ATLANTA–(BUSINESS WIRE)–Nov 19, 2007 – Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that it has signed an exclusive agreement with Novo Nordisk Inc. to market Prandin(R) (repaglinide). Under the terms of the agreement, Sciele will exclusively market Prandin(R) and, upon approval by the U.S. Food & Drug Administration (FDA), PrandiMet(R) (the name submitted to the FDA for a repaglinide/metformin fixed dose combination tablet) to physicians in the U.S., and will have the right of first refusal to obtain marketing rights in the U.S. to other Novo Nordisk products containing repaglinide, the active pharmaceutical ingredient in both Prandin(R) and PrandiMet(R).Prandin(R) is an oral blood glucose-lowering drug of the meglitinide class used in the management of Type 2 diabetes mellitus. PrandiMet(R) is a combination tablet of repaglinide and metformin.
“This partnership in the U.S. will enable us to increase the oral treatment options for people with Type 2 diabetes to help them gain good glycemic control,” said Martin Soeters, president of Novo Nordisk Inc. “It will also allow Novo Nordisk to concentrate on bringing our complete portfolio of three insulin analogs to health care providers, which provides the most viable opportunity to both help improve patient outcomes and realize our business aspirations, in the name of Changing Diabetes(R).”
Patrick Fourteau, president and CEO of Sciele Pharma, Inc., added, “We are pleased to initiate this partnership with Novo Nordisk, a company that is widely recognized as a global leader in diabetes care. Prandin(R) and potentially PrandiMet(R) (upon FDA approval) fit well within our Diabetes product portfolio and will be an excellent complement to Fortamet(R). Promoted by our Primary Care sales force, Prandin and PrandiMet will strengthen our presence in the diabetes treatment market.”
While specific terms of the agreement were not disclosed, Sciele Pharma may receive revenue based on certain dollar baseline targets being met. The Company expects this agreement to be immediately accretive, and as a result, is increasing its full-year 2008 revenue guidance to $440 million to $455 million, up approximately $10 million over previously announced guidance. The Company also expects full-year 2008 earnings per share to increase to $1.97 to $2.07 per share, up approximately $0.10 from its previously announced guidance. This guidance does not include any unapproved products except the new Sular formulation, or any potential one-time charges related to the new Sular conversion.
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Tags: Conditions & Treatments, Medications, Prandin (Repaglinide), Type 2 Diabetes