Chronic remitting pouchitis


Medical Need enters into a collaboration with Atlantic Pharmaceuticals on first-in-class therapy for inflammatory bowel disease

Medical Need, Stockholm Sweden and Atlantic Pharmaceuticals Ltd, Cambridge UK, announced today that they have entered into an exclusive agreement relating to, Alicaforsen enema, in development for the treatment of inflammatory bowel disease (IBD). Under the agreement, Medical Need will, on request, provide the product in Denmark, Finland, Iceland, Norway and Sweden and will be responsible for supply in this territory under international and national named patient regulations.

The enema product has been investigated in five Phase II IBD clinical studies. It is commencing a Phase III program which includes single pivotal studies in Orphan indication pouchitis as well as acute distal ulcerative colitis where patients no longer are responding to first-line therapy. With no cure for the disease, up to 40% of patients with ulcerative colitis will progress to and require surgery to remove diseased tissue.

Inflammatory Bowel Disease (IBD) collectively refers to Crohn’s disease and Ulcerative colitis, chronic autoimmune conditions in which the body’s immune system attacks the mucosal lining of the gastro-intestinal system. Alicaforsen utilizes a technology called anti-sense RNA, to suppress the cellular expression of a key protein in the inflammatory cascade, ICAM-1, thereby reducing inflammation. Alicaforsen is administered as a rectal solution, thus focusing its effect locally in the area of disease without significant systemic exposure.

“We are very happy to initiate this partnership with Atlantic Pharmaceuticals” said Kennet Rooth, COO of Medical Need, and continued, “IBD can cause significant suffering for patients with moderate-severe disease, for which there are limited treatment options. The clinical studies conducted to date with Alicaforsen enema show that it has the potential to be a safe and effective option for alleviating the underlying inflammation and symptoms in specific situations, including pouchitis, where there are currently no approved treatments.”

Amjid Shah, European Medical Liaison Manager of Atlantic Pharmaceuticals Ltd said, “We are delighted to be able to provide local access to Alicaforsen through Medical Need where regulating authorities have approved named patient use of Alicaforsen for patients in need of treatment”.

Alicaforsen has been granted Orphan drug designation by the EMA for the treatment of pouchitis within the EU, which following marketing authorization provides up to 12 years of market exclusivity. The product has, upon request from prescribing physicians, been used on a so called named patient basis across Europe and further afield, under special license approval from the national regulatory authorities.

For further information, please contact:

Medical Need
Peder Walberg, CEO
Email: peder.walberg@medicalneed.com

Atlantic Pharmaceuticals Ltd
Amjid Shah, Medical Liaison Manager – Europe
M: +44 7850 647767
Email: amjid.shah@atlantichc.com

Editors Notes and Further Information

About Inflammatory Bowel Disease (IBD) and pouchitis

It is estimated that between 2.5 and 3 million patients in the European Union suffer from Inflammatory Bowel Disease (IBD). IBD is used to collectively refer to Crohn’s disease and Ulcerative colitis (UC), chronic autoimmune conditions in which the body’s immune system attacks the mucosal lining of the gastro-intestinal tract. Typical symptoms include frequent diarrhea with blood, pus and/or mucus, stomach pain, fever and weight loss. The symptoms and severity vary between individuals and over time, and usually takes a relapse-remitting character with periods of worse symptoms (flares) followed by longer periods with less or no symptoms. Flares may be triggered by various things, such as stress, infection or diet, but may also occur without any obvious trigger. Drug therapies slow progression of the disease. In severely affected patients or during severe flares, patients may require hospitalization and may require surgery to remove diseased bowel tissue. Pharmacological treatment typically includes systemic and/or topical anti-inflammatory agents, ranging from mesalazine and cortisone to methotrexate and anti-TNF antibodies.

Up to 40% of patients require surgery and removal of the whole of the large intestine (colon). In the majority of cases, further surgery is undertaken to create a pouch of small intestine, which acts as a fecal reservoir. Over time, the pouch can become subject to a chronic and resilient inflammation, called pouchitis, which causes symptoms such as diarrhea, increased defecation, incontinence, bleeding, cramps, fever and dehydration. Pouchitis is a long-term debilitating disease that has a large impact on the quality of life of patients particularly because of incontinence and dehydration. In addition, if such pouchitis is not possible to control , the only remaining option for the patient may be to undergo surgery to remove the pouch and have an ostomy, whereby feces is collected in a plastic bag attached to the patient’s intestine through a stoma in the abdomen. It is estimated that approximately 100,000 individuals in the EU are suffering from pouchitis at any one point in time. There are currently no pharmaceuticals approved for the treatment of pouchitis within the EU or elsewhere in the world.

About Alicaforsen

Alicaforsen belongs to a class of pharmaceuticals called antisense RNA-inhibitors, which act in a targeted way by blocking certain sequences of RNA, thereby preventing the production of specific proteins in the cells. Alicaforsen exerts its anti-inflammatory activity by inhibiting the expression of the protein ICAM-1, a key molecule in the inflammatory cascade, responsible for the adherence, mobilization and activation of white blood cells. White blood cell recruitment and activation is a critical step for the propagation and upkeep of inflammation in the affected tissue.

Alicaforsen is delivered locally as a rectal solution, thus focusing its anti-inflammatory effects topically and locally on the intestinal mucosa, with very limited systemic exposure. To date, five Phase II studies of Alicaforsen enema have been undertaken involving approximately 400 patients for the treatment of ulcerative colitis and/or pouchitis. Additionally, approximately 800 patients have received Alicaforsen systemically as an intravenous infusion. Phase III trials are commencing, in both chronic unremitting pouchitis and severe distal ulcerative colitis. The product has, on request from a prescribing physician, also been provided across Europe and elsewhere, on a named patient basis, under special license approval by regulatory authorities in several countries.

There is a significant unmet medical need in the field of IBD, where there are limited treatment options. Currently there are no products approved in the European Union for the treatment of pouchitis. The product holds an orphan drug designation within the EU, which following marketing authorization will render the product at least ten years of market exclusivity.

About Atlantic Pharmaceuticals Ltd

Atlantic Pharmaceuticals Ltd is a member of the Atlantic Healthcare plc group of companies and is an international specialty pharmaceutical group, focused on the development and commercialisation of products that address niche unmet needs of patients under the management of physicians in the hospital and specialist care sector. .Atlantic Pharmaceuticals is focused on the key markets of Europe (“EU”) and the United States (“US”), within the global hospital specialist sector.. Atlantic Pharmaceuticals Ltd is currently completing clinical development of Alicaforsen enema and based on request from specialist physicians in many countries, provide the product after national health authorities have granted permission for so called Named Patient use.

Further information on Atlantic Healthcare can be found on the Company’s website: www.atlantichc.com

 

For additional information, please contact either Medical Need Europe AB, COO Kennet Rooth, on tel. +46 702 741 553 (kennet.rooth@medicalneed.com) or Atlantic Pharmaceuticals Ltd, Amjid Shah, Medical Liaison Manager – Europe
tel: +44 7850 647767 (amjid.shah@atlantichc.com)