The structure of the Indian company is fighting for the supply of an Iranian drug for the treatment of hemophilia to Russia

The Russian structure of the Indian pharmaceutical company Jodas Expoim is trying through the court to obtain supplies under an exclusive agreement of the Iranian drug “ArioSeven” based on eptacog alfa, used in the treatment of hemophilia. The volume of federal purchases of drugs based on this active substance last year exceeded 2 billion rubles. The situation for Jodas Expoim is aggravated by the fact that the rights to the drug have been assigned to the Russian PSK Pharma since 2020.

Jodas Expoim, a subsidiary of the Indian Jodas Expoim, filed a lawsuit in the Arbitration Court of the Moscow Region to oblige the Iranian AryoGen Pharmed to supply the drug, Kommersant found in the file of arbitration cases. Jodas Expoim explained to Kommersant that we are talking about eptacog alfa for the treatment of hemophilia. An Iranian company produces this drug under the brand “ArioSeven”.

“Jodas Expoim,” as the company said, in May 2023 entered into an agreement with AryoGen, under which it received exclusive rights to distribute the drug “ArioSeven” in the Russian Federation and permission to use the trademark. But back in 2020, the Russian pharmaceutical company PSK Pharma registered a certificate for the drug, which also packages the drug at its facilities in Dubna. This medicine is purchased from her by distributors who supply it under government contracts within the framework of the state program “14 high-cost nosologies.”

At the end of 2022, under this program, 2.36 billion rubles worth of Eptacoga alpha was purchased using funds from the Russian budget, Kommersant calculated based on government procurement materials. In addition to ArioSeven, Coagil-VII from SGC Biotech is also being purchased through state tenders.

Under the terms of the agreement with AryoGen and Jodas Expoim, the exclusive rights to AryoSeven, which were previously issued to PSK Pharma, cease to be valid. But in fact, the Iranian side did not cancel the agreement with PSK Pharma, explains Jodas Expoim. The company, according to its representative, submitted documents to the Ministry of Health to re-register the certificate for the drug in its name, but was refused twice. “This deprived us of the opportunity to import AryoGen products,” Jodas Expoim emphasizes. AryoGen, PSK Pharma and the Ministry of Health did not respond to Kommersant’s request.

At the same time, Jodas Expoim managed to make commercial offers to two distributors, notifying AryoGen about the required volumes of purchases, but they did not supply the drug. We can talk about Medicare and Drugservice, which have entered into contracts for the supply of eptacog alfa for a total amount of 280 million rubles. with the Federal Center for Planning and Medical Provision of Citizens, subordinate to the Ministry of Health. But in August, FKU terminated these contracts. The reason was the appeal of PSK Pharma, which stated that the distributors did not ask the company to confirm deliveries.

In addition, the refusal of the Iranian company to supply the drug Jodas Expoim did not allow Medicare and Drugservice to fulfill their obligations to the PKU. This became the reason for these distributors to be included in the register of unscrupulous suppliers, follows from the decision of the Federal Antimonopoly Service.

Without the re-registration of the registration certificate, Jodas Expoim would not have been able to put ArioSeven into circulation, says Alexey Fedorov, an expert at the All-Russian Patients’ Union. There is no direct ban on the import of the drug without notifying the holder of the registration certificate, but a problem would arise with the means of identification for the labeling system, which are issued specifically by the holder of the registration certificate, the expert points out.

This is a new situation for the market when agreements are concluded simultaneously with two exclusive counterparties, says DSM Group CEO Sergei Shulyak. He suggests that AryoGen tried to avoid supply disruptions without terminating the contract with the previous partner.

Polina Gritsenko