Recipharm AB has announced that it is working with Vectura Group plc to provide access to its license for the regulatory dossier of Asmasal® for the Chinese regulatory authorities as part of the Chinese market approval process.
The regulatory submission will be led by Vectura’s recently announced new strategic joint venture, Tianjin Kinnovata Pharmaceutical Company Limited (Kinnovata), (http://www.vectura.com/media/press-releases/2013/13-may-2013.aspx).
Asmasal® Clickhaler® is a dry powder inhaler which contains the active ingredient salbutamol which is used in conditions where there is narrowing of the airways, such as asthma or chronic obstructive pulmonary disease (COPD).
Vectura’s Clickhaler® device allows the active to be delivered directly into the lungs.
An application for the import of Asmasal® Clickhaler® (salbutamol) has been filed with the Chinese State Food and Drug Administration (SFDA) and this collaboration will see Recipharm manufacturing finished product for Kinnovata and the Chinese market.
Recipharm will also provide technical assistance to Kinnovata to transfer the manufacturing know-how to Kinnovata facilities in China.
“We are happy to be involved with Vectura’s joint venture in the Chinese pharma market and we believe that we can contribute to this, not just from providing access to the product but also from providing services to Kinnovata until its local manufacturing is up and running” says Carl-Johan Spak, Executive Vice President, Development & Technology at Recipharm.
China’s pharmaceutical market, is growing at a rapid rate and is expected to reach $40B in market size in 2020, making it the 3rd largest pharmaceutical market worldwide.
Recent estimates suggest the overall incidence of asthma in China is approximately 2.0%; of a patient population of more than 25 million people.
COPD is an even bigger challenge, with approximately 42 million people suffering in China, and forecasts estimate that this number will increase to nearly 56 million by 2021.
The agreement between Recipharm and Vectura provides an opportunity for a well established product to be used to help fill the need for affordable treatment in China.