media centre

05 November 2007

Clinical Trials Update

West Malling, UK, 5 November 2007: Phoqus Pharmaceuticals plc (AIM: PQS) (“Phoqus Pharmaceuticals” or the “Company”), the speciality pharmaceutical company, today announces an update on the progress and design of the clinical trial programme for Chronocort^TM, its novel product in development for the treatment of patients with congenital adrenal hyperplasia (CAH) and acquired adrenal insufficiency (AI).

Chronocort^TM is currently undergoing a Phase II clinical trial (Study #004) in patients with CAH that is being conducted at the US National Institutes of Health (NIH). The open-label trial in 12 CAH patients, which commenced at the beginning of September, is progressing well, with 6 patients already enrolled and on treatment with Chronocort^TM and the remaining patients identified by the NIH. The Company now expects to release the results of Study #004 during the first quarter of 2008. Detailed planning is currently underway for the proposed pivotal Phase III clinical trial in CAH which the Company now expects to commence during the first half of 2008, subject to further consultation with the FDA. The Company is planning for the potential launch of ChronocortTM in its lead indication of CAH during the last quarter of 2009/early 2010.

Separately, under the protocol assistance available due to Chronocort^TM’s orphan drug designation, Phoqus Pharmaceuticals has received regulatory feedback from the EMEA over the design of clinical trials in Chronocort^TM’s second indication, AI. The guidance from the EMEA enables a more straightforward pivotal clinical trial design than had originally been anticipated, with agreement to utilise a pharmacokinetic primary endpoint instead of quality of life (QOL). This has the potential to reduce the risk of the pivotal trial as the Company has already demonstrated that Chronocort^TM can achieve the required pharmacokinetic profile in healthy volunteers. As a result of the feedback, Phoqus Pharmaceuticals plans to undertake a small Phase II study in patients with AI prior to commencing a pivotal Phase III trial. Further updates regarding the proposed AI clinical programme design and anticipated timings will be provided by the Company in due course.

Phoqus Pharmaceuticals’ CEO, Dr Richard Mason, commented:

“We are pleased with the progress of Study #004 and look forward to completing the trial and releasing the results in due course.  Chronocort has the potential to provide real clinical benefit to patients with congenital adrenal hyperplasia and Study #004 should provide us with the first evidence of this.”

“With respect to Chronocort’s second indication of acquired adrenal insufficiency, the guidance received from the EMEA on the design of the clinical trials has been extremely helpful and provides for a simpler and lower risk clinical trial programme than we had originally envisaged.”

Enquiries:

Phoqus Pharmaceuticals plc - Tel: 01732 870227
Dr Richard Mason, CEO
Dr Peter Johnson, CFO

Financial Dynamics - Tel: 020 7831 3113
David Yates/Sue Quigley

Nomura Code Securities Limited - Tel: 020 7776 1200
Juliet Thompson / Phil Walker

Notes to Editors

About Chronocort^TM
Chronocort^TM is the first circadian endocrine treatment for congenital adrenal hyperplasia (“CAH”) and adrenal insufficiency (“AI”).  Chronocort™ uses Phoqus’ proprietary Qtrol™ modified release technology to provide a delayed-and-sustained release profile of hydrocortisone to mimic the natural over-night and early morning hormone levels found in healthy individuals that are considered important in controlling both actual disease symptoms and also reducing unwanted side effects resulting from excess steroid treatment.

Phoqus appointed a medical advisory board at the beginning of 2007 comprising leading endocrinologists from Europe and the USA to assist the Company in the design of the clinical development programmes able to demonstrate patient benefits and clinical superiority of Chronocort^TM over existing therapies for both CAH and AI.

Some of the underlying intellectual property supporting the Chronocort^TM product is licensed from Diurnal Limited, a spin-out from the University of Sheffield financed by Biofusion plc.  Phoqus and Diurnal collaborate on certain aspects of Chronocort^TM’s development.

About Phoqus
Phoqus Pharmaceuticals is a speciality pharmaceutical company that develops differentiated products for use in high value, specialist indications. It seeks to accelerate the rate and lower the risk of new drug development by applying its novel re-formulation expertise and drug delivery technologies to finding new indications for known, approved drugs. This avoids the high failure rate typically associated with new chemical entities (NCEs) which often founder due to safety issues encountered early in development.

The company’s lead product is Chronocort^TM for the treatment of patients with cortisol deficiency due to diseases such as congenital adrenal hyperplasia and Addison’s Disease. It is differentiated from existing therapies because it is designed to release steroid in a pattern that mirrors a healthy subject. At present Chronocort^TM is scheduled to reach the market in 2009/10.

Phoqus Pharmaceuticals aims to in-license product development opportunities from academia and university spin-out companies. By collaborating with these groups the company will access fundamental biological and clinical insights into existing drug action and apply this knowledge to develop new indications for those drugs. The company aims to capitalise on accelerated regulatory pathways such as the priority review process to further fast track products to market.

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

  
Phoqus Pharmaceuticals plc
10 Kings Hill Avenue, Kings Hill, West Malling, Kent, ME19 4PQ
Telephone: +44 (0)1732 870227, Fax: +44 (0)1732 870228
Email: info@phoqus.com

www.phoqus.com