お知らせ • Aug 12
Kamada Ltd. Announces FDA Approval of its Plasma Collection Center in Houston, Texas
Kamada Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the supplement to its existing Biologics License Application (BLA) for Kamada Plasma's collection center in Houston, TX. The approval was obtained following an on-site inspection made by the FDA during the second quarter of this year. The center is now cleared to commence commercial sales of normal source plasma. The 12,000 square foot Houston facility supports 50 donor beds, with a planned capacity of approximately 50,000 liters per year, and is anticipated to be one of the largest collection centers for specialty plasma in the U.S. Following FDA's approval of the Houston location, Kamada intends to seek a subsequent inspection and approval by the European Medicines Agency (EMA) of this site. In addition to its Houston and Beaumont, TX, locations, in March 2025, Kamada announced the opening of its third center in San Antonio, TX. The Company's strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®?, CYTOGAM®?, GLASSIA®?, WINRHO SDF®?, VARIZIG®? and HEPAGAM B®?, as well as KAMRAB®?, KAMRHO (D) and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company's marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Lastly, the Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with the lead product candidate Inhaled AAT, for which the Company is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to the evolving nature of the conflicts in the Middle East and the impact of such conflicts in Israel, the Middle East and the rest of the world, the impact of these conflicts on market conditions and the general economic, industry, and political conditions in Israel, the U.S. and globally, effect of potential imposed tariff on overall international trade and specifically on Kamada's ability to continue maintaining expected sales and profit levels in light of such potential tariff, the effect on establishment and timing of business initiatives, Kamada's ability to leverage new business opportunities and integrate it with its existing product portfolio, unexpected results of clinical and development programs, regulatory delays, and other risks detailed in Kamada's filings with the U.S. Securities and Exchange Commission (the "the "the "the " "the "the "the" "We are extremely pleased to announce the FDA approval of our state-of-the-art plasma collection center in Houston, Texas" and for the work of our dedicated team of plasma collection experts who achieved the approval of this facility.