Torrent Pharmaceuticals Ltd.

Novartis has filed a lawsuit against the FDA after the agency approved a generic version of its top-selling product Entresto. Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.”What the company appears to be finding unmanageable, however, is potential near-term generic competition to its heart failure blockbuster Entresto.On Wednesday afternoon in federal court in Washington, D.C., the Swiss company filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful.The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-orchestrated Citizen Petition, which asked it to block the entry of generic versions of Entresto.The petition, which was submitted in September 2022, had asked the agency to deny the approval of any Entresto generic until Feb. 16 of this year. It also petitioned to prevent the FDA from approving any Entresto generics that would violate Novartis patents due to expire in 2033 and 2036. The FDA rejected the first request because it has already passed. The second and third requests were denied because the agency said that generics can avoid infringement simply by adjusting their labels.Novartis is seeking to preserve U.S. exclusivity for Entresto as long as possible. The company owns a series of patents on the drug, with some expiring in 2025, 2026 and 2027, according to FDA records.In 2026, government-negotiated prices Entresto will kick in. Those prices are set to be published Sept. 1 of this year. Entresto was approved by the FDA in 2015. The oral treatment is a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan.In its complaint, Novartis alleges the FDA’s conduct is unlawful because it encourages labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis also argues that MSN’s label for its generic “deletes critical safety information contained in the Entresto labeling.” Further, the company contends that the FDA, in denying Novartis’ petition, has “bound itself to approved generics that do not have identical active ingredients to Entresto.” This is another in Novartis’ attempts to derail generic competition for Entresto. In 2022, the company filed a lawsuit against generic drug makers Viatris, Alembic, Crystal and Nanjing Noratech, as well as MSN. In that complaint, the company claimed infringement against a patent due to expire in November 2026.That suit followed an infringement claim against generics maker Torrent Pharma, which was filed in December 2021.In addition to reaching confidential settlements with "several" generics filers, the company has had mixed success in other court cases against generic drug makers.Entresto is Novartis’ top-selling product, raking in revenue of $6 billion last year and $3.8 billion in the first half of this year.

BOSTON--(BUSINESS WIRE)-- Cycle Pharmaceuticals Limited (Cycle) is pleased to announce the launch of tiopronin delayed-release tablets as a treatment option for patients with cystinuria.1 Tiopronin delayed-release tablets are available in 100 mg and 300 mg doses, and are approved by the US Food and Drug Administration (FDA).1 Generic tiopronin delayed-release tablets must be taken without food.1 Cystinuria is the most common inheritable cause of kidney stone disease. Incidence of the condition is estimated to be 1 in 7,000 worldwide.2 The launch of tiopronin delayed-release tablets is a partnership between Cycle and Torrent Pharma Inc. (Torrent) utilizing Anovo Specialty Pharmacy (Anovo) in which all three companies are committed to providing patients with rare diseases the medication and patient support they need. Tiopronin delayed-release tablets are a treatment option for patients with cystinuria who want to benefit from the support services provided by Cycle Vita™, a dedicated support platform which provides individualized product support* for patients, and ongoing dispensing and support services provided by Anovo, the exclusive specialty pharmacy for this product. “Cystinuria is a chronic lifelong condition in which stones commonly reoccur.3 In addition, close control of a patient’s diet, specifically a reduction in salt and methionine intake, can have an impact on the likelihood of stones forming.3 We are fully aware of the unique personal challenges these patients face in effectively managing their cystinuria. That’s why we’re providing individualized support including a Bridge Program* and Co-pay Assistance Program*. In addition, a Patient Nutrition Program* will be available to reinforce the clinic’s nutrition plan,” says Chikai Lai, SVP & Chief Commercial Officer, Cycle. Tiopronin delayed-release tablets are Cycle’s fifth commercial product to be launched in the US, building on the launch of: NITYR® (nitisinone) Tablets in 2017 SAJAZIR™ (icatibant) Injection in 2021 JAVYGTOR™ (sapropterin dihydrochloride) Tablets for Oral Use and Powder for Oral Solution in 2022; and TASCENSO ODT® (fingolimod) in 2023 Tiopronin delayed-release tablets are indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Tiopronin delayed-release tablets must be taken without food.1 To find out more about Cycle Vita, please visit or call +1 (888) 360-8482 and find the Full Prescribing Information available at . Important Safety Information Important Safety Information is below. Full Prescribing Information is available at . INDICATIONS Tiopronin delayed-release tablets are a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for prevention of cystine stone formation in adult and pediatric patients 9 years of age and older with severe homozygous cystinuria who are not responsive to these measures alone. WARNINGS AND PRECAUTIONS Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Hypersensitivity reactions (drug fever, rash, fever, arthralgia and lymphadenopathy) have been reported. MOST COMMON ADVERSE REACTIONS Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. DRUG INTERACTIONS Alcohol: Tiopronin is released faster from tiopronin delayed-release tablets in the presence of alcohol and the risk for adverse events associated with tiopronin delayed-release tablets when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking tiopronin delayed-release tablets. USE IN SPECIFIC POPULATIONS: Pregnancy: Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes. Tell your healthcare provider immediately if you become pregnant or planning to become pregnant. Lactation: There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. A published study suggests that tiopronin may suppress milk production. Because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. Tell your healthcare provider immediately if you plan on breast feeding. Pediatric Use: Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone. Tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. For more detailed information, please refer to the full Prescribing Information at . If you get any side effects, talk to your healthcare provider. This includes possible side effects not listed in this material. You may also report side effects directly by calling Torrent Pharma Inc. at: 1-800-912-9561 or FDA at: 1-800-FDA-1088 or . This material is for education purposes only. It is not intended to be, and should not be used as, a substitute for medical advice. US-TIO-2400004 (February 2024) References Tiopronin Delayed-Release Tablets. Prescribing Information. Torrent Pharma Inc. Leslie, S.W., Sajjad, H. and Nazzal, L. (2023). Cystinuria. [online] Nih.gov. Available at: [Accessed Feb 9 2024]. Cystinuria UK - Diet - what should I eat (2023). Cystinuria UK - Diet - what should I eat? [online] Cystinuriauk.co.uk. Available at: [Accessed Feb 9 2024]. * Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482. The US Prescribing Information provides the indications for which the product is approved in the US. Please consult the US Prescribing Information and product labeling for information about the specific uses for which the product is indicated in the US. –ENDS– Cycle Vita™, SAJAZIR™ and JAVYGTOR™ are trademarks of Cycle Pharmaceuticals Limited in the United States. NITYR® is a registered trademark of Cycle Pharmaceuticals Limited in the United States. TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC. ©2024 Cycle Pharmaceuticals Limited. All rights reserved. About Cycle Pharmaceuticals Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit and follow us on X, LinkedIn and Facebook. About Torrent Pharma Inc. Torrent Pharma is one of the leading Pharma companies in India. Torrent is the pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). Torrent also has significant presence in diabetology, pain management, gynecology, oncology and anti-infective segments. Torrent Pharma is present in more than 40 countries. It is ranked first amongst Indian Companies for having largest market share in Brazil and Germany. About Anovo Anovo was founded in 2012 as an exclusive provider of comprehensive end-to-end services for manufacturers of rare disease drugs and patients who need the drugs, including specialty wholesale/3PL distribution services, specialty pharmacy services, and patient support hub programs. Anovo benefits all parties involved by navigating all the complexities of managing rare disease medications and providing the related support needed by patients, caregivers and prescribers. View source version on businesswire.com: Contacts Marketing@cyclepharma.com Cycle Pharmaceuticals Tel: +44 1223 354 118 Source: Cycle Pharmaceuticals Limited View this news release online at:

