DGAP-News: STADA Arzneimittel AG: STADA and Richter cooperate for development of two biosimilar products for two monoclonal antibodies: Rituximab and Trastuzumab
(firmenpresse) - DGAP-News: STADA Arzneimittel AG / Key word(s): Alliance
STADA Arzneimittel AG: STADA and Richter cooperate for development of
two biosimilar products for two monoclonal antibodies: Rituximab and
Trastuzumab
30.08.2011 / 08:15
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Corporate News
STADA and Richter cooperate for development of two biosimilar products for
two monoclonal antibodies: Rituximab and Trastuzumab
Bad Vilbel and Budapest August 30, 2011 - STADA Arzneimittel AG ('STADA')
and Gedeon Richter Plc. ('Richter') today announce that the two companies
have signed two separate license and collaboration agreements in respect of
the development and marketing of two biosimilar products for the two
monoclonal antibodies Rituximab and Trastuzumab.
According to the agreement STADA receives non exclusive distribution rights
for the area of geographical Europe and the CIS area, but due to regulatory
reasons, excluding Russia, for the biopharmaceutical active ingredient
Rituximab, which Richter is currently developing as a biosimilar and whose
approval from today's perspective can be expected at the end of 2017. In
addition to STADA and eventual own marketing, Richter may grant a maximum
of one additional partner a relevant distribution license in the contract
area. If such a partially exclusive license marketing in Russia become
regulatory possible, STADA would also receive such a distribution license
there from Richter.
Under the terms of the agreement in addition to a payment at the signing of
the contract, STADA is obliged to make further payments each depending on
the progress of the project which amount in total to a low double-digit
million euro figure. STADA will exclusively purchase the Rituximab
biosimilar from Richter for marketing and distribution of the product for
which the major commercial terms have already been agreed on.
STADA, as is known, has done preparatory work for a biosimilar for the
biopharmaceutical active ingredient Trastuzumab, which, however, was
stopped at the end of 2010 because STADA made the strategic decision to
pursue the lower-cost approach of an in-licensing. The stage of development
that STADA had reached up until that point will now be acquired by Richter
as part of a contract concluded today for a low single-digit million
figure, in order to thus accelerate the ongoing own development for a
Trastuzumab biosimilar. In addition, STADA receives, at the time of the
beginning of the clinical studies in approximately two years, a
unilaterally for STADA exercisable option from Richter to acquire also for
such a Trastuzumab biosimilar a distribution license at commercial
conditions analogous to those of the Rituximab.
The CEOs of both STADA and Richter expressed their commitment to the
established cooperation.
For Hartmut Retzlaff, Chairman of the Executive Board of STADA Arzneimittel
AG, the cooperation agreed on today shows that the STADA strategy of
refraining from its own cost-intensive biosimilar development and to
instead rely on cooperations and licenses for these biosimilar projects was
correct. 'With today's cooperation we have secured marketing access to two
biosimilars with particularly high sales potential for our core markets in
Europe at substantially more favorable conditions than with a development
of our own - and that with such an outstanding partner like Richter which
is known in the industry for its high degree of expertise and reliability',
said Retzlaff.
Erik Bogsch, CEO of Gedeon Richter Plc., added the following comments on
today's contracts: 'We always considered the development of biosimilar
products an important strategic initiative for Richter and we have made
significant efforts to establish our future presence in the field of
biotechnology, thereby enhancing the proportion of high added value
products. This agreement is considered a significant move in line with
Richter's aim to find strategic partners for the development, marketing and
distribution of our biosimilar product portfolio. With STADA, we have
gained an excellent, reputable cooperation partner whose traditionally
strong presence and expertise in the field of developing and marketing both
generic and biosimilar product groups will contribute to the fulfillment of
our long term strategy.'
The development of both biosimilars will now be continued under the
leadership of Richter. A supporting function from STADA for specific patent
rights questions in both projects has also already been agreed upon today.
STADA will also support if necessary the relevant approval processes with
its own expertise in the area of EU approvals of biosimilars.
About biosimilars:
A biosimilar is defined as a biopharmaceutical product - i.e. a drug with a
protein as an active ingredient which is produced by genetically modified
cell lines which, despite different producing cell lines, compared to an
initial supplier product which is already on the market, is so similar that
the biosimilar has proven therapeutic equivalence.
About the monoclonal antibodies Rituximab and Trastuzumab
Monoclonal antibodies represent an active ingredient class of
biopharmaceuticals, which when applied as pharmaceuticals activate the
body's natural defense processes against diseases and which are used in
particular for cancer therapy and for the treatment of auto-immune
diseases. Rituximab is a monoclonal antibody which is used in the treatment
of various forms of cancer such as non-hodgkins lymphoma as well as various
auto-immune diseases such as rheumatoid arthritis and whose current market
volume at ex-factory prices for Europe on the basis of market data provided
by various international market research companies is estimated at approx.
EUR 1.15 billion annually. Trastuzumab is a monoclonal antibody for the
treatment of certain forms of breast cancer and stomach cancer and whose
current market volume at ex-factory prices for Europe on the basis of
market data provided by various international market research companies is
estimated at approx. EUR 1.39 billion annually.
Additional information:
STADA Arzneimittel AG / Corporate Communications / Stadastraße 2-18 / D -
61118 Bad Vilbel /
Phone: +49 (0) 6101 603-113 / Fax: +49 (0) 6101 603-506 / E-mail:
communications(at)stada.de
Or visit us in the Internet at www.stada.com.
End of Corporate News
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30.08.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Language: English
Company: STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel
Germany
Phone: +49 (0)6101 603- 113
Fax: +49 (0)6101 603- 506
E-mail: communications(at)stada.de
Internet: www.stada.deISIN: DE0007251803, DE0007251845,
WKN: 725180, 725184,
Listed: Regulierter Markt in Düsseldorf, Frankfurt (Prime
Standard); Freiverkehr in Berlin, Hamburg, Hannover,
München, Stuttgart
End of News DGAP News-Service
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137264 30.08.2011
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