Vectura Earns $11-Million Milestone as Hikma Receives US FDA Approval for Generic Advair DiskusR

Vectura Group plc recently announced its partner Hikma Pharmaceuticals has launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder), 100 mcg/50 mcg and 250 mcg/50 mcg doses, in the US. The launch of the product follows approval by the US FDA.

As a result of this approval, Vectura will receive a milestone payment of $11 million, which will be recognized in 2020, and will earn a mid-teen royalty on net sales of the product.

Hikma’s fluticasone propionate and salmeterol inhalation powder is indicated for the treatment of asthma, the maintenance treatment of airflow obstruction, and for reducing exacerbations in patients with chronic obstructive pulmonary disease. It is delivered using Vectura’s proprietary lever-operated multi-dose inhaler (LOMI) device technology.

This marks the first US FDA approval of a Vectura dry powder inhaler and joins the growing Vectura franchise of approved inhalation devices in Europe and Rest of World such as GyroHaler and FOX.

Will Downie, Chief Executive Officer of Vectura, said “This is excellent news for Vectura and for people living with asthma and COPD in the US. Approval of this high quality substitutable generic product for Advair Diskus validates Vectura’s rare, industry-leading development capabilities and the strong partnership we have with Hikma. Approval of this product paves the way for our substitutable drug-device combination programme, also partnered with Hikma, for generic versions of the GSK Ellipta portfolio, in the coming years.”

Vectura is a provider of innovative inhaled drug delivery solutions that enable partners and customers to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.

Vectura has eleven key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, Bayer, Chiesi, Almirall, and Tianjin KingYork. For further information, visit www.vectura.com.

For more than 40 years, they’ve been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, they are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and they use their unique insight and expertise to transform cutting-edge science into innovative solutions that transform people’s lives. They’re committed to their customers, and the people they care for, and by thinking creatively and acting practically, they provide them with a broad range of branded and non-branded generic medicines. Their 8,600 colleagues are helping to shape a healthier world that enriches all their communities. Hikma are a leading licensing partner, and through their venture capital arm, they are helping bring innovative health technologies to people around the world. For more information, visit www.hikma.com.