UPDATE: Roche Diabetes Drug Faces Delay Due To Safety Action
June 18 2010 - 4:08AM
Dow Jones News
Roche Holding AG (ROG.VX) Friday said new safety concerns about
potential billion-dollar drug taspoglutide require deeper
monitoring of patient's response to the medicine, which will push
back a possible launch by as much as 18 months.
Roche said some patients in the ongoing Phase III study proved
to be hypersensitive, showing skin reactions and gastrointestinal
symptoms and less frequently cardiovascular and respiratory
symptoms. All patients recovered without complications.
The incidence of hypersensitivity reactions was higher than
expected although it remains uncommon at less than 1%, according to
the company.
In a media call, Roche executive Fouzia Laghrissi Thode said
Roche took the step proactively, noting the company anticipates a
filing delay of 12 to 18 months at least.
She said she couldn't provide an estimate for a worst-case
scenario.
Analysts said this is bad news. However, the measure indicates
the company is aware the issue needs to be taken seriously,
Vontobel analyst Andrew Weiss said. He has a buy rating on Roche
stock, with a CHF210 price target.
On the Swiss bourse at 0720 GMT, Roche shares fell CHF3.30, or
2.1%, to CHF155.60 in a slightly higher general market.
In April, Roche said taspoglutide showed promising results in a
late phase test, raising chances the drug could live up to its
blockbuster potential if it makes it to the market. It acquired
exclusive worldwide rights to develop and market the drug from
French drugmaker Ipsen (IPN.FR).
Roche believes the drug can become a major seller in the
so-called GLP-1 drug market.
It had expected to file the medicine for approval in the U.S.
and Europe by 2011.
Taspoglutide is the first once-weekly human glucagon-like
peptide-1 analogue being developed to address the unmet needs of
patients with a specific form of diabetes.
Roche's product would be a rival to Novo Nordisk A/S's
(NOVO-B.KO) recently launched Victoza and to Byetta, the diabetes
treatment developed by Amylin Pharmaceuticals Inc. (AMLN) and Eli
Lilly & Co. (LLY). Numerous other drugmakers also have
experimental GLP-1s in development.
Company website: www.roche.com
-By Martin Gelnar, Dow Jones Newswires; +41 43 443 8042;
martin.gelnar@dowjones.com
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