Methylphenidate HCl Tablets are
a leading product in the treatment of ADHD (Attention-Deficit/Hyperactivity
Disorder), a disorder prevalent in school age children. Since
1990 there has been a significant increase in the diagnosis of
ADHD and in the use of Methylphenidate as treatment. Combined
brand and generic sales of this product during 1996 were estimated
to be $281 million, representing 10% growth over the previous
year.
Schein Pharmaceutical's Methylphenidate
HCl tablets are the generic equivalent to Ritalin®*. The generic
alternative has been available since 1985 and prescription data
estimates that 72% of all prescriptions for this drug are dispensed
using the generic product. As a leading manufacturer and marketer
of prescription medications, Schein Pharmaceutical projects it
will capture approximately one quarter of the generic market
sales.
Available raw material is dependent
upon allocation of Drug Enforcement Administration (DEA) quotas.
As a new manufacturer of this product, Schein Pharmaceutical
will increase its customer base and make its product available
in gradual stages over the next few months to ensure continuity
of supply. The first shipments will begin during the fourth quarter.
Methylphenidate HCl Tablets are
the first controlled schedule II product (a US government designation
with specified security requirements) to be produced at Schein
Pharmaceutical's Danbury Pharmacal facility. Schedule II products
are currently manufactured at other Schein Pharmaceutical facilities.
Schein Pharmaceutical will receive
Methylphenidate raw material from Johnson Matthey's Pharmaceutical
Materials business, based in West Deptford, New Jersey, USA,
which manufactures a broad range of active ingredients for sale
to pharmaceutical companies. Its major products include a range
of generic and patent - protected drugs, including platinum anti-cancer
drugs and substances regulated by the DEA.
Johnson Matthey Pharmaceutical
Materials was granted registration by the DEA as a bulk manufacturer
of Methylphenidate in May 1995.It received approval as a manufacturer
from the FDA on 25th August 1997.
Commenting on the receipt of
FDA approval, Dr Michael Cleare, Johnson Matthey's Managing Director
with responsibility for the Pharmaceutical Materials business
said:
"Johnson Matthey is very pleased
to receive this approval, which is the culmination of a long
and extremely close collaboration with Schein Pharmaceutical.
Methylphenidate is an exciting extension to the range of controlled
substances manufactured by our Pharmaceutical Materials business
and FDA approval as a manufacturer of the product represents
an important step forward in our growth strategy."
Martin Sperber, Chairman and
CEO of Schein Pharmaceutical said:
"Methylphenidate is a significant
product in health care and an important product for us. We are
pleased to be able to offer a cost saving alternative for patients
and their families. This product is a significant addition to
our broad line of products and further strengthens our position
as a leader in pharmaceutical manufacturing."
*Ritalin® is registered trademark
of Ciba- Geigy Corporation.