28/03/2006
Nottingham, UK, 28th March 2006 – Innovata plc (LSE: IOV) today announces that its ADEPT® adhesion reduction solution, for use in obstetric and gynecologic surgery, received a unanimous recommendation for marketing approval by the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA).
The FDA advisory panel has recommended that ADEPT should be indicated as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynaecologic laparoscopic surgery which includes adhesiolysis.
Professor Dan Martin, from the University of Tennessee, Center for the Health Sciences, one of the lead investigators in the pivotal Phase III trial of ADEPT and former President of the American Association of Gynecologic Laparoscopists, said:
"We welcome the US FDA advisory panel's recommendation which helps to pave the way for the benefits of ADEPT to be seen by surgeons and patients across the USA. More than two million OB/GYN procedures are performed annually in the USA, including approximately 500,000 gynecologic laparoscopic procedures. ADEPT has the potential to reduce the number of adhesion-related complications, which can lead to hospitalisation and even infertility, in women undergoing such procedures."
Available in Europe since 2000, ADEPT is a 4% icodextrin solution that has been used in adhesion reduction in over 100,000 surgical patients. The Phase III study supporting Innovata's filing submission was conducted in over 400 patients undergoing gynecological laparoscopic adhesiolysis in the USA. The results showed that ADEPT reduced the number of adhesions following surgery as well as reducing pain scores while the overall incidence of adverse events in the ADEPT and control groups was similar.
ADEPT is licensed to Baxter International Inc. on a global basis under an agreement formed in January 2006. ADEPT is marketed by Baxter's BioSurgery business, a business unit that is focused on developing and commercializing novel biomaterials and biosurgery products.
Kieran Murphy, Chief Executive Officer of Innovata, said:
"ADEPT is one of the most important surgical device developments in the last decade, filling a niche where there are limited options. The positive review by the FDA advisory panel brings us closer to approval of ADEPT in the USA and, should it be successful, it will strengthen the product's market position in Europe and support the regulatory approval process in additional markets, including Japan."
Contacts:
Innovata plc Tel: 0115 974 7474Kieran Murphy, Chief Executive OfficerPeter Shennan, Finance Director Financial Dynamics Tel: 020 7831 3113Sarah MacLeod / John Gilbert
Notes to Editors
About Adhesions
An adhesion is a band of scar tissue that binds two planes of tissue together which should remain separate. Studies suggest that adhesions may form in over 10% of patients who have never had surgery and in 93% of patients having abdominal or pelvic surgery1 . Pelvic and abdominal adhesions are a significant women’s health issue as they can be associated with infertility, small bowel obstruction and chronic pelvic pain.
The use of anti-adhesion products has been limited by their difficulty in use and lack of clinical efficacy data 2.
About Innovata plc
Innovata plc specialises in the development of pulmonary products for the treatment of respiratory disorders and other serious diseases. Using its proprietary dry powder inhaler and drug formulation technologies, the company has developed a pipeline of revenue-generating/marketed and clinical-stage products. In addition, the Company has a portfolio of non-pulmonary products with growing revenues. Innovata has established development and marketing partnerships with a number of pharmaceutical companies including Baxter, Merck KGaA, UCB and Otsuka. Innovata was formed in July 2005 when ML Laboratories PLC acquired Quadrant Technologies Limited and the remaining minority interest in Innovata Biomed Limited. The company has over 90 employees of whom of 65 are engaged in research and development, mainly based at Innovata plc’s headquarters in Rudding
1 Menzies, D. and Ellis, H. (1990) Intestinal obstruction from adhesions—How big is the problem? Ann. R. Coll. Surg. Engl., 72, 72–60. 2 Frost and Sullivan, March 2005
http://www.innovataplc.com/iov/media/latestreleases/2006/2006-03-28/
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