Company*
(Country;
Symbol)		 Product Description Indication Status (Date)
AUTOIMMUNE
Abbott
Laboratories
(NYSE:ABT)		 Humira (FDA-approved) Adalimumab; fully human antibody designed to block TNF- alpha Moderately to severely active Crohn's disease FDA approved Humira as a treatment for reducing the signs and symptoms, and inducing and maintaining clinical remission in adults who have had an inadequate response to conventional therapy (2/27)
CANCER
Pfizer Inc.
(NYSE:PFE)		 Sutent (FDA-approved) Sunitinib malate; a multiple-receptor tyrosine kinase inhibitor Advanced renal cell carcinoma FDA approved new labeling to include first-line treatment (2/8)
Pharmacyclics
Inc. (PCYC)		 Xcytrin Motexafin gadolinium; small molecule from the texaphyrin class designed to induce apoptosis Brain metastases due to non-small-cell lung cancer FDA rejected the NDA because the trials did not demonstrate statistically significant differences between treatment arms in the prespecified endpoints (2/21)
Pro-
Pharmaceuticals
Inc. (AMEX:PRW)		 Davanet A carbohydrate polymer, composed of mannose and galactose (galactomannan) Cancer Began filing NDA as a treatment in combination with 5-fluorouracil (2/7)
Seattle Genetics
Inc. (SGEN)		 SGN-33 Lintuzumab; a humanized monoclonal antibody targeