PARIS & LAGUNA NIGUEL, Calif.–(Business Wire)–
Regulatory News:
Ipsen (Euronext : FR0010259150; IPN) and Inspiration Biopharmaceuticals, Inc.
(Inspiration) announced today that the Committee for Orphan Medicinal Products
of the European Medicines Agency has issued a positive opinion on the granting
of orphan drug status for OBI-1 for the treatment of hemophilia. Final adoption
of the opinion is expected from the European Commission later this year and
subject to it being finally granted, the orphan drug status would trigger a
10-year market exclusivity to OBI-1 in the European Union after its marketing
approval. The FDA also issued an Orphan Drug Designation for OBI-1 in March
2004.
Jean-Luc Bélingard, Chairman and Chief Executive Officer of Ipsen said: “Our
transaction with Inspiration in late January of this year expresses Ipsen`s long
term strategy to create a world leading hemophilia franchise. We are honored
that the Committee for Orphan Medicinal Products of the European Medicines
Agency shares our view of the medical benefit provided by OBI-1 to the
hemophilia community.”
John Taylor, Co-Founder and Chairman of Inspiration added: “We are pleased with
the continued progress of OBI-1 as a new, innovative therapy in the treatment of
unmet medical needs in hemophilia.”
About Hemophilia
Hemophilia, congenital or acquired, is a bleeding disorder caused by low levels
or absence of a protein called a coagulation factor, essential for blood
clotting. The two most common forms of hemophilia are types A and B. Hemophilia
A is caused by a factor VIII deficiency and occurs in ~1 out of every 5,000 male
births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of
every 30,000 male births. Approximately 60% of persons with hemophilia have a
severe condition, which results in frequent spontaneous bleeding episodes in
addition to serious bleeding after injuries. The market for hemophilia treatment
is 7.5 billion dollars annually.
About OBI-1
About a third of patients with congenital hemophilia A and patients with
acquired hemophilia develop an immune reaction to human forms of FVIII (hFVIII)
and can no longer respond to human Factor VIII. Since OBI-1 possesses low cross
reactivity to anti-hFVIII antibodies, it is expected that OBI-1 can provide
therapeutic benefits to patients who are not able to use hFVIII.
OBI-1, a recombinant B-domain deleted FVIII bioengineered for low cross
reactivity to anti-human FVIII inhibitors based on the porcine amino acid
sequence, has recently been tested in a Phase II trial. OBI-1 was administered
to patients with congenital hemophilia A complicated by the presence of human
FVIII inhibitors experiencing a non-life/non-limb threatening bleed. A total of
25 bleeding episodes in 9 patients were treated with OBI-1, and all were
successfully controlled. One subject had a mild infusion reaction andwhen
re-treated for a subsequent bleed the subject did not report any adverse event.
Eight out of nine (89%) subjects developed anti-pFVIII antibodies following
exposure to OBI-1 and in subjects receiving repeated OBI-1 treatment higher
anti-pFVIII titres did not affect efficacy or safety. The study demonstrated
that OBI-1 is well-tolerated and can be given as a short infusion. OBI-1 is
expected to enter phase III in 2010.
About Ipsen
Ipsen is a global biopharmaceutical group with total sales in excess of 1
billion euros in 2009, and total worldwide staff of more than 4,400. Its
strategy is based on fast growing specialty care drugs in oncology,
endocrinology, neurology and hematology, and primary care drugs, which
significantly contribute to research financing. This strategy is also supported
by an active policy of partnerships. Ipsen`s specific Research & Development
(R&D) centers and peptide & protein engineering platform give the Group a
competitive edge. Nearly 900 people are dedicated to the discovery and
development of innovative drugs for patient care. Nearly 900 people are
dedicated to the discovery and development of innovative drugs for patient care.
In 2009, R&D spend reached close to €200 million, representing more than 19% of
total Group sales. Ipsen`s shares are traded on Segment A of Euronext Paris
(stock code: IPN, ISIN code: FR0010259150). Ipsen`s shares are eligible to the
“Service de Règlement Différé” (“SRD”) and the Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary Receipt
(ADR) program, which trade on the over-the-counter market in the United States
under the symbol IPSEY. For more information on Ipsen, visit our website at
www.ipsen.com.
