INDIANAPOLIS—Eli Lilly & Co. Inc. and Dako, an AgilentTechnologies company, have agreed upon a master framework for a collaborationon the development and commercialization of companion diagnostics (CDx) forLilly's oncology product pipeline. These diagnostic tests will help to identifypatients who are most likely to benefit from oncology medicines currently underdevelopment by Lilly.
The framework also defines and outlines the terms of thecollaboration between Dako and Lilly in such as way that contractualnegotiations for current and future companion diagnostics projects between thetwo companies can be executed more swiftly.
Under the agreed-upon framework, Lilly will be exclusivelyresponsible for the development and registration of the therapeutics, includingclinical trials. Dako/Agilent will be responsible for developing and registeringthe CDx assay/system solution.
"Companion diagnostics are cornerstones of personalizedmedicine," says Susanne Munksted, director of PharmDx Commercial Management atDako. "Dako has a strong heritage developing companion diagnostic tests incollaboration with pharmaceutical companies."
Dako has previously announced similar partnerships todevelop CDx with AstraZeneca PLC, Bristol-Myers Squibb Co., OSI PharmaceuticalsLLC, Amgen and Genentech, among others. Dako is responsible for developing andcommercializing HercepTest, which was the first tissue-based CDx in oncology in1998.
Creating CDx for Lilly's oncology pipeline will help itsscientists to create tailored therapies, which is one of the major pillars ofthe company's current R&D strategy.
"Tailored therapies may help to identify patients who aremost likely to respond to a specific therapy and, just as importantly, whichpatients will not," says Eva Groves, communications manager at Lilly. "Forpatients, this means a patient-specific treatment regimen and, hopefully,improved outcomes. For payers, this means they can be more confident of thevalue for which they are paying, because our studies will be designed todemonstrate the benefits to specific patient populations."
The agreement plays to the goal shared by both companies ofexpediting oncology medicines into the hands of patients with unmet medicalneeds.
"It is Dako and Agilent's aim to build strategicpartnerships with companies who have a global presence and the strength and marketleadership within oncology to drive therapeutic products through development,registration and commercialization," says Munksted.
"Companion diagnostics play an important role in ourtailoring efforts, and we'll continue to partner with leading diagnosticscompanies like Dako in an effort to bring our investigational medicines, pairedwith diagnostics, to patients who are waiting," says Groves.
"I warmly welcome Lilly, and I am excited about what we mayaccomplish together for the benefit of patients worldwide," Dako CEO andAgilent Senior Vice President Lars Holmkvist said in a media release announcingthe collaboration. "This agreement heralds our mutual commitment to fightingcancer."
Lilly is the 10th largest pharmaceutical company in theworld, with total assets in excess of $33 billion. It manufactures suchwell-recognized pharmaceuticals brands as Cialis, Cymbalta, Methadone andProzac, among many others. It currently employs approximately 38,000 peopleworldwide, including about 6,000 in the United States.
Dako is a Denmark-based cancer diagnostics company thatprovides antibodies, scientific instruments and software pathologylaboratories. California-based Agilent purchased the company in May 2012 from aSwedish private equity firm for $2.2 billion. Dako has annual revenue of morethan $300 million and about 1,000 employees. Agilent employs approximately20,500 people, and reported annual revenues of $6.6 billion in 2011.
