NESS ZIONA, Israel--(BUSINESS WIRE)--
Kamada Ltd. (Nasdaq and TASE: KMDA) today announced that Israeli Ministry of Health (IMOH) has completed a successful Good Manufacturing Practice (GMP) audit of the Company's manufacturing facility in Beit Kama, Israel. The audit was performed as part of the Ministry of Health's routine evaluation of the company's manufacturing process for its plasma-derived protein therapeutics.
The audit concludes that Kamada complies with the GMP requirements of the IMOH. As the IMOH is also a member of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), this audit is also issued under the provisions of the Conformity Assessment and Acceptance of Industrial Products (CAA) Agreement between the European Union and Israel. The audit concludes that Kamada complies with GMP requirements for the manufacture of medicinal products, the importation of medicinal products and the manufacture of active substances using biological processes. This compliance status is good for three years from the time of the audit.
“Kamada takes great pride in maintaining the highest quality manufacturing processes as it is a core competency of the Company and a cornerstone of our commercial success. This positive audit underscores the viability, quality and high standards Kamada upholds in the manufacture of our plasma-derived therapeutic proteins both for commercial use and for products under development in compliance with international standards,” said David Tsur, the Chief Executive Officer of Kamada.
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust late-stage product pipeline. The company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived proteins. AAT has known and newly discovered therapeutic roles given its immuno-modulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets Glassia in the U.S. through a strategic partnership with Baxter International. Kamada has nine other injectable pharmaceutical products that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil and other countries in Latin America, India, Eastern Europe and Asia. Kamada has five plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that is in pivotal Phase II/III clinical trials in Europe and Canada and will be entering Phase II clinical trials in the U.S. In addition, Kamada leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing 10 complementary products in Israel that are manufactured by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release contains forward-looking statements that involve risks, uncertainties and assumptions, such as statements regarding the EMA and U.S. FDA marketing authorization of our Inhaled AAT for AATD, timing of clinical trials. 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, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market, further regulatory delays. The forward-looking statements made herein speak only as of the date of this release and the Company undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
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