Patient Centric - Pharmaceutical Executive


Patient Centric
Five years ago, in the race to deliver Gleevec, Novartis leaders glimpsed what a pharma company could be. Today, across the company, theyre putting that experience to work.

Pharmaceutical Executive

In the crucial hypertension franchise, Novartis has a first-in-class drug in Phase III: the renin inhibitor SPP 100. Like many other antihypertensives, this compound acts on the renin-angiotensin cascade, which controls water-sodium balance and blood pressure—but it does so at the very beginning of the cascade, potentially providing improved organ protection. "The product can be combined with other antihypertensive treatments," says Reinhardt. "It will be interesting to see whether blocking the cascade at two different levels will lead to better organ protection." SPP 100 was licensed from the Basel-based biotech Speedel, which licensed it from Novartis in 1999.

FTY 720, licensed from Mitsubishi Pharma, is the first member of a new class of drugs for organ transplantation. The company describes it as "a lymphocyte homing agent, which reversibly redirects lymphocytes away from the graft." The drug lacks the immunosuppressive effects of many other drugs in the category. As a result, Reinhardt says, it should not lead to infections or to lymphoma or other cancers. In Phase II trials, FTY 720 is being tested with full and reduced doses of Novartis' Neoral (cyclosporine), but the company intends eventually to test it as monotherapy.

Additional products of interest include:

  • Enablex for overactive bladder, was recently approved in Europe and is under review at FDA. It could be approved before the end of the year.
  • QAB 149, for asthma and chronic obstructive pulmonary disease. "It's the first quick-onset beta agonist with 24-hour duration of action," says Reinhardt. QAB 149 is in Phase IIb.
  • Aclasta (zoledronic acid), a once-a-year injection for osteoporosis, currently in Phase III.
  • AAE 581, another treatment for osteoporosis, which is the first in the class of cathepsin K inhibitors, which is expected to reach Phase III in 2005.
  • LTD 600 for hepatitis B, which is in phase III and is expected to file for approval by the end of 2005.

Novartis continues to work on shortening average development time. Reinhardt says the use of electronic data capture (EDC) in clinical trials has been responsible for substantial improvement. But the current effort has to do with the handoff between research and development. In the past, research would receive credit for a compound after animal trials. Now, says Reinhardt, "research will only get credit for a new compound once it has shown a real biological response in the proof-of-concept trial. The idea is to get rid of compounds that may show an interesting profile in animals but would fail later. In many companies that is not a responsibility of research. In our company it is."

Engaged and Competitive Bill Trombetta analyzes the performance of top pharma companies each year, using dozens of business metrics and ratios, for Pharm Exec's annual "Industry Audit." He says the numbers on Novartis reveal a strong company with interesting challenges.

"The most important thing is they're the innovator," Trombetta says. "Their percent of revenue from new products is third out of the 15 top companies. They're the most productive company in the industry in coming out with new products. But look at their ratio of enterprise value to sales. They come in high in terms of absolute value because they do a lot of business, but when you divide that number by sales, they're in the middle of the pack. That means they still have some issues with profitability. Their gross margin, which tells you about pricing power, comes in ninth. Their increased US presence will help get higher prices, but they still have work to do. In price to earnings, they are ninth. [Last year, Novartis ranked seventh in global pharma sales.] That means that however good they are, the market is not assessing their growth and profit opportunities yet. Maybe that will change this year."


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here