Schering-Plough Announces Two European Filings

Validations received for combination inhaled asthma maintenance treatment and
for novel oral contraceptive

KENILWORTH, N.J., Aug. 26 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation, (NYSE: SGP), today announced that the European Medicines Agency
(EMEA) has validated (accepted for review) the company's Marketing
Authorization Application (MAA) for a fixed-dose combination of mometasone
furoate and formoterol fumarate for the maintenance treatment of asthma in
patients 12 years of age and older. The company also announced today that the
EMEA has validated the MAA for nomegestrol acetate (2.5 mg) / 17
beta-estradiol (1.5mg), a combined oral contraceptive (COC) containing a
unique combination of a natural estrogen identical to the estrogen produced by
a woman's own body and a selective progestin.

Mometasone furoate/formoterol fumarate combines mometasone furoate, the active
ingredient of the inhaled corticosteroid, ASMANEX(R), with formoterol
fumarate, the active ingredient of the long-acting beta2-agonist, FORADIL(R),
administered via a single metered-dose inhaler.

Marketing approval from the EMEA is being sought for nomegestrol acetate/17
beta-estradiol as an oral treatment for women to prevent pregnancy.

Both applications will follow the Centralized Procedure.

"These two regulatory milestones are important steps toward advancing our
late-stage pipeline and meeting patient needs. If approved by the EMEA, the
mometasone furoate/formoterol fumarate combination would represent an
important additional treatment option for physicians and their patients and
further strengthen Schering-Plough's portfolio of respiratory products," said
Thomas P. Koestler, Ph.D., executive vice president and president,
Schering-Plough Research Institute. "Schering-Plough is also committed to
providing women a variety of birth control options to meet diverse lifestyle
needs and choices."

About the Investigational Mometasone Furoate and Formoterol Fumarate
Combination
Schering-Plough has exclusive worldwide rights for the development and
commercialization of the mometasone furoate and formoterol fumarate fixed-dose
combination. In the United States, a New Drug Application (NDA) for the
fixed-dose combination of mometasone furoate and formoterol fumarate for the
maintenance treatment of asthma in patients 12 years of age and older is
currently under review by the U.S. Food and Drug Administration (FDA).

Combination products containing inhaled corticosteroids and long-acting
beta2-agonists are the largest segment of the worldwide market for asthma and
chronic obstructive pulmonary disease (COPD) medications, in terms of dollar
sales.(1) The fixed-dose combination of mometasone furoate and formoterol
fumarate for the treatment of asthma in patients younger than 12 years of age
and for use in COPD is currently in Phase III development.

About Nomegestrol Acetate/17 beta-estradiol
Nomegestrol acetate/17 beta-estradiol is a combined oral contraceptive in a
monophasic dosing regimen. The progestin (nomegestrol acetate) is derived
from, and structurally similar to, the naturally occurring steroid hormone
progesterone, while 17 beta-estradiol, a natural estrogen is identical to the
endogenous estrogen a woman's body produces on its own. If approved, this
unique monophasic combination of a progestin and natural estrogen can offer
women effective pregnancy prevention.

In clinical trials with nomegestrol acetate/17 beta-estradiol, commonly
reported in-treatment adverse events included acne, weight increase, headache
and irregular withdrawal bleeding.

Nomegestrol acetate/17 beta-estradiol is licensed from Theramex, S.A.M., an
affiliate of Merck KGaA, Darmstadt, Germany. Theramex has retained rights for
marketing and distribution of the product in certain countries. In Europe, the
filing was made by Merck Serono, the division for innovative pharmaceuticals
of Merck KGaA, Darmstadt, Germany. In the U.S., Schering-Plough is working
with the FDA and anticipates filing nomegestrol acetate/17 beta-estradiol in
2010.

