TIDMMPH
RNS Number : 7241C
Mereo BioPharma Group plc
30 June 2016
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Mereo BioPharma Group plc
MEREO'S BPS-804 GRANTED EU ORPHAN DRUG STATUS FOR OSTEOGENESIS
IMPERFECTA
London, 30 June 2016 - Mereo BioPharma Group plc ("Mereo" or the
"Company") (AIM:MPH), a clinical stage, UK-based, biopharmaceutical
company focused on rare and specialty diseases, is pleased to
announce that the European Commission (EC) has granted BPS-804
orphan drug designation for the treatment of osteogenesis
imperfecta (OI), a rare, chronic genetic disorder that results in
bones that can break easily. The Company intends to initiate a
potential registration trial of BPS-804 in the second half of
2016.
In March 2016, BPS-804 was granted orphan drug designation for
the treatment of OI by the U.S. Food and Drug Administration
(FDA).
OI is a rare condition that is estimated to affect a minimum of
approximately 20,000 and possibly as many as 50,000 patients in the
United States. In Europe, approximately 7.5 out of 100,000 people
have the condition. Current treatment largely relies on the acute
management of fractures as they occur and the use of bisphosphonate
drugs, although the Company believes there is no clear data
demonstrating that bisphosphonate drugs reduce fractures. BPS-804
aims to demonstrate a benefit compared to placebo in terms of
fractures in OI patients. BPS-804 works by inhibiting sclerostin,
which inhibits the activity of bone-forming cells, known as
osteoblasts. The Company believes that by blocking sclerostin,
BPS-804 will induce or increase osteoblast function and maturation
of these cells, increasing bone formation and reducing bone
resorption, thereby reducing fractures in OI patients. Phase 2
proof of concept data in OI patients demonstrated a statistically
significant improvement in bone biomarkers and bone mineral
density.
Commenting on today's announcement, Dr Denise Scots-Knight, CEO
of Mereo said:
"Osteogenesis imperfecta is a debilitating and painful disease.
The EC orphan drug designation grant follows the recent grant from
the FDA. It is another important regulatory milestone and marks a
significant step forward for BPS-804. We believe BPS-804 has the
potential to become the first therapy to reduce fractures and
improve quality of life in osteogenesis imperfecta patients.
Initial clinical data generated with BPS-804 has been highly
encouraging and we look forward to progressing this product
candidate towards registration."
The EC may grant orphan drug designation to drugs intended for
the treatment of life threatening or chronically debilitating rare
diseases where no therapeutic options are either authorised or
where the drugs will be of significant benefit to those affected by
the condition. Rare diseases are those defined as having a
prevalence of no more than five in 10,000 persons in Europe. The
designation provides development and commercial incentives,
including 10 years of market exclusivity, protocol assistance on
the development of the drug, including clinical studies, and
certain exemptions from or reductions in regulatory fees.
Enquiries
Mereo BioPharma Group
plc +44 (0)333 023 7319
Denise Scots-Knight, Chief
Executive Officer
Richard Bungay, Chief
Financial Officer & COO
Nominated Adviser and
Joint Broker
Cantor Fitzgerald Europe +44 (0)20 7894 7000
Phil Davies
Will Goode
Rick Thompson
Callum Butterfield
Joint Broker
RBC Capital Markets +44 (0)20 7653 4000
Paul Tomasic
Rupert Walford
Thomas Stockman
Laura White
Financial Adviser to the
Company
Evercore +44 (0)20 7653 6000
Julian Oakley
Tom Watson
Public Relations Adviser
to Mereo Biopharma
FTI Consulting +44 (0)20 3727 1000
Ben Atwell
Simon Conway
Brett Pollard
About Mereo
Mereo is a UK-based specialty biopharmaceutical company focused
on the development of innovative medicines that aim to address
unmet medical needs in rare and specialty disease areas and improve
patient quality of life.
Pharmaceutical companies face increasingly difficult choices in
the allocation of internal resources to their drug development
programs. With significant P&L constraints and rich pipelines
it has become increasingly difficult for many companies to fully
fund and advance development all of their drug candidates,
especially beyond Phase 2. Mereo has been formed to take advantage
of the global pharmaceutical industry's drive for creative ways to
progress their clinical development pipelines.
Mereo's initial mid-late stage portfolio consists of three
exceptionally well characterised novel products for the treatment
of diseases with considerable unmet medical need, which it acquired
from Novartis Pharmaceuticals in July 2015. Each of these
programmes has a comprehensive dataset for both pre-clinical and
proof-of-concept clinical studies. Since that time the Company has
initiated a Phase 2 study and a Phase 2b study in relation to two
of the product candidates in 2016 and intends to commence
registration studies during H2 2016 for the third product
candidate. Additional product opportunities are under
evaluation.
Mereo's focus is the development of innovative medicines that
have the potential to significantly transform the lives of patients
suffering from rare and other specialised conditions around the
world. To do this, the Company depends on the combination of its
team's expertise in selecting and acquiring product opportunities,
creating value in the development pipeline and structuring creative
transactions. Mereo's internal expertise is complemented by a
unique partnership with a leading global CRO, ICON.
Mereo combines the operational discipline and efficiency of a
small company with the financial resources to conduct comprehensive
clinical studies. Mereo will rapidly progress each of the products
through further value inflection points before partnering or
divesting its products. The Company also has the option to directly
commercialise products, for example in orphan disease
indications.
About osteogenesis imperfecta (OI)
OI is an orphan genetic disorder that is characterized by
fragile bones that break easily. In addition to fractures, people
with OI often have muscle weakness, hearing loss, fatigue, joint
laxity, curved bones, scoliosis, and short stature. The majority of
cases of OI (estimated at approximately 90 %) are caused by a
dominant mutation in a gene coding for type I collagen, a key
component of healthy bone. Treatment of OI is supportive, focusing
on minimizing fractures and maximizing mobility, but to date, there
are no treatments that address the underlying bone weakness.
Disclaimers
This announcement is not for publication or distribution,
directly or indirectly, in or into the United States of America
(including its territories and possessions, any State of the United
States and the District of Columbia). This announcement is not an
offer of or solicitation to purchase or subscribe for securities in
the United States. The securities referred to herein have not been
and will not be registered under the U.S. Securities Act of 1933,
and may not be offered or sold in the United States, except
pursuant to an applicable exemption from registration. No public
offering of securities is being made in the United States.
In any EEA Member State that has implemented the Prospectus
Directive, this communication is only addressed to and is only
directed at qualified investors in that Member State within the
meaning of the Prospectus Directive, and such other persons as this
document may be addressed on legal grounds, and no person that is
not a relevant person or qualified investor may act or rely on this
document or any of its contents.. The expression "Prospectus
Directive" means Directive 2003/71/EC (and amendments thereto,
including Directive 2010/73/EU to the extent implemented in any
relevant Member State) and includes any relevant implementing
measure in the relevant Member State
This information is provided by RNS
The company news service from the London Stock Exchange
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