Novartis Expects 14 New Blockbusters

Novartis recently provided an update on its leading Research and Development (R&D) pipeline and plans for turning these assets into commercial success to provide the basis for continued growth of the group through 2017. Continuing R&D productivity in the Pharmaceuticals Division has fueled an industry-leading pipeline with 139 projects in clinical development with more than 73 New Molecular Entities (NMEs) across a multitude of disease areas. Highlights include RLX030 and LCZ696 in heart failure as well as AIN457 in psoriasis and multiple sclerosis. In addition, the company will showcase a comprehensive early and late-stage pipeline of novel oncology compounds.

“As a science-driven company, Novartis is focused on innovation to address unmet medical needs for patients around the world,” said Joseph Jimenez, CEO of Novartis. “As a result, our leading pipeline in all phases of development positions us well for continued future growth.”

Novartis Group continues to lead the industry with 56 new approvals in the US, Europe, Japan, and China since 2007. In 2012 alone, the Pharmaceuticals division has received nine approvals or positive recommendations to date. Novartis Pharmaceuticals has established a strong foundation for the company’s ongoing growth based on currently marketed products. In addition for the next 12 months, Pharmaceuticals expects data read-out on 13 pivotal studies, 9 filings, and 7 regulatory decisions. For the following 13 to 24 months, strong pipeline newsflow is expected to continue with a further 11 pivotal trials read-out, 11 filings, and 10 regulatory decisions.

As evidenced by the recent launches of Afinitor, Seebri Breezhaler, Jakavi, and Signifor, Novartis has a proven track record of bringing innovative products to market. With the current marketed portfolio, Pharmaceuticals is expected to grow from the second half of next year despite loss of exclusivity on mature brands like Diovan, Zometa, and Aclasta.

The Novartis Oncology portfolio has delivered approvals for six indications, including two new molecular entities so far this year and anticipates continued growth over the next 5 years. One of the major growth drivers, Afinitor, has five indications already approved and has the potential to exceed sales of $2 billion in breast cancer alone by 2017. In addition, launches of Jakavi and the planned launches of pipeline projects such as BKM120 for various tumors and LDK378 in lung cancer have the potential to contribute more than $1 billion in sales by 2017.

Novartis has transformed Ph+ chronic myeloid leukemia (CML) to a treatable, chronic condition and is again on the way to redefine what is possible in CML. The new goal is for patients to live free of drug therapy once they have achieved long-term response to treatment. Tasigna, a potent second-generation targeted therapy for CML, has demonstrated a reduced risk of progression and deeper and more sustained molecular response than Glivec. Based on these advances, as well as advances in molecular response monitoring, in 2013 the company plans to initiate Tasigna clinical trials to explore the goal of achieving sustained treatment-free remission in patients living with CML. If positive, this could lead to a major paradigm shift in CML treatment.

Novartis has initiated a broad-scale clinical development program named PRISM for its leading PI3K inhibitor BKM120 across multiple indications, both as a single agent and in combination with other therapeutic agents in various breast cancer settings, as well as other indications. The company also plans to initiate pivotal studies of LDK378, an ALK inhibitor that has shown potent activity in patients with Alk+ non-small cell lung cancer (NSCLC) as well as activity on brain metastases, in December 2012. Additional trials planned for 2013 and regulatory filings expected to begin in 2014 if trials are successful.

Regarding its strong data in heart failure, Novartis recently presented data for RLX030 show that patients receiving a single infusion of RLX030 had both short-term and long-term benefits. In the short-term, RLX030 treated patients had improved heart failure symptoms such as dyspnea (shortness of breath) and edema, in addition to having a shorter stay in the hospital. The long-term benefits of RLX030 resulted in a statistically significant 37% reduction in cardiovascular mortality and all-cause mortality. Furthermore, fewer patients treated with RLX030 had worsening of heart failure as measured on day 5 and day 14 after treatment. Worsening of heart failure during hospitalization was defined as intensification of intravenous therapy or mechanical ventilator or circulatory support. Based on these findings of the RELAX-AHF study, Novartis plans to initiate regulatory filings for RLX030 in early 2013 in the US and Europe.

Novartis is also progressing its comprehensive clinical program in respiratory to meet the needs of patients with chronic obstructive pulmonary disease (COPD). QVA149 has the potential to establish a new standard of care for patients with COPD, preventing exacerbations and showing improvement in bronchodilation compared to placebo and current standard of care. Across numerous clinical studies, QVA149 enables the limited use of inhaled corticosteroids (ICS) as rescue medications as recommended by the GOLD treatment guidelines for COPD.

Clinical data for AIN457, a highly effective novel IL-17 inhibitor, across multiple disease areas including psoriasis, ankylosing spondylitis, rheumatoid arthritis, and multiple sclerosis were presented. In Phase II clinical studies, AIN457 has shown rapid improvement of psoriasis signs and symptoms in patients with moderate to severe psoriasis. Phase III studies for AIN457 in this setting are ongoing with regulatory filings expected to start in late 2013. In addition, the company is investigating AIN457 across multiple indications including multiple sclerosis.

The discovery process in the Novartis Institute of BioMedical Research (NIBR) focuses on disorders in which there is unmet medical need and good mechanistic understanding. This approach has increased the success rate from preclinical through Phase II trials to more than 20%, three times the industry average. Companion diagnostics and biomarkers, especially in oncology, where most Phase I and II trials have patient selection markers included, have enabled early patient selection for clinical trials, reducing overall development timelines and costs. As a result, Novartis has shown greater than average pipeline return on investment achieving highest average annual peak sales of first launched productsamongst industry.

In addition, Novartis is striving to increase efficiency and productivity to manage more projects while keeping costs at a stable level. Introducing novel technologies and methods reduce recruitment time and trial costs, while improving study quality and patient comfort and safety. These include mobile field monitoring, continuous manufacturing, and Telehealth. In addition, through a research initiative with Walgreens in the US, clinical trials will provide more real-world evidence and lower access barriers for participants.