As with the sale of EQUETRO, these products are being divested as they are no longer core to Shire's strategy of building market leading positions in specialty markets through the development and commercialization of global products with strong intellectual property protection.
FOSRENOL(R) (lanthanum carbonate) - Chronic Kidney Disease ("CKD")
On October 16, 2007 the Food and Drug Administration ("FDA") Cardiovascular and Renal Drugs Advisory Committee recommended the use of phosphate binders, including Shire's FOSRENOL, to treat hyperphosphatemia (elevated levels of phosphorus in the blood) in CKD stage 4 patients. The FDA Advisory Committee's recommendation is not binding on the FDA, and no time has been set by which the FDA will decide whether to follow this recommendation.
ELAPRASE(R) (idursulfase) - Hunter Syndrome
On October 17, 2007 Shire's ELAPRASE was launched in Japan following receipt of marketing and reimbursement approval. As a result of a 2003 agreement, Genzyme Corporation ("Genzyme") will manage sales and distribution of ELAPRASE in Japan. Shire's gross profit on the arrangement will equate to an effective royalty of approximately 25%-30%, but revenues will be recorded in product sales.
Milestones totaling $7 million are due to Shire from Genzyme following marketing and reimbursement approval. These milestones will be recognized into other revenue over the expected duration of the agreement.
JUVISTA(R) (Human TGF beta 3)
On September 12, 2007 Renovo Group plc ("Renovo") announced positive
Phase 2 clinical trial results for its lead drug, JUVISTA. This is the
fifth statistically significant Phase 2 efficacy trial announced by Renovo
and forms part of an ongoing range of Phas
|SOURCE Shire plc|
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