For our lead hepatitis B drug candidate, telbivudine, which is licensed by Novartis, Idenix is leading the clinical development
for a large international Phase III registration trial that is being conducted at more than 130 medical centers in 20 countries,
including sites in China, where 10 percent of the population is infected with chronic hepatitis B. This is a major undertaking
for a biotech company and a significant achievement. Idenix is responsible for filing the new drug application with FDA in
the electronic common technical document (eCTD) format, which, within months of our NDA filing, allows Novartis to file on
a worldwide basis in almost every major market.
Additionally, the discovery expertise that we apply to drug design and preclinical development to bring forward novel antiretrovirals
in areas of unmet medical need will potentially fuel the pipeline of both companies, as Novartis has the option to license
any drug candidates discovered by Idenix.
What actions does your partner take that make the alliance work?
EBELING: The most important aspect on both sides of the alliance is our close alignment and understanding of our mutual goals, as well
as respect for the strategies of the individual companies.
Idenix is focused on going beyond simply researching treatments for infectious diseases and is attempting to radically improve
the current standards of care for patients in the disease areas it focuses on. For example, the current standard treatment
available for hepatitis B inadequately meets the goals of therapy, and drugs with improved efficacy, safety, and less resistance
are badly needed. Telbivudine is in a new class of drugs, and in trials to date, it has proven highly effective and safe.
In the area of hepatitis C, Idenix is poised to be first-to-market with a new therapy that will be used in combination with
interferon and that will serve as a replacement for ribavirin, which causes severe side effects for many patients. There is
a major unmet need in the area of hepatitis C due to the large patient population—more than 170 million people worldwide are
infected, and about half of patients treated with the current standard of care fail treatment and are left with no other options.
SOMMADOSSI: Since the formation of our strategic alliance with Novartis in May 2003, the company has shared our vision for building a
leading antiretroviral franchise at all levels of the organization. There is trust between both companies, especially at the
top-management level, so we can move forward at a fast pace while keeping open communication to obtain input and agreement
and to ensure all issues are addressed. Novartis has supported our goal of becoming a top-tier, fully integrated biotech company
through our introduction into the public market. The collaboration has allowed us to accelerate our discovery and development
programs while building our own commercial infrastructure. And Novartis complements our antiretroviral expertise with tremendous
global manufacturing, regulatory, and marketing capabilities. It has assembled teams across all these functional areas to
focus on our co-promoted products so we can provide antiviral treatments to patients worldwide.
What's the biggest challenge your company presents to your partner?
EBELING: Idenix is focused solely on developing medicines to treat infectious diseases, whereas Novartis' efforts are spread over
a greater breadth of disease areas, which splits our attention many different ways. This is not a challenge per se, but more
a difference between our companies. I think it is actually beneficial, because each partner brings different—yet compatible—skill
sets to the table, allowing us to do more than either company could accomplish individually. For example, Idenix has a deep
knowledge of the infectious-disease landscape and a strong R&D program.
In addition to our own R&D and other partnerships in infectious disease, Novartis offers well-established structures and processes
for developing drugs and selling them in the marketplace with considerable breadth and reach in the US, Europe, and the Far
East. Novartis is a Big Pharma company with a long-term strategic perspective and high standards that can occasionally cause
some minor tensions. But because of our strong relationship, we are able to solve these matters constructively and quickly.
SOMMADOSSI: As a small biotech, Idenix operates with entrepreneurial spirit and has quick turnaround times and decision-making abilities.
Our single focus is infectious-disease drug development, and we want to do this rapidly and on target. We have different processes
and levels of infrastructure compared with a large global pharma company like Novartis, so both companies must work toward
a middle ground that satisfies the needs of both companies while achieving the goals of the alliance.