Levolta Pharmaceuticals, Inc. has entered into an exclusive licensing and distribution agreement for VOLT01 with Tabuk Pharmaceutical Manufacturing Company of Riyadh, Saudi Arabia, for the commercialization of investigational osteoarthritis (OA) therapy in the Middle East and Africa (MEA) region, excluding South Africa.
VOLT01 is a patented novel combination drug that has shown promise in Phase II and Phase IIb/III clinical trials in treating OA, which has no cure.
“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,” Levolta Chief Executive Officer (CEO) Richard P. Becker, Jr said.
“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.”
Tabuk Pharmaceuticals, a fully owned subsidiary of Astra Industrial Group, will hold the marketing authorization and be responsible for registering, importing, and commercializing VOLT01 in the MEA region.
“At Tabuk Pharmaceuticals, we believe in our vital role to provide patients across the Middle East and Africa with unique healthcare solutions that support their wellbeing,” Mohammed Al Hagbani, CEO of Tabuk Pharmaceuticals and President of Astra Industrial Group said.
“We are confident that VOLT01 will play a major role in improving the health condition of more than 5 million osteoarthritis patients in Saudi Arabia as well as many other patients across the region suffering from this disease.
“Our partnership with Levolta will strengthen our commitment to further support the Kingdom with the 2030 vision of providing unique medications addressing different therapy areas.
“Tabuk is committed to providing MEA region patients with the highest quality medications.”
OA is a major, but poorly understood public health problem. Musculoskeletal disorders are the leading cause of disability in the U.S., according to the Council for Disability Awareness.
Osteoarthritis is the most common form of arthritis among older adults and one of the most common causes of physical disability among adults, the National Institute on Aging reports.
“The development of a disease-modifying drug for osteoarthritis has been an unachievable quest so far, but with VOLT01, that goal may finally be achieved,” Levolta Chief Medical Officer, Ketan Desai said.
“Our Phase II studies demonstrate long-lasting pain relief, up to 9 months, in patients with osteoarthritis after a single 30-minute intravenous infusion.
“More importantly, VOLT01 showed disease-modifying activity as measured by MRI with pain relief correlating with disease modification.
“We look forward to pivotal studies that will enable VOLT01 to have a label for pain relief of osteoarthritis in all joints along with disease modification after a single yearly infusion.”
Levolta expects to begin Phase III clinical trials for VOLT01 in late 2023 /early 2024.
Levolta will be responsible for product manufacturing and quality assurance initiatives as part of the Tabuk agreement.
The company expects to launch similar partnerships with other pharmaceutical companies globally.
“We are excited at Tabuk to partner with Levolta, an innovation-led company, to commercialize difficult-to-manufacture products,” Wisam Alkhatib, Tabuk Pharmaceuticals Vice President of Strategy and Business Development said.
“We believe that such agreements tend to strengthen our leading position in the MEA region, targeting new therapy areas and specialty medications.
“We are confident that VOLT01 will play an important role in enhancing the well-being of osteoarthritis patients.“
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