BIOTIE THERAPIES CORP. Stock Exchange Release 4 May, 2012 at
9.00 a.m.
Biotie Interim report 1 January - 31 March 2012
Biotie reports Q1 2012 results; clinical development remains on track, with
important inflection points expected in H2 2012 and beyond
Company Highlights
* Successfully completed a clinical PET imaging study with SYN120
* Partner Lundbeck presented data at the 2012 European Congress of Psychiatry
showing that Selincro reduces total alcohol consumption by two-thirds on
average after six months of treatment, further data to be presented at a
medical conference in the summer
* Panu Miettinen appointed Chief Financial Officer (CFO) and a member of the
Group's management team, effective March 15, 2012
Key Financials for the period ending March 31, 2012
Figures in brackets, unless otherwise stated, refer to the same period in the
previous year (EUR million)
* Revenues EUR 0.0 million (0.5)
* Research and development costs EUR 5.8 million (4.9)
* Financial Result (Net loss) EUR -7.5 million (-7.7)
* Cash flow from operating activities, continuing operations EUR -9.3 million
(-4.2)
* Liquid assets at the end of period EUR 24.7 million (46.8)
* Earnings per share -0.02 (-0.03)
The interim report is unaudited. Liquid assets are comprised of cash, cash
equivalents and investments held to maturity.
Timo Veromaa, Biotie's President and CEO commented, "We are very pleased with
the progress of our clinical studies. With our lead asset, Selincro, under
review at the European Medicines Agency with our partner Lundbeck, our focus is
on driving forward the next wave of products in our pipeline, for which we could
see a number of important datapoints in the next 12 - 18 months".
Outlook for 2012 and key upcoming milestones in 2012
Selincro (nalmefene): A marketing authorization application (MAA) for Selincro
for alcohol dependence, submitted by Biotie's partner Lundbeck, was accepted for
review by the European Medicines Agency (EMA) in December 2011. Pending
approval, the next milestone payments to Biotie are expected on commercial
launch of Selincro and on the product reaching certain predetermined sales.
Tozadenant (SYN115): A Phase 2b study in Parkinson's disease, funded by Biotie,
is ongoing with top-line data expected H1 2013.
SYN120: Roche has an option to license SYN120 for development and
commercialization following the completion of the clinical PET imaging study.
Nepicastat (SYN117): Phase 2 study ongoing, funded by the US Department of
Defense, for the treatment of post-traumatic stress disorder (PTSD); top-line
data are expected in H2 2012.
Under the agreement with the National Institute on Drug Abuse (NIDA) at the US
National Institutes of Health, NIDA and Biotie are jointly investigating the
safety and efficacy of nepicastat in the treatment of cocaine dependence. The
trial is expected to start in H2 2012.
BTT-1023 (VAP-1 antibody): Biotie is currently optimizing the scale-up of the
manufacturing process for BTT-1023 and expects to start proof-of-concept
clinical studies in selected indications in H2 2012.
Ronomilast: Biotie is seeking a partner for further development and
commercialization of this product.
Disclosure procedure
Biotie Therapies Corp. has started to follow the disclosure procedure enabled by
Standard 5.2b published by the Finnish Financial Supervision Authority and
hereby publishes its Interim Report for January-March 2012 attached to this
stock exchange release in pdf format. The Interim Report is also available on
the company's web site at www.biotie.com.
Conference call
An analyst and media conference call will take place on 4 May 2012 at 10:00 a.m.
Central European Time. The conference call will be held in English.
Lines are to be reserved ten minutes before the start of conference call. The
event can also be viewed as a live webcast at www.biotie.com. An on demand
version of the conference will be published on Biotie's website later during the
day
Telephone conference numbers:
US callers: +1 646 254 3360
UK callers: +44 (0)20 7136 2051
Finnish callers: +358 (0)9 2310 1621
Access code: 1547005
In case you need additional information or assistance, please contact: Virve
Nurmi, IR Manager, Tel: +358 2 2748 911
Key events after the reporting period
Biotie announced on 24 April 2012 that it has agreed with its partner Seikagaku
Corporation to terminate with immediate effect their License Agreement on
Biotie's VAP-1 antibody program, BTT-1023. The license, under which Biotie had
granted Seikagaku exclusive rights for development and commercialization of BTT-
1023 in Japan, Taiwan, Singapore, New Zealand and Australia, was executed in
April 2003 and was built around Seikagaku's expertise in locomotive diseases.
Biotie has re-profiled BTT-1023 to focus on fibrotic diseases, and this is not a
focus in Seikagaku's development strategy. The license agreement also included
an option for Biotie's VAP-1 SSAO small molecule inhibitors.
Biotie announced on 2 May 2012 that Dr. James S. Shannon has notified the
company that he will resign from the Board of Directors of Biotie, effective
immediately. Dr. Shannon has been appointed Corporate Chief Medical Officer with
GlaxoSmithKline in London as of May 1st 2012 and will resign from all external
Board positions.
As a consequence, the Board of Directors in its meeting of 3 May 2012 appointed
Guido Magni as a member of the Audit Committee. The composition of the committee
after the nomination is Bernd Kastler as Chairman and Merja Karhapää and Guido
Magni as members.
About Biotie
Biotie is a specialized drug development company focused on the development of
drugs for neurodegenerative and psychiatric disorders (e.g. Parkinson's disease,
Alzheimer's disease and other cognitive disorders, alcohol and drug dependence
(addiction) and post traumatic stress disorder ), and inflammatory and fibrotic
liver disease. The company has a strong and balanced development portfolio with
several innovative small molecule and biological drug candidates at different
stages of clinical development. Biotie's products address diseases with high
unmet medical need and significant market potential.
Partnerships with top-tier pharmaceutical partners are in place for several
programs as well as a strategic collaboration with UCB Pharma S.A. The Marketing
Authorization Application for Biotie's most advanced product, SelincroTM
(nalmefene) for alcohol dependence was filed in the EU by our partner H.
Lundbeck A/S and was accepted for review by the European Medicines Agency in
December 2011.
Turku, 4 May 2012
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Virve Nurmi, Investor Relations Manager
tel. +358 2 274 8900
e-mail: virve.nurmi@biotie.com
Distribution:
NASDAQ OMX Helsinki Ltd
Main media
www.biotie.com
Attachment:
Biotie_Q1 2012 Interim report
[HUG#1608761]
