GENZ Seems ready to continue the upmove that started Monday.
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It received approval in Japan to market its Elaprase for HS
bizjournals.com
Genzyme gets approval in Japan for Elaprase
Friday October 5, 11:15 am ET
Genzyme Corp. said Friday it has received approval to market Elaprase in Japan for the treatment of Hunter syndrome.
Cambridge, Mass.-based Genzyme said Elaprase, which is also known as idursulfase, is an enzyme replacement therapy developed by Shire Human Genetic Therapies Inc., and Genzyme is commercializing the product in Japan and other Asia Pacific countries under an agreement with Shire.
Genzyme intends to launch Elaprase this quarter, following reimbursement approval, the firm said in a statement.
Under its agreement with Shire, Genzyme will record product sales in the region and allocate approximately one-third of net sales to Shire.
Genzyme will make a $3 million milestone payment to Shire in recognition of Japanese marketing approval, and it will make a $4 million milestone payment upon reimbursement approval.
Hunter syndrome, also known as Mucopolysaccharidosis II, is a rare, life-threatening genetic condition mainly affecting males that results from the absence or insufficient levels of the lysosomal enzyme iduronate-2-sulfatase.
Without this enzyme, cellular waste products accumulate in tissues and organs which then begin to malfunction, leading to severe clinical complications and early mortality.
Elaprase is the fifth enzyme replacement therapy that Genzyme has introduced in Japan.
Genzyme officials said the firm is currently working to obtain marketing approval for Elaprase in several additional countries. The company anticipates approval in Australia by the end of this year and in Taiwan and South Korea next year.
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GENZ has 4Qs of better revenues & earnings. The EE for 2007 are around $3.40 vs. the $2.77 in 2006 & for 2008 another 15% in earnings is expected.
The stock needs to get over its Nov 2005 H of 77.82 in order to make an all time H.
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Bernard |
