New study finds ADEPT® effective in reducing Adhesions following Gynecological Laparoscopic Surgery

1 November 2007

New study finds ADEPT^® effective in reducing Adhesions following Gynecological Laparoscopic Surgery

- Anti-adhesion agent may reduce infertility due to adhesions after surgery -

DEERFIELD, Ill., and CHIPPENHAM UK, November 1, 2007 — Baxter International Inc. (NYSE: BAX) and Vectura Group plc (LSE: VEC) today announced publication of data in the November 2007 issue of Fertility and Sterility of the first randomized, double-blind trial of an adhesion reduction agent, ADEPT Adhesion Reduction Solution [4% Icodextrin Solution] in gynecological laparoscopic surgery compared to lactated Ringer’s solution (LRS). In one of the largest adhesion reduction agent trials performed, ADEPT was shown to be more effective than lactated Ringer’s solution (LRS) in reducing the incidence of post-operative adhesions in patients undergoing gynecological laparoscopic adhesiolysis. ADEPT was also found to be safe and in particular showed efficacy in infertility patients.

“Adhesions can take several days to form following surgery,” said Ron Lloyd, vice president of Baxter’s BioTherapeutics and Regenerative Medicine business. “Other solutions used, although not approved, for adhesion reduction during laparoscopic gynecological surgery are absorbed within hours, reducing their effectiveness in preventing adhesions. ADEPT forms a fluid reservoir in the peritoneal cavity that resides there during the critical period of adhesion formation, separating and minimizing contact between organs.”

Adhesions are abnormal fibrous attachments between tissues or organs that develop following pelvic or abdominal surgery. The incidence of adhesion formation has increased with the rise in gynecological surgery, and it has been shown that between 60 and 90 percent of women suffer post-operative adhesions following major gynecological procedures. Pelvic factors such as adhesions account for between 20 and 40 percent of infertility cases in women and can cause other complications, increasing patient morbidity and healthcare costs.

“Increased use of laparoscopic surgery as an alternative to open surgery has helped reduce post-operative adhesions, but they remain a major problem,” said Dr. Tom Lyons, MD, director Center of Women’s Care and Reproductive Surgery and Clinical Assistant Professor, Dept. of OB/GYN, Emory University Medical School. “Solutions used to address adhesions in the past have been largely ineffective, and none have been approved by the FDA for use in laparoscopic procedures. An effective adhesion-reduction agent like ADEPT that is approved for use in laparoscopic procedures provides a major clinical benefit.”

The study, conducted by Innovata Ltd, now part of Vectura Group plc, involved more than 400 patients at 16 sites in the United States. Two hundred and three patients undergoing gynecological laparoscopic surgery involving adhesiolysis were administered ADEPT during surgery and 199 patients were administered LRS. Patients’ primary diagnoses included pelvic pain, infertility, endometriosis and known adhesions. A second follow-up laparoscopy was scheduled four to eight weeks later.

Among patients in the ADEPT group, more than 45 percent achieved “clinical success” during the second physician observation compared to 35.6 percent in the LRS group (Intent to Treat population). Clinical success was defined as the greater of a reduction in adhesions of at least three or 30 percent of sites lysed between the first and second laparoscopies. Among infertility patients, 52.9 percent of patients in the ADEPT group had a positive reduction in American Fertility Score (AFS), the standardized method to score and classify adhesions to the ovaries or fallopian tubes that may affect fertility, compared to 30.4 percent in the LRS group (per protocol population).

ADEPT is a four percent icodextrin solution that has been approved for adhesion reduction in Europe since 2000, and since July 2006 in the United States for gynecological laparoscopic procedures involving adhesiolysis. ADEPT is the first and only anti-adhesion agent approved for use in laparoscopic surgery in the United States. As a fluid, ADEPT is easy to use in laparoscopic procedures, as it can be delivered directly and rapidly through a laparoscopic port during surgery. Innovata Ltd (part of Vectura Group plc) conducted the study as part of the ADEPT development program before licensing ADEPT to Baxter in January 2006. ADEPT is part of Baxter’s Regenerative Medicine business unit within the BioScience division. The Regenerative Medicine business unit also sells products used in hemostasis, wound sealing and tissue regeneration, and products used in adult stem-call therapies.

About ADEPT

ADEPT Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

ADEPT is for direct intraperitoneal administration only NOT for intravenous (IV) administration. ADEPT is contraindicated in patients with known or suspected allergy to cornstarch based on polymers, e.g., icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease. ADEPT is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection.

There have been rare reports of sterile peritonitis following the use of icodextrin. Leakage of ADEPT from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage through laparoscopic port sites post-operatively. There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia. Anaphylaxis has been reported in a few patients. Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.

In the pivotal study, the most frequently occurring treatment-related adverse events between surgeries were post-procedural leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.

RX Only: For safe and proper use of this device, please refer to full device “Instructions For Use.”

About Baxter International

Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

About Vectura

Vectura is a pulmonary drug development company focused principally on the development of a range of inhaled therapies for the treatment of respiratory and neurological diseases. Vectura develops products to treat respiratory diseases such as asthma, COPD and cystic fibrosis. The Company also targets opportunities where optimized delivery via the lungs into the blood stream can provide significant benefits, such as a rapid onset of action, improved efficacy and improved tolerability compared with current therapies. Vectura has eight marketed products and a portfolio of drugs in clinical and pre-clinical development, some of which have been licensed to major pharmaceutical companies. The Company also seeks to develop certain programmes further through development to optimise value at a later licensing stage. Vectura also offers its formulation and inhalation technologies to other pharmaceutical companies on a licensing basis where this complements Vectura’s business strategy.

Vectura has development collaborations with a broad range of pharmaceutical companies including Boehringer Ingelheim, Novartis and Chiesi. The acquisition of Innovata in January 2007 brought established alliances with a number of additional companies, such as Baxter, GSK, Merck Generics (part of Mylan Inc), UCB and Otsuka as well providing revenue streams, complementary products and critical mass.

For further information, please visit Vectura’s website at www.vectura.com

ADEPT is a registered trademark of Innovata Ltd.