Speedel achieves milestone as Novartis applies to FDA for high blood pressure drug Rasilez

By E. Janene Geiss

Philadelphia, April 20 - Speedel said it achieved a major milestone Thursday with Novartis' filing the first regulatory submission of SPP100, known as Rasilez.

The Food and Drug Administration accepted for review Novartis' New Drug Application for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives, according to a company news release.

The application includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials, officials said.

SPP100 is the first-in-class once daily oral renin inhibitor that Speedel developed through phase 1 and 2 clinical trials before Novartis exercised its license-back option in 2002. Novartis also reconfirmed Thursday that it is on track for regulatory submission of SPP100 in the European Union during 2006, officials said.

"Speedel is at the forefront of research and development of renin inhibitors, and we are well on our way to our goal of building a Speedel family of renin inhibitors as the gold standard therapy over the next decade," Alice Huxley, chief executive officer, said in the release.

Speedel is developing a series of innovative new compounds, each of which is expected to have different and improved properties offering incremental protection from the harm caused by high blood pressure, officials said.

Speedel said it believes that SPP100 has a five-year lead over the next generation of renin inhibitors being developed in the industry.

Speedel's own family of renin inhibitors includes SPP635 currently in phase 1 trials with results due in the second half of 2006, followed by the SPP1100 series currently in toxicology testing with a compound due for human testing before the end of 2006, and the SPP800 series currently in late-stage preclinical profiling.

Speedel in-licensed SPP100 from Novartis in 1999, and successfully completed 18 clinical trials through phase 1 and 2 in about 500 patients and healthy volunteers.

Based on the results generated during this program, Novartis exercised a license-back option in 2002, and in March 2004 Novartis started trials with SPP100 in phase 3 as monotherapy for hypertension and in phase 2b as combination therapy. Phase 3 trials are ongoing in the United States, European Union and Japan.

Speedel is a Basel, Switzerland, biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases.

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