Navigation Links
Sosei Announces Approval to Start AD 923 Phase III Studies in Europe
Date:11/28/2007

TOKYO, November 28 /PRNewswire-FirstCall/ -- Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), a biopharmaceutical company, today announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Phase III clinical trial programme for its fentanyl sublingual spray (AD 923), an opioid analgesic for the treatment of cancer breakthrough pain.

The clinical trial authorisation (CTA) covers two multi-centre pivotal Phase III efficacy studies followed by an open label safety study. Patient enrolment in the UK is expected to commence before the end of the year and will be the subject of a separate announcement. Applications have been made in other European countries and further patient recruitment will be initiated as soon as approval is received from the relevant local regulatory body.

This first CTA in a major European country will also trigger the receipt of a project milestone payment under the AD 923 Licence Agreement signed with Mundipharma in June 2006.

Mr Shinichi Tamura, President & CEO of Sosei, said: "Receipt of our first Phase III CTA represents an important milestone in the evolution of Sosei and the continuing progress of the AD 923 development programme. We look forward to enlisting our first patients in the trial".

Notes to Editors:

About Sosei

Sosei Group Corporation is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.

For further information about Sosei, please visit http://www.sosei.com

About AD 923

AD 923 is an optimised, sublingual formulation of the strong opioid analgesic fentanyl. It has been specifically designed to provide rapid onset of analgesia in a device that is easy to use by either the patient or their care giver. An additional benefit is the lockout system that prevents inadvertent overdosing. Sosei has concluded a range of studies that confirm the potential of this novel product.

In June 2006, Sosei entered into an agreement with Mundipharma International Corporation Limited for the development and commercialisation of AD 923 in Europe and other international markets, excluding North America and Japan. Sosei is currently evaluating its commercialisation options for the un-partnered territories.

About Cancer Breakthrough Pain

Cancer breakthrough pain is characterised by temporary exacerbations of moderate to severe pain in cancer patients that "breakthrough" their around-the-clock opioid treatments. Each episode may be spontaneous or incidental to an activity. It is estimated that the condition is prevalent in approximately 60% of cancer pain patients across Europe, the US and Japan, representing a total population size of 2.3 million. Most current treatments for cancer breakthrough pain are considered sub-optimal. The market seeks products which have a rapid onset of action and are easy to use. The current worldwide market for cancer breakthrough pain drug treatment is estimated to be worth $1.5bn and represents a growing market opportunity.


'/>"/>
SOURCE Sosei Group Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Sosei and Vectura Announce Start of Phase II Studies of QVA149 for the Treatment of COPD
2. Sosei Announces Update on Phase I Trials for SD118
3. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
4. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
5. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
6. HEI, Inc. Announces Sale of RFID Division Assets
7. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
8. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
9. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
10. Brooke Franchise Corporation Announces Selected July Results
11. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... ... January 20, 2017 , ... A new partnership between Goodwill® and ... longer use or need, from clothes to couches to dressers and bicycles. Roadie — ... them to the nearest Goodwill donation center through February 28th. , “January is ...
(Date:1/20/2017)... ... January 20, 2017 , ... Source Vitál Apothecary, a skin ... pure essential oils, announced the company had a successful visit to the 2017 ECRM ... event gives companies that work in the nutritional, sports and health industries a chance ...
(Date:1/20/2017)... ... January 20, 2017 , ... Bionic Sports Nutrition LLC, ... of life, announced it had a successful January ECRM Trade Show in Hilton Head, ... United States, which allows it to provide its products to all clients at reasonable ...
(Date:1/20/2017)... ... January 20, 2017 , ... ATP Science, an Australian-based company ... attended the January ECRM Trade Show in Hilton Head, SC, benefiting from outstanding ... range of supplements that keep the body functioning at its peak performance by ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... Michael and ... Dana Farber Cancer Institute. For Betsy, the clinical trial has been life-saving as ... has not worsened. , Betsy Brauser was diagnosed with ovarian cancer in 2009. ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... Jan 20, 2017 Research and Markets ... Market Trends, Opportunities, and Future" report to their offering. ... This research service ... trends, and technologies, and provides a snapshot of the key participants ... and forecasts are provided from 2016 to 2020. The market is ...
(Date:1/19/2017)... LONDON , Jan. 19, 2017 ... 2022 Summary GlobalData,s new report, "Germany Cataract ... data on the Germany Cataract Surgery Devices market. The ... (in units) and average prices (USD) within market segements ... The report also provides company shares and distribution shares ...
(Date:1/19/2017)... Conference Call and Webcast to Follow Vanda ... will release results for the fourth quarter of 2016 on Wednesday, ... ... at 4:30 PM ET on Wednesday, February 15, 2017, during which ... results and other corporate activities. To participate in the conference call, ...
Breaking Medicine Technology: