Zydus Lifesciences?Strengthens Its Portfolio With Drug Launches and Regulatory Approval

Ahmedabad-based Zydus Lifesciences has launched ANVIMO, the world's first drug to prevent Cytomegalovirus (CMV) infection in haematopoietic stem cell transplant (HSCT) and kidney transplant patients in?India. CMV is recognised as a significant complication in transplant recipients, often implicated in allograft rejection, decreased survival,?and increased length of hospitalisation. Ganciclovir, valganciclovir and?other traditional treatments are limited by their toxicity and bone marrow suppression. ANVIMO,?which contains letermovir, is positioned as safer and more effective with improved tolerability and reduced side effects and may result in improved transplant outcomes.

Shares of Zydus Life soared 1.85 per?cent on the BSE at ?887.95, following these announcements on Wednesday, March 5, 2025 Despite the 1-day spike, the stock was?down 8.80 per cent YTD. Volume for the stock was?above the two-week average. According to Trendlyne data, the average?target of Zydus Lifesciences stock is ?1,075 implying a potential upside of 21% over the ongoing market price. Forwardz at the long time no doubt are?on the buy end due to no drop strategy. The company had a market capitalisation of??89,308 crore.

One of the most significant parts of ANVIMO's intro is its?affordability. The innovator Letermovir 240 mg had been imported into India at a cost of over ?5 lakh?per month, which greatly limited access. With the launch of ANVIMO, Zydus has brought down this cost by 91% and enabled widespread CMV prophylaxis in Indian?patients.

According to the company, ANVIMO is shown to be bioequivalent to the reference product, and is produced at considerably lower?price, but with a comparable quality. Calling the launch a "first" in India, Dr. Sharvil P. Patel, MD of Zydus Lifesciences, said this marked a new era in the country for bone marrow and kidney transplant patients, vowing the company to continue its work?of providing affordable and life-saving therapies to patients.

Based on Zydus Lifesciences, ANVIMO has the potential to revolutionise the CMV prophylaxis landscape?in India, as more patients will be able to get timely and effective CMV prophylaxis thus contributing towards improving survival and quality of life.

At the same time, Zydus Lifesciences has also received the?final nod from the USFDA to produce Dasatinib tablets of various strengths, such as 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. Dasatinib is indicated for the treatment of adults with newly diagnosed Philadelphia chromosome-positive?(Ph+) chronic myeloid leukaemia (CML) in the chronic phase. It is also indicated for the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase Ph+ CML resistant or intolerant?to prior therapy including imatinib and for adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) resistant or intolerant to prior therapy

The newly approved?Dasatinib Tablets are the generic of Sprycel Tablets, with annual sales of $1,807.7 million as per IQVIA MAT Jan 2025. These tablets will be manufactured by Zydus at its SEZ facility located in?Ahmedabad. As of December 31, 2024, Zydus has received 415 approvals?and has filed 483 ANDAs since its filing process started in FY 2003-04.

This is the first drug for?which Zydus Lifesciences has entered into a consecutive transaction for six consecutive years, enabling the company to leverage the demand for a relatively affordable and highly effective drug and obtain USFDA approval for the product with a high sales rate on a generic basis. Reduction of CMV prophylaxis cost in?India will significantly enhance patient accessibility, and USFDA approval will open a large market for leukaemia treatment for Zydus.?

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