Elevar therapeutics, a U.S. subsidiary of HLB, said that the United Arab Emirates government has approved its plans to set up Neolevar FZ-LLC, a joint venture with Neo Pharma, in Dubai.
"Neolevar's legal approval, which had been expected to take about three to four weeks after the companies submitted documents in November, was delayed slightly due to administrative procedures," the company said. "Dubai's corporate establishment process has two stages --approval of the corporate establishment and a corporate operation permit."
The UAE government gave Neolevar one year to establish a corporation. The next year, it will get a corporate operating permit by submitting additional information related to facility design, facility inspection, and a non-clinical operating permit (NOP) related to health and safety and the environment.
The NOP is then renewed every two years.
"Accordingly, HLB is going to follow up with Neo Pharma and obtain a corporation operation permit as soon as possible," the company said.
The approval came after Elevar and Neo Pharma signed an agreement to conduct business in the Middle East, North Africa, and India in July last year. They also signed an additional agreement to establish a joint venture in September.
"Based on rivoceranib's global phase 3 clinical results, the company had a pre-new drug application (NDA) meeting with the U.S. Food and Drug Administration in October," a company official said. "We are preparing to submit the NDA."
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