The overseas business partners of Kolon Life Science are waiting for the results of cell analysis of Invossa-K Inj. to be released on April 15 and the subsequent response of the Ministry of Food and Drug Safety (MFDS).
The Korean drugmaker has inked deals with four companies including Mundipharma to license out Invossa, a gene therapy to treat degenerative arthritis.
Under the deals, Invossa was scheduled to be exported to 16 countries including Japan, China (Hainan), Saudi Arabia, Hong Kong, the Philippines, and Australia. The deals are worth 1.04 trillion won ($912.8 million) in total.
Hong Kong and Macao have granted conditional approval for Invossa to be prescribed under the discretion of a physician. In other countries, the drug needs to obtain a regulatory license.
However, Kolon Life Science’s export of Invossa has been suspended due to the company’s recent revelation that it has mislabeled Invossa’s cell ingredient for 15 years. The company immediately suspended the phase-
3 trials in the U.S., as well as the sales of the drug in Hong Kong and Macao.
It is uncertain whether clinical data submitted for Invossa approval in other countries will be judged as valid.
If the company confirms that Invossa sold in Korea also had mislabeled cells, the worst scenario could become a reality by nullifying its license, with which partner companies could take issues.
However, the four partner companies are not so pessimistic over Invossa’s future, and they are paying close attention to the upcoming test results.
China Life Medical Centre, in charge of supply and regulatory approval of Invossa in Hainan, said its officials would shortly visit Kolon Life Science to hold a meeting.
“At present, there is no concern about the contract with Kolon, and there is no plan to amend or cancel it,” the Chinese firm said, adding that it was waiting for the Korean ministry’s investigation results.
Kolon Life Science said it was having talks with its partner companies, but the talks will have further progress after the test results on April 15. “There is no change in the contract or a complaint from a partner firm,” an official at Kolon Life Science said.
In a news conference on April 1, Kolon Life Science CEO Lee Woo-suk said the partner companies must have chosen Invossa in three key aspects – safety, efficacy, and business prospect.
“The food and drug safety ministry seems to be assured about Invossa’s safety and efficacy. If these two are verified, there is no problem for a business prospect. There might be some delays in approval procedures, but they will be back on track soon,” Lee said.
The ministry cautiously predicted that Invossa would not have a grave safety concern, on the condition that “the company’s claim is never false.”
With the concerns growing that Invossa might have used cancerous 293 cells, the ministry said it was surveying all patients who have been treated with the drug.
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