Collaboration is an important component of Zalicus' business strategy. Zalicus forms collaborations with pharmaceutical and biotechnology companies, as well as US government agencies, to support the development and commercialization of select product candidates generated by our discovery technologies. Zalicus has multiple revenue-generating collaborations and continues to leverage its proprietary discovery technologies with ongoing research collaborations that provide access to additional development, financial and commercial resources.
Our collaboration partners include:
The rights to Exalgo® (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients were acquired by Mallinckrodt in June 2009 for $15 million in upfront payments and additional development funding of Exalgo. Exalgo received FDA approval in March 2010, triggering an approval milestone of $40 million. Exalgo was launched in April 2010, and Zalicus is eligible for tiered royalties on net sales of Exalgo by Mallinckrodt.
In January 2006, Zalicus entered into a research and license agreement with Fovea Pharmaceuticals SA, now a division of Sanofi, in which Sanofi will fund and develop selected Zalicus product candidates for ophthalmic diseases including Prednisporin™/FOV1101, a product candidate being developed by Sanofi to treat allergic conjunctivitis. Under the agreement, Sanofi received an exclusive worldwide license to Prednisporin/FOV1101 and certain other drug combinations to treat allergic and inflammatory diseases of the front of the eye. Sanofi has advanced Prednisporin/FOV1101 through Phase 2b clinical development for persistent allergic conjunctivitis. For Prednisporin/FOV1101, Zalicus has received payments totaling $1.5 million, and is eligible to receive up to $39 million in development and regulatory milestone payments. Zalicus is also eligible to receive royalties on net sales of Prednisporin/FOV1101 by Sanofi.
In May 2009, Zalicus and Novartis entered into a strategic alliance focused on the discovery of novel anti-cancer combinations. The collaboration explores combination effects in cell lines representing a broad spectrum of cancers to provide a robust and systematic understanding of combination therapy opportunities. The alliance also explores important differences in response by cancer type, including genotype and other mutational differences. Each party will contribute compounds from its compound library and evaluate the anti-cancer effects by utilizing the Zalicus proprietary combination high throughput screening (cHTS™) platform and Chalice analyzer software.
Under the agreement, Zalicus received a $4 million upfront payment and funding for research support for two years. In addition, for each combination advanced to the market from the collaboration, Zalicus is eligible to receive up to $58 million in clinical, regulatory and commercial milestones. The alliance had an initial two-year term that may be extended by Novartis for three additional one-year periods and has been renewed into October 2014. Zalicus retains the right to conduct oncology research on its own behalf as well as partner with others in the field of oncology.
In February 2012, we entered into a research collaboration agreement with Hydra Biosciences Inc., to advance the development of our preclinical ion channel modulator product candidates for the treatment of pain. The collaboration brings together our portfolio of novel, preclinical ion channel product candidates, representing multiple calcium and sodium channel modulators, with Hydra's expertise in novel ion channel discovery and preclinical drug development with the goal of advancing ion channel drug candidates into clinical development for the treatment of pain. Under the terms of the research collaboration agreement, we will fund research and development activities at Hydra for a two year period, during which time Hydra will perform the preclinical development work necessary to advance our preclinical ion channel product candidates toward clinical development. In addition, we will retain all intellectual property and commercial rights to our ion channel product candidates that are studied under the research collaboration agreement.
Zalicus has received approximately $3.5 million in funded research grants from the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) for the research and discovery of potential treatments for a number of biothreat agents, including several viral hemorrhagic fevers (VHFs) such as Ebola and encephalitic alphavirus infections. VHFs are caused by several distinct families of viruses that affect multiple organ systems in the body and are often accompanied by hemorrhage (bleeding). Many of these viruses cause severe, life-threatening disease. The Alphavirus genus includes Venezuelan equine encephalitis virus (VEE), Eastern equine encephalitis virus (EEE) and Western equine encephalitis virus (WEE), which are mosquito-borne viruses that can cause severe and fatal encephalitis in humans.
If you have business development inquiries regarding our product candidates, utilizing our cHTS technology platform, or our selective ion channel modulation platform, please contact bizdev@Zalicus.com.