Table of Contents
Progenics began developing RELISTOR in 2001 and continued development and commercialization worldwide except Japan withWyeth Pharmaceuticals (now a Pfizer Inc.subsidiary) pursuant to a 2005 collaboration agreement that was terminated in October 2009.
Progenics公司開始于2001年開發(fā)RELISTOR產(chǎn)品,根據(jù)2005年的一項(xiàng)合作協(xié)議,除日本惠氏制藥公司(現(xiàn)在是輝瑞公司的子公司)以外的全球開發(fā)和商業(yè)化,2009年10月后被終止。
Under our 2008 License Agreement, Ono began clinical testing of RELISTOR subcutaneous injection in June 2009. See Licenses – RELISTOR . Inaddition to our pending sNDA for subcutaneous RELISTOR in non-cancer pain patients, we have also received U.S., E.U. and Canadianapprovals to market RELISTOR in pre-filled syringes, which are designed to ease preparation and administration for patients and caregivers,and expect Salix to begin distributing RELISTOR in this presentation later this year.
Oral RELISTOR. As noted above, we and Salix recently announced top-line data from a phase 3 trial of oral RELISTOR in patients
with non-cancer pain.http://www.mythingswp7.com/Thesis_Tips/
Oncology
Through PSMA Development Company LLC, our wholly owned subsidiary, we conduct research and development programs directedat prostate specific membrane antigen , or PSMA , a protein that is abundantly expressed on the surface of prostate cancer cells as well ascells in the newly formed blood vessels of many other solid tumors. The principal focus of these efforts is our fully human monoclonal ADC ,which utilizes technology licensed to us from Sloan-Kettering Institute for Cancer Research and Seattle Genetics, and is designed to deliver achemotherapeutic agent to cancer cells by targeting the three-dimensional structure of the PSMA protein on these cells and binding to andinternalizing within the cell. We believe a PSMA-directed therapy may have application in prostate cancer and solid tumors of other types ofcancer. We are conducting a phase 1 clinical trial of PSMA ADC for the treatment of prostate cancer which we expect will be completed in2012, and if the results are successful we plan then to commence a Phase 2 trial of PSMA ADC in advanced prostate cancer.
We also recently presented data from preclinical studies of novel multiplex phosphoinositide 3-kinase (PI3K) inhibitors -- synthetic,
我們最近還提出了新穎的復(fù)用磷酸肌醇3 - 激酶(PI3K)抑制劑的臨床前研究的數(shù)據(jù) - 合成。
small-molecule compounds identified by us that in laboratory studies have blocked both PI3K, a key regulator of one molecular signaling,pathway, and MNK, an oncogenic kinase in the Ras pathway. We believe simultaneously blocking these interlinked cellular pathways mayprovide a strategy to combat some of the most aggressive forms of cancer.
We are seeking to in-license or acquire opportunities in the oncology field and related supportive, diagnostic and/or other areas thatare complementary to these ongoing initiatives and our oncology focus generally.
Licenses
Following is a summary of significant license agreements under which we have in- and/or out-licensed rights to use certain
technologies and materials related to RELISTOR and product candidates in our pipeline.
以下是總結(jié)重要的許可協(xié)議,據(jù)此,本公司有特許權(quán)使用某些RELISTOR和產(chǎn)品的候選人在我們的內(nèi)部查看相關(guān)的技術(shù)和材料。
RELISTOR. Under our License Agreement, Salix Pharmaceuticals is responsible for further developing and commercializingsubcutaneous RELISTOR worldwide other than Japan, including completing clinical development necessary to support regulatory marketingapprovals for potential new indications and formulations, and marketing and selling the product. Salix is marketing RELISTOR directlythrough its specialty sales force in the U.S., and outside the U.S., directly through distribution and marketing partners and sublicensing regional companies. Among the rights we have licensed to Salix are our exclusive rights to develop and commercialize methylnaltrexone, the active ingredient of RELISTOR, which we in-licensed from the University of Chicago and for which we are obligated to make milestone and royalty payments to the University. Salix is paying us royalties ranging from 15 to 19 percent on its net sales of RELISTOR as well as 60% of anyupfront, milestone, reimbursement or other revenue (net of costs of goods sold, as defined, and territory-specific research and development
expense reimbursement) it receives from sublicensees in respect of any country outside the U.S. We have licensed to Ono Pharmaceutical the rights to subcutaneous RELISTOR in Japan, where Ono is responsible for developingand commercializing subcutaneous RELISTOR, including conducting clinical development to support regulatory marketing approval and will own the subcutaneous filings and approvals relating to RELISTOR. We received a $15.0 million upfront payment from Ono, and are entitled to receive up to an additional $20.0 million upon achievement of development milestones. Ono is also obligated to pay us royalties and commercialization milestones on sales of subcutaneous RELISTOR in Japan. Ono has the option to acquire the rights to develop andcommercialize other formulations of RELISTOR in Japan, on terms to be negotiated separately. Supervision of and consultation with respect Ono’s development and commercialization responsibilities are carried out by joint committees. The Ono License contains, among other terms,provisions which permit termination by either party upon the occurrence of certain events.
許可協(xié)議包含在其他條款中,規(guī)定允許的事件發(fā)生后,任何一方的權(quán)利都將被終止。
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