Hikma Pharmaceuticals and Vectura Group have signed an agreement for the global development and commercialization of generic versions of GlaxoSmithKline‘s Ellipta portfolio, using Vectura’s proprietary Open-Inhale-Close dry powder inhaler device.

The two companies believe the inhaler device has the potential to be developed as an AB-rated substitutable drug-device combination for the generic versions.

Net sales for Ellipta products in the U.S. are projected to be $4 billion by 2024 and approximately $5.5 billion globally, according to GlobalData (October 2018).

While the program includes the development of generics of up to five GSK respiratory medicines, Hikma and Vectura plan to  commercialize at least three of the products, with a generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) during the first wave.

Breo 100/25 is for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for reducing COPD exacerbations in patients with a history of exacerbations, according to GSK.

As part of the agreement, Hikma will make an upfront payment of $15 million to Vectura and Vectura will be responsible for, and fund, initial device and formulation development.

“The generic respiratory market is a key area of pipeline focus for Hikma,” Siggi Olafsson, chief executive officer of Hikma, said.  “This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus program. 

(Source: Hikma Pharmaceuticals PLC)