Amicus Therapeutics and GSK Announce Revised Fabry Agreement

Amicus Therapeutics and GSK Announce Revised Fabry Agreement

    Amicus Acquires Full Rights to Global Drug Development, Regulatory and
                   Commercial Activities for Migalastat HCl

   GSK Retains Interest through Additional Equity Investment in Amicus, and
                       Future Milestones and Royalties

                    Conference Call Today at 5:00 p.m. ET

CRANBURY, N.J. and LONDON, Nov. 20, 2013 (GLOBE NEWSWIRE) -- Amicus
Therapeutics (Nasdaq:FOLD) and GlaxoSmithKline (GSK) today announced that
Amicus has obtained global rights to develop and commercialize the
investigational pharmacological chaperone migalastat HCl as a monotherapy and
in combination with enzyme replacement therapy (ERT) for Fabry disease.

Key Highlights of Revised Agreement:

  *Amicus will have sole rights to the global drug development, regulatory
    and commercial activities for the next-generation Fabry ERT (migalastat
    HCl co-formulated with ERT) as well as migalastat HCl monotherapy.
  *GSK will be eligible for future regulatory and commercial milestone
    payments, as well as royalty payments.
  *GSK will further invest $3 million in Amicus through an equity investment
    in a concurrent private placement in public equity (PIPE) transaction.

Under the terms of the revised agreement, there is no upfront payment from
Amicus to GSK. For the next-generation Fabry ERT, GSK is eligible to receive
single-digit royalties on net sales in eight major markets outside the U.S.
For migalastat HCl monotherapy, GSK is eligible to receive post-approval and
sales-based milestones, as well as tiered royalties in the mid-teens in eight
major markets outside the United States. The terms of the revised agreement
replace the prior agreement in its entirety. Under the prior agreement entered
into in July 2012, Amicus and GSK were co-developing migalastat HCl globally
and GSK had rights to commercialize migalastat HCl outside the U.S.

Moncef Slaoui, Chairman of GSK R&D, commented, "With internal expertise and
established relationships within the rare disease community, we believe Amicus
is well positioned to maintain momentum of the programs, maximizing their
potential for success, which we hope will provide benefits to patients living
with Fabry disease. GSK will continue to support Amicus through our equity
investment and share in the future value of migalastat HCl as the Fabry
program meets certain regulatory and sales milestones."

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics,
Inc., stated, "This transaction is very important for Amicus and for our
future. It delivers what we believe to be immediate and significant value to
our shareholders while allowing us to maintain a strong relationship with GSK,
our largest shareholder. GSK has been an excellent active development partner
for us on these programs for three years. With this transaction we are gaining
worldwide rights to our first proprietary next generation co-formulated
product, as well as migalastat HCl monotherapy. We look forward to advancing
these programs to major milestones into 2014."

About Migalastat HCl

Migalastat HCl is an investigational pharmacological chaperone in development
as a monotherapy and in combination with ERT for the treatment of Fabry
disease. As a monotherapy, migalastat HCl is designed to bind to and
stabilize, or "chaperone" a patient's own alpha-galactosidase A (alpha-Gal A)
enzyme in those with genetic mutations that are amenable to this chaperone in
a cell-based assay. For patients currently receiving ERT for Fabry disease,
migalastat HCl in combination with ERT may improve ERT outcomes by keeping the
infused alpha-Gal A enzyme in its properly folded and active form.

Amicus Solo Conference Call and Webcast

Amicus Therapeutics will host a conference call and audio webcast today,
November 20, 2013 at 5:00 p.m. ET. Interested participants and investors may
access the conference call at 5:00 p.m. ET by dialing 877-303-5859
(U.S./Canada) or 678-224-7784 (international).

