Meda and Cipla sue Apotex to enforce Dymista® patents


Meda Pharmaceuticals Inc. and Cipla Ltd. today announced that they sued Apotex
Inc. and Apotex Corp. ("Apotex") in Federal District Court in Delaware to
enforce the Orange-Book listed patents covering Dymista (azelastine
HCl/fluticasone propionate) Nasal Spray in response to Apotex's submission to
the US Food and Drug Administration (“FDA”) of an Abbreviated New Drug
Application (“ANDA”), and accompanying Paragraph IV certification, seeking
approval to market a generic version of Meda’s Dymista prior to expiration of
the Dymista patents.

The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV
certification notice, thus triggering an automatic stay preventing the FDA from
approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered
otherwise by a district court. Meda has the exclusive licenses to U.S. Patent
Nos. 8,163,723 and 8,168,620 covering the Dymista composition and its approved
uses, which does not expire until 2026. Meda holds the New Drug Application
(“NDA”) to manufacture and market Dymista in the US for the treatment of
seasonal allergic rhinitis.

"Meda will vigorously enforce the Dymista patent rights against Apotex and any
other company who challenges these patents", said Dr. Jörg-Thomas Dierks, CEO of
Meda.

Meda and Cipla are jointly represented by attorneys from Sterne, Kessler,
Goldstein & Fox P.L.L.C. and Ashby & Geddes, PA.

For further inquiries, please contact:

For Meda:

Paula Treutiger, VP Corporate Communications & Sustainability
ph: +46 733-666 599
paula.treutiger@meda.se

For Cipla:

Charlotte Chunawala
ph: +91 7506 257 377
charlotte.chunawala@cipla.com

Meda AB discloses the information provided herein pursuant to the Securities
Markets Act and/or the Financial Instruments Trading Act. The information was
submitted for publication on December 3, 2014, at 8:00 CET.

MEDA AB (publ) is a leading international specialty pharma company. Meda’s
products are sold in more than 150 countries worldwide and the company is
represented by its own organizations in over 60 countries. The Meda share is
listed under Large Cap on Nasdaq Stockholm. Find out more, visit www.meda.se.

Cipla Ltd. (publ) Cipla is a global pharmaceutical company which uses cutting
edge technology and innovation to meet the everyday needs of all patients. For
more than 70 years, Cipla has emerged as one of the most respected
pharmaceutical names in India as well as across more than 150 countries. Cipla’s
portfolio includes over 1500 products in various therapeutic categories with one
quality standard globally. Cipla’s turnover in 2013/14 was 1.7 billion USD.

Cipla’s research and development focuses on developing innovative products and
drug delivery systems and has given India and the world many ‘firsts’ for
instance Triomune. In a tightly regulated environment, the company’s
manufacturing facilities have approvals from all the main regulators including
US FDA, UKMHRA, WHO, MCC, ANVISA, and PMDA which means the company provides one
universal standard both domestically and internationally.

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