Israel-Medical-Healthcare

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Kamada stock jumps as FDA okays Phase III trials of emphysema drug

09.3.06 | 11:50 By Sharon Shpurer

Shares in Kamada are leaping on news that the United States Food and Drug Administration has agreed to let the biotechnology company conduct phase III clinical trials of its Alpha 1-Proteinase Inhibitor (API), a treatment under development for panacinar emphysema.

Kamada was not only the first biotechnology company to list on the Tel Aviv Stock Exchange: it is now the first to reach the last phase of clinical trials before marketing.

As of writing shares in Kamada are rising 6.4% on the TASE, on heavy turnover of NIS 0.8 million.

The FDA notified Kamada that its clinical hold status has been lifted. The company may commence clinical trials in the U.S. without requiring further permits.

The trials will be conducted on 50 emphysema patients, based on a protocol approved by the FDA.
API is being developed as a treatment for hereditary emphysema, caused by a deficiency of Alpha 1-Proteinase inhibition enzymes in the body. The product, which is extracted from blood plasma, is already being marketed in several countries.

Kamada's product is apparently the only one that can be injected directly into patients, without being mixed or diluted or otherwise processed. Meanwhile the company is working on a next-generation product for administration by inhaler.

If and when it receives marketing permits from the U.S. and European authorities, Kamada believes the drug's contribution to its sales will be material.

It notes that API does not cure the disease. It merely alleviates the symptom. The patient would need to take the medicine for life.

More than 200,000 people in the U.S. and Europe are believed to suffer from hereditary emphysema, though less than 10% have been diagnosed. Only about 4,000 have been diagnosed and are being treaded at costs ranging from $60,000 to $100,000 a year, each. Medical insurance usually covers most of the bill for drugs.

The company believes that although the market is small, the drug has sales potential in the tens of millions of dollars a year.

http://www.haaretz.com/hasen/spages/692237.html

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