Pharming and Sanofi Chimie sign manufacturing agreement for the drug substance of Ruconest(TM)
(Thomson Reuters ONE) -
Leiden, the Netherlands and Aramon, France, July 6(th), 2010. Biotech company
Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) and Sanofi Chimie, wholly
owned subsidiary of sanofi-aventis (NYSE Euronext: SAN, NYSE: SNY) announced
today the signing of a toll manufacturing agreement to increase the production
capacity of the drug substance of Ruconest(TM), which will improve Ruconest(TM)
cost of goods and competitiveness and will put Pharming in the position to
satisfy future global demand.
Since 2005, Pharming has an ongoing manufacturing agreement with MSD (formerly
Schering-Plough/Organon) for the production of Ruconest(TM). Pharming will
launch and supply the markets with material from MSD until the process,
up-scaled by Sanofi Chimie, has been validated. In addition, the agreement will
enable Pharming to lower cost of goods and will provide Pharming with sufficient
production capacity, at one of Sanofi Chimie's existing manufacturing
facilities, to meet future global demands. The financial details of the
agreement have not been disclosed.
"For the anticipated market launch of Ruconest(TM) this year in Germany and the
UK and the further roll-out of the product in the European Economic Area and
beyond, we will continue the cooperation with MSD for the supply of
Ruconest(TM)," said Dr. Bruno Giannetti, Chief Operations Officer of Pharming.
"Meanwhile, we need to take the next step towards becoming a profitable
pharmaceutical company. With a limited investment for technology transfer, we
will effectuate the up-scaling of the production process, which will
significantly lower cost of goods of Ruconest(TM)."
"Last month's positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) for Ruconest(TM) for the treatment of angioedema attacks was a
major step towards validation and commercialization of Pharming's proprietary
technology. We are very pleased to be involved in this exciting project," said
Francis Carré, Chief Executive Officer of Sanofi Chimie. "Pharming is the first
European company with a recombinant biopharmaceutical product from this platform
to be approved in Europe and we are proud to be able to support the
commercialization of this innovative and highly effective product on a
world-wide basis."
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, ageing diseases, specialty products for surgical indications, and
nutritional products. On June 24, the European Medicines Agency adopted a
positive opinion for Ruconest(TM) (Rhucin) for the treatment of angioedema
attacks. Market Authorization in the European Economic Area is therefore
expected to be granted in September 2010. The product is also under development
for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed
graft function (DGF) following kidney transplantation. The advanced technologies
of the Company include innovative platforms for the production of protein
therapeutics, technology and processes for the purification and formulation of
these products, as well as technology in the field of DNA repair (via DNage).
Recently the partial spin off of DNage was initiated. Additional information is
available on the Pharming website,http://www.pharming.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and
distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Chimie is a wholly owned subsidiary of sanofi-aventis, which deals with
active pharmaceutical ingredients manufacture, both for internal and external
purposes.
This press release contains forward looking statements that involve known and
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially different
from the results, performance or achievements expressed or implied by these
forward looking statements.
Pharming contact:
Ms. Marjolein van Helmond
T: +31 (0)71 52 47 431
T: +31 (0)6 109 299 54
Sanofi Chimie contact:
Mr. Michel Arraou
T: +33 (0) 4 66 57 71 30
[HUG#1429831]
Press release (PDF) : http://hugin.info/132866/R/1429831/376822.pdf
This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients.
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
All reproduction for further distribution is prohibited.
Source: Pharming Group N.V. via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 06.07.2010 - 13:00 Uhr
Sprache: Deutsch
News-ID 23531
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contact information:
Town:
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Kategorie:
Business News
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