| Ipsen Limited, the UK-based pharmaceutical company and subsidiary of the Beaufour Ipsen Group has announced the beginning of Phase II clinical trials in the United States of America (USA) on its botulinum toxin type A for use in aesthetic medicine. "Patients have now been enrolled and are being treated in this important study of botulinum toxin" said Dr Gary Monheit, a Dermatologist in Birmingham, Alabama, and Co-Principal Investigator in the study. |    |
This announcement follows the filing of an Investigational New Drug (IND) application in September 2002, and the signing in July 2002 of a definitive agreement with Inamed Corporation, a global medical device company based in California. The agreement gives Inamed exclusive rights to develop and distribute Ipsen’s botulinum toxin type A for cosmetic indications in the USA, Canada and Japan.
In the past few years, botulinum toxin type A in its purified form, has revolutionised the face of cosmetic dermatology. It is a simple, reliable, reproducible, non-invasive procedure that can be administered successfully to manage a variety of cosmetic issues.
Dr Alistair Stokes, Chief Executive Officer of Ipsen and Group Vice-President, Corporate Development, Beaufour Ipsen said "These trials are part of our worldwide strategy to develop botulinum toxin in aesthetic medicine. Inamed has an excellent reputation in this marketplace, and our relationship with the company will help us to achieve our goal of increasing the use of botulinum toxin as a cosmetic treatment".
"The market in the USA for botulinum toxins is projected to exceed $400 million in 2002 and approach $800 million by 2005. The partnership with Ipsen gives us the potential to expand our product portfolio for the customer in a significant way" said Nick Teti, Inamed’s Chairman, President and Chief Executive Officer.
The exact nature of the cosmetic indication that will be submitted by Inamed will depend on the outcome of the clinical trial programme.
Botulinum toxin will be manufactured by Ipsen Biopharm in Wrexham, North Wales and supplied to Inamed for distribution in North America and Japan. Ipsen Biopharm is the UK pharmaceutical manufacturing and distribution arm of the Beaufour Ipsen Group.
Notes to editor
Botulinum toxin
Beaufour Ipsen’s botulinum toxin type A (which is branded as Dysport®) is
now licensed in 50 countries for a variety of neuromuscular indications including: cervical dystonia, blepharospasm, hemifacial spasm, and the treatment of dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy. In addition Dysport® is licensed in some countries for post-stroke spasticity and hyperhidrosis.Beaufour Ipsen
Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France.
The Group specialises in oncology, haematology, neurology and endocrinology and has a portfolio of 30 products which are either peptides, derived from biotechnology, or based on natural sources. In 2001, 16.4% of Beaufour Ipsen’s turnover was reinvested in Research and Development (R&D).
The Group’s website is www.beaufour-ipsen.com
Inamed Corporation
Inamed is a global medical device company engaged in the development, manufacturing and marketing of products for breast and facial aesthetics and obesity intervention. These products include breast implants for aesthetic augmentation and for reconstructive surgery following a mastectomy; a range of dermal products to correct facial wrinkles; and minimally invasive devices for obesity intervention, including the LAPBAND® System indicated for severe obesity.
The Company’s website is www.inamed.com
Source: Ipsen
