2nd UPDATE: Roche Diabetes Drug Faces Delay On Safety Action
June 18 2010 - 4:41AM
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 but noted Roche's quick action,
made possible by its in-house diagnostics capability, indicates the
company is aware the issue needs to be taken seriously.
The drug is still very efficient, Zuercher Kantonalbank analyst
Michael Nawrath said. However, the fact that may increase blood
pressure is clearly a problem, according to the analyst. Nawrath
expects some studies predicting between $2.5 billion to $3 billion
in annual sales for taspoglutide to be revised downwards by "a
quarter or a third," he added. Nawrath expects an approval for the
drug in 2013 rather than in 2011.
Zuercher Kantonalbank has a market outperform rating on the
stock.
On the Swiss bourse at 0900 GMT, Roche shares fell CHF3.90, or
2.5%, to CHF155 in a slightly higher market.
Roche taspoglutide is emblematic for the company's recent
efforts to diversify into areas outside cancer medicines.
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.
Roche's setback boosted Novo Nordisk shares in early Friday
trading, with the stock gaining 3.3%, or DKK16.30 to DKK505 in a
slightly firmer Copenhagen market.
Company website: www.roche.com
-By Martin Gelnar, Dow Jones Newswires; +41 43 443 8042;
martin.gelnar@dowjones.com (johan.anderberg@dowjones.com)
Ipsen (PK) (USOTC:IPSEY)
Historical Stock Chart
From May 2024 to Jun 2024
Ipsen (PK) (USOTC:IPSEY)
Historical Stock Chart
From Jun 2023 to Jun 2024