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Novartis Plans Three NME Filings In 2005, Including First Oral VEGF Inhibitor

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis plans three NME filings in 2005, including first oral VEGF agent, firm says during Jan. 20 R&D day. PTK787 has blockbuster potential in colorectal cancer, Novartis says. Nine more NME filings are scheduled for next two years

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Novartis Exjade Review Complicated By Use Of SQUID To Measure Iron Levels

Use of a superconducting quantum interference device (SQUID) is "inadequate" to accurately measure liver iron concentration, FDA determined in its review of Novartis’ oral iron chelating agent Exjade.

Novartis Rasilez NDA in early ‘06

Novartis is on track to submit its oral renin inhibitor Rasilez (aliskiren, formerly SPP100) in early 2006 and in the EU in the fourth quarter, the firm says Jan. 19. The submissions will pursue both monotherapy and combination treatment based on Novartis' 8,000-patient program. Also on Jan. 19, the company reported Phase III data "reconfirming SPP100 as a potential gold standard." Building on co-administration data released in 2005, the firm disclosed key results from Phase III studies looking at monotherapy and co-administration with amlodipine and ramipril. The three studies showed "strong monotherapy efficacy at least as good as or better than other classes of hypertensive therapies" and "superior blood pressure lowering" in combination with any of the four main antihypertensive classes. The company has pointed to aliskiren's potential to be used as both monotherapy and combination therapy and to the agent's improved end-organ protection as advantages (1Pharmaceutical Approvals Monthly February 2005, p. 3)...

Novartis telbivudine Phase III HBV data

novartis' hepatitis B agent telbivudine meets its primary endpoint of one-year response in the pivotal GLOBE trial, the firm reports July 28. The composite endpoint, "designed to assess if telbivudine was at least as effective as lamivudine [GlaxoSmithKline's Epivir], evaluated the combination of viral suppression…with either improved liver function…or loss of detectable hepatitis B e-antigen," Novartis says. The two-year, 1,350-patient trial is ongoing and includes both antigen positive and negative patients. "The one-year analysis of this trial will be the primary data used" in the NDA, which Novartis continues to project submitting by the end of 2005. Novartis believes that emerging Epivir resistance could be an advantage for telbivudine (1Pharmaceutical Approvals Monthly February 2005, p. 3)...

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