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Developer • Designation • Affiliations |
Development Status • Indication |
| GENMAB
• R1507, RG1507, formerly Roche 1
Affiliate(s):
Roche (terminated 12/09)
In December 2009, Roche Holding terminated development of RG1507. The decision was based on the clinical data to date, the large number of molecules targeting the same pathway presently in development, and the prioritization of the Roche portfolio, and not on any safety concerns.
In December 2007, initiation of a phase II clinical trial in sarcoma triggered a $500,000.milestone payment to Genmab.
In June 2002, Roche and Genmab agreed on a broad expansion of a collaboration for the creation and development of human antibody therapeutic products for life-threatening and debilitating diseases. Roche also made an equity investment in Genmab totaling $20 million at a price of DKK 180 per share. This expanded program involves a number of new disease targets from Roche. Genmab expects to initiate approximately 15 new projects in the coming year across a number of therapeutic areas. The program is coordinated by Roche's Pharmaceutical Research and will expand the company's significant commitment to the development of biologicals as innovative new medicines. Under the current agreement Roche has access to Genmab's antibody development capabilities as well as its preclinical and clinical development capabilities. Genmab will receive milestones as well as royalty payments on successful products. In certain circumstances, Genmab could obtain rights to develop products based on disease targets identified by Roche. If all goals are reached, the value of the collaboration could be as high as $100 million.
Current as of: April 30, 2010 |
Phase I (begin 4/06, closed 1/09) USA, phase I (completed 10/07) USA, phase I (begin 11/07, closed 2/10) USA; phase Ib (begin 1/09, ongoing 4/10) USA - solid tumors, locally advanced or metastatic •
solid tumors, advanced, malignant, refractory •
solid tumors, pediatric, relapsed or refractory •
non-Hodgkin's lymphoma (NHL), advanced •
Hodgkin's lymphoma, advanced
Phase II (begin 11/07, closed 7/09) USA - sarcoma, refractory or recurrent
Phase II (begin 11/08, ongoing 3/10) USA, Australia, Canada, Europe (Austria, Belgium, France, Germany, Ireland, Italy, Poland, Spain, UK) (combination), phase II (begin 11/08, ongoing 3/10) USA, Canada, Europe (France, Poland) (combination) - non-small cell lung cancer (nsclc), locally advanced or metastatic, refractory
Phase I (begin 7/09, ongoing 4/10) Europe (UK); phase II (begin 1/09, ongoing 3/10) USA (combination) - breast cancer, invasive, operable •
breast cancer, postmenopausal, locally advanced or metastatic
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MERCK
• AV-299, SCH900105, SCH 900105
Affiliate(s):
Xoma
In July 2010, Xoma recieved a $750,000 milestone payment under its collaboration with Aveo Pharmaceuticals as a result of AVEO's initiation of a phase II clinical trial to evaluate AV-299 in the treatment of non-small cell lung cancer.
In September 2006, Xoma and Aveo Pharmaceuticals entered into a $6 million agreement under which Xoma will manufacture and supply AV-299, Aveo's novel anti-HGF antibody, in support of early clinical trials. Xoma has successfully completed the Human Engineering (HE) of AV-299. This agreement further strengthens the collaboration between the companies that began with the humanization of AV-299. Under the supply agreement, Xoma will create AV-299 production cell lines, and conduct process and assay development, as well as cGMP manufacturing activities in support of Aveo's IND filing and early clinical trials.
In April 2006, Xoma and Aveo Pharmaceuticals entered into an agreement for Xoma to use its Human Engineering (HE) technology to humanize AV-299. For work conducted and licenses granted, Aveo will pay Xoma an upfront license fee, development milestones and royalties. Aveo retains all development and commercialization rights to AV-299. Additional financial terms were not disclosed.
Aveo Pharmaceuticals
In June 2010, the initiation of a phase II clinical trial in non-small sell lung cancer triggered an $8.5 million milestone payment by Merck to Aveo.
In September 2008, initiation of a phase III clinical trial with AV-299 triggered a $3.0 million milestone payment from Schering-Plough to Aveo Pharmaceuticals.
In April 2007, Aveo Pharmaceuticals entered into an exclusive worldwide agreement with Schering-Plough to develop and commercialize AV-299. It is expected to enter clinical trials in early 2008. Aveo’s Human Response Prediction (HRP) platform will be used to guide the clinical development of AV-299. Under the terms of the agreement, Aveo will have primary responsibility for clinical development of AV-299 through proof-of-concept in man. Aveo will also apply its HRP platform during a multi-year translational research program designed to discover biomarker profiles of patients most likely to benefit from treatment with AV-299. Results of this research will be used to design the optimal clinical development plan for AV-299. AVEO retains the option to co-promote AV-299 in the USA for certain oncology indications. In consideration of the exclusive worldwide license, Aveo will receive a $7.5 million upfront payment and a $10 million equity investment from Schering-Plough. Schering-Plough will fund all R&D expenses. Milestone payments for the successful development and commercialization of AV-299, if all approvals in multiple indications and all sales milestones are achieved, could exceed $460 million. Upon commercialization, Aveo is eligible to receive royalties on net sales.
Current as of: August 04, 2010 |
Phase I (begin 8/08, ongoing 8/10) USA - solid tumors, advanced, recurrent, metastatic or inoperable •
lymphoma, advanced, recurrent, metastatic or inoperable
Phase I (begin 7/09, ongoing 8/10) USA - solid tumors, advanced, metastasized to the liver
Phase Ib/II (begin 12/09, ongoing 8/10) Singapore (combination) - solid tumors, advanced, refractory •
non-small cell lung cancer, locally advanced, inoperable or metastatic, first or second line
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NEW MEDICINE, INC.
P.O. BOX 909, LAKE FOREST, CA 92609
PHONE: 1-949-830-0448 FAX: 1-949-830-0887
INFO@NEWMEDINC.COM
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