Merck Announces FDA Approval of KEYTRUDA. Provided to Investors as a Reference

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1 Merck Announces FDA Approval of KEYTRUDA Provided to Investors as a Reference

2 Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of These statements are based upon the current beliefs and expectations of Merck s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck s patents and other protections for innovative products; and the exposure to litigation, including patent 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 2013 Annual Report on Form 10-K and the company s other filings with the Securities and Exchange Commission (SEC) available at the SEC s Internet site (

3 KEYTRUDA: The first anti-pd-1 therapy approved in the U.S. The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Received FDA Breakthrough Therapy designation for advanced melanoma Rapid execution: Clinical program initiation to FDA approval in ~3.5 years KEYTRUDA embodies Merck s commitment to bring forward breakthrough innovations to help people with the most challenging diseases like advanced melanoma.

4 U.S. Market Snapshot: Metastatic Melanoma 76,000 Annual Melanoma Diagnoses (any stage) 10,000 Annual Metastatic Melanoma Patients Treatment Pathway Treatment Pathway 5,000 BRAF wild-type Yervoy (possibly followed by Chemo) KEYTRUDA Chemo OR 5,000 BRAF mutated Taf + Mek or Zelboraf Yervoy KEYTRUDA Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through May 2014

5 Who is being treated for metastatic melanoma today? ~5000 metastatic melanoma patients are being treated each month in the U.S. 25% of these patients may be eligible for treatment with KEYTRUDA based on patients who have previously progressed or those who may progress in the future following treatment with ipilimumab or BRAF inhibitor, if BRAF mutant-positive. Additional patients become eligible over time for treatment with KEYTRUDA due to disease progression on other therapies Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through May 2014

6 Current U.S. Melanoma Market by Treatment 6,000 5,000 4,000 3,000 2,000 1,000 Total Patients Chemo Yervoy Zelboraf Taf+Mek 0 Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through April 2014

7 Value of KEYTRUDA KEYTRUDA is the first anti-pd-1 (programmed death receptor-1) therapy approved in the United States and received FDA s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. Access: Merck is committed to making KEYTRUDA accessible to patients. Support for eligible patients is available through Merck Access Program. Merck s patient assistance program can provide free medicine to eligible patients. Price: The wholesale acquisition cost (WAC) for the 50 mg vial (lyophilized) of KEYTRUDA is $2,158. Like other cancer treatments, the total cost of therapy with KEYTRUDA will vary based on patient weight and how long they receive treatment. For most patients, 3 or 4 vials will be used per infusion. The estimated cost for many patients will be approximately $12,500 per month, which is generally consistent with other innovative oncology medicines. Duration: In the patient population described in the label who received KEYTRUDA 2 mg/kg (n=89), the median duration of exposure was 6.2 months (range 1 day to 15.3 months), with a median of nine doses (range 1 to 23).