Recipharm AB provides access to Asmasal Clickhaler dossier for Vectura plc Chinese market approval
Recipharm AB is pleased to announce that it is working with Vectura Group plc to provide access to its licence 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).
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. Recipharm currently supply the product to markets in the UK and France.
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.
Notes to editors
Recipharm AB is a leading contract development and manufacturing organization (CDMO) based in Sweden employing some 1600 employees. The Company operates development and manufacturing facilities in Sweden, France, the UK, Germany and Spain and is headquartered near Stockholm. Recipharm supplies the global pharmaceuticals market with hundreds of different products in multiple dosage forms that include solid dose, semi solids, steriles (liquids and freeze dried), beta-lactams, hormones and dry powder inhalers, oral liquids and granulates. For more information visit www.recipharm.com
About Tianjin KingYork Group Company, Limited
In November 2001, Tianjin KingYork Group Company Limited was established as part of the Tianjin Pharmaceuticals Group Company Limited, which was founded in 1939 and is a State Owned Enterprise (SOE). It has developed into a major enterprise with total assets of RMB 17 billion (£1.8 bn), and includes more than 40 companies. It is currently mainly engaged in the production of corticosteroid API & related products, amino acid API & products, and produces cardiovascular drugs, ointment, injections, tablets and health food products totaling more than 350 products. In 2010, it ranked 7th of National Pharmaceuticals Industry Top 100 and is also one of the Top 500 National Manufacturing Enterprises in 2011. (Source: www.kingyork.biz)
Clickhaler is a marketed, reservoir-based, multi-dose, passive dry powder inhalation device that offers the benefits of ease of use, a dose counter, locking ability as well as a quality look and feel. The products developed in Clickhaler to date, have been designed to be directly comparable to the originator drug, to ensure confidence when switching patients to the lower cost product.
Five products have gained regulatory approvals for the treatment of asthma that are delivered using Clickhaler. Asmasal® and Asmabec® are marketed by Recipharm in the UK, France and Ireland. Asmasal® contains salbutamol, a short-acting beta2-agonist for the rapid relief of asthma symptoms. Asmabec® contains beclometasone, an inhaled steroid used as standard preventative therapy for asthma. Meptin® (procaterol) is a short-acting beta2-agonist for the rapid relief of mild, intermittent asthma symptoms, marketed by Otsuka Pharmaceutical in Japan. Regulatory approvals have also been received for Clickhaler® budesonide in Germany, the Netherlands and New Zealand, with approvals for Clickhaler® formoterol received in Denmark, the Netherlands, South Africa and New Zealand; these products are not currently marketed.
Duohaler is a breath actuated, dry powder inhaler with a novel dual reservoir system that is specifically designed for the co-delivery of two separate formulations of active ingredients for combination therapy. The formulations of the two active ingredients remain separate until the point of delivery, but the formulations are designed to give the same delivery dynamics as co-formulated combinations of active ingredients. The co-delivery of two independent formulations simplifies development and manufacturing and also gives options for delivery of triple therapies and high powder masses. Its novel patented airway design enables the efficient aerosolisation of two formulations with a single inhalation, so that the product remains easy to use.
Vectura Group plc and its subsidiaries is a product development company that focuses on the development of pharmaceutical therapies for the treatment of airway diseases. This growing market includes asthma and chronic obstructive pulmonary disease (COPD) and is estimated to be worth in excess of $30 billion worldwide.
Vectura has seven products marketed by its partners and a portfolio of drugs in clinical development, a number of which have been licensed to major pharmaceutical companies. Vectura has development collaborations and licence agreements with several pharmaceutical companies, including Novartis, Sandoz (the generics arm of Novartis), Baxter, GlaxoSmithKline (GSK) and Tianjin King York Group Company Limited (KingYork).
Vectura seeks to develop certain programmes itself where this will optimise value. Vectura’s formulation and inhalation technologies are available to other pharmaceutical companies on an out-licensing basis where this complements Vectura’s business strategy. For further information, please visit Vectura’s website at www.vectura.com
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