Kamada Announces Receipt of Marketing Authorization for Glassia for Treatment of Alpha-1 Antitrypsin Deficiency in Switzerland - Seite 2

Glassia previously received FDA approval in 2010, and the product is approved for use in multiple other international markets, including Argentina, Russia, Israel, and Brazil. In the U.S., Kamada currently receives royalties, anticipated to be in the range of $10 million to $20 million per year through 2040, for Glassia from Takeda. Ex-U.S. sales of Glassia were approximately $6 million in 2022.

In addition to its focus on expanding the commercialization of Glassia in the international markets, Kamada is also committed to advancing the development of an Inhaled AAT treatment, conductingthe InnovAATe study, an ongoing pivotal Phase 3 clinical trial ofInhaled AAT for patients with AATD. The Company intends to meet with the FDA and the European Medicines Agency to discuss study progress and potential opportunities to shorten regulatory pathways in the first half of 2023.

About Glassia
GLASSIA is an Alpha1 -Proteinase Inhibitor (Human), indicated for chronic augmentation and maintenance therapy in individuals with clinically evident emphysema due to severe hereditary deficiency of Alpha1, also known as alpha1-antitrypsin (AAT) deficiency. GLASSIA increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1.

About Kamada

Kamada Ltd. (the “Company”) is a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, focused on diseases of limited treatment alternatives. The Company is also advancing an innovative development pipeline targeting areas of significant unmet medical need. The Company’s strategy is focused on driving profitable growth from its significant commercial catalysts as well as its manufacturing and development expertise in the plasma-derived and biopharmaceutical fields. The Company’s commercial products portfolio includes six FDA approved plasma-derived biopharmaceutical products: CYTOGAM, KEDRAB, WINRHO SDF, VARIZIG, HEPAGAM B and GLASSIA, as well as KAMRAB, KAMRHO (D) and two types of equine-based anti-snake venom (ASV) products. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Argentina, Brazil, India, Australia and other countries in Latin America, Europe, Middle East, and Asia. The Company leverages its expertise and presence in the Israeli market to distribute, for use in Israel, more than 25 pharmaceutical products that are supplied by international manufacturers and during recent years added eleven biosimilar products to its Israeli distribution portfolio, which, subject to the European Medicines Agency (EMA) and the Israeli Ministry of Health approvals, are expected to be launched in Israel through 2028. The Company owns an FDA licensed plasma collection center in Beaumont, Texas, which currently specializes in the collection of hyper-immune plasma used in the manufacture of KAMRHO (D). In addition to the Company’s commercial operation, it invests in research and development of new product candidates. The Company’s leading investigational product is an inhaled AAT for the treatment of AAT deficiency, for which it is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.