Semaglutide (Novo Nordisk)

New Delhi: Setting its sights on high-growth therapeutic areas Hyderabad-based drugmaker Granules India is preparing to boost its product portfolio with several inhouse candidates and plans to launch its big-ticket oncology and GLP-1 candidates over the next five years, starting FY28. In an exclusive interaction with ETPharma Granules India Executive Director (ED) Priyanka Chigurupati shared that, “In the US market, we have between 11-15 product launches in the pipeline across our core OTC and prescription (Rx) segments particularly in CNS and ADHD. Several of these products have already received regulatory approval and will be launched soon.” According to the senior executive, some approvals have been delayed due to the warning letter situation, and the drugmaker is looking to approach the authorities for a meeting or reinspection by September this year. In February this year, the company's Gagillapur facility received a warning letter from the FDA based on an inspection undertaken in August 2024. Following the inspection, the company voluntarily paused the plant's operations to conduct a thorough risk assessment and implement a comprehensive remediation plan. Notably, the plant is one of the company’s largest production facilities, with a finished dosage (FD) capacity of 26.8 billion units and a pharmaceutical formulation intermediate (PFI) capacity of 23,200 tonnes per annum (TPA). 'The company is aiming to ensure its presence across the value chain, with a strong emphasis on the front end. Over the next one to two years, we plan to significantly expand our front-end operations (drug commercialization) and replicate our US growth strategy in other international markets such as Europe, Latin America,” the executive director noted. Over the years, North America has been the key growth driver for Granules', consistently contributing nearly two-thirds of the company's total revenue. In FY25, at ₹3,453 crore the region accounted for 77 per cent of the drugmaker’s total fiscal revenue, up by 16 per cent over the previous fiscal period. To drive its medium-term growth the drugmaker is banking on its oncology pipeline and is looking to start their launch by FY28. "At present, we have filed two products for which final approvals are anticipated by FY28, along with 11 more products in the pipeline. The projected timeline for market launches spans between FY28 to FY35, and aiming to secure 180-day exclusivity for some of these filings,” the executive director told the website. For its core sales driving market--the US, Chigurupati shared that the company is looking to market them by itself while for other markets like Europe, Latin America, it is considering out-licensing options. To unlock its first mover's advantage and immune the portfolio from patent violation lawsuits, the company is choosing the paragraph IV (P IV) certification route A Paragraph IV certification is a statement that a generic drug applicant files, asserting that a listed patent for the brand-name drug is either invalid, not infringed by the generic drug, or will not be infringed by the generic product. According to the FDA under the Abbreviated New Drug Application (ANDA), through a P IV certification, a company can seek its approval “to market a generic drug before the expiration of patents related to the brand-name drug that the generic seeks to copy.” While the patent holder holds the right to file an infringement suit, the approval route opens a window of 180-days of market exclusivity period for the generic applicant. Besides Oncology, the company has also ventured into the peptide space with the acquisition of a Swiss CDMO , Senn Chemicals AG for ₹192 crore. "The acquired entity will help us to make a gradual entry into the CDMO space and within the next five years, peptide will be the potential next big jump that will begin first with contract manufacturing and then be integrated into the portfolio as well," Chigurupati said. At the time of announcing the details, the company's official release stated, “Granules and Senn have been developing two GLP-1 based APIs, and more peptide-based APIs are planned to be added to the portfolio.” While the senior executive did not disclose the details of underdevelopment APIs, but indicated that the company is working on some of the biggest ones and may include some high-profile candidates, such as semaglutide. Strikingly, semaglutide is one of the leading GLP-1 drug in the weight-loss and type 2 diabetes therapy segment. It is currently used as the active ingredient in Danish drugmaker Novo Nordisk’s blockbuster brands—Ozempic, Wegovy , and Rybelsus—and is expected to go off-patent in March 2026. On future acquisitions, the Executive Director