PQS Phoqus

RNS Number:2964X
Phoqus Group plc
29 May 2007




  ChronocortTM granted second Orphan Medicinal Product Designation by European
                     Commission, for adrenal insufficiency

West Malling, UK, 29 May 2007: Phoqus Group plc (AIM: PQS) ("Phoqus"), the oral
drug delivery and development company, announces that the European Commission
has granted Orphan Medicinal Product Designation to ChronocortTM for the
treatment of adrenal insufficiency ("AI"). This is the second indication for
which ChronocortTM has received Orphan Medicinal Product Designation from the
European Commission. Orphan Medicinal Product Designation was originally granted
in respect of the genetic disorder congenital adrenal hyperplasia ("CAH") in
2005.

The EU Orphan Medicinal Product Designation is intended to promote the
development of drugs that may provide significant benefit to patients suffering
from rare diseases identified as serious or life-threatening. Under EMEA
guidelines, Orphan Medicinal Product Designation provides the sponsor access to
free protocol assistance to aid the development of clinical trials, waivers of
fees relating to the marketing approval process, centralised registration
procedure and ten years of marketing exclusivity once the product is approved
for the designated indication in the European Union. Early discussions are now
underway with the US Food and Drug Administration ("FDA") to seek equivalent
orphan drug designations in the US.

ChronocortTM is a modified release tablet containing hydrocortisone that is
under development by Phoqus for both AI, the failure of the adrenal glands to
produce sufficient steroid hormones, and congenital CAH. CAH is a serious
genetic disorder caused by the deficiency of an enzyme responsible for cortisol
production.

Both conditions require patients to take life-long corticosteroid hormone
replacement therapy. Current therapy does not provide steroid in a natural
physiological manner and as a result often only poorly controls disease symptoms
and can lead to the unwanted side effects of steroid therapy. ChronocortTM is
designed to provide a new form of corticosteroid hormone replacement therapy by
releasing hydrocortisone in a manner that will enable doctors to achieve a daily
cycle (circadian rhythm) of cortisol levels in patients that closely matches
that of the normal population. This in turn should improve disease symptom
control and may also increase the accuracy of the disease treatment and
monitoring regimen, potentially reducing the incidence of over or under exposure
to steroids.

The ChronocortTM tablet utilises Phoqus' QtrolTM modified release technology to
provide a delayed-and-sustained release profile of hydrocortisone to mimic the
natural overnight and early morning hormone levels in healthy individuals
considered important in controlling disease symptoms and reducing unwanted side
effects. Current therapies do not provide effective treatment because they can
only be taken upon waking and do not therefore provide the critical natural rise
in overnight cortisol levels.

Planning is underway for the full clinical development programme which includes
pivotal pre-registration studies in both CAH patients and patients suffering
from AI that are scheduled to commence in the latter half of 2007 in both the EU
and the US, subject to regulatory approval. ChronocortTM is currently under
evaluation in healthy volunteer studies to confirm its pharmacokinetic profile.

In the EU and US combined there are estimated to be between 78,000 and 206,000
patients with acquired AI (due to conditions such as Addison's Disease and
hypopituitarism) and a further 44,000 to 53,000 patients with the genetic
disorder CAH.

Phoqus' CEO, Dr. Richard Mason, commented:

"Adrenal insufficiency is a disease of significant unmet therapeutic need and
results in patients having a quality of life similar to chronic congestive heart
failure. Subject to regulatory approval, we are planning to commence pivotal
pre-registration clinical trials for both adrenal insufficiency and congenital
adrenal hyperplasia in the second half of this year, and the orphan drug
designation granted by the EMEA will be of great benefit to our clinical
programme. Based on reasonable assumptions, we believe that Chronocort has the
potential to generate peak annual sales in excess of $200m from use in these two
orphan indications."

Enquiries:

Phoqus Group plc Tel: 01732 870227
Dr Richard Mason, CEO

Financial Dynamics Tel: 020 7831 3113
David Yates/John Gilbert

Notes to Editors

About Phoqus
Phoqus is an oral drug delivery and development company. It creates new
therapeutic products for both in-house and collaborative development programmes
using its proprietary electrostatic powder coating technology, LeQtracoat(R).
This technology provides Phoqus with an extensive range of innovative drug
delivery systems that are applied to pharmaceuticals to provide benefits such as
controlling the release of a drug into the body, enhancing patient compliance
and improving the performance and efficacy of an existing drug. In turn, these
benefits enable the development of new products that better meet the unmet
medical needs of patients. They can also allow pharmaceutical companies to
extend the life cycles of their products, strengthen their patent protection and
thereby enhance the value of their marketed products and development pipelines.
Phoqus is the only company using electrostatic powder coating technology for
pharmaceutical applications and has over 120 granted patents.

Based in Kent, Phoqus was established in 1998 as a spin-out from Colorcon, a
division of Berwind Pharmaceutical Services Inc. The Company was admitted to
trading on AIM in November 2005 and is listed under the symbol "PQS".

Further background on the Company can be found at www.phoqus.com.



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