Pharming Announces Receipt Of US$10 Million Milestone Payment
Leiden, The Netherlands, November, 26, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that following the announcement by Pharming and Santarus on November 7, 2012 that the pivotal Phase III clinical study of RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met its primary endpoint, and in accordance with the terms of the license agreement between Pharming and Santarus, a US$10 million milestone has now been paid to Pharming.
An additional US$5 million milestone will be payable to Pharming upon U.S. Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA) for review. Pharming and Santarus expect to submit the BLA for RUCONEST to the FDA in the first half of 2013.
Sijmen de Vries, Pharming CEO, commented: “We are pleased to have received this US$10 million milestone from our partner Santarus, which significantly strengthens our balance sheet and signals the beginning of a new chapter in the development of the Company.”
About RUCONEST® and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the
human protein C1 inhibitor (C1INH). RUCONEST is produced through
Pharming’s proprietary technology in milk of transgenic
rabbits and is approved in Europe for treatment of acute angioedema
attacks in patients with HAE. RUCONEST® is an investigational
drug in the U.S. and has been granted orphan drug designation for
the treatment of acute attacks and prophylaxis of HAE, a genetic
disorder in which the patient is deficient in or lacks a functional
plasma protein C1 inhibitor, resulting in unpredictable and debil
itating episodes of intense swelling of the extremities, face,
trunk, genitals, abdomen and upper airway. The frequency and
severity of HAE attacks vary and are most serious when they involve
laryngeal edema, which can close the upper airway and cause death
by asphyxiation. According to the U.S. Hereditary Angioedema
Association, epidemiological estimates for HAE range from one in
10,000 to one in 50,000 individuals.
About Pharming Group NV
Pharming Group NV is developing innovative products for the
treatment of unmet medical needs. RUCONEST® (RHUCIN® in
non-European territories) is a recombinant human C1 inhibitor
approved for the treatment of angioedema attacks in patients with
HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein,
and is distributed in the EU by Swedish Orphan Biovitrum.
Rhucin® is partnered with Santarus Inc (NASDAQ: SNTS) in North
America where the drug has completed Phase III clinical
development. The product is also being evaluated for various
follow-on indications. Pharming has a unique GMP compliant,
validated rabbit platform for the production of recombinant human
proteins that, with the EU approval of Pharming’s rhC1
inhibitor, has proven capable of producing industrial volumes of
high quality recombinant human protein in a significantly more
economical way through low upfront capital investment and
manufacturing costs, compared to current cell based technologies.
Pharming now plans to utilise this platform for the development of
rhFVIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website, 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
Pharming
Sijmen de Vries, CEO: T: +31 524 7400
FTI Consulting
Julia Phillips/ John Dineen, T: +44 (0)207 269 7193
Posted: November 2012
