Vernalis Plc Initiates a Phase I Trial of a Promising New Approach to Treating Obesity and Related Disorders - Including Type II Diabetes
11 December 2006
WINNERSH, U.K., December 11, 2006 -- Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced that it has started a Phase I trial of V24343, a CB1 antagonist, as a potential treatment for obesity, type II diabetes and related disorders.
Cannabinoid type 1 receptors, (CB1) are widely expressed both in peripheral tissues involved in lipid and glucose metabolism and in the brain regions controlling appetite. Blockade of these receptors by selective CB1 receptor antagonists causes weight loss and ameliorates risk factors for obesity related disorders such as cardiovascular disease and type II diabetes. The efficacy of CB1 receptor antagonists in the treatment of obesity, type II diabetes and associated disorders has been clinically demonstrated in recent trials of Rimonabant.
Simon Sturge, CEO of Vernalis commented:
“There are only two drugs approved in the United States for long-term treatment of obesity; both of which are limited by side effects. The knowledge that CB1 antagonists reduce weight and have the capability to improve glucose control in diabetics has led to this promising new approach. Prevalence of obesity in the US and Europe has reached epidemic levels and there is a clear opportunity for an effective and well-tolerated anti-obesity drug.”
The Phase I double-blind, randomised, placebo-controlled study in overweight and mildly obese volunteers will be conducted in two parts; a single ascending dose followed by a multiple ascending dose and is expected to complete in mid-2007. The primary objectives of the Phase I programme are to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of V24343; however, having overweight and mildly obese subjects in the trial ensures that the evaluation of V24343 is carried out in clinically relevant subjects.
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| Enquiries: | |
| Vernalis plc | +44 (0) 118 977 3133 |
| Simon Sturge, Chief Executive Officer | |
| John Hutchison, Development Director | |
| Julia Wilson, Head of Corporate Communications | |
| Brunswick Group | +44 (0) 20 7404 5959 |
| Jon Coles | |
| Justine McIlroy | |
| Lazar Partners Ltd | |
| Gregory Gin | 212-867-1762 |
Notes to Editors
About Obesity
Obesity, defined as a body mass index of greater than 30, arises
from the accumulation of excess fat in the body from over
consumption of fatty foods According to the American Obesity
Association, obesity is a disease that affects nearly one-third of
the adult American population (approximately 60 million). The
number of overweight and obese Americans has continued to increase
since 1960, a trend that is not slowing down. Today, 64.5 percent
of adult Americans (about 127 million) are categorized as being
overweight or obese. Each year, obesity causes at least 300,000
excess deaths in the U.S., and healthcare costs of American adults
with obesity amount to approximately $100 billion. The World Health
Organisation state that obesity is a major contributor to the
global burden of chronic disease and disability and has reached
epidemic proportions globally, with more than one billion adults
overweight, at least 300 million of them being classed as
clinically obese. People with obesity are at risk of developing one
or more serious medical conditions, which can cause poor health and
premature death. Obesity is associated with more than 30 medical
conditions, and scientific evidence has established a strong
relationship with at least 15 of those conditions.
About Diabetes
Diabetes is a disease whereby the body does not produce or properly
use insulin. Insulin is a hormone that is needed to convert sugar,
starches and other food into energy. The dramatic rise in the
incidence of type II diabetes is thought to be largely due to the
increased prevalence of obesity. Type I diabetes results from the
body's failure to produce insulin and it is estimated that 5-10% of
Americans who are diagnosed with diabetes have type I diabetes. The
more prevalent, type II diabetes results from insulin resistance (a
condition in which the body fails to properly use insulin),
combined with relative insulin deficiency and accounts for between
85 - 95% of all people with diabetes. According to the American
Diabetes Association, there are 20.8 million children and adults in
the United States who have diabetes. While an estimated 14.6
million of these have been diagnosed almost one-third are unaware
that they have the disease.
About Vernalis
Vernalis is a speciality bio-pharmaceutical company focused on
products marketed to specialist neurologists. The company has two
marketed products, Frova® and Apokyn®, and a development
pipeline focused on neurology and central nervous system disorders.
The company has eight products in clinical development and
collaborations with leading, global pharmaceutical companies
including Novartis, Biogen Idec and Serono. Vernalis has
established a US commercial operation to promote Apokyn® and
co-promote Frova® alongside its North American licensing
partner, Endo Pharmaceuticals, progressing the company towards its
goal of becoming a sustainable, self-funding, R&D-driven,
speciality bio-pharmaceutical company. For further information
about Vernalis, please visit:
www.vernalis.com.
| Product | Indication | Phase I |
Phase II |
Phase III |
Registration | Market | Marketing Rights |
|---|---|---|---|---|---|---|---|
| Apokyn® | Parkinson’s Disease | X | North America | ||||
| Frova® | Migraine | X | US milestones & royalties - Endo (EU – royalties) | ||||
| Frova® | Menstrual Migraine Prevention | X | US milestones & royalties - Endo (EU – royalties) | ||||
| V1512 | Parkinson’s Disease | X | World Wide (excl. Italy) | ||||
| V10153 | Ischaemic stroke | X | World Wide | ||||
| V1003 | Acute Pain | X | US Profit share Option Reckitt Benckiser | ||||
| V3381 | Neuropathic Pain | X | World Wide | ||||
| V2006 | Parkinson’s Disease | X | US Co-promotion Biogen Idec | ||||
| MMPI | Multiple Sclerosis | X | None - royalty (Serono) | ||||
| V24343 | Obesity | X | World Wide |
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that
reflect the Company’s current expectations regarding future
events including the clinical development and regulatory clearance
of the Company’s products, the Company’s ability to
find partners for the development and commercialisation of its
products, as well as the Company’s future capital raising
activities. Forward-looking statements involve risks and
uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors including the
success of the Company’s research strategies, the
applicability of the discoveries made therein, the successful and
timely completion of clinical studies, the uncertainties related to
the regulatory process, the ability of the Company to identify and
agree beneficial terms with suitable partners for the
commercialisation and/or development of its products, as well as
the achievement of expected synergies from such transactions, the
acceptance of Frova® and Apokyn® and other products by
consumers and medical professionals, the successful integration of
completed mergers and acquisitions and achievement of expected
synergies from such transactions, and the ability of the Company to
identify and consummate suitable strategic and business combination
transactions.
