United States-based Levolta Pharmaceuticals, Inc., announced on Thursday that it has signed a licensing and distribution agreement with Tabuk Pharmaceutical Manufacturing Company of Riyadh, Saudi Arabia for the commercialisation of VOLT01, an investigational osteoarthritis (OA) therapy, in the Middle East and Africa (MEA) region, excluding South Africa.
The product, a patented novel combination drug, has indicated promise in Phase II and Phase IIb/III clinical trials for the treatment of OA.
Tabuk Pharmaceuticals, a fully owned subsidiary of Astra Industrial Group, has the marketing authorisation and is responsible for registering, importing, and selling the product in the MEA region. Under the contract, Levolta will manage product manufacturing and quality assurance initiatives. Levolta is likely to commence Phase III clinical trials for VOLT01 during late 2023 or early 2024.
Levolta CEO Richard P Becker, Jr, said, 'We are excited to announce this partnership with Tabuk Pharmaceuticals, as it represents the next step in bringing the first disease modifying therapy for osteoarthritis to market. Our goal is to fill the global void in the treatment of osteoarthritis, which affects more than 32.5 million adults in the United States alone. Tabuk is the market leader in MEA and will be a valuable partner in fulfilling that mission.'
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