Mundipharma AG Appointed As Development And Marketing Partner For Flutiform In Mexico, Central And South America

LONDON, UK, 28 January, 2016 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug development company, today announces that the Group has entered into agreements with Sanofi Winthrop Industrie (“Sanofi”) and Mundipharma International Corporation Limited to transfer the exclusive development, licensing and marketing rights for flutiform® for Mexico, Central and South America (“Territory”) to the Mundipharma network of independent associated companies (“Mundipharma”).

Mundipharma already has exclusive development, licensing and marketing rights for flutiform® in most markets outside Japan and the Americas. flutiform®, the novel combination of the fast-acting long-acting beta agonist (LABA), formoterol, and the most widely prescribed inhaled corticosteroid (ICS), fluticasone, has been launched, and is being marketed successfully, by Mundipharma in 29 countries and Mundipharma now intends to leverage this experience in the Territory. Sanofi has obtained approvals for the product in Argentina and Colombia and has agreed to transfer these registrations to Mundipharma.

The transfer to Mundipharma follows a review by Sanofi of its strategy in the region and has been implemented by mutual agreement. It has been effected by way of novation of the original development, licensing and marketing agreement which Skyepharma agreed with Sanofi in 2011. Subject to minor adjustments, the terms of the novated agreement remain the same. This transfer has no effect on the contract manufacturing arrangement whereby the Sanofi group manufactures flutiform®, for Skyepharma in its factory in Holmes Chapel, UK.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

“Mundipharma has made very good progress with flutiform in markets around the world and we welcome the opportunity to further extend our partnership with its international network. Mundipharma is in an excellent position to leverage its substantial experience with flutiform and to bring this important new treatment option to patients in Mexico, Central and South America.”

Raman Singh, President, Mundipharma Asia Pacific, Latin America, Middle East and North Africa, said:

“Asthma has a significant impact on people’s quality of life by affecting the most essential function: the ability to breathe. We at Mundipharma have been focused on developing new and innovative asthma treatment options, and this partnership will enable us to leverage our growing success with flutiform in the Latin American region. In the many markets where we have launched flutiform, we have found that it offers a valuable treatment option for patients whose asthma symptoms are not adequately controlled and we believe this will also be the case in Mexico, Central and South America.”

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