Meda has settled the U.S. Astelin® patent litigation with Apotex

Meda has settled the U.S. Astelin® patent litigation with Apotex

Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has
entered into a settlement agreement with Apotex Inc. and Apotex Corp. (hereafter
Apotex) that resolves the U.S. patent litigation between the companies regarding
Apotex's proposed generic versions of Astelin® and Optivar®.
Astelin® (azelastine hydrochloride nasal spray) is used for treatment of
allergic and non-allergic rhinitis and Optivar® (azelastine hydrochloride
ophthalmic solution) is used for treatment of allergic conjunctivitis. These
products are protected in the U.S. by a patent that expires on 1 November 2010,
with paediatric exclusivity extending until 1 May 2011.

The settlement agreement resolves patent infringement actions filed by Meda
after Apotex's submission of ANDAs (Abbreviated New Drug Applications) to the
U.S. FDA (Food & Drug Administration) for generic versions of Astelin® and
Optivar® in 2006 and 2007, respectively. Under the settlement agreement, Apotex
admits infringement of Meda's patent. Given the settlement agreement, the
parties will jointly request that scheduled trials regarding Apotex's proposed
generic version of Astelin® in May 2008 and proposed generic version of Optivar®
in February 2009 be adjourned and the actions closed.

The settlement agreement allows Apotex to launch a generic version of Astelin®,
under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5%
of their net sales of this product to Meda until 1 February 2011. The agreement
also allows Apotex to launch a generic version of Optivar®, under license from
Meda, on 1 December 2009, without further payments to Meda. 

“This settlement agreement brings clarity to Meda's intellectual property rights
on the U.S. patent for Astelin® and Optivar®,” said Anders Lönner, CEO Meda.

In compliance with U.S. law, the settlement agreement will be submitted to the
U.S. Federal Trade Commission and Department of Justice and is subject to their
review.

This settlement agreement does not settle the two remaining patent infringement
actions brought by Meda in the U.S. against Sun Pharmaceutical Industries Ltd.
(hereafter Sun) regarding a proposed generic version of Optivar® and Cobalt 
Pharmaceuticals Inc. (hereafter Cobalt) regarding a proposed generic version of
Astelin®. The trial with Sun is scheduled to start on 20 July 2009. The trial
with Cobalt has not been scheduled.


For more information, please contact:

Anders Larnholt, Investor Relations, tel. +46 8 630 19 62, +46 709 458 878
email: anders.larnholt@meda.se

MEDA AB (publ) is an international specialty pharma company that concentrates on
marketing and market-adapted product development. Acquisitions and long-term
partnerships are fundamental factors that drive the company's strategy. Meda is
represented with own organisations in 26 countries and with more than 1 500
employees within marketing and sales. Meda's products are sold in approximately
120 countries world-wide. The Meda share is listed under Large Cap on the OMX
Nordic Stock Exchange. Find out more, visit www.meda.se.