REHOVOT, Israel, Sept. 03, 2019 (GLOBE NEWSWIRE) — Kamada Ltd. (NASDAQ and TASE: KMDA), a plasma-derived protein therapeutics company, announced today the extension of its strategic supply agreement with Takeda for GLASSIA® [Alpha1-Proteinase Inhibitor (Human)].  Kamada will now continue to produce GLASSIA for Takeda through 2021.  Based on the extended agreement, Kamada projects that total revenues from sales of GLASSIA to Takeda during the years 2019-2021 will be in the range of $155 million to $180 million. On an annual basis, Kamada projects revenues of approximately $65 million during each of 2019 and 2020, and between $25 million to $50 million during 2021, based on Takeda’s needs.

As a reminder, Kamada is the holder of the U.S. Food and Drug Administration (FDA) Biologics License Applications (BLA) for GLASSIA. Based on the licensing and technology transfer agreement signed by the two companies in 2010, Takeda is planning to complete the technology transfer of GLASSIA, and pending FDA approval, will initiate its own production of GLASSIA for the U.S. market in 2021. Accordingly, based on the agreement between the companies, upon initiation of sales of GLASSIA manufactured by Takeda, it will pay royalties to Kamada at a rate of 12% on net sales through August 2025, and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually, for each of the years from 2022 to 2040.

Although the transition of the agreement to its royalties phase will result in a reduction of Kamada’s revenue from Takeda, based on current GLASSIA sales in the U.S. and forecasted future growth, Kamada projects receiving royalties from Takeda in the range of $10 million to $20 million per year for 2022 to 2040.

Kamada is reiterating its full-year 2019 revenue guidance of $125 million to $130 million. The Company plans to provide its 2020 revenue guidance by the end of 2019.

“Kamada and Takeda remain firmly committed to the AAT Deficiency community and we are jointly continuing to support patients through our strong partnership,” said Amir London, Kamada’s Chief Executive Officer.  “The extension of the supply agreement and the projected significant long-term royalty stream provide a solid financial foundation for Kamada.  Upon successful completion of the technology transfer to Takeda, we intend to utilize our FDA-approved manufacturing plant to continue supporting the growth of KedRAB, our anti-Rabies IgG product in the U.S., our immunoglobulins products, and GLASSIA in existing and new markets in Asia, Latin America and other territories, as well as the manufacturing of our Inhaled AAT for its current clinical development and, pending regulatory approval, its future commercial launch. We are also proactively exploring opportunities to leverage our experience and manufacturing capacity to initiate the production of new plasma-derived products. We expect that these activities will enable us to utilize most of our plant’s available capacity.”

“Beyond GLASSIA, Kamada is focused on developing its next-generation treatment for AATD, Inhaled AAT, for which the Company is on track to initiate a global Phase 3 trial with expected dosing of the first patients in Europe before the end of the year and, pending FDA approval of the Investigational New Drug application, begin recruiting patients in the U.S.  We are very excited about the prospects for this program in the AATD market, which, based on market data, currently consists of approximately $1 billion of IV AAT global sales, and is anticipated to be growing at 6-8% annually,” concluded Mr. London

About GLASSIAGLASSIA was the first available ready-to-infuse liquid alpha1-proteinase inhibitor and is indicated as a chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency. GLASSIA is administered intravenously once a week to augment the levels of AAT in the blood.  AAT is a protein derived from human plasma with known and newly discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue protective and antimicrobial properties. GLASSIA is approved by the FDA and is marketed through a strategic partnership with Takeda in the United States. Takeda has distribution rights and an exclusive license to GLASSIA for all IV indications in the U.S., Canada, Australia, and New Zealand, while Kamada maintains rights in all other territories and for all other AAT routes of administration, including Inhaled AAT.

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