Mereo BioPharma Group plc BPS-804 granted EU orphan drug status (7241C)

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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                          [phone] 
 Denise Scots-Knight, Chief 
  Executive Officer 
 Richard Bungay, Chief 
  Financial Officer & COO 
 
 Nominated Adviser and 
  Joint Broker 
  Cantor Fitzgerald Europe     [phone] 
 Phil Davies 
 Will Goode 
 Rick Thompson 
 Callum Butterfield 
 
 Joint Broker 
  RBC Capital Markets          [phone] 
 Paul Tomasic 
 Rupert Walford 
 Thomas Stockman 
 Laura White 
 
 Financial Adviser to the 
  Company 
  Evercore                     [phone] 
 Julian Oakley 
 Tom Watson 
 
 Public Relations Adviser 
  to Mereo Biopharma 
  FTI Consulting               [phone] 
 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

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June 30, 2016 02:00 ET (06:00 GMT)