BioMarin Pharmaceutical To New High On FDA Approval

BioMarin Pharmaceutical rose more than 5% on Thursday after the FDA granted marketing approval for the PKU drug Kuvan tablets. The stock drifted lower until about 12:30 pm when it jumped higher with an increase in volume. BMRN continued its gains for about a half hour when it leveled off to close at $29.76, up $1.58.

Thursday's gains brought the stock above resistance to a new high.
BioMarin Pharmaceutical said that the U.S. Food and Drug Administration has granted marketing approval for phenylketonuria or PKU drug Kuvan tablets.
Phenylketonuria is a genetic disorder that is characterized by an inability of the body to utilize the essential amino acid, phenylalanine. Kuvan is the first specific drug therapy approved for the treatment of PKU.

The company will begin Shipments to the distribution channel tomorrow and it will begin promotion of Kuvan immediately.
Post-marketing commitments include a PKU registry program, a 2-year extension study for pivotal study patients (ending in mid-2008 for U.S. patients), a single-dose QT cardiovascular study in healthy volunteers, and a 7-year open-label clinical study in an estimated 50 PKU patients less than or equal to 8 years of age.

The latter study will verify that control of Phe levels with Kuvan provides a similar benefit on intellectual function as expected with dietary Phe restriction. It will also provide requested safety, efficacy, and pharmacokinetic data in PKU patients less than or equal to 4 years of age.

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