According to researchers at Kepler European Research, four new drugs are expected to be launched in 2006 alone, more than twice as many as any other European blue-chip pharmaceutical company.
Novartis' most prominent drug candidate is its VEGF inhibitor PTK787, currently in Phase III for use in colorectal cancer patients. Novartis are prioritising this drug for an early release as current treatments remain ineffective for this type of cancer, which has a 5-year survival rate of only 10 per cent.
Many argue that PTK787 is better than its nearest rival Avastin and thus has huge market potential. So much so that industry analysts believe that Novartis may be interested in buying Schering to gain full access to PTK787.
Such is the potential of PTK787, Novartis are evaluating the compound for a number of additional cancers. With sales in Novartis' oncology sector up 40 per cent compared to 25 per cent for the market segment, the long-term potential of PTK787 could be large.
Novartis' research strategy saw them enter PTK787 enter Phase III trials with little data, a risky decision. However, the report acknowledged that cancer was a high-risk business in which there were no guarantees.
While progression free survival is an accepted endpoint, filing and approval will largely depend on the quality of the data/or safety issues. Novartis/Schering plan to file PTK787 for approval in Q2 with a 2006 release date allowing Avastin to maintain its market position advantage for some time.
Novartis' project pipeline also includes the compound ICL670, an iron chelator designed to improve Novartis' existing product Desferal, which had sales of $117m in 2003.
The current standard iron chelation therapy, Desferal (deferoxamine), requires administration by an infusion process that lasts eight to 12 hours per day, for at least five days per week. As a once-daily oral treatment, ICL670 is designed to be easier to use and more convenient than deferoxamine.
As the trial did not meet its primary endpoint, the risk of approval delay is higher. The report said Novartis acknowledged the missed primary endpoint "may impact review timing and/or labelling." An ongoing trial in sickle cell anaemia patients will be added to the planned Q1 filing and given that the first clinical trial did not meet its endpoint, a clear, positive result is critical for the second trial.
ICL670 has fast track status in the US and if approved in a timely fashion, will be on the market by early 2006. Novartis has forecasted 2007 sales of $250 million for ICL670 based on the assumption of an on-time launch, a higher price and improved compliance versus Desferal. In addition, opportunities to expand patient populations could boost sales above this forecast.
Another important development to come out of Novartis' pipeline is LDT600 (telbivudine). Currently in phase III trials for treatment of hepatitis B, Novartis expects filings to begin at the end of 2005.
Chronic hepatitis B is a leading cause of liver disease globally with at least 400 million people chronically infected with the virus representing huge potential for a new drug. However, the majority of people of people infected with HBV are in the developing world.
Established treatments for hepatitis B including Hepsersa have been hit with low sales. Combined with other treatment options in late-stage development leads Kepler to forecast only modest sales for LDT600. This view seems to be shared with Novartis, who said that sales of LDT600 are not expected to be huge.
One drug that is expected to make waves in the long term is transplant drug FTY720. The treatment works by a unique mechanism of action, directing T-cells away from the graft.
Despite its long-term importance, in the short and medium term only modest sales are expected due to the need to build clinical trial data and to the conservative nature of transplantation physicians. Transplantation is seen as a good business, that requires little marketing and relative lack of competition for effective treatments
There is potential for FTY720 in multiple sclerosis (currently in Phase II, data expected January 20). However, the company acknowledged that it would likely be five years before FTY720 has an impact on Novartis' sales. Phase III data in 2005, was expected with a 2006 launch anticipated.
Novartis' approach to its diabetes drug does away with the need for injections despite it being the optimal choice of therapy. The trend in this sector sees drug companies developing a number of oral treatment options.
Novartis' approach is the regulation of glucagon-like peptide-1 (GLP-1). This peptide, produced in the intestine, induces insulin secretion in a glucose dependent manner, controls gastric emptying and inhibits food intake as well as glucagons and somatostatin secretion. These attributes give GLP-1, a unique profile, which is considered highly desirable for a diabetic drug.
The natural GLP-1 molecule rapidly degrades in the blood and therefore needs to be stabilized to be clinically useful. A number of GLP-1 analogues, which have longer half-lives are therefore being investigated.
Researchers at Novartis theorised that rather than adding GLP-1, a therapy that inhibits dipeptidyl peptidase IV might also be effective in diabetes control. A therapy that inhibits Novartis' LAF237 is the most advanced dipeptidyl peptidase IV (DPP-IV) inhibitor in clinical development for the control of diabetes.
First Phase III data for diabetes drug LAF237 are expected towards the end of 2005, with filing forecast by Novartis for 2006 with a 2007 launch anticipated.