China’s biotech firm Zai Lab has returned the exclusive sales license of anticancer treatment Olita to its developer Hanmi Pharmaceutical.
In 2016, Boehringer Ingelheim also notified Hanmi that it would end the 850 billion won ($800 million) deal over Olita during a phase-2 clinical trial, ELUXA 1.
Zai Lab, which had bought Olita’s sales rights in China, Hong Kong, and Macau, announced recently that it would terminate the 90.52 billion won deal over Olmutinib, the ingredient of Olita.
On the news of Zai Lab’s dumping of Olita’s license, Hanmi Pharm shares dropped to as much as 497,000 won on Friday morning, down 3.87 percent from the previous day.
Some experts raised concerns that the drugmaker’s licensing-out deals, which have helped Hanmo grow so far, could hurt the company if it fails to sustain the deals.
However, others said Hanmi still had strong growth potential. More than half of the company’s licensing-out deals are ongoing ones.
Hanmi Pharma has a deal with Spectrum Pharmaceuticals over anticancer treatment Poziotinib, another with Eli Lilly over BTK (Bruton's tyrosine kinase) inhibitor (HM71224), with Janssen over a diabetes drug candidate HM12525A, and with Genentech over RAF (rapidly accelerated fibrosarcoma) targeted cancer therapy.
There are more ongoing deals than expired ones, which include one with Zai Lab and Boehringer Ingelheim over Olmutinib, and another with Sanofi over long-lasting insulin.
According to Hanmi Pharm CEO Woo Jong-soo, Hanmi’s new antidiabetic agent Efpeglenatide, which was licensed out to Sanofi, is being tested in global phase-3 clinical trials. Janssen is also carrying out global phase-1 trials over HM12525A.
Eli Lilly also said it decided to abandon phase-2 trials over HM71224 but would not terminate the contract with Hanmi and search for new indications instead.
Poziotinib, licensed out to Spectrum, is in global phase-2 trials in patients with non-small cell lung cancer. Spectrum is also conducting a global phase-3 study on a long-acting neutropenia drug candidate called “Rolontis” (ingredient: Eflapegrastim).
Analysts said Rolontis was expected to be the first to arrive in the market among Hanmi’s drug candidates. If the drug wins sales approval, Hanmi will be able to buffer the shocks caused by discontinued licensing-out deals.
“Hanmi Pharm is one of the largest pharmaceutical firms in Korea. Despite the risks of deal expirations, the company has many global clinical trials still ongoing,” an analyst, who wished to be unnamed, said. “Investors will begin to assess the company after completion of the Rolontis’ phase-3 study.”
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