According to the company, the approval covers Tofacitinib Tablets indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), moderately to severely active ulcerative colitis (UC), active PsA, and active polyarticular course juvenile idiopathic arthritis (pcJIA).
The regulatory approval has been granted by the U.S. Food and Drug Administration, the company said in its filing. Concord Biotech stated that the approval aligns with its growth strategy and is expected to strengthen its position in the U.S. market. The company added that the clearance allows it to expand its product portfolio and pursue opportunities in the U.S. and international markets.
According to market estimates cited by the company, the U.S. market opportunity for Tofacitinib Tablets across the 5 mg and 10 mg strengths is approximately $500 million. The approval pertains specifically to the company’s ANDA for Tofacitinib Tablets in the two approved dosage strengths. The company said the development supports its long-term growth plans and enhances its ability to participate in the relevant therapeutic segments in the United States.
The company noted that the approval for Tofacitinib Tablets, 5 mg and 10 mg, is expected to strengthen its presence in the U.S. market while broadening its range of offerings. The approval also provides access to a market that the company estimates at approximately $500 million for the two strengths combined.
Concord Q4 snapshot
The R&D-focused biopharmaceutical company reported a 36.8% year-on-year decline in fourth-quarter net profit at Rs 88.8 crore, compared with Rs 140.4 crore in the corresponding period last year, as lower revenue and margin compression weighed on earnings.
Revenue from operations fell 24.1% to Rs 326.1 crore from Rs 429.9 crore a year earlier. EBITDA for the quarter declined 37.8% year-on-year to Rs 118.5 crore, while the EBITDA margin contracted to 36.4% from 44.3% in the year-ago quarter.
Concord share price is down 36% in the last 1 year. (Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
