CHADDS FORD, Pa., Oct. 17 /PRNewswire-FirstCall/ -- Endo
Pharmaceuticals Holdings Inc. (Nasdaq: ENDP) announced today that its
wholly owned subsidiary, Endo Pharmaceuticals Inc., has learned that the
Division of Bioequivalence, Office of Generic Drugs, Center for Drug
Evaluation and Research ("OGD") has issued, in response to an inquiry,
bioequivalence recommendations regarding Endo's patent-protected product,
Lidoderm(R) (lidocaine topical patch 5%).
The company has learned that OGD has recommended a bioequivalence study
characterizing the pharmacokinetic profile of lidocaine as well as a skin
irritation/sensitization study of any lidocaine-containing patch
formulation. This deviates from Endo's understanding of the applicable
regulations and of OGD's past practices, which, for a topically acting
product, have generally required demonstration of bioequivalence through a
comparative clinical efficacy study. It should be noted that Lidoderm is a
topically acting product that works locally at the site of application
rather than through systemic absorption of the active ingredient.
Accordingly, Endo believes that clinical studies consistent with those
required for other topical products are more appropriate in proving
bioequivalence to Lidoderm. Endo has already expressed this view to OGD,
and these discussions are ongoing.
Importantly, Lidoderm is covered by five Orange Book-listed patents,
the last of which is set to expire in 2015. These patents form the basis of
what the company believes is a strong intellectual property estate around
Lidoderm and cover not only the product's method of use in neuropathic
pain, including post-herpetic neuralgia pain, but also its formulation.
Endo intends to vigorously assert these patents against any challenge to
Lidoderm.
Note to Investors
Endo will conduct a conference call with financial analysts to discuss
this news release today at 5:00 p.m. ET. Investors and other interested
parties may access the conference call by dialing (800) 299-0148 (domestic)
or (617) 801-9711 (international), passcode 55254338. Please dial in 10
minutes prior to the scheduled start time. A replay of the call will be
available from October 17, 2006 at 7:00 p.m. ET by dialing (888) 286-8010
(domestic) or (617) 801-6888 (international), passcode 93932186, and will
run until 12:00 a.m. ET on October 24, 2006.
A simultaneous webcast of the call for interested investors and others
may be accessed by visiting http://www.endo.com. In addition, a replay of
the webcast will be available until 12:00 a.m. ET on October 24, 2006. The
replay can be accessed by clicking on "Events" in the Investor Relations
section of the website.
About Lidoderm(R)
Lidoderm (lidocaine patch 5%) is a topical analgesic patch approved by
the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain
associated with post-herpetic neuralgia (PHN), a chronic condition
resulting from nerve damage caused by shingles. Lidoderm produces an
analgesic effect by the penetration of lidocaine. Lidoderm should only be
applied to intact skin. Lidoderm is contraindicated in patients with a
history of sensitivity to local anesthetics (amide type) or any product
component. The potential exists for a small child or a pet to suffer
serious adverse effects from chewing or ingesting a new or used Lidoderm
patch, although the risk with this formulation has not been evaluated. It
is important for patients to store and dispose of Lidoderm out of the reach
of children and pets.
Excessive dosing of Lidoderm could result in increased absorption of
lidocaine and high blood concentrations leading to serious adverse effects.
Lidoderm should be used with caution in patients with severe hepatic
disease, pregnant or nursing mothers, or those receiving Class 1
antiarrhythmic drugs (such as tocainide and mexiletine) because of the
potential for serious adverse effects. Avoid contact of Lidoderm with the
eye. If eye contact occurs, immediately wash out the eye with water or
saline and protect the eye until sensation returns. During or immediately
after Lidoderm treatment, application-site reactions may occur. The most
commonly reported post- marketing adverse events are: application-site
erythema, burning sensation, dizziness, erythema, headache, nausea, pain
exacerbated, pruritus (itching), rash, and rash erythematous.
The FDA-approved dosing for Lidoderm is up to three patches applied for
up to 12 hours within a 24-hour period. Lidoderm has not been approved by
the FDA for any indications other than for the relief of pain associated
with PHN, and its safety and efficacy in other indications have not been
established.
Lidoderm(R) is a registered trademark of Hind Healthcare Inc.
About Endo
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty
pharmaceutical company with market leadership in pain management products.
Through its Endo Pharmaceuticals Inc. subsidiary, the company researches,
develops, produces and markets a broad product offering of both branded and
generic pharmaceuticals, meeting the needs of healthcare professionals and
consumers alike. More information, including this and past press releases
of Endo Pharmaceuticals Holdings Inc., is available online at
http://www.endo.com.
Forward-Looking Statements
This press release contains forward-looking statements, within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, as amended, that are based on management's
beliefs and assumptions, current expectations, estimates and projections.
Statements that are not historical facts, including statements which are
preceded by, followed by, or that include, the words "believes,"
"anticipates," "plans," "expects" or similar expressions and statements are
forward-looking statements. Endo's estimated or anticipated future results,
product performance or other non- historical facts are forward-looking and
reflect Endo's current perspective on existing trends and information. Many
of the factors that will determine the Company's future results are beyond
the ability of the Company to control or predict. These statements are
subject to risks and uncertainties and, therefore, actual results may
differ materially from those expressed or implied by these forward-looking
statements. The reader should not rely on any forward-looking statement.
The Company undertakes no obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise. Several important factors, in addition to the specific factors
discussed in connection with these forward-looking statements individually,
could affect the future results of Endo and could cause those results to
differ materially from those expressed in the forward-looking statements
contained in this press release. Important factors that may affect future
results include, but are not limited to: market acceptance of the Company's
products and the impact of competitive products and pricing; dependence on
sole source suppliers; the success of the Company's product development
activities and the timeliness with which regulatory authorizations and
product launches may be achieved; successful compliance with extensive,
costly, complex and evolving governmental regulations and restrictions; the
availability on commercially reasonable terms of raw materials and other
third party manufactured products; exposure to product liability and other
lawsuits and contingencies; dependence on third party suppliers,
distributors and collaboration partners; the ability to timely and cost
effectively integrate acquisitions; uncertainty associated with pre-
clinical studies and clinical trials and regulatory approval; uncertainty
of market acceptance of new products; the difficulty of predicting FDA
approvals; risks with respect to technology and product development; the
effect of competing products and prices; uncertainties regarding
intellectual property protection; uncertainties as to the outcome of
litigation; changes in operating results; impact of competitive products
and pricing; product development; changes in laws and regulations; customer
demand; possible future litigation; availability of future financing and
reimbursement policies of government and private health insurers and
others; and other risks and uncertainties detailed in Endo's filings with
the Securities and Exchange Commission, including its Registration
Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should
evaluate any statement in light of these important factors.
SOURCE Endo Pharmaceuticals Holdings Inc.
 back to top
Related links:
http://www.endo.com
CONTACT:
Bill Newbould of Endo Pharmaceuticals,
+1-610-558-9800
|
