Biotech Values

[DewDiligence]

NVS’ Galvus Gets Approvable Letter Mandating New Study

[Trading has not yet opened in Zurich, but NVS will probably be hit hard today. The delay gives MRK’s Januvia a big head start in the DPP-4 market. Perhaps NVS will have better luck in the EU, where they submitted an MAA ahead of MRK (#msg-12724932).]

http://www.novartis.com/newsroom/index.shtml

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26-Feb-2007, 07.15 AM CET

Novartis committed to making Galvus® available for patients with type 2 diabetes after US regulators issue 'approvable letter'

• Novartis confident in safety and efficacy of Galvus as a once-daily oral treatment for patients with type 2 diabetes, over 8,000 patients in clinical trial program

• US Food and Drug Administration (FDA) requests additional data, including a clinical study in patients with renal impairment

• Discussions to continue with the FDA to obtain final US approval for Galvus

Basel, February 26, 2007 - Novartis announced today that it has received an "approvable letter" from the US Food and Drug Administration (FDA) for Galvus® (vildagliptin), under review for US approval as a new once-daily oral treatment for patients with type 2 diabetes.

An "approvable letter" means the FDA is prepared to approve an investigational medicine and contains conditions that must be met prior to final US approval. The FDA has requested additional data, including a clinical study to demonstrate the safety and efficacy of Galvus in specific patient groups with renal (kidney) impairment.

"We are confident in the safety and efficacy of Galvus and will continue working closely with the FDA to agree on what final actions are required to obtain US approval," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.

The 2007 financial outlook previously communicated in January remains unchanged for the Pharmaceuticals division and for the Group.

Galvus was submitted for US approval in January 2006 as a new therapy to reduce blood sugar levels in patients with type 2 diabetes, both as a monotherapy and in use with other anti-diabetic medicines.

The global clinical trial program to date has included over 8,000 patients, with some 5,500 treated with Galvus. Submission for European Union approval was made in August 2006.

About Novartis

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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