CORRECTED-UPDATE 2-Columbia Labs, Watson say drug cuts preterm births by 45 pct

(Corrects analyst’s quote in paragraph 3)

* Cuts risks of pre-mature birth before 33 weeks of

* Cos say on track to file for marketing application in Q2

* Columbia Labs shares touch a new 52-week high of $4.31

(Adds details, analyst comments; updates stock movement)

By Rajarshi Basu and Krishnakali Sengupta

BANGALORE, April 6 (Reuters) – Columbia Laboratories Inc
and Watson Pharmaceuticals Inc said a
late-stage study showed that their vaginal gel helped reduce
incidence of premature birth by almost 45 percent in women with
short cervical length, improving the drug’s chances of getting a
marketing nod.

Columbia Labs shares, which have more than doubled in value
since December 6 — when the company said the drug, Prochieve,
had met the main trial goal of significantly reducing the risk
of premature birth — were trading down 2 percent at $3.89 at
noon on Wednesday on Nasdaq. They had earlier touched a new
52-week high of $4.31.

“This (Wednesday’s) data very much supports approval, the
reason is it shows good statistical significance,” Benchmark
Company analyst Raymond Myers said.

The companies said they were on track to file marketing
application for the drug — a hormone-containing vaginal gel —
in the second quarter of this year.

In December last year, the drug Prochieve, met the main goal
of its late-stage trial by significantly reducing premature
birth risks. [ID:nSGE6B509U].]

The latest data presented the numerical evidence, compared
with the December data, Myers, who has a “buy” rating and a
price target of $7 on the Columbia Labs stock, said.

Preterm birth affects 10-12 percent of all pregnancies in
the United States and costs about $26 billion annually.
Recently, the U.S. health regulators approved a similar drug by
K-V Pharmaceutical Co (KVa.N: Quote, Profile, Research). [ID:nSGE7130A7]

The new set of data suggested that the drug significantly
lowers risk of preterm birth before 33 weeks gestation, compared
with those treated with a dummy drug.

The drug was also associated with a significant reduction in
respiratory distress syndrome, neonatal morbidity or mortality
event and birth weight.

Watson shares were up about a percent at $58.40 on the New
York Stock Exchange.
(Reporting by Krishnakali Sengupta and Rajarshi Basu in
([email protected]; Within U.S. +1 646 223
8780; Outside U.S. +91 80 4135 5800; Reuters Messaging:
[email protected]))

CORRECTED-UPDATE 2-Columbia Labs, Watson say drug cuts preterm births by 45 pct