Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nyse  >  Pfizer Inc       

SummaryChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

FDA Approves Protalix, Pfizer Drug To Treat Gaucher Disease

share with twitter share with LinkedIn share with facebook
share via e-mail
0
05/01/2012 | 11:51pm CEST

--FDA approves new Protalix/Pfizer treatment for a type of Gaucher disease

--Elelyso approved for use in adults; will compete with Shire, Sanofi products

--People with Gaucher disease lack glucocerebrosidase, which causes an accumulation of a fatty substance inside cells

(Updates with additional information about Elelyso clinical studies starting in eighth paragraph. )

   By Jennifer Corbett Dooren 
   Of  
 

The U.S. Food and Drug Administration on Tuesday approved a new treatment developed by Protalix BioTherapeutics Inc. (PLX, PLX.TV) for adults with a type of Gaucher disease, a rare genetic disorder.

The treatment, taliglucerase alfa, will be sold in the U.S. under the brand name Elelyso by Pfizer Inc. (>> Pfizer Inc.).

Pfizer also will sell the drug in most places outside the U.S. The drug, which is the first plant-derived cell-based enzyme replacement, replaces an enzyme called glucocerebrosidase in people with type 1 Gaucher disease. Elelyso is produced using genetically engineered carrot cells.

People with Gaucher disease lack glucocerebrosidase, which causes an accumulation of a fatty substance inside cells. The fatty accumulation can lead to enlargement and malfunctioning of the liver, spleen, bone marrow and occasionally, the lung, kidney, and intestine. About 6,000 people in the U.S. have type 1 Gaucher disease, according to the FDA.

Pfizer and Protalix have already been making Elelyso available to some Gaucher disease patients as part of an early access program because of manufacturing issues at Genzyme, a unit of Sanofi SA (SNY, SAN.FR), which makes another glucocerebrosidase-enzyme replacement product, Cerezyme. Earlier this year, Genzyme said the manufacturing problems had been fixed and that the company is able to make enough of the product to supply current patients in the U.S.

Shire PLC (SHPGY, SHP.LN), which also makes a Gaucher disease treatment, Vpriv, has said inventories of the product will be "below target levels" until the FDA signs off on a second manufacturing plant in the U.S. However, the company also said it has the capacity to meet anticipated demand for Vpriv. Cerezyme and Vpriv are approved for use in children as well as adults.

Officials from Pfizer and Protalix said the companies have already built enough inventory of Elelyso to supply to patients for at least 24 months.

Elelyso is an infusion that is administered by health-care professionals every other week.

The FDA said the approval of Elelyso was based on two studies involving 56 patients with type 1 Gaucher disease. One study looked at 31 patients who had not previously received enzyme-replacement therapy. The study showed Elelyso reduced the size of patients' spleens by an average of 29% to 40%, depending on the dose of the drug, after nine months of treatment. The other study involved 25 patients who were switched from Cerezyme. The FDA said that study showed Elelyso was effective in maintaining spleen and liver volumes, blood platelet counts and hemoglobin levels during a nine-month evaluation period.

The agency said the most common side effects were infusion reactions and allergic reactions.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

Stocks mentioned in the article : Pfizer Inc.
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on PFIZER INC
10:18a PFIZER : Service expansions one step in fulfilling pledge to grow capabilities
03/29 PFIZER : XELJANZ (tofacitinib citrate) licensed for use in the UK for the treatm..
03/29 PFIZER : Confirms MHRA Review of Sildenafil 50mg for Reclassification as Non-Pre..
03/29 PFIZER : EC approves Pfizer`s Xeljanz to treat rheumatoid arthritis in EU
03/29 GLAXOSMITHKLINE : Selling GSK would be a mistake
03/28 GLAXOSMITHKLINE : What to do with GSK
03/28 PFIZER : XELJANZ (tofacitinib citrate) Receives Marketing Authorisation In The E..
03/28 PFIZER : MSF launches new strategies to help gov'ts buy 'expensive' pneumonia va..
03/28 TALK OF BRISTOL-MYERS SQUIBB CO (NYS : BMY) Acquisition By Pfizer Inc. (NYSE:PFE..
03/28 PFIZER : FDA Approves PD-L1 Immunotherapy Developed by Pfizer and Merck KGaA
More news
Sector news : Pharmaceuticals - NEC
03/29 FDA, Mylan silence on generic Advair may be good news for GSK
03/29 British business navigates rocky path to Brexit
03/29 ConvaTec's majority investors raise $1.2 billion via stake sale
03/28DJSenator McCaskill Begins Probe of Prescription Opioid Marketing -- 2nd Update
03/28DJSHIRE : Files 8K - Other Events
More sector news : Pharmaceuticals - NEC
News from SeekingAlpha
2015 Tracking Prem Watsa's Fairfax Financial Holdings Portfolio - Q2 2015 Update
2015 Antibiotics Stocks To Benefit From 21st Century Cures Act
2015 ISIS PHARMA STOCK DROPS ON GOOD NEWS : Re-Evaluating The Bull Case
2015 DOW DOGS : 14.63% More Returns From 5 Lowest Priced As Of August 6 Per indexArb
2015 Pfizer's GL-2045 an Orphan Drug for CIDP
Advertisement
Financials ($)
Sales 2017 53 399 M
EBIT 2017 20 360 M
Net income 2017 13 219 M
Debt 2017 23 547 M
Yield 2017 3,73%
P/E ratio 2017 14,75
P/E ratio 2018 13,90
EV / Sales 2017 4,27x
EV / Sales 2018 4,01x
Capitalization 204 439 M
More Financials
Chart PFIZER INC
Duration : Period :
Pfizer Inc Technical Analysis Chart | 4-Traders
Full-screen chart
Income Statement Evolution
More Financials
Consensus 
Mean consensus OUTPERFORM
Number of Analysts 22
Average target price 38,1 $
Spread / Average Target 11%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Ian C. Read Chairman & Chief Executive Officer
Frank A. D'Amelio Chief Financial Officer & EVP-Business Operations
Freda C. Lewis-Hall Chief Medical Officer & Executive Vice President
Mikael Dolsten President-Worldwide Research & Development
Ole Isacson Chief Scientific Officer
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
PFIZER INC13.96%204 439
JOHNSON & JOHNSON9.07%338 645
ROCHE HOLDING LTD.8.81%221 440
PFIZER INC.5.70%204 439
NOVARTIS AG-0.47%197 239
MERCK & CO., INC.8.10%174 728
More Results