An audio webcast can also be accessed via the Investors section of the Amicus
Therapeutics corporate web site at, and will be
archived for 30 days. Web participants are encouraged to go to the web site 15
minutes prior to the start of the call to register, download and install any
necessary software. A telephonic replay of the call will be available for
seven days beginning at 8:00 p.m. ET today. Access numbers for this replay are
855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code

About Amicus Therapeutics

Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the
forefront of therapies for rare and orphan diseases. The Company is developing
novel, first-in-class treatments for a broad range of human genetic diseases,
with a focus on delivering new benefits to individuals with lysosomal storage
diseases. Amicus' lead programs include the small molecule pharmacological
chaperones migalastat HCl as a monotherapy and in combination with enzyme
replacement therapy (ERT) for Fabry disease; and AT2220 (duvoglustat HCl) in
combination with ERT for Pompe disease.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further
information please visit

Amicus Forward-Looking Statements

This press release contains, and the accompanying conference call will
contain, "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 relating to the ongoing collaboration
with GSK, preclinical and clinical development of Amicus' candidate drug
products, the timing and reporting of results from preclinical studies and
clinical trials evaluating Amicus' candidate drug products, and the projected
cash position for the Company. Words such as, but not limited to, "look
forward to," "believe," "expect," "anticipate," "estimate," "intend,"
"potential," "plan," "targets," "likely," "may," "will," "would," "should" and
"could," and similar expressions or words identify forward-looking statements.
Such forward-looking statements are based upon current expectations that
involve risks, changes in circumstances, assumptions and uncertainties. The
inclusion of forward-looking statements should not be regarded as a
representation by Amicus that any of its plans will be achieved. Any or all of
the forward-looking statements in this press release may turn out to be wrong.
They can be affected by inaccurate assumptions Amicus might make or by known
or unknown risks and uncertainties. For example, with respect to statements
regarding the goals, progress, timing and outcomes of discussions with
regulatory authorities and the potential goals, progress, timing and results
of preclinical studies and clinical trials, actual results may differ
materially from those set forth in this release due to the risks and
uncertainties inherent in the business of Amicus, including, without
limitation: the potential that results of clinical or pre-clinical studies
indicate that the product candidates are unsafe or ineffective; the potential
that it may be difficult to enroll patients in our clinical trials; the
potential that regulatory authorities may not grant or may delay approval for
our product candidates; the potential that preclinical and clinical studies
could be delayed because we identify serious side effects or other safety
issues; the potential that we will need additional funding to complete all of
our studies and, our dependence on third parties in the conduct of our
clinical studies. Further, the results of earlier preclinical studies and/or
clinical trials may not be predictive of future results. With respect to
statements regarding projections of the Company's cash position, actual
results may differ based on market factors and the Company's ability to
execute its operational and budget plans. In addition, all forward looking
statements are subject to other risks detailed in our Annual Report on Form
10-K for the year ended December 31, 2012. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date hereof. All forward-looking statements are qualified in their entirety by
this cautionary statement, and Amicus undertakes no obligation to revise or
update this news release to reflect events or circumstances after the date
hereof. This caution is made under the safe harbor provisions of Section 21E
of the Private Securities Litigation Reform Act of 1995.

Amicus Contact:

Investors/Media: Sara Pellegrino (609) 662-5044/

Media: Dan Budwick (973) 271-6085 /

GSK enquiries:                                              
UK Media enquiries:         David Mawdsley       +44 (0) 20   (London)
                                                 8047 5502
                           Simon Steel          +44 (0) 20   (London)
                                                 8047 5502
                           David Daley          +44 (0) 20   (London)
                                                 8047 5502
                           Catherine Hartley    +44 (0) 20   (London)
                                                 8047 5502
US Media enquiries:         Stephen Rea          +1 215 751   (Philadelphia)
                           Melinda Stubbee      +1 919 483   (North Carolina)
                           Mary Anne Rhyne      +1 919 483   (North Carolina)
                           Sarah Alspach        +1 202 715   (Washington, DC)
                           Jennifer Armstrong   +1 215 751   (Philadelphia)
Analyst/Investor enquiries: Sally Jackson        +44 20 8047  (London)
                           Kirsty Collins (SRI  +44 20 8047  (London)
                            & CG)                5534
                           Tom Curry            + 1 215 751  (Philadelphia)
                           Gary Davies          + 44 (0) 20  (London)
                                                 8047 5503
                           James Dodwell        + 44 (0) 20  (London)
                                                 8047 2406
                           Jeff McLaughlin      + 1 215 751  (Philadelphia)
                           Ziba Shamsi          + 44 (0) 20  (London)
                                                 8047 3289
                           Lucy Singah          +44 (0) 20   (London)
                                                 8047 2248

GSK Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect GSK' s operations are described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

Press spacebar to pause and continue. Press esc to stop.