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Vol. 2 | August 2009
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TLV Spotlight
Kamada: A breath of innovation
TLV Insider interview with David Tsur, CEO
Highlights
Market Cap (10.08.09 in Millions of $) 177
Yield YTD
(10.08.09)
540%
TASE Index TA 100
Tel-Tech 15
Number of employees 219
Key personnel Chairman:
Ralph Hahn

CEO: David Tsur
CFO: Eyal Leibovitz
First trading Date August 2005
Life savers: A biopharmaceutical company founded in 1990 and headquartered in Israel’s prestigious Weizmann Science Park, Kamada develops, produces and markets a line
of specialty, life-saving biotherapeutics.

Flagship product: Alpha 1 Antitrypsin (AAT) was developed for the treatment of alpha-1 antitrypsin deficiency, a rare genetic disease that afflicts the lungs and gradually destroys the respiratory system. Administered intravenously, AAT enables people affected with the disorder to live a normal life. The second generation AAT product, to be administered via inhalation, is designated as an orphan drug for the AAT deficiency indication as well as additional respiratory conditions (Cystic Fibrosis and Bronchiectasis) by the EMEA and FDA.

Purity: Kamada produces exceptionally pure, ready-to-use products in liquid form with maximum safety and efficacy levels. The Company uses a proprietary chromatographic purification technology that enables it to achieve large scale production in its state-of-the-art cGMP compliant facility.

Rich, late-stage pipeline: Several of Kamada's products are in advanced clinical development stages, among them: intravenous AAT (Phase 3 trial in the US complete); the inhaled version of AAT for the treatment of alpha-1 antitrypsin deficiency (Pivotal Phase 2-3 trial imminent in the EU); the inhaled version of AAT for the treatment of cystic fibrosis (Phase 2 study completed); inhaled AAT for the treatment of bronchiectasis (Phase 2 trial completed); a rabies human immune globulin indicated for post-exposure prophylaxis of rabies infection (an approved IND from US-FDA to start a Phase 2-3 study exist ); and an anti-venom product for the treatment of snakebites recently commissioned by the Israeli Ministry of Health

Bottom line: To date, the Company has sold more then 50 million vials of its products, equivalent to approximately $US 200 million, and distributes more than 10 products in over 15 countries

Market precedents: Kamada bears the distinction of being the first biopharmaceutical company to be traded on TASE (Symbol: KMDA; since 2005), and is one of only two companies in the life sciences to have entered the prestigious Tel Aviv 100 Index.

TLV Insider recently sat down with David Tsur, the Company’s Chief Executive Officer, to discuss Kamada’s prominent role in this crucial industry:

To what extent is biopharmaceutics revolutionizing the treatment of various diseases?

Biopharmaceutical products are based on biological compounds, which may be derived from either animal or human plasma sources or genetically engineered. They typically are developed to address the unmet needs of various diseases that aren’t fulfilled by more conventional treatments and, more specifically, rare diseases that have no alternative treatment or cure.

What specifically does Kamada bring to the table that i unique in the industry?

Kamada specializes in the large scale production of biopharmaceuticals derived from human plasma and its fractions, which contain a wealth of different proteins and can address multiple therapeutic indications. Over the years, we’ve developed proprietary expertise in extracting these proteins, purifying them into extremely clean, ready-to-use liquid products. What Kamada introduces to the market are products with considerable advantages for patients: a high safety profile, high tolerability of treatment and user-friendly convenience – all of which translate into better quality of life.

Take for example, our AAT intravenous (IV) product. Compared with three US competitors, we have the only ready-to-use solution on the market. All the others are lyophilized powders that require reconstitution. When you consider that this is a life long treatment that requires a weekly infusion of 5-6 vials of 50ml per dosage, you begin to comprehend what a major lifestyle advantage this represents for patients. There is less chance of contamination of the product during its preparation prior to infusion. Add to that the fact that we have a higher purity profile that does not include any stabilizers, preservatives or added substances that may cause allergic reactions, and you have a product that brings a great added value to patients for whom quality of treatment is a first priority.

