Novartis Completes Early U.S./European Submissions for Tasigna and Aclasta

At a time when Big Pharma rivals such as AstraZeneca (U.K.) and GlaxoSmithKline (U.K.) attempt to reassure jittery investors about the long-term viability of their research and development (R&D) pipelines, Switzerland's Novartis provided an update of its own well-stocked pipeline at a research and development (R&D) day in London. Most of the news was good, with multiple new product approvals and launches planned for the next two years and six drug candidates moving into Phase III trials.

Novartis now has 138 projects in clinical development, representing "one of the strongest pipelines" in the pharmaceutical industry, it claimed. Of the total, 94 projects are in confirmatory development (i.e., Phase IIb, Phase III or awaiting approval) and more than 20 have been added to the pipeline this year. The key development areas are cardiovascular/metabolic conditions, oncology and neuroscience, as well as respiratory and infectious diseases.

New does not necessarily mean brand new, though: just 50 of the 138 projects in development are new molecular entities, while 88 are lifecycle-management projects involving new indications or formulations.

Among the near-term highlights was news that approval filings for Tasigna (nilotionib) and Aclasta/Reclast (zoledronic acid) in the United States and the European Union (EU) have already gone in, ahead of expected submissions in late 2006 or 2007.

Novartis had previously said it was bringing forward the planned filing date for Tasigna to late 2006 (see Switzerland: 18 July 2006: Novartis Brings Forward Gleevec Filing Date, Plans to Refile Prexige in EU). The drug is a follow-up to blockbuster anticancer Glivec/Gleevec (imitanib), which faces new competition in the U.S. and European markets from Bristol-Myers Squibb's anticancer, Sprycel (dasatinib). Aclasta is once-yearly bisphosphonate currently marketed for the treatment of Paget's disease. In the much larger osteoporosis segment, Phase III data recently indicated that Aclasta could reduce the risk of new spine fractures by 70% and of hip fractures by 40% (see Switzerland: 18 September 2006: Phase III Data Prime Novartis' Aclasta for O/D Osteoporosis Treatment).

Novartis also said it had filed for European approval of the adjuvanted H5N1 pre-pandemic vaccine it acquired last year with U.S. biotech Chiron. The company presented encouraging results from a Phase II trial of the vaccine in 500 volunteers, who achieved the various levels mandated by European regulators for seroprotection, seroconversion increase and mean geometric increase of H5N1-specific antibodies. Novartis recently secured a contract with the U.S. Department of Health and Human Services for 800,000 doses of its vaccine against the H5N1 avian influenza ('flu) strain (see United States: 21 November 2006: HHS Awards US$199.45 mil. in Additional Pandemic 'Flu contracts).

Further down the pipeline, Novartis reported that six compounds are now moving into Phase III trials: FTY720 (fingolimod) for multiple sclerosis; QAB149 (indacaterol) for chronic obstructive pulmonary disease and asthma; AG0178 (agomelatine) for depression; ABF656 (Albuferon) for hepatitis C; RAD001 (everolimus) for cancer; and SOM230 (pasireotide) for Cushing's disease. There have also been some casualties in the development programme: XBD173 for generalised anxiety disorder and AAE581 for osteoporosis have been dropped, while development of LIC477 for bipolar disorder has been delayed.

Outlook and Implications

Given the recent uncertainties around AstraZeneca's and GlaxoSmithKline's pipelines, not to mention Novartis' own late-stage setbacks with its diabetes drug Galvus in the United States and the antifungal Mycograb in Europe, there was plenty of countervailing evidence in London of a strong and diversified development pipeline, with a number of promising candidates set to reach the market in the near and medium term.

Novartis reiterated its confidence of gaining U.S. approval for Galvus, whose review period was recently extended by three months to allow for the submission of additional clinical data (see Switzerland: 13 November 2006: Three-Month Extension for U.S. Galvus Review as Novartis Files More Data). A U.S. submission for Mycograb, which has been stymied by European concerns over its quality and safety (see Switzerland: 21November 2006:Two Steps Forward, One Step Back for Novartis as CHMP Gives Verdict on Lucentis, Exforge, Mycograb) is planned for 2009. All in all, though, Novartis seems to be going forward in good shape.