HAYWARD, CA & CUPERTINO, CA, USA I January 7, 2014 I Impax Laboratories, Inc.(IPXL) and DURECT Corporation (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.
SOURCE: Durect Corp
Post Views: 83
HAYWARD, CA & CUPERTINO, CA, USA I January 7, 2014 I Impax Laboratories, Inc.(IPXL) and DURECT Corporation (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.
SOURCE: Durect Corp
Post Views: 83
