This excerpt taken from the SHPGY 8-K filed Dec 14, 2006.
Basingstoke, UK and Philadelphia, US December 14th 2006 Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that core labelling information, part of Shires Marketing Authorisation Application for MEZAVANT, has been agreed by the regulatory agencies for the 15 European countries (including UK, Germany, France and Spain) participating in the decentralised procedure. Following closure of the decentralised procedure, associated national approvals should follow in the first quarter of 2007, enabling Shire to make a phased launch of MEZAVANT in Europe.
MEZAVANT is the only ulcerative colitis treatment that utilizes novel MMX MULTI MATRIX SYSTEM drug delivery technology to provide gastro-resistant, prolonged release of mesalazine throughout the colon in a once daily dose. Available as a single strength tablet, containing mesalazine 1200mg, MEZAVANT will be indicated both for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis; and for maintenance of remission. In 2005, over 450,000 patients were identified to be suffering with ulcerative colitis in Europe. In the US, the new drug application (NDA) was submitted to the U.S. Food and Drug Administration on December 22, 2005 and the PDUFA date is January 21, 2007.
Shire has in-licensed the exclusive rights from Giuliani S.p.A. to develop and commercialize MEZAVANT in the US, Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A. has developed MEZAVANT from proof of concept to Phase IIa and retains the development and commercialization rights in Italy and in South and Central America. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX MULTI MATRIX SYSTEM technology and owns the trademark, MMX MULTI MATRIX SYSTEM.
This excerpt taken from the SHPGY 8-K filed Nov 3, 2005.
Basingstoke, UK and Philadelphia, US November 3, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces results for the third quarter to September 30, 2005.
This excerpt taken from the SHPGY 8-K filed Jun 7, 2005.
Basingstoke, UK and Philadelphia, US June 7, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) remains committed to protecting the patents which it has relating to ADDERALL XR® , its product for treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Shire has received a second Paragraph IV notice letter from Teva Pharmaceuticals USA, Inc. advising of an amendment to Teva's existing ANDA for generic versions of ADDERALL XR® . The amendment is directed to additional strengths of 5 mg, 15 mg, and 20 mg dosages. As previously announced Teva's February 2005 Paragraph IV notice letter was directed only to 10 mg and 30 mg dosages.
Shire has also previously announced the receipt of Paragraph IV notice letters advising of the filing of ANDAs for generic versions of ADDERALL XR® from Barr Laboratories, Inc., Impax Laboratories, Inc. and Colony Pharmaceuticals Inc. Shire has filed lawsuits against Barr and Impax, the first and second companies to send notice letters. Shire is currently reviewing the details of Tevas Paragraph IV notice letter directed to 5 mg, 15 mg and 20 mg dosages. Shire has previously chosen not to sue Teva for the ANDA directed to the 10 mg and 30 mg dosages.
Barr, Impax, Colony and Teva may not launch a generic version of ADDERALL XR® before receiving final approval of their respective ANDAs from the US Food and Drug Administration (FDA). Should Barr receive a tentative approval from the FDA, it cannot lawfully launch its generic version before the earlier of the expiration of the currently pending 30-month stays or a district court decision in its favor. Neither Impax, Colony nor Teva will be able to lawfully launch a generic version of ADDERALL XR® without the necessary final approval from the FDA and the expiration of the "first to file's" exclusivity rights. The FDA may grant 180 days of generic market exclusivity to the "first to file". The Barr court case is scheduled to go to trial in January 2006. In the Barr case, the 30 month stay for the '819 patent began in January 2003 and with respect to the '300 patent it began in August 2003.
The Impax 30 month stay for the 30 mg product began in November 2003 and for the new strengths of 5 mg, 10 mg, 15 mg, 20 mg and 25 mg in December 2004. The Impax court case has been consolidated and is scheduled to go to trial in February 2006.
This excerpt taken from the SHPGY 8-K filed Apr 29, 2005.
Basingstoke, UK and Philadelphia, US April 29, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces results for the first quarter to March 31, 2005.