Vectura and Hikma Pharmaceuticals have announced a deal for development and commercialization of generic versions of GSK’s Ellipta dry powder inhalers. Hikma will pay Vectura $15 million up front, $5 million at the start of clinical manufacturing for the first product, up to $75 million in development milestones, a percentage of distributable share of net profit on approval of each product, and sales milestones.
A contribution by Vectura toward Hikma’s development costs of up to $70 million will be deferred and later deducted from any profit sharing payments. Vectura will develop the formulations and device, using its Open-Inhale-Close DPI, while Hikma will be responsible for clinical development, regulatory submissions, and commercialization.
The deal covers up to 5 generic versions of Ellipta DPIs, with the companies agreeing to develop at least 3. Development a generic version of Breo Ellipta fluticasone furoate/vilanterol is the top priority and is already underway, the companies said.
Vectura CEO James Ward-Lilley commented, “This is a highly significant and valuable agreement for Vectura, reflecting our increased focus in our complex inhaled generic portfolio. The agreement validates Vectura’s rare, industry-leading development capabilities. It also reflects the strong existing relationship we have with Hikma and their confidence in the future of the substitutable inhaled generic segment including VR315 our joint Advair generic program.”
Hikma CEO Siggi Olafsson said, “The generic respiratory market is a key area of pipeline focus for Hikma. This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus program. By strengthening and expanding our partnership with Vectura, we will develop a pipeline of complex respiratory products that will enable us to deliver sustainable long-term growth.”
In May 2017, the FDA issued a complete response letter in response to Hikma’s ANDA for VR315. In March 2018, Hikma said that the FDA had requested an additional clinical trial and that the company expected to submit new clinical data in 2019.
Read the Vectura press release.
Read the Hikma press release.
