| 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. | ||||