which has benefited from challenging the
patents of other pharmaceutical companies, against generic
competitors to protect the exclusivity of its own brand.
Drug makers can ask the FDA to use special criteria when
considering approval of generic copies of branded drugs, citing
health or safety reasons. The petitions can slow the approval
process and prolong market exclusivity for branded drugs, but
recent rules require the FDA to respond to such requests within six
months.
Officials from Teva, Mylan and Momenta weren't immediately
available for comment.
In its original letter, Teva claims generic drug makers can't
show their drug is a precise copy of Copaxone--a fact that should
preclude market approval. It claimed that current analytical
methods aren't capable of characterizing Copaxone's make-up and
reverse engineering won't create an identical product.
In the latest FDA response, which is eight pages longer than the
previous four-page rejection, the agency repeatedly asserts its
"broad discretion" in determining whether the submitted information
is enough to conclude that the generic product is the same as the
original.
The agency said it will continue to take the specific drug into
account when making its determination, and may require a generic
company to prove sameness "although we cannot state with any
certainty what these criteria may be."
"A finding of sameness does not, however, necessitate a finding
of 'complete chemical identity.' Thus, the Agency may consider
other criteria to determine sameness, taking into account the
complexity of the active ingredient," it said.
Teva had also asserted that tests of a generic version sold in
India and Ukraine produced by Natco Pharma Ltd. (524816.BY)
"differed greatly" from branded Copaxone. Mylan signed a worldwide
marketing and distribution license with Natco for its generic
version of Copaxone in 2008.
The agency called Teva's contentions "unpersuasive" because
those products weren't approved by the FDA and their existence
doesn't preclude the possibility that a generic could meet
"rigorous standards for demonstrating sameness" to Copaxone.
Despite the rejection, the FDA said the information in Teva's
letter will help the agency's assessment of the types of
information needed to support generic Copaxone.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com