HAYWARD, Calif. & CUPERTINO, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc.(NASDAQ:IPXL) and DURECT Corporation
(Nasdaq:DRRX) announced today that they have entered into an agreement
granting Impax the exclusive worldwide rights to develop and
commercialize ELADUR®, DURECT’s investigational transdermal
bupivacaine patch for the treatment of pain associated with
post-herpetic neuralgia (PHN).
Under the terms of the agreement, Impax will pay DURECT an upfront fee
of $2 million, with possible additional payments of up to $61 million
upon the achievement of predefined development and commercialization
milestones. If ELADUR is commercialized, DURECT would also receive a
tiered royalty on product sales. Impax will control and fund the
development program.
“We’re pleased to be moving ELADUR back into development through this
collaboration with Impax,” stated James E. Brown, president and CEO of
DURECT. “Existing patches used to treat PHN pain are limited by their 12
hour duration, followed by a rest period in which the patient is not to
wear a patch for 12 hours. Episodes of break-through pain are frequently
reported to occur during rest periods for existing patches. We share a
vision with Impax to develop a patch that has the potential to reduce
these episodes of break-through pain.”
Michael Nestor, president of Impax Pharmaceuticals added, “This
agreement is another example of our commitment to building a strong
brand pipeline through internal R&D and external business development.
We are excited to collaborate with DURECT as this product could, if
approved, fit well with the capabilities of our neurology focused
specialty sales force.”
ELADUR is an investigational transdermal drug patch intended to deliver
bupivacaine for up to three days from a single application. DURECT has
previously announced positive results for ELADUR from a 60 patient Phase
IIa clinical trial of patients suffering from PHN.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of central nervous
system disorder branded products. Impax markets its generic products
through its Global Pharmaceuticals division and markets its branded
products through the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such as
injectables, nasal sprays, inhalers, patches, creams and ointments. For
more information, please visit the Company's Web site at: www.impaxlabs.com.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing innovative drugs
for pain and other chronic diseases, with late-stage development
programs including REMOXY®, POSIDUR™, ELADUR®,
and TRANSDUR®-Sufentanil. DURECT’s proprietary oral,
transdermal and injectable depot delivery technologies enable new
indications and superior clinical/commercial attributes such as abuse
deterrence, improved convenience, compliance, efficacy and safety for
small molecule and biologic drugs. For more information, please visit www.durect.com.
Impax Laboratories Forward-Looking Statement
To the extent any statements made in this news release contain
information that is not historical, these statements are forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, fluctuations in revenues and operating income, the Company’s
ability to promptly correct the issues raised in the warning letter and
Form 483 observations received from the FDA, the Company’s ability to
successfully develop and commercialize pharmaceutical products in a
timely manner, reductions or loss of business with any significant
customer, the impact of consolidation of the Company’s customer base,
the impact of competition, the Company’s ability to sustain
profitability and positive cash flows, any delays or unanticipated
expenses in connection with the operation of the
Company’s Taiwan facility, the effect of foreign economic, political,
legal and other risks on the Company’s operations abroad, the
uncertainty of patent litigation, the increased government scrutiny on
the Company’s agreements with brand pharmaceutical companies, consumer
acceptance and demand for new pharmaceutical products, the impact of
market perceptions of the Company and the safety and quality of the
Company’s products, the difficulty of predicting FDA filings and
approvals, the Company’s ability to achieve returns on its investments
in research and development activities, the Company’s inexperience in
conducting clinical trials and submitting new drug applications, the
Company’s ability to successfully conduct clinical trials, the Company’s
reliance on third parties to conduct clinical trials and testing, impact
of illegal distribution and sale by third parties of counterfeits or
stolen products, the availability of raw materials and impact of
interruptions in the Company’s supply chain, the use of controlled
substances in the Company’s products, disruptions or failures in the
Company’s information technology systems and network infrastructure, the
Company’s reliance on alliance and collaboration agreements, the
Company’s dependence on certain employees, the Company’s ability to
comply with legal and regulatory requirements governing the healthcare
industry, the regulatory environment, the Company’s ability to protect
its intellectual property, exposure to product liability claims, changes
in tax regulations, the Company’s ability to manage growth, including
through potential acquisitions, the restrictions imposed by the
Company’s credit facility, uncertainties involved in the preparation of
the Company’s financial statements, the Company’s ability to maintain an
effective system of internal control over financial reporting, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines and other risks described in the Company’s
periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and the Company undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
DURECT Forward-Looking Statement
The statements in this press release regarding ELADUR, its anticipated
attributes, potential uses and commercial potential, and the milestone
and royalty payments that may be potentially paid to DURECT under
DURECT’s license agreement with Impax are forward-looking statements
involving risks and uncertainties that can cause actual results to
differ materially from those in such forward-looking statements.
Potential risks and uncertainties include, but are not limited to, the
risk that ELADUR may not receive regulatory approval, Impax’s ability to
design, enroll, conduct and complete clinical trials to support
regulatory approval, and DURECT and Impax’s ability to complete the
design, development, and manufacturing process development of ELADUR,
Impax’s ability to manufacture and commercialize ELADUR, marketplace
acceptance of the product candidate and the risk that Impax may
terminate the agreement under conditions specified in the agreement.
Further information regarding these and other risks is included in
DURECT's Form 10-Q dated November 5, 2013 filed with the Securities and
Exchange Commission under the heading "Risk Factors."
NOTE: ORADUR®, POSIDUR™, SABER®,
TRANSDUR®, and ELADUR® are trademarks of DURECT
Corporation. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug
candidates under development and have not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities.
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Source: Impax Laboratories, Inc.