Dallas, Texas 04/09/2014 (FINANCIALSTRENDS) – Dyax Corp. (NASDAQ:DYAX) the biopharmaceutical service provider which has finally received positive news for its plasma inhibitor called KALBITOR.
Food and Drug Administration has indicated that the peptide-based inhibitor can now be used for treating a special medical condition called Hereditary Angioedema or HAE for patients aged 12 years and more.
Incidentally, this is the first, subcutaneous therapy to treat acute HAE attacks for patients less than 12 years.
Dyax Corp. (NASDAQ:DYAX) has reported that this drug is the only approved therapy which will not purify human plasma, when it is used to treat patient populations.
KALBITOR is the only product Dyax Corp markets.
Dyax Corp. (NASDAQ:DYAX) has been able to seek FDA approval for this late 2009 approved drug, then limited to use on patients above 16 years, because of the data it was able to establish for its twin Phase 3 trails – EDEMA 3 and EDEMA4, both of which were completed earlier. The results of this data along with the DX-88/19 study have led encouraging efficacy and sustainable use, allowing FDA to stamp approval.
Kalbitor, the unique plasma inhibitor in Dyax Corp. (NASDAQ:DYAX) single-product portfolio. The company has reported net sales this year to the tune of $40.5million in 2013.
This product is expecting net sales in the range of $44million to $49 million in 2014. It is expected that the product will see high sales this year. HAE, which is a genetic deficiency of the rarest kind is typically severe and will also cause swelling which is painful.
For this rare disease therapy provider, the immediate competition comes from products developed by Shire. The products are named Cinryze and Firazyr. As per latest country-wide statistics on the number of HEA affected, nearly 6,500 are noticeably HAE positive and need medical intervention.