Teva Moves Pipeline Assets from Process to Product
By Mia Burns (firstname.lastname@example.org)
Teva executives say that developing new pipeline assets through the New Therapeutic Entities, or NTE process is a major element in the company’s growth strategy. Teva is using the NTE process to develop late-stage products from known molecules that offer incremental – but also extremely important – improvements for patients. The advances hold the potential for better adherence, lower costs, and ultimately better outcomes. Associate Web Editor Mia Burns interviewed Elizabeth Kogan, SVP, global generics R&D at Teva Pharmaceuticals about this R&D strategy.
Q: Has Teva ever had 14 new products in development simultaneously before now?
A: Teva has a broad range of specialty products already in development, but this is probably the first time such a number of potential products have entered development within the same year – however, this is precisely what the NTE program was developed for and is in-keeping with the number we expected for this year.
Q: How was Teva able to reach a point in which the company will have 10 new development products each year after 2013? About how much will this cost the company per year and when does Teva plan to adjust this period for risk?
A: Teva’s unique integrated generics and specialty R&D is pivotal in our ability to deliver 10 new development projects each year. The NTE process was specifically devised and developed to leverage our integrated R&D in order to “industrialize” the generation and development of such a large number of new potential products that bring added value in addressing unmet medical needs by changes to formulation, delivery route, combination, or indication of known molecules. We have a very robust process for identifying and evaluating product concepts and our mix of an extensive molecule catalog, technological capabilities, formulations skills, therapeutic area expertise, and regulatory and IP abilities enable us to pursue this target. We have stated that each NTE-derived product program will cost between $10 to $50 million and take three to six years each. In terms of adjusting for risk we believe that across the NTE program six out of every 10 projects that enter development will make it through to launch.
Q: How did Teva come up with the six risk areas of technology, clinical development, regulatory, blocking intellectual property, exclusivity, and competition?
A: These are areas of risk that are consistent with most drug development programs – especially when looking to improve on existing molecules.
Q: In your view, what makes the Teva skill set unique regarding the development of the right technological solutions? How would you define the “right” technological solutions?
A: Teva has developed more than 1000 products over its many years as a leader in the industry. In order to create such a large portfolio of drugs, Teva has built a very diversified/broad technological platform for delivering drugs to patients in various delivery system such as oral, injectables, inhalers, transdermal, eye drop. Teva’s 250 formulation specialists are capable of developing formulations to achieve extended release profiles, solubility enhancement, gastric retention, abuse deterrence, and many more targeted profiles. When we assess an NTE concept, we not only look at the technologies available to us in-house, but also look to find the right technology externally and build partnerships to utilize them.
Q: What did Teva scientists do to acquire their deep medical understanding of patient needs?
A: Teva has been active in specialty medicines for many years and has built up deep knowledge and understanding in the areas we operate in – and these therapeutic areas provide a focus and guide for the NTE program. Our cross-functional development teams are highly experienced pharmaceutical development professionals that have a strong mix of expertise that cover all the key elements needed for successful drug development, including; physicians, clinical development experts, preclinical capability, and personalized medicine and pharmacogenomics expertise, in addition to the skills mentioned above. Additionally, as part of the NTE process, our clinical & medical experts reach out to key opinion leaders to get their feedback on medical needs.
Posted: December 2013