NEW FORMULATION OF EMEND® IV APPROVED IN CANADA

One dose helps prevent chemotherapy-related nausea and vomiting

MONTREAL, May 12 /CNW Telbec/ - Today Merck announced that Health Canada has approved the new intravenous formulation of EMEND® IV (fosaprepitant dimeglumine).  Used in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone, fosaprepitant dimeglumine is indicated for the prevention of acute and delayed nausea and vomiting due to highly emetogenic cancer chemotherapy.1

The new EMEND® IV formulation is given on day one of chemotherapy. According to a study published in the April 10, 2011 issue of Journal of Clinical Oncology, the new formulation was found to be as effective as the standard 3-day oral course of aprepitant for preventing chemotherapy-induced nausea and vomiting (CINV).2 The study also noted that the equally effective single dose formulation could maintain overall therapeutic benefit for patients with greater convenience and adherence.2

"Neurokinin 1 antagonists such as fosaprepitant are an important advance in the prevention of delayed nausea and vomiting for patients undertaking chemotherapy treatment," said Dr. Steven Grunberg, University of Vermont Department of Medicine, lead author and initiator of the study that led to the new EMEND® IV formulation. "The new single dose formulation benefits patients as well as the medical staff. It is a convenient and reliable way of administering this agent to protect our cancer patients from CINV, a common side effect of chemotherapy.  Our goal is to maintain the highest quality of life for patients during chemotherapy".

The oral form of EMEND® remains available and is given as a series of oral doses (125 mg on day 1, 80 mg on day 2, and 80 mg on day 3 of chemotherapy) in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone. Emend® IV may prove to be ideal for patients who have difficulty swallowing, and is a convenient way to deliver this novel anti-emetic.

Over the past ten years new treatments have been developed for control of CINV, however CINV remains a significant problem in the context of current practice.3

Consequences of chemotherapy-induced nausea and vomiting
Approximately 70 to 80 per cent of cancer patients can experience CINV.4 Patients who are beginning cancer treatment consistently list CINV as one of their greatest fears.5 Uncontrolled nausea and vomiting might even influence patients to discontinue their treatment early.3

"Nausea and vomiting are among the most distressing side effects for patients undergoing cancer chemotherapy," added Dr. Grunberg.  "Cancer patients might even consider sacrificing life expectancy to not experience any nausea."

The burden that CINV places on patients with cancer and the healthcare system can be considerable.  In observational studies:

  • 90 per cent of patients affected with both acute and delayed nausea or vomiting due to chemotherapy reported an impact on their quality of life6
  • One in seven patients had a follow-up hospital visit associated with CINV defined as outpatient hospital visit, emergency room visit or hospitalization.  Hospitalization was the most common type of visit for uncontrolled CINV.7

Information about EMEND® IV
EMEND® IV (fosaprepitant dimeglumine), in combination with a 5-HT3 antagonist class of antiemetics and dexamethasone, is indicated for the prevention of acute and delayed nausea and vomiting due to highly emetogenic cancer chemotherapy.

EMEND® IV is contraindicated in patients who are hypersensitive to EMEND® IV, aprepitant, polysorbate 80, or to any ingredient in the formulation and should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.

Fosaprepitant is a prodrug* of aprepitant, and accordingly, its antiemetic effects are attributable to aprepitant.  Aprepitant has a unique mode of action; it is a selective high affinity antagonist at human substance P neurokinin 1 (NK1) receptors.

EMEND® IV is for intravenous infusion only, upon reconstitution and dilution, and for single use only.

About Merck

Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.

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; the impact of pharmaceutical industry regulation and health care legislation; 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 United States 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 2009 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 (www.sec.gov).

EMEND® is a Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Used under license.

Notes:

____________________________
1 EMEND® IV Product Monograph February 8, 2011.
2 Grunberg SG, et al.  Single-dose fosprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized double-blind study protocol. J Clin Oncol 2011; 29:11: 1495-1501.
3 Lachaine J, Yelle L, Kaizer L, Dufour A, et al. Chemotherapy-induced emesis : quality of life and economic impact in the context of current practice in Canada. Supportive Cancer Therapy 2005;2:181-7.
4 NCCN Clinical Practice Guidelines in Oncology; Antiemesis, Version 2.2010.
5 Viale PH. Integrating aprepitant and palonosertron into clinical practice: a role for the new antiemetics. Clin J Oncol Nurs 2005; 9:77-84.
6 Ballatori E, Roila F. Ruggeri B, et al. The impact of chemotherapy-induced nausea and vomiting on health-related quality of life. Support Care Cancer 2007; 15:179-85
7 Burke TA, Wisniewski T, Ernst FR. Resource utilization and costs associated with chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting. Support Care Cancer. 2011 Jan;19(1):131-40. Epub 2010 Jan 26

* A prodrug is inactive until the body's normal metabolic processes converts into its active form.

SOURCE MERCK

For further information:

Elise Giasson
Merck
(514) 428-3711
elise.giasson@merck.com
  Emily Farlow
MT&L  Halifax
(902) 425-1860 ext. 254
efarlow@mtlpr.ca
  Stephanie Lyttle
NATIONAL Public Relations
(514) 843-2365
slyttle@national.ca

 

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