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
Relateret debat
29 sep - 
I need a thorough explanation on it, mind if you could ..

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

Schouw/CEO: Har flere opkøb i kikkerten

30-10-2014 15:39:25
Industrikonglomeratet Schouw & Co. har appetit på yderligere opkøb til sine porteføljevirksomheder.Det siger selskabets administrerende direktør Jens Bjerg Søre..

Novo/S&P Capital: Hæver kursmål til 273 kr. fra 253 kr.

30-10-2014 13:03:29
Analytikerne hos S&P Capital IQ er blevet mere positivt stemt over for Novo Nordisk-aktien.I hvert fald hæver finanshuset kursmålet til 273 kr. fra tidligere 25..

Aktier/åbning: Danske Bank og Novo fører an efter regnskaber

30-10-2014 09:14:46
To af de tunge spillere i eliteindekset C20, Danske Bank og Novo Nordisk, kom torsdag morgen med kvartalsregnskaber inden børsåbning.Og det er da også de to akt..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Novo/Sydbank: Levemir-tal gør frygt til skamme
2
Coloplast Q4: Absolut ingen slinger i valsen
3
Aktier/tendens: Novo fører an i regnskabsbølge
4
Danske Q3: Opjusterer efter overraskende stærkt kvartal
5
Aktier/åbning: Danske Bank og Novo fører an efter regnskaber

Relaterede aktiekurser

Pfizer Inc 29,84 0,0% Aktiekurs uændret
Shire ORD 5P 4.164,00 0,0% Aktiekurs uændret
Pfizer 28,25 0,0% Aktiekurs uændret
Pfizer Incorporated COM .. 29,83 0,0% Aktiekurs uændret
Pfizer Inc 218,50 0,0% Aktiekurs uændret

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.
Euroinvestor i andre lande: Euroinvestor.com | Euroinvestor.se | Euroinvestor.no | Euroinvestor.fr | Forexinvestor.com| Wisselkoersen.nl | Valuta.se | Valutaveksel.no | Divisas.es | Valute.it
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.
 
31. oktober 2014 07:58:13
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20141028.2 - EUROWEB7 - 2014-10-31 07:58:13 - 2014-10-31 07:58:13 - 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