Swiss drugmaker Novartis AG (NVS) Tuesday said it has submitted a bone and a cancer drug for regulatory approval earlier than planned, and added that it is starting late-stage testing on five experimental medicines.
Demonstrating that it has one of the strongest pipeline of new drugs in the industry, Novartis, based in Basel, said it has a total of 138 projects in development, comprising both new possible treatments for disease for which there is no cure, as well as studies for possible new uses of medicines that are already on the market.
Around two thirds of these projects are in the second and third phase of clinical testing. Most drugs are being studied in three phases of testing before companies submit them for regulatory approval.
"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," chief executive Daniel Vasella said in a statement.
The Swiss drugmaker also suffered some setbacks, terminating the development of osteoporosis medicine AAE581 and of anxiety drug XBD173, while saying that the development of LIC477, a potential new treatment for manic-depression, was delayed. Analysts had expected Novartis to submit LIC477 for regulatory approval next year.
Development of cancer drug EPO906 is also progressing more slowly than planned because the company failed to recruit patients fast enough to the clinical testing phase.
In addition, experimental diabetes treatment Galvus, a potential blockbuster with expected annual sales of at least $1 billion, was shown to work less well than metformin in a two-year trial, confirming results already seen after one year of treatment.
Novartis expects the U.S. Food and Drug Administration to decide on approving this drug in the first half of 2007. Analysts generally expect Galvus to win approval, but that the drug, which treats diabetes in a new way, will come to the market about half a year later than Januvia, a similar drug, for which its maker Merck & Co. (MRK) gained U.S. approval recently.
In contrast, hypertension drug Tekturna, another potential blockbuster, was shown to lower blood pressure more effectively than a diuretic, or water pill. Diuretics are commonly prescribed hypertension treatments, and are available as cheap generics. Tekturna, which was developed jointly with Speedel Holding AG, a small Swiss pharmaceutical company, was also shown to work well in combination with Diovan, the company's best-selling drug.
"The data on the Tekturna-Diovan combination are very important, because they will essentially allow Novartis to double the life cycle of Diovan," said Karl-Heinz Koch, analyst in Zurich with private bank Vontobel, who has a buy rating on the stock. "As a result, rather than falling to around $2 billion as expected, hypertension sales will remain at around $6 billion after the patent expiration of Diovan."
Diovan, which had sales of $3.68 billion in 2005, will lose patent protection in 2012.
Having accelerated the submissions for regulatory approval in Europe and the U.S., Novartis has filed for approval of cancer drug Tasigna, and bone drug Aclasta. Many analysts had expected the filing of these drugs only later in 2006 or next year.
Tasigna, or nilotinib, was filed for approval for use in patients with resistance or intolerance to treatment with Gleevec for certain forms of chronic myeloid leukemia. Gleevec is also a Novartis drug and the company's second-best selling product after hypertension drug Diovan. A few months ago, Bristol-Myers Squibb Co. (BMY) received U.S. approval for Sprycel, a drug that some analysts consider a potential threat to Gleevec sales. Sprycel was approved for use in patients for whom Gleevec doesn't work.
The second drug, Aclasta, or zoledronic acid, is a once a year infusion for the treatment of women with postmenopausal osteoporosis. The most frequently prescribed osteoporosis drugs available today need to be taken once a week, which is a drawback that leads to poor compliance among patients, because the drugs are cumbersome to take.
In its first detailed update on drugs in development in almost two years, Novartis also said that five experimental drugs are moving into the third, and usually last, phase of clinical testing.
They are: FTY720, or fingolimod, for multiple sclerosis, QAB149, or indacaterol for smoker's cough and asthma, AG0178, or agomelatine, for depression and ABF656, or albuferon for hepatitis C, as well as RAD001, or everolimus, for cancer and SOM230, asireotide, for Cushing's disease.
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