Cumberland Pharmaceuticals (NSDQ:CPIX) said today that it acquired exclusive U.S. rights to Nordic Group‘s injectable methotrexate product line to treat rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis.
Nordic Group has registered the product line for patient use in European countries, so Cumberland will register and commercialize the products in the U.S.
According to the agreement, Cumberland is responsible for the FDA submission and registration process. The regulatory submission is expected to occur in the 1st half of 2017. Cumberland is also responsible for product launch and commercialization, which will include all marketing, promotion and distribution within the U.S.
Cumberland said it projects building to $40 million in annual sales over time for the methotrexate portfolio. The Nashville, Tenn.-based company will make milestone payments to Nordic following FDA approval and achievement of sales milestones. Nordic is responsible for manufacture and will receive a transfer price on supplies of the products, according to Cumberland.
Methotrexate has been shown to reduce inflammation and slow the progression of arthritis by interfering with cell growth in the body. Delivering the drug through a subcutaneous injection enables the patient to deliver a larger therapeutic dose and ensure maximum bioavailability. Cumberland said that its injection device provides patients that have reduced dexterity the option for self-injection with secure handling and more autonomy.
“We have worked to deliver innovative, patient friendly, and cost effective treatments for arthritis patients,” Nordic Group CEO Hans Schram said in prepared remarks. “These products have been successfully launched in Europe in 2016 and our agreement with Cumberland, and the upcoming U.S. launch, will be another significant step in their geographic expansion.”
“We continue to be very selective in the brands we choose to bring into our portfolio,” Cumberland CEO A.J. Kazimi added. “We believe that these innovative products from Nordic will be an excellent fit for our field based commercial division and their ongoing support of office based physicians. We look forward to bringing these Nordic products into the U.S. in order to better address the care of arthritis patients here.”
CPIX shares were trading at $5.30 apiece in mid-morning activity, up 6%.
