PHARMING UNDERTAKES REVIEW OF STRATEGIC OPTIONS
(Thomson Reuters ONE) -
- Roth Capital Partners and Nomura Code to assist in exploring strategic
alternatives
- Update on Study 1310
Leiden, The Netherlands, June 12, 2012. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that it has
engaged Roth Capital Partners and Nomura Code to assist it in exploring
strategic alternatives and provides an update on Study 1310 for Ruconest.
As the European capital markets continue to be challenging for Life Science
companies, Pharming's Board and management team have engaged Nomura Code
alongside long term advisor, Roth Capital Partners, to assist in a review of
strategic options which could include a merger, equity investment or sale. No
decision has been made to enter into any specific transaction at this time and
there is no certainty that Pharming will enter into a transaction in the future.
This review will be accompanied by additional cost containment measures and the
ongoing discussions on platform technology collaborations. We expect to be able
to update the market in Q3, 2012. Recruitment for Pharming's Study 1310, the
US pivotal trial for Ruconest is ongoing (68 patients recruited to date) and it
is expected that full enrollment (75 patients) could be achieved within the next
few weeks, in line with expectations. However, an internal oversight has
recently come to our attention that could potentially delay the unblinding of
the top-line data by up to three months in order to complete the statistical
package required by the FDA. This matter is currently being investigated.
The potential delay relates to the final step to completion of the trial
consists of an additional blinded follow up period of up to 90 days, depending
on when patients experience a subsequent attack. Once the last patient has
completed the blinded follow-up period (experienced an attack or reached the 90
day mark), the data base will be locked and data analysis will begin. Our
experience with this trial is that participating patients are typically having a
subsequent attack significantly sooner than 90 days, which means that locking
of the data base and top-line results would still become available in Q3,
2012, however if the last patient entering the trial takes the full 90 days
then top line results will be in Q4 2012.
Completion of Study 1310 and read-out of the top-line results will, if
positive, trigger a US$10 million milestone payment from Pharming's US partner
Santarus Inc.
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 of HAE, a genetic disorder in which the
patient is deficient in or lacks a functional plasma protein C1 inhibitor,
resulting in unpredictable and debilitating 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® 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 (OMX: SOBI). RUCONEST(®) is partnered with Santarus, Inc
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III clinical
development. The product is also being evaluated for follow-on indications in
the areas of transplantation and reperfusion injury. The advanced technologies
of the Company include innovative and validated platforms for the production of
protein therapeutics, technology and processes for the purification and
formulation of these products. A feasibility study, using the validated
transgenic rabbit platform, aimed at the development of recombinant Factor VIII
for the treatment of Haemophilia A is underway with partner, Renova Life, Inc.
Additional information is available on the Pharming website, www.pharming.com.
To download the Pharming Group Investor Relations App, click here.
About Roth Capital Partners
Roth is an investment banking firm dedicated to the small-cap public market. The
Investment Banking Group focuses on identifying and financing emerging growth
companies as they expand and develop into tomorrow's market leaders. ROTH
provides emerging growth companies with ready access to the capital markets and
a wide variety of financial advisory services. By focusing exclusively on
emerging growth companies, ROTH has developed an unparalleled understanding of
these companies, their entrepreneurial managers and their highly specialized
financing needs. Additional information is available on the Roth website,
www.roth.com.
About Nomura Code
Nomura Code is a full service investment bank providing expertise to small and
medium sized companies in three sectors of industry: Healthcare, Clean
Technology and Technology. Nomura Code is a wholly owned autonomous subsidiary
of Nomura Europe Holdings and benefits from its parent's multinational presence
and its larger company capabilities. Nomura Code's team of thirty professionals
offers sector-specific services in Corporate Finance, Research, Institutional
Sales and Market Making. Focussing on just three industry sectors allows Nomura
Code to provide an in-depth knowledge and understanding of its clients'
businesses. Additional information is available on the Nomura Code website,
www.nomuracode.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 (0)71 524 7400
Karl Keegan, CFO: T: +31 (0)71 524 7400
FTI Consulting
Julia Phillips, T: +44 (0)207 269 7187
John Dineen, T: +44 (0)207 269 7193
# # #
Press release (PDF) :
http://hugin.info/132866/R/1619092/517074.pdf
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originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1619092]
Unternehmensinformation / Kurzprofil:
Datum: 12.06.2012 - 13:31 Uhr
Sprache: Deutsch
News-ID 155642
Anzahl Zeichen: 8086
contact information:
Town:
Leiden
Kategorie:
Business News
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