Cipla secures USFDA nod on Sumatriptan nasal spray

The drug major has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan nasal spray, 20 mg from the United States Food and Drug Administration (USFDA).

The product is an AB-rated generic therapeutic equivalent version of GlaxoSmithKline's Imitrex nasal spray. Imitrex is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults.

According to IQVIA (IMS Health), Imitrex nasal spray 20 mg and its generic equivalents had US sales of approximately $53.3 million for the 12-month period ending December 2020.

Separately, Cipla announced that its subsidiary, Cipla Gulf FZ LCC, is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand.

As part of this strategic alliance, Cipla Gulf will be responsible for commercialization of patented biosimilars of the biologic medicine brands, Aflibercept (Eylea), Ustekimumab (Stelara), Denosumab (Prolia, Xgeva) and Golimumab (Simponi). These are leading products covering therapeutic categories across immunology, osteoporosis, oncology as well as ophthalmology (eg. Aflibercept is indicated for nAMD and other serious eye diseases).

The products are developed and manufactured by Alvotech and will be distributed by Cipla Gulf through Australia and New Zealand distribution networks. These innovative products recorded $700 million in aggregate 2020 sales in Australia. Cipla Gulf had previously entered into a similar agreement with Alvotech in July 2019 for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets.

On a consolidated basis, the drug major's net profit surged 112.8% to Rs 752.51 crore on 21.7% rise in net sales to Rs 5,154.17 crore in Q3 FY21 over Q3 FY20.

Shares of Cipla rose 0.70% to Rs 795 on BSE. Cipla is a global pharmaceutical company focused on complex generics, and deepening its portfolio in the markets of India, South Africa, North America, and key regulated and emerging markets.

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