Le Lézard
Classified in: Health
Subject: TRI

EMA Grants Orphan Drug Designation to Debiopharm International SA's FGFR Inhibitor Debio 1347 in the Treatment of Biliary Tract Cancer


LAUSANNE, Switzerland, November 14, 2017 /PRNewswire/ --

Debiopharm International SA (Debiopharm - http://www.debiopharm.com), part of Debiopharm Grouptm, a Swiss-based global biopharmaceutical company, today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to Debio 1347 for treatment of Biliary Tract Cancer affecting around 77,000 people in the European Union (EU).

Orphan Drug Designation by the EMA provides regulatory and financial incentives to develop therapies for life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in EU, and for which no satisfactory treatment is available.

Debio 1347 is an orally available small molecule selectively targeting FGFR 1, 2, 3 signaling pathways and is currently tested in a phase I study in patients with FGFR genomically activated advanced solid tumors (including patients with biliary tract cancer).

Further to the encouraging signs of efficacy observed during clinical phase I and supported by this significant regulatory milestone, Debiopharm will expand the clinical development of this therapy to these patients.

"Obtaining orphan designation for Debio 1347 in the European Union is an important regulatory milestone", stated Peggy Lipp, Director, Regulatory Affairs, Business Intelligence & Market Access, Debiopharm International S.A. "It speaks to the need for new treatment options in this chronically debilitating and life threatening condition and the potential role of Debio 1347's mode of action. This orphan drug designation is a proof of our commitment to developing innovative therapies for oncology patients".

About Debiopharm International SA 
Part of Debiopharm Grouptm - a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management - Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.

For more information, please visit http://www.debiopharm.com

We are on Twitter. Follow us @DebiopharmNews


Debiopharm International SA Contact
Christelle von Büren
Communication Coordinator
[email protected] 
Tel: +41(0)21-321-01-11

SOURCE Debiopharm International SA


These press releases may also interest you

at 17:21
CHEMISTREE DEBENTUREHOLDERS APPROVE DEBT RESTRUCTURING
Chemistree Technology Inc. (US OTC: CHMJF) (the "Company" or "Chemistree"), is pleased to announce that the adjourned extraordinary meeting of the holders of the 10% senior unsecured convertible debentures of the Company (the "Debentures") was...

at 17:15
Public Advisory - Fake Viagra seized from Jug City store in Scarborough, ON
Summary Product: Counterfeit Viagra, 100 mg sildenafil tabletsIssue: Health products - Product safety, Unauthorized productWhat to do: Immediately stop using and safely dispose of this product. Consult your health care provider if you have taken this...

at 17:00
GBLT Receives Shareholder Approval for Delisting from TSX Venture Exchange
GBLT Corp. ("GBLT" or the "Company") announces that minority shareholders have approved the voluntary delisting (the "Delisting") of the common shares of the Company from the TSX Venture Exchange ("TSXV").  Approval for the delisting was received at...

at 17:00
L.A. Care and Blue Shield of California Promise Health Plans Celebrate New Community Resource Center in West Los Angeles, Highlight Five-Year Partnership Milestone
L.A. Care Health Plan and Blue Shield of California Promise Health Plan today held a grand opening ceremony for their Community Resource Center (CRC) in West Los Angeles (West L.A.) at 11173 W. Pico Blvd in Los Angeles....

at 16:55
Veterinary Management Groups (VMG) Launches Innovative Veterinary Economic Dashboard
Veterinary Management Groups (VMG) is proud to...

at 16:45
Cronos Group Inc. to Hold Virtual 2024 Annual Meeting of Shareholders
Cronos Group Inc. ("Cronos" or the "Company") will hold its 2024 Annual Meeting of Shareholders on Thursday, June 20, 2024, at 11:00 a.m. ET. Cronos will be conducting the meeting in a virtual-only format via live audio webcast. Registered...

More news about Health...


News published on and distributed by: