Pharming receives positive opinion from European Medicines Agency on Rhucin
(Thomson Reuters ONE) -
Product name in Europe changed to Ruconest
Leiden, The Netherlands, June 24, 2010. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that the
European Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion on Ruconest (Rhucin) for the treatment of
acute angioedema attacks in patients with Hereditary Angioedema (HAE). With this
positive opinion, the CHMP recommends the European Commission to grant the
European Marketing Authorization (MA). The product will be marketed in the
European Union (EU) under the name Ruconest.
After review of the dossier, the CHMP has concluded that there is a favourable
benefit to risk balance for Pharming's product. It was also concluded that the
name Rhucin may lead to confusion with a similarly sounding product marketed in
some EU countries. Rhucin will therefore be marketed in the EU as Ruconest. The
CHMP will prepare an assessment report (EPAR) including the reasons for the CHMP
opinion and details of the evaluation. This report will be published on the EMA
website after the granting of the MA by the European Commission, which is
expected early September 2010.
Following the granting of the MA, Ruconest will be authorised for marketing in
all 30 countries of the European Economic Area (the EEA includes all 27 EU
countries plus Norway, Iceland and Liechtenstein). Pharming has marketing and
distribution partnerships in place covering all countries of the EEA:
Laboratorios del Dr Esteve for Spain, Portugal, Greece and Andorra, and Swedish
Orphan Biovitrum International (SOBI) for all other European countries. SOBI is
preparing the imminent launch of Ruconest in Germany and the UK. Simultaneously,
pricing and reimbursement discussions in the other European Area countries will
be initiated. SOBI estimates the current value of the European HAE market at
approximately ?110 million and sees the potential of the HAE market to increase
with the introduction of Ruconest as a new treatment alternative. Upon the
granting of the MA, SOBI will pay to Pharming an undisclosed milestone payment.
"The CHMP's positive opinion for Ruconest is a landmark event for our Company.
We have now made the final step towards validation and commercialization of our
proprietary technology. Ruconest will be the first recombinant biopharmaceutical
product from this platform to be approved in Europe and I am very proud that we
have achieved this major milestone," said Dr. Bruno Giannetti, Chief Operations
Officer of Pharming. "We are looking forward to be able to make Ruconest
available to HAE patients in the EEA. Following European approval, health care
professionals will have an innovative and highly effective product with a
favorable safety profile to treat patients with hereditary angioedema."
Conference call information
Chief Executive Officer Sijmen de Vries will discuss this opinion on Ruconest
and next steps in a conference call for press and analysts at 5.15 pm 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
Following a short introduction, the lines will be opened for a question and
answer session. An audio cast of the conference calls will be available on
Pharming's website shortly thereafter.
About Ruconest (Rhucin)
Ruconest (INN conestat alfa) is a recombinant version of the human C1 inhibitor
(C1INH) protein for acute treatment of Hereditary Angioedema (HAE) attacks. The
product is produced through Pharming's proprietary technology. 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. Ruconest holds an orphan drug
designation both from the US FDA and EMA.
About Hereditary Angioedema
Hereditary Angioedema (HAE) is a debilitating and potentially life-threatening
genetic condition, resulting in spontaneous and recurring attacks of angioedema.
Angioedema attacks are characterized by swelling of soft tissue in a reaction
visually similar to severe allergic reactions. Attacks may affect various
locations such as the intestines, the face, extremities or mouth and throat.
Without treatment, attacks progress during the first 24 hours and then subside
over another two to five days. Attacks are painful and disfiguring and cause
significant morbidity. In addition to the life-threatening nature of the
disease, quality of life for individuals with the disease may be seriously
impaired.
HAE is caused by the lack or deficiency of endogenous C1INH activity, which
results in an overreaction of the immune system. Patients typically present in
late childhood, with the mean onset at 11 years. The prevalence of HAE is
approximately 1 in 30.000 individuals. The frequency of attacks varies
significantly in the affected population. Current treatment options include
prophylactic treatment with tranexamic acid and androgens, which may reduce the
frequency of attacks. The average frequency even under such anabolic steroid
prophylaxis is still estimated to be 6-8 treatment requiring attacks per year.
For the treatment of acute attacks, the current standard of care in Europe is
plasma derived C1 inhibitor from human donors. Swedish Orphan Biovitrum
International estimates the current value of the European HAE market to
approximately ?110 million and sees the potential of the HAE market to increase
with the introduction of Rhucin® as one of several new treatment alternatives.
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. Following a positive opinion from the European authorities
(EMA's CHMP), Pharming's lead product Ruconest (Rhucin) for acute HAE attacks is
awaiting the EU Marketing Authorization. The product is also under development
for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed
graft function (DGF) following kidney transplantation. Prodarsan® - a product
under development by Pharming's subsidiary DNage - is in early stage clinical
development for Cockayne Syndrome and lactoferrin for use in food products. 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.
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.
Contact:
Ms. Marjolein van Helmond, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54
[HUG#1427079]
Press release (PDF): http://hugin.info/132866/R/1427079/374756.pdf
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(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: 24.06.2010 - 16:21 Uhr
Sprache: Deutsch
News-ID 22992
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