Pharming Undertakes Review Of Strategic Options
Roth Capital Partners and Nomura Code to assist in exploring strategic alternatives
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. Th is 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 (expe rienced 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
at tacks 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 pa tients 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 Ro th 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
Posted: June 2012
