Staring down some deep-seated worries about looming generic competition and serious doubts about its upbeat assessment of a pivotal trial earlier this week, Novartis ($NVS) will step forward today to make the case that it is on track to gain approvals on at least 14 new blockbusters over the next 5 years. And in a preview of its R&D showcase, the pharma giant--which spent an industry-leading $9.58 billion on R&D last year--offered a bullish assessment of a slate of experimental therapies it believes can break past the $1 billion annual revenue mark.
In an industry growing increasingly focused on the potential impact of individual programs, Novartis came out swinging with raw numbers, with 139 clinical development projects in the pipeline and 73 new chemical entities targeting a range of diseases. Breaking that down to near-term prospects, its R&D team promised a read-out on 13 late-stage projects, with 9 regulatory filings and a shot at 7 regulatory decisions over the next 12 months. In the year after, Novartis promised 11 pivotal trials read-outs, 11 filings and 10 regulatory decisions.
Like its Big Pharma rivals, Basel-based Novartis has a blockbuster headache to face as some long-term drug franchises go over the patent cliff. Gleevec, Diovan and other leading products will soon face generic competition. Today it will try to convince analysts that it has the pipeline goods necessary to turn around falling pharma sales by the second half of next year.
Exhibit A, though, could stir up doubts. The heart drug serelaxin--RLX030--hit one key endpoint in a pivotal heart study, but fell short of others. That left analysts wondering whether the drug could pass muster with increasingly demanding payers, even if regulators give it a green light next year.
Oncology is expected to deliver big revenue gains, with growing numbers for Afinitor and Jakafi and new trails to blaze with BKM120 for various tumors and LDK378 in lung cancer. The PI3K inhibitor BKM120 is being studied for several indications. And the ALK inhibitor LDK378 is being prepped for pivotal studies after investigators pinned down activity in patients with Alk+ non-small cell lung cancer and efficacy against brain metastases.
The late-stage IL-17 inhibitor AIN457 is being studied for psoriasis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis. And of course Novartis has high hopes for its COPD drug QVA149.
"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, in a statement. "As a result, our leading pipeline in all phases of development positions us well for continued future growth."
- here's the press release
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