Novartis’ R&D day in London showed that the Swiss firm is making great strides in getting drugs to the filing stage and the state of its pipeline softens the recent disappointment suffered with the delay of getting approval for Galvus (vildagliptin) for type 2 diabetes.
The company currently has 138 projects in clinical development including 94 in Phase IIb, III or registration but most of the focus was on the fact that US and EU regulatory submissions have been completed well ahead of schedule for two compounds: Tasigna (nilotinib) for patients with resistance and/or intolerance to treatment with Gleevec/Glivec (imatinib) for certain forms of chronic myeloid leukemia, and Aclasta/Reclast (zoledronic acid), a once-yearly bisphosphonate infusion for women with postmenopausal osteoporosis.
Novartis also confirmed that US regulatory decisions are expected for Tekturna (aliskiren), a renin inhibitor for hypertension partnered with Speedel, and Exforge (valsartan and amlodipine), a single-tablet combination of the two most prescribed hypertension medicines in their respective classes. The firm also presented new data on a combination of Tekturna and Diovan (valsartan) which showed a significant additive reduction in blood pressure compared to Diovan alone.
Back to Galvus and Novartis reiterated its confident in the efficacy and safety of the product and in obtaining US approval, despite the Food and Drug and Drug Administration recently extending its review period. The company also presented new data at the London event of a 104-week trial which 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 and Novartis is also planning to submit a combination of Galvus and metformin for approval in the first quarter of 2007.
The company also highlighted six compounds which are moving into pivotal late-stage trials: FTY720 (fingolimod) for multiple sclerosis, QAB149 (indacaterol) for chronic obstructive pulmonary disease and asthma, AG0178 (agomelatine) for depression and ABF656 (albuferon)) for hepatitis C as well as RAD001 (everolimus) for cancer and SOM230 (pasireotide) for Cushing’s disease.
Projects that have been terminated include XBD173 for generalised anxiety disorder and AAE581 for osteoporosis, while LIC477 for bipolar disorder has been delayed.
Analyst reaction to the R&D day was generally positive. Karl-Heinz Koch at Vontobel said the data on the Tekturna-Diovan combination are very important, “because they will essentially allow Novartis to double the life cycle of Diovan.” Dresdner Kleinwort was also impressed but said that “bears however will focus on the slightly negative two-year data on Galvus” and indeed this was highlighted by Andrew Fellows at Swiss broker Helvea. He pointed out that the drug is unlikely to hit the $3 billion mark forecast by some analysts.
Also at the meeting, Novartis chief executive Daniel Vasella hinted that the company is prepared to sell baby food maker Gerber as nutrition is not a core business. Nestle has been mentioned as a likely buyer.