(Pr)OTEZLA® (apremilast tablets), First in a New Class of Oral Treatment, Receives Health Canada Approval for Plaque Psoriasis

Treatment for lifelong skin disease that affects nearly a million Canadians showed significant and clinically meaningful improvements in clinical studies

Canadian approval comes just weeks after first global approval for the psoriasis indication by the United States FDA

MISSISSAUGA, ON, Nov. 18, 2014 /CNW/ - Celgene Corporation today announced the approval of ^PrOTEZLA^® (apremilast tablets) by Health Canada for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Canadians with this inflammatory skin disorder will now have a new oral treatment option available to them. This is newsworthy for the patient community. Psoriasis affects 1 million Canadians, with plaque psoriasis being the most common type, affecting approximately 90 per cent of patients.ⁱ

OTEZLA is the first in a new class of oral treatment for psoriasis, acting as an inhibitor of phosphodiesterase 4 (PDE4), which plays an important role in the chronic inflammation associated with the development of skin symptoms in psoriasis.ⁱⁱ Canada is the second country to approve OTEZLA for plaque psoriasis, following the first worldwide approval in this indication by the United States Food and Drug Administration on September 23.ⁱⁱⁱ

"The approval of OTEZLA is a signature event for Canadians with plaque psoriasis. For patients whose symptoms are not adequately controlled with their current treatment OTEZLA provides an additional option. Clinical studies have shown that OTEZLA is effective and has a generally favourable safety profile," said Dr. Kim Papp, a dermatologist and Founder and President of Probity Medical Research in Waterloo, Ontario. "As the first PDE4 inhibitor to treat this disease, it is likely to become a very useful and effective option for psoriasis patients. This is especially good news for newly diagnosed patients with moderate to severe plaque psoriasis and also for my treatment-experienced patients." 

"The approval of this new option for plaque psoriasis is welcome news because it is a novel treatment that has shown both effectiveness and a generally favourable safety profile in studies," said Dr. Yves Poulin, a dermatologist with the Centre dermatologique du Québec métropolitain (CDQ) in Quebec City. "OTEZLA is an important addition to the treatment choices we currently have because there are patients who are not able to adequately manage their symptoms with  available treatment options, including topicals, phototherapy or traditional systemic agents. This new option is an important advance for patients who have to live with this lifelong and difficult condition."

Psoriasis is an immune-mediated, non-contagious chronic inflammatory skin disorder with no known cause. Existing systemic therapies for psoriasis include conventional oral treatments as well as biologic therapies which must be administered by injection.

"Plaque psoriasis, simply put, is not easy to live with. Some patients are able to manage the disease while others struggle with different treatments. Having a new treatment is definitely good news for patients living with this type of psoriasis. The fact that it is taken orally can be a bonus for the patient," said Christine Janus, Executive Director of the Canadian Association of Psoriasis Patients (CAPP). "Bottom line, the more options patients have available, the more likely they will find something that will help them manage their disease, which is the goal we all seek."

ESTEEM 1 and ESTEEM 2 study results^iv

The approval of OTEZLA was based primarily on safety and efficacy results from two multi-centre, randomized, double-blind, placebo-controlled studies – ESTEEM 1 and ESTEEM 2 – conducted in approximately 1,250 adult patients with moderate to severe plaque psoriasis: body surface area (BSA) involvement of ≥10%, static Physician Global Assessment (sPGA) of ≥3 (moderate or severe disease), Psoriasis Area and Severity Index (PASI) score ≥12, and candidates for phototherapy or systemic therapy.

OTEZLA treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI scores at week 16. Clinical improvement as measured by sPGA scores of clear to almost clear were also demonstrated in both studies.

About OTEZLA
OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients with psoriasis   is not well defined.

OTEZLA has not been studied and is therefore not indicated in combination with other systemic (conventional or biologic) therapies or phototherapy for psoriasis.

The safety of OTEZLA was assessed in the ESTEEM 1 and ESTEEM 2 clinical trials.  Common side effects of OTEZLA were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Before starting OTEZLA, patients should inform their doctor if they have a history of depression or suicidal behavior and if these conditions or other mood changes develop or worsen while taking OTEZLA. Patients taking OTEZLA should have their weight checked regularly.

Please refer to the OTEZLA Product Monograph for complete contraindications, warnings and precautions and safety information^v. To obtain a copy of the OTEZLA Product Monograph, call 1-888-712-2353.

OTEZLA will be commercially available in Canada in the coming weeks.

About psoriasis
Psoriasis is a chronic recurring condition which varies in severity from minor localized patches to complete body coverage. Plaque psoriasis is the most common type of psoriasis. About 90 per cent of people who develop psoriasis have plaque psoriasis, which appears as patches of raised, reddish skin covered by silvery-white scales. These patches, or plaques, frequently form on the elbows, knees, lower back and scalp. Psoriasis occurs nearly equally in males and females. Psoriasis is believed to be most common in Caucasians and slightly less common in other ethnic groups. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.

About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.

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ⁱ Canadian Dermatology Association, Living with Psoriasis, accessed at: http://www.dermatology.ca/skin-hair-nails/skin/psoriasis/#!/skin-hair-nails/skin/psoriasis/living-with-psoriasis/ 
ⁱⁱ Schett G, Elewaut D, McInnes IB, Dayer JM, Neurath MF. How cytokine networks fuel inflammation: Toward a cytokine-based disease taxonomy. Nat Med. Jul 2013;19(7):822-824, cited at: http://discoverpde4.com/ 
ⁱⁱⁱ Celgene Corporation., Oral OTEZLA^® (apremilast) Approved by the U.S. Food and Drug Administration for the Treatment of Patients with Moderate to Severe Plaque Psoriasis, Press release, Sept. 23, 2014 accessed at: http://ir.celgene.com/releasedetail.cfm?ReleaseID=872240
^iv Reich K, Papp K, Leonardi C, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe psoriasis: 16-week results of a phase III, randomized, controlled trial (Esteem 1). Late breaking abstract presented at: 71st Annual Meeting of the American Academy of Dermatology (AAD). Miami Beach, FL USA: 2013.

Paul C, Crowley J, Cather J, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe psoriasis: 16-week results of a phase 3, randomized, controlled trial (ESTEEM 2). J Am Acad Dermatol. 2014;70(5Suppl 1):AB164. Abstract No:P8412
^v Celgene Corporation. OTEZLA (apremilast tablets) Product Monograph. November 12, 2014.

^®OTEZLA is a registered trademark of Celgene Corporation

SOURCE: Celgene Corporation

Natalie Pavlenko, Weber Shandwick for Celgene, 416 642 7939, [email protected]; Victoria Cacioppo, Weber Shandwick for Celgene, 416 642 7916, [email protected]