South Korea's Ministry of Food and Drug Safety (MFDS) has announced that it would continue to "conditionally" allow marketing approval for Hanmi Pharmaceutical (South Korea)'s lung cancer candidate Olita (olmutinib), as the company comes under increasing scrutiny for allegedly delaying the disclosure of side effects that led to the deaths of two patients.
Implications | The MFDS is holding discussions to determine the relationship between the administration of Olita and its side effects, which may result in the drug being pulled from the market. |
Outlook | The latest events are expected to cast an increasing pall not only over Olita's prospects, but over South Korea's overall drive to become a hub of pharmaceutical and biotech innovation. |
The Ministry of Food and Drug Safety (MFDS) has now banned physicians from prescribing Olita to new patients, and will monitor patients already taking the treatment. Olita is a therapy for EGFR-positive lung cancer in patients who have developed a tolerance to existing therapies. In addition, the MFDS is holding discussions to determine the link between Olita and its side effects, which may result in the drug being pulled from the market altogether, according to Yonhap News Agency.
In the meantime, Hanmi Pharma has said that it planned to continue its clinical trials of Olita in 127 patients who showed no adverse symptoms from the treatment, but planned to suspend clinical trials on new patients.
Last week, Boehringer Ingelheim (Germany) pulled out of its collaboration with Hanmi on olmutinib – which had been struck to considerable fanfare in 2015 – after two patients died from severe adverse effects from the drug (see South Korea: 30 September 2016: Boehringer Ingelheim returns licence for lung cancer candidate HM61713 to Hanmi Pharma after patient deaths). However, this information was allegedly only released after Hanmi announced a licensing deal with Genentech (a unit of Roche, Switzerland), sparking accusations from investors that Hanmi had deliberately tried to delay revealing negative news (see South Korea: 29 September 2016: Hanmi Pharmaceutical signs licensing agreement with Genentech for targeted cancer candidate HM95573). According to The Korea Herald, Hanmi allegedly delayed making a public announcement to the South Korean stock exchange in an attempt to prevent a slide in its share price.
According to media reports, out of the 730 patients who received Olita as part of clinical trials, two patients developed symptoms of toxic epidermal necrolysis (TEN), and another patient developed Stevens-Johnson syndrome. Out of the two patients with TEN, one died and the other recovered. The patient with Stevens-Johnson syndrome died due to lung cancer.
Outlook and implications
In terms of effects on pharmaceutical multinationals, the latest events are expected to cast an increasing pall over Olita's prospects, not only due to its side effects, but also because of market competition. According to industry insiders quoted in local South Korean media, Boehringer Ingelheim's pulling out from its licensing deal with Hanmi Pharma may be explained not just by Olita's side effects, but also due to the strides made by rival AstraZeneca (UK)'s lung cancer drug Tagrisso (osimertinib) – another EGFR receptor antagonist. Given the fallout surrounding Hanmi Pharma, the chances of Olita competing against Tagrisso are relatively slim – which may have prompted Boehringer Ingelheim to effectively cut its losses (see United Kingdom: 18 July 2016: AstraZeneca's Tagrisso meets primary endpoint in second-line lung cancer).
Overall, the developments are a significant and embarrassing blow to South Korea's attempts to scale its pharmaceutical and biotech industry as its next major economic growth driver. Although Olita was expected to become a major step forward in putting South Korea on the map as an innovation hub, Hanmi Pharma's alleged delay in announcing bad news is expected to add to the negative fallout from the side effects of the drug itself.