BioWorld International Correspondent
Speedel Holding AG remains on track to begin booking revenues in 2007 from sales of SPP100 (aliskiren), following the release Tuesday of positive data from several Phase III trials by its development partner, Novartis AG .
However, the sales ramp-up could take a longer than first anticipated. As it previously indicated, Novartis intends to complete a regulatory filing in the U.S. early next year, but the program has encountered a blip on the other side of the Atlantic. Originally, a global submission had been anticipated early next year, but Novartis now has pushed out the date of its European filing to the fourth quarter of 2006.
"There's a slight delay to the European filing because we believe they need to do a longer comparison trial," Nick Miles, director of communications and investor relations at Speedel, told BioWorld International.
Novartis, of Basel, Switzerland, presented new data on the SPP100 program at an R&D day in London. The compound, it said, offered "excellent 24-hour blood-pressure control with placebo-like tolerability," confirming double-digit reductions in blood pressure vs. placebo previously seen in Phase II studies. It also reported Phase III data for the first time on SPP100 in combination with another drug. An additive effect on blood pressure lowering was found in combination with the diuretic hydrochlorothiazide. Novartis plans to unveil data on additional combination trials - involving an angiotensin-converting-enzyme inhibitor (ACE inhibitor) and a calcium channel blocker - next year.
Basel-based Speedel licensed the compound from Novartis in 1999 and put it through Phase I and Phase II development before the pharmaceutical firm exercised a callback option in 2002. Neither party has disclosed the terms of the agreement, but analyst estimates indicate that SPP100 will be a significant source of revenue for Speedel.
"The product is targeting a $40 billion market, of which renin inhibition is considered the Holy Grail," said Bob Pooler, biotechnology analyst at Lombard Odier Darier Hentsch, of Geneva. It is expected to attain blockbuster status, which would place a significant fraction of the resulting revenues into Speedel's coffers. "We think they have a royalty rate of about 10 percent," Pooler said.
SPP100 is a first-in-class, orally available inhibitor of renin, the enzyme that catalyzes the first and the rate-limiting step in the Renin Angiotensin System (RAS) cascade. The pathway results in the production of angiotensin II, a peptide hormone that causes vasoconstriction when it binds to its receptor. Previous efforts to produce effective renin inhibitors were hampered by poor bioavailability and by high production costs.
Novartis, Miles said, intends to promote SPP100 both as monotherapy and in combination with other hypertension drugs, such as ACE inhibitors, angiotensin receptor blockers, diuretics and calcium channel blockers. Treatment guidelines call for multiple mechanisms of action in the control of blood pressure, said Chris Jenson, director of pharmacology at Speedel. "SPP100 will fit nicely into this ability to mix and match the drugs," he said. In addition, some physicians will opt to put de novo patients on the drug. "Some people have been waiting for this mode of action for 40 years," he said.
Speedel's share price rose slightly during morning trading on the Swiss Stock Exchange in Zurich to CHF153.80 (US$120, from its previous close of CHF152.50. However, the stock had climbed more sharply during trading Friday and Monday, in anticipation of good news.
Speedel listed earlier this month, so Pooler does not yet have a price recommendation. "We believe it should trade at a discount to Actelion [AG, of Allschwil, Switzerland], and it should trade at a premium to Basilea [Pharmaceutica AG, of Basel]," he said. "They're still in the approval risk period."