Page 150 - CW E-Magazine (17-12-2024)

Pharmaceuticals

INDIGENOUS DEVELOPMENT
India’s fi rst locally developed wet AMD drug awaits

fi nal regulatory nod

Mumbai-based Vav Life Sciences existing product in this therapeutic seg-
and Madurai’s Aurolab Trust are col- ment is imported at about Rs. 70,000,
laborating to launch India’s fi rst locally the report quoted a company offi cial as
developed wet AMD (age-related macu- saying. The product will be less expen-
lar degeneration) treatment by early sive and “more bio-available (better
2025. Aurolab Trust is the manufactur- absorbed into the body)”, said Mr. Kedia.
ing division of Aravind Eye Hospital. The formulation uses VAV’s synthetic
phospholipid for better delivery of the
The product is waiting for a fi nal drug, he explained.
regulatory approval from the Central nanotechnology research-based company
Drugs Standard Control Organisation that makes lipids used in drug delivery While the CDSCO’s response is awaited,
(CDSCO), according to a report in the and during COVID-19, it was among he said, the Aurolabs team is working on
Hindu BusinessLine. Mr. Arun Kedia, four global companies making phospho- its manufacturing capacity, as the entire
Managing Director of Vav Life Sciences lipids for mRNA COVID-19 vaccines. product would have to be produced at the
informed that “all development work site. The hospital’s approach has been to
including cell line studies, in-vivo eva- The product involves an intrave- produce treatment free or at subsidised
luations and long-term stability trials are nous liposomal Verteporfi n injection, rates, and that philosophy would prevail
completed.” It has been developed by along with photodynamic therapy with the latest product as well. AMD is
the inhouse scientifi c team of Aurolab, (light), to treat AMD. According to a global concern, with a largely ageing
with inputs from VAV’s nanotechno- industry experts, there are no locally population particularly vulnerable to
logy scientists, he added. VAV is a made products to treat wet AMD. The the condition.

Piramal Pharma to settle dispute with US-based VetDC

Piramal Pharma has said it will pay litigation, the company and VetDC no responsibility for any other costs
$407,400 to US-based VetDC, Inc. to have both decided to settle,” Piramal beyond the amount of $407,400, it
settle a dispute over rejected batches of Pharma said. The company shall have added.
a product.
Aurobindo unit gets USFDA nod
Piramal Pharma Solutions Inc., a
unit of the company, and VetDC, Inc. for generic cancer drug
have entered into a settlement agree-
ment, the drug maker said in a regula- Aurobindo Pharma said its subsi- peutically equivalent to Novartis
tory fi ling. VetDC had claimed damages diary has received approval from the US Pharmaceuticals Corporation’s Votrient
on account of rejection of certain health regulator to market a cancer treat- tablets (200-mg), it added. The pro-
batches of product manufactured and ment medication in the US. Eugia Pharma duct is expected to be launched in
supplied by Piramal Pharma Solutions Inc. Specialities, a wholly-owned unit of the Q4FY25. According to IQVIA data,
company, has received fi nal approval the product has an estimated market
“While the company continues to from the US Food & Drug Administra- size of $106-mn for the 12-month
believe that its legal stand is appro- tion (USFDA) to manufacture and mar- period ended October 2024. Pazopanib
priate against claims made by VetDC and ket Pazopanib Tablets (200-mg) in the Tablets (200-mg) are indicated for the
maintains that it has defence to VetDC’s US market, the Hyderabad-based drug treatment of adults with advanced
claims of liabilities and damages, in maker said in a regulatory fi ling. renal cell carcinoma and advanced
order to solely avoid continued legal soft tissue sarcoma who have received
costs and uncertainties of protracted The company’s product is thera- prior chemotherapy.

150 Chemical Weekly December 17, 2024

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