R&D Performance Data Summary 2005-2008*
|
2008 |
2007 |
2006 |
2005 |
| Total investment in R&D(US$Bn) |
4.8 |
4.9 |
4.8 |
3.8 |
| Number of people employed in Merck Research Laboratories |
11,000 |
11,700 |
11,400 |
12,400 |
| Number of medicines and vaccines in development, as disclosed at end of year |
47 |
49 |
57 |
58 |
| Number of products approved |
1 |
2 |
5 |
2 |
| Percentage of top 20 global burdens of illness addressed by our products and pipeline (as defined by WHO and excluding accidents, premature birth and self-inflicted injuries) |
53%† |
60% |
N/A |
N/R |
N/R: Not reported.
N/A: Data not available for that year.
*Research activities and investments include all Merck divisions.
†Decrease due mainly to the changing nature of the Global Burden of Disease as defined by WHO.
Merck has a strong commitment to R&D, and we have consistently invested approximately $5 billion in R&D annually.
In 2008, we advanced 31 candidates to the next clinical development stage. As of July 15, 2009, we had 47 candidates in Phase I-III development.
In 2008, Merck gained approval for one new medicine and expanded the use of one medicine and one vaccine:
- EMEND® (fosaprepitant dimeglumine) for Injection 115 mg, for the prevention of chemotherapy-induced nausea and vomitting was approved by the FDA in January 2008. EMEND for Injection provides a new option for day one, as a substitute for EMEND (125 mg) taken orally, as part of the recommended three-day regimen. Prior to the FDA decision, on January 11, 2008, the European Union ("EU") granted marketing approval for EMEND for Injection, known as IVEMEND in the EU, an action that applies to all 27 EU member countries as well as Norway and Iceland;
- CANCIDAS® (caspofungin acetate) a novel drug for the treatment of fungal infections, received approval for expanded use in pediatric patients aged three months to 17 years, in July 2008;
- GARDASIL® [human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant], for the prevention of vulvar and vaginal cancers, in September 2008.
In 2009, we stated our intention to file three new drug applications with the U.S. Food and Drug Administration:
-
MK-7418, rolofylline, a potential first-in-class selective adenosine A1 antagonist being evaluated for the treatment of acute heart failure;
-
MK-0974, telcagepant, our new, first-in-class oral calcitonin gene-related peptide receptor antagonist, which represents a new mechanism for the treatment of migraine;
-
MK-0653C, a combination of ezetimibe, the active ingredient in ZETIA®, with atorvastatin, the active ingredient in Lipitor, as another treatment option for patients with high cholesterol.
On June 5, 2009, Merck reported that the preliminary results for the pivotal Phase III study of rolofylline (MK-7418) showed that rolofylline did not meet the primary or secondary efficacy endpoints, and that while Merck will continue to analyze the data with outside experts, the Company will not file applications for regulatory approval this year.
On April 21, 2009, Merck announced a delay in the US filing of telcagepant (MK-974). A new drug application is no longer expected to be filed with the FDA in 2009. A new timeline will be developed as additional information is available.
TREDAPTIVE® (CORDAPTIVE in Latin America), a lipid-modifying therapy for patients with mixed dyslipidemia and primary hypercholesterolemia, has been approved in 42 countries, including the European Union, as of August 2009. It is currently being launched in international markets and remains investigational in the United States.
On July 8, 2009 the U.S. Food and Drug Administration recently approved an expanded indication for ISENTRESS®, our integrase inhibitor for treating HIV-1 infection, in combination with other antiretroviral medicines in adult patients, including treatment-naïve patients as well as treatment-experienced patients. We are continuing to move forward with filings in additional countries around the world.
We also anticipate regulatory action in 2009 on a supplemental filing submitted to the FDA for GARDASIL, our HPV vaccine, for the new indication for use in males to prevent external genital lesions.
The majority of our research investment is in our in-house research but we are also committed to working with strategic partners who can help us achieve our research and financial objectives. In 2008, Merck signed 46 external deals to leverage innovative science that is conducted outside of Merck.
The content on this page was last modified on September 15, 2009.
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