LEIDEN, NETHERLANDS--(Marketwire - October 28, 2010) -
Leiden, The Netherlands, and Stockholm, Sweden October 28, 2010.
company Pharming Group NV (Pharming or "the Company") (NYSE Euronext: PHARM) and
Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced that the
Commission has granted Pharming Marketing Authorization for its lead
Ruconest™ for the treatment of acute attacks of Hereditary Angioedema
Pharming will now receive a EUR5 million milestone payment from
distribution partner Sobi.
Following the unanimous positive opinion adopted by the Committee for
Products for Human Use (CHMP), Ruconest's Marketing Authorization has now
ratified by the European Committee.
Patients suffering from HAE experience unpredictable, painful and
attacks, due to reduced levels of C1 inhibitor, resulting in intense
parts of the body (for example, face, throat, abdomen) which can last up to
days if left untreated. Ruconest is a recombinant version of the
inhibitor protein, produced by Pharming's proprietary transgenic
published in last October's issue of the Journal of Allergy and
Immunology, Ruconest has been shown to have excellent efficacy and
Pharming has withdrawn the orphan status application in order to avoid
commercializing the product.
Dr Marco Cicardi, MD, Professor of Internal Medicine at the University of
Italy, said: "Patients with HAE experience an average of eight attacks a
This distressing and potentially life-threatening condition requires
approaches for acute treatment and Ruconest offers this. This
product is the only HAE treatment achieving circa 90% of success in
Ruconest is now approved for use in the 27 EU countries plus Norway,
Liechtenstein. Sobi will launch Ruconest initially in Germany, the UK,
Finland and Denmark, followed by a rolling launch in each of the other
Sijmen de Vries, CEO of Pharming: "The granting of marketing
Ruconest™ is a very important step in Pharming's evolution from a
development company to a commercial specialty pharmaceutical business.
with our marketing partners, we look forward to the launch of Ruconest this
and making this novel new treatment available to the European HAE
would also like to thank the many European physicians and
participated in our clinical trial program with Ruconest."
"Ruconest has the potential to offer patients with significant medical
safe and valuable alternative treatment. Moreover, it is a good fit with
commercial portfolio of rare disease products. We are very much looking
to exciting fruitful partnership with Pharming and the opportunity to
this new exciting product to patients who need it in Europe," said
Nicklasson, CEO of Sobi.
Conference call information
Pharming's management team will be available for questions on today's
approval of Ruconest in a conference call tomorrow, October 29, at 8:30 am
To participate in the call, please call one of the following numbers:
- From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6901
- From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027
An audio cast of the conference calls will be available on Pharming's
About Ruconest (Rhucin in non-European countries)
Ruconest (INN conestat alfa) is a recombinant version of the human C1
(C1INH) protein. The product is produced through Pharming's
technology in milk of transgenic rabbits. Ruconest has identical amino
sequence as endogenous human C1INH. The safety and efficacy of Ruconest has
demonstrated in two placebo controlled and four open-label studies.
randomized placebo-controlled clinical trials showed statistically
and clinically relevant improvement in time to relief of symptoms and
minimal symptoms compared to placebo.
The European public assessment report (EPAR) for Ruconest will be
the EMA website. It explains how the CHMP assessed Ruconest and
recommendations on the conditions for use of Ruconest.
About Hereditary Angioedema
HAE is a human genetic disorder in which the patient is deficient in or
functional plasma protein C1 inhibitor, resulting in an overreaction
immune system. The disease is characterized by unpredictable and
episodes of intense swelling of the extremities, face, trunk, genitals,
and upper airway, which may last up to five days when untreated. In
the life-threatening nature of the disease in case of laryngeal attacks,
of life for individuals with the disease may be seriously
Approximately one in 30,000 individuals (1:10,000 - 1:50,000) suffers
with an average of approximately eight acute attacks per year.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty
company with an international market presence. The company is
providing and developing specialist pharmaceuticals for rare disease
with high medical needs. The portfolio consists of about 60 marketed
and an emerging late stage clinical development pipe-line. Our focus areas
hemophilia, inflammation/autoimmune diseases, fat malabsorption,
inherited metabolic disorders. Swedish Orphan Biovitrum had pro-forma
2009e of about 2 BSEK and approximately 500 employees. The head
located in Sweden and the share (STO: SOBI) is listed on NASDAQ OMX
For more information please visitwww.sobi.com.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of
disorders, specialty products for surgical indications, and
products. Pharming's lead product Ruconest™ (Rhucin in non-EU
has Market Authorization in the European Economic Area. The product is
under development for follow-on indications, i.e. antibody-mediated
(AMR) and delayed graft function (DGF) following kidney
technologies of the Company include innovative platforms for the
protein therapeutics, including technology and processes for the
and formulation of these products. Additional information is available
This press release contains forward looking statements that involve
unknown risks, uncertainties and other factors, which may cause the
results, performance or achievements of the Company to be materially
from the results, performance or achievements expressed or implied by
forward looking statements.
Swedish Orphan Biovitrum may be required to disclose the information
herein pursuant to the Swedish Securities Markets Act. The
provided for public release on October 28, 2010 at 16:30 a.m. CET.
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Source: Pharming Group N.V. via Thomson Reuters ONE