Orion and Bayer enter global agreement for development and commercialization of novel prostate cancer treatment - Orion upgrades full-year outlook for 2014

Bayer HealthCare US-Hauptsitz in Whippany, New Jersey ©iStock

ORION CORPORATION STOCK EXCHANGE RELEASE 2 JUNE 2014 at 08.00 EEST

Orion and Bayer enter global agreement for development and commercialization of novel prostate cancer treatment - Orion upgrades full-year outlook for 2014

Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) has entered into a global partnership with Bayer for the development and commercialization of the compound ODM-201, an investigational novel oral androgen receptor inhibitor. ODM-201 is in clinical development for the treatment of patients with prostate cancer. Bayer and Orion will start jointly a clinical Phase III program to further evaluate the efficacy and safety of ODM-201 in patients with non-metastatic castration-resistant prostate cancer (nm-CRPC) in 2014. As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 2014.

Under the terms of the agreement, Orion and Bayer will jointly develop ODM-201, with Bayer contributing a major share of the costs of future development. Bayer will commercialize ODM-201 globally, Orion has the option to co-promote ODM-201 in Europe and Orion is eligible to receive substantial royalties on the product sales. Orion will be responsible for manufacturing of the product.

Dr. Reijo Salonen, Senior Vice President of R&D at Orion commented:

"Joining forces with Bayer, I believe that we have again achieved a collaboration that represents the best of all worlds," said Dr. Reijo Salonen, SVP R&D and Chief Medical Officer for Orion. "Bayer has recently committed to developing therapies in Oncology, particularly for Prostate Cancer. At Orion, we continue our track record of inventing innovative molecules. And most importantly, for patients with prostate cancer, this partnership will bring a medicine that will make an important difference to their lives."

Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development commented:

"We see in ODM-201 a potential new treatment for patients with high risk non-metastatic castration-resistant prostate cancer and are looking forward to developing this promising compound," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. "From a clinical perspective, ODM-201 has the potential to complement our portfolio in prostate cancer and enables us to deliver new treatment options for patients who desperately need them."

Under the terms of the agreement, Orion will receive an upfront payment of EUR 50 million and is eligible to receive milestone payments from Bayer upon achievement of certain development, tech transfer and commercialization milestones, as well as substantial royalties on future sales. Orion will use significant part of the upfront payment this year against the costs of the Phase III study to be started this year.

As a result of the agreement Orion Corporation upgrades the full-year outlook estimate for 2014 provided on 4 February 2014. The company estimates that the full-year operating profit will be at similar level to 2013 (operating profit in 2013 was EUR 268 million).

New full-year outlook estimate for 2014, provided on 2 June 2014

Net sales will be at similar level to 2013 (net sales in 2013 were EUR 1,007 million).

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Operating profit will be at similar level to 2013 (operating profit in 2013 was EUR 268 million).

The Group's capital expenditure will be about EUR 60 million excluding substantial corporate or product acquisitions (the Group's capital expenditure in 2013 was EUR 78 million).

Previous full-year outlook estimate for 2014, provided on 4 February 2014

Net sales will be at similar level to 2013 (net sales in 2013 were EUR 1,007 million).

Operating profit will be slightly lower than in 2013 (operating profit in 2013 was EUR 268 million).

The Group's capital expenditure will be about EUR 60 million excluding substantial corporate or product acquisitions (the Group's capital expenditure in 2013 was EUR 78 million).

Prostate cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. Hormonal deprivation therapy allows long-lasting and effective control of cancer-related symptoms in advanced stages. Despite effective treatment strategies, in some patients with prostate cancer the disease will progress and become castration-resistant. CRPC is characterized by persistent, high level AR function and resistance to conventional anti-androgens such as bicalutamide. Effective treatment options for castrate-resistant patients are still limited, with the field evolving rapidly.

About ODM-201
ODM-201 is an investigational novel AR inhibitor with unique chemistry that is designed to block the growth of CRPC. ODM-201 binds to AR with high affinity and inhibits receptor function by blocking the nuclear translocation of AR. Unlike other AR inhibitors, ODM-201 does not enter the brain in nonclinical models.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

Orion Corporation

Timo Lappalainen
President and CEO

Olli Huotari
SVP, Corporate Functions

Teleconference for analysts, media and institutional investors

A Q&A teleconference on the release will be held today, Monday 2 June 2014, at 11:00 a.m. EEST. President and CEO Timo Lappalainen and CFO Jari Karlson will answer the questions asked by telephone in Finnish and English.

A recording of the teleconference is accessible at Orion's website at www.orion.fi/en during Monday 2 June 2014.

The teleconference code is 945173 and to participate in the teleconference, please call:

from United States: +1 334 323 6201
from Finland: +358 (0)9 2313 9201
from Sweden: +46 (0)8 5052 0110
from UK and other countries: +44 (0)20 7162 0077

Contact persons:

Orion Corporation

Tuukka Hirvonen, Communications Manager, IR & Financial Communications
tel. +358 50 966 2721
e-mail: tuukka.hirvonen@orion.fi

Bayer Pharma AG
Astrid Kranz, Corporate Communications & Public Affairs
tel. +49 30 468 12057
e-mail: astrid.kranz@bayer.com

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 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. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.

Orion's net sales in 2013 amounted to EUR 1,007 million and the company had about 3,500 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Orion Oyj via Globenewswire

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