Amicus Therapeutics, Inc. Announces Second Quarter 2009 Financial Results

CRANBURY, N.J., Aug. 5 /PRNewswire-FirstCall/ -- Amicus Therapeutics today announced financial results for the second quarter 2009.

John F. Crowley, President and CEO of Amicus stated, "The second quarter was marked by a significant achievement for Amicus with our lead program, Amigal for Fabry disease, entering Phase 3 development." Crowley continued, "This is a major step for the Company as we have now transitioned to a late-stage biopharmaceutical company and are one step closer to bringing to market an important, novel treatment to patients who suffer with Fabry disease."

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

As previously announced, the Phase 3 trial will evaluate the efficacy, safety, and pharmacodynamics of Amigal in males and females with Fabry disease. The trial will consist of a six-month double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60 subjects who are naive to enzyme replacement therapy (ERT) or who have not received ERT for at least six months prior to the start of treatment with Amigal. The Amigal treatment arm dose and regimen will be 150 mg every other day.

Additionally, the FDA and Amicus reached agreement on an improved methodology for the histological evaluation of GL-3 in the kidney biopsies. An analysis of the Phase 2 and Phase 2 extension study biopsies using the improved methodology demonstrated that all of the evaluable baseline samples had detectable interstitial capillary GL-3 and that reductions were observed in eight of the nine responders.

Plicera(TM) (afegostat tartrate) for the treatment of Gaucher Disease

Amicus continues to work closely with its partner, Shire HGT, to prepare for Phase 3 development of Plicera pending the results of the ongoing Phase 2 trial.

As previously reported, the Company suspended enrollment for the Phase 2 clinical trial of its investigational drug AT2220 for the treatment of Pompe Disease and received notice from the U.S. Food and Drug Administration (FDA) that the trial is on clinical hold.

Additionally, Amicus continues to be encouraged with its preclinical studies with AT2220 in combination with ERT. As previously announced, the Company expects to report additional data from these activities throughout the remainder of 2009.

Amicus continues to invest in research to assess the potential for applying its versatile chaperone technology platform to the treatment of a broad range of human genetic diseases. As part of this effort, Amicus continues to conduct preclinical studies in Parkinson's disease and is investing in new research aimed at evaluating disease targets for other neurodegenerative and genetic disorders.

The Company announced today the election of James Barrett, Ph.D., to its Board of Directors. Dr. Barrett currently serves as General Partner of New Enterprise Associates (NEA), the Company's single largest shareholder, where he specializes in biotechnology and works with members of NEA's healthcare investment group on medical devices, healthcare information systems and healthcare services companies. Prior to joining NEA in 2001, Dr. Barrett served as Founder, Chairman and CEO of Sensors for Medicine and Science (1997 - 2001) where he remains Chairman. Prior to that, he led three NEA-funded companies, serving as Chairman and CEO of Genetic Therapy, Inc. (1987 - 1995), President and CEO of Life Technologies (1985 - 1987), and President and CEO of Bethesda Research Labs (1982 - 1983). He currently serves on the Board of Directors for several life sciences companies including Inhibitex, Inc. and Targacept, Inc.

Shire HGT Collaboration

Additional Financial Results & Notes

Amicus recorded revenue during the second quarter of 2009 representing two different revenue streams from the Shire agreement. Upon signing the agreement, Amicus received an upfront payment of $50 million that will be recognized as revenue on a straight-line basis over 18 years from the date of the agreement. In the second quarter of 2009, Amicus recognized $0.7 million of the Shire upfront payment and $4.7 million of research revenue on reimbursed research and development costs.

Use of Non-GAAP Financial Measures

(1) Stock option expense -- Non-GAAP net loss and diluted net loss per common share exclude the impact of the stock option expense recorded in accordance with SFAS No. 123R. Amicus believes that excluding the impact of expensing stock options better reflects the recurring economic characteristics of its business.

Amicus will host a conference call to discuss financial and operational results for the second quarter 2009, today, August 5, 2009 at 5 p.m. EDT. Interested participants and investors may access the conference call by dialing 877-591-4949 (U.S./Canada) or 719-325-4889 (international). A telephonic replay of the call will be available for seven days beginning at 8 p.m. EDT. Access numbers for this replay are 888-203-1112 (U.S./Canada) and 719-457-0820 (international); participant code 4035217.

Amicus' press releases are available at www.amicustherapeutics.com.

New Enterprise Associates, Inc. (NEA) is a leading venture capital firm focused on helping entrepreneurs create and build major new enterprises that use technology to improve the way we live, work and play. Since its founding in 1978, the firm has followed the same core principles: supporting its entrepreneurs, providing an excellent return to its limited partners, and practicing its profession with the highest standards and respect. Through its affiliated funds, NEA focuses on investments at all stages of a company's development, from seed stage through IPO. With approximately $8.5 billion in committed capital, NEA's experienced management team has invested in over 650 companies, of which more than 160 have gone public and more than 250 have been acquired. NEA has U.S. offices in Chevy Chase, Maryland; Menlo Park, California; and Baltimore, Maryland. In addition, New Enterprise Associates (India) Pvt. Ltd. has offices in Bangalore and Mumbai, India and New Enterprise Associates (Beijing), Ltd. has offices in Beijing and Shanghai, China. For additional information, visit www.nea.com.

Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs.

Forward-Looking Statements

FOLD-G

SOURCE Amicus Therapeutics

CONTACT: Jenene Thomas, Director, Investor Relations of Amicus
Therapeutics, +1-609-662-5084

Web site: http://www.amicustherapeutics.com/

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