SEASONIQUE an extended cycle oral contraceptive
In August 2006 Shire entered into a license agreement in respect of Duramed Pharmaceuticals, Inc's ('Duramed') oral contraceptive, SEASONIQUE. Duramed markets SEASONIQUE in the US. Shire has the rights to market this product in a number of territories outside of North America, including the larger European markets.
On February 24, 2009, Shire and Duramed amended this agreement and it will terminate on December 31, 2009. Pursuant to this amendment, Shire agreed to return to Duramed its rights under the agreement effective February 24, 2009.
Projects in pre-clinical development
A number of projects are underway in the early stages of pre-clinical development for the Specialty Pharmaceuticals area.
Human Genetic Therapies
Treatments for Angioedema
FIRAZYR for hereditary angioedema ('HAE') in the US
FIRAZYR is a treatment for acute HAE which Shire added to the portfolio through its acquisition of a majority voting interest in Jerini during 2008. Jerini received a not approvable letter for FIRAZYR for use in the US from the FDA in April 2008, and met with FDA in December 2008 to discuss the development of FIRAZYR. It was agreed that an additional clinical study would be required before approval could be considered and that a complete response to the not approvable letter would be filed after completion of this study. This additional study will be initiated during the third quarter of 2009.
Velaglucerase alfa (GA-GCB) - for the treatment of Gaucher disease
Velaglucerase alfa is an enzyme replacement therapy being developed for
the treatment of Gaucher disease. Shire has completed enrolment in a
worldwide Phase 3 clinical program for velaglucerase alfa. This comprehensive
development program includes the evaluation of velaglucerase alfa in nai
|SOURCE Shire Plc|
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