TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, and Strides Pharma Science Limited (Strides, BSE: 532531, NSE: STAR), a global pharmaceutical company, today announced that the Central Drugs Standard Control Organization (CDSCO) of India has approved TLC’s New Drug Application (NDA) of Amphotericin B Liposome for Injection 50mg (known as Ampholipad® in Taiwan and AmphoTLCTM in India) for immediate importation per approved usage and indication, to aid in the country’s emergency of acute liposomal amphotericin B shortage.
AmphoTLCTM will be imported from Taiwan by Stelis Biopharma Private Limited (Stelis), the biotech arm of Strides group, and will be launched and distributed in India immediately by Strides.
George Yeh, President, TLC, commented: “AmphoTLCTM is the first and only complex generic drug to have achieved bioequivalence to Gilead’s AmBisome, proving its sameness to the safest form of amphotericin B in the world. We are glad that the result of years of our hard work can help India in its times of need. With this approval and prompt delivery of our product, thousands of patients will have the opportunity to receive early treatment with AmphoTLCTM, reducing the fatality rate brought on by the sudden influx of mucormycosis.”
Dr R Ananthanarayanan, CEO and Managing Director, Strides, stated: “We are pleased to partner with TLC for the distribution of liposomal amphotericin B. This approval from CDSCO allows us to immediately import and distribute the product in India and help ease the crisis arising out of an unprecedented rise in Covid-19 related mucormycosis cases. We have expanded our Covid-19 portfolio further with the TLC partnership and reinforced our effort and commitment to fight against this global pandemic.”
Dr. Keelung Hong, Founder, Chairman and CEO, TLC, commented: “TLC appreciates the support of Indian authorities who thoroughly and expeditiously approved AmphoTLCTM. We are pleased to be able to address the current emergency in India by fulfilling an unmet need for one of the safest and most effective drugs to treat COVID-19 patients afflicted with this debilitating infection, and we will start delivering shipments of AmphoTLCTM to India immediately.”
Barbara Li, General Manager, Yung Shin Pharmaceutical Industrial Co., the contract manufacturer for AmphoTLCTM commented: “We are glad to be lending a helping hand in conjunction with TLC in this dark hour, bringing a ray of light by delivering AmphoTLCTM to those in need to help them get over this severe infection.”
AmphoTLCTM is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis. The drug is approved in Taiwan and has been marketed and sold for several years, with a steady increase in the market share each year; market authorization of the drug in China is under review. The approval of AmphoTLCTM in India follows the conduct of complete due diligence by regulators in India based on the numerous years of development TLC has dedicated and its quality performance in the developed markets.
With a soaring number of COVID-19 infections in India, the number of COVID-19 associated mucormycosis (CAM) cases has also been on the rise. Mucormycosis is a serious fungal infection also known as “black fungus”, and CAM is a life-threatening form of mucormycosis which has emerged as a post-COVID complication, infecting about 30% of COVID patients who are diabetic or otherwise immunocompromised. If the progression of infection is not treated early, over 60% of patients could die. The increasing number of CAM cases has resulted in unprecedently high demand for liposomal amphotericin B, the key drug to treat mucormycosis, causing an acute shortage of the drug. Exploitation by sellers on the black market, who are marking up the price of liposomal amphotericin B by three times, is further exacerbating the situation. The steep increase in price and the financial burden it brings is forcing patients to opt for conventional amphotericin B, which is known for its nephrotoxicity, with many patients having to discontinue usage due to renal toxicities.
In light of the ongoing COVID-19 pandemic situation and in response to the humanitarian crisis, the new drug registration for AmphoTLCTM was promptly granted in India. The registration allows for immediate importation of AmphoTLCTM as per approved usage and indication of liposomal amphotericin B in India, including mucormycosis, to help alleviate the urgent need for the drug.