NEWSROOM

NEWSROOM

Merck and Novartis Statement in Response to the FDA’s February 18, 2010 Communication Regarding Long-Acting Beta2-Agonists, including FORADIL® AEROLIZER® (formoterol fumarate inhalation powder)

WHITEHOUSE STATION, N.J., Feb. 18, 2010 -The U.S. Food and Drug Administration (FDA) issued a communication today regarding guidance for long-acting beta2-agonists (LABAs) and LABA-containing medicines, including FORADIL® AEROLIZER® (formoterol fumarate inhalation powder), in the maintenance treatment of asthma. The safety of patients is a primary concern at Merck and Novartis. FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs.

FDA has requested updates to the prescribing information, including a requirement that LABAs only be used concomitantly with other controller medications in the treatment of asthma.

Novartis and Merck will work closely with the FDA to assess the guidance provided in the Communication and determine appropriate next steps. We are committed to helping ensure that healthcare providers and patients have the most accurate and complete information regarding the safe and appropriate use of FORADIL. We will continue communicating with patients, caregivers and healthcare providers about FORADIL in ways that will help inform their decisions about appropriate treatment choices.

Patients or caregivers should talk with their healthcare providers if they have any questions about the appropriate use of FORADIL. Patients currently being treated with FORADIL should not make any changes to their current treatment regimen, except as directed by their healthcare provider.

Currently, FORADIL AEROLIZER is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in those 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma. FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. FORADIL AEROLIZER is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta2-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled, short-acting beta2-agonists.

FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm in those 5 years of age and older when administered on an occasional, as-needed basis.

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

Schering Corporation, a subsidiary of Merck & Co, Inc., has exclusive U.S. distribution and marketing rights to Novartis’ FORADIL AEROLIZER. The product has been available in the United States since 2001.

Important Safety Information about FORADIL® AEROLIZER®
FORADIL® belongs to a class of medications known as long-acting beta2-adrenergic receptor 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 or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.

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.

Forward Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2008 Annual Report on Form 10-K, Schering-Plough’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site:( www.sec.gov.)

FORADIL® is a registered trademark of Astellas Pharma Inc. AEROLIZER® is a registered trademark of Novartis AG.

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