Our inhaled AAT product, which is the second generation of the IV product, is even more groundbreaking. The treatment indication is the same, but instead of having the patient use an invasive, painful treatment, they can use a sophisticated, lightweight and user friendly inhaler that brings the AAT directly to their lungs without going into the blood stream first. To the best of our knowledge we’re the most advanced company to have developed an inhaled formula. Consider the notion of casually using an inhaler to treat a chronic lung disorder while watching TV in your own living room; it’s win/win all around: a far more convenient and patient friendly alternative to invasive intravenous treatment and far greater cost efficiency.

With so many diseases out there in dire need of innovative cures, what makes you decide on a given target for development? Is it demand driven in areas where standard pharmaceuticals are simply less effective or is it purely opportunity based?

It’s both, clearly. The choice of development target is a meeting point of where our relative strengths in protein purification and production come to the fore and converge with unmet market needs. The pure, liquid form of our products is an ideal complement for inhalation technology, enabling us to produce high added value products that can compete more effectively in the market arena.

Kamada started out developing what it terms “life-saving injectable pharmaceuticals” and made a shift to specialty products based on plasma derivitaves. Can you address this strategic shift and its significance?

The strategic shift was from the commodities side to the specialty products side. The life saving category is still applicable to both sides. The shift from commodities to specialty products enabled the company to focus on niche markets with higher profit margins and to focus its expertise towards certain indications and patient populations while the commodities side of this business leads to a more dispersed approach. There are probably a hundred manufacturers in the market who can produce Albumin; but, developing an effective, patient friendly treatment for respiratory indications such as cystic fibrosis for example, that is delivered via an inhalator – that’s a paradigm shift that will impact the lives of tens of thousands who suffer from this disease all over the world.

The development pipeline in the pharmaceutical industry has a relatively long arc. It’s easy to find yourself several years into the development of a product and then discover that some new technology or research trend is about to leapfrog your efforts. How strategically prepared is Kamada to maintain its edge and ensure the viability of its investments throughout the development lifecycle?

It is true that development of pharma products takes several years and sometimes up to 12 years, so statistics say. Yet, the emergence of new technologies and the subsequent development of pharma products based on these new technologies are bound to such periods as well and actually take sometimes far longer due to the regulatory considerations that the authorities set. For instance where products are developed using new procedures, the regulatory bodies typically have a long list of safety demands that have to be adequately addressed, which translates into many more clinical and pre clinical studies. The classic method of purifying a product derived from human plasma is still considered the "safe and more acceptable" approach while the new technologies of recombinant and transgenic products (and possibly gene therapy) are required to conduct many more clinical studies as well as pre clinical and in vitro studies. The risk, though it exists, is therefore not a threat at this point. With that said, Kamada is closely attuned to new technological developments and is not ruling out applying a new technology in the long run.

Why is Kamada an attractive target for investors?

Well first off, despite the advanced stages in our clinical trials and product developments, the Company’s share price is still relatively low and appealing. We were one of the first Israeli life science companies to enter the US market and have experience, both in selling our legacy products as well as the high potential upside of inhaled AAT. Kamada has the ability to produce high quality, innovative products with a competitive edge mainly due to our technology expertise, the advantageous nature of the products and the orphan designations of the products. We’ve shown a proven ability to expand our product line to more products based on our unique purification technology and to contract these purification services to others. Add to that the fact that we have sold in excess of $200 million worth of product vials over the years, and I think we are an intriguing investment horizon for anyone looking to diversify their portfolio.

For Market Data & More Details from the TASE Website, click here >>

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Evogene, one of the world's most established Ag-Biotech companies, leverages three extremely strong foundations that Israel is recognized for all over the world
Kamada: A breath of innovation
Kamada produces human plasma-derived biopharmaceutical products with considerable advantages for patients.
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