Hikma Pharmaceutical PLC (LON: HIK) announced on 17 December) that it had received necessary approval required from the Food & Drugs Administration (FDA) for launching its generic version of GlaxoSmithKline's Advair Diskus®.
- The dosage strengths to be launched in the US are 100mcg/50mcg and 250mcg/50mcg doses.
- Hikma has been Vectura’s partner in developing the proprietary dry powder inhaler and formulation technology. Based in the UK, Vectura Group is a provider of innovative inhaler drug delivery solutions.
- The British pharma major’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 (COPD).
- The powder is delivered using Vectura’s proprietary lever-operated multi-dose inhaler device technology.
- Vectura will receive a payment of $11 million and will also earn a mid-teen royalty on net sales of the product.
- An estimated sale of $2 billion in the 12 months ending September 2020 has been recorded for the Fluticasone Propionate and Salmeterol Inhalation Powder USP in the US for 100mcg/50mcg and 250mcg/50mcg, according to IQVIA.
- Hikma’s Chief Executive Officer, Siggi Olafsson said that the approval of the generic version of Advair Diskus® has proven to be an important milestone in the company’s strategy in developing more complex respiratory products.
- The shares of Hikma Pharmaceuticals surged after the company disclosed that it had received the approval from FDA.