TLC and Zydus Enter Agreement to Launch AmphoTLC™ in India

Rhea-AI Summary

TLC (NASDAQ: TLC, TWO: 4152) has announced a license supply and commercialization agreement with Zydus Healthcare to market AmphoTLC™ in India. AmphoTLC™, a complex generic drug, is bioequivalent to Gilead’s AmBisome® and aims to address the severe shortage of liposomal amphotericin B in India amidst rising COVID-19 associated mucormycosis cases. TLC received necessary regulatory approvals from India's CDSCO on May 25, 2021, enabling immediate distribution to combat this life-threatening infection.

Positive

• Agreement for commercialization of AmphoTLC™ in India may increase revenue.
• AmphoTLC™ is the only bioequivalent to the established Gilead drug, enhancing credibility.
• Direct response to a critical shortage in India, improving market presence.

Negative

• Acute shortage reflects operational or supply chain vulnerabilities.
• Dependence on Zydus for commercialization may limit TLC's control over market strategy.

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, May 26, 2021 (GLOBE NEWSWIRE) -- TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, and Zydus Healthcare Limited, part of Zydus Cadila group (Zydus) (NSE: CADILAHC), an innovative, global pharmaceutical group that discovers, develops, manufactures and markets a broad range of healthcare therapies, today announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) 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.

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 recent surge of infections in India, AmphoTLC™ will address the country’s acute liposomal amphotericin B shortage.

TLC has obtained the necessary approvals for AmphoTLC™ from the regulatory authorities in India with the assistance of Zydus, including a new drug registration with India’s Central Drugs Standard Control Organization (CDSCO) on May 25, 2021, for immediate importation as per approved usage and indication of liposomal amphotericin B.

Speaking on the development, Dr. 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.”

About AmphoTLC™

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 marketed and sold for several years under the name Ampholipad^®, with a steady increase in market share each year; market authorization of the drug in China is under review. The approval of AmphoTLC™ in India follows the conduct of complete 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.

About mucormycosis

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 progression of the 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.

About Zydus

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics and vaccines. The group employs nearly 25,000 people worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating healthier communities globally. www.zyduscadila.com

About TLC

TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage, specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD™), including BioSeizer^® sustained release technology and NanoX™ active drug loading technology, which are versatile in the choice of active pharmaceutical ingredients and scalable in manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics targeting areas of unmet medical need in pain management, ophthalmology, oncology and infectious diseases. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations.

FAQ

What is AmphoTLC™ and its significance in India?

AmphoTLC™ is a liposomal amphotericin B injection, crucial for treating mucormycosis in India, particularly during the COVID-19 pandemic.

What agreement did TLC sign with Zydus Healthcare?

TLC signed a license supply and commercialization agreement with Zydus Healthcare to distribute AmphoTLC™ in India.

When was AmphoTLC™ approved for use in India?

AmphoTLC™ received approval from India's CDSCO on May 25, 2021.

How does AmphoTLC™ compare to Gilead’s AmBisome®?

AmphoTLC™ is the first complex generic drug to achieve bioequivalence with Gilead’s AmBisome®, ensuring similar efficacy and safety.

Why is AmphoTLC™ critical now?

Due to the surge in COVID-19 cases, there has been a significant increase in mucormycosis cases, leading to a critical shortage of liposomal amphotericin B.