With over 15% -25% of diabetic patients suffering from DFU at least once in their lifetime, DFU is the most prevalent complication caused by chronic diabetes. The approval of NovaLead’s patented repurposed drug is significant because DFU is the leading cause of lower limb amputations globally, with about 100,000 annual incidences in India alone.

“The approval of this drug marks an important moment for people suffering from DFU, who until now had limited drug options for complete wound closure. Approval of this drug is also a demonstration of effective Public-Private partnership as its development was partly funded by BIRAC, a govt. of India initiative.” said Supreet Deshpande, Chief Executive Officer at NovaLead Pharma Pvt. Ltd., Pune – India.

“Although it is a repurposed drug, we developed it as a new drug with comprehensive preclinical and clinical investigations, keeping patient safety at the forefront. Its approval is based on statistically significant positive results over the standard of care treatment in a randomized, double-blind Phase 3 clinical trial,” said Dr. Sudhir Kulkarni, Vice President- of Discovery, at NovaLead.

This drug is a novel topical gel formulation of Esmolol hydrochloride, which is already approved in several countries for cardiac conditions via intravenous injection. Thus, this novel topical gel discovered and developed by NovaLead is a new indication as well as a new formulation to be first launched in India. NovaLead has been granted patents for this drug in several countries including regulated markets of the USA, EU, and Japan.

Atul Aslekar, COO of NovaLead, mentioned that “a start-up traversing the highly challenging drug development cycle right from discovery to approval, spanning over a decade and a half, makes NovaLead a unique success story in Indian pharma”.

“The drug will be made available to the patients of DFU in India by one of the leading Indian pharmaceutical companies through an exclusive IP licensing arrangement with NovaLead. Going forward, NovaLead will focus on the development of this repurposed drug for regulated markets of USA and Europe,” said Supreet Deshpande.

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Phoenix Marketcity Pune, Viman Nagar, Nagar Road, stands firmly against the use of illegal substances. Our policies and practices ensure a safe and secure environment for all our patrons. Our security team is highly vigilant and conducts regular checks to prevent any unlawful activities on our premises. We adhere strictly to all rules and regulations mandated by the state government to maintain a safe and enjoyable shopping experience for everyone.

We are deeply concerned about the misinformation being spread and the unfounded association of our mall with such activities. We request all media outlets and individuals on social media to verify facts before disseminating information. The spread of unverified information can cause undue harm to our reputation and distress among our patrons.

Phoenix Marketcity Pune, Viman Nagar, Nagar Road, remains committed to providing a safe, family-friendly environment. We take pride in our stringent security measures and the trust our visitors place in us. We encourage our visitors to report any suspicious activities immediately to our security team to help us maintain a secure atmosphere for all.”

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The anti-diabetic biosimilar has been launched under the brand name Lirafit and is indicated for improving glycemic control in adult patients with type 2 diabetes mellitus.

Lirafit will sharply lower the daily cost of therapy by around 70% to around INR 100; making the drug more accessible to a larger number of patients with type 2 diabetes mellitus in the country.

PUNE: Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, global pharmaceutical company, has launched a biosimilar of the popular anti-diabetic drug, Liraglutide, for the first time in India. The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI). Priced at around INR 100 for a standard dose of 1.2 mg (per day), this will lower the cost of therapy by approximately 70%, and will be available only under prescription.

Liraglutide belongs to the class of glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, which increase glucose-dependent insulin secretion and decrease inappropriate glucagon secretion.^12,13  It has been approved globally for the management of type 2 diabetes mellitus in adult patients in the United States and the European Union.¹⁴

“Glenmark is proud to introduce Lirafit, a novel and affordable biosimilar of the drug liraglutide, for the first time in India. Clinical trials have shown that it helps improve glycemic control in adult type 2 diabetes mellitus patients along with atherosclerotic cardiovascular diseases (ASCVD) and obesity. Liraglutide has also proven to have a positive impact on cardiac and renal safety outcomes among patients in clinical trials, making it an effective choice of treatment for patients with type 2 diabetes mellitus. With this launch, we have now ventured into the injectable anti-diabetic market taking another significant stride in the diabetes therapy space,” remarked Alok Malik, President and Business Head ‐ India Formulations, Glenmark Pharmaceuticals Ltd.

Liraglutide and its role in the treatment of type 2 diabetes

Liraglutide has a proven efficacy in improving glycemic control in patients with type 2 diabetes mellitus. Clinical trials on Indian adult patients with type 2 diabetes mellitus over 24 weeks have demonstrated Lirafit to be effective, safe, and well-tolerated. The trials also revealed non-inferior efficacy and a safety profile with that of the reference liraglutide. Additional benefits of liraglutide include effectively lowering glycemic parameters, weight reduction, and cardiovascular safety in patients with type 2 diabetes mellitus.  

