AstraZeneca PLC
22 November 2006
AstraZeneca signs distribution agreement with Par Pharmaceuticals for an
authorized generic version of TOPROL-XL
AstraZeneca today announced it has entered into a supply and distribution
agreement with Par Pharmaceutical to distribute an authorized generic version of
metoprolol succinate in the United States. Currently, the authorized generic
product will be distributed in the 25 mg dosage strength. The signing of this
agreement does not affect the availability of AstraZeneca's branded version of
metoprolol succinate, TOPROL-XL. AstraZeneca will continue to manufacture and
make TOPROL-XL available in the United States.
A 25 mg version of metoprolol succinate was launched in the United States
yesterday by Eon Labs, part of Sandoz. The 25 mg dose accounts for an estimated
20 per cent of AstraZeneca's TOPROL-XL sales in the US.
The Full Year EPS guidance of $3.85 to $3.95 announced with the Third Quarter
2006 results excluded any one-off costs and inventory adjustments associated
with the possible launch of generic metoprolol succinate. These one-off costs
and inventory adjustments are now calculated to be approximately $150m or 8
cents per share and will be charged in the fourth quarter. After accounting for
this, the company now expects the full year EPS guidance to be at the lower end
of the $3.85 to $3.95 range previously announced.
On January 17, 2006, a US District Court, in litigation involving KV
Pharmaceutical Company, Andrx Pharmaceuticals LLC, Andrx Corporation, and Eon
Labs Manufacturing, Inc., held the patents covering TOPROL-XL (metoprolol
succinate) extended release tablets to be invalid and unenforceable.
AstraZeneca strongly disagrees with the court's decision, and filed a Notice of
Appeal in February to the US Court of Appeals for the Federal Circuit. A
decision regarding this appeal is pending. The patent protecting TOPROL-XL
expires September 18, 2007.
-ends -
November 22, 2006
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