- The stock price of TLC (Nasdaq: TLC) increased by 28.69% yesterday. This is why it happened.
The stock price of TLC (Nasdaq: TLC) – a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need – increased by 28.69% yesterday. Investors responded positively to the company announcing that the Central Drugs Standard Control Organization (CDSCO) of India has approved the New Drug Application (NDA) of Amphotericin B Liposome for Injection 50mg (known as Ampholipad in Taiwan and AmphoTLC in India) for immediate importation per approved usage and indication, to aid in the country’s emergency of acute liposomal amphotericin B shortage.
AmphoTLC is a liposomal amphotericin B injection indicated for severe systemic fungal infections like mucormycosis. And the drug is approved in Taiwan and has been marketed and sold for several years with a steady increase in market share each year; market authorization of the drug in China is under review. And 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.
Due to 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 the infection is not treated early, over 60% of patients could die. And the increasing number of CAM cases has resulted in an unprecedently high demand for liposomal amphotericin B, the key drug to treat mucormycosis, causing an acute shortage of the drug. The exploitation by sellers on the black market – who are marking up the price of liposomal amphotericin B by 3x – 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.
Due to the ongoing COVID-19 pandemic situation and in response to the humanitarian crisis, the new drug registration for AmphoTLC was promptly granted in India. And the registration allows for immediate importation of AmphoTLC as per approved usage and indication of liposomal amphotericin B in India – which includes mucormycosis, to help alleviate the urgent need for the drug.
“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. We are glad that the result of years of our hard work is able to help India in their times of need. With this approval and prompt delivery of our product, thousands of patients will have the opportunity to receive early treatment with AmphoTLC, reducing the fatality rate brought on by the sudden influx of mucormycosis.”
— George Yeh, President of TLC
“We are glad to be lending a helping hand in conjunction with TLC in this dark hour, bringing a ray of light by delivering AmphoTLC to those in need to help them get over this severe infection.”
— Barbara Li, General Manager of Yung Shin Pharmaceutical Industrial Co., contract manufacturer for AmphoTLC
“TLC appreciates the support of Indian authorities who thoroughly and expeditiously granted the approval of AmphoTLC. 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 AmphoTLC to India immediately.”
— Dr. Keelung Hong, Founder, Chairman and CEO of TLC
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.