* 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 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
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
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.
SALES FORECASTS SLIDE
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
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
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
(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)