Company*
(Country;
Symbol)		 Product Description Indication Status (Date)
CANCER
BioCryst
Pharmaceuticals
Inc. (BCRX)		 Fodosine A transition-state analog inhibitor of purine nucleoside phosphorylase Cutaneous T-cell lymphoma European regulators granted orphan drug status (2/6)
Bioenvision Inc.
(BIVN)		 Evoltra Clofarabine; a purine nucleoside analog Pediatric relapsed or refractory acute lymphoblastic leukemia Filed an application with the EMEA (2/7)
Genta Inc.
(GNTA)		 Genasense Oblimersen sodium Advanced melanoma Completed its response to outstanding issues from the EMEA regarding the MAA (2/2)
ImClone
Systems Inc.
(IMCL) and
Bristol-Myers
Squibb Co. 		Erbitux Cetuximab; antibody that blocks the epidermal growth factor receptor Advanced 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 Cancer An undisclosed licensee began European clinical trials (2/22)
CARDIOVASCULAR
Sangart Inc.* Hemospan An oxygen therapeutic designed to be an alternative to blood transfusions To deliver oxygen to tissues Began enrolling patients in two parallel European Phase III trials (2/13)
ThromboGenics
NV (Belgium;
BR:THR) and
BioInvent
International AB
(Sweden; SSE:BINV)		 TB-402 Antibody that binds Factor VIII; antithrombotic To prevent blood clots Received approval from the Danish Medicines Agency to begin a Phase I trial (2/12)
CENTRAL NERVOUS SYSTEM
CeNeS
Pharmaceuticals
plc (UK; LSE:CEN)		 M6G Morphine-6-glucuronide peptide vector Postoperative pain Pivotal 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)		 Alzhemed Tramiprosate; small molecule designed to interfere with association between glycosamino-glycans and A-beta protein Alzheimer's disease Received 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)		 IoGen Iodine-based oral drug Fibrocystic breast pain German 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-B Vaccine Hepatitis B Filed for Chinese approval (2/8)
Tibotec
Pharmaceuticals
Ltd. (Ireland; unit
of Johnson &
Johnson)		 Prezista A protease inhibitor HIV-1 European Commission granted conditional marketing authorization; additional data is needed for full authorization (2/19)
Transgene SA
(France; PARIS:TNG)		 TG4040 MVA-HCV; vaccine Hepatitis C virus Enrolled patients in a Phase I trial conducted in France (2/13)
MISCELLANEOUS
Shire plc (UK;
LSE:SHP)		 Fosrenol (FDA-approved) Lanthanum carbonate; phosphate-binding agent Hyperphosphatemia Launched 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.