Novo Nordisk expands licensing rights to AERx® iDMS inhaled insulin programme from Aradigm and obtains full development and manufacturing rights

Bagsværd, Denmark and Hayward, California - Novo Nordisk and Aradigm Corporation today announced an agreement giving Novo Nordisk full development and manufacturing rights to the AERx® insulin Diabetes Management System (iDMS) programme. Under the agreement, Novo Nordisk will purchase manufacturing equipment and leasehold improvements currently utilised by Aradigm in the AERx® iDMS programme for an estimated cash payment of USD 55 million. Novo Nordisk will assume all further responsibilities for AERx® iDMS development and funding. Aradigm will maintain a long-term interest in the programme through an adjusted royalty on future AERx® iDMS net sales.

 

As a result of the expanded licensing agreement, Novo Nordisk has formed a new affiliate, Novo Nordisk Delivery Technologies, Inc based in Hayward, California, which will assume the leases and operational overhead on two of Aradigm's current three buildings, and will offer employment to approximately 130 Aradigm employees who have been dedicated to iDMS. The companies have the option to continue collaborating in specific areas such as next-generation AERx® technologies. If needed, Novo Nordisk will provide certain contract manufacturing services to support other AERx® programmes for up to three years.

 

"Novo Nordisk remains committed to the development of inhaled insulin. The AERx® iDMS is an excellent fit within our portfolio of insulin delivery systems," stated Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk. "We are confident that the transition will be smooth, and that both companies will benefit from the new structure."

 

"We are pleased that Novo Nordisk has assumed a greater role in completing the development of the AERx® iDMS system," added Dr Bryan Lawlis, Aradigm's president and chief executive officer. "This agreement establishes two key components for Aradigm's future success: it confirms Novo Nordisk's commitment to the AERx® iDMS programme, and it provides Aradigm the financial flexibility to accelerate the development of additional AERx® and Intraject® applications. In addition to the cash payment at closing, Aradigm will no longer be responsible for the expenditures associated with commercial scale-up and manufacturing of AERx® iDMS."

 

Finalisation of the agreement is subject to customary closing conditions, including approvals from regulatory authorities, as well as approval from Aradigm common and preferred shareholders, which is expected at a special shareholder's meeting to be held later in 2004. The agreement is expected to close by the end of 2004. The transaction does not change Novo Nordisk's expectations for the financial results for 2004.

 

Forward-looking statement

The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide current expectations or forecasts of events such as new product introductions, product approvals and financial performance.

 

Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. 

Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 27 February 2004. Please also refer to the section 'Management of risk in Novo Nordisk' in the Annual Financial Report 2003. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.

 

Please note: Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the timely availability and acceptance of new products, the impact of competitive products and pricing, and the management of growth, as well as the other risks detailed from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Registration Statements, including the company's Annual Report on Form 10-K as amended and its Quarterly Reports on Form 10-Q.

 

 

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