dissertation写作中关于溴化甲基纳曲酮皮下注射剂（RELISTOR）产品的功能介绍
01-03, 2013
RELISTOR 溴化甲基纳曲酮皮下注射剂
Opioid-based medications such as morphine and codeine are used to control moderate-to-severe pain in patients receiving palliativecare, undergoing surgery, experiencing chronic pain or with other medical conditions.
吗啡和可卡因等阿片类药物为基础的药物是用来控制中度至重度疼痛的，患者需要接受保健或者接受手术治疗来缓解慢性疼痛，或在其他医疗条件下进行。
Opioids relieve pain by interacting with receptors located in the brain and spinal cord, but also activate receptors in the gut, often resulting in constipation, referred to as opioid-induced constipation orOIC. As a result of OIC, many patients may stop or reduce their opioid therapy, opting to endure pain in order to obtain relief from their OICand its associated side effects.
RELISTOR, the first approved treatment for OIC that addresses the underlying mechanism of this condition, is a selective,peripherally acting, mu-opioid-receptor antagonist that decreases theconstipating side effects induced by opioid pain medications in the gastrointestinal tract without diminishing the ability of these medications to relieve pain. Relief of OIC is an important need that is notadequately met by any other approved drug or intervention. Because of its chemical composition, RELISTOR has restricted access to the blood-brain barrier to enter the central nervous system, where pain is perceived. Outside the central nervous system, RELISTOR competes with opioid pain medications for binding sites on opioid receptors, displacing the pain medications only in the periphery and selectively “turning off” the constipating effects of those medications on the gastrointestinal tract without affecting pain relief occurring in the central nervous system.除了中枢神经系统外，RELISTOR阿片类止痛药物阿片作用于受体的结合位点，只能在外围取代止痛药物并有选择地“转关闭“发生在中枢神经的疼痛，而这些药物不会对胃肠道产生便秘的效果。
Under our 2011 License Agreement, Salix is responsible for further developing and commercializing subcutaneous RELISTOR,including completing clinical development necessary to support regulatory marketing approvals for potential new indications and formulations of the drug. Through December 31, 2011, we have received under this Agreement a $60.0 million upfront cash payment and $0.2 million in respect of Salix ex-U.S. sublicensee revenue and are eligible to receive (i) up to $40.0 million upon U.S.
marketing approval for subcutaneous RELISTOR in non-cancer pain patients, (ii) up to $50.0 million upon U.S. marketing approval of an oral formulation of RELISTOR, (iii) up to $200.0 million of commercialization milestone payments upon achievement of specified U.S. sales targets, (iv) royalties ranging from 15 to 19 percent of net sales by Salix and its affiliates, and (v) 60% of any upfront, milestone, reimbursement or other revenue (net of costs of goods sold, as defined, and territory-specific research and development expense reimbursement) Salix receives from sublicensees outside the U.S. http://www.ukthesis.org/Thesis_Tips/
In the event that either marketing approval is subject to a Black Box Warning or Risk Evaluation and Mitigation Strategy (REMS), payment of a portion of the milestone amount would be deferred, and subject, to achievement of the first commercialization milestone.
Subcutaneous RELISTOR. RELISTOR has been approved by regulatory authorities in the U.S., countries in the European Union,
在美国，在欧洲联盟的国家，皮下RELISTOR已通过监管部门批准。
Canada and Australia since 2008 for treatment of OIC in advanced-illness patients receiving palliative care when laxative therapy has not been sufficient. Marketing applications are pending elsewhere throughout the world. Salix, Progenics, and Progenics’ former collaborator Wyeth have transitioned U.S., European and other marketing authorizations and are transitioning additional commercialization outside the U.S. and Japan. Salix has secured distribution and marketing partners for RELISTOR in the European territory and has licensed Link Medical Products Pty Limited for distribution in Australia, New Zealand, South Africa and certain other markets in Asia. Salix is continuing efforts to secure
additional distribution partners and/or sublicensees.
RELISTOR net sales and related royalties earned through the end of 2011 are set forth below. Our recognition of royalty revenue for financial reporting purposes is explained in Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) and our financial statements included elsewhere in this document. Royalties in 2011 are based on net sales reported by Salix; royalties through September 30, 2010 were based on net sales reported by Wyeth.#p#分页标题#e#
Opioid-based medications such as morphine and codeine are used to control moderate-to-severe pain in patients receiving palliativecare, undergoing surgery, experiencing chronic pain or with other medical conditions.
吗啡和可卡因等阿片类药物为基础的药物是用来控制中度至重度疼痛的，患者需要接受保健或者接受手术治疗来缓解慢性疼痛，或在其他医疗条件下进行。
Opioids relieve pain by interacting with receptors located in the brain and spinal cord, but also activate receptors in the gut, often resulting in constipation, referred to as opioid-induced constipation orOIC. As a result of OIC, many patients may stop or reduce their opioid therapy, opting to endure pain in order to obtain relief from their OICand its associated side effects.
RELISTOR, the first approved treatment for OIC that addresses the underlying mechanism of this condition, is a selective,peripherally acting, mu-opioid-receptor antagonist that decreases theconstipating side effects induced by opioid pain medications in the gastrointestinal tract without diminishing the ability of these medications to relieve pain. Relief of OIC is an important need that is notadequately met by any other approved drug or intervention. Because of its chemical composition, RELISTOR has restricted access to the blood-brain barrier to enter the central nervous system, where pain is perceived. Outside the central nervous system, RELISTOR competes with opioid pain medications for binding sites on opioid receptors, displacing the pain medications only in the periphery and selectively “turning off” the constipating effects of those medications on the gastrointestinal tract without affecting pain relief occurring in the central nervous system.除了中枢神经系统外，RELISTOR阿片类止痛药物阿片作用于受体的结合位点，只能在外围取代止痛药物并有选择地“转关闭“发生在中枢神经的疼痛，而这些药物不会对胃肠道产生便秘的效果。
Under our 2011 License Agreement, Salix is responsible for further developing and commercializing subcutaneous RELISTOR,including completing clinical development necessary to support regulatory marketing approvals for potential new indications and formulations of the drug. Through December 31, 2011, we have received under this Agreement a $60.0 million upfront cash payment and $0.2 million in respect of Salix ex-U.S. sublicensee revenue and are eligible to receive (i) up to $40.0 million upon U.S.
marketing approval for subcutaneous RELISTOR in non-cancer pain patients, (ii) up to $50.0 million upon U.S. marketing approval of an oral formulation of RELISTOR, (iii) up to $200.0 million of commercialization milestone payments upon achievement of specified U.S. sales targets, (iv) royalties ranging from 15 to 19 percent of net sales by Salix and its affiliates, and (v) 60% of any upfront, milestone, reimbursement or other revenue (net of costs of goods sold, as defined, and territory-specific research and development expense reimbursement) Salix receives from sublicensees outside the U.S. http://www.ukthesis.org/Thesis_Tips/
In the event that either marketing approval is subject to a Black Box Warning or Risk Evaluation and Mitigation Strategy (REMS), payment of a portion of the milestone amount would be deferred, and subject, to achievement of the first commercialization milestone.
Subcutaneous RELISTOR. RELISTOR has been approved by regulatory authorities in the U.S., countries in the European Union,
在美国，在欧洲联盟的国家，皮下RELISTOR已通过监管部门批准。
Canada and Australia since 2008 for treatment of OIC in advanced-illness patients receiving palliative care when laxative therapy has not been sufficient. Marketing applications are pending elsewhere throughout the world. Salix, Progenics, and Progenics’ former collaborator Wyeth have transitioned U.S., European and other marketing authorizations and are transitioning additional commercialization outside the U.S. and Japan. Salix has secured distribution and marketing partners for RELISTOR in the European territory and has licensed Link Medical Products Pty Limited for distribution in Australia, New Zealand, South Africa and certain other markets in Asia. Salix is continuing efforts to secure
additional distribution partners and/or sublicensees.
RELISTOR net sales and related royalties earned through the end of 2011 are set forth below. Our recognition of royalty revenue for financial reporting purposes is explained in Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) and our financial statements included elsewhere in this document. Royalties in 2011 are based on net sales reported by Salix; royalties through September 30, 2010 were based on net sales reported by Wyeth.#p#分页标题#e#
Get expert help on all your writing
立即预定