UPDATE 3-U.S. OKs HRA Pharma, Watson’s "morning-after" pill

* FDA: ella can prevent pregnancy up to 5 days after sex

* Pill made by France’s HRA Pharma, Watson to sell in U.S.

* Drug should be available later this year
(Adds comments from Planned Parenthood, conservative group)

By Susan Heavey and Lisa Richwine

WASHINGTON, Aug 13 (BestGrowthStock) – U.S. health officials on
Friday approved a new, longer-lasting “morning-after” pill to
prevent pregnancy after unprotected sex.

The prescription drug, called ella, is made by French
company HRA Pharma and will be sold in the United States by
Watson Pharmaceuticals (WPI.N: ).

It is the first emergency contraceptive approved since a
five-year battle under the Bush administration ended with
limited over-the-counter sales and age checks by pharmacists
for a rival pill.

Ella has been shown to prevent pregnancy for up to five
days after unprotected sex.

The Food and Drug Administration said it cleared ella based
on two clinical trials that showed the drug was safe and
effective. The drug “is not intended for routine use as a
contraceptive,” the FDA said in a statement.

Watson said it planned to launch ella in the fourth quarter
of 2010. The company has not announced a price.

The drug will compete with Teva Pharmaceutical Industries
Ltd’s (TEVA.TA: ) (TEVA.O: ) Plan B, which works for up to three
days after intercourse. Plan B is available without a
prescription for those aged 17 and older, but ella will require
a prescription for all ages.

Plan B, first cleared as a prescription drug in 1999, saw
dozens of medical and other groups push for over-the-counter
use starting in 2001. The Bush administration approved limited
“behind-the-counter” sales in 2006.

Watson sells a generic version of Plan B called Next

While morning-after pills have not been huge money-makers,
they have generated controversy, especially in the United

Sex, birth control and abortion are perennial political
hotbeds even though emergency birth control drugs had been
available for decades.

Conservatives, Republicans and other critics have said
making another morning-after pill available — one that works
even longer after sex — will further promote promiscuity. They
also question ella’s safety and say the drug is more akin to an
abortion pill than birth control.

“The FDA opted against including the critical fact that
ella can cause an abortion on a baby already implanted in its
mother’s womb in the drug labeling information,” Jeanne
Monahan, director of the Center for Human Dignity at the Family
Research Council, said in a statement.

Women’s groups, Democrats and other advocates say the pills
offer women much-needed options to plan their families and
provide a safety net when other birth control methods fail or
women are raped.

“Every woman deserves every option available to prevent an
unplanned pregnancy, and there are many reasons why a woman may
face the risk of unintended pregnancy — from failure or
improper use of birth control, to sexual assault,” Cecile
Richards, president of Planned Parenthood Federation of
America, said in a statement.

Ella is a type of selective progesterone receptor
modulator, making it part of a class of drugs that interfere
with the hormone progesterone that is crucial for pregnancy.
The class also includes the abortion pill known as RU-486, or
mifepristone, and sold as Danco Laboratories’ Mifeprex.

Watson said the overall pregnancy rate for women who took
ella within three days of sex was 1.9 percent, lower than the
anticipated rate of 5.6 percent. For women who took the drug
two days to five days after sex, the pregnancy rate was 2.2
percent, lower than an expected rate of 5.5 percent.

Company officials and the FDA have said ella appears to
work primarily by preventing the release of a woman’s egg for
up to five days after unprotected sex, although the lining of
the uterus is also affected.

Common side effects with ella include nausea, headache and
abdominal pain, according to the company’s clinical data.

Women with known or suspected pregnancy and women who are
breast-feeding should not use ella, the FDA said.

Known chemically as ulipristal, the drug already is sold in
several European countries under the name ellaOne. HRA Pharma
has said it has also begun seeking approval in other
(Additional reporting by Deena Beasley; editing by Bernard Orr
and Carol Bishopric)

UPDATE 3-U.S. OKs HRA Pharma, Watson’s "morning-after" pill