Pharmosa Biopharm Inc. (PBI) announced on the 2nd that it has signed an amended licensing agreement with its North American partner, Liquidia, extending the licensing of its novel drug L606 to global markets outside of North America (excluding Taiwan, South Korea, Southeast Asia, China, the Middle East, North Africa, and Turkey). Under the revised agreement, Pharmosa will receive a signing bonus of $3.5 million. Additionally, the company is eligible to receive milestone payments of up to $157.75 million based on the progress of product development and sales, bringing the total licensing agreement to $161.25 million (approximately NT$5.1 billion).
In addition, both companies signed a new exclusive licensing agreement for the use of Pharmosa's proprietary nebulizer in conjunction with the L606 combination product. This allows Liquidia to develop and commercialize the L606 combination therapy with Pharmosa's nebulizer in the licensed regions.
Under the new agreements, Pharmosa will supply Liquidia with the L606 drug and its proprietary nebulizer at mutually agreed prices. Liquidia will be responsible for conducting clinical trials, securing regulatory approvals, and managing marketing activities in the licensed regions, covering all associated costs. After the launch of the L606 drug-device combination, Pharmosa will receive a low double-digit percentage of the net sales royalties based on sales milestones.
Kan Pei, CEO of Pharmosa Biopharm, expressed his satisfaction with the strengthened partnership with Liquidia. He noted that after licensing L606, an inhaled drug for treating both PAH (Pulmonary Arterial Hypertension) and PH-ILD (Pulmonary Hypertension associated with Interstitial Lung Disease), for $225 million in June of last year, this new collaboration further enhances their relationship. The total licensing fees for L606 have now reached $386.25 million under the original and newly amended agreements.
Kan also emphasized that the new agreement not only expands the licensed regions but also integrates Pharmosa's own brand of next-generation vibrating mesh nebulizers as the delivery device. This drug-device combination enhances the product's competitive edge and marks a new milestone in the collaboration.
Liquidia is confident that L606 will address unmet medical needs and sees great potential for the drug in the pulmonary hypertension field. The company is currently advancing Phase III clinical trials for PAH in the U.S. and has completed consultations with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for initiating Phase III trials for PH-ILD. The global Phase III trials are expected to commence this year. With the newly added licensing regions, Liquidia’s expertise in developing, obtaining regulatory approvals, and commercializing pulmonary hypertension drugs will accelerate the market entry and sales of L606 in Europe and Japan, positively impacting both companies' future revenue and profitability.
Pharmosa highlighted that with the newly amended licensing agreement, Liquidia now holds key market access for pulmonary hypertension drugs in the U.S. and Europe. Particularly in Europe, no approved treatments for PH-ILD currently exist. L606, with its long-acting formulation, low side effects, and ease of use, has the potential to become the first approved product. In the PAH market, L606 offers advantages such as convenience and higher tolerable doses compared to existing competitors, potentially allowing it to capture market share in the prostacyclin drug segment.
According to research, the total number of patients with PH-ILD and PAH in North America and Europe exceeds 200,000, with the annual drug cost per patient estimated at $160,000 and $100,000, respectively. The potential market is substantial. With the strengthened partnership between Pharmosa and Liquidia, both companies are confident in accelerating the market launch of L606, benefiting patients and contributing to both companies' operations, creating a win-win situation.
Resource (mandarin): 國邑與 Liquidia 增訂合約 L606累積授權金上看3.9億美元
