Deuruxolitinib Phosphate

New Delhi: India’s largest drug maker Sun Pharmaceutical has no plans to further expand its manufacturing base in the US even as potential reciprocal tariff remains a significant unknown that could disrupt the sector that operates on thin margins. “We have a significant footprint in the United States and at this time we have no plans to move further manufacturing to the US,” Richard Ashcroft, CEO of Sun Pharma's North American business said over an investor call on Thursday. Dilip Shanghvi, chairman and MD, agreed the company’s current manufacturing capacity in the US is good enough and there are no plans to add on there. Onshoring manufacturing or expanding existing base in the US is being seen as one of the options for the Indian generic drug makers to offset tariff impact if it is imposed. Sun Pharma already has its manufacturing facilities in North America. According to Shanghvi the pharma sector continues to be exempt from the US reciprocal tariff levy so far until the outcome of an ongoing investigation under Section 232 of the US Trade Expansion Act. “My understanding is that post 232 investigation report, the US government will decide on the next step. Till that time, I think pharma will continue to be exempt from basic tariff,” Shanghvi said. On Wednesday, the US announced a 25 per cent general tariff on Indian imports from August 1. Though the exact contours of the levy is not yet clear, industry experts said drug formulations and APIs are as of now excluded . A framework announced by the US in April had explicitly exempted pharmaceuticals. Sun Pharma on Thursday reported a 20 per cent decline in its Apr-Jun consolidated net profit to Rs 2,278 crore. However, its revenue from operations rose 10 per cent to Rs 13,786 crore led by volume growth and new product launches. The decline in net profit was mainly on account of a one-time exceptional charge of Rs 818 crore. Its Earnings Before Interest, Taxes, Depreciation and Amortisation (EBITDA) for the first quarter stood at Rs 4,302 crore, up 19.2%, with the resulting EBITDA margin of 31.1 per cent due to improvement in raw material cost, higher specialty sales and branded formulation business in product mix. The company’s US formulation sales were at $473 million, accounting for over 29.3 per cent of total consolidated sales during the quarter. Its formulation sales in India were at Rs 4,721 crore, up by 13.9 per cent, accounting for 34.2 per cent of total consolidated sales for the quarter. "The overall growth reflects steady progress across all our markets. India continues to show strong momentum, contributing meaningfully to our performance,” said Shanghvi. “The US launch of Leqselvi represents an important step forward. It augments our portfolio in dermatology and adds a growth engine," he added. In July, Sun launched its much-awaited novel alopecia or anti-baldness drug Leqselvi in the US following an out-of-court settlement of a patent dispute with US-based Incyte Corp. On plans in the weight-loss drug space, COO Aalok Shanghvi said the company will be in the first wave of GLP1 launch in India. “We are working in that direction so that we come first to the market,” he said. By Rica Bhattacharyya ,

iStock, Nitcharee Sukhontapirom Rinvoq’s efficacy in alopecia areata is “impressive,” according to Guggenheim analysts, who said the drug could have a competitive edge over other JAK inhibitors in the space. AbbVie’s Rinvoq significantly lowered scalp hair loss in a pivotal Phase III study of alopecia areata, positioning the JAK inhibitor as a challenger to other therapies in this space. Calling AbbVie’s readout “impressive” in a Thursday note to investors, Guggenheim analysts noted that Rinvoq is “the dominant JAK inhibitor on the market,” suggesting that it has “a clear advantage over competitors in terms of physician familiarity and patient access.” AbbVie is studying Rinvoq in the Phase III UP-AA program, comprising two pivotal trials that tested 15-mg and 30-mg doses of Rinvoq in patients with severe alopecia areata, defined as having roughly 16% scalp hair coverage at baseline, as measured by scores on the Severity of Alopecia Tool (SALT). Results showed that at 24 weeks, 44.6% of patients on a 15-mg dose of Rinvoq achieved SALT scores indicating at least 80% scalp hair coverage, as compared with 3.4% of placebo comparators. This figure improved slightly to 54.3% in those treated with the 30-mg dose. AbbVie also reported that 36.0% and 47.1% of patients in the respective dose groups saw at least 90% scalp hair coverage versus 1.4% in the placebo group. “We are very impressed by the SALT score ≤ 10 results,” the Guggenheim analysts wrote on Thursday. “The placebo-adjusted SALT score. . .are much higher than what we have seen for other JAK inhibitors in the space,” they added, pointing at Eli Lilly’s Oluminant, Pfizer’s Litfulo and Sun Pharma’s Leqselvi. Guggenheim estimates alopecia areata “to add several hundred million to $1Bn+ in annual sales [for Rinvoq] by the early 2030’s.” AbbVie stock was up about 4% in pre-market trading, just before the company announced its second-quarter earnings Thursday morning. As for safety, AbbVie reported that side effects in Thursday’s readout were “generally consistent” with what had been established for Rinvoq in prior trials. There were no major adverse cardiovascular events (MACE), malignancies or deaths. The pharma expects to report data from another UP-AA study in Q3. Given orally, Rinvoq is a JAK inhibitor approved for various immune-mediated conditions, including Crohn’s disease, ulcerative colitis, atopic dermatitis and psoriatic arthritis. It most recently added to its label with an April approval for giant cell arteritis. The drug works by disrupting signaling pathways involved in the immune and inflammatory response. Its label comes with a boxed warning for serious infections, death, MACE, malignancy and thrombosis. Rinvoq is one of two drugs—the other one being the biologic Skyrizi—that AbbVie is primarily leaning on to soften the blow of Humira’s patent cliff. In 2024, Rinvoq brought in $5.971 billion in global net revenues.