LAF237 (diabetes) and SPP100 (hypertension) set for submission in 2006

Pharmacology
LAF237 (diabetes) and SPP100 (hypertension) set for submission in 2006
By Novartis
Sep 20, 2005, 20:18

Novartis unveiled new pivotal Phase III data at a pipeline update today on two important projects � LAF237 (diabetes) and SPP100 (hypertension) �and intends to make regulatory submissions in 2006 for these two novel compounds with first-in-class potential.

Novartis also announced significant progress in other aspects of its industry-leading pipeline, which is comprised of 75 projects in clinical development, including 52 in Phase II, Phase III or registration and of which 46 are new molecular entities (NMEs). Key areas of development are cardiovascular & metabolism and oncology as well as neuroscience, respiratory diseases and anti-virals, with promising compounds in both general and specialty medicines.

A number of important regulatory milestones are on track to be achieved during the next 12 months, including anticipated US and EU approvals for Exjade (iron overload), Xolair (asthma) in the EU, Aclasta (Paget's disease) in the US, Femara in the US and EU for use in treating women with breast cancer immediately following surgery (adjuvant setting) and Zelmac/Zelnorm (irritable bowel syndrome with chronic constipation) in the EU. Planned new product submissions in addition to LAF and SPP include Lucentis (age-related macular degeneration) in the EU, LDT600 (hepatitis B) in both the US and EU as well as a new Diovan combination with amlodipine (hypertension).

"The positive results of our two highly innovative medicines for patients with Type II diabetes and hypertension � two medically important and very frequent diseases � highlight the dynamic momentum in our rich and attractive pipeline. With several novel compounds in late-stage development and one of the highest R&D productivity rates in the pharmaceutical industry, we anticipate sustaining our leading position in bringing innovative therapies to patients," said Dr. Daniel Vasella, Chairman and CEO of Novartis.

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