Novartis unveiled today new data on its promising pipeline amid plans for multiple new product approvals and launches over the next two years. Many of these anticipated approvals are for potentially best-in-class medicines that would advance treatment standards for patients with hypertension, diabetes, cancer and other diseases.
Novartis highlighted progress throughout its pipeline, particularly the advance of pharmaceutical compounds to pivotal trials before regulatory submission as well as the development portfolio in the newly created Vaccines and Diagnostics division.
The following compounds are moving into pivotal late-stage trials: FTY720 (fingolimod) for multiple sclerosis, QAB149 (indacaterol) for COPD and asthma, AG0178 (agomelatine) for depression and ABF656 (Albuferon(TM)) for hepatitis C as well as RAD001 (everolimus) for cancer and SOM230 (pasireotide) for Cushing's disease.
"I am pleased that our sustained focus on innovation and drive to address unmet medical needs have enabled us to further strengthen our pipeline and file several new drugs for regulatory review over the past 12 months," said Dr. Daniel Vasella, Chairman and CEO of Novartis.
"Over the next two years we will launch several innovative medicines and continue to invest aggressively in discovery research and development activities and complement our own skills and technologies through attractive collaborations," Dr. Vasella said.
In total, Novartis now has 138 projects in pharmaceutical clinical development. Of these, 94 projects are in confirmatory development (Phase IIb, Phase III or registration with regulatory authorities). A total of 50 are new molecular entities (NMEs), while 88 are life-cycle management projects involving new indications or formulations.[2] More than 20 projects have been added to the pipeline during 2006. Key R&D areas are cardiovascular/metabolic conditions, oncology and neuroscience as well as respiratory and infectious diseases.
Novartis has completed many submissions in 2006 to regulatory authorities for new compounds as well as new indications for medicines already available to patients.
The US and EU regulatory submissions were accelerated and completed ahead of schedule in 2006 for two compounds: Tasigna (nilotinib) as a new treatment option for patients with resistance and/or intolerance to treatment with Gleevec/Glivec for certain forms of chronic myeloid leukemia (CML), and also for Aclasta/Reclast (zoledronic acid) as a once-yearly bisphosphonate infusion for women with postmenopausal osteoporosis.
US regulatory decisions are also expected for Tekturna (aliskiren), a renin inhibitor for hypertension, and Exforge (valsartan and amlodipine), a single-tablet combination of the two most prescribed hypertension medicines in their respective classes.
Awaiting European Commission approval are Exforge and Lucentis, a new treatment option for patients with the "wet" form of age-related macular degeneration (AMD), after both compounds received positive recommendations in November from the Committee for Medicinal Products for Human Use (CHMP). The Commission generally follows the recommendations of the CHMP and delivers a final decision within two to three months.
A US regulatory decision is also expected in the first half of 2007 for Galvus (vildagliptin) as a once-daily oral treatment for patients with type 2 diabetes. The US Food and Drug Administration (FDA) extended the review period for Galvus by three months from November 2006 after recently available clinical data were submitted to support the proposed dosing and indications as well as complement earlier data on the risk/benefit profile.
Sustained leadership in hypertension
Approvals of Exforge and Tekturna would further strengthen the leadership of Novartis in offering a broad range of treatments for patients with hypertension, complementing the in-market brands Diovan and Lotrel.
High blood pressure - and its consequences - is the world's No. 1 killer, estimated by the American Heart Association to affect one in four adults, or around one billion people globally. Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach target blood pressure levels. Many require two or more medicines to gain control.
Exforge is the first medicine to combine the angiotensin receptor blocker (ARB) valsartan (Diovan) and the calcium channel blocker (CCB) amlodipine besylate. More than 80% of Exforge patients in studies reached their recommended blood pressure goals and also experienced a lower rate of peripheral edema (swelling of the ankles) compared to those taking amlodipine alone.
Tekturna, which was developed in collaboration with Speedel, has shown a strong efficacy profile in hypertension patients. New data presented at the event showed Tekturna demonstrated a statistically significant (p=0.0004) reduction in blood pressure compared to a diuretic (hydrochlorothiazide), while results from this 12-week trial also showed strong efficacy in combination with the same diuretic in obese patients. Tekturna has shown placebo-like safety at the proposed maximum once-daily dose of 300 mg.
