Positive Phoqus Results

Biofusion PLC
04 March 2008


For immediate release                                           4th March 2008


                                 BIOFUSION PLC
                         ("Biofusion" or "the Company")



    Phoqus Pharmaceuticals Announces Positive Results from a Phase II Study
            incorporating Diurnal's endocrine Intellectual property



Biofusion plc (AIM: BFN), the university IP commercialisation company that turns
world class research into business, is today pleased to note that Phoqus
Pharmaceuticals plc ("Phoqus"), the speciality pharmaceutical company  that is
working in collaboration with Biofusion's subsidiary company Diurnal Limited ("
Diurnal"), the Sheffield-based drug development company, has announced positive
results from a Phase II study of its Novel Cortisol Replacement Therapy,
Chronocort(R) in Congenital Adrenal Hyperplasia.



Some of the underlying intellectual property supporting the Chronocort(R)
product is licensed from Diurnal Limited, a spin-out from the University of
Sheffield, founded by Professor Richard Ross in which Biofusion has a 60%
shareholding. Phoqus and Diurnal collaborate on certain aspects of Chronocort's
(R) development.



The press release issued yesterday by Phoqus Group plc follows in full below:



West Malling, UK, 3 March 2008: Phoqus Pharmaceuticals plc (AIM: PQS) ("Phoqus
Pharmaceuticals" or "Company"), the speciality pharmaceutical company, today
announces positive results from a Phase II study evaluating its delayed,
sustained release hydrocortisone therapy Chronocort(R), in patients with
Congenital Adrenal Hyperplasia ("CAH").  CAH is a genetic enzyme disorder
characterised by deficiency of the hormone cortisol and excess production of
androgens (male sex hormones). Raised androgens, together with a lack of
cortisol, are responsible for the majority of symptoms such as fatigue,
infertility, hirsutism and obesity.



In healthy subjects, cortisol is produced in a distinct circadian rhythm:
building over night, peaking early in the morning and declining throughout the
day to its lowest point around midnight. CAH patients lack the enzyme to convert
17-Hydroxyprogesterone ("17-OHP") into cortisol. In the absence of cortisol,
which acts as a brake to 17-OHP production, 17-OHP and other androgens
accumulate.  17-OHP levels are used to adjust the dose of steroid replacement
but with conventional therapy it is very difficult to replicate the natural
circadian rhythm and to get the balance right between under and over treatment.
This leaves patients at chronic risk of steroid excess which may lead to
obesity, high blood pressure, diabetes and osteoporosis.



The Phase II trial, which was conducted at the National Institutes of Health in
Bethesda, Maryland, showed that treatment with Chronocort(R) gave an overnight
cortisol profile much closer to the normal physiological profile than
conventional immediate release hydrocortisone. In addition, the majority of
patients had lower morning levels of 17-OHP when treated with Chronocort(R)
compared with conventional therapy.



Fourteen patients with CAH received a 7 day run-in period of immediate release
hydrocortisone given three times a day. They then switched to a single dose of
Chronocort(R) at 10.00pm for 28 days. A 24 hour pharmacokinetic ("PK") profile
was performed at the end of each treatment period. The primary endpoint was the
24 hour cortisol profiles which, during the Chronocort(R) treatment period, more
closely matched the overnight physiological pattern than with conventional
immediate release treatment. An important secondary endpoint (and key
pharmacodynamic measure) was the morning 17-OHP level which showed reduced mean
levels with Chronocort(R) compared with conventional treatment. These results
give confidence that Chronocort(R) has performed as designed and allow the
design of an appropriate dosing regimen for a Phase III pivotal trial.  The
Company is now preparing to discuss such a trial with regulatory authorities.
The data will be submitted for publication in a peer reviewed journal in due
course.



Chronocort(R) was well tolerated with no serious adverse events.