GLP-1 RA class of drugs and their mechanism of action

GLP-1 RA (Glucagon-like peptide-1 receptor agonists) are a group of drugs used in the treatment of type 2 diabetes. GLP-1 RAs are very effective in lowering blood sugar levels. Several trials have demonstrated that GLP-1 RAs reduce cardiovascular risk in patients with type 2 diabetes mellitusand ASCVD or high cardiovascular risk and have beneficial effects on cardio-renal outcomes beyond their blood glucose-lowering effects in type 2 diabetes patients. Their mechanism of action involves the release of insulin, in the presence of elevated glucose concentrations, thus decreasing glucagon secretion. GLP-1 RAs are recommended in the treatment guidelines by the American Diabetes Association as well as the American Association of Clinical Endocrinology (AACE) Consensus Statement & European Society of Cardiology for type 2 diabetes mellitus patients with co-morbidities like established atherosclerotic cardiovascular disease and obesity. The American Diabetes Association (ADA) also recommends GLP1RAs therapy for weight loss & lesser risk of hypoglycemia in type 2 diabetes mellitus patients.^6,7 Drugs belonging to this class include liraglutide, semaglutide, and dulaglutide, among others.

Glenmark’s expertise in diabetes management

Glenmark has a strong legacy of bringing in new, effective, and affordable treatment options for diabetic patients, especially for those suffering from uncontrolled Type 2 diabetes. In 2015, Glenmark was the first to launch the DPP4 inhibitor, Teneligliptin (Zita Plus® and Ziten®), followed by a FDC of Teneligliptin + Metformin (Zita-Met Plus® and Ziten-M®). Glenmark later introduced Remogliflozin (Remo® and Remozen), a novel SGLT-2 inhibitor in 2019; and subsequently, its combinations (Remo-V®, Remozen-V, Remo MV®, and Remozen MV). Glenmark followed that up with the launch of Sitagliptin (Sitazit®) and its FDCs in 2022. Then came Lobeglitazone (LOBG®) and additional FDCs of Teneligliptin, including its combinations with Pioglitazone (Zita Pio), Pioglitazone + Metformin (Zita®-PioMet), Dapagliflozin (Zita-D), and Dapagliflozin + Metformin (Zita® DM). Liraglutide (Lirafit®), a glucagon-like peptide-1 receptor agonist (GLP-1 RA) is the latest affordable offering from Glenmark, marking its entry into the injectable anti-diabetic market.

Prevalence of diabetes in India

As per the ICMR-INDIAB study conducted between October 2008 and December 2020, the overall weighted prevalence of diabetes was 11.4%. According to IQVIA sales data for the 12 months ending August 2023 (MAT August 2023), the market for GLP-1 RA in India is estimated to be INR 259 crores, with an annual growth of 108% against the corresponding period last year (MAT August 2022). 

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Reverse-payment settlements, also known as pay-for-delay, are agreements in which a brand-name drug manufacturer pays a would-be generic competitor—whether in monetary or non-monetary form—to abandon a patent challenge and refrain from offering its generic drug product for a number of years. In this specific case, the plaintiffs, which are purchasers of Bystolic, allege that Forest used the pretext of contemporaneous business deals to mask reverse payments to six would-be generic rivals. Under these deals, the generic rivals agreed to stop challenging Forest’s patents and to refrain from selling generic versions of Bystolic for at least eight years.

In its landmark 2013 decision, Federal Trade Commission v. Actavis Inc., the U.S. Supreme Court held that “large” and “unjustified” reverse payments can violate antitrust laws. Actavis, which stemmed from the FTC’s own pay-for-delay case against several pharmaceutical manufacturers, recognized that while some reverse payments may have legitimate business explanations, others may reflect nothing other than the settling parties’ desire to avoid competition. The Supreme Court placed the burden of justifying reverse payments principally on the defendants.

As detailed in the FTC’s amicus brief, the FTC argued that the U.S. District Court for the Southern District of New York erred when it dismissed plaintiffs’ allegations that Forest’s payments to the drug manufacturers were unjustified and that it wrongly offered its own hypothetical justifications for Forest’s side deals. Plaintiffs challenging a reverse payment settlement only need to plead market power and facts from which a court can infer a large and unjustified reverse payment was tendered.

In this case, the FTC argues plaintiffs did meet these standards. The district court was incorrect in dismissing their claims because the court did not place the burden principally on Forest and the other defendants to justify the reverse payments. As the brief explains, the district court also improperly found facts and drew inferences against the plaintiffs, unfairly faulted them for not producing evidence at the pleading stage, and failed to assess the allegations of the complaint holistically.

Unless corrected, the district court’s ruling threatens to impair the effective enforcement of antitrust laws in the pharmaceutical industry, the FTC told the Second Circuit.

The Commission vote approving the filing of the amicus brief was 3-0.

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