| Developer Designation Affiliations | Development Status Indication |
ROCHE
R1507 Affiliate(s):
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: December 04, 2007 | Phase I (begin 4/06, closed 9/07) USA - solid tumors, locally advanced or metastatic
non-Hodgkin's lymphoma (NHL), advanced
Hodgkin's lymphoma, advanced
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SCHERING-PLOUGH
AV-299 Affiliate(s):
Xoma
In September 28, 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 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. Aveos 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: December 01, 2007 | Preclin (ongoing 12/07) USA - solid tumors
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SUPRATEK PHARMA
Doxorubicin SP1049C Affiliate(s):
Cancer Research UK Switch Pharma
In March 2005, Bioaccelerate Holdings closed a $5.0 million equity investment in the common stock of Supratek Pharma. The funds will be used to further develop SP1049C in the treatment of solid tumors, and hematologic malignancies. Bioaccelerate plans to work closely with Supratek to bring SP1049C through clinical development and commercialization. Current as of: December 04, 2007 | Phase I (ongoing 8/00, completed 11/03) Europe (UK), Canada - malignancies, advanced
Phase II (begin 2/02, ongoing 6/05) Europe (UK); phase III (planned 11/07) USA - esophageal cancer, metastatic
adenocarcinoma, upper gastroentestinal (GI) tract, advanced, metastatic, refractory
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SYNDAX PHARMACEUTICALS
MS-275
MS275
SNDX-275 Pyridin-3-ylmethyl N-[[4-[(2-aminophenyl)carbamoyl] phenyl]methyl]carbamate; C21H20N4O3 Affiliate(s):
Bayer Schering Pharma
Syndax acquired worldwide development and commercial rights to SNDX-275 (formerly MS-275) from Bayer Schering Pharma in February 2007. Under terms of the agreement, Syndax will develop and commercialize the compound, while Bayer Schering Pharma will receive upfront and milestone payments. The HDACi becomes Syndaxs lead product candidate to be developed in combination with other oncology therapies. Financial terms of the agreement were not announced. Current as of: December 01, 2007 | Phase I (began 3/01, closed 06) USA; phase I (begin 11/04, closed 9/06) USA (combination) - solid tumors, refractory
non-Hodgkin's lymphoma (NHL), refractory
Phase I (begin 2/01, closed 7/05) USA - leukemia, advanced, refractory
hematologic malignancies
Phase I (begin 12/04, closed 8/07) USA (combination) - chronic myelomonocytic leukemia (CML)
myelodysplastic syndrome (MDS)
acute myeloid leukemia (AML)
Phase II (begin 12/04, completed 11/06) USA - melanoma, malignant, advanced
Phase I/II (begin 8/06, ongoing 12/07) USA - non-small cell lung cancer (nsclc), metastatic or inoperable, refractory, second line
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SYSTEMS MEDICINE
Brostallicin PNU-166196
PNU-166196A Affiliate(s):
Nerviano Medical Sciences
In 2007, Nerviano licensed worldwide rights to brostallicin to Systems Medicine. Brostallicin was originally developed by Pharmacia. Current as of: December 04, 2007 | Phase I (ongoing 01) Europe (The Netherlands); phase I (ongoing 01) USA; phase Ib/II (begin 10/07, ongoing 10/07) USA (combination) - solid tumors
Phase II (begin 5/02, closed 7/04) Europe (Belgium, France, Hungary, The Netherlands, UK) - soft-tissue sarcoma, locally advanced or metastatic, refractory, second line
Phase II (begin 10/06, ongoing 7/07) Europe (Netherlands) - soft tissue sarcoma, advanced or metastatic, first line
Phase II (ongoing 10/07) - colorectal cancer, advanced or metastatic, third/fourth line
Phase II (ongoing 10/07) - ovarian cancer, advanced or metastatic, second/third line
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TRANSMOLECULAR
Chlorotoxin 131-I-TM-601 Affiliate(s):
University of Alabama
TransMolecular licensed technology based on ion channels selectively expressed in the central nervous system and related tissues, from the University of Alabama. Yale University
TransMolecular licensed technology based on ion channels selectively expressed in the central nervous system and related tissues, from Yale University. Current as of: December 04, 2007 | Phase I/II (begin 5/02, completed 7/03) USA; phase II (begin 11/04, ongoing 11/07) USA; phase II (planned 2007) USA; phase I (planned 2007) USA - glioma, high-grade, adult, recurrent
glioma, high-grade, adult, recurrent, malignant
Phase I (begin 8/06, ongoing 11/07) USA - solid tumors
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