Phoqus Pharmaceuticals' Chief Executive Officer, Richard Mason said:



"These successful clinical trial results are extremely important as they
demonstrate for the first time the potential important clinical benefit that
Chronocort may provide to patients with Congenital Adrenal Hyperplasia, with
potentially greater control of adrenal androgen secretion through more
physiological cortisol replacement. Following discussions with regulatory
agencies we will plan a Phase III pivotal trial in this indication which will be
undertaken in the EU and US. All being well, we aim to file for marketing
authorisation in Europe and the US in 2009.  We believe Chronocort has broad
relevance to patients with cortisol deficiency or insufficiency, including
sufferers of CAH and Addison's Disease."



"This is a significant value-driving event for Phoqus Pharmaceuticals. We are
exploring a range of commercialisation options, including entering into
relationships with pharmaceutical and biotechnology companies, to bring
Chronocort to the market. These results are also a landmark for Phoqus
Pharmaceuticals' Qtrol drug delivery technology platform, demonstrating its
ability to achieve challenging drug release profiles in order to enhance drug
effectiveness in patients."

Phoqus Pharmaceuticals believes that Chronocort(R) has the potential to be a
commercially important orphan drug, with peak sales potentially in excess of
$200m. Chronocort(R) has Orphan Drug Designation for both CAH and acquired
causes of adrenal insufficiency in Europe.  Phoqus is applying for the same in
the US. Such orphan status grants the Company, on product approval, 10 and 7
years of market exclusivity in the EU and US respectively.



Note: No endorsement of any organization, product or service mentioned here is
intended by the National Institutes of Health or its employees or should be
inferred.
--------------------------------------------------------------------------------



For further information about Biofusion, please contact:


Biofusion
David Baynes / Stuart Gall                                                           [phone]

Buchanan Communications
Mary-Jane Johnson / Lisa Baderoon / Catherine Breen          [phone]

Phil Walker                                                     [phone]





About Biofusion



Biofusion was established in 2002 to commercialise university-generated IP.
Biofusion has signed long-term agreements with two of the UK's top ten research
intensive universities (University of Sheffield and Cardiff University) giving a
combined R&D spend attributable to Biofusion of approximately £114 million a
year.



Biofusion's first agreement was a ten-year exclusive arrangement with the
University of Sheffield for the commercialisation of IP owned by the University
in the area of medical life sciences. Biofusion has shareholdings in a portfolio
of Sheffield University spin-out companies including Asterion, Axordia,
Biohydrogen, Lifestyle Choices, Diurnal and Phase Focus. The University of
Sheffield was ranked 5th in the UK for the quality of its life sciences research
and will be spending an estimated £0.5bn of research funding over the lifetime
over the life of the Sheffield Agreement.



In January 2007, Biofusion completed a long-term exclusive agreement with
Cardiff University, to commercialise 100% of all Cardiff University's
research-generated IP.  Biofusion has shareholdings in a portfolio of Cardiff
University spin-out companies including Abcellute, Q-Chip and Morvus. Cardiff
University was ranked 7th in the UK in the most recent research rankings and
will be spending more than £1.0bn of research funding over the lifetime over the
life of the Cardiff Agreement.



About Diurnal

Founded in November 2004, Diurnal is focused on developing physiological
endocrine replacement therapy to optimise efficacy. Its first programme has led
to intellectual property covering the delivery of hydrocortisone in a manner
that mimics the normal physiological circadian rhythm of cortisol. This clearly
defined rhythm, with high levels in the morning and low levels at night, is lost
in patients with adrenal insufficiency and congenital adrenal hyperplasia.
Current therapies cannot adequately control the condition, so the Diurnal
management team believes that this product should offer a much needed
improvement in treatment for patients.



Chronocort is being developed by Phoqus, an emerging UK speciality
pharmaceutical company, which has an exclusive licence to the 'delayed and
sustained release therapy' patent. In 2005 Professor Richard Ross, founding
Director of Diurnal received Orphan Medicinal Product designation for this
product from the European Medicines Agency, which affords 10 years of market
exclusivity after the grant of a marketing authorisation in Europe. The product
has now successfully completed Phase 2 clinical studies.



Diurnal has a pipeline of programs addressing the unmet needs of endocrine
patients using physiological hormone replacement.












                      This information is provided by RNS
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