This particular blog is on the subject matter that how a drug patent can be…
French compatriots Ipsen and bioMérieux, have been few most potential companies since 2007 in the development of companion assay to assess patient benefit from a compound useful for treating several severe forms of cancers. The partnership between two companies has focused on the two main broad areas of pharma research: Personalized medicine and Theranostics. Personalized medicine basically emphasizes the customization of healthcare, with all decisions and practices being tailored to individual patients in whatever ways possible. It involves the systematic use of genetic or other information about an individual patient to select or optimize that patient’s preventative and therapeutic care.
While theranostics involves the development of innovative therapeutic agents such as with diagnostic companion tests—may be the key to improve treatment efficacy and safety through the identification of potential responding patients. This method is looked upon as the possible end result of new advances made in Pharmacogenomics, Drug Discovery using Genetics, Molecular Biology, and Microarray chips technology whereby it accelerates the time-to-market of new compounds through an improved selection of patients enrolled in clinical trials. This in turn helps to address the global challenge of R&D productivity, as stated by the companies.
Prof. Christian Bréchot, vice president of bioMérieux and a member of bioMérieux’s board have addressed: “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,’”. 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.
Hence, for the purpose of this newly established collaboration, both companies will jointly identify programs and measures that would benefit from the co-development of a therapeutic and a companion diagnostic test, 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 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.”
As already extensive research work has been conducted for the development of companion diagnostic tests and innovative compounds, it is believed that the partners (companies) might produce an early clinical proof of concept and also would be able to support the registration of Ipsen clinical drug candidates.
As per Veron, “There is strong scientific evidence that in many diseases, physiopathological processes, as well as response to treatments, is determined by genetics. This is particularly true in oncology, where the identification of relevant biomarkers is key in predicting patient response and monitoring their treatments,”
About the companies:
Ipsen, is 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. Drug market analysis has shown that Ipsen’s sale exceeded $1.4 billion in 2009. On the same line of context, bioMérieux, a leading pharma company for more than 45 years in the field of in-vitro diagnostics, extends 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 revenues reached $1.9 billion in 2010.
Looking into the current scenario of various cancers, its chemical, biological/genetic cause, and therapeutic measures, it is observed that companies are extensively involved in research in developing both personalized medicines and theranostics. This concept in therapeutic step has proved to be a more efficient measure in treating cancers like prostate cancer, breast cancer, endometrial cancer, etc which involves basically a combinational or companion assay wherein the patient receives the therapeutic effect of two potential drugs with minimal side effects, and capable of fighting against the disease/cancer more effectively in less time. Hence, the joint collaboration of such two potential companies for adapting this kind of cancer therapy has proved to be a successful approach in the fields of pharmacogenetics.
About the Author:- Ms. Minusmita Ray, a Patent Specialist in IIPRD and can be reached at [email protected]