Lupin gains after Florida facility gets EIR from USFDA

Lupin rose 2.92% to Rs 562.95 after the drug major said its Inhalation Research Center in Florida received Establishment Inspection Report (EIR) from the US drug regulator.

Lupin on Monday (30 March) announced the receipt of the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for the company's Inhalation Research Center located at Coral Springs in Florida, USA.

The facility was inspected by the USFDA, between 19th and 26th February 2020, on behalf of the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for Lupin's generic Fostair application to the U.K. MHRA.

Lupin's Inhalation Research Center at Coral Springs, Florida, inaugurated in August 2015, focuses on research and development of respiratoryproducts for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.

Commenting on the receipt of the EIR, Vinita Gupta, CEO, Lupinsaid, The Inhalation Research Centerat Florida was established to develop quality respiratory products to benefit patients across the US and other advanced markets. The receipt of the EIR with satisfactory VAI status validates our commitment towards ensuring the highest levels of quality and CGMP compliance at all our sites. We are grateful for the U.S. FDA's confidence in our team during this critical juncture in the fight against COVID-19, when it has become imperative that we focus onbringinghigh quality respiratory products to market.

Meanwhile, on Friday (27 March), Lupin and Mylan N.V. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for member countries of the EU. The decision on the EC's approval is expected in May 2020. Enbrel had sales of approximately $9.6 billion globally for the 12 months ending December 2019, according to IQVIA.

In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets.

On a consolidated basis, Lupin reported a net loss of Rs 835 crore in Q3 December 2019 as against a net loss of Rs 151.75 crore in Q3 December 2018. Net sales declined 2.75% to Rs 3,716.09 crore in Q3 December 2019 over Q3 December 2018.

Lupin is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world. The firm offers products in the cardiovascular, diabetology, asthma, pediatrics, central nervous system, gastro-intestinal, anti-infectives and non-steroidal anti-inflammatory drug therapy areas.

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