FC303 Narrowly Avoided Repeating Medy-Tox Inc.’s Mistakes… FutureChem Co., Ltd.: “Currently in Technology Transfer Negotiations with Two European Companies”
[Edaily Reporter SONG YOUNG-DOO ] FutureChem Co., Ltd.(220100)has terminated its European technology transfer agreement for “FC303,” a radiopharmaceutical for prostate cancer diagnosis, even while covering the research and development (R&D) costs. Analysis suggests that the company’s decision to request the termination of the agreement—despite incurring a cost of 1 billion won—was based on a strategic judgment that took into account the partner company’s inexplicable obstinacy, the resulting delays in clinical trials, and ongoing negotiations with a new European partner.
From Technology Transfer to Rights Repatriation... The Full Story Behind the Contract Termination
In 2020, FutureChem Co., Ltd. signed a joint development and technology transfer agreement with IASON, an Austrian nuclear medicine specialist, for the European clinical trials and commercialization of FC303, a radiopharmaceutical (RPT) for prostate cancer diagnosis. Under the agreement, IASON was responsible for clinical trials, regulatory approval, and commercialization across all of Europe, excluding Turkey.
However, the situation began to change when IASON was acquired by Curium, a global nuclear medicine company. IASON was integrated into Curium Austria, and during this process, the European Phase 3 clinical trial for FC303 was repeatedly delayed.
A key point of interest for the radiopharmaceutical industry is that Curium holds the European rights to Pylarify, a product developed by the U.S.-based company Lantheus, which is the global market leader in prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostic agents. Given that Curium was already marketing Pylarify in the same market, it is interpreted that the company had little incentive to actively invest in the development of FC303, a competing product.
A representative of FutureChem Co., Ltd. stated, “Clinical trials continued to be delayed due to due diligence requirements and other issues following the acquisition,” adding, “Ultimately, we determined that momentum for the project had waned, so we took the initiative to request termination of the contract.”
Competitive Pipeline ‘Adrift’ After Acquisition… A Recurring Pattern in the Industry
Since FutureChem Co., Ltd. initiated the termination, it also bore the financial burden. During the contract period, FutureChem Co., Ltd. received approximately 600 million won from Iason. However, it paid approximately 1.6 billion won as part of the termination settlement, resulting in a net loss of about 1 billion won.
Timing was a key factor behind this decision. At the time FutureChem Co., Ltd. was considering terminating the contract, it had already received partnership proposals from multiple European companies. A FutureChem Co., Ltd. official said, “Since we were the ones who requested the contract termination, we bore the associated costs. “While this is a loss in the short term, it is far more beneficial for the company in the long run,” the official added, noting, “At the same time, we were in discussions regarding term sheets with two European companies that had contacted us.” It is reported that FutureChem Co., Ltd. is currently negotiating the terms of technology transfer and joint development with these two European companies.
Within the radiopharmaceutical industry, there is a view that FutureChem Co., Ltd.’s case resembles a structural pattern often observed in the global pharmaceutical market. Specifically, there have been repeated instances where large pharmaceutical or medical companies acquire firms with competing pipelines and then lower the development priority—or effectively halt—assets that directly compete with their core products.
The most frequently cited examples in Korea are the technology transfer deals involving Medy-Tox Inc.(086900), Allergan, and AbbVie. In 2013, Medy-Tox Inc. signed a licensing agreement with Allergan—then the global leader in the botulinum toxin market—for MT10109L, a next-generation liquid botulinum toxin candidate. The total contract value was $362 million (approximately 400 billion won), and Medytox received an upfront payment of $65 million (approximately 99 billion won) and milestone payments totaling $35 million (approximately 53 billion won).
However, AbbVie, which acquired Allergan in 2020, returned the development and commercialization rights for MT10109L to Medy-Tox Inc. in September 2021 without having conducted any substantial research and development on the candidate. Given that development of the candidate drug remained stagnant for approximately eight years—from the signing of the contract to the return of the rights—the Botox industry has consistently speculated that Allergan and AbbVie, which own Botox, were not actively pursuing the development of competing products.
In the case of FutureChem Co., Ltd., the prevailing view in the radiopharmaceutical industry is that Curium—which holds the European rights to Piralipay, the top-selling product in the global PSMA PET diagnostic market—would have found it difficult to prioritize the development of FC303. FutureChem Co., Ltd.’s decision to terminate the contract, even at the cost of 1 billion won, is interpreted as a move to escape this structural dilemma.
The global radiopharmaceutical market has shown steep growth in recent years. With Novartis’s Lutathera, Flubicto, and Piralipay receiving approvals one after another, market interest in nuclear medicine diagnostics and therapeutics is also on the rise. Amid this trend, FutureChem Co., Ltd.’s strategy to re-enter the European market is viewed as an issue that could lead to a revaluation of the company’s overall value, going beyond the simple overseas expansion of its pipeline.
A Pipeline That Nearly Failed... Technology Transfer Negotiations with Two European Companies
FC303 is a PSMA-targeted radiopharmaceutical used to diagnose prostate cancer recurrence and metastasis. It utilizes a radioactive tracer that binds to the PSMA protein, which is overexpressed on the surface of prostate cancer cells, to acquire PET images. In South Korea, it was approved last month under the brand name Prostavue.
According to FutureChem Co., Ltd., in a Phase 3 clinical trial conducted on patients with recurrent or metastatic prostate cancer, Prostavue recorded a positive predictive value (PPV) of 86.96%. This exceeds the PPV of Piralipay, which stands at 81.9%. It is also higher than the 77.8% lesion-level predictive value of PSMA-1007 (ABX), which was recently approved in South Korea. Based on these clinical data, FutureChem Co., Ltd. reports that FC303 has secured a competitive advantage in terms of clinical accuracy.
Having reacquired the rights, FutureChem Co., Ltd. anticipates that the European Phase 3 clinical trial will take approximately two years once a contract is signed with a new European partner.
A representative of FutureChem Co., Ltd. stated, “We are currently in the process of finalizing the detailed terms of the agreement, and once a local partner is confirmed, we will move full steam ahead with the European Phase 3 clinical trial,” adding, “Once a European partner is selected, we expect the Phase 3 clinical trial to take about two years. We are reviewing plans to submit domestic clinical data to the European Medicines Agency (EMA) and streamline local clinical procedures to expedite marketing authorization.”
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