Joint venture partner approved for trials
15 4월 2009 - 3:00PM
RNS Non-Regulatory
TIDMPYN
Phynova Group PLC
15 April 2009
?
Chinese State Food and Drug Administration (SFDA) approves Phynova's Chinese
joint venture partner's application to carry out a first clinical study with TQS
(licensed to Phynova as 'PYN9') in post operative ileus
15 April 2009
Phynova Group plc
("Phynova" or the "Company")
Chinese State Food and Drug Administration (SFDA) approves Phynova's Chinese
joint venture partner's application to carry out a first clinical study with TQS
(licensed to Phynova as 'PYN9') in post operative ileus
Phynova (AIM: PYN), the developer of prescription pharmaceuticals derived from
plants used in Chinese medicines, today announces that its Chinese joint venture
partner, Botanic Century (Beijing) Ltd (BCCL) has received approval from the
Chinese regulatory authority (the SFDA) to begin clinical studies on its
candidate treatment for post operative ileus, TQS. Post operative ileus is a
condition that has multifactorial causes, including surgical manipulation, the
anti inflammatory response to surgery and the use of opiates in pain management.
The result is that the bowel temporarily stops functioning following abdominal
surgery. It is responsible for prolonged post- surgery discomfort and
contributes significantly to increased hospitalisation and associated health
care costs (estimated to be approximately $1 billion in the US). There is only
one approved drug in the West for this indication. Through its joint venture
with BCCL Phynova has the rights to BCCL's candidate TQS (which Phynova calls
PYN9) in all territories outside China.
BCCL expects to begin a randomised placebo controlled study of TQS in patients
undergoing abdominal surgery in the third quarter of 2009 and hopes to have
Phase II results about 12 months later.
Dr Tony Mills, CEO of Phynova Limited commented "We are delighted to learn that
BCCL's application has been successful. Post operative ileus is a clinical
problem recognised world wide as a serious complication of abdominal surgery.
There are no approved drugs for this indication in China and in the US there is
only one approved drug. In the US there are believed to be around 500,000 bowel
procedures per year that might benefit from ileus relief."
Dr Mills added "Our partnership with BCCL allows Phynova access to potentially
valuable drug candidates from China at greatly reduced costs in terms of both
development and clinical trials. It represents a business model that we believe
will be of increasing value to potential partners in western pharmaceutical
markets as they look for new products in the face of high profile drug failures
and patent expirations. Because PYN9 is a botanical drug we believe it
functions through a multimodal action, which may be ideal in the treatment of a
multifactorial condition such as post operative ileus. The efficacy data that
BCCL will generate from its clinical trials (BCCL has permission to carry out
studies through Phase III) will be a huge help to Phynova in attracting
commercial partners for PYN9 in the West."
For further information, please contact:
+----------------------------------------------------+----------------------+
| Phynova Group plc | |
| John K Pool (Chairman, Phynova) | Tel: 01993 880700 |
| Tony Mills (CEO Phynova Limited) | |
| Robert Miller (CEO Phynova China Limited) | |
+----------------------------------------------------+----------------------+
| | |
+----------------------------------------------------+----------------------+
| John East & Partners Limited | |
| John East/Simon Clements | Tel: 020 7618 2200 |
+----------------------------------------------------+----------------------+
| | |
+----------------------------------------------------+----------------------+
| Capital MS&L | |
| Mary Clark/Anna Mitchell | Tel: 020 7307 5330 |
+----------------------------------------------------+----------------------+
Notes to editors:
About Phynova
Phynova (AIM: PYN) is a UK company developing new prescription pharmaceuticals
derived from plants used in Chinese medicines. The Company is focused on viral
and bacterial diseases, metabolic diseases and cancer. Phynova´s lead product
for hepatitis C has now completed a Phase I/II trial in the US. One further
product, for post-operative ileus, is targeted for entry to the clinic and there
are a further four products in preclinical development.
For further information please visit www.phynova.com
About Botanic Century (Beijing) Ltd (BCCL)
BCCL is a pharmaceutical research and development company based in Beijing,
China, which develops botanical drugs. The company was founded in November 2003
by Professor Xie Chen PhD, Mr. Liu Wei Qun, and Mr Zhong Zhong.
Since its founding, BCCL has taken four botanical drugs through the Chinese
licensing system as a Contract Research Organisation for its clients. The drugs
in BCCL's own pipeline are for the treatment of post-operative ileus, bacterial
infections and type II diabetes. They address areas of significant clinical need
in the Chinese market.
BCCL is also a developer of functional ingredients for the nutriceutical and
cosmetic industries, including products targeting fatigue and skin anti-ageing
Phynova has in licensed two drug candidates from BCCL, the antibacterial PYN6
and the post operative ileus candidate, PYN9. In November 2006 Phynova acquired
a 45 per cent. shareholding in BCCL.
For further information please visit www.botaniccentury.com
About post operative ileus (POI)
Up to 500,000 patients in the US alone undergo bowel surgery each year and
virtually all experience POI, a post-surgical interruption of bowel function.
POI is characterised by the inability to take solid foods, delayed flatus and
stool and is often accompanied with abdominal pain and distension, nausea,
vomiting and gas or fluid accumulation in the bowel. The causes of POI are
multifactorial but include the inflammatory response that arises through
surgical manipulation. Various estimates put the cost of POI to the US health
system at around $1 billion per year, mainly representing the increased time
patients experiencing POI spend in hospital after surgery, before they can be
sent home, including the associated costs of additional nursing involved.
Attempts to ameliorate the effects of POI have involved the use of (e.g)
nasogastric tubes to decompress the stomach and the one recently approved US
drug has represented the first approval of a drug specifically targeting POI.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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