Navigation Links
NewBridge Pharmaceuticals Signs Agreement for Abstral™ for the Middle East and Africa
Date:9/22/2010

DUBAI, United Arab Emirates, Sept. 22 /PRNewswire/ -- NewBridge Pharmaceuticals announced that it has signed an exclusive licensing and distribution agreement with Orexo AB (STO: ORX) that grants NewBridge rights to seek approval for Abstral™, Orexo's product for treatment of breakthrough cancer pain, in the Middle East and Africa and, where approval is granted, to market and sell the product in these territories.  The agreement covers 64 countries across the Middle East and Africa, and excludes Israel where the product is already partnered.

Under the terms of the agreement, Orexo will supply NewBridge with Abstral™ product. The agreement includes milestone and revenue sharing payments; the detailed financial terms are not being disclosed.  NewBridge will also be responsible for managing the regulatory approval process and commercialisation in each of the relevant countries.

Key Points

  • Abstral is a rapidly-disintegrating tablet for sublingual (under the tongue) administration of fentanyl intended for the management of breakthrough pain in cancer patients who are already receiving opioid analgesics for their underlying persistent cancer pain.
  • Abstral was launched in the principal European markets during the course of 2009 and generated sales of 7.4m pounds Sterling in the first six months of 2010 in Europe.
  • Abstral achieved a 24% market share by tablet volume of short-acting fentanyl products in the top five European markets (Source: IMS data, June 2010)
  • Abstral is awaiting a decision from the United States Food & Drug Administration in respect of its approval in the US.

Joe Henein, President and CEO of NewBridge

"Abstral™ is a valuable addition to enhance our growing oncology portfolio.  Across our core geographic region there are many markets with strong economic growth and increased demand for improved health care and more effective products. We strongly believe that Abstral™ has a great potential in the territory and will contribute significantly to physicians' abilities to treat patients experiencing breakthrough cancer pain, hence improving quality of life for these patients."

Torbjorn Bjerke President and CEO of Orexo

"This agreement with NewBridge will enable sales of Abstral™ in additional geographic territories and is another step in developing Abstral™ into a global brand. Our partnership with NewBridge will allow Abstral™ to be available for thousand of doctors to help them manage patients suffering breakthrough cancer pain."

About Abstral™

Abstral™ is a fast-dissolving tablet for sub-lingual administration of fentanyl, intended for the management of breakthrough cancer pain in patients who are already receiving opioid analgesics. It is based on Orexo's unique and patented sublingual tablet technology in which a rapidly dissolving tablet is placed under the tongue and the active substance is absorbed by the mucous membrane. Currently Abstral™ is sold in fourteen countries in Europe, and reached sales of 7.4 M pounds in the first half of 2010.

About Breakthrough Cancer Pain

Breakthrough pain ("BTP") is an acute and often severe flare of pain experienced by patients suffering from cancer that occurs even though a person may be taking opioid pain relief medicine regularly for their persistent pain. It is known as breakthrough pain because it is pain that "breaks through" a regular pain medicine schedule. It may be caused by the cancer itself or it may be related to cancer treatment. For some people, breakthrough pain occurs during certain everyday activities, such as walking or dressing. For others, it occurs unexpectedly without any apparent cause.

Between 64% and 89% of patients with cancer experience BTP, and they average 4 to 7 episodes per day.  In a recent survey of patients with cancer BTP:

  • 89% stated that BTP negatively affected their quality of life
  • 73% stated that BTP wakes them from a deep sleep at least once a month
  • 76% stated that BTP affects their ability to perform everyday household chores
  • 75% stated that BTP is one of the most challenging effects of having cancer
  • 35% stated that BTP affects their relationships with their family members
  • 82% stated that BTP negatively affects their emotional health

The American Pain Foundation. Breakthrough Cancer Pain Survey Fact Sheet.

Available at: http://www.painfoundation.org

About NewBridge Pharmaceuticals

NewBridge Pharmaceuticals is a specialty pharmaceutical, biologics, diagnostics and medical device company serving the Middle East, Africa, Turkey, and Caspian regions (collectively, AfMET) to address the unmet needs of diseases with high regional prevalence such as diabetes, obesity, oncology, cardiovascular diseases and other metabolic disorders. NewBridge in-licenses and commercializes FDA and EMA approved therapeutics and devices. Headquartered in Dubai, United Arab Emirates with Business Development Capabilities in the US, NewBridge was founded by Burrill & Company, a San Francisco-based Life Science Venture Capital, Private Equity, Merchant Banking and Media firm.  NewBridge Pharmaceuticals is uniquely positioned to be the partner of choice for pharmaceutical, biotechnology, molecular diagnostic and medical device companies seeking to create value for their products in these high growth emerging markets. NewBridge was advised on this Transaction by Burrill Merchant Bank, LLC.

More information can be found at www.nbpharma.com

About Orexo

Orexo is a pharmaceutical company focusing on developing treatments for pain and inflammation. Orexo is developing proprietary products based on its proven reformulation technologies, targeted at the Specialty Pharmaceutical market. Orexo intends to commercialise some of these products itself in one or more major markets. Its development activity builds on Orexo's core competences in R&D, which have previously resulted in several successful products, currently out-licensed through worldwide partnership agreements to larger pharmaceutical companies.

Today, Orexo has four products on the market of which Abstral™ is a leading brand for the treatment of breakthrough pain in cancer patients in most of Europe. Orexo also has three significant partnerships with major pharmaceutical companies for research and development programs: discovery stage collaborations with Ortho-McNeil Janssen and Janssen Pharmaceutica in respiratory inflammation and with Boehringer Ingelheim for pain, both within the arachidonic acid cascade and a clinical stage development agreement with Novartis in gastrointestinal disorders. Orexo's head office is located in Uppsala, Sweden.

More information can be found at www.orexo.com.


'/>"/>
SOURCE NewBridge Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. NewBridge Pharmaceuticals Completes $12 Million First Close of Series B Financing, Announces Senior Executive Appointments
2. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
5. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
6. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
7. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
8. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
9. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
10. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
11. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... Divoti USA will engrave and process all non-coated stainless ... FDA requirements, which stipulates new criteria regarding medical device manufacture and ... ID jewelry such as Medical ID Bracelets, can rest assured that ... the new FDA requirements . ... Divoti offers this dark mark fiber laser engraving process with ...
(Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
(Date:10/4/2017)... Korea , Oct. 4, 2017  South Korean-based ... next-generation CPR training aide "cprCUBE" on Kickstarter. The device ... compression during cardiac arrests with better efficiency compared to ... also offers real-time feedback on efficacy of the compression ... crowdfunding campaign has a goal to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest ... the greater Dallas, Miami, and Raleigh regions, is organizing an extended charity drive ... rare and deadly chromosome abnormality. , After struggling since birth with several health ...
(Date:10/13/2017)... Pekin, IL (PRWEB) , ... October 13, 2017 ... ... Foundation, which established the certification process to promote standards of excellence for the ... iaedp™ Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that covers ... companies have a waiver for care if the client has a cognitive impairment diagnosis. ... pays for care, is often waived, so the benefits from their insurance start immediately,” ...
(Date:10/13/2017)... ... 13, 2017 , ... Talented host, actor Rob Lowe, is ... a new episode of "Success Files," which is an award-winning educational program broadcasted ... each subject in-depth with passion and integrity. , Sciatica occurs when the sciatic ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... are now treating sleep apnea using cutting-edge Oventus O2Vent technology. As ... serious sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer ...
Breaking Medicine News(10 mins):