|
Table of Contents目录
RELISTOR. RELISTOR has been approved by regulatory authorities in the U.S., countries in the European Union, 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.
在美国，RELISTOR已通过监管部门批准，自2008年伊斯兰会议组织在欧洲联盟，加拿大和国家，澳大利亚召开后，致力于消除病患的行动中，该种药品的销售使用体系遍布全球。
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 formulationsof the drug. Through December 31, 2011, we have received under this Agreement a $60.0 million upfront cash payment and $0.2 million inrespect of Salix ex-U.S. sublicensee revenue and are eligible to receive (i) up to $40.0 million upon U.S. marketing approval for subcutaneousRELISTOR 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 19percent of net sales by Salix and its affiliates, and (v) 60% of any upfront, milestone, reimbursement or other revenue (net of costs of goodssold, as defined, and territory-specific research and development expense reimbursement) Salix receives from sublicensees outside the U.S. In
the event that either marketing approval is subject to a Black Box Warning or Risk Evaluation and Mitigation Strategy (REMS), payment of aportion of the milestone amount would be deferred, and subject, to achievement of the first commercialization milestone.
RELISTOR was previously developed and commercialized worldwide except Japan with Wyeth pursuant to a 2005 collaboration
agreement that was terminated in October 2009. Salix, Progenics, and Progenics’ former collaborator Wyeth have transitioned U.S., Europeanand other marketing authorizations and are transitioning additional commercialization outside the U.S. and Japan. Salix has secured distributionand marketing partners for RELISTOR in the European territory and has licensed Link Medical Products Pty Limited for distribution inAustralia, New Zealand, South Africa and certain other markets in Asia. Salix is continuing efforts to secure additional distribution partnersand/or sublicensees. Royalty income in 2011 is based on net sales reported by Salix; royalty income through September 30, 2010 was based onnet sales reported by Wyeth. Under the Transition Agreement, Wyeth paid us $10.0 million in six quarterly installments through January2011. Wyeth also provided financial resources for the development of a multi-dose pen for subcutaneous RELISTOR for which werecognized$1.6 million in 2011 and $1.2 million in 2010. http://www.ukassignment.org/yylwtm/
Together with Salix we have applied to the U.S. Food and Drug Administration to expand the population that can be treated with
subcutaneous RELISTOR to include patients taking opioids for non-cancer pain, and who suffer from OIC as a result. This population includespatients taking opioids for conditions such as back pain or joint pain.柳本公司已向美国食品和药物管理局（FDA），将扩大可以治疗的皮下RELISTOR包括非癌性疼痛的患者服用阿片类药物在人口中的使用范围，遭受伊斯兰会议组织反对的结果。这个人群包含的条件，如需要背部疼痛或关节疼痛，才能服用这些阿片类药物。
We have also received U.S., E.U. and Canadian approvals to marketRELISTOR in pre-filled syringes, which are designed to ease preparation and administration for patients and caregivers, and expect Salix tointroduce that product in 2012. In return for our October 2008 out-license to Ono Pharmaceutical of the rights to subcutaneous RELISTOR inJapan, we received an upfront payment of $15.0 million and the right to receive potential milestones, upon achievement of developmentresponsibilities by Ono, of up to $20.0 million, commercial milestones and royalties on sales by Ono of subcutaneous RELISTOR in Japan.Ono also has the option to acquire from us the rights to develop and commercialize in Japan other formulations of RELISTOR on terms to benegotiated separately.
Ono may request us to perform activities related to its development and commercialization responsibilities beyond ourparticipation in joint committees and specified technology transfer related tasks which will be at its expense, and reimbursable at the time weperform these services.大野可能会要求我们进行相关的开发和商业化，联合委员会指定的技术转让相关的任务，这将都是自费的，这些服务都将会被提出来。
Royalty and milestone payments will depend on success in development and commercialization of RELISTOR, which is dependent onmany factors, such as the actions of Salix and Ono and any other business partner(s) with which we may collaborate, decisions by the FDA andother regulatory bodies, the outcome of clinical and other testing of RELISTOR, and our own efforts. Many of these matters are outside ourcontrol. In particular, we cannot guarantee that Salix will be successful in furthering the development and commercialization of the RELISTORfranchise.特别是，我们不能保证，沙柳在未来能够成功的发展企业，并使得RELISTOR这个产品商业化。
Oncology. We recently announced preliminary data from a phase 1 clinical trial of a fully human monoclonal ADC directed against
PSMA for the treatment of prostate cancer and recently presented data from preclinical studies of novel multiplex phosphoinositide 3-kinase(PI3K) inhibitors for the treatment of cancer.
|
 |
|||
| 网站地图 |
