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Pharma & Bio Ingredients
Mr. Clark and Merck's senior management team have led a Company-wide effort to change every aspect of Merck's business. Under the new operating model, customer focus drives the drug discovery, development, and marketing process.
"During 2006, we have gathered the momentum we need to continue towards the performance goals we established last year: delivering double-digit compound annual earnings per share growth, excluding charges and one-time items, by 2010 from our 2005 base," said Mr. Clark.
"Of course, even as we change our business model, one thing remains the same. We are still a company whose mission is to discover and develop novel medicines and vaccines that address unmet medical needs and to get those products to the people who need them."
Building on the five FDA approvals Merck received in 2006, the company anticipates three NDA filings in 2007 including MK-0518, a first-in-class HIV integrase inhibitor; Gaboxadol, a novel compound from Merck's alliance with H. Lundbeck A/S for the treatment of insomnia; and MK-0524A, an extended-release niacin combined with a novel flushing pathway inhibitor. These filings are in addition to the three products currently under FDA review--Janumet (previously referred to as MK-0431A) for the treatment of type 2 diabetes; Emend IV (MK-0517), an intravenous therapy for chemotherapy-induced nausea and vomiting; and Arcoxia, Merck's selective Cox-2 inhibitor for osteoarthritis.
Of course, Arcoxia faces a tough road ahead. Merck has been advised that the FDA will hold an Advisory Committee meeting, but no timing has been disclosed.
"Our focus on targeted therapeutic areas has helped us advance promising products through every phase of development in our pipeline. In addition to the three anticipated FDA filings in 2007, Merck also has, or expects to have by mid-year 2007, four products in Phase III development," according to Peter S. Kim, Ph.D., president of Merck Research Laboratories.
These four products are:As of Dec. 12, 2006, Merck's pipeline includes 28 distinct therapeutic programs in Phase I and 21 in Phase II. In addition, there are five programs currently in Phase III and three submissions currently under FDA review. In the pipeline review, Merck does not include back-up compounds; additional indications for a compound in the same therapeutic area; or additional claims, line extensions or formulations for existing products.
According to Dr. Kim, "Merck has already delivered an almost four-fold increase in research productivity in its early-stage pipeline since 2002. This is resulting in a progression of candidates into our later stages of development and a sustainable increase in our productivity without compromising Merck's high standards."
