Pharming signs commercialization agreement with Santarus for Rhucin® in North America
(Thomson Reuters ONE) -
Leiden, The Netherlands, September 13, 2010. Biotech company Pharming Group NV
("Pharming") (NYSE Euronext: PHARM) today announced that it has entered into an
agreement with specialty biopharmaceutical company Santarus, Inc ("Santarus")
(NASDAQ: SNTS) for the commercialization of Rhucin® (recombinant human C1
inhibitor; Ruconest(TM) in Europe) in North America (the United States, Canada
and Mexico) for the treatment of acute angioedema attacks in patients with
Hereditary Angioedema (HAE) and other future indications.
Under the agreement, Santarus will pay Pharming a USD 15 million upfront fee
upon signing. Furthermore, Santarus will pay a USD 5 million milestone payment
upon acceptance of the Rhucin Biologic License Application (BLA) by the US Food
and Drug Administration (FDA). Additional payments are payable upon completing
clinical and commercial milestones. Santarus will purchase its commercial supply
of Rhucin from Pharming at a tiered supply price, based on a percentage of net
sales of Rhucin.
Pharming is responsible under the agreement for the clinical development of
Rhucin for HAE and all HAE related regulatory activities in the US, whereas
Santarus will be responsible for regulatory approval in Canada and Mexico. In
addition, Santarus and Pharming will share responsibility and costs for the
clinical development of Rhucin for the treatment or prevention of renal
transplantation rejection. Santarus will be responsible for related regulatory
activities in North America.
Sijmen de Vries, CEO of Pharming commented, "We are excited to have taken a
significant step closer to making Rhucin, an innovative, highly effective and
safe replacement therapy, available for HAE patients in North Amercia. In
Santarus we have a commercialization partner with a proven track record in
clinical development and commercialization of high value pharmaceutical
products. We are confident that they will provide a sound commercialisation
platform for Rhucin in North America. We also look forward to working with
Santarus on developing Rhucin in its next indication .
Rhucin® (recombinant human C1 esterase inhibitor, Ruconest in Europe) is a human
protein developed through Pharming's proprietary technology where the human
protein is expressed in milk of transgenic rabbits. Pharming is developing
Rhucin/Ruconest for treatment of patients with acute attacks of Hereditary
Angioedema (HAE). HAE is a human genetic disorder in which the patient is
deficient in or lacks a functional plasma protein C1-inhibitor, resulting in an
overreaction of the immune system. The disease is characterized by unpredictable
and debilitating episodes of intense swelling of the extremities, face, trunk,
genitals, abdomen and upper airway, which may last up to five days when
untreated. In addition to the life-threatening nature of the disease in case of
laryngeal attacks, quality of life for individuals with the disease may be
seriously impaired. Approximately one in 30,000 individuals (1:10,000 -
1:50,000) suffers from HAE with an average of approximately eight acute attacks
per year.
Conference call information
Pharming has scheduled a conference call regarding this announcement for
analysts at 9:30 am CET and for press at 11:00 am CET. To participate, please
call one of the following numbers:
Analyst call (conference ID 4364219):
* From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6902
* From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027
* From the US: +1 877 941 2930 (toll-free) or +1 480 629 9726
Press call (conference ID 4364227):
* From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6902
* From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027
* From the US: +1 877 941 2928 (toll-free) or +1 480 629 9725
An audio cast of the conference calls will be available on Pharming's website
shortly thereafter.
About Santarus, Inc
Santarus, Inc is a specialty biopharmaceutical company focused on acquiring,
developing and commercializing proprietary products that address the needs of
patients treated by gastroenterologists, endocrinologists and other physicians.
The company's current commercial efforts are focused on GLUMETZA((R) )(metformin
hydrochloride extended release tablets) and CYCLOSET((R)) (bromocriptine
mesylate) tablets, which are indicated as adjuncts to diet and exercise to
improve glycemic control in adults with type 2 diabetes. Santarus is also
developing two late-stage GI product candidates, budesonide MMX((R)) and
rifamycin SV MMX((R)), for the US market. Budesonide MMX is being investigated
in a Phase III clinical program for the induction of remission of mild or
moderate active ulcerative colitis. Santarus began Phase III clinical testing of
rifamycin SV MMX in patients with travelers' diarrhea in the second quarter of
2010. More information about Santarus is available on the company's website at
www.santarus.com.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic
disorders, specialty products for surgical indications, and nutritional
products. On June 24, the European Medicines Agency adopted a positive opinion
for Ruconest(TM) (Rhucin® in non-EU territories) for the treatment of angioedema
attacks. Market Authorization in the European Economic Area is therefore
expected imminently with an anticipated market launch in the fourth quarter
2010. The product is also under development for follow-on indications, i.e.
antibody-mediated rejection (AMR) and delayed graft function (DGF) following
kidney transplantation. 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. In July, the
partial spin-off of DNage was completed. 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:
Ms. Marjolein van Helmond, Manager Corporate Communications, T: +31(0)715247431
or +31(0)610929954
[HUG#1443965]
Press release (PDF):
http://hugin.info/132866/R/1443965/387851.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
Unternehmensinformation / Kurzprofil:
Datum: 13.09.2010 - 08:00 Uhr
Sprache: Deutsch
News-ID 42210
Anzahl Zeichen: 0
contact information:
Town:
Leiden
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 173 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Pharming signs commercialization agreement with Santarus for Rhucin® in North America"
steht unter der journalistisch-redaktionellen Verantwortung von
Pharming Group N.V. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
