aveo pharmaceuticals inc (AVEO) Key Developments
Aveo Oncology and Biodesix, Inc. Enters into Worldwide Agreement to Co-Develop and Commercialize Ficlatuzumab with Companion Diagnostic for Treatment of NSCLC
Apr 14 14
Aveo Oncology and Biodesix, Inc. announced that they have entered into a worldwide agreement to develop and commercialize Aveo's hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix companion diagnostic test. According to a release, this agreement and the clinical development program will leverage VeriStrat, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab. The company noted that an exploratory analysis from Aveo's Phase 2 study in first-line NSCLC suggested that VeriStrat was prognostic for outcome in the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints. Additionally, under the terms of the agreement, Aveo will conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test. Biodesix will fund up to $15 million of the cost of the study. The companies expect to initiate this clinical study later this year. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally as will any potential profits. Subject to regulatory approval, Aveo will lead worldwide commercialization of ficlatuzumab. Biodesix will be responsible for all development, including FDA engagement activities, sales and marketing costs for VeriStrat, and will retain total revenues for sales of VeriStrat.
Agreement with Biogen Idec Allows AVEO Oncology to Seek Partner to Accelerate Clinical Development
Mar 20 14
AVEO Oncology announced that it has regained worldwide rights to AV-203, a clinical-stage ErbB3 (HER3) inhibitory antibody candidate, from Biogen Idec. AVEO retained the exclusive right to commercialize ErbB3 antibody products in North America. Under the terms of the amended agreement, Biogen waives its option to rights outside of North America to AV-203, thereby providing worldwide rights to AV-203 to AVEO. In exchange, AVEO will have certain financial obligations to Biogen with respect to amounts AVEO receives from certain development and sales milestones and royalties on net sales for AV-203.
AVEO Pharmaceuticals, Inc. Announces Unaudited Consolidated Financial Results for the Fourth Quarter and Year Ended December 31, 2013
Mar 13 14
AVEO Pharmaceuticals, Inc. announced unaudited consolidated financial results for the fourth quarter and year ended December 31, 2013. For the quarter, the company reported collaboration revenue of $0.323 million against $15.531 million a year ago. Loss from operations was $16.069 million against $20.598 million a year ago. Net loss was $16.725 million or $0.32 per diluted share against $21.480 million or $0.49 per diluted share a year ago.
For the year, the company reported collaboration revenue of $1.293 million against $19.286 million a year ago. Loss from operations was $103.904 million against $111.637 million a year ago. Net loss was $107.029 million or $2.10 per diluted share against $114.394 million or $2.64 per diluted share a year ago. The decrease in revenue was primarily due to revenue recognized during 2012 that did not recur during 2013, including a $15.0 million milestone payment earned under AVEO's collaboration agreement with Astellas related to the FDA's acceptance of the NDA filing for tivozanib and revenue earned under AVEO's agreements with OSI Pharmaceuticals, Inc. and Centocor Ortho Biotech Inc.
AVEO Pharmaceuticals Seeks Acquisitions
Mar 13 14
AVEO Pharmaceuticals, Inc. (NasdaqGS:AVEO) seeks acquisitions. "Our strategy going forward will focus on driving growth by investing in the continued advancement of our AV-380 program in cachexia and pursuing further development of our clinical-stage assets through collaborations. In addition, we will continue to evaluate opportunities to acquire or in-license compounds that will further accelerate value creation," said Tuan Ha-Ngoc, President and Chief Executive Officer of AVEO.
AVEO Pharmaceuticals, Inc. to Report Q4, 2013 Results on Mar 13, 2014
Mar 4 14
AVEO Pharmaceuticals, Inc. announced that they will report Q4, 2013 results at 5:00 PM, Eastern Standard Time on Mar 13, 2014