UPDATE: Ranbaxy Launches Generic Valtrex In US, Shares Rise
November 27 2009 - 4:22AM
Dow Jones News
Ranbaxy Laboratories Ltd. (500359.BY) Friday said it has
launched a generic version of GlaxoSmithKline's (GSK.LN)
anti-herpes medicine Valtrex in the U.S., a development expected to
significantly boost its financial results.
Ranbaxy--a unit of Japan's Daiichi Sankyo Co.--launched the
generic drug, valacyclovir hydrochloride, in the U.S on Nov.
25.
The news underscores Ranbaxy's confidence that, despite facing
regulatory issues in the U.S., it will not miss out on
opportunities stemming from being the first to file generic
applications with the Food and Drug Administration.
The news pushed Ranbaxy shares higher on the Bombay Stock
Exchange, where they were up 2.9% to INR442.50 at 0840 GMT, while
the benchmark Sensitive Index was down 2.5%.
Ranbaxy will have a 180-day exclusive marketing period for the
medicine as "first-to-file" status lets it be the only maker of the
drug, other than GlaxoSmithKline, for the first six months from the
patent's expiry.
Annual U.S. sales for valacyclovir tablets stood at $2.2
billion, according to September data from market research firm
IMS.
"Valtrex is expected to contribute $200 million to sales and $80
million to the bottom line during the six months of exclusivity,"
said Sushant Dalmia, pharma analyst at Mumbai-based Angel
Broking.
"Ranbaxy Pharmaceuticals has introduced valacyclovir
hydrochloride, 500 milligram and 1 gram tablets, having previously
been granted U.S. FDA approval for these oral dosage forms," a
Ranbaxy spokesman told Dow Jones Newswires.
"Ranbaxy Pharmaceuticals, being the first to file and to
successfully challenge the valacyclovir patents, is the first
generic pharmaceutical manufacturer entitled to offer an affordable
alternative to the brand," he said.
Ranbaxy Pharmaceuticals Inc., which sells generic products in
the U.S, is a wholly owned unit of Ranbaxy.
Ranbaxy's spokesman said the product is being manufactured from
the production facility of its Ohm Laboratories Inc. unit in New
Jersey.
In July 2007 Ranbaxy settled litigation with GlaxoSmithKline
over the U.S. patent covering Valtrex. Under the agreement, Ranbaxy
was to launch its generic copies of Valtrex in the U.S. in late
2009 with 180-day exclusivity.
It received final approval from the U.S. FDA to manufacture and
sell generic Valtrex in early February 2007.
However, there were doubts Ranbaxy would be able to launch in
time as the FDA banned it from importing more than 30 generic drugs
into the U.S. in September 2008 because of violations of certain
manufacturing practices at its plants at Dewas and Paonta Sahib in
India.
The patent for Valtrex--which was launched in 1995 to treat
genital herpes, cold sores and shingles--expires in 2009 in the
U.S. and Europe, with the exception of Greece and Spain, where it
expired in 2008.
Angel Broking's Dalmia said the generic Valtrex launch
demonstrates Ranbaxy's ability to protect its first-to-file
opportunities, despite facing FDA action and has raised confidence
it will be able to do so again in future.
Ranbaxy had previously lost out on a lucrative opportunity to be
the first to launch a generic version of GlaxoSmithKline's migraine
drug Imitrex in the U.S. because of a delay in receiving FDA
approval.
-By Rumman Ahmed, Dow Jones Newswires; 91-9845104173;
rumman.ahmed@dowjones.com