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Amicus Update on Strategy, Guidance

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Amicus Therapeutics (FOLD - Free Report) participated in the 32nd annual J.P. Morgan Healthcare Conference. The presentation focused on its strategic outlook and financial guidance for 2014.

Amicus’ strategy is to advance the development of next-generation Enzyme Replacement Therapies (ERTs). Amicus will enter the clinic with lead programs in Fabry, Pompe and mucopolysaccharidosis I (MPS I) in the year 2014, 2015 and 2016 respectively. The proof-of-concept preclinical data for next-generation ERTs for Fabry and Pompe will be presented in the first half of 2014.

Amicus expects cash, cash equivalents and marketable securities of $82.0 million as of Dec 31, 2013. Amicus expects 2014 net cash spend in the range of $54 million to $59 million. The company predicts that the current cash position should fund operations into the second half of 2015.  

Amicus and GlaxoSmithKline (GSK - Free Report) are conducting two phase III studies – FACETS Study and ATTRACT Study – to investigate migalastat HCl monotherapy in patients with Fabry’s disease. Data from FACET study is expected in the second quarter this year and the top-line data from the ATTRACT study is expected in the second half of 2014.

We note that the Amicus-Glaxo collaboration for migalastat HCl dates back to 2010. This agreement was amended in Nov 2013. As per the agreement, Amicus will have the sole worldwide rights to develop and commercialize migalastat HCl (both as monotherapy and in combination with ERT) for Fabry’s disease. 

Amcius currently carries a Zacks Rank #2 (Buy). Better-ranked stocks include Lannett Company, Inc. (LCI - Free Report) and Endocyte, Inc. (ECYT - Free Report) . Both these stocks carry a Zacks Rank #1 (Strong Buy).

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