Hikma Pharmaceuticals, through its wholly owned US affiliate, West-Ward Pharmaceuticals Corp. (West-Ward), and Vectura have signed a development and licensing agreement for Vectura’s generic salmeterol product VR730, for the US market.
Generic salmeterol is a generic long acting beta-agonists (LABA) for the treatment of asthma and COPD, delivered using Vectura’s proprietary dry powder inhalation technology and device. According to IMS Health, US sales of inhaled DPI and pMDI LABAs were approximately $150 million in 2015, Hikma noted.
According to the agreement, Hikma will be responsible for the clinical development, manufacture and commercialisation of the product, while Vectura will complete the formulation development of generic salmeterol, which will largely be funded by Hikma.
Vectura will receive an initial payment of $375,000 and potential further development, filing, approval and launch milestones up to an aggregate amount of $1.125 million. Vectura is also eligible for a share of future returns of the product, subject to certain recoveries by Hikma for the costs of the clinical endpoint pivotal trial.
Mike Raya, Chief Executive Officer of West-Ward Pharmaceuticals said, “We are very pleased to be extending our partnership with Vectura. This builds on the strong relationship we have established through our programme for the development of generic Advair Diskus. By leveraging Hikma’s strong R&D, high-quality manufacturing and excellent commercial capabilities, we are successfully executing our pipeline development strategy for our US generics business and improving patient access to high quality, affordable medicines.”
James Ward-Lilley CEO of Vectura, commented:
“Extending collaborations with our existing partners is a key part of our strategy and this agreement reflects the excellent strategic relationship we have with Hikma. VR730 has good market potential and is a logical expansion of our work on the existing generic programmes with Hikma, VR315, the generic Advair programme, and VR506 a generic, inhaled monotheraphy for asthma. This latest agreement further validates Vectura’s technology and value potential in the generics area which was strengthened by the merger with Skyepharma and the addition of the pressurised metered dose platform.
“As well as the development of VR730 with Hikma, the Group is actively pursuing additional generic opportunities with significant potential. As announced in our trading update in September, we are initiating development of three to five new generic inhalation assets that we expect to progress further with partners adding to our exciting pipeline of partnered novel and wholly-owned specialist assets.”