22 jun: Belgium June Business Confidence -13.2 Vs -11.2 In May
22 jun: Brazil Government Will Cut Fuel Tax To Help Petrobras -Report
22-06-2012 15:35:00

EMA Recommends Against Marketing Authorization to Pfizer and Protalix for Gaucher Treatment

Relateret indhold

By Saabira Chaudhuri

The European Medicines Agency has recommended against marketing authorization for Pfizer Inc. (PFE) and Protalix BioTherapeutics Inc. (PLX) for their Gaucher disease treatment, taliglucerase alfa.

Protalix's shares were down 12% premarket to $5.83. The stock is up 34% year-to-date. Pfizer's shares were flat premarket at $22.60. The stock is up 4% year-to-date.

The European agency made a positive risk-benefit assessment, concluding that the benefits of the treatment outweighed its risks, but didn't recommend marketing authorization because Shire PLC's (SHPGY, SHP.LN) velaglucerase alfa has received prior marketing authorization with an orphan drug designation for the same condition. Shire's treatment has marketing exclusivity in the European Union for 10 years from August 2010, the time of authorization.

"While we are disappointed by the CHMP's [EMA's Committee for Medicinal Products for Human Use] recommendation, we are encouraged that the committee gave a positive risk-benefit assessment. The recommendation was based solely on orphan market exclusivity and not the safety and efficacy profile of taliglucerase alfa," said General Manager Diem Nguyen of Pfizer's Biosimilars division. "Pfizer will continue to work with relevant stakeholders to determine appropriate next steps."

Pfizer and Protalix BioTherapeutics entered into an agreement to develop and commercialize taliglucerase alfa, an enzyme replacement therapy, in November 2009. The treatment was approved by the Food and Drug Administration last month for the long term enzyme replacement therapy of adults with a confirmed diagnosis of Type 1 Gaucher disease.

According to the National Institute of Health's National Institute of Neurological Disorders and Stroke, Gaucher disease is the most common of the inherited metabolic disorder known as lipid storage diseases. Lipids are fatty materials that include oils, fatty acids, waxes, and steroids [such as cholesterol and estrogen]. Gaucher disease is caused by a deficiency of the enzyme glucocerebrosidase. Fatty materials can accumulate in the spleen, liver, lungs, bone marrow, and brain. Symptoms may include skeletal disorders, enlarged spleen and liver, liver malfunction, anemia, and yellow spots in the eyes.

Write to Saabira Chaudhuri at saabira.chaudhuri@dowjones.com

(END) Dow Jones Newswires

June 22, 2012 09:35 ET (13:35 GMT)

Copyright (c) 2012 Dow Jones & Company, Inc.

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
Ingen indlæg

Fondsbørsmeddelelser

Vestas vinder ordre på 34 MW i Tyrkiet - NY

19-12-2014 16:36:45
Vestas har fredag vundet en tyrkisk ordre på levering af 17 vindmøller med en samlet kapacitet på 34 megawatt.Det fremgår af en pressemeddelelse fra den danske ..

Novo Nordisk: Tresiba får positiv anbefaling om brug til børn

19-12-2014 13:26:58
En lægemiddelkomité under de europæiske sundhedsmyndigheder, EMA, anbefaler en udvidet indikation af diabetesmidlet Tresiba.Lægemiddelkomitéen, CHMP, anbefaler,..

Aktier/middag:Carlsberg presset i positivt C20

19-12-2014 11:42:20
Noget tyder på, at julestemningen har smittet af på investorerne på det danske aktiemarked. I hvert fald gør købelysten på det danske C20 Cap-indeks sig gældend..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Nye stigninger på vej
2
Novo Nordisk: Tresiba får positiv anbefaling om brug til børn
3
Nordjyske-formand: Vi er helt oppe på tåspidserne
4
EU's udenrigschef: Putin må skifte kurs
5
Nordjyske Bank melder sig i kampen om Nørresundby Bank - NY

Relaterede aktiekurser

Pfizer Inc 31,89 -0,3% Fald i aktiekurs
Shire ORD 5P 4.623,00 -1,3% Fald i aktiekurs
Pfizer Inc 244,00 0,6% Stigning i aktiekurs
Pfizer 31,15 5,4% Stigning i aktiekurs
Pfizer Incorporated COM .. 31,88 0,6% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen
Køb

Relaterede selskaber
Få adgang til information og anbefalinger af relaterede selskaber med PLUS pakken.

Du får adgang til 7 værdifulde investorværktøjer til investering.

Klik her og læs mere om PLUS pakken.

Copyright Euroinvestor A/S 2014  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
19. december 2014 17:28:22
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20141211.1 - EUROWEB4 - 2014-12-19 17:28:22 - 2014-12-19 17:28:22 - 1 - Website: OKAY

Når du besøger Euroinvestor.dk accepterer du, at der anvendes cookies, som vi og vores samarbejdspartnere benytter til funktionalitet, statistik og markedsføring. Læs mere om cookies på Euroinvestor.dk her

x