Biovail Corporation

Biovail Corporation

March 30, 2005 08:32 ET

Biovail Updates Status of NDA for Tramadol ER


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: BIOVAIL CORPORATION

NYSE, TSX SYMBOL: BVF

MARCH 30, 2005 - 08:32 ET

Biovail Updates Status of NDA for Tramadol ER

TORONTO--(CCNMatthews - Mar 30, 2005) -

Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced that it has
received comments from the United States Food and Drug Administration
(FDA) with regard to its New Drug Application (NDA) for Tramadol ER, an
extended-release, once-daily formulation of tramadol hydrochloride.

The FDA has acknowledged that Biovail's Complete Response to the
Tramadol ER Approvable Letter is a Class 2 response, which is therefore
subject to a six-month review. The FDA has also advised that, upon
preliminary review, it is of the opinion that additional clinical trial
data will be required. Biovail's view is that the clinical data
contained within the original NDA and the March 2005 Complete Response
fully support 505(b)(2) filing requirements, and the Company is
considering a number of options. Biovail expects to meet with the FDA to
discuss these options promptly. In the meantime, however, Biovail will
immediately undertake a clinical program to address the FDA's comments.
Biovail anticipates the submission of new clinical data in late 2005 or
early 2006. Biovail believes that a new six-month review period would
then be initiated.

Biovail's original application was submitted December 31, 2003 under
provisions of Section 505(b)(2) of the Food, Drug and Cosmetic Act. The
application included clinical and safety data obtained from four
original adequate and well-controlled trials involving more than 3,000
patients who received doses of up to 400mg of Tramadol ER once daily.
The application also included 12 definitive and five supportive
pharmacokinetic studies which demonstrated that once-daily dosing of
Tramadol ER delivers the equivalent amount of drug as Ultram®
(tramadol hydrochloride tablets) given three times (TID) or four times
(QID) per day.

In October 2004, Biovail's NDA for Tramadol ER received an Approvable
Letter from the FDA. In March 2005, Biovail submitted a Complete
Response to the FDA, which included a significant amount of statistical
analyses, but no new clinical data. The response also addressed other
items raised in the Approvable Letter, including discontinuation rates
of clinical-trial participants (dropouts), which are common in pain
trials, and previously well documented in studies involving tramadol.

About Biovail Corporation

Biovail Corporation is an international full-service pharmaceutical
company, engaged in the formulation, clinical testing, registration,
manufacture, sale and promotion of pharmaceutical products utilizing
advanced drug-delivery technologies.

For further information, please contact Ken Howling at 905-286-3000 or
send inquiries to ir@biovail.com.

"Safe Harbor" Statement Under the Private Securities Litigation Reform
Act of 1995

To the extent any statements made in this release contain information
that is not historical, these statements are forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. We have based these forward-looking statements on our current
expectations and projections about future events. Our actual results
could differ materially from those discussed in, or implied by, these
forward-looking statements. Forward-looking statements are identified by
words such as "believe", "anticipate", "expect", "intend", "plan",
"will", "may" and other similar expressions. In addition, any statements
that refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements.
Forward-looking statements include, but are not necessarily limited to,
risks and uncertainties, including the difficulty of predicting U.S.
Food and Drug Administration and Canadian Therapeutic Products
Directorate approvals, acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, new product
development and launch, reliance on key strategic alliances,
availability of raw materials and finished products, the regulatory
environment, the outcome of legal proceedings, fluctuations in operating
results and other risks detailed from time to time in the Company's
filings with the Securities and Exchange Commission and the Ontario
Securities Commission. Biovail undertakes no obligation to update or
revise any forward-looking statement.

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    Biovail Corporation
    Kenneth G. Howling, 905-286-3000