Healthcare Industry News:  Innocoll Pharmaceuticals 


 News Release - March 31, 2009

EUSA Pharma Completes the European Launch of CAPHOSOL(R) for Prevention and Treatment of Oral Mucositis Caused by Cancer Therapy

DOYLESTOWN, Pennsylvania and OXFORD, England, March 31 -- (Healthcare Sales & Marketing Network) -- EUSA Pharma Inc ('EUSA'), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, announced today the successful completion of its European launch of CAPHOSOL® for the prevention and treatment of oral mucositis associated with cancer therapy, as an adjunct to standard oral care. CAPHOSOL is also indicated for hyposalivation and xerostomia (dryness of the mouth or throat) irrespective of the cause.

"CAPHOSOL's European launch represents an important strategic milestone for EUSA as it is the first product to leverage our recently constructed commercial infrastructure, which now spans both Europe and North America," said Bryan Morton, EUSA Pharma's President and Chief Executive Officer. "CAPHOSOL's introduction into the key French, German, Italian, Spanish, Benelux and UK markets, as well as a number of other EU countries, represents an important opportunity for EUSA to continue its rapid growth as the company commercializes its growing portfolio of speciality medicines on both sides of the Atlantic. Based on EUSA's expanding market presence across the company's areas of medical and geographic focus, we can increasingly compete with major players as a partner of choice for those seeking transatlantic commercial and late-stage development expertise."

Mr Morton continued, "We are proud to introduce CAPHOSOL as it brings important patient benefits, because oral mucositis is a particularly common and often devastating side effect of cancer therapy, with limited treatment options. CAPHOSOL has been available since 2007 in the US, and with our recent introductions in the EU, this preventative treatment is now available to the large number of European cancer patients at risk of developing this debilitating condition. As part of EUSA's commitment to the oncology field, we also intend to work with our broader distribution network to introduce CAPHOSOL on a global basis."

About oral mucositis and CAPHOSOL

Oral mucositis is one of the most common and debilitating complications of radiation and high dose chemotherapy, with limited options for its prevention and treatment. The condition, which affects approximately 40% of patients who receive conventional chemotherapy [1] and nearly all patients receiving radiation therapy for head and neck cancer [2], is an inflammation of the mucous membranes of the mouth with symptoms ranging from redness to severe ulceration. This can cause intense pain requiring opioid treatment and can prevent patients taking anything by mouth, which may interrupt cancer therapy and result in hospitalization. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy. CAPHOSOL, a supersaturated calcium phosphate rinse with a high concentration of electrolytes, lubricates the tissues allowing them to slide on contact and minimizing friction, ulceration and corresponding pain and discomfort.

In a prospective, randomized clinical trial CAPHOSOL treatment resulted in a significant improvement of oral mucositis caused by radiation and/or chemotherapy, with the frequency, duration and severity significantly reduced amongst those who received CAPHOSOL compared with patients in the control group. The results of the 95-patient trial demonstrated that those receiving CAPHOSOL experienced approximately half the number of days of mucositis (3.72 vs. 7.22, P<0.001), under half the days of pain (2.86 vs. 7.67, P<0.0001), needed less than a third the dose of morphine (34.54 mg vs. 122.78 mg, P<0.0001) and endured two-thirds fewer days requiring morphine (1.26 vs. 4.02, P<0.00015) compared with patients administered a control treatment [3].

About EUSA Pharma

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has eight marketed products, including Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, Collatamp® G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint® for imaging the extent and spread of prostate cancer and Quadramet® for the treatment of pain in patients whose cancer has spread to the bones. EUSA also has several products in late-stage development.

Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, TVM Capital, NeoMed and NovaQuest. Since its foundation, the company has raised over $275 million, and completed several significant transactions, including the acquisitions of Cytogen Corporation, Talisker Pharma Limited, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. Key to its rapid growth strategy is the company's established commercial infrastructure in the US, pan-European presence covering over 20 countries and wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing, in line with its ambitious target to become the leading specialty company in its areas of therapeutic and geographic focus.

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[1] Kostler WJ, Hejna M, Wenzel C, Zielinski CC. Oral mucositis complicating chemotherapy and/or radiotherapy: options for prevention and treatment. CA Cancer J Clin 2001;51:290-315.

[2] Sonis, Stephen T. "Oral Mucositis in Cancer Therapy." Supportive Oncology 2 (2004): 3-8.

[3] Papas AS et al. A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant 2003;31:705-712

Source: EUSA Pharma

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