Amicus Therapeutics Strengthens Biologics Business Strategy
Callidus Biopharma Acquisition Adds Next-Generation Pompe ERT and Enzyme
Revised Agreement with GSK Provides Global Development & Commercial Rights to
Next-Generation Fabry ERT
Company Funded into Late 2015 with $40 Million in Equity and Expected Debt
Conference Call Today at 5:00 p.m. ET
CRANBURY, N.J., Nov. 20, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics
(Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for
rare and orphan diseases, today announced a broad strengthening of its
biologics business strategy. The details of this important strategic
repositioning, updates on all development programs, and upcoming milestones
will be discussed during a conference call and webcast at 5:00 p.m. ET today.
-- Amicus now owns exclusive worldwide rights to three next-generation Enzyme
Replacement Therapies (ERTs) in preclinical development.
*Callidus Biopharma acquisition adds next-generation Pompe ERT and
complementary enzyme targeting technologies.
*Revised GSK collaboration provides full ex-US rights to next-generation
*Next-generation ERT for MPS I continues to be supported by a grant from
anonymous U.S.-based donor
-- Current cash, including $40 million in equity and expected debt financing,
anticipated to fund operating plan into late 2015.
-- Organization restructured and realigned to support next-generation
biologics development strategy, saving approximately $4.0 million annually.
-- Monotherapy programs in ongoing Phase 3 studies for Fabry disease and in
preclinical studies for Parkinson's disease.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics,
Inc., stated, "Today marks a bold step forward for Amicus shareholders and the
orphan disease community, especially patients with Fabry, Pompe and MPS I.
With the culmination of several transformative business development
transactions and a new financing, we are advancing an Amicus that is better
resourced and more sharply focused toward our valuable biologics business. Not
only do we own global rights to all of our CHART and Fabry monotherapy
programs, but we have also brought in a uniquely engineered, proprietary
next-generation ERT in late preclinical development for Pompe disease. We
believe we now have the optimal set of technologies, portfolio, financing and
leadership team to be able to advance our vision of developing improved
therapies for people living with many rare and orphan diseases."
Callidus Biopharma Acquisition
Amicus has acquired Callidus Biopharma, a privately-held biologics company
focused on developing best-in-class enzyme replacement therapies (ERTs) for
lysosomal storage diseases (LSDs). Callidus' lead ERT is a recombinant human
acid-alpha glucosidase (rhGAA) for Pompe disease in late preclinical
development. This Pompe ERT has shown superior uptake and activity when
compared to Lumizyme^® in preclinical studies, and may be further improved by
incorporating Amicus' pharmacological chaperone AT2220 as a stabilizer to
potentially enhance tissue uptake and reduce the immunogenicity of the ERT.
Callidus' enzyme targeting technology is also applicable to multiple ERTs.
These Callidus assets complement Amicus' CHART™ platform for the development
of bio-betters for multiple LSDs.
"We believe that this is a highly synergistic strategic combination," said Mr.
Crowley. "With the addition of Callidus' Pompe program, we can move a
next-generation Pompe ERT into the clinic in early 2015, approximately 12
months faster than our internal Pompe program. Even more significantly, we
believe that the Callidus ERT for Pompe is a highly innovative and potentially
superior ERT due to its carbohydrate structure which should provide for
greater uptake of the ERT into target muscle cells in Pompe patients. For
these reasons we believe that the best course forward for patients is to
advance the next-generation ERT as quickly as possible instead of the planned
Phase 2 study of AT2220 co-administered with ERT. In addition, we believe
Callidus' targeting technology complements our CHART platform and can be used
together to develop bio-better ERTs."
Under terms of the agreement, Callidus shareholders will receive $15 million
in shares of Amicus common stock; up to $10 million in milestone payments
through Phase 2 development of the Pompe program; and up to $105 million for
the achievement of late-stage development, regulatory, and approval milestones
spread across three products. In conjunction with the transaction, Hung Do,
PhD, Founder and Chief Scientific Officer of Callidus Biopharma, has been
appointed Amicus' Senior Vice President, Discovery Biology. Dr. Do has nearly
fifteen years of experience in the field of LSDs and ERTs while working at
Novazyme, Genzyme, Amicus, and Callidus.
$40 Million in Equity and Expected Debt Financing
Amicus has secured approximately $40 million in equity and expected debt
*$15 million was raised in a private placement of 7.5 million shares of
common stock priced at $2.00 per share, plus the issuance of warrants to
purchase an additional 1.6 million shares at $2.50/share, with a one-year
term exercisable between July 1, 2014 and June 30, 2015. Participants were
Redmile Group and GSK.
*$25 million in debt financing expected to close in coming weeks, at a cost
of capital of less than 10%, with no warrant coverage
The Company projects that the current cash position, including the proceeds
from the private placement and debt financings, are sufficient to fund
operations into late 2015.
Amicus has additionally restructured the organization to reduce costs and to
align its resources with its biologics business strategy. The workforce,
including full-time employees across all levels and departments, has been
reduced by approximately 14% to 91 employees. Amicus will also close its San
Diego research facility and will consolidate all operations at its Cranbury,
NJ headquarters. As part of this restructuring, David J. Lockhart, PhD, will
step down from his role as Chief Scientific Officer and will continue as a
member of Amicus' Scientific Advisory Board.
"In broadening our biologics business strategy, and as part of our commitment
to judiciously manage our cash flow, we have had to make some difficult
decisions in restructuring and realigning our organization," said Mr. Crowley.
"These employees have made significant contributions during their time at
Amicus. On behalf of the executive team and our board of directors, I am very
grateful for their commitment to Amicus during their time here and wish them
well in their future endeavors, especially Dr. David Lockhart, our Chief
Scientific Officer who will be leaving Amicus. David is a brilliant scientist
and has been a great leader for Amicus. As our strategy evolves towards a
focus on the development of next-generation ERTs, I look forward to working
with David as a member of our Scientific Advisory Board."
The company estimates that it will record charges of approximately $2.5
million during the fourth quarter of 2013 for employment termination costs
payable in cash in connection with the workforce reduction, as well as
facilities closing costs. The restructuring is expected to save approximately
$4.0 million annually.
Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today,
November 20, 2013 at 5:00 p.m. ET to discuss the strengthening of its business
strategy. 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
An audio webcast can also be accessed via the Investors section of the Amicus
Therapeutics corporate web site at http://www.amicusrx.com, 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 Chaperone-Advanced Replacement Therapy (CHART)
The Chaperone-Advanced Replacement Therapy (CHART™) platform combines unique
pharmacological chaperones with enzyme replacement therapies (ERTs) for
lysosomal storage diseases (LSDs). Amicus is leveraging the CHART platform to
develop proprietary next-generation therapies that consist of lysosomal
enzymes co-formulated with pharmacological chaperones.
In a chaperone-advanced replacement therapy, a unique pharmacological
chaperone is designed to bind to and stabilize a specific therapeutic enzyme
in its properly folded and active form. This proposed CHART mechanism may
allow for enhanced tissue uptake of active enzyme, greater lysosomal activity,
more reduction of substrate, and lower immunogenicity compared to ERT alone.
Improvements in enzyme stability may also enable more convenient delivery of
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 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, financing plans, 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.
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