ARIAD Pharmaceuticals, Inc. (ARIA) announced its key strategic objectives for 2015 as well as its aim to increase research and development (R&D) activities and expand business development initiatives. Details will be discussed at the annual J.P. Morgan Healthcare Conference.
For the year ended Dec 31, 2014, ARIAD expects net sales of Iclusig to be approximately $55 million. License revenues are expected at about $45 million. Additionally, ARIAD anticipates R&D expenses to be approximately $120 million, below the previous guidance of $125 million – $130 million. Selling, general and administrative expenses are expected to come at around $140 million.
Pipeline Update
ARIAD is working on further studying its lead product, Iclusig, in earlier lines of therapy. We note that the drug is already approved in the U.S. and Europe for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. The company expects Iclusig to be approved in Canada and Israel in 2015 and in Japan in 2016.
Meanwhile, ARIAD intends to initiate three studies on Iclusig in 2015. The first phase III study will evaluate Iclusig in comparison to Novartis’ (NVS) Tasigna for the second-line treatment of patients suffering from chronic-phase CML who failed Gleevec therapy. Patient enrollment is expected to commence in the second half of 2015. This study is expected to be will be vital in potentially expanding Iclusig into earlier lines of treatment.
Secondly, the company intends to start enrolling patients in a dose-ranging, third-line study on Iclusig in chronic-phase CML patients, who have previously shown resistance to at least two tyrosine kinase inhibitors, by mid-2015.
Thirdly, ARIAD will begin an investigator-sponsored early-switch study (SPIRIT3) on Iclusig for the second-line treatment of chronic-phase CML patients in the UK in the first half of 2015.
Additionally, ARIAD expects to sign a collaboration agreement in 2015 for the co-development and co-commercialization of its lung cancer candidate, brigatinib (AP26113). The company will likely file for the candidate’s approval (currently being evaluated in the phase II ALTA study) in mid-2016. Brigatinib received Breakthrough Therapy status from the FDA in Oct 2014 for the treatment of patients with anaplastic lymphoma kinase positive metastatic non-small cell lung cancer who are resistant to Pfizer’s (PFE) Xalkori. This designation may accelerate the candidate’s regulatory approval timeline.
Strategic Moves Toward Profitability
Meanwhile, ARIAD is considering strategic investment options in order to leverage its commercial presence in the U.S. and 16 major countries in the EU. Besides, the company said that it will be able to fund its operations without the need for additional equity capital once it enters into a partnership related to brigatinib. 2018 is expected to mark the beginning of the company funding its own operations without additional equity financing.
ARIAD expects its strategic initiatives pertaining to R&D and business development activities to lead to sustained profitability starting in 2018, when it expects its global product revenues to cross $400 million driven by Iclusig revenue growth in the U.S., Europe and other new geographies (including Japan, Canada and Israel).
ARIAD carries a Zacks Rank #3 (Hold). A better-ranked stocks in the pharmaceutical sector is Endo International plc (ENDP), carrying a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment