Patient-driven, not disease-driven
PARIS—Having worked together since 2007 on the development of a companion assay to assess patient benefit from a compound with the promise to treat several insidious forms of cancer, French compatriots Ipsen and bioMérieux in late February announced they are furthering this work through broad global collaboration in theranostics, with a focus on hormone-dependent cancers.
The partnership is strongly focused on two burgeoning areas of research that are becoming buzzwords in pharma: personalized medicine and theranostics. According to the companies, personalized medicine will change the face of patient care by using individual molecular information to tailor specific preventive and therapeutic solutions, while theranostics—the development of innovative therapeutic agents with diagnostic companion tests—may be the key to improving treatment efficacy and safety through the identification of potential responding patients.
In particular, theranostics offers a cutting-edge solution to optimize healthcare by making sure the best medicine is available to the right patients. It may also accelerate time-to-market of new compounds through an improved selection of patients enrolled in clinical trials, thereby helping to address the global challenge of R&D productivity, the companies say.
"Our goal is to reinforce personalized medicine and contribute through this partnership to the novel paradigm in medicine, which is increasingly 'patient-driven,' rather than 'disease-driven,'" says Prof. Christian Bréchot, vice president of Institut Mérieux and a member of bioMérieux's board.
The partners plan to achieve this paradigm shift in patient treatment by combining Ipsen's compound portfolio and bioMérieux 's diagnostic tests. For the last three years, Ipsen and bioMÈrieux have been developing a companion assay to determine the patients best suited to benefit from BN83495 (Irosustat), Ipsen's steroid sulfatase enzyme (STS) inhibitor compound, currently in Phase I clinical development for the treatment of breast and prostate cancers, and in Phase II for the treatment of advanced endometrial cancer.
"The STS mRNA NASBA assay has been successfully developed and is currently used ad-hoc in our oncology clinical trials, even though we now know that STS mRNA levels are not predictive of STS enzymatic inhibition, and hence cannot be developed as an efficacy biomarker," says Didier Véron, Ipsen's general manager.
In this newly established collaboration, both companies will jointly identify programs that stand to benefit from the co-development of a therapeutic and a companion diagnostic test, notably in the prevention and treatment of prostate and breast cancers, neuroendocrine tumors and pituitary tumors.
"At this stage," Véron explains, "the agreement between our two companies is a framework contract that sets a common governance to analyze areas of cooperation. Specific agreements will be signed on a project-by-project basis, and those will focus on medical, scientific, financial and regulatory issues. Although the partnership agreement covers our overall pipeline, a particular focus was given to the areas that are more relevant for personalized medicine."
The early development of companion diagnostic tests and innovative compounds, the partners say, may accelerate early clinical proof-of-concept and support the registration of Ipsen clinical drug candidates.
"There is strong scientific evidence that in many diseases, physiopathological processes, as well as response to treatments, are determined by genetics. This is particularly true in oncology, where the identification of relevant biomarkers is key in predicting patients response and monitoring their treatments," Véron says.
Ipsen, a global biopharmaceutical group with a worldwide staff of more than 4,400 employees, is focused on the development of primary care drugs as well as specialty care drugs in oncology, endocrinology, neurology and hematology. Ipsen's sales exceeded $1.4 billion in 2009.
A world leader in the field of in-vitro diagnostics for more than 45 years, bioMérieux's presence extends to more than 150 countries through 39 subsidiaries and a large network of distributors. Its products are used for diagnosing infectious diseases and providing high medical value results for cancer screening and monitoring and cardiovascular emergencies. The company has stated that it is committed to making personalized medicine a reality by building partnerships to develop theranostics for infectious diseases, cancer and cardiovascular diseases. bioMérieux's revenues reached $1.9 billion in 2010.