Sun Pharmaceutical Industries Ltd.

New Delhi: Amid the growing interest of Indian companies in the rapidly unfolding GLP-1 space, led by the forthcoming LOE window, under its near-focus Alembic pharmaceuticals is developing pipeline of peptides including Tirzepatide while Semaglutide is under consideration, said Pranav Amin, MD, Alembic Pharmaceuticals. In a written response to queries from ETPharma, Pranav Amin, MD, Alembic Pharmaceuticals, stated, “we are developing a differentiated pipeline of complex injectables and peptides including Tirzepatide”-- a blockbuster GIP/GLP-1 dual agonist marketed by US giant Eli Lilly under brand names Zepbound (weight-loss) and Mounjaro (type-2 diabetes). On Semaglutide which is set to lose it exclusivity by early next year, Amin said, “Semaglutide remains under consideration, but we acknowledge we were late for the initial wave of submissions in the US as well as Rest-of-world markets, and are evaluating entry in the second wave.” “While we are evaluating Semaglutide, Tirzepatide represents our near-term focus for which we are aiming to catch the first wave,” he added. Elaborating the company peptide plans—the structural foundation of GLP-1 drugs —the company MD outlined that, Alembic is expanding its strategy of backward integration (APIs) and has invested in a peptide block to manufacture peptides including GLP-1 analogs . Alembic has commissioned its sterile and onco (cancer) injectable facility in FY23, with capabilities spanning vials, lyophilized products, prefilled syringes and microsphere formulations. “Alongside our own portfolio build-out, we are also exploring select CDMO opportunities to leverage available capacity and expand customer partnerships,” Amin said. Both Semaglutide and Tirzepatide are synthetic peptides marketed by Denmark based-Novo Nordisk and US-based Eli Lilly respectively. However they represent different technological and biochemical approaches. The former is a GLP-1 agonist while Tirzepatide is a dual action therapy which targets two incretin hormone receptors, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). As per Lilly 2024 financial results the drug had reported worldwide annual sales of more than $16 billion—$11.5 billion (Mounjaro) and $4.96 billion (Zepbound). For India, a monthly sales tracker PharmaTrac , suggests, in four months since its launch the drug sales have rallied at a two-fold rate reaching ₹98 crore (gross) and ₹47 crore in July alone. Notably as several companies have already advanced their generic formulation plans to later stages like Biocon which is set to file this quarter, garnering a meaningful value traction in an increasingly crowded market remains a tough challenge. Last week, presenting the tracker July updates Sheetal Sapale, VP, Commercial Pharmarack, had noted, “once generics enter the market the game will play out on volume because extracting the same value will be difficult.” While the molecule patent expiry is still a long way off, projections of an impending obesity surge–around 500 million both men and women by Lancet—by 2030 triggered a renewed focus and a strong market potential also viewed by other leading companies such as Sun Pharma, working on their in-house innovators with plans of entering market “in five years.” By Abhijeet Singh ,

There are three oral JAK inhibitors on the market to treat alopecia areata. AbbVie has shown data for Rinvoq that shows it may be set up to become the fourth entrant in the indication. While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.Meanwhile, across the same two Rinvoq doses, 36% and 47.1% of patients achieved 90% or more scalp hair coverage versus just 1.4% of patients in the trial’s control arm, AbbVie said.Rinvoq also met several secondary endpoints in the study by improving eyebrow and eyelash coverage and helping a certain percentage of patients on both doses achieve complete scalp hair coverage at the trial’s 24-week mark."Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes," Kori Wallace, M.D., Ph.D., AbbVie's vice global head of immunology clinical development, said in a release. "UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth."AbbVie did not indicate a regulatory plan for Rinvoq in the indication. The company is awaiting results from a parallel replicate study, which are expected later this quarter. While cross-trial comparisons are often problematic because of differences in timing, patient populations and other variables, Rinvoq appears to provide better results than three other JAK inhibitors currently on the market in the indication.The most recently approved treatment for alopecia, Sun Pharma’s Leqselvi, was tested on 1,220 patients in two trials with an average scalp coverage of 13%. At the 24-week mark, more than 30% of patients saw their scalp coverage increase to at least 80%.Eli Lilly’s Olumiant was approved in 2022 for alopecia based on trials that showed between 17% and 22% of patients taking a 2 mg daily dose achieve 80% scalp coverage after 36 weeks, while 32% to 35% of patients taking a 4 mg daily dose reached the same standard. Pfizer’s Litfulo was approved in 2023 after a study showed 23% of patients reached 80% or more of scalp coverage after six months of treatment.Last week, AbbVie reported Rinvoq’s second-quarter sales at $2.03 billion for a 42% year-over-year increase. The product generated $5.97 billion in revenue last year. The treatment hit the market in 2019 to treat patients with rheumatoid arthritis. Since then, it has been cleared in several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease and ulcerative colitis.

Sun Pharmaceutical has announced it will not expand its US manufacturing footprint, citing concerns over potential reciprocal tariffs following Washington’s announcement of a 25% duty on Indian imports from August 1. CEO Richard Ashcroft confirmed there are currently no plans to increase US production, noting the existing facilities are sufficient for the company’s needs. Chairman Dilip Shanghvi stated that, so far, pharmaceuticals remain exempt from the new tariffs pending the results of an ongoing Section 232 investigation under the US Trade Expansion Act. He added, “Till that time, I think pharma will continue to be exempt from basic tariff.” Sun Pharma reported a 20% decline in April-June consolidated net profit, down to Rs 2,278 crore, mainly due to an exceptional charge of Rs 818 crore. However, operational revenue rose by 10% to Rs 13,786 crore, driven by volume gains and new product launches. First quarter EBITDA increased 19.2% to Rs 4,302 crore, with a margin of 31.1% due to improved raw material cost structure and a stronger branded product mix. US formulation sales contributed over $473 million, accounting for 29.3% of total sales, while Indian formulation revenue reached Rs 4,721 crore (34.2% of sales). The company’s recent US launch of Leqselvi, an anti-baldness drug, and plans to be an early entrant in India’s GLP1 weight-loss market, underscore its innovation push despite global trade headwinds. Industry experts note that while drug formulations and APIs are currently excluded from new tariffs, the final outcome remains uncertain. Sun Pharma’s decision reflects the sector’s cautious approach amidst volatile trade policies.