Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals Litigation

 News Release - June 27, 2006

Novo Nordisk Prevails in sanofi-aventis Challenge to Levemir(R) - Up to 24 Hours Duration of Action and Other Claims Upheld

PRINCETON, N.J., June 27 (HSMN NewsFeed) -- Novo Nordisk announced today a victory in a lawsuit in which sanofi-aventis sought a preliminary injunction against Novo Nordisk's pre-launch and launch materials for LevemirŽ (insulin detemir [rDNA origin] injection), Novo Nordisk's new long-acting basal insulin.

The lawsuit, filed in United States District Court for the District of New Jersey by sanofi-aventis, alleges that Novo Nordisk engaged in false advertising in pre-launch and launch materials for Levemir. However, during the court hearing on April 11, sanofi-aventis dropped its attack on the launch materials. Ruling on the remaining claims about the pre-launch materials, Judge Mary Cooper found that there was no "reasonable probability of success on the merits" of sanofi-aventis's claims in the lawsuit.

On March 27th, Novo Nordisk launched the long-acting basal insulin analog Levemir and Levemir FlexPenŽ for the treatment of type 1 and type 2 diabetes. Levemir is proven to help patients reach glycemic targets with up to 24 hours of control, and has demonstrated low rates of hypoglycemia, less weight gain than NPH and consistent blood glucose response. Specifically, the 56-page opinion rejected challenges to Novo Nordisk's statements that Levemir:

* Works for up to 24 hours;
* Can be used once daily;
* Causes less weight gain than NPH insulin; and
* Causes less injection to injection variability.

"We are pleased with this court action, and are confident that the ultimate outcome of this litigation will support our position on this issue. It is unfortunate this lawsuit is diverting attention from the real issue -- ensuring patients have access to individualized treatment options," said Martin Soeters, president of Novo Nordisk. "Novo Nordisk is committed to alleviating the burden of diabetes, working as a catalyst to advance care through innovation, awareness, and education. We believe our recent launch of Levemir and Levemir FlexPen offer important treatment options for people living with uncontrolled diabetes."

Levemir is widely available in over 44,000 pharmacies throughout the United States. Levemir is currently approved in 50 countries worldwide. With the introduction of Levemir, Novo Nordisk is the only company to provide a complete portfolio of insulin analogs.

About Levemir

Levemir (insulin detemir [rDNA origin] injection) is a long-acting basal insulin analog indicated for once- or twice-daily subcutaneous administration for the treatment of adults and children with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

Levemir is contraindicated in patients hypersensitive to insulin detemir or its excipients. Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir. As with all insulins, the timing of hypoglycemic events may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Other adverse events commonly associated with insulin therapy may include injection site reactions (on average 3-4% of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, or inflammation.

Any change of insulin dose should be made cautiously and only under medical supervision. Levemir should not be diluted or mixed with any other insulin preparations or used in insulin infusion pumps. Whether the observed differences in weight represent true differences in the effects of Levemir and NPH insulin is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established.

About Novo Nordisk

Novo Nordisk is a healthcare company with an 80-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs approximately 22,000 full- time employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.

Full prescribing information for Levemir is available by contacting Novo Nordisk Inc. or visiting novonordisk-us.com.

Levemir and FlexPen are registered trademarks of Novo Nordisk A/S.


Source: Novo Nordisk

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