Oct. 29, 2009 (PR Newswire) -- CRANBURY, N.J., Oct. 29 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD) today announced financial results for the third quarter 2009. Additionally, Amicus also today announced that it has reacquired all global development and commercialization rights from its partner, Shire, for its lead lysosomal storage disease programs as a result of the parties' mutual termination of their collaboration. The Company also announced a workforce reduction of approximately 20 percent and provided cash guidance into the second half of 2011.

Amicus/Shire Collaboration Mutual Termination:

Amicus and Shire have reached a mutual termination agreement with respect to their collaboration to jointly develop Amicus' three lead pharmacological chaperone compounds for the treatment of lysosomal storage disorders, effective immediately. As a result of this agreement, Amicus has regained exclusive worldwide rights to develop and commercialize Amigal(TM) (migalastat hydrochloride), Plicera(TM) (afegostat tartrate) and AT2220 (1-deoxynojirimycin HCl) outside of the United States (U.S.) and now owns worldwide rights for these programs. Shire will pay Amicus $5.2 million in the fourth quarter as full and final payment for any amounts that may be due to the Company under the collaboration, and both parties will be relieved of all other future obligations, financial or otherwise.

John F. Crowley, President and CEO of Amicus Therapeutics stated, "Shire has been an excellent partner to work with during the past two years. However, reacquiring the ex-U.S. commercial rights to Amigal furthers our desire to enhance the value of that program for our shareholders. Since Shire and Amicus mutually concluded that Plicera will not move forward to Phase 3 development in Gaucher disease, having global rights to Amigal was of critical importance to Amicus."

Amicus will continue to manage global clinical operations for Amigal Phase 3 development and expects to initiate more than thirty investigational sites worldwide. As previously announced, the first global Phase 3 Amigal study is a 60 patient randomized, double-blind placebo controlled six month study intended to support U.S. registration. The primary surrogate endpoint agreed to with the U.S. Food and Drug Administration (FDA) is a histological evaluation of the change in GL-3 levels in the interstitial capillary cells of the kidney. The first patient was randomized into this study in mid-October. The Company estimates it will complete enrollment for this trial by the end of 2010 and expects to have data available in mid-2011. A separate Phase 3 study for registration in the European Union comparing Amigal with Fabrazyme® is required by the European Medicines Agency (EMEA). Amicus expects to provide a further update on that proposed study for the EMEA in 2010 as the supply constraints with Fabrazyme become clearer.

Key Strategic Priorities and Workforce Reduction:

As part of its strategic business plan, Amicus will focus its resources in three key areas:

--  The Phase 3 development of Amigal for Fabry disease;
--  Advancement of its lead pre-clinical programs that utilize its
pharmacological chaperone technology for the treatment of diseases of
neurodegeneration.  The Company has an advanced pre-clinical program in
Parkinson's disease, as well as an earlier stage pre-clinical program in
an as yet undisclosed neurodegenerative target disease; and

--  Advancement of pharmacological chaperones used in combination with
enzyme replacement therapies (ERT) for the treatment of lysosomal
storage diseases.

"By focusing our resources on these three value creating centers within Amicus, we will balance the execution of our global late stage clinical program in Fabry disease with continued significant investment with the chaperone platform in diseases of neurodegeneration, which continue to yield very exciting near-term and long-term potential value for the Company. The chaperone-ERT combination approach is also one of potentially significant value for Amicus shareholders as a further extension of our technology," said John F. Crowley.

The Company also announced today a work-force reduction of approximately 20 percent, or 26 employees, as a part of a corporate restructuring, with reductions occurring across all levels and organizations within the Company. In addition, Amicus is terminating its relationship with approximately 17 contractors currently working at the Company. Amicus is taking this step to reduce costs and to align its resources with its key strategic priorities. The Company estimates that it will record charges of approximately $0.9 million during the fourth quarter of 2009 for employment termination costs payable in cash in connection with the workforce reduction.

"After extensive review of our business plan, we have made some very difficult decisions to restructure our workforce to best enable us to align the Company around the three key strategic priorities for Amicus going forward," said John F. Crowley. "Specifically, we expect that these changes will enable our current cash to last into the second half of 2011. It is exceptionally difficult to implement these employee changes as so many remarkably dedicated and talented persons, including Jim Dentzer, our Chief Financial Officer, will be leaving Amicus. All of them have contributed significantly to the Company, and I cannot thank them enough for all of their tireless efforts, passion and contributions."

"We are highly confident that with this restructuring and strategic repositioning, we are well poised to maximize shareholder value while ensuring that we deliver on our mission to provide innovative and high quality therapies to people afflicted with these diseases. We remain fully committed to the success of Amicus," concluded John F. Crowley.

Financial Guidance:

Based on current projections of net operating expense, the Company reiterates its expectation to end 2009 with approximately $70-$80 million in cash, cash equivalents and marketable securities. Additionally, the Company expects that its current cash, cash equivalents and marketable securities together with the fourth quarter $5.2 million payment from Shire will be sufficient to fund operations and capital expenditure requirements into the second half of 2011.

Third Quarter 2009 Results Summary

On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Amicus announced a net loss attributable to common stockholders of $0.59 per share ($0.51 per share on a non-GAAP basis) for the three months ended September 30, 2009. As of September 30, 2009, cash, cash equivalents and marketable securities totaled $89.3 million.

Clinical Program Updates

Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease

In the second quarter of 2009, Amicus announced that the Company reached agreement with the FDA on the key protocol design elements of its pivotal trial, including the use of the surrogate primary endpoint of the change in the amount of kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for Amigal according to Subpart H regulations.