* 63 pct Gattex patients had at least 20 pct PN reduction
* US FDA filing expected second-half 2011
* NPS shares jump 30 percent
(Adds analyst comment, updates share price)
By Deena Beasley
LOS ANGELES, Jan 31 NPS Pharmaceuticals Inc
NPSP.O said its experimental drug Gattex reduced the need for
intravenous feeding in nearly two-thirds of patients with short
bowel syndrome, sending its shares up 30 percent.
The Phase 3 trial showed that 63 percent of patients
treated with the injected drug for 24 weeks had at least a 20
percent reduction in the need for intravenous nutrition,
compared with 30 percent of patients given a placebo.
Short bowel syndrome (SBS) refers to problems related to
poor absorption of nutrients that can occur in people who have
had part of their small intestine removed due to Crohn's
disease, cancer surgery or other conditions.
The trial results "should support Gattex FDA (Food and Drug
Administration) approval and ensure adoption in the SBS
treatment market," Canaccord Genuity analyst George Farmer said
in a research note.
The main goal of the trial was the percentage of patients
who achieved a 20 percent or greater reduction in weekly
parenteral nutrition (PN).
NPS said the 86-patient trial, which tested a 0.05 mg/kg
dose of Gattex, showed that patients given the drug had a 4.4
liter average reduction in weekly PN volume, compared with a
reduction of 2.3 liters for placebo patients.
Patients with SBS typically receive 12 to 13 liters per
week of intravenous feeding, according to NPS.
An earlier 12-month trial -- for which results were
announced in 2007 -- failed to show that a higher dose of
Gattex was effective.
Francois Nader, chief executive officer at NPS, said he
expects a two-year follow-on study will show that, over the
longer term, the lower dose of the drug further reduces the
need for parenteral nutrition.
NPS plans to file for U.S. regulatory review of Gattex,
also known as teduglutide, in the second half of this year.
The drug is an altered version of GLP-2, a
Nader said Gattex works through three mechanisms to improve
nutritional absorption: regeneration of the intestinal lining,
slowing down transit through the gut and increasing blood
Side effects in the trial included nausea and vomiting. One
patient dropped out of the trial due to a Gattex-related
adverse event, and three placebo-treated patients dropped out
due to side effects. Another four patients left the trial for
other reasons, the company said.
NPS has licensed rights to Gattex outside of North America
to Switzerland's Nycomed [NYCMD.UL], but plans to retain U.S.
rights, the CEO said.
Nycomed expects to file in the first half of this year for
approval in Europe, according to NPS.
Nader estimated that there are between 10,000 and 15,000
adult SBS patients in the United States who are chronically
dependent on intravenous nutrition.
The CEO also estimated peak U.S. sales at $350 million.
Shares of NPS were up $2.25 to $9.86 in noon trading Monday
on the Nasdaq.
(Editing by Carol Bishopric, Derek Caney and Tim Dobbyn)