Strides Pharma Science arm gets USFDA nod for Ethacrynic Acid tablets

 

Drug firm Strides Pharma Science on Tuesday said its step down subsidiary has received approval from the US health regulator for Ethacrynic Acid tablets, used to treat fluid retention (edema).

The approved product is a generic version of Edecrin tablets, 25 mg, of Bausch Health Americas.

Strides Pharma Global, Singapore, has received approval for Ethacrynic Acid tablets USP in the strengths of 25 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.

Quoting IQVIA moving annual total (MAT) August 2020 data, Strides Pharma Science said the US market for Ethacrynic Acid tablets USP, 25 mg, is approximately USD 14 million.

The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma in the US market, the company added.

The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 92 ANDAs have been approved and 34 are pending for approval.

Ethacrynic acid is in a class of medications called diuretics (water pills). It is used to treat edema (excess fluid held in body tissues) in adults and children caused by medical problems such as cancer, heart, kidney, or liver disease.

Shares of Strides Pharma Science were trading 0.95 per cent higher at Rs 753.60 apiece on BSE.

Strides Pharma posts threefold rise in profit-before-tax at Rs 103.6 crore

Pharmaceutical major Strides Pharma Science posted a threefold rise in profit-before-tax (PBT) at Rs 103.6 crore for the third quarter ended December 31. It had posted a pre-tax profit of Rs 27.6 crore in the corresponding period of the previous fiscal.

Led by stellar growth in regulated markets, the Bengaluru-headquartered company posted a 358 per cent rise in net profit at 101 crore as compared to the corresponding quarter of the previous financial year.

“Our contrarian strategies continue to play out for the regulated markets, which are now delivering growth with industry leading post R&D EBITDA margins,” said Arun Kumar, founder of the company.

US business clocked $66 million quarterly revenues with 90 per cent revenues from the own front end. However, the performance in the emerging market registering a decline of 62 per cent YoY on account of strategic realignment initiated in the last financial year.

The company posted a 28 per cent growth in revenue at Rs 735 crore as compared with Q3FY19. Its EBITDA margins stood at 25.2 per cent for the period.

Strides Pharma likely to launch affordable insulin from Stelis stable

Strides Pharma Science could get access to the insulin market as Stelis Biopharma, in which it is in the process of acquiring a controlling stake, is building an integrated insulin and insulin analogue platform with proprietary technology.

The Bengaluru-headquartered company believes Stelis could be a disruptor in insulin accessibility and affordability. Strides may commercialise the insulin coming out of the R&D facility in future but has not set a timeline for the same.

A World Health Organization (WHO) report says there are 73 million people suffering from diabetes in India and the prices of insulin in the country have gone up by 20 per cent between June 2018 and June 2019 due to rising demand and a weakening rupee.

“Stelis’ R&D and clinical strategy for insulins are designed for the global markets,” said Strides.

With the prices of insulin rising globally and reports of people rationing the usage, which is even leading to deaths, a breakthrough in insulin affordability would have several takers around the world.

Biopharmaceutical major Biocon had also recently announced that it would be reducing the rates of insulin from the current $5 Rs 350) to 7 cents (Rs 10) per day for lower and middle income countries, including India.

Strides is in the process of reclaiming control of Stelis, five years after it sold its stake to GMS Holdings, and is injecting an additional $40 million in the company. It holds 43 per cent stake in Stelis Biopharma.

Stelis has received over $160 million in investments, of which $91 million is represented by equity capital infused by Strides and its equity partners. The company has already invested $35 million in Stelis.

With the proposed infusion of up to $40 million by the company and pending equity commitments from other partners, Stelis would have attained critical size to break even at the operational level in the next 18 months. At the closing of the proposed investments, Strides would have a controlling stake in Stelis with $75 million investments in the latter.

Strides acquires USFDA approved manufacturing facility in Florida

Strides Pharma Science Ltd on Tuesday said its step down subsidiary Strides Pharma Inc has acquired a US health regulator approved manufacturing facility in Florida from Micelle BioPharma Inc.

"Strides Pharma Inc has acquired the manufacturing facility under an asset purchase agreement with Micelle Biopharma Inc for a consideration of USD 0.5 million (Rs 3.59 crore) and will invest up to USD 10 million (Rs 71.85 crore) to build incremental capabilities and add additional dosage formats," the company said in a regulatory filing.

Strides Pharma Science said the site has undergone several successful USFDA inspections and has no outstanding observations.

"Micelle's facility is based in Riviera Beach, Florida and is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs. It is also the only US Food and Drug Administration (USFDA) approved integrated manufacturing-packaging SGC facility in the US," the company added.

Elaborating on the strategic rationale behind the acquisition, Strides Pharma Science said US business for Strides has seen a significant ramp up over the last few quarters driven by sustained business growth in base products and new product introductions through its own front-end.

SGC is one of the important pivots in the company's growth. Strides has portfolio of over 10 approved SGCs in the US and other regulated markets and a pipeline of 15 SGC abbreviated new drug application (ANDAs) filed/under filing for the US, the company added.

Strides Pharma Science said the company has over 2 billion annual capacity of SGC at its flagship site in Bangalore. The Florida site will augment this capacity and will offer an alternate site to support the company's growth plans.

Strides Pharma Science said with the addition of the Florida site, Strides now has eight formulation sites globally catering to the regulated and emerging markets.

Shares of Strides Pharma Science were trading 1.81 per cent lower at Rs 382.65 apiece on BSE.