About Inspiration Biopharmaceuticals
Inspiration Biopharmaceuticals was founded in 2004 with the mission to
revolutionize treatments for hemophilia. The Company is focused on developing
products that have the potential to broaden patient access to therapy, including
prophylactic use. Greater access and more frequent prophylactic therapy have
been shown to reduce complications of the disease and enhance patients’
long-term health and quality of life. Underlying the Company’s programs is a
novel, proprietary manufacturing technology that allows a greater yield of
high-quality protein. Inspirations` lead product candidate, IB1001 is an
intravenous recombinant factor IX product for the acute and preventative
treatment of bleeding in patients with hemophilia B. The development of
Inspiration`s lead product, IB1001 for the treatment of Hemophilia B and its
earlier stage coagulation factor product candidates have been partially funded
to date by Celtic Pharma, a global private equity and drug development firm.
Inspiration is utilizing its proprietary technology to develop a broad portfolio
of hemophilia and bleeding disorder products that address a $7.5 billion market
worldwide, which has grown historically at a 12% CAGR. With over 130 years of
combined management experience in commercializing hemophilia products at firms
such as Baxter and Bayer, Inspiration has been able to rapidly and efficiently
develop protein therapeutics for hemophilia.
Ipsen`s Forward Looking Statement
The forward-looking statements, objectives and targets contained herein are
based on the Group`s management strategy, current views and assumptions. Such
statements involve known and unknown risks and uncertainties that may cause
actual results, performance or events to differ materially from those
anticipated herein. Moreover, the targets described in this document were
prepared without taking into account external growth assumptions and potential
future acquisitions, which may alter these parameters. These objectives are
based on data and assumptions regarded as reasonable by the Group. These targets
depend on conditions or facts likely to happen in the future, and not
exclusively on historical data. Notably, future currency fluctuations may
negatively impact the profitability of the Group and its ability to reach its
objectives. Actual results may depart significantly from these targets given the
occurrence of certain risks and uncertainties. The Group does not commit nor
gives any guarantee that it will meet the targets mentioned above. Furthermore,
the Research and Development process involves several stages each of which
involve the substantial risk that the Group may fail to achieve its objectives
and be forced to abandon its efforts with regards to a product in which it has
invested significant sums. Therefore, the Group cannot be certain that
favourable results obtained during pre-clinical trials will be confirmed
subsequently during clinical trials, or that the results of clinical trials will
be sufficient to demonstrate the safe and effective nature of the product
concerned. The Group also depends on third parties to develop and market some of
its products which could potentially generate substantial royalties; these
partners could behave in such ways which could cause damage to the Group`s
activities and financial results. The Group expressly disclaims any obligation
or undertaking to update or revise any forward looking statements, targets or
estimates contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such statements are based,
unless so required by applicable law. The Group`s business is subject to the
risk factors outlined in its registration documents filed with the French
Autorité des Marchés Financiers.
Ipsen
Media
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 58 33 51 16
Fax: +33 (0)1 58 33 50 58
E-mail: didier.veron@ipsen.com
or
Financial Community
David Schilansky
Vice President Finance
Tel.: +33 (0)1 58 33 51 30
Fax: +33 (0)1 58 33 50 63
E-mail: david.schilansky@ipsen.com
or
Pierre Kemula
Investor Relations Officer
Tel.: +33 (0)1 58 33 60 08
Fax: +33 (0)1 58 33 50 63
E-mail: pierre.kemula@ipsen.com
or
Inspiration
Media
Kathy Nugent, Ph.D.
Burns McClellan
Tel : +1-205-401-0260
Email: knugent@burnsmc.com
or
Company
Alison Arter
Senior V.P. and Chief Commercial Officer
Tel: +1-919-360-8611
Email: aarter@InspirationBio.com
Copyright Business Wire 2010