Pharmosa Biopharm reported a net loss of NT$0.45 per share for the first quarter, as its new drugs are still in the research and clinical trial stage. General Manager Pei Gan pointed out that L606, a new drug for treating Group 1 Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), has been authorized in the US market and is now actively initiating another wave of licensing outside of North America.
On the 7th, Pharmosa held a board meeting, during which, in addition to announcing first-quarter financial results, it also approved the nomination list of seven candidates for the next board of directors (including three independent directors), including directors Jian-Zhi Wang, Lin-Quan Yan, Pei Gan, and Greg Stewart, and independent directors Yan-Ling Fang, Wen-Chang Chang, and Li-Ren Wu. The election will take place at the shareholders' meeting on June 26th.
Pei Gan pointed out that as there are currently no approved drugs for PH-ILD outside of North America, L606 has the opportunity to become the first drug approved and marketed outside of North America. According to the agreement with licensing partner Liquidia, Pharmosa can use Liquidia's future Phase III clinical trial data for PH-ILD globally as the basis for applying for drug approval at no cost. With this advantage, the commercial value of L606 can be significantly increased, and the licensing process for this year can be accelerated. Currently, negotiations for commercial licensing are underway in Europe, Asia (such as Japan, China, the Middle East), and Taiwan. The goal of completing licensing outside of North America this year remains unchanged.
According to statistics, there are approximately 60,000 PH-ILD patients in the United States. In 2021, the inhalable drug Tyvaso was expanded to treat PH-ILD, becoming the only treatment for PH-ILD currently available. According to United Therapeutics' annual report, the drug's total sales reached $1.23 billion last year, a 41% increase year-on-year, with over 8,000 patients treated. In the first quarter of this year, sales amounted to $370 million, a 56% increase year-on-year, demonstrating continued rapid growth and indicating a strong demand for PH-ILD medication. Additionally, there are over 180,000 PH-ILD patients in Europe, Japan, the Middle East, Taiwan, and China combined, making the potential drug market patient base three to four times larger than that of the North American market.
Pei Gan stated that international licensing is the main operational model for research-based pharmaceutical companies and is a key source of profits. L606 has already been licensed for the North American market for $225 million, and efforts are being made this year to secure licensing in other regions.
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