Timely record-keeping, quality control oversight, written procedures and more proved points of contention for FDA investigators, who ran their inspection of Sichuan Deebio Pharmaceutical's plant from Sept. 4-8, 2023. When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list. Now, China’s Sichuan Deebio Pharmaceutical is learning that lesson the hard way in the aftermath of a U.S. regulatory inspection carried out in September. In a Form 483 recently made public, the FDA chided Sichuan Deebio for multiple serious manufacturing and quality lapses at its active pharmaceutical ingredient (API) facility in the Chinese city of Guanghan in the Sichuan province. Timely record-keeping, quality control oversight and written procedures and more proved points of contention for FDA investigators, who ran their inspection of Sichuan Deebio’s plant from Sept. 4-8, 2023. The FDA’s first observation in its manufacturing write-up is perhaps the most damning, centering on the company’s failure to complete lab records in a thorough, consistent and timely manner. The Form 483 relays an especially troubling event during the inspection when Sichuan Deebio’s quality control team leader provided “misleading information” about records on the results of a microbiology test. At first, the quality control chief lied about viewing those test results, logging them and leaving them with another team member on a different floor of the facility, the FDA contends in its report. Then she changed tack, claiming she had not read the results, before switching back to a story similar to her first. At last, the QC chief “finally” admitted that she was “not telling the truth about recording the results on respective data worksheets, and no worksheet existed,” investigators wrote in the Form 483. To make matters worse, investigators subsequently asked the quality leader how she kept track of the test results, to which she replied that they were “in her ‘mind.’” Beyond that infraction, the FDA claimed Sichuan Deebio’s quality control unit “lacks responsibility” to approve procedures, specifications or test methods that weigh on the strength and purity of drug substance. Investigators specifically harangued Sichuan Deebio for poor supervisory oversight of laboratory electronic systems and data. The company also dropped the ball when it comes to writing up established procedures for production and process controls for consistent drugmaking, the FDA said. Further, Sichuan Deebio’s investigation archives for batch failures or discrepancies “do not always include the conclusions and follow-up,” the regulator added. Codified procedures for equipment maintenance and cleaning were subpar as well, the FDA wrote in its Form 483. Lastly, Sichuan Deebio failed to implement control procedures to validate manufacturing processes tied to potential variability of the drug substance the company cranks out. While still less than two months into to 2024, the FDA has already been busy dishing out manufacturing reprimands at a steady pace. In early January, the FDA unleashed a salvo of 483s aimed at Indian drugmakers Dr. Reddy’s, Laurus Synthesis and Torrent Pharmaceuticals, rebuking the companies for problems not limited to record-keeping, employee training, quality lapses and poor equipment hygiene. Later that same month, biosimilar developer Alvotech received yet another Form 483 at its facility in Reykjavik, Iceland. Still, the company was quick to parry with its belief that the “observation is readily addressable,” Alvotech’s CEO Robert Wessman said in a press release last month. Toward the end of January, Aurobindo subsidiary Eugia U.S. received its own production reprimand with a whopping 10 observations at its facility in New Jersey. Among other problems, investigators turned up a damaged HVAC system near a classified aseptic processing line, plus what “appeared to be damage caused by ceiling leaks” next to Eugia’s aseptic processing area.