- Roth Capital Partners and Nomura Code to assist in exploring
strategic alternatives
- Update on Study 1310
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(http://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(http://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(http://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.
# # #
Press release (PDF) :
http://hugin.info/132866/R/1619092/517074.pdf(http://hugin.info/132866/R/1619092/517074.pdf)
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(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.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1619092]
