LEIDEN, Netherlands and
BRIDGEWATER, New Jersey,
October 8, 2015 /PRNewswire/ --
Pharming Group NV (EURONEXT: PHARM) and Salix Pharmaceuticals
announced today that the U.S. Food and Drug Administration (FDA)
has granted 12 years of exclusivity to RUCONEST® (C1
esterase inhibitor [recombinant]) 50 IU/kg. The determination of
exclusivity ensures that FDA will not approve before July 16, 2026 any applications for biosimilars of
RUCONEST- i.e. applications for recombinant C1 esterase inhibitors
referencing RUCONEST submitted under section 351(k) of the Public
Health Service Act under the framework established by the Biologics
Price Competition and Innovation Act of 2009.
RUCONEST was approved by the FDA on July
16, 2014, for the treatment of acute angioedema attacks in
adult and adolescent patients with hereditary angioedema (HAE).
Effectiveness was not established in HAE patients with laryngeal
attacks.
A rare condition occurring in about 1 in 10,000 to 1 in 50,000
people worldwide, HAE is potentially life-threatening and stems
from a genetic defect that impacts the production of C1-INH
protein.[1] This can lead to a biochemical imbalance
that causes swelling in various parts of the body, including the
hands, feet and face.[1] Swelling in the
intestinal wall can also cause severe abdominal pain, nausea and
vomiting.[1] Due to its rarity, many patients
often remain undiagnosed for years.[1]
RUCONEST is contraindicated in patients with a history of
allergy to rabbits, or rabbit-derived products, and patients with a
history of life-threatening immediate hypersensitivity reactions to
C1 esterase preparations, including anaphylaxis.
Under the Biologics Price Competition and Innovation Act of
2009, exclusivity for licensed biologics-like RUCONEST-can be
granted for a 12-year period from the date of first licensure of
the product.
"We are pleased the anticipated exclusivity for RUCONEST has
been formally granted," said Deb
Jorn, Executive Vice President/Company Group Chairman,
Valeant Pharmaceuticals. "The response to RUCONEST has been
positive since its launch in November
2014 and we look forward to continued growth."
Sijmen de Vries, Pharming's CEO, commented: "Pharming strived to
make RUCONEST available to the HAE patient community in the US,
because we were aware of the great value and benefits that RUCONEST
could provide to patients. That the FDA granted 12 year
exclusivity for RUCONEST reinforces this long-standing commitment
and we are excited to continue to work closely with Salix to ensure
patients in the US have access to RUCONEST."
Please see Important Safety Information below and click here for
Prescribing Information. For more information on RUCONEST visit
http://www.RUCONEST.com
INDICATION:
RUCONEST® (C1 esterase inhibitor [recombinant])
is indicated for the treatment of acute attacks in adult and
adolescent patients with hereditary angioedema (HAE). Effectiveness
in clinical studies was not established in HAE patients with
laryngeal attacks.
Important Safety Information for RUCONEST
RUCONEST® (C1 esterase inhibitor [recombinant]) is not for
everyone. Do not take RUCONEST if you have a known history of
allergy to rabbits or products from rabbits. Do not take RUCONEST
if you have a history of life-threatening immediate allergic
reactions to C1 esterase inhibitor preparations, including
anaphylaxis.
If you experience hives, pale red, raised, itchy bumps
(urticaria), tightness of the chest, wheezing, low blood pressure
(hypotension), and/or anaphylaxis during or after injection of
RUCONEST, discontinue RUCONEST and immediately contact your doctor.
These may be signs and symptoms of allergic reactions.
Products similar to RUCONEST have been associated with
thromboembolic events. Before taking RUCONEST, please notify your
doctor if you have an indwelling venous catheter/access device,
history of blood clot (thrombosis), been told you have thickening
of the walls of your arteries (atherosclerosis), use oral
contraceptives (i.e. estrogen or progesterone), are extremely
overweight and have significant difficulty moving around.
If you are pregnant, planning to become pregnant, or nursing,
talk to your healthcare provider before taking RUCONEST.
The most common RUCONEST side effects in clinical studies
include: headache, nausea, and diarrhea. Serious side effect
anaphylaxis has been reported in RUCONEST clinical studies.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
http://www.fda.gov/medwatch/ , or call 1-800-FDA-1088.
For product information, adverse event reports, and product
complaint reports, please contact:
Salix Product Information Call Center
Phone: +1-800-508-0024
Fax: +1-510-595-8183
Email: Salix@medcomsol.com
Please click here for Prescribing
Information for RUCONEST.
About RUCONEST®
RUCONEST® (C1 esterase inhibitor [recombinant])
is indicated for the treatment of acute attacks in adult and
adolescent patients with hereditary angioedema (HAE). Effectiveness
in clinical studies was not established in HAE patients with
laryngeal attacks.
HAE is caused by a deficiency of the C1 esterase inhibitor
protein, which is present in blood and helps control inflammation
(swelling) and parts of the immune system. A shortage of C1
esterase inhibitor can lead to repeated attacks of swelling, pain
in the abdomen, difficulty breathing and other symptoms.
RUCONEST® contains C1 esterase
inhibitor at 50 IU/kg.
When administered at the onset of HAE attack symptoms at the
recommended dose, RUCONEST may help to return a
patient's C1-INH levels to normal range and relieve the symptoms of
an HAE attack with a low recurrence of symptoms within 24
hours.
RUCONEST is the only recombinant C1-INH approval from the
U.S. Food and Drug Administration (FDA) and was approved in
July 2014.
RUCONEST is designated as an orphan drug by the FDA for the
treatment of acute attacks of angioedema caused by hereditary or
acquired C1-INH deficiency.
About Salix Pharmaceuticals
Salix Pharmaceuticals, a division of Valeant Pharmaceuticals
International, Inc., develops and markets prescription
pharmaceutical products and medical devices for the prevention and
treatment of gastrointestinal diseases. Salix's strategy is to
in-license late-stage or marketed proprietary therapeutic products,
complete any required development and regulatory submission of
these products, and commercialize them through the Company's
specialty sales forces.
RUCONEST is a registered trademark of Pharming Group NV used
under license.
Distributed and marketed by: Salix Pharmaceuticals, a division
of Valeant Pharmaceuticals North America LLC.
©Valeant Pharmaceuticals North America LLC
RUC-US-0120
About Pharming Group NV
Pharming Group NV is developing innovative products for the
treatment of unmet medical needs. RUCONEST® (conestat alfa) is a
recombinant human C1 esterase inhibitor approved for the treatment
of angioedema attacks in patients with HAE in the USA, Israel,
all 28 EU countries plus Norway,
Iceland, and Liechtenstein.
RUCONEST is commercialized by Pharming in Austria, Germany and The
Netherlands.
RUCONEST is distributed by Swedish Orphan Biovitrum AB (publ)
(SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia, and Ukraine.
RUCONEST is partnered with Salix Pharmaceuticals, Ltd. ("Salix")
in North America. Valeant
Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX) completed
its acquisition of Salix Pharmaceuticals, Ltd. on April 1, 2015.
Pharming has a unique GMP compliant, validated platform for the
production of recombinant human proteins that has proven capable of
producing industrial volumes of high quality recombinant human
protein in a more economical way compared to current cell-based
technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe,
Fabry's and Gaucher's diseases are under early evaluation. The
platform is partnered with Shanghai Institute of Pharmaceutical
Industry (SIPI), a Sinopharm Company, for joint global development
of new products. Pre-clinical development and manufacturing will
take place at SIPI and are funded by SIPI. Pharming and SIPI
initially plan to utilise this platform for the development of
recombinant human Factor VIII for the treatment of Haemophilia A.
For more information, please visit http://www.pharming.com
Pharming Disclosure Notice
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.
(1) US Hereditary Angioedema Association. What is HAE?
http://www.haea.org/patients/what-is-hae . Accessed
7/6/2015.
Pharming Group
Sijmen de Vries, Chief Executive Officer
Tel: +31-71-5247400
FTI Consulting (Pharming media relations)
Julia Phillips / Victoria Foster Mitchell
Tel: +44-203-727 1136
Salix Media Contact:
Sarah Hamilton
Edelman Public Relations on behalf of Salix Pharmaceuticals
Tel: +1(404)460-9675 or Sarah.Hamilton@edelman.com
PRN NLD