4 Aug. 2012
Ness Ziona, Israel, August 5, 2012. Kamada, Ltd. (TASE: KMDA), a biopharmaceutical company engaged in development, manufacturing and marketing of specialty life-saving therapeutics announced today it has entered into 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 (AATD-IH).
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 during the first 5 years 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 AATD-IH 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. The results of Phase II/III clinical trials of AATD-IH in Europe are expected in 2013 and Kamada estimates to complete the drug registration and begin sales no earlier than 2015.
Chiesi is an international Company with a large distribution network and more than Euro1 billion revenues per year, mainly from the respiratory market. According to the agreement, Chiesi will be responsible for the distribution of Kamada's AATD-IH product in Europe, Turkey and former CIS countries including promoting the drug, identifying patients and handling reimbursements. Kamada retains all rights in its AAT-IV products or other AAT-IH indications products and it was agreed that both companies will examine additional cooperation for other indications for the inhaled AAT drug in the future.
Kamada's drug may be the world's first drug designed to treat patients suffering from genetic Alpha1-Antitrypsin Deficiency through inhalation. This medical and technological breakthrough adds to Kamada's additional Alpha-1through intravenous product (AATD-IV), being the sole liquid, ready to use and high purity level product for the treatment of Alpha-1 antitrypsin Deficiency
"I'm proud and pleased with this strategic distribution agreement for the inhaled AAT product, said David Tsur, Kamada CEO. "This is an important agreement with hundreds of millions of dollar revenue potential for the company. This agreement is yet another evidence for the great interest in the inhalation product in the global Alpha-1 industry, as well as among physicians and patients looking forward for the successful completion of the clinical trials ".
" Chiesi is an ideal partner for Kamada for its specialty, large experience and impressive reputation in the respiratory market ", added David Tsur." This allows us to best prepare for market penetration immediately after the successful completion of the pivotal clinical trial and receipt of all necessary approvals. I'm confident that Kamada' advanced technology alongside Chiesi's sales and marketing abilities will ensure the success of this partnership".
“We are delighted to enter this strategic alliance on inhaled AAT as this product has the potential to change the life of thousands of patients, suffering from this life-threatening genetic disorder” said Alberto Chiesi, Chiesi President and Chairman.
“We are glad to add Inhaled AAT to our already strong late stage pipeline as it represents a perfect fit with Chiesi strategy, being a special care product with Orphan Drug status targeting a respiratory disease, consolidating our leadership position in some key countries.” added Ugo Di Francesco, Chiesi CEO.
Kamada is a public biopharmaceutical company traded in the Tel-Aviv Stock Exchange (TASE: KMDA) developing, manufacturing and marketing specialty, life-saving therapeutics using a sophisticated chromatographic purification platform technology. Utilizing its proprietary know-how, Kamada manufactures more than 10 high quality biopharmaceuticals which are marketed in more than 15 countries around the world. Kamada also has a number of products in development and has completed six clinical trials for its high-purity, liquid formulation of alpha-1 antitrypsin protein which is suitable for inhalation and intravenous use. The results of Phase II/III clinical trials of AATD-IH in Europe are expected in 2013 and completion of registration and commencement of sales not earlier than 2015. Kamada will announce the results of its Phase I/II clinical trial of the intravenous AAT drug for the treatment of Type 1 (juvenile) diabetes in the end of 2012.
Chiesi Farmaceutici is a 77 years old R&D driven private Pharmaceutical company, with HQ in Parma (Italy) and a worldwide presence through 25 affiliates in Europe, USA, China, South Amerrica. The company focus on Respiratory and special care diseases and – in 2011 – sales exceeded Euro 1 Bn with over 70% of turnover outside of Italy.
In 2011 investment in R&D reached Euro 170 million Euro. The research centre in Parma and the laboratories in Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to work together on the Group's pre-clinical, clinical and registration research programmes.
At the end of 2011, the Chiesi Group's total staff stood at over 3,800 people.
It is clarified that the estimates described above regarding the completion of the phase 2/3 clinical trials, the receipt of the EMA marketing approval, receipt of the milestone payments and achievement of sales targets, are forward looking statements and are subject to targets which Kamada has no certainty of the achievement thereof.