Log in
Forgot password ?
Become a member for free
Sign up
Sign up
Dynamic quotes 

4-Traders Homepage  >  Equities  >  Nyse  >  Pfizer Inc       

News SummaryMost relevantAll newsSector news 

FDA Approves Protalix, Pfizer Drug To Treat Gaucher Disease

share with twitter share with LinkedIn share with facebook
share via e-mail
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 

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
Latest news on PFIZER INC
01:15a PFIZER : Ex-Oppenheimer & Co. worker pleads guilty to insider trading
10/24 ASTELLAS PHARMA : FDA Approves Supplemental New Drug Application for XTANDI (enz..
10/21 PFIZER : FDA Approves Supplemental New Drug Application for XTANDI® (enzalutamid..
10/21 CHEMOCENTRYX : Appoints Henry A. McKinnell, Jr. to Board of Directors
10/20 PFIZER : Patent Application Titled "Sildenafil Sublingual Spray Formulations" Pu..
10/20 PFIZER : Presents Promising New Immunotherapy Combination Data With INLYTA® axit..
10/20 PFIZER : CDC Advisory Committee on Immunization Practices Votes to Recommend New..
10/20 PFIZER : CDC Advisory Committee on Immunization Practices Votes to Recommend New..
10/19 PFIZER : Awarded Grant to Evaluate Vaccine to Protect Newborns Against Group B S..
More news
Sector news : Pharmaceuticals - NEC
10/25DJMERCK : Profit Rises on Cancer Drugs, Vaccines
10/25DJMERCK : Revenue and Profit Rise on Cancer Drugs, Vaccines -- Update
10/25 ChemChina ready for concessions to clinch delayed Syngenta deal in 2017 - sou..
10/25DJMERCK : Revenue and Profit Rise on Cancer Drugs, Vaccines
10/25DJMARKET SNAPSHOT : U.S. Stock Futures Point To Modest Gains, With Apple Set To Ta..
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
Financials ($)
Sales 2016 52 982 M
EBIT 2016 19 366 M
Net income 2016 10 639 M
Debt 2016 28 244 M
Yield 2016 3,69%
P/E ratio 2016 17,82
P/E ratio 2017 14,56
EV / Sales 2016 4,23x
EV / Sales 2017 3,93x
Capitalization 195 799 M
More Financials
Duration : Period :
Pfizer Inc Technical Analysis Chart | 4-Traders
Full-screen chart
Income Statement Evolution
More Financials
Mean consensus OUTPERFORM
Number of Analysts 22
Average target price 38,7 $
Spread / Average Target 20%
Consensus details
EPS Revisions
More Estimates Revisions
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%194 889
JOHNSON & JOHNSON10.94%310 823
ROCHE HOLDING LTD.-16.53%200 485
NOVARTIS AG-14.06%197 285
PFIZER INC.0.00%194 889
MERCK & CO., INC.17.29%167 986
More Results