Nuvo provides update on discussions with the FDA related to Pennsaid approval



    MISSISSAUGA, ON, June 19 /CNW/ - Nuvo Research Inc. (TSX: NRI) today
announced additional information related to the expected path forward to
Pennsaid approval by the U.S. Food and Drug Administration ("FDA").
    In recent communications, the FDA has clarified certain of its
requirements for additional information relating to Pennsaid. As a result,
management intends to commence all requested long-term dermal animal studies
and believes that the longest study can be completed post approval, provided
no safety concerns have arisen from any of the studies prior to resubmitting
the application for Pennsaid approval.
    These communications have been confirmed in written correspondence from
the FDA, but have not yet been recorded in official FDA minutes, which Nuvo
expects to receive in the coming weeks. On the basis of this clarification,
Nuvo anticipates that it will be in a position to complete all necessary
studies and file a complete resubmission of its application for Pennsaid
approval with the FDA in the first half of 2009 and be eligible to receive
final marketing approval in the second half of 2009. There can be no assurance
that these anticipated timelines will be achieved, as they are dependant on a
number of factors, including successful completion of other shorter studies to
address other conditions within the Approvable Letter, nor can there be any
assurance that the official FDA minutes will confirm the written
correspondence received from the FDA.
    In the Approvable Letter, the FDA confirmed that Pennsaid could be
approved for sale in the U.S. once certain conditions were satisfied,
including the provision of additional dermal safety data. None of the
conditions relate to clinical efficacy or clinical safety of Pennsaid, which
were evidenced in Nuvo's Phase III trials. The FDA has not requested that Nuvo
conduct any additional Phase III clinical trials.

    About Pennsaid(R)

    Pennsaid(R) is a topical non-steroidal anti-inflammatory drug (NSAID) for
the treatment of osteoarthritis and is currently approved for sale in Canada
and several European countries. Pennsaid(R) allows the diclofenac solution to
be delivered to a specific site via the surface of the skin. The systemic
exposure of Pennsaid is approximately 1/200th of that from the oral dosage
form of diclofenac, greatly decreasing the potential for complications
associated with the oral route of delivery. According to published clinical
trials, Pennsaid(R) is as effective as the maximum daily dose of comparable
oral medication at relieving pain and stiffness associated with osteoarthritis
of the knee, as well as improving overall well-being.

    About Nuvo Research Inc.

    Nuvo is focused on developing innovative site-specific therapeutics that
are delivered topically using the Company's skin-penetrating technologies.
Nuvo's lead product is Pennsaid(R), a topical non-steroidal anti-inflammatory
drug (NSAID) used for the treatment of osteoarthritis. Nuvo intends to
leverage its skin-penetrating technologies to create a portfolio of
transdermal products targeting a variety of indications. Nuvo Research Inc. is
a publicly traded, Canadian pharmaceutical company headquartered in
Mississauga, Ontario, with manufacturing facilities in Varennes, Québec and
Wanzleben, Germany and a research and development facility in San Diego,
California. For more information, please visit www.nuvoresearch.com.

    This release may contain forward-looking statements, subject to risks and
uncertainties beyond management's control. Actual results could differ
materially from those expressed here. Risk factors are discussed in the
Company's annual information form filed with the securities commissions in
each of the provinces of Canada. The Company undertakes no obligation to
revise forward-looking statements in light of future events.

    %SEDAR: 00002418E




For further information:

For further information: Investor Relations: Christina Bessant, Equicom
Group Inc., (416) 815-0700 x269, cbessant@equicomgroup.com

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