Pharming Provides Business Update at UBS Conference
Database for Rhucin® Significantly Expanded
Leiden, The Netherlands, September 22, 2008. Biotech company
Pharming Group NV ("Pharming" or "The Company") (Euronext: PHARM)
today announced that Dr. Francis J. Pinto, CEO will provide a
business update during the UBS Global Life Sciences Conference in New
York City.
During the presentation of Dr. Pinto, which will be available on
Pharming's website, data will be shown that illustrate the marked
progress made over the last few months in the development of its late
stage product, Rhucin®. In particular, much focus was given on the
analysis of patients receiving repeat treatments of Rhucin® and
patients suffering from severe attacks which were of concern to
regulatory authorities earlier this year.
In the data presented, Pharming has shown that over 300
administrations of Rhucin® have now been analyzed, with more than
half in repeat treatments. One patient received 12 administrations so
far. There was no sign of any relevant safety issues in these repeat
treatments and the efficacy remains excellent. The database on very
severe attacks has also been expanded to include now seven laryngeal
attacks, which have all been successfully treated with Rhucin®. In
all treatments performed with Rhucin® in patients so far, no allergic
reaction has been observed.
Pharming believes that it has successfully addressed the concerns
raised by Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency (EMEA). In its opinion in March 2008,
the CHMP requested a larger clinical database to ensure the safety
and efficacy of the product upon repeat use. The committee also paid
attention to potential allergic reactions and the risk/benefit ratio
in severe attacks (especially of the larynx).
Dr Francis J. Pinto, Chief Executive Officer, commented: "We are very
excited about the progress made over the last few months in our
Rhucin® program. The database is now much stronger and larger than at
the time of our initial filing at the EMEA about two years ago. In
particular we have been able to address the issues raised by the
European Authorities in a very promising way thereby generating data
that confirm the effectiveness and safety of Rhucin® in repeat use.
We are convinced that we now have an improved and very strong data
package supporting the upcoming registration files. We are in
discussions with the relevant authorities regarding the submission of
our data packages which we hope to complete as soon as practically
possible."
Pharming is planning to submit the Biological License Application
(BLA) for Rhucin® with the US Food and Drug Administration (FDA) by
the end of the year. The Company expects to follow the BLA filing
with its Market Authorization Application for Rhucin® to EMEA shortly
thereafter.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment
of genetic disorders, ageing diseases, specialty products for
surgical indications, intermediates for various applications and
nutritional products. Pharming has two products in late stage
development - Rhucin® for Hereditary Angioedema and human 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). Additional information is available on the
Pharming website, http://www.pharming.com and on http://www.dnage.nl.
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:
Carina Hamaker, Investor Voice, T: +31 (0)6 537 499 59 or T: +31
(0)71 52 47 400
Julia Philips (UK), Financial Dynamics, T: +44 (0)20 7269 7187 or T:
+44 (0)7770 827 263
Samir Singh (US), Pharming Group NV, T: +1 908 720 6224
Rein Strijker, Pharming Group NV, T: +31 (0)71 52 47 400