About Asthma
Asthma is a chronic lung disease characterised by inflammation of the air
passages, resulting in the temporary narrowing of the airways that transport
air from the nose and mouth to the lungs.(2) Asthma symptoms can be triggered
by allergens or irritants and can include difficulty breathing, wheezing,
coughing, shortness of breath and tightness in the chest.(2)

There are approximately 30 million people living with asthma in Europe, with
as many as six million suffering from severe symptoms. With asthma affecting
as many as 300 million people worldwide, it is now one of the world's most
common long-term conditions and its prevalence is estimated to increase by a
further 100 million by 2025. It is also estimated that asthma accounts for
about 1 in every 250 deaths worldwide, many of which are preventable.(3)
There is no cure for asthma, but asthma can be managed with proper
treatment.(2)

Important Information about ASMANEX(R) TWISTHALER(R) in the U.S.
ASMANEX(R) TWISTHALER(R) (mometasone furoate inhalation powder) is approved in
the U.S. for the maintenance treatment of asthma in patients 4 years of age
and older. ASMANEX TWISTHALER will not relieve sudden asthma symptoms and is
not for children under the age of 4.

ASMANEX TWISTHALER is available in two dose strengths in the U.S., 110 mcg for
children between 4 and 11 years old, and 220 mcg for patients 12 and older.

ASMANEX has not been demonstrated to be effective in treating asthma symptoms
caused by specific asthma triggers.

Important Safety Information for ASMANEX(R) TWISTHALER(R)
ASMANEX(R) TWISTHALER(R) is not a rescue inhaler and should not be used to
treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma
symptoms.

ASMANEX should not be used to treat acute asthma episodes (including status
asthmaticus) where extra measures are required.

ASMANEX is not for patients who have a hypersensitivity (including allergic
reactions) to mometasone or any of the ingredients in ASMANEX. There have been
cases of hypersensitivity, allergic reactions, facial swelling, hives, and
throat tightness reported.

Patients who use inhaled steroid medicines for asthma may develop a fungal
infection of the mouth and throat. Rinse your mouth after using ASMANEX.

It is possible that hypercorticism (an excess level of steroids in your body)
or adrenal insufficiency (your adrenal gland cannot produce enough steroids)
may appear in a small number of patients, particularly when ASMANEX is
administered at higher than recommended doses over prolonged periods of time.
If such effects occur, consult your health care provider as the dosage of
ASMANEX should be reduced slowly.

If you or your child took steroids by mouth and are having them decreased or
are being switched to ASMANEX, you should be followed closely by your health
care provider and the oral steroids should be reduced slowly. Deaths due to
adrenal insufficiency have occurred during and after switching from oral
steroids to inhaled steroids. Tell your health care provider right away about
any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting,
or symptoms of low blood pressure (such as dizziness or faintness). If you or
your child is under stress, such as with surgery, after surgery, or trauma,
you may need steroids by mouth again.

Avoid coming in contact with measles, chicken pox virus, tuberculosis, or any
other infections before or while using ASMANEX. Contact your health care
provider immediately if you or your child have been exposed.

Patients who use inhaled steroids, including ASMANEX, for a long time may have
an increased risk of decreased bone mass, which can affect bone strength.
Patients who are at increased risk of decreased bone mass should be monitored.

Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity
when administered to pediatric patients. The long-term effect on final adult
height is unknown. Health care providers should closely follow the growth of
children and adolescents taking corticosteroids by any route, and reduce each
patient's dose to the lowest dose that effectively controls his/her symptoms.

ASMANEX may increase the risk of some eye problems such as cataracts,
glaucoma, and increased intraocular pressure. Patients with a change in vision
or a history of eye problems should be monitored by their health care
provider.

Use ASMANEX as directed by your health care provider, since its ability to
work in your lungs depends on regular use. Maximum benefit may take 1 to 2
weeks or longer. If your asthma symptoms do not improve, or get worse, contact
your health care provider.

The most common side effects with ASMANEX in patients 4-11 years old include
fever, allergic rhinitis, abdominal pain, vomiting, urinary tract infection,
and bruise.