In another new study, the combination of Tekturna and Diovan showed a significant additive reduction in blood pressure compared to Diovan alone, with a drop in systolic blood pressure of about 17 mm Hg compared to about 13 mm Hg for either Tekturna or Diovan alone.
Additional data support efficacy and safety of Galvus
Novartis is confident in the efficacy and safety of Galvus and in obtaining US approval for this once-daily oral treatment for patients with type 2 diabetes. Results from recently completed clinical trials are being submitted to the FDA involving an additional 1,000 patient-years of treatment experience.
These data include results from short- and long-term studies for periods of up to two years, both as a monotherapy or in combination with other anti-diabetes medicines. They further support the proposed dosing regimen and indications as well as complement the risk/benefit profile of Galvus. In particular, they provide further evidence confirming data submitted earlier to the FDA showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with type 2 diabetes patients.
New data presented at the event again confirmed the once-daily efficacy of Galvus, while pooled monotherapy data showed a 1.1% reduction in HbA1c (a measure of average blood sugar levels) in initial use by type 2 diabetes patients starting treatment. The results of a 104-week trial continued to show the sustained reduction of 1% in HbA1c seen at 52 weeks, but narrowly missed the primary endpoint of non-inferiority versus metformin. However, Galvus was better tolerated than metformin, particularly with a superior gastrointestinal tolerability profile.
Vaccines pipeline supports existing franchises and explores new fields
Novartis has assembled a strong pipeline of investigational human vaccine projects following the acquisition of Chiron in April 2006, focusing on supporting existing franchises in influenza, meningitis and travel vaccines while exploring new disease areas.
Among new data presented at the event were the positive results of a Phase II trial involving 500 volunteers inoculated with an adjuvanted H5N1 pre-pandemic vaccine. Results showed that various levels mandated by European regulators for seroprotection, seroconversion increase and mean geometric increase of H5N1-specific antibodies were achieved. Novartis announced today that this vaccine has been submitted for European approval for use as a pre-pandemic vaccine to boost the immune system's ability to defend against infections from an H5N1 strain.
The OptaFlu seasonal influenza vaccine, which is based on novel cell culture technology instead of traditional egg-based production, showed in pivotal Phase III data that it was highly capable of producing an immune response ("immunogenic"), at least as strong as the egg-based vaccine Agrippal® for each of the three influenza strains studied. It was also well tolerated, showing no meaningful differences in the safety profile compared to traditional egg-based vaccines. The EU submission was completed in 2006, while the US submission is planned for 2008.
Novartis also announced progress in the development of its conjugate quadrivalent MenACWY vaccine against the A, C, W135 and Y serogroups of Neisseria meningitides, important causes of bacterial meningitis. This devastating disease is estimated to strike about three to five of 100,000 people per year - particularly infants and children. Phase III trials involving 13,000 people started in April 2006, targeting regulatory submission for use in infants, adolescents and adults.
A vaccine for the B serogroup of meningitis B, for which there is currently no effective vaccine, is also in Phase II studies to identify dosing in adolescents, with data expected by the end of 2007.
Productive innovation filling the early-stage pipeline
New discovery approaches at the Novartis Institutes for BioMedical Research (NIBR), which was created four years ago to enhance the Group's long tradition of drug discovery, are contributing novel compounds to clinical development.
The number of new molecular entities in the NIBR portfolio has increased to more than 70 in 2006 (compared to 55 in 2004), driven in part by new target discovery, enhanced structural biology, and rapid growth in the number of biological therapeutic drug candidates. These include antibodies, which now constitute about 25% of the NIBR portfolio.
Selected Pipeline Event highlights
Among projects highlighted at the event were the following:
Aclasta/Reclast (zoledronic acid), a once-yearly bisphosphonate treatment for women with postmenopausal osteoporosis, has been submitted for US and EU approval earlier than planned. This was based on pivotal Phase III data showing that patients taking Aclasta/Reclast experienced a highly significant 70% risk reduction in new spine fractures (p
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