Orion - Company Announcement

Orion and Bayer expand clinical development program for ODM-201 (BAY-1841788) and initiate a new phase III study ARASENS in patients with metastatic hormone-sensitive prostate cancer

ORION CORPORATION      STOCK EXCHANGE RELEASE 3 JUNE 2016 at 9.30
EEST


Orion and Bayer expand clinical development program for ODM-201 (BAY-1841788)
and initiate a new phase III study ARASENS in patients with metastatic hormone-
sensitive prostate cancer


Orion Corporation (Nasdaq Helsinki: ORNAV and ORNBV) and Bayer have agreed to
start in 2016 a new Phase III study with oral androgen receptor antagonist ODM-
201 (BAY-1841788). The new Phase III study ARASENS will evaluate the safety and
efficacy of the compound in combination with standard androgen deprivation
therapy (ADT) and the chemotherapy docetaxel in men with newly diagnosed
metastatic hormone-sensitive prostate cancer (mHSPC), who are starting first
line hormone therapy.

In 2014, Orion and Bayer entered into a global partnership for the development
and commercialization of ODM-201 (BAY-1841788). The companies have expanded the
2014 agreement to include the joint development of ODM-201 (BAY-1841788) for
mHSPC. The compound is currently in Phase III study ARAMIS for high-risk non-
metastatic castration-resistant prostate cancer (nmCRPC). The new trial ARASENS
is expected to start the enrolment of patients towards the end of 2016.

As disclosed in a stock exchange release of 2 June 2014, Orion is eligible to
receive milestone payments from Bayer upon achievement of certain ODM-201
related development, tech transfer and commercialization milestones, as well as
substantial royalties on future sales. In addition, Orion will be responsible
for manufacturing of the product. Orion and Bayer will jointly develop ODM-201
with Bayer contributing a major share of the costs of the development. Bayer
will commercialize the product globally and Orion has the option to co-promote
it in Europe.

In this individual case Orion deviates from one main rule of its disclosure
policy, according to which Orion publishes information on its R&D projects
mainly in its interim reports and/or press releases, but, as a main rule,
provides information on the results of clinical Phase III trials in separate
stock exchange releases.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer (PC) is the second most common form of cancer worldwide and the
fifth leading cause of cancer-related death in men. More than 1.1 million men
worldwide were diagnosed with the disease in 2012. (Source: GLOBOCAN 2012:
Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012.)

At the time of diagnosis, most men have localized prostate cancer, meaning their
cancer is confined to the prostate gland and can be treated with curative
surgery or radiotherapy. Upon relapse when the disease will metastasize or
spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for
this hormone-sensitive disease. Approximately five percent of men will already
suffer from prostate cancer with distant metastases when first diagnosed.
(Source: University of Maryland Medical Center. Prostate Cancer. Available at:
http://umm.edu/health/medical/reports/articles/prostate-cancer.)

Men with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC)
will start their treatment with hormone therapy, such as ADT or a combination of
the chemotherapy docetaxel and ADT. Despite this first line treatment, most men
with metastatic HSPC will eventually progress to castration-resistant prostate
cancer (CRPC), which can impact survival and quality of life. (Source: National
Cancer Institute. Hormone Therapy for Prostate Cancer. Available at:
http://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet.)

About ODM-201 (BAY-1841788)

ODM-201 (BAY-1841788) is an investigational oral androgen receptor (AR)
antagonist that has a unique chemical structure designed to block the growth of
cancer cells through binding to the AR with high affinity and inhibiting the
receptor function. In preclinical studies, ODM-201 and its main circulating
metabolite are active also in known AR mutants (ex W742L, F877L), and have been
found to have negligible blood-brain barrier penetration.



Orion Corporation



 Timo Lappalainen    Olli Huotari
 President and CEO   SVP, Corporate Functions



Contact persons:
Tuukka Hirvonen, Communications Manager, Financial Communications and Investor
Relations
tel. +358 10 426 2721

Reijo Salonen, SVP, Pharmaceutical Research and Development, Chief Medical
Officer
tel. +358 50 966 3647, available from 14.30 EEST (6.30 a.m. CDT) onwards.



Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02101 Espoo, Finland
Homepage: www.orion.fi


Orion is a globally operating Finnish company developing pharmaceuticals and
diagnostic tests - a builder of well-being. Orion develops, manufactures and
markets human and veterinary pharmaceuticals, active pharmaceutical ingredients
and diagnostic tests. The company is continuously developing new drugs and
treatment methods. The core therapy areas of Orion's pharmaceutical R&D are
central nervous system (CNS) disorders, oncology and respiratory for which Orion
developes inhaled Easyhaler® pulmonary drugs.

Orion's net sales in 2015 amounted to EUR 1,016 million and the Company had
about 3,400 employees. Orion's A and B shares are listed on Nasdaq Helsinki.


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