Meda acquires exclusive rights to potential specialty blockbuster product in the US


Meda acquires exclusive rights to potential specialty blockbuster product in the
US

Meda has entered into an exclusive and perpetual license agreement with
BioDelivery Sciences International Inc (BDSI) for marketing of a potential
specialty blockbuster product in the US, Canada and Mexico. Filing for
registration with the FDA (Food and Drug Administration) is planned this year,
giving a potential launch in late 2008. The product, BEMA Fentanyl, is patented
and has a unique delivery system designed to give rapid and reliable delivery of
fentanyl for treatment of breakthrough pain in cancer patients. 

BEMA Fentanyl consists of a small, dissolvable, polymer disc, formulated with
the opioid narcotic fentanyl, for application to the buccal (inner lining of
cheek) membranes. BEMA Fentanyl has shown in clinical studies important patient
advantages compared to competing products, especially fewer side effects. The
two currently largest competing fentanyl products in the US with the same
indication had combined sales of about USD 700 millions in 2006 and grew by
approximately 60% versus 2005.

Meda and BDSI started their collaboration in 2006 with BEMA Fentanyl for all the
European markets. In July this year, Meda announced the acquisition of the US
specialty pharma company MedPointe Inc, an acquisition which immediately gave
access to a strong platform in the US with about 500 employees within marketing
and sales. Through this acquisition and Meda's rapid development in Europe,
Meda's annual turnover has increased from around USD 30 million in 2002 to now
approaching USD 1,4 billion (including MedPointe). 
“It is optimal timing for us to acquire BEMA Fentanyl rights so soon after the
acquisition of our US platform MedPointe. BEMA Fentanyl represents a huge
opportunity for us in the US. Our ambition with this unique product within the
breakthrough cancer pain indication is to reach well over USD 200 million in
yearly sales. Our US marketing organisation has good experience in the pain area
and is well acquainted with the target group. Pain is a priority therapy area
and with this deal we now add a significant potential for Meda in the US
market”, says Anders Lonner, CEO Meda AB.
Financial aspects:
• 1st milestone: USD 30 million payable by Meda on closing. Closing is
contingent upon antitrust approval by the Federal Trade Commission.

• 2nd milestone: USD 30 million payable by Meda upon receipt of FDA approval.

• A gross margin above 70% is secured for Meda. 

• Royalty: BDSI to receive a significant double digit royalty on net sales.
Guaranteed minimum annual royalties based on low sales levels during the first 7
years. 

• Sales milestones: A total of $30 million payable by Meda at 
    - $10 million when annualized sales exceeds $75 million
    - $10 million when annualized sales exceeds $125 million
    - $10 million when annualized sales exceeds $175 million

Meda and BDSI will collaborate on the development for expanding the indication
for BEMA Fentanyl, which could fourfold the market potential. Meda will fund
this development, and will also get a right of first refusal to future
development projects based on BEMA Fentanyl. 

“This is a landmark event for BDSI, and based on our standing relationship with
Meda in Europe, we believe Meda is going to be a terrific marketing partner for
BEMA Fentanyl here in the US.” said Mark A. Sirgo, BDSI's President and CEO. 
“Meda already knows BDSI and the product they will be selling here in the US.
When they recently entered the US marketplace by purchasing MedPointe, they
actively pursued the US BEMA Fentanyl opportunity with us given the natural
strategic fit. We believe Meda provides BDSI a commercial partner with global
reach and abundant resources to support our lead product. Importantly, this
transaction along with the anticipated submission of our BEMA Fentanyl NDA will
allow us to achieve BDSI's highest priorities for 2007. We could not be more
pleased.”


For more information, please contact:

Anders Larnholt, Investor Relations, tel. +46 709 458 878

Meda AB  
MEDA AB (publ) is an international specialty pharma company that concentrates on
marketing and market-adapted product development. Acquisitions and long-term
partnerships are fundamental factors that drive the company's strategy. Meda is
represented with own organisations in 26 countries and with more than 1 500
employees within marketing and sales. Meda's products are sold in approximately
120 countries world-wide. The Meda share is listed under Large Cap on the OMX
Nordic Stock Exchange. Find out more, visit www.meda.se.  

BioDelivery Sciences International Inc 
BioDelivery Sciences International, Inc. is a specialty pharmaceutical company
that is focused on developing innovative products to treat acute conditions such
as pain.  The company utilizes its owned and licensed patented drug delivery
technologies to develop, partner and commercialize, clinically-significant new
products using proven therapeutics. The company's headquarters are located in
Morrisville, North Carolina and its principal laboratory is located in Newark,
New Jersey.  For more information please visit www.bdsinternational.com.

Attachments

09052129.pdf