ProStrakan Announces US Co-Promotion Agreement for Oncology Support Product, GELCLAIR

Share Article

ProStrakan Group plc has signed an exclusive co-promotion agreement with EKR Therapeutics Inc. (EKR) in the United States for GELCLAIR, a bioadherent mouth gel indicated for the management and relief of pain associated with Oral Mucositis (OM).

GELCLAIR and SANCUSO are highly complementary. The addition of GELCLAIR to our US product range presents ProStrakan with an excellent opportunity to capitalize on the access that SANCUSO has created for our team to oncologists and oncology nurses across the US. We hope that in this way we can help to improve the quality of life for more chemotherapy patients.

Galashiels, Scotland, (PRWEB) 20 April 2009: ProStrakan Group plc, the international specialty pharmaceutical company, today announces that it has signed an exclusive co-promotion agreement with EKR Therapeutics Inc. (EKR) in the United States for GELCLAIR, a bioadherent mouth gel indicated for the management and relief of pain associated with Oral Mucositis (OM).

GELCLAIR to be marketed alongside SANCUSO®

ProStrakan has strengthened its presence in oncology supportive care and will promote GELCLAIR alongside SANCUSO, a unique transdermal patch for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to five consecutive days duration. SANCUSO received approval from the US Food and Drug Administration (FDA) in September 2008.

ProStrakan will offer GELCLAIR as a second detail to oncologists and oncology nurses across the US through its US sales force, which is already promoting SANCUSO.

Commenting on the addition of GELCLAIR to ProStrakan's US product range, ProStrakan's Chief Executive, Dr Wilson Totten, said, "GELCLAIR and SANCUSO are highly complementary. The addition of GELCLAIR to our US product range presents ProStrakan with an excellent opportunity to capitalize on the access that SANCUSO has created for our team to oncologists and oncology nurses across the US. We hope that in this way we can help to improve the quality of life for more chemotherapy patients."

In addition to SANCUSO and GELCLAIR, ProStrakan is planning to further improve the lives of oncology patients with a new sublingual formulation of fentanyl. Fentanyl is an opioid used to manage episodes of severe breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain. ProStrakan is planning to file a New Drug Application (NDA) with the US FDA for this fentanyl sublingual; this will further expand its supportive care commitment in oncology.

GELCLAIR Relieves Pain From Oral Mucositis (OM), A Chemotherapy And Radiotherapy Side Effect

Similar to nausea and vomiting, OM is experienced by many patients going through chemotherapy and radiotherapy. Every year in the US, 400,000+ patients suffer from OM(1) - inflammation and ulceration of the mucous membrane of the mouth that occurs after radiation to the head and neck and after chemotherapy(2). OM occurs in approximately 40% of patients receiving standard dose chemotherapy(3)(4) and this incidence increases to 80% in patients receiving high dose therapy(2).

The clinical manifestation of OM can include: severe pain; difficulty in eating, drinking, swallowing and speaking. These may, in turn, result in poor nutrition, weight loss, deterioration in quality of life and the delay, reduction or cessation of chemotherapy treatment(1)(3)(5)(6).

Gelclair is an FDA-approved medical device in the form of a dilutable gel, packaged in 15ml sachets. Patients mix the product with water then rinse the Gelclair solution around the mouth at least one hour before eating or drinking. Gelclair works by forming a barrier that protects the exposed nerve endings that cause pain. Study results have shown that Gelclair significantly reduces OM pain for five to seven hours after administration(7).

PROSTRAKAN

ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets.

ProStrakan's head office is situated in Galashiels in Scotland. The company's development capabilities are centred on Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain and other EU countries. http://www.prostrakan.com.

References:

1. ccc_mouth_pain.pdf (application/pdf Object) [Internet]. [cited 2009 Mar 9] Available from: http://www.cancercare.org/pdf/booklets/ccc_mouth_pain.pdf

2. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent. Clin. North Am. 2008; 52(1): 61-77, viii.

3. Köstler 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(5):290-315.

4. Gibson RJ, Bowen JM, Keefe DMK. Technological advances in mucositis research: new insights and new issues. Cancer Treat Rev. 2008; 34(5): 476-82.

5. Bellm LA, Epstein JB, Rose-Ped A, Martin P, Fuchs HJ. Patient reports of complications of bone marrow transplantation. Support Care Cancer. 2000; 8(1): 33-9.

6. D'Hondt L, Lonchey C, Andre, M, Canon, JL C. Oral mucositis induced by anticancer treatments: physiopathology and treatments. Ther Clin Risk Manag. 2006;2(2): 159-168.

7. Innocenti M, Moscatelli G, Lopez S. Efficacy of gelclair in reducing pain in palliative care patients with oral lesions: preliminary findings from an open pilot study. Journal of Pain and Symptom Management. 2002; 24(5): 456-7.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Douglas Neale
Visit website