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6 May. 2015

Kamada to Present Key Results from European Phase 2/3 Clinical Study of Inhaled Alpha-1 Antitrypsin During the American Thoracic Society (ATS) 2015 International Conference

NESS ZIONA, Israel (May 6, 2015) – Kamada Ltd. (Nasdaq and TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces that the Company will host a panel discussion titled, “New Treatment Prospects for AATD Patients: Results from a Phase 2/3 Inhaled AAT Trial,” which will be led by Key Opinion Leaders (KOLs) who specialize in treating patients with alpha-1 antitrypsin deficiency (AATD) during the upcoming American Thoracic Society (ATS) 2015 International Conference being held May 15-20, 2015 in Denver, Colorado. The panel discussion will take place on Tuesday, May 19, 2015 from noon to 2:00 pm Mountain Time at the Westin Denver Downtown.

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The panel discussion will be moderated by Pnina Strauss, Vice President-Clinical Development and Intellectual Property at Kamada, who will initiate the discussion with a presentation of the full data set from the Phase 2/3 clinical study of inhaled AAT for the treatment of AATD, which will include the recently reported analyses of lung function and quality-of-life data as well as of other parameters.

The panel discussion will be moderated by Pnina Strauss, Vice President-Clinical Development and Intellectual Property at Kamada, who will initiate the discussion with a presentation of the full data set from the Phase 2/3 clinical study of inhaled AAT for the treatment of AATD, which will include the recently reported analyses of lung function and quality-of-life data as well as of other parameters.

The event and accompanying slides will be available in the Investor Relations section of the Company's website at www.kamada.com beginning on May 20, 2015.

The panel session will be chaired by Professor Robert A. Sandhaus, Ph.D., M.D., FCCP, Founder and Director of the Alpha1-Antitrypsin Deficiency Program at National Jewish Health Hospital in Denver, Colorado, and the Clinical Director of the Alpha-1 Foundation.

Panel participants include:

  • Professor Kenneth R. Chapman, M.D., Director, Canadian Registry for Alpha-1 Antitrypsin Deficiency Asthma and Airway Centre, Toronto Western Hospital, University of Toronto in Toronto, Canada;
  • Professor Gerry McElvaney, M.D., Professor of Medicine at RCSI, Beaumont Hospital, Dublin, Ireland;
  • Professor Robert A. Stockley, M.D., Lung Investigation Unit, Queen Elizabeth Hospital, Birmingham University, Birmingham, United Kingdom; and
  • Jan Stolk, M.D., Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands and acting Chairman of the Alpha 1 International Registry (AIR).

“We are delighted to bring together this panel of renowned Key Opinion Leaders, who have a special interest and expertise in AATD to discuss the final results from our European Phase 2/3 clinical study of the Company's inhaled AAT therapy to treat AATD,” said David Tsur, co-founder and Chief Executive Officer of Kamada. “The recently reported final results from the study showed clinically and statistically significant improvements in spirometric measures of lung function, particularly in bronchial airflow measurements FEV1 (L), FEV1% predicted and FEV1/SVC. These favorable results were even more evident when analyzing the overall treatment effect throughout the full year. “

“We believe the combination of lung functions, which are the gold standard measurements for pulmonary diseases, and symptom improvements, along with the safety profile of the product, give us confidence that these data support our decision to submit a Marketing Authorization Application with the European Medicines Agency for Conditional Approval of our inhaled AAT therapy to treat AATD patients."

“We look forward to a dynamic discussion of the potential for inhaled AAT as an effective treatment option for patients suffering with AATD by this distinguished panel of clinicians,” concluded Mr. Tsur.

Mr. Tsur and other senior executives from Kamada will attend the event and be available to answer delegates' questions.

About 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 is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, 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. In addition to Glassia, Kamada has a product line of nine other pharmaceutical products that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia. Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that completed a pivotal Phase 2/3 clinical trials in Europe and has initiated Phase 2 clinical trials in the U.S. Kamada also 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. For more information, visit www.kamada.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials, Intellectual Property, the EMA and U.S. FDA filings and authorizations and timing of clinical trials. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. 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, unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contacts:
Gil Efron, CFO
ir@kamada.com

Anne Marie Fields, LHA
212-838-3777
afields@lhai.com