to-BBB, the Dutch brain drug delivery company, has received a positive
opinion from the Committee for Orphan Medicinal Products (COMP) on the
orphan medicinal product designation for the company's brain cancer lead
candidate 2B3-101.
As a proprietary brain-targeted version of the marketed product
Caelyx®/Doxil® (PEG-liposomal doxorubicin), 2B3-101 uses glutathione
(GSH) to safely enhance the delivery of doxorubicin across the blood-brain
barrier. The therapeutic benefit and predictable safety profile of
2B3-101has been successfully demonstrated in pre-clinical studies and the
product is ready to enter clinical trials end of 2010. The product can be
developed for multiple brain cancer indications and to-BBB considers
development for brain metastases of breast cancer as well as glioma.
The positive opinion for 2B3-101 by the COMP has specifically been granted
for the treatment of glioma, which affects less than 5 per 10,000 people
in the European Community. The low prevalence of this life-threatening
condition makes drug development otherwise unappealing, especially for
emerging biotech companies such as to-BBB. However, when the European
Commission decides to grant the orphan drug status following the positive
opinion of the COMP, to-BBB would receive additional market exclusivity
for a period of ten years following approval
of its drug candidate for this indication in Europe. Thereby the Orphan
Drug Designation will increase the likelihood that 2B3-101 will become
available for glioma patients.
"We thank the COMP for their positive opinion," says Willem van Weperen, CEO of to-BBB.
"We are excited
about the potential of 2B3-101 and, supported by the benefits of the
Orphan Drug Designation, we will continue to execute our strategy to
develop this therapy for patients with life-threatening brain cancer."
The Commission typically grants orphan drug status following a positive
opinion from the COMP to a medicinal product intended for the diagnosis,
prevention or treatment of a life threatening or a chronically
debilitating condition when the application for designation is submitted.
About the COMP
The Committee for Orphan Medicinal Products (COMP) is responsible for
reviewing applications from persons or companies seeking 'orphan medicinal
product designation' for products they intend to develop for the
diagnosis, prevention or treatment of life-threatening or very serious
conditions that affect not more than 5 in 10,000 persons in the European
Union.
The COMP is also responsible for advising the European Commission on the
establishment and development of a policy on orphan medicinal products in
the EU, and assists the Commission in drawing up detailed guidelines and
liaising internationally on matters relating to orphan medicinal products.
About to-BBB
to-BBB is a Dutch biotechnology company in the field of enhanced
drug delivery across the blood-brain barrier. The company is developing
novel treatments for brain disorders by combining existing drugs with its
proprietary brain drug delivery platform. The company's vision is that
the treatment of currently unserved brain diseases will be best achieved
by safely enhancing the blood-to-brain delivery of drugs.
To-BBB is
headquartered in The Netherlands at the Leiden Bio Science Park and has
established a fully owned subsidiary, to-BBB Taiwan Ltd., in Taipei,
Taiwan.
Contact
Willem van Weperen, MSc, MBA
Chief Executive Officer
Phone: +31 71 3322252
Mobile: +31 634 054812
E-mail: vanweperen@toBBB.com
to-BBB technologies BV
Niels Bohrweg 11, 2333 CA Leiden
BioScience Park Leiden
Bio Partner Center II
The Netherlands
www.toBBB.com