Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Novartis Rasilez NDA in early ‘06

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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)...

You may also be interested in...

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

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

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts