Barr went to a clinical trial to prove "substitutability" for Coumadin
Thomas, I think this release from Barr is really interesting. Notice the extreme vitriol directed against DuPont. Do you think there's much at stake here? LOL
--------------------------------------------------------------------------------
Barr Says Clinical Trial Confirms Substitutability of Generic Coumadin; Study Dispels DuPont Merck's Patient Safety Claims
POMONA, N.Y., Nov. 17 /PRNewswire/ -- Barr Laboratories, Inc. (Amex: BRL)
today announced that it has received the results of an independent clinical
trial that further demonstrates the interchangeability of Barr's generic
Warfarin Sodium product for DuPont Merck's Coumadin anti-coagulant. The study
was conducted to confirm that Coumadin and Barr's Warfarin Sodium products
have equivalent safety and efficacy and that no additional blood tests are
required when the products are interchanged.
The single center, observer blind, randomized, crossover study, was
designed to test the interchangeability of Coumadin and Barr's Warfarin Sodium
product by measuring the relative INR levels, which is the preferred
laboratory method for monitoring oral anti-coagulant therapy. Patients
enrolled in the study were on stable doses of the drug for the prophylaxis
and/or treatment of thromboembolic complications associated with atrial
fibrillation. The study was conducted at the V.A. Medical Center, Long Beach,
CA, under the supervision of Joel Neutel, M.D., Director of Research, Orange
County Heart Institute, with a total of 39 evaluable patients included in the
primary efficacy analysis. Patients on stable doses of Coumadin were
randomized to continue on Coumadin or switch to the Barr product for 21 days,
and then switched to the alternate product for two, consecutive 21-day
treatment periods. Independent statistical analysis of the study results
demonstrated that the mean INR levels achieved on the DuPont Merck product or
the Barr product were equivalent throughout the treatment period of the study.
The study confirms that these Warfarin Sodium preparations are therapeutically
equivalent and can be safely interchanged with no additional patient
monitoring as a result of the switch.
"This clinical study confirms what was obvious from the beginning, that
Barr's generic Warfarin Sodium is fully substitutable for DuPont Merck's
Coumadin anti-coagulant therapy. It validates the scientific conclusions of
the FDA, USP and state regulatory authorities that special restrictions on
substitution of generic Warfarin Sodium are unnecessary. It should finally
dispel any lingering doubt about DuPont Merck's true motivation in claiming
that patients are at risk when switched from brand to generic," said Bruce L.
Downey, Barr's Chairman, President and CEO. "With this clinical data, DuPont
Merck can no longer hide behind false and misleading medical and scientific
statements that create fear and confusion."
The Company said the results of this clinical study will be submitted for
publication in early 1998. Once published, Barr plans to widely distribute
the article detailing the results of this clinical trial.
Barr launched Warfarin Sodium in July, announcing that it would invest
approximately $5 million in 1997 to support the product. The program includes
materials targeted to the physician, pharmacist and patient, as well as trade
advertising, direct mail components, and attendance at major trade
conventions. It also includes a toll-free number -- 1-888-WARFARIN
(927-3274).
Barr Laboratories, Inc. is a leading independent developer, manufacturer
and marketer of high quality generic pharmaceuticals.
Bladerunner
Market Data 
Markets 
AI