The most common side effects with ASMANEX in patients greater than or equal to
12 years old include headache, allergic rhinitis, sore throat, and upper
respiratory infection.

Please see additional important product information for ASMANEX TWISTHALER.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Information About FORADIL(R) AEROLIZER(R) in the U.S.

FORADIL(R) AEROLIZER(R) is for the maintenance treatment of asthma in those 5
years and older when taken on a long-term, twice-daily basis. FORADIL
AEROLIZER should only be used as additional therapy for patients not
adequately controlled on other asthma controller medications.

FORADIL AEROLIZER is not indicated for patients whose asthma can be managed by
occasional use of fast-acting rescue inhalers. FORADIL AEROLIZER is also for
the acute prevention of exercise-induced bronchospasm (EIB) in those 5 years
of age and older when administered on an occasional, as-needed basis at least
15 minutes before exercise.

FORADIL AEROLIZER is for the long-term, twice-daily (morning and evening)
administration in the maintenance treatment of bronchoconstriction in patients
with chronic obstructive pulmonary disease (COPD) including chronic bronchitis
and emphysema.

FORADIL is not marketed by Schering-Plough in the European Union.

Important Safety Information for FORADIL(R) AEROLIZER(R) in the U.S.

FORADIL(R) belongs to a class of medications known as long-acting
beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs may
increase the chance of asthma related death. Therefore, FORADIL should only be
used as additional therapy for patients not adequately controlled on other
asthma controller medications.

In asthma clinical trials, the most common adverse events reported with
FORADIL AEROLIZER were viral infection, bronchitis, and chest infection.

In COPD clinical trials, the most common adverse events reported with FORADIL
AEROLIZER were upper respiratory infection, back pain, and sore throat.

FORADIL capsules should only be inhaled orally using the AEROLIZER inhaler.
The capsules should not be swallowed.

FORADIL AEROLIZER should not be used to treat acute symptoms. Acute symptoms
should be treated with fast-acting rescue inhalers. Do not use more than one
capsule twice daily. FORADIL AEROLIZER should be used with caution in patients
with cardiovascular disorders. FORADIL AEROLIZER is not a substitute for
inhaled or oral corticosteroids and, in the treatment of asthma, they should
not be stopped or reduced at the time FORADIL AEROLIZER is initiated.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see additional important product information for FORADIL AEROLIZER.

About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care
company. Through its own biopharmaceutical research and collaborations with
partners, Schering-Plough creates therapies that help save and improve lives
around the world. The company applies its research-and-development platform to
human prescription and consumer products as well as to animal health products.
Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors,
patients, customers and other stakeholders served by its colleagues around the
world. The company is based in Kenilworth, N.J., and its Web site is
www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including statements
relating to the plans for, the potential of and the potential market for
investigational mometasone furoate/formoterol fumarate MDI and nomegestrol
acetate/17 beta-estradiol. Forward-looking statements relate to expectations
or forecasts of future events. Schering-Plough does not assume the obligation
to update any forward-looking statement. Many factors could cause actual
results to differ materially from Schering-Plough's forward-looking
statements, including the regulatory process for approval of investigational
mometasone furoate/formoterol fumarate MDI and nomegestrol acetate/17
beta-estradiol, among other uncertainties. For further details about these
and other factors that may impact the forward-looking statements, see
Schering-Plough's Securities and Exchange Commission filings, including Part
II, Item 1A. "Risk Factors" in the Company's second quarter 2009 10-Q, filed
July 24, 2009.

References
1. IMS Midas data, 2003-2008.
2. "Asthma Facts and Figures." Asthma and Allergy Foundation of America, 2005.
Available at: http://www.aafa.org/display.cfm?id=8&sub=42.
3. Masoli, Matthew, "Global Burden of Asthma." Medical Research Institute of
New Zealand, December 2003.

SOURCE Schering-Plough Corporation

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