shared, “Under our (Granules) forward integration strategy, one potential area for expansion is an injectable facility to support the growth of our API peptide business, but nothing has been finalised at this stage.” “Yet, if something comes, we will ensure it aligns with our acceptable budget limits as we aim to maintain a strong debt-to-EBITDA ratio and keep things within our control,” she added. Commenting on the possibility of expanding the manufacturing base, Chigurupati said that, “in terms of expanding the manufacturing and technical capacities, we are going to stick with our current setup and if there is something that adds strategic value might consider for acquisition or expansion via both organic and inorganic means.” Ever since the drugmaker traversed from APIs, intermediaries (PFIs) to the finished dosage segment in 2008, it had consistently clocked an annual revenue growth of 15–20 per cent, but over the past few fiscals, the numbers have moderated, with FY25 ending in negative territory, recording a 1 per cent year-on-year decline compared to the previous fiscal. However, the senior executive suggests that the ongoing regulatory closures and its planned launches are likely to bring it back on track and regain the momentum. By Abhijeet Singh ,

Scholar Rock said Wednesday its experimental drug apitegromab helped preserve muscle mass in patients taking Eli Lilly's weight-loss treatment Zepbound (tirzepatide), addressing mounting concerns that powerful new obesity medications may cause patients to lose too much lean tissue alongside unwanted fat.Apitegromab is a monoclonal antibody that inhibits myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. Scholar Rock is already developing it for spinal muscular atrophy (SMA), which is the company's primary focus and where the drug succeeded in a Phase III trial last year.  However, the company is one of a handful of others like Regeneron Pharmaceuticals and Biohaven that are testing whether drugs originally designed for muscle-wasting diseases can also help maintain muscle mass in people who want to lose weight."GLP therapies have been an effective and important innovation for individuals living with obesity and cardiometabolic disorders; however, these treatments can result in substantial loss of lean muscle mass for patients, leading to unwanted health risks," remarked Akshay Vaishnaw, Scholar Rock's president of R&D.The Phase II proof-of-concept study enrolled 102 patients with obesity or who were overweight with weight-related conditions. Patients receiving apitegromab with Zepbound lost 12.3% of their body weight after 24 weeks versus 13.4% for the arm that took Zepbound and a placebo.However, the combo arm achieved 85.3% of total weight reduction coming from fat mass, with lean mass accounting for just 14.6% of the weight lost. The placebo group saw 69.5% of the total weight reduction coming from fat and 30.2% from lean mass.The results reported Wednesday validate "our hypothesis that our platform of highly selective myostatin inhibitors has the potential to support healthier weight loss for millions of patients on GLP therapies," Vaishnaw said.From a safety perspective, Scholar Rock said its drug demonstrated an "encouraging safety profile," with no serious adverse events or discontinuations considered to be related to apitegromab treatment. When asked for more details during a company call, Vaishnaw said, "I think no news is good news… Essentially the safety profile looks very much like whatever we're seeing, in the balance between the arms, associated with the tirzepatide effect on the GI tract, which are well known for GLPs."The biotech plans to advance a next-generation subcutaneous anti-myostatin antibody called SRK-439, with an IND application expected in the second half of 2025. "We remain focused on preparing for the launch of apitegromab, and following its potential approval in SMA, we look forward to studying it in a range of neuromuscular diseases," Vaishnaw said.Regeneron recently reported that its anti-myostatin antibody trevogrumab helped preserve lean mass in a Phase II study with Novo Nordisk's Wegovy (semaglutide), while Roche began testing its myostatin antibody RO7204239 in a Phase II study with Zepbound last month.Industry observers also await closely watched data from Eli Lilly's bimagrumab, acquired via its $2-billion Versanis buy in 2023, and which is set to be presented at the upcoming American Diabetes Association (ADA) meeting. The drug targets activin type II receptors to inhibit myostatin and activin, and is being evaluated in a Phase II study, with or without Zepbound. For more, see – Vital Signs: Regeneron stacks the deck for myostatin targeting ahead of Eli Lilly's ADA reveal.