Biotie Therapies Oyj: Interim report on biotie therapies corp. january 1 - september 30, 2005
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE
October 27, 2005 at 9.30 a.m.
INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - SEPTEMBER 30,
2005
January – September 2005 in brief
· BioTie North-American licensing partner Somaxon
Pharmaceuticals has started a phase II/III clinical study in
patients suffering from pathological gambling and a pilot phase II
study in nicotine addiction (smoking cessation). Results are
expected late 2006.
· After the reporting period, BioTie reported that the
company and sanofi-aventis have agreed not to renew the option
agreement that ended on March 31, 2005. Based on the good
technical progress during the collaboration BioTie plans to
continue the recombinant heparin program with a new development
partner.
· This interim review is prepared in accordance with the
IFRS recognition and measurement principles. BioTie adopted IFRS
at the beginning of 2005.
· The net loss in January – September, 2005 stood at EUR
-6.2 million (in 2004 EUR -7.3 million). Cash flow before financing
items was EUR -6.1 million (EUR -6.5 million in 2004).
· The company’s liquid assets amounted to EUR 8.7 million
as at September 30, 2005 (at September 30, 2004, EUR 7.0 million).
The company has liquid assets to finance its operations
approximately to the middle of 2006 without any revenues.
Drug development projects
Nalmefene program
In November 2004 Biotie Therapies Corp. and Somaxon
Pharmaceuticals, Inc. signed an exclusive licence agreement of the
North American rights regarding nalmefene. Somaxon paid BioTie USD
3 million as signing fee. The remaining milestone payments may add
up to USD 10 million for the lead indication, pathological
gambling. Additionally, BioTie will receive royalty on sales.
Under the terms of the agreement, BioTie has granted Somaxon an
exclusive license in North America to clinically develop,
manufacture and market nalmefene for the treatment of impulse
control disorders, alcoholism and alcohol abuse as well as
nicotine dependence. Somaxon intends to develop nalmefene for the
treatment of pathological gambling in the United States.
Somaxon has started a phase II/III clinical study in the US in
patients suffering from pathological gambling. Additionally,
Somaxon has initiated a pilot phase II clinical study in the
treatment of nicotine dependence. Results from these studies are
expected late 2006.
BioTie aims at commercializing the European rights of Nalmefene.
Recombinant heparin program
BioTie and Aventis (currently sanofi-aventis) signed on March 2004
a commercial research and option agreement covering the joint
development of a new oral heparin like product for the prevention
and treatment of blood coagulation disorders. Under the terms of
the agreement, BioTie granted Aventis the exclusive right to
negotiate an exclusive global licensing agreement by 31.3.2005.
Based upon the progress of the joint project, BioTie and sanofi-
aventis have continued negotiations on the extension of the said
agreement.
After the reporting period on October 17, 2005, BioTie reported
that the two companies have agreed not to renew the option
agreement. Based on the good technical progress during the
collaboration BioTie plans to continue the recombinant heparin
program with a new development partner.
In addition to the signing fee of one million euros, Aventis paid
a milestone payment of one million euros when the agreed milestone
was reached in 2004.
Vascular Adhesion Protein-1 (VAP-1)
BioTie’s proprietary drug development target, Vascular Adhesion
Protein-1 (VAP-1), is a dual-function molecule with enzymatic and
adhesion activities. VAP-1 mediates the migration of pro-
inflammatory cells into inflamed tissue and the amount of VAP-1 is
greatly amplified in inflamed blood vessels. VAP-1 SSAO enzyme
contributes to the production of molecules that exacerbate
inflammation. Both VAP-1 specific monoclonal antibodies and VAP-1
SSAO small molecule inhibitors have been shown in animal models to
be potent inhibitors of inflammatory diseases.
VAP-1 monoclonal antibody program
Development activities of a fully human monoclonal antibody
continued during the reporting period. Co-operation with Seikagaku
Corporation proceeded as planned.
VAP-1 SSAO small molecule inhibitor program
In December 2004, F. Hoffmann-La Roche Ltd. (Roche) and BioTie
announced a collaboration and option agreement to develop BioTie’s
proprietary small molecule vascular adhesion protein-1 (VAP-1)
program targeting inflammatory diseases. Preclinical evaluation of
lead drug candidates and backup molecules continued during the
reporting period.
Under the terms of the agreement, Roche will contribute its
expertise to BioTie’s development of VAP-1 small molecule
inhibitor candidates. At defined stages, Roche will have exclusive
option rights to exclusively license any VAP-1 inhibitor candidate
worldwide, excluding Japan, Taiwan, Singapore, New Zealand, and
Australia. By extending its option right to phase IIb, Roche could
pay BioTie EUR 5 million. BioTie will retain all rights to any
compounds developed until a license is granted.
Alfa2beta1 integrin small molecule inhibitor program
The screening and preclinical development of new alfa2beta1
integrin inhibitors continued in cooperation with the University
of Turku, Åbo Akademi University and the University of Helsinki.
Alfa2beta1 integrin inhibitors provide new methods for preventing
thrombosis caused by vascular damage as well as preventing cancer
metastasis. Two new patent applications were filed in the EU to
strengthen the IP position of the identified compounds.
