Navigation Links
Amicus Therapeutics Announces Third Quarter 2009 Financial Results and Strategic Business Updates
Date:10/29/2009

ies 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. Amicus began submitting the Phase 3 protocol to investigational sites worldwide in June 2009 and patient enrollment and dosing are now underway.

Furthermore, Amicus previously reported that it completed a series of discussions with the EMEA regarding the clinical study requ
'/>"/>

SOURCE Amicus Therapeutics
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related biology technology :

1. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotech & Medtech 2007 Conference
2. Amicus Therapeutics Announces Third Quarter 2007 Financial Results
3. Meredith Martin Addy Named Chair of AIPLAs Amicus Committee
4. Amicus Therapeutics to Present at the Lazard Capital Markets Fourth Annual Healthcare Conference
5. Amicus Therapeutics to Host R&D Day
6. Amicus Therapeutics Announces Positive Results From Phase 2 Clinical Trials of Amigal(TM) for Fabry Disease
7. Amicus Therapeutics Announces Fourth Quarter and Full Year 2007 Financial Results & Program Advancements
8. Amicus Therapeutics to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
9. Amicus Therapeutics to Present at the BIO CEO & Investor Conference 2008
10. Amicus Therapeutics Presents Positive Data from Phase 2 Clinical Trial of Plicera(TM) for Gaucher Disease
11. Amicus Therapeutics to Present at the Morgan Stanley Global Healthcare Unplugged Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... , Oct. 1, 2014  Discovery Laboratories, ... has been awarded a Phase II Small Business ... $3.0 million from the National Institute of Allergy ... of Health (NIH) to support the development of ... a medical countermeasure to mitigate acute and chronic/late-phase ...
(Date:10/1/2014)... Switzerland (PRWEB) October 01, 2014 ... the quality of the final product. However, while ... regulated, regulatory frameworks such as Good Manufacturing Practices ... the responsibility of the manufacturer to interpret these ... consistent weighing performance quality. METTLER TOLEDO experts have ...
(Date:10/1/2014)... Pfanstiehl has announced the launch of ... the USA under ICH ... for playing a key role in protein glycosylation.  ... that media supplementation with mannose can improve overall ... to Dr. Christopher Wilcox , VP, Business ...
(Date:10/1/2014)... (PRWEB) September 30, 2014 The participants ... designs, but to spending their own time adjusting, tweaking ... their complex designs were ready for judging. , “I ... design firm thought leader. “The entries showed a ... the physical characteristics of the print medium and the ...
Breaking Biology Technology:Discovery Labs Receives SBIR Grant Valued up to $3.0 Million to Support Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury 2Discovery Labs Receives SBIR Grant Valued up to $3.0 Million to Support Development of Aerosolized KL4 Surfactant to Address Radiation-Induced Lung Injury 3Comply with Weighing-Related Regulations in Pharma Manufacturing 2Pfanstiehl Launches cGMP-produced Mannose for Cell Culture Media Optimization & Glycoprotein Biosynthesis 2Array Architects Challenges Staff to Create with 3D Printer 2
... Dec. 30, 2010 Renowned biotech specialist, venture ... predictions for biotech. He sees a dynamic industry writing ... that: favors risk mitigated companies rather than earlier stage ... emerging biotech markets, particularly in Brazil, Chile, China, India, ...
... and pilot whales that are known to have anti-fouling ... are using nanotechnology to create synthetic, chemical-free, anti-bacterial surfaces. ... as S. aureus and E. coli ... devices, lenses and even ship hulls. Conventional methods for ...
... STATION, Dec. 23, 2010 An international team of ... announced a breakthrough that gives a new spin to ... The team has developed an electrically controllable device whose ... the culmination of a 20-year scientific quest involving many ...
Cached Biology Technology:Biotech Guru G. Steven Burrill Offers his Predictions on What Lies Ahead for the Biotech Industry in 2011 2Biotech Guru G. Steven Burrill Offers his Predictions on What Lies Ahead for the Biotech Industry in 2011 3Biotech Guru G. Steven Burrill Offers his Predictions on What Lies Ahead for the Biotech Industry in 2011 4Singapore consortium learns from nature to produce new chemical-free, anti-bacteria plastic 'skins' 2Singapore consortium learns from nature to produce new chemical-free, anti-bacteria plastic 'skins' 3Texas A&M professor helps develop first high-temp spin-field-effect transistor 2Texas A&M professor helps develop first high-temp spin-field-effect transistor 3
(Date:9/30/2014)... HEIGHTS, Ill. (September 30, 2014) People who suffer ... can do to control their asthma besides properly taking ... a new article in the Annals of Allergy, ... American College of Allergy, Asthma and Immunology (ACAAI), asthma ... examining their lifestyle. The woman described in the Annals ...
(Date:9/29/2014)... Clostridium ramosum , coupled with a high-fat diet, may ... week in mBio , the online open-access journal of ... from the German Institute of Human Nutrition Potsdam-Rehbruecke in Nuthetal ... ramosum gained weight when fed a high-fat diet. Mice ... obese even when consuming a high-fat diet, and mice that ...
(Date:9/29/2014)... WASHINGTON, DC September 29, 2014 -- Plants ... ,commensal, bacteria help the pants extract nutrients and ... preventing pathogens from contaminating fruits and vegetables. Now, ... commensal bacteria inside of seeds; thus ensuring that ... researchers, from the University of Notre Dame, presented ...
Breaking Biology News(10 mins):Asthma symptoms kicking up? Check your exposure to air pollution 2Gut bacteria promote obesity in mice 2Plants prepackage beneficial microbes in their seeds 2
... possibility that life exists beyond Earth. The quest for ... "following the water" turns out to be too general ... possess liquid water is growing faster than can be ... teams, Arizona State University researchers intend to boost extraterrestrial ...
... evolutionary biologists are still debating this question, a ... PLoS ONE, supports the view that the ... thousands of years before the French Revolution, Marx, ... power struggle and their origin had dramatic implications ...
... A UC Riverside-led team of biomedical scientists has found that ... acne and skin infections, can be used to treat ... mental impairment and the most common cause of autism. ... approval of a new clinical trial in Toronto, Canada, that ...
Cached Biology News:NASA picks ASU research team to guide study of search for life 2NASA picks ASU research team to guide study of search for life 3Egalitarian revolution in the Pleistocene? 2Egalitarian revolution in the Pleistocene? 3Egalitarian revolution in the Pleistocene? 4UCR researchers propose minocycline as a promising drug for patients with Fragile X syndrome 2UCR researchers propose minocycline as a promising drug for patients with Fragile X syndrome 3
... Mini-Sub cell GT cell and PowerPac basic power ... of nucleic acids in agarose gels. The Mini-Sub ... with cables and electrodes, a 7 x 7 ... casting gates, and two 1.5 mm fixed-height combs ...
... 96 and PowerPac basic power supply are used ... in agarose gels. This Model 96 cell includes ... UV-transparent gel tray with fluorescent ruler, and a ... and 220-240 V, provides output of 10-300 V, ...
... basic power supply are used for submerged horizontal ... This Model 192 cell includes a buffer tank, ... with fluorescent ruler, and a gel caster. The ... provides output of 10-300 V, 4-400 mA, and ...
... The Sequi-Gen GT and PowerPac 3000 system, ... using a 38 x 30 cm vertical slab ... GT electrophoresis cell, which is capable of separating ... an integral plate chamber (IPC) assembly (IPC and ...
Biology Products: