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Amicus Therapeutics Inc.

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Migalastat for Fabry Disease

Migalastat is an oral personalized medicine intended to treat Fabry disease in patients who have amenable genetic mutations. Amicus has built a commercial organization that is prepared to launch migalastat upon approval in the EU and other international territories.

The European Medicines Agency's (EMA) review of the Marketing Authorisation Application (MAA) for migalastat is currently in progress. Amicus provided an Oral Explanation before the CHMP in February 2016, which included members of the Amicus team and Key Opinion Leaders from the Fabry treatment community. An Oral Explanation is part of the MAA process for many novel orphan drugs, and the Opinion will often follow in a subsequent CHMP meeting. Following the Oral Explanation, Amicus is likely to receive the Opinion for migalastat at the next CHMP meeting (March 29 - April 1, 2016), which is consistent with prior Company guidance.

In the U.S., the Company is on track to complete the Integrated Safety Summary across all clinical studies as well as the additional data analyses from existing Phase 3 studies, as requested by the U.S. Food and Drug Administration (FDA). Specifically, the Company has collected and analyzed additional histopathology data and gastrointestinal symptom data, as well as longer-term renal and cardiac data across both Phase 3 clinical studies. The Company expects to meet with the FDA in the second quarter of 2016 to present these data and discuss a potential pathway to submit a New Drug Application (NDA) for migalastat in the U.S.

Anticipated Upcoming Fabry Disease Program Milestones:

Oral presentations and posters at WORLDSymposium™ 2016 in San Diego (February 29 - March 3, 2016)
CHMP Opinion in EU
FDA meeting and U.S. regulatory update
Publication of migalastat Fabry Clinical Study 011 in top-tier medical journal
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Source: press release, 2/26/16. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=957422

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Amicus has made significant progress in building the commercial organization and preparing for the launch of migalastat in Europe and other international geographies. The European Medicines Agency's (EMA) review of the marketing authorization application (MAA) for migalastat remains on track under accelerated assessment. The Day 120 questions have been received and Amicus continues to expect an opinion from the Committee for Medicinal Products for Human Use (CHMP) in late 2015 or early 2016. As previously reported, the timing of an NDA submission in the U.S. will be based on the determination of the optimal regulatory pathway. An update on the U.S. strategy for migalastat will be provided by Amicus in the first quarter of 2016.
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Source: press release, 11/03/15. http://ir.amicustherapeutics.com/common/mobile/iphone/releasedetail.cfm?...

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Amicus Therapeutics Announces Galafold(TM) Marketing Authorization Application (MAA) Validated by European Medicines Agency (EMA)

Centralized Procedure Has Begun Under Accelerated Assessment

CRANBURY, N.J., June 25, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) and the Centralized Procedure has begun for the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. As previously announced, Galafold is the first investigational Fabry drug to be granted Accelerated Assessment in the EU. In the U.S., Amicus plans to conduct a pre-NDA meeting with the FDA and to submit a New Drug Application (NDA) for Galafold under Subpart H1 in the second half of 2015. Following the MAA validation, Amicus is also initiating the regulatory submission process in several additional geographies.

"We are pleased to announce that Galafold has entered the formal regulatory review process in the European Union," stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics. "With a majority of Fabry patients residing outside the United States, the MAA validation also allows us to prepare for the regulatory process in additional geographies where the MAA may serve as the basis for submission. In the United States, we remain on track to hold a pre-NDA meeting with the FDA and to submit an NDA for Galafold under Subpart H in the second half of 2015. Our global strategy is to bring this novel orally bioavailable personalized medicine to as many people living with Fabry disease as quickly as possible."

Under Accelerated Assessment, the Committee for Medicinal Products for Human Use (CHMP) may shorten the MAA review period from 210 days, under standard review, to 150 days under Accelerated Assessment. The CHMP opinion is then reviewed by the European Commission, which generally issues a final decision on EU approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states. Once authorized, Amicus would then begin the country-by-country reimbursement approval process.

Approximately 90 individuals around the world are currently being treated with Galafold as their only therapy for Fabry disease in ongoing long-term extension studies. Amicus previously reported positive Phase 3 data for Galafold in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT). Results from these studies have shown that treatment with Galafold has resulted in reductions in disease substrate, stability of kidney function, reduction in cardiac mass, and a positive impact on patient-reported outcomes in patients with amenable mutations.

Today approximately 5,000 to 10,000 individuals are diagnosed with Fabry disease; however, an estimated 40% to 50% of diagnosed patients are not currently on treatment. If approved, Amicus estimates that 30% to 50% of Fabry patients may benefit from Galafold on the basis of their genotype. Based on third party research, the Company also projects a 10% annual growth rate in diagnosis that is expected to continue.
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Source: press release, 6/25/15. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=919552

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Amicus Therapeutics Submits Marketing Authorization Application (MAA) for Full Approval of Fabry Monotherapy Galafold(TM) (Migalastat) in European Union
MAA Submission Under "Accelerated Assessment"

Brand Name Galafold™ Approved by Regulatory Authorities in EU and U.S.

CRANBURY, N.J., June 3, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorization application (MAA) to request full approval of the oral small molecule pharmacological chaperone Galafold (migalastat HCl) for Fabry patients who have amenable genetic mutations. The brand name Galafold has been approved by both the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).

"This filing represents the single greatest milestone in the history of Amicus," stated John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics. "The MAA submission for Galafold is the first marketing application for Amicus. This comprehensive regulatory submission is the result of the tireless efforts of so many Amicus employees, investigators, consultants and, most importantly, the Fabry patients who have volunteered to participate in our clinical trials over the years. Our goal now is crystal clear: to bring this novel small molecule, orally bioavailable personalized medicine to as many people living with this devastating genetic disease as quickly as possible. We could not be more proud of our team and thankful to the entire Fabry community as we are today."

As previously announced, Galafold is the first investigational Fabry drug to be granted Accelerated Assessment in the EU. Under Accelerated Assessment, the Committee for Medicinal Products for Human Use (CHMP) may shorten the MAA review period from 210 days, under standard review, to 150 days under Accelerated Assessment. The CHMP opinion is then reviewed by the European Commission, which generally issues a final decision on EU approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states. Once authorized, Amicus would then begin the country-by-country reimbursement approval process.

Amicus also plans to conduct a pre-NDA meeting with the US FDA and to submit a New Drug Application (NDA) for Galafold in the United States under Subpart H1 in the second half of 2015.

Approximately 90 individuals around the world are currently being treated with Galafold as their only therapy for Fabry disease in ongoing long-term extension studies. Amicus previously reported positive Phase 3 data for Galafold in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT). Results from these studies have shown that treatment with Galafold has resulted in reductions in disease substrate, stability of kidney function, reduction in cardiac mass, and a positive impact on patient-reported outcomes in patients with amenable mutations.

Today approximately 5,000 to 10,000 individuals are diagnosed with Fabry disease, however, an estimated 40% to 50% of diagnosed patients are not currently on treatment. If approved, Amicus estimates that 30% to 50% of Fabry patients may benefit from Galafold on the basis of their genotype. Based on third party research, the Company also projects a 10% annual growth rate in diagnosis that is expected to continue.
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Source: press release, 6/03/15. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=916195

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May 26, 2015

Amicus Therapeutics' Fabry Monotherapy Granted Accelerated Assessment by European Regulators

First Investigational Therapy for Fabry Disease to be Granted Accelerated Assessment

Planned MAA Submission on Track for 2Q15 to Request Full Approval in European Union

CRANBURY, N.J., May 26, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Accelerated Assessment to the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") monotherapy for Fabry patients who have amenable genetic mutations.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "The designation of Accelerated Assessment in the European Union (EU) demonstrates that the EMA understands the current unmet medical need in Fabry disease as a major public health interest, and with this designation may accelerate the approval and our launch timelines to make migalastat available for patients very rapidly. This is excellent news for so many citizens in the EU and in other geographies around the world. As part of our global strategy, we also plan to submit our new drug application for U.S. approval in the second half of this year. We are committed to getting this personalized medicine approved as quickly as possible for Fabry patients with amenable genetic mutations around the world."

Migalastat is the first investigational Fabry drug to be granted Accelerated Assessment. Amicus requested Accelerated Assessment in accordance with the EMA guidelines, which justify Accelerated Assessment for therapies that are expected to be of major public health interest and therapeutic innovation, addressing the greater unmet needs for maintaining and improving the health of the Community.1 Over the past three years, positive opinions were granted after an Accelerated Assessment for a total of just 14 therapies.2 The most recent innovative treatment options to have been granted Accelerated Assessment include therapies for rare diseases such as Morquio A Syndrome (MPS IVA), Lysosomal Acid Lipase Deficiency (LAL D), and Cystic Fibrosis (CF).

Under Accelerated Assessment, the CHMP may shorten the Marketing Authorisation Assessment (MAA) review period from 210 days, under standard review, to 150 days under Accelerated Assessment. The CHMP opinion is then reviewed by the European Commission, which generally issues a final decision on EU approval within three months. If approved, Amicus would then begin the country-by-country reimbursement approval process. Amicus is on track to submit the MAA to request full approval for migalastat monotherapy in the EU in the second quarter of 2015.

Amicus previously reported positive Phase 3 data for migalastat in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT). Results from these studies have shown that treatment with migalastat has resulted in reductions in disease substrate, stability of kidney function, reduction in cardiac mass, and a positive impact on patient-reported outcomes in patients with amenable mutations.
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Source: press release, 5/26/15. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=914720

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March 19, 2015

Amicus Therapeutics Provides Positive Global Regulatory Updates From EMA and FDA Meetings for Fabry Monotherapy MAA Submission for Full Approval Planned in European Union - Company to Accelerate Submission Timeline for MAA Filing to 2Q15

NDA Submission for Accelerated Approval (Subpart H) Planned in United States for 2H15

Conference Call and Webcast Today at 8:00 a.m. ET

CRANBURY, N.J., March 19, 2015 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that it has met very recently with regulatory authorities in Europe and the U.S. to discuss the approval pathways for the oral small molecule pharmacological chaperone migalastat HCl ("migalastat") as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations.
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Source: press release, 3/19/15. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=902396

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John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, "Our vision at Amicus is very clear: to build one of the most significant and lasting global biotechnology companies in the world, focused on transformational treatments for people living with devastating rare diseases. We will achieve this vision with world-class science and clinical medicine. To augment these areas of expertise we are currently in the process of building a global commercial leadership team. We remain on track for a mid-year marketing application in Europe for migalastat monotherapy for Fabry disease and we look forward to an upcoming meeting with the FDA to discuss a path forward for an NDA submission for migalastat monotherapy in the United States. We continue to believe firmly that the totality of the data with this important new precision medicine-based therapy should be available to Fabry patients in the U.S. as soon as possible. Finally, advancing our next-generation enzyme replacement therapy for people living with Pompe disease is a key priority and that important program remains on track. Indeed, a busy and important set of activities are ahead for the Amicus team this year. We hope that success in these endeavors will enhance the lives of many people living with Fabry and Pompe diseases."
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Source: press release, 3/03/15. http://ir.amicustherapeutics.com/releasedetail.cfm?ReleaseID=899693

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December 11, 2014
Amicus Therapeutics to Submit European Marketing Application for Migalastat Monotherapy for Fabry Disease
Successful Pre-Submission Meeting with European Medicines Agency Completed

MAA Submission Anticipated in Mid-2015

CRANBURY, N.J., Dec. 11, 2014 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced that it has conducted a successful pre-submission meeting with the European Medicines Agency (EMA) to discuss the registration of migalastat HCl ("migalastat") monotherapy for the treatment of Fabry disease. Migalastat is an oral small molecule pharmacological chaperone in development for Fabry patients with amenable mutations. Amicus has begun preparing a marketing authorization application (MAA) that it plans to submit to the EMA in the middle of 2015 under the Centralized Procedure.

"The submission of our marketing application in Europe will be an important milestone in our global strategy to get migalastat approved for Fabry patients with amenable mutations as quickly as possible," said John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics. "We believe significant unmet need still exists in the treatment of Fabry disease and that migalastat could become a very important, differentiated oral therapy. We also look forward to meeting with the FDA in the first quarter of 2015 to discuss the U.S. regulatory path."

As previously reported, migalastat successfully met both co-primary endpoints of comparability to enzyme replacement therapy (ERT) on both key measures of kidney function in a Phase 3 global registration study (Study 012) that compared migalastat to standard-of-care ERTs in Fabry patients with amenable mutations. Study 012 was designed based on feedback from the EMA. The Company has also previously announced positive 12- and 24-month results from a Phase 3 global registration study (Study 011) that demonstrated the benefit of migalastat compared to placebo in Fabry patients with amenable mutations.
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Source: press release, 12/11/14. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=887228

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Amigal (migalastat hydrochloride, AT1001)Medical GeneticsFabry diseasePharmacological chaperonealpha-galactosidase A

Mechanism of action: Amigal (migalastat hydrochloride, AT1001), a SM- chaperone decrease accumulation of globotriaosylceramide (GL-3) in the lysosome via promotion of the proper folding of the metabolic enzyme alpha-galactosidase A.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-04-01

Results:

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AMICUS THERAPEUTICS ANNOUNCES EUROPEAN COMMISSION APPROVAL FOR GALAFOLD™ (MIGALASTAT) IN PATIENTS WITH FABRY DISEASE IN EUROPEAN UNION
Launch has Begun in Germany

Broad Label for All Fabry Patients with an Amenable Genetic Mutation

First Precision Medicine Approved for Fabry Disease

CRANBURY, N.J., May 31, 2016 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of rare and orphan diseases, today announced that the European Commission has granted full approval for the oral small molecule pharmacological chaperone Galafold™ (migalastat) as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. Amicus began supplying the market in Germany on Monday, May 30, 2016 and will commence the reimbursement processes with healthcare authorities in each of the major European countries.

Galafold is the first oral treatment as well as the first precision medicine for Fabry disease. The broad label includes 269 Fabry-causing mutations which represent 35 percent to 50 percent of all patients with Fabry disease. The label also references a website www.galafoldamenabilitytable.com where EU healthcare providers can quickly and accurately determine which mutations are amenable to Galafold.

"This EU approval for Galafold is a significant advancement in the field of precision genetic medicine and a tremendous milestone for the Fabry community," said John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. "This approval also completes our transformation to a global, fully-integrated, commercial biotechnology company focused on rare and devastating diseases. Our world-class commercial and business leadership team has done an outstanding job preparing for this day. We have begun the launch of Galafold in Germany and will commence the country-by-country reimbursement processes throughout the EU. We are grateful for the ongoing support from our Amicus employees and the Fabry community, in particular those physicians and patients who participated in the clinical studies of Galafold and their families who made this approval possible. As we move forward with the commercial launch of Galafold, we will continue to invest in the innovation of our pipeline. Our vision today is more focused than ever - to build on our strong science and clinical experience to bring forward the highest quality therapies for Fabry, Pompe, EB and other rare and devastating diseases."

The EC approval was based on clinical data from two Phase 3 pivotal studies in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT), as well as ongoing long-term extension studies. Fabry disease is a rare genetic disease and potentially life-threatening condition caused by the accumulation of disease substrate (globotriaosylceramide, GL-3) in the lysosome due to a dysfunctional or deficient enzyme. Galafold works by stabilizing the body's own dysfunctional enzyme, so it can clear the accumulation of disease substrate in patients who have amenable mutations. An amenable mutation is one that is responsive to therapy with Galafold based on predefined criteria.

"As principal investigator in both Galafold pivotal studies, I have experience treating both naïve and treatment-experienced Fabry patients with Galafold," said Derralynn Hughes MA DPhil FRCP FRCPath, Senior Lecturer in Haematology at University College London, UK with clinical responsibilities in haematology and lysosomal storage disorders. "I am pleased that the European Commission has approved this new treatment option and I believe it has the potential to address unmet needs among Fabry patients who have amenable mutations."

"The EU approval of the first oral precision medicine for Fabry disease is a major step forward for patients in Europe," said Christine Lavery, President of the Fabry International Network (FIN). "We appreciate Amicus' commitment to the Fabry community and its dedication to develop high quality therapies for Fabry disease. For the first time in more than a decade, patients with Fabry disease who have amenable mutations now have a choice for an innovative new treatment option."

François Eyskens, MD, PhD, Department of Experimental Medicine and Pediatrics, University of Antwerp, Antwerpen, stated, "During my 20 years in treating Fabry disease, I am convinced that it is underdiagnosed and that significant unmet need remains among these patients. Galafold is an innovative oral precision medicine with a unique mechanism of action that has demonstrated compelling results in naïve and treatment-experienced Fabry patients who have amenable mutations. I am looking forward to offering a differentiated treatment option for the many Fabry patients who have an amenable mutation."

The EC approval of Galafold follows the unanimous April 2016 positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) and applies to all 28-member states of the EU and Liechtenstein, with final authorization pending in Iceland and Norway. The EC approval provides a platform to begin accessing the more than 70 percent of the Fabry global market, including the EU member states as well as several international territories that accept the EC approval as the basis for marketing submissions. The Company is also pursuing independent regulatory processes in several international territories outside of Europe, including Japan, Australia and Canada. Amicus also expects to meet with the U.S. Food and Drug Administration (FDA) in the middle of 2016 to clarify a potential U.S. regulatory pathway for Galafold.
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Source: press release, 5/31/16. http://ir.amicusrx.com/releaseDetail.cfm?ReleaseID=973355

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Amicus Therapeutics Receives Positive CHMP Opinion for Approval of Migalastat in Patients with Fabry Disease in European Union
Broad Label for All Fabry Patients with an Amenable Genetic Mutation

Conference Call Today at 12:30 pm ET

CRANBURY, N.J., April 01, 2016 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of rare and orphan diseases, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to approve the oral small molecule pharmacological chaperone migalastat as a first line therapy for Fabry disease in all patients who have an amenable genetic mutation. A final decision from the European Commission (EC) is expected in the second quarter of 2016, after which the Company will begin the country-by-country reimbursement processes. The label approved by the CHMP includes 269 Fabry causing mutations which represent up to half of all patients with Fabry disease.

"This positive CHMP opinion for migalastat is a huge milestone for the Fabry community and a significant step towards our vision to become a leading global biotechnology company focused on rare and devastating diseases," said John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc. "Oral migalastat represents a groundbreaking approach to personalized medicine. We are very pleased that the CHMP has adopted a positive opinion to approve migalastat with a broad label that includes all 269 amenable mutations screened through our Amenability Assay, as well as a fully searchable Amenability website for physicians. These amenable genetic mutations are represented in an estimated 35% to 50% of the diagnosed Fabry population today, which is a significant opportunity for Amicus to deliver a therapy option for many patients in need. We are grateful for the ongoing support from the Fabry community to advance migalastat, in particular those patients who participated in the clinical studies of migalastat and their families. Our world-class commercial and business leadership team is already in place in key launch countries in Europe, and we look forward to a final EC decision in the coming months. We are fully prepared and sharply focused on the launch of migalastat to complete our transformation into a global commercial organization."

"As a treating physician, and principal investigator for France in the clinical studies of migalastat over the past decade, I believe that the positive CHMP opinion is a significant milestone toward providing a novel personalized medicine for people affected by Fabry disease," said Prof. Dominique P. Germain, MD, PhD, Division of Medical Genetics at the University of Versailles and Assistance Publique - Hôpitaux de Paris. "Migalastat is an oral pharmacological chaperone with a unique mechanism of action that has the potential to address unmet medical needs and may shift the treatment standard for Fabry patients who have amenable genetic mutations. An approval by the European Commission will allow many Fabry patients across Europe to access this novel treatment, a paradigm of precision medicine."

The proposed full indication for migalastat is for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. The CHMP Summary of Opinion includes information about the benefits of migalastat and can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici....

A copy of the European Medicine Agency's (EMA) press release can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2....

The CHMP based its opinion on clinical data from Phase 3 pivotal studies in both treatment naïve (Study 011, or FACETS) and enzyme replacement therapy (ERT) switch patients (Study 012, or ATTRACT), as well as ongoing long-term extension studies.

Based on the positive CHMP opinion, the company expects to increase net cash spend in support of commercialization activities. This increase in net cash spend on a go-forward basis is expected to be 10-15% over the company's initial full-year 2016 net cash spend guidance of between $135 million and $155 million. The company's first quarter 2016 net cash spend is expected to be consistent with the company's assumptions in determining its initial full-year 2016 net cash spend guidance and further information will be provided in the company's first quarter earnings release.

The CHMP is a scientific committee composed of representatives from the 28-member states of the EU, and Iceland and Norway. The committee reviews medical product applications on their scientific and clinical merit and provides advice to the EC, which has the authority to approve medicines for the EU. The EC, which generally follows the recommendation of the CHMP, is expected to make its final decision in the second quarter of 2016.

Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, April 1, 2016 at 12:30 p.m. ET to discuss the positive CHMP opinion. Interested participants and investors may access the conference call at 12:30 p.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international).

An audio webcast and slide presentation 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 3:30 p.m. ET today. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); conference ID: 83075996.
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Source: press release, 4/01/16. http://ir.amicustherapeutics.com/releaseDetail.cfm?ReleaseID=963155

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