- Agency issues Complete Response letter requesting more data to support approval; Novartis will continue to work with the FDA on next steps
- Novartis remains committed to studying ACZ885 in inflammatory diseases where interleukin-1 beta plays a key role

Basel, August 29, 2011 - Novartis has received a Complete Response letter from the US Food and Drug Administration (FDA) as part of the US regulatory review for ACZ885 (canakinumab) in gouty arthritis patients. In its letter, the FDA requested additional information, including clinical data to evaluate the benefit risk profile in refractory patients.

On June 21, an advisory committee of the FDA voted in favor of the overall efficacy, but recommended that additional retreatment data would be needed to assess the overall safety profile of ACZ885.

Novartis submitted ACZ885 for regulatory review in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011. These submissions were based on clinical trials that showed gouty arthritis patients treated with ACZ885 at the time of an attack experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA)[1].

ACZ885 was generally well tolerated in these studies, with most adverse events being mild to moderate in severity. Adverse events which included among others infections, were reported more frequently in patients treated with ACZ885 vs. those treated with TA[1].

Novartis International BioCamp spotlights how diversity spurs innovation across the company and inspires future science leaders.
- The interactive BioCamp program engages students around scientific advances and entrepreneurial opportunities
- The eighth annual event brings 60 top university students from 24 countries and territories to Novartis headquarters in Basel, Switzerland
- Novartis is an inclusive high-performance environment which values and leverages diversity to help create innovative solutions to meet patients' unmet medical needs
Basel, August 29, 2011 - Today, Novartis opened its eighth annual International Biotechnology Leadership Camp (BioCamp), a three-day seminar bringing biotechnology and business experts together with 60 selected students from leading international universities in 24 countries and territories. This year, Novartis highlighted the growing role of diversity in Group Companies worldwide to drive innovation in all aspects of the company including scientific research and development.

"Diversity and inclusion is a pivotal foundational stone of our core strategies. It is through diversity in people, cultures, thought and approach that leads to breakthrough medicines," said Joseph Jimenez, CEO of Novartis. "Our goal at Novartis, beyond creating next-generation medicines, is to educate and inspire the next generation of scientists - building the talent pool not only for Novartis affiliates, but leaders for the entire healthcare industry."

International BioCamp participants interact with key Novartis scientists who lead the company's unique approach to drug discovery and learn about breakthrough new medicines to address patients' unmet medical needs. The interactive program is designed to help students understand trends and challenges in the biotechnology and life sciences sectors as well as receive first-hand experience about starting and running a biotech company. BioCamp also allows students to explore career opportunities in the pharmaceutical and biotech industries and network with talented students from other countries.

"Innovation is enhanced by a diversity of opinions, perspectives and ideas from people with different cultural backgrounds and professional experiences. By fostering diversity in the Novartis workplace, we continue to strengthen a culture that is innovative, respectful and inclusive," commented Colin Pillai, Head of the Diversity & Inclusion Office in Novartis Pharmaceuticals Development.

"Our scientific approach is open, entrepreneurial, and collegial fostering an environment that is unwilling to accept barriers or conventional wisdom. Advances in drug discovery and biomedical research increasingly require diverse, multicultural, cross-disciplinary and team-based approaches," noted Dhavalkumar D. Patel, MD, Ph.D., Head of Novartis Institutes for BioMedical Research (NIBR) in Europe and Global Head of the Autoimmunity, Transplantation and Inflammation Disease Area.

Students will also visit some of the newest Novartis laboratory facilities. The visionary Novartis Campus in Basel fosters innovation and creativity with workspace that encourages collaboration and teamwork. The Campus Project includes 14 new research and office buildings that are already open and plans are underway for 4 additional buildings. Currently, over 7,000 associates work at the Novartis Campus. Ultimately, the site will provide a work environment for approximately 13,000 associates.

On the final day of the program, BioCamp participants, working in groups, will present business cases to a jury of experts. The jury will select three individual winners and one winning team based on their contribution, performance, leadership and teamwork. This year, participants for International BioCamp were chosen through an application process in 15 countries as well as through 9 local and regional BioCamp programs run in Bangladesh, India, Japan, Korea, Pakistan, Philippines, Singapore, Slovenia and Taiwan.

Workshops and presentations will be led by industry experts including Joseph Jimenez, Novartis CEO; Ann Fudge, Member of the Novartis AG Board of Directors; Juergen Brokatzky-Geiger, Ph.D., Head of Human Resources, Novartis; Dr. Dhavalkumar D. Patel, Head of NIBR Europe; Dr. Rino Rappuoli, Global Head of Research for Novartis Vaccines & Diagnostics; Dr. Romeo Paioni, Head of Novartis Scientific and External Affairs, Novartis Pharmaceuticals AG; Prof. Susan Gasser, Director of the Friedrich Miescher Institute for Biomedical Research; Prof. Francis Waldvogel, Chairman of the Novartis Venture Fund, as well as Dr. Martin Horst, CEO and Board Member of MyoPowers.

About BioCamp
First started eight years ago in Taiwan, the BioCamp has developed into an international forum for science and business students from around the world to learn, exchange ideas and work together in a highly competitive business environment. Previously hosted in Tokyo, Hong Kong and Cambridge, Massachusetts, today's seminar marks the second time International BioCamp is hosted at the state-of-the-art Novartis global headquarters in Basel, Switzerland.