AmphoTLC™ Lifts Off for Delivery to India
SOUTH SAN FRANCISCO, California and TAIPEI, Taiwan – May 30, 2021 – TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, is delivering its promise to help India with 18,760 vials of AmphoTLC™ to help fulfill the urgent unmet need for liposomal amphotericin B, putting the words “TLC is helping” into action.
Following a recent new drug registration with India’s Central Drugs Standard Control Organization (CDSCO), TLC entered separate non-exclusive commercialization agreements with Zydus Healthcare Limited (Zydus, part of Zydus Cadila) and Strides Pharma Science Limited (Strides) for immediate importation of its liposomal amphotericin B product as per approved usage and indication, for Zydus and Strides to market and sell in India. Today, TLC has shipped 10,670 vials to Zydus and 8,000 vials to Strides; the shipment to Zydus will arrive in Mumbai shortly after midnight on May 31, and the shipment to Strides is expected to arrive in Bengaluru in the evening of the same day.
“I continue to be amazed at the speed at which this nearly impossible mission has been made possible with the keen involvement of the TLC team, the Taiwan Food and Drug Administration, our Contract Manufacturing Organization and Taiwan distributor Yung Shin Pharmaceuticals, and Marken Taiwan Ltd. None of this would have been possible without the help of this elite team,” commented George Yeh, President of TLC. “What our corporate tagline – Delivering Hope for Life™ – delivers is so much more than hope; it is to deliver life-saving, efficacious and safe medicines to those in need.”
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.
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.
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®). TLC’s deep experience with liposome science allows a combination of onset speed and benefit duration, improving active drug concentrations while decreasing unwanted systemic exposures. TLC’s BioSeizer® technology is designed to enable local sustained release of therapeutic agents at the site of disease or injury; its NanoX® active drug loading technology has been proven in two approved drugs and is designed to alter the systemic exposure of a drug, potentially reducing dosing frequency and enhancing distribution of liposome-encapsulated active agents to the desired site. These technologies are versatile in the choice of active pharmaceutical ingredients, and scalable with respect to manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics that target areas of unmet medical need in pain management, ophthalmology, and oncology. TLC is consistently ranked in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. For more information, visit www.tlcbio.com.
TLC: Dawn Chi / Corporate Communications / email@example.com