Teva Begins Testing Copycat Version Of Biogen, Roche's Rituxan
25 Mai 2010 - 6:40PM
Dow Jones News
Teva Pharmaceuticals Industries Ltd. (TEVA, TEVA.TV) has begun
testing of a copycat version of cancer and rheumatoid arthritis
drug Rituxan, sold by Biogen Idec Inc (BIIB) and Roche Holding AG
(RHHBY, ROG.VX).
The drug may take years to reach the market, something that
isn't assured, but it will be aiming for a large market. Rituxan,
which had 2009 global sales of $5.7 billion, is significant to the
businesses of both Biogen and Roche, which are working on
second-generation versions of the drug.
Rituxan is approved to treat non-Hodgkin's lymphoma, chronic
lymphocytic leukemia and rheumatoid arthritis. According to a U.S.
government website, the Israeli Teva has launched a clinical trial
of the drug, called TL011, in severe, active rheumatoid arthritis
that will be complete in mid-2011.
The recent health-care overhaul opened a regulatory pathway for
biosimilars--the closest thing possible to a genetic version of
complex biotech drugs--and unlike traditional generics the approval
of many of the drugs is expected to require clinical testing. The
market could be large, and Teva projected earlier this year that
about $53 billion in branded biologic sales will be exposed to
biosimilar competition by 2015 through patent expirations
alone.
The testing of Teva's drug, enrolling 60 patients in Germany and
Hungary, will show how the drug interacts with the body in
comparison to Rituxan, along with safety and preliminary
effectiveness data.
Officials from Teva said the drug is part of its joint venture
with Lonza Group AG (LONN.VX) to develop biosimilars. Additional
details weren't available and the company's intentions for the drug
are unclear. It may need to conduct additional testing to bring
such a drug to market in either the U.S. or Europe, where Rituxan
is sold as MabThera.
A Roche spokeswoman said that generic versions of Rituxan need
to go through extensive testing to be safe. "This is of vital
interest to us," she said.
Officials from Biogen weren't immediately available for
comment.
Teva is expected to be a major force in the biosimilars market
and has already filed for approval of a biosimilar version of Amgen
Inc.'s (AMGN) Neupogen, a move that Amgen is trying to block
through litigation.
According to regulatory filings, the main patents related to
Rituxan expire in the U.S. between 2015 and 2018 and in the rest of
the world in 2013.
Roche and Biogen are clearly interested in defending Rituxan.
Earlier this year, they filed a lawsuit alleging that
GlaxoSmithKline PLC's (GSK, GSK.LN) cancer treatment Arzerra
infringes a recently issued patent covering the mechanism of
Rituxan in treating CLL.
Rituxan was approved in 1997 as the first cancer-specific
monoclonal antibody to reach the market and copying such a therapy
would be notable.
The drugs are large proteins produced through biological
processes--usually using Chinese hamster ovary cells--and usually
seek out very specific cell-based targets in the body.
Many current biologic blockbusters are monoclonal antibodies,
including Roche's cancer drug Avastin and Biogen's multiple
sclerosis drug Tysabri, and many more are in development.
Rituxan works by binding to an antigen called CD20, which is
located on the surface of most B cells, a type of immune cell. The
use of Rituxan stops the B cells, which are involved in the
development of multiple types of blood cancers.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com