- Hikma Pharmaceuticals on Thursday announced a partnership with Vectura Group to develop generic versions of GlaxoSmithKline’s Ellipta respiratory medicines, focusing first on Breo.
- The company says it will build on experience gained while trying to bring a copycat of Glaxo’s blockbuster asthma medicine Advair to market. Hikma says interactions with the FDA have led the companies to believe that Vectura's Open-Inhale-Close dry powder inhaler device can win the agency's blessing as generic copies to GSK's Ellipta products.
- Vectura will be responsible for developing the formulation for the products. Hikma, which will be in charge of clinical development, regulatory applications and marketing, will make payments to Vectura upon reaching various milestones, including an initial $15 million at deal signing.
The deal hints at new threats to GSK's respiratory portfolio, which also faces challenges from brand-name rivals and pricing pressures.
Hikma said it will work with Vectura on at least three generic versions of Ellipta products, while development of the Open-Inhale-Close dry power inhaler could yield copies to as many as five GSK medicines.
Ellipta products are a core part of GSK's respiratory business, earning nearly a third of the pharma's total sales for the segment during the third quarter.
Breo Ellipta (fluticasone furoate/vilanterol) — sold as Relvar Ellipta in other markets — is the largest product of the five marketed Ellipta products, with sales growing to £258 million, or about $340 million, during the third quarter
Company executives are already warning investors that Breo is the most vulnerable of the Ellipta products when generics to Advair (fluticasone/salmetrol) enter the market.
Sales of Advair, currently GSK's top-selling respiratory drug, have fallen steadily in recent quarters and are expected to tumble further with generic competition.
Hikma has attempted to win approval of a generic Advair copy before, only to have the Food and Drug Administration reject its application. The company expects to resubmit in 2019.
The threats have GSK focusing more on its biologic Nucala (mepolizumab) as well as its newly approved three-in-one inhaler Trelegy Ellipta (fluticasone fuorate/umeclidinium/vilanterol).