Search in our News Channels
|
|
Search in our Online Store
|
|
STADA receives "positive opinion" for Epo-zeta from EMEA |
|
|
|
20 Oct 2007 |
Yesterday, STADA received in the ongoing EU-wide approval process for Erythropoietin-zeta, a “positive opinion” from the responsible EU approval agency EMEA
BAD VILBEL, Germany | October 19, 2007 | Yesterday, on October 18, 2007, STADA received, as expected, in the ongoing EU-wide approval process for Erythropoietin-zeta (Epo-zeta), a “positive opinion” from the responsible EU approval agency EMEA.
The “positive opinion” includes, as requested, the indications nephrology (dialysis) and oncology. Thus, an EU-wide approval of Epo-zeta for these indications can still be expected in the current year.
As is known, the STADA Group’s biosimilar projects, including in particular the development of Epo-zeta, are pursued through BIOCEUTICALS Arzneimittel AG, a company initiated by STADA and predominantly financed via venture capital, in which STADA currently owns 14.99% of shares. STADA continues to hold a call option which can be exercised annually from 2011, according to which STADA can acquire all shares in BIOCEUTICALS at a price which is already defined via a formula. In addition, as is known, STADA also holds semi-exclusive distribution rights for Epo-zeta in Germany in the form of a license from BIOCEUTICALS, whereas BIOCEUTICALS, at the end of 2006, awarded the exclusive distribution rights for Epo-zeta for the EU countries (with the exception of Germany, where the distribution rights are semi-exclusive), several additional European countries as well as the USA and Canada to the US hospital products company Hospira against one-time payments, some of which have already been received and some of which are still outstanding depending on the further progress of the project, as well as sales-related royalty payments (see STADA Corporate News from November 20, 2006). For all other countries, Hospira has a right of first refusal.
After today’s positive decision by EMEA, STADA will probably be in a position to market Epo-zeta in Germany in the first quarter of 2008 via the Group-owned sales company cell pharm GmbH. Hospira is also preparing a market launch of Epo-zeta in various EU countries as of the first quarter of 2008.
Furthermore, STADA controlled the development process and then conducted the approval process for the Epo-zeta project on behalf of BIOCEUTICALS. Christof Schumann, member of STADA’s Executive Board responsible for the project, was very pleased with today’s decision by the EMEA: “This has proven that STADA is also able to complete a very complex and scientifically highly demanding development project with success. It shows the high level that STADA’s development and approval departments work at and underlines our claim to be able, by means of a continuous inflow of new products, to provide STADA’s sales companies with a product portfolio that is always up to date.”
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 Erythropoietin:
Erythropoietin (abbreviation Epo) is a biopharmaceutical active ingredient in protein form, which is produced by living cell lines. Depending on the individual cell lines used and the production process associated with it, so-called glyco structures (oligosaccharide-chains) can differ minimally; the Erythropoietin biosimilar being developed by BIOCEUTICALS is Epo-zeta. Erythropoietin is used, among other things, in Nephrology for dialysis patients to stimulate hematopoieses as well as in cancer therapy. The current market volume for Erythropoietin at ex-factory prices, based on market data from various international market research organizations, is estimated at approx. EUR 1.2 billion per year for the EU and approx. EUR 200 million per year for Germany.
SOURCE: STADA |
|
For immediate assistance, please call us during business hours: Mon-Fri 09:00am - 18:30pm; GMT+01
La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com
All contents © by La Merie S. L
|
 |
|
|
