Zydus and TLC, a specialty pharmaceutical company in Taiwan, today announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC (Amphotericin B Liposome for Injection 50mg) in India.
AmphoTLC is a critical drug to treat Mucormycosis or Black Fungus in India. Under the terms of the agreement, TLC will manufacture and supply AmphoTLC on a non-exclusive basis to Zydus, and Zydus will commercialize AmphoTLC in India.
The Central Drugs Standard Control Organization (CDSCO) of India has approved the New Drug Application (NDA) of TLC for Amphotericin B Liposome for Injection 50mg or AmphoTLC for immediate importation as per approved usage and indication.
AmphoTLC 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. With the surge of infections in India in the recent days AmphoTLC will address the country’s acute liposomal amphotericin B shortage.
Mucormycosis is a serious fungal infection also known as black fungus, and COVID Associated Mucormycosis 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 progression of the infection is not treated early, over 60% of patients could die. The increasing number of CAM cases has resulted in unprecedented demand for liposomal amphotericin B, the key drug to treat mucormycosis, causing an acute shortage of the drug.
AmphoTLC is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis. The drug is approved in Taiwan and has been manufactured and sold by Yung Shin Pharmaceutical Industrial Co. (YSP) for several years. The approval of AmphoTLC in India follows the conduct of comprehensive due diligence by regulators in India based on the numerous years of development TLC has dedicated as well as its quality performance in the developed markets. 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.
Speaking on the development, Sharvil Patel, Managing Director, of Cadila Healthcare Ltd, said, “With India facing an acute shortage of the drug to treat mucormycosis, we are making this critical drug available in India on an immediate basis. The need of the hour is to tackle this life-threatening infection with a safe and effective therapy.”
Commenting on the speed of the process, George Yeh, President of TLC, said, “We would like to thank Zydus for their quick action and cooperation in enabling a swift commercialization process. TLC is glad to be able to assist in the humanitarian crisis in such a quick fashion, and as our corporate tagline Delivering Hope for Life depicts, we will be delivering the first batch of AmphoTLC to India to help assuage the urgent need for one of the safest and most effective antifungal drugs very soon.”