Meda (US$2.7 bn market cap), a Sweden-based specialty company, announced extension of its partnership with Cipla for proprietary
combination nasal spray product (fluticasone and azelastine), which is in Phase III clinical trials in the US.
Cipla/Meda together are developing novel nasal spray using combination of azelastine (anti-histamine) and fluticasone (corticosteroid). Per Meda, NDA submission is likely in 2H10. Today, Meda announced geographic expansion of the deal to include Europe, Japan, Brazil, S Korea and Australia. Cipla will manufacture the product.
Cipla will receive $15 mn milestone payment (including $5 mn upon regulatory approval in the first market). We expect the combination product to be approved in the key US market by 2012, by which time azelastine and fluticasone would likely have high generic penetration. Meda has to show significant clinical benefits for this product to succeed, we believe.