Pharming's Ruconest(TM) for HAE granted European Marketing Authorization
Leiden, The Netherlands, and Stockholm, Sweden October 28, 2010. Biotech
company Pharming Group NV (Pharming or "the Company") (NYSE Euronext: PHARM) and
Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced that the European
Commission has granted Pharming Marketing Authorization for its lead product
Ruconest(TM) for the treatment of acute attacks of Hereditary Angioedema (HAE).
Pharming will now receive a €5 million milestone payment from marketing and
distribution partner Sobi.
Following the unanimous positive opinion adopted by the Committee for Medicinal
Products for Human Use (CHMP), Ruconest's Marketing Authorization has now been
ratified by the European Committee.
Patients suffering from HAE experience unpredictable, painful and debilitating
attacks, due to reduced levels of C1 inhibitor, resulting in intense swelling of
parts of the body (for example, face, throat, abdomen) which can last up to five
days if left untreated. Ruconest is a recombinant version of the human C1
inhibitor protein, produced by Pharming's proprietary transgenic technology. As
published in last October's issue of the Journal of Allergy and Clinical
Immunology, Ruconest has been shown to have excellent efficacy and safety.
Pharming has withdrawn the orphan status application in order to avoid delays in
commercializing the product.
Dr Marco Cicardi, MD, Professor of Internal Medicine at the University of Milan,
Italy, said: "Patients with HAE experience an average of eight attacks a year.
This distressing and potentially life-threatening condition requires new
approaches for acute treatment and Ruconest offers this. This recombinant
product is the only HAE treatment achieving circa 90% of success in treating
attacks."
Ruconest is now approved for use in the 27 EU countries plus Norway, Iceland and
Liechtenstein. Sobi will launch Ruconest initially in Germany, the UK, Sweden,
Finland and Denmark, followed by a rolling launch in each of the other European
Area countries.
Sijmen de Vries, CEO of Pharming: "The granting of marketing authorization for
Ruconest(TM) is a very important step in Pharming's evolution from a drug
development company to a commercial specialty pharmaceutical business. Together
with our marketing partners, we look forward to the launch of Ruconest this year
and making this novel new treatment available to the European HAE population. I
would also like to thank the many European physicians and patients who
participated in our clinical trial program with Ruconest."
"Ruconest has the potential to offer patients with significant medical needs a
safe and valuable alternative treatment. Moreover, it is a good fit with Sobi's
commercial portfolio of rare disease products. We are very much looking forward
to exciting fruitful partnership with Pharming and the opportunity to provide
this new exciting product to patients who need it in Europe," said Martin
Nicklasson, CEO of Sobi.
Conference call information
Pharming's management team will be available for questions on today's marketing
approval of Ruconest in a conference call tomorrow, October 29, at 8:30 am CET.
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 website
shortly thereafter.
About Ruconest (Rhucin in non-European countries)
Ruconest (INN conestat alfa) is a recombinant version of the human C1 inhibitor
(C1INH) protein. The product is produced through Pharming's proprietary
technology in milk of transgenic rabbits. Ruconest has identical amino acid
sequence as endogenous human C1INH. The safety and efficacy of Ruconest has been
demonstrated in two placebo controlled and four open-label studies. Both
randomized placebo-controlled clinical trials showed statistically significant
and clinically relevant improvement in time to relief of symptoms and time to
minimal symptoms compared to placebo.
The European public assessment report (EPAR) for Ruconest will be published on
the EMA website. It explains how the CHMP assessed Ruconest and its
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 lacks a
functional plasma protein C1 inhibitor, resulting in an overreaction of the
immune system. The disease is characterized by unpredictable and debilitating
episodes of intense swelling of the extremities, face, trunk, genitals, abdomen
and upper airway, which may last up to five days when untreated. In addition to
the life-threatening nature of the disease in case of laryngeal attacks, quality
of life for individuals with the disease may be seriously impaired.
Approximately one in 30,000 individuals (1:10,000 - 1:50,000) suffers from HAE
with an average of approximately eight acute attacks per year.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical
company with an international market presence. The company is focused on
providing and developing specialist pharmaceuticals for rare disease patients
with high medical needs. The portfolio consists of about 60 marketed products
and an emerging late stage clinical development pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and
inherited metabolic disorders. Swedish Orphan Biovitrum had pro-forma revenues
2009e of about 2 BSEK and approximately 500 employees. The head office is
located in Sweden and the share (STO: SOBI) is listed on NASDAQ OMX Stockholm.
For more information please visitwww.sobi.com.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, specialty products for surgical indications, and nutritional
products. Pharming's lead product Ruconest(TM) (Rhucin in non-EU territories)
has Market Authorization in the European Economic Area. 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
technologies of the Company include innovative platforms for the production of
protein therapeutics, including technology and processes for the purification
and formulation of these products. Additional information is available on the
Pharming websitewww.pharming.com.
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.
Swedish Orphan Biovitrum may be required to disclose the information provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on October 28, 2010 at 16:30 a.m. CET.
For more information please contact:
Swedish Orphan Biovitrum: Pharming Group NV:
Erik Kinnman, VP Investor Relations Marjolein van Helmond
Phone: +46 73 422 15 40 Phone: +31 71 52 47 431
erik.kinnman@sobi.com Mobile: +31 6 109 299 54
m.vanhelmond@pharming.com
Martin Nicklasson, CEO
Phone: +46 8 697 20 00 Financial Dynamics:
Julia Phillips,
Phone: +44 20 7269 7187
John Dineen
+44 20 7269 7193
[HUG#1456753]
Press release (PDF):
http://hugin.info/132866/R/1456753/396590.pdf
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Source: Pharming Group N.V. via Thomson Reuters ONE