June 18, 2010 / 6:33 AM / 7 years ago

UPDATE 4-Roche, Ipsen drug faces at least 12-18 month delay

* Roche previously aimed for regulatory filings in 2011

* Change in clinical trial protocols causes delay

* Follows hypersensitivity reactions in some patients

* Ipsen shares down 15 pct, Roche 2.5 pct; Novo up 4.4 pct

* Amylin shares up 18 pct, Alkermes up 10 pct

(Adds more analyst comment; Amylin, Alkermes share prices)

By Ben Hirschler

LONDON, June 18 (Reuters) - An experimental diabetes drug being developed by Roche ROG.VX under license from French group Ipsen (IPN.PA) faces a delay of at least 12-18 months after hypersensitivity problems were seen in some patients.

The setback raises questions about the commercial potential of taspoglutide in diabetes -- a disease that is on the rise worldwide and is a key focus for many drug companies -- and helped push share prices for rival drugmakers higher.

“Now the product can’t launch before 2014. We question to some extent whether it can be launched at all,” Jefferies industry analyst Jeffrey Holford said.

He expects the main beneficiary to be Novo Nordisk’s (NOVOb.CO) drug Victoza, which is already on the market and belongs to the same Glucagon-like peptide (GLP-1) class.

Shares of San Diego-based Amylin Pharmaceuticals Inc AMLN.O, which is awaiting a U.S. regulatory decision on its experimental once-weekly GLP-1 drug called Bydureon, rose 18 percent.

J.P. Morgan analyst Cory Kasimov called the news from Roche a “significant break” for Bydureon and upgraded shares of Amylin to “overweight” from “neutral.”

Swiss-based Roche said on Friday it was implementing a risk mitigation plan in the taspoglutide Phase III programme following cases of hypersensitivity reactions to the medicine, which is also given once weekly by injection.

“The impact of this plan on the project and in particular on the timelines for regulatory filing are currently being assessed, however, a minimum of 12 to 18 months delay is anticipated,” Roche said.

It had been aiming to file taspoglutide worldwide in 2011, implying a market launch a year later.

Roche shares fell 2.5 percent, while Ipsen -- a much smaller company whose fortunes are tied closely to the experimental compound -- tumbled 15 percent.


The most common symptoms in patients with hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.

Roche has said in the past that taspoglutide could see peak sales of at least 2 billion Swiss francs ($1.77 billion) if it gets to market.

Analysts, however, had already become more wary about the drug’s prospects before Friday’s news, following tolerability problems reported in scientific abstracts to be released at a big U.S. diabetes meeting this month.

As a result, consensus 2014 sales forecasts are a relative modest $490 million -- a figure that now looks set to tumble further.

Novo shares were up 4.4 percent on the setback for the Roche product, which Morgan Stanley analysts said looked increasingly less competitive against the growing competition in the GLP-1 class.

Amylin is developing Bydureon in partnership with Eli Lilly (LLY.N) and Alkermes Inc (ALKS.O). Shares of Lilly were up 0.5 percent while Alkermes rose 10 percent.

For Roche, given its size, the problems with taspoglutide will not have a significant financial impact. But Deutsche Bank analyst Tim Race said they would hurt investor sentiment since taspoglutide was part of Roche’s strategy to expand sales outside of oncology and into the primary care setting.

Roche exercised its licensing option for taspoglutide from Ipsen in 2006 and acquired exclusive worldwide rights to develop and market the drug, except in Japan where these rights are shared with Teijin and in France where Ipsen has retained co-marketing rights.

(Reporting by Ben Hirschler in London; Additional reporting by Anna Ringstrom in Copenhagen and Deena Beasley in Los Angeles; Editing by Hans Peters, Mike Nesbit, Phil Berlowitz)

$1=1.130 Swiss Franc

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