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Kamada announced that over dozens of patients with alpha-1 antitrypsin deficiency have already begun treatment of inhaled AAT beyond the time frame of the Phase II/III clinical trial; Kamada estimates that dozens of additional patients are expected to apply for continuation of treatment
The additional clinical data that will be obtained in addition to the phase II/III clinical trial is of a high value and importance for preparing the company for market entry
Kamada and Chiesi, its strategic partner for distribution of the drug in Europe have started to prepare for the drug marketing authorization application (MAA), which is expected in 2014
Kamada's inhaled AAT has demonstrated a high safety profile in more than 160 patients tested in the clinical trial to date
Ness Ziona, Israel, April 4, 2013. Kamada, Ltd. (TASE: KMDA), an orphan drug focused, plasma-derived protein therapeutics company with an existing marketed product portfolio and a robust late-stage product pipeline, announced today that over dozens of patients with a genetic deficiency of alpha-1 protein that completed their participation in the phase II/III pivotal clinical trial that the company is conducting in Europe and Canada have elected to continue to receive treatment of inhaled AAT, beyond the stipulated time frame and outline of the protocol as a part of the trial )OLE). The pivotal phase II/III clinical trial is expected to be completed this year, and Kamada estimates that the dozens of patients who continue treatment may contribute additional and valuable clinical information for the Company's preparation for market entry.
Kamada also announces that in cooperation with Chiesi Farmaceutici S.p.A, the companies have begun to prepare for marketing authorization application, expected in 2014, subject to the clinical trial success.
Results of the present interim report of the pivotal clinical trial (phase II-III inhaled AAT) in Europe and in Canada for AAT deficiency (Inherited Emphysema) based on data of all patients in the trial to date, are supportive and consistent with the previous reports and demonstrate a high safety and tolerability profile. To date, the adverse events that were observed were related to the expected known symptoms of the Inherited Emphysema that the patients suffer from. No allergic reactions or signs of any risk related to the use of the inhalation device were observed. The trial will end in 2013 and the final clinical report is expected to be published in the first months of 2014.
We believe that the unique clinical study conducted by Kamada, with the inhaled AAT for AATD drug is the only and in most advanced development stage in the world.
In August 2012, Kamada signed an exclusive distribution agreement with Chiesi Farmaceutici S.p.A, a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, for the distribution of its breakthrough inhaled alpha-1 antitrypsin for treatment of alpha-1 antitrypsin deficiency (Inhaled AAT for AATD). Under the terms of the agreement, Kamada will receive milestone payments of $60 million, subject to achievement of certain regulatory and sales targets. In addition, Chiesi is committed to minimum purchases tens of millions USD following the acceptance of the required regulatory approvals. The agreement is for 12 years and Kamada estimates that the sales potential from the distribution agreement, if and as long as its Inhaled AAT for AATD product, which has orphan drug designation, completes its Phase II/III clinical trials successfully and receives the EMA approval, may reach hundreds of millions of dollars in the coming years.
Kamada has recently reported the approval of IND (Investigational New Drug Application) from the FDA for a clinical trial (Phase II) for Inhaled AAT for AATD in the US, and announces that the trial is expected to start in the second half of 2013.
Kamada's intravenous AAT for AATD (Glassia) has been sold in the US in the past two and a half years and generates revenues of tens of millions of dollars for the company.
We are an orphan drug focused, plasma-derived protein therapeutics company with an existing marketed product portfolio and a robust late-stage product pipeline. We develop and produce specialty plasma-derived protein therapeutics and currently market these products through strategic partners in the United States and directly, through local distributors, in several emerging markets. We use our proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (‘‘AAT'') in a high purity, 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 immuno-modulatory, anti-inflammatory, tissue protective and antimicrobial properties. Our flagship product, Glassia, is the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the United States Food and Drug Administration (the ‘‘FDA''). We market Glassia through a strategic partnership with Baxter International Inc. in the United States. Additionally, we have a product line consisting of nine other injectable pharmaceutical products which are marketed, in addition to Glassia, in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia. We currently have five plasma-derived protein products in our development pipeline, including an inhaled formulation of AAT for treatment of AAT deficiency that is in pivotal Phase II/III clinical trials in Europe and entering into Phase II clinical trials in the United States. In addition, we leverage our expertise and presence in the plasma-derived protein therapeutics market by distributing ten complementary products in Israel that are manufactured by third parties.
Additional information is available at www.kamada.com.
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Cautionary Note Regarding Forward-Looking Statements
This release contains forward-looking statements that involve risks, uncertainties and assumptions, such as statements regarding the EMEA and US 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 US FDA or the EMEA 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.