AMGN In The Race For Humira Biosimilar, EXEL On Watch, IPXL Gets EC Nod

(RTTNews) - Amgen (AMGN) has submitted its Biologics License Application with the FDA for ABP 501, a biosimilar candidate to AbbVie's (ABBV) Humira. The filing represents Amgen's first BLA submission using the 351(k) biosimilar pathway.

Humira, which is used to treat rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis and ankylosing spondylitis, was the world's top-selling drug last year - with global sales of $12 billion.

Amgen is not the only one to have set eyes on Humira. The first biosimilar version of Humira was launched in India by Zydus Cadila last December, under the name Exemptia. Novartis (NVS), Boehringer Ingelheim and Coherus Biosciences are the other companies developing a biosimilar version of Humira.

While biosimilar products have been available in Europe since 2006, it was only very recently did the FDA give green light to the first biosimilar product in the U.S. - to Novartis' Zarxio.

Zarxio is biosimilar to Amgen's white blood cell booster Neupogen. Approved by the FDA on March 6, 2015, Zarxio was launched in the U.S. in September, priced at 15% discount to Neupogen. Zarxio has been available in Europe since 2009.

AMGN closed Wednesday's trading at $163.95, up 0.72%.

Cellceutix Corp.'s (CTIX.OB) drug candidate Brilacidin-OM for the prevention of oral mucositis has been granted Fast Track Designation by the FDA.

In an ongoing phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer.

CTIX.OB closed Wednesday's trading at $1.79, up 13.96%.

Impax Laboratories Inc.'s (IPXL) combo drug NUMIENT has been approved by the European Commission for the symptomatic treatment of adult patients with Parkinson's disease. The active substances of NUMIENT are Levodopa and Carbidopa.

In the U.S., NUMIENT is marketed under the name Rytary, which has been available since February of this year.

IPXL closed Wednesday's trading at $44.72, up 1.45%.

Roche Holding AG's (RHHBY.OB) COTELLIC has been approved by the European Commission for use in combination with its drug Vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

This is COTELLIC's third regulatory approval, following approval in Switzerland in August 2015 and in the U.S. early this month.

COTELLIC was licensed from Exelixis Inc. (EXEL) in 2006. Under the collaboration agreement, Exelixis is eligible to receive low double-digit royalties on sales of COTELLIC outside the United States.

In the United States, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote COTELLIC in the United States and will field 25 percent of the U.S. sales force.

EXEL closed Wednesday's trading at $5.49, down 0.18%.