Eugia US Manufacturing LLC, a wholly-owned subsidiary of Aurobindo Pharma Ltd. based in the USA, has entered into an agreement to sell its business assets, along with related assets, liabilities, and employees, to Empower Clinic Services New Jersey, LLC. The deal, valued at $52 million, is part of Aurobindo Pharma's strategy to enhance capacities and operations in other units of the company. Amid this development, shares of Aurobindo Pharma dipped 4.4% to ₹1,057.85 apiece on BSE today.
Following the closure of the transaction, Eugia will engage in contract manufacturing with the buyer. The $52 million consideration for asset disposal will be supplemented by an additional $58 million in lease payments over a 20-year term, including extensions, to Eugia US Manufacturing LLC and/or its affiliates.
The completion of the transaction is anticipated within 90 days, contingent upon meeting closing conditions outlined in the definitive agreement, including financial closure by the buyer. “Empower Clinic Services New Jersey, LLC is the buyer. The buyer does not belong to the promoter/promoter group companies,” Aurobindo Pharma says.
Recently, the USFDA inspection at Unit-III of Eugia Pharma, another entity of Aurobindo Pharma, has concluded with nine observations issued to the facility. Consequently, Aurobindo Pharma has temporarily halted manufacturing on certain lines to conduct a comprehensive investigation and partial distribution adjustments. The company is collaborating with regulatory authorities and third-party consultants to expedite the resumption of production. Aurobindo Pharma asserts that, at present, the business impact of this action is not considered substantial.
The inspection at Unit-III, a formulations manufacturing facility, took place from January 22 to February 2, 2024.
On January 17, Aurobindo Pharma issued a statement revealing its wholly-owned subsidiary, CuraTeQ Biologics Pvt. Ltd., has received a recommendation for the grant of marketing authorisation for biosimilar trastuzumab from the Subject Experts Committee (SEC) operating under the umbrella of CDSCO (Central Drugs Standard Control Organisation).
“Trastuzumab biosimilar, supplied in single dose glass vials containing 150 mg and 420 mg lyophilized powder for concentrate for solution for infusion, is a humanised monoclonal antibody for treating metastatic breast cancer and early breast cancer that is human epidermal growth factor receptor 2 positive,” the filing says.
As part of the conditions, CuraTeQ has been instructed to submit the Phase IV clinical trial protocol to CDSCO within three months of obtaining the marketing authorisation.
In the last week of December 2023, Eugia Pharma Specialities Ltd, a fully-owned subsidiary of Aurobindo Pharma, received the final approval from the US FDA for manufacturing and marketing a posaconazole injection at a concentration of 300 mg/16.7 mL (18 mg/mL), provided in a single-dose vial. In an official filing, the company affirmed that the approved product is considered bioequivalent to the reference listed drug (RLD), Noxafil Injection, offered by Merck Sharp & Dohme LLC.
As per the filing, the authorised product is projected to address a market size of $25.4 million for the 12 months ending in October 2023, as indicated by IQVIA, a clinical research services provider based in the United States.
