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Algeta Signs $800 Million (EUR560m) Global Agreement With Bayer for Development and Commercialization of Alpharadin for Bone Metastases

September 3, 2009
    OSLO, September 3 /PRNewswire-FirstCall/ --
    - Algeta Retains Option for Co-promotion and Profit Sharing in USA

    - Potential deal value of $800 million (EUR560m*) plus tiered
      double digit royalties
    - Algeta to receive $61 million (EUR42.5m) cash upfront, followed
      by development and sales milestones
    - Algeta retains option for co-promotion and profit-sharing in USA
    - Algeta and Bayer will jointly develop Alpharadin, with Bayer
      contributing a substantial majority of the costs of future development

Algeta ASA (OSE:ALGETA), the cancer therapeutics company, announces today
that it has entered into a global agreement with Bayer for the development
and commercialization of Algeta’s first-in-class alpha-pharmaceutical,
Alpharadin. Alpharadin is currently being evaluated in a global phase III
trial in men with hormone-refractory prostate cancer (HRPC) that has spread
to the bone.

A conference call for analysts, press and investors hosted by President &
CEO Andrew Kay will be held today at 10:00 CET – dial in details are given
below.

Under the terms of the agreement, Algeta has an option for up to 50%
co-promotion with Bayer in the United States under a profit-share
arrangement. Bayer will commercialize Alpharadin globally and pay tiered
double-digit royalties on net sales in markets where there is no co-promotion.

The Alpharadin deal with Bayer totals up to $800 million (EUR560m) to
Algeta. This is made up of an upfront payment of $61 million (EUR42.5m) plus
further cash payments based upon the achievement of certain development,
production and commercialization milestones. Algeta will be responsible for
manufacturing and supply of the commercial product.

Bayer will also contribute a substantial majority of the costs of future
development of Alpharadin as a treatment for bone metastases resulting from
HRPC and from other cancer indications, and will fully fund any additional
late-stage trials.

Alpharadin is Algeta’s lead cancer therapeutic. It is the first in a new
class of alpha-emitting pharmaceuticals ( ‘alpha-pharmaceutical’) and is
based on radium-223. Alpharadin is in a global phase III clinical trial
(ALSYMPCA) designed to confirm its efficacy and safety as a targeted
treatment for bone metastases in patients with HRPC. Alpharadin is
administered as a simple injection and has a unique mode of action whereby it
targets bone metastases specifically and exerts a highly localized effect on
tumor cells while minimizing damage to normal surrounding tissues. In phase
II studies, Alpharadin demonstrated strong evidence that it can prolong
patient survival, improve quality of life and offer a benign safety profile.

Andrew Kay, CEO of Algeta, said, “This agreement is the culmination of an
extensive process to establish and deliver the best possible
commercialization strategy for Alpharadin. In Bayer we have selected a
world-class oncology company with a proven global track record of launching
major cancer products. We are very excited about working with the Bayer team
to deliver this novel and potentially first choice treatment for cancer
patients with bone metastases.”

Kemal Malik, Head of Global Development and member of the Bayer
HealthCare Executive Committee said, “We recognize the tremendous potential
of Algeta’s Alpharadin as a possible treatment for bone metastases in cancer
patients – a serious, life-threatening condition. The data we have seen
suggest that Alpharadin represents a highly targeted treatment option with
convenient handling and manageable side effects. Bayer is committed to its
global oncology franchise and has made significant progress in building a
comprehensive pipeline of promising compounds that may provide innovative
therapies to cancer patients in need of treatment.”

Conference call details

A conference call for analysts, investors and press will take place today
at 10:00 CET.

To participate in the conference call, please dial the appropriate number
below:

800-80-119 (from Norway)

+47-23-00-04-00 (from abroad)

The presentation will be made available on http://www.algeta.com in the
Investors section from 09:00 CET.

To access the replay, please dial +47-67-89-40-91. Enter account no. 1428
followed by #, then press 1, conference no. 428 followed by #. Press 1 to
play. A replay version of the conference call will also be available at
http://www.algeta.com

Upfronts, milestones and royalty payments according to the agreement
between Bayer and Algeta will be in EUR. USD amounts provided in this release
have been translated at 1 Euro:USD1.43

About Algeta

Algeta ASA is a cancer therapeutics company built on world-leading,
proprietary technology. Algeta is developing a new generation of targeted
cancer therapeutics (alpha-pharmaceuticals) that harness the unique
characteristics of alpha particle emitters and are potent, well-tolerated and
convenient to use.

Algeta’s lead alpha-pharmaceutical candidate, Alpharadin (based on
radium-223), has blockbuster potential for treating bone metastases arising
from multiple major cancer types, owing to its bone-targeting nature, potent
efficacy (therapeutic and palliative) and benign, placebo-like safety
profile. Development of Alpharadin is most advanced targeting bone metastases
resulting from hormone-refractory prostate cancer (HRPC), and it entered an
international phase III clinical trial (ALSYMPCA) in mid-2008 based on
compelling clinical results from a comprehensive phase II program. This trial
is currently open for recruitment.

In September 2009, Algeta entered into an global agreement with Bayer
Healthcare AG for the development and commercialization of Alpharadin. As
part of the agreement, Algeta retains an option to co-promote Alpharadin in
the United States and to share profits from future sales.

Algeta is also developing other technologies for delivering
alpha-pharmaceuticals. These include methods to enhance the potency of
therapeutic antibodies and other tumor-targeting molecules by linking them to
the alpha particle emitter thorium-227. The Company is headquartered in Oslo,
Norway
, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in
March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

About Bayer Schering Pharma

The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer HealthCare, a
subsidiary of Bayer AG, 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,
Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer
HealthCare’s aim is to discover and manufacture products that will improve
human and animal health worldwide. Find more information at
http://www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
company. Its research and business activities are focused on the following
areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at
http://www.bayerscheringpharma.de.

Forward-looking Statement

This news release contains forward-looking statements and forecasts based
on uncertainty, since they relate to events and depend on circumstances that
will occur in the future and which, by their nature, will have an impact on
results of operations and the financial condition of Algeta. There are a
number of factors that could cause actual results and developments to differ
materially from those expressed or implied by these forward-looking
statements. Theses factors include, among other things, risks associated with
technological development, the risk that research & development will not
yield new products that achieve commercial success, the impact of
competition, the ability to close viable and profitable business deals, the
risk of non-approval of patents not yet granted and difficulties of obtaining
relevant governmental approvals for new products.


    For further information, please contact:
    For Algeta:
    Andrew Kay, CEO
    +47-2300-6742 / +47-4840-1360 (mob)
    0ystein Soug, CFO
    +47-2300-7984 / +47-9065-6525 (mob)
    post@algeta.com

    Citigate Dewe Rogerson:
    (PR Advisor to Algeta)
    David Dible / Helena Galilee / Mark Swallow
    +44(0)207-638-9571
    david.dible@citigatedr.co.uk

SOURCE Algeta


Source: newswire



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