Noven To Commence Manufacture Of Daytrana(TM) Methylphenidate Transdermal System
作者: 整理时间:2005-12-20
12/14/2005
Miami, FL - Noven Pharmaceuticals, Inc. announced recently that it expects to commence the manufacture of launch supplies of Daytrana(TM) (methylphenidate transdermal system) this week.
Daytrana(TM), licensed globally to Shire plc, is an
investigational transdermal patch designed for once-daily use to treat
attention deficit hyperactivity disorder (ADHD) in children aged 6 to
12 years. An amended New Drug Application (NDA) for the product is
currently pending at the U.S. Food and Drug Administration (FDA). The
FDA regulatory review period under the Prescription Drug User Fee Act
for Daytrana(TM) is scheduled to conclude December 28, 2005.
Earlier in December 2005, the U.S. Drug Enforcement Administration
(DEA) granted Noven procurement quota (methylphenidate raw material)
sufficient to manufacture launch supplies. Noven's application for
additional procurement quota is currently pending at the DEA.
If the amended NDA is approved, Noven will be entitled to a $50
million milestone payment from Shire, and may earn additional
milestone payments totaling $75 million depending on commercial sales
of the product. Noven also expects to earn a profit on the manufacture
and supply of finished product to Shire. Under the agreements between
Noven and Shire, Shire bears financial responsibility for Daytrana(TM)
inventory if the product is not approved or cannot otherwise be sold.
SOURCE: Noven Pharmaceuticals, Inc.
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