Navigation Links
BDSI secures US commercial partnership for BEMA Fentanyl with Meda AB

MORRISVILLE, N.C.--(BUSINESS WIRE) September 5, 2007 BioDelivery Sciences International, Inc. (Nasdaq: BDSI) has entered into an exclusive and perpetual license and related supply agreement with Meda for the U.S., Canadian and Mexican commercialization rights to BDSIs flagship BEMATM Fentanyl product for the treatment of breakthrough cancer pain. Under this agreement, Meda will be responsible for the marketing and distribution of BEMA Fentanyl in the U.S., whose launch is anticipated in late 2008. In addition, Meda will be responsible for the management of the post-NDA approval clinical development program.

Financial Aspects of the Partnership:

  • 1st milestone: $30 million upon closing which is contingent upon antitrust approval by the Federal Trade Commission, which typically occurs within 30 days of filing.

  • 2nd milestone: $30 million upon receipt of FDA approval, which is anticipated in late 2008.

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

  • Sales milestones: A total of $30 million payable 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
  • A gross margin above 70% is secured for Meda.

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. According to published results, the two currently largest competing fentanyl products in the U.S. with the same indication had combined sales of nearly $700 million in 2006 and grew by approximately 60% versus 2005.

Sales, marketing, and clinical studies, post-approval, to support competitive claims and expanded indications will be the responsibility of Meda. Meda and BDSI will also collaborate on expanding the indications for BEMA Fentanyl, which could increase fourfold the market potential. Meda will fund this development, and will also get a right of first refusal on the commercialization rights to future development projects based on BEMA Fentanyl.

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 U.S. 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 Medas rapid development in Europe, Medas annual turnover has increased from around $30 million in 2002 to now approaching $1.4 billion (including MedPointe).

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 U.S. said Dr. Mark A. Sirgo, BDSIs President and CEO. Meda already knows BDSI and the product they will be selling here in the U.S. When they recently entered the U.S. marketplace by purchasing MedPointe, they actively pursued the U.S. 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 BDSIs highest priorities for 2007. We could not be more pleased.

Anders Lonner, CEO of Meda, stated It is optimal timing for us to acquire the BEMA Fentanyl rights so soon after the acquisition of our U.S. platform MedPointe. BEMA Fentanyl represents a huge opportunity for us in the U.S. Our ambition with this product within the breakthrough cancer pain indication is to reach well over $200 million in yearly sales. Our U.S. marketing organization 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 U.S. market.


Contact: Bill Douglass
BioDelivery Sciences

Related medicine news :

1. TV drug commercials prompt prescriptions
2. Commercialization of Biotech Discoveries, An Encouragement For Researchers
3. A Move To Help Commercial Sex Workers Quit Their Business
4. Commercial grape juices and vinegars found rich in antioxidants
5. Widespread Commercialisation Of Human Organ Donation In China
6. Commercialization of drugs by fast tracking is a cause of concern
7. Formula milk suffering due to commercial interests
8. Spine Gourd Variety Helpful For Diabetics Is Ready For Commercial Cultivation
9. Updated Sleep Apnea Screening Recommended for Commercial Drivers
10. The Psyche Behind Drug Commercials
11. Magnets in Commercial Products may Cause a Fatal Attraction
Post Your Comments:
(Date:12/1/2015)... ... December 01, 2015 , ... Nurotron Biotechnology Co., Ltd., maker ... order to date. , The order will be from the China Disabled Persons’ ... Implant System is an effective solution for children and adults suffering from severe ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... Brooke Bennett are collaborating with brands across various categories through traditional and social ... make up an elite group of Gold Medal Moms who can connect with ...
(Date:11/30/2015)... ... December 01, 2015 , ... The ... a 2015-2016 inductee into its VIP Woman of the Year Circle. She is ... leading networking organization exclusively for professional women, boasting 850,000 members and over 200 ...
(Date:11/30/2015)... Alexandria, VA (PRWEB) , ... November 30, 2015 ... ... Applied Research Foundation (Meso Foundation) released information for caregivers and held two webinars ... webinars are available on demand free of charge at . , ...
(Date:11/30/2015)... ... ... MOSI recently added two state-of-the-art augmented reality (AR) experiences from INDE Broadcast ... collection of interactive exhibits within the Kids In Charge! building. In collaboration with the ... closer than ever to a range of animals as they drink, sleep and play ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... 2015 Diplomat Pharmacy, Inc. (NYSE: DPLO ... Detroit Free Press as a Top Workplace , among ... to work for in 2015. ... winners annually, based on employee surveys rating company leadership, career ... are based solely on employee feedback. The survey is conducted ...
(Date:11/30/2015)... 2015   Royal Philips  (NYSE: PHG ... Radiology Solutions, a fully integrated, consultative approach to ... data-driven practice management approaches that combine imaging systems, ... improve care delivery and reduce costs. Making its ... North America Annual Meeting (RSNA) in ...
(Date:11/30/2015)... , November 30, 2015 global cell culture ... US$6.1 bn to US$11.3 bn by 2022 at a CAGR of ... expected to grow from its 2013 value of US$6.1 bn to ... --> Transparency Market Research has announced the release of a ... to the report, titled ,Cell Culture Market - Global Industry Analysis, ...
Breaking Medicine Technology: