Bethlehem-based Levolta Pharmaceuticals, Inc. has entered into an exclusive licensing and distribution agreement with a Saudia Arabia company for the commercialization of an investigational osteoarthritis (OA) therapy.
The agreement with Tabuk Pharmaceutical Manufacturing Co. of Riyadh, Saudi Arabia will bring VOTL01, 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.
It will be distributed to the Middle East and Africa (MEA) region, excluding South Africa, the company 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,” said Levolta CEO Richard P. Becker, Jr. “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, according to a statement from Levolta.
“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,” said Mohammed Al Hagbani, CEO of Tabuk Pharmaceuticals and president of Astra Industrial Group.
“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,” Hagbani said. “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,” said Levolta Chief Medical Officer Dr. Ketan Desai. “Our Phase II studies demonstrate long lasting pain relief, up to 9 months, in patients with osteoarthritis after a single 30-minute intravenous infusion.”
Desai said 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,” Desai said.
Levolta expects to begin Phase III clinical trials for VOLT01 in late 2023 or early 2024.
Levolta will be responsible for product manufacturing and quality assurance initiatives as part of the Tabuk agreement. The company said it expects to launch similar partnerships with other pharmaceutical companies globally.