Company*
(Country;
Symbol)
Product Description Indication Status (Date)

CANCER
BioCryst
Pharmaceuticals
Inc.
(BCRX)
FodosineA transition-state analog inhibitor of purine nucleoside phosphorylaseCutaneous T-cell lymphomaEuropean regulators granted orphan drug status (2/6)
Bioenvision Inc.
(BIVN)
EvoltraClofarabine; a purine nucleoside analogPediatric relapsed or refractory acute lymphoblastic leukemiaFiled an application with the EMEA (2/7)
Genta Inc.
(GNTA)
GenasenseOblimersen sodiumAdvanced melanomaCompleted its response to outstanding issues from the EMEA regarding the MAA (2/2)
ImClone
Systems Inc.
(IMCL) and
Bristol-Myers
Squibb Co.
ErbituxCetuximab; antibody that blocks the epidermal growth factor receptorAdvanced colorectal cancer Filed an application with Japanese regulatory authorities seeking approval there (2/5)
Peregrine
Pharmaceuticals
Inc.
(PPHM)
Anticancer agent developed with tumor necorsis therapy technology, which targets DNA that is released by dead and dying cells found at the center of tumors CancerAn undisclosed licensee began European clinical trials (2/22)
CARDIOVASCULAR
Sangart Inc.*HemospanAn oxygen therapeutic designed to be an alternative to blood transfusionsTo deliver oxygen to tissuesBegan enrolling patients in two parallel European Phase III trials (2/13)
ThromboGenics
NV
(Belgium;
BR:THR) and
BioInvent
International AB
(Sweden; SSE:BINV)
TB-402Antibody that binds Factor VIII; antithromboticTo prevent blood clotsReceived approval from the Danish Medicines Agency to begin a Phase I trial (2/12)
CENTRAL NERVOUS SYSTEM
CeNeS
Pharmaceuticals
plc
(UK; LSE:CEN)
M6GMorphine-6-glucuronide peptide vectorPostoperative painPivotal Phase III data from a European trial showed it did not reach statistical significance in the primary endpoint of overall reduction of nausea and vomiting, but did show it is as good as morphine in terms of anal- gesia (2/21)**
Neurochem Inc.
(Canada; NRMX;
TSX:NRM)
AlzhemedTramiprosate; small molecule designed to interfere with association between glycosamino-glycans and A-beta proteinAlzheimer's diseaseReceived a second recommendation from the European data safety monitoring board to continue its ongoing Phase III trial (2/13)
Symbollon
Pharmaceuticals
Inc.
(OTC BB:SYMBA)
IoGenIodine-based oral drugFibrocystic breast painGerman regulatory authorities agreed to allow the company to submit its ongoing Phase III study in support of marketing approval (2/28)
INFECTION
Idenix
Pharmaceuticals
Inc.
(IDIX)
Sebivo Telbivudine; once-a-day tablet Chronic hepatitis B infection CMPH recommended granting marketing authorization (2/23)
Sinovac Biotech
Ltd.
(AMEX:SVA)
Euvax-BVaccineHepatitis BFiled for Chinese approval (2/8)
Tibotec
Pharmaceuticals
Ltd.
(Ireland; unit
of Johnson &
Johnson
)
PrezistaA protease inhibitorHIV-1European Commission granted conditional marketing authorization; additional data is needed for full authorization (2/19)
Transgene SA
(France; PARIS:TNG)
TG4040MVA-HCV; vaccineHepatitis C virusEnrolled patients in a Phase I trial conducted in France (2/13)
MISCELLANEOUS
Shire plc (UK;
LSE:SHP)
Fosrenol (FDA-approved)Lanthanum carbonate; phosphate-binding agentHyperphosphatemiaLaunched Fosrenol in the UK, following its approval to control hyperphosphatemia in chronic renal failure patients on hemodialysis or continuous ambulatory peritoneal dialysis (2/22)

Notes:
* Privately held.
CMPH = Committee for Medicinal Products for Human Use; EMEA = European Medicines Agency; MAA = Marketing authorization application; MRP = Mutual Recognition Procedure.
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.
AMEX = American Stock Exchange; BR = Brussels Stock Exchange; LSE = London Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SSE = Stockholm Stock Exchange; TSX = Toronto Stock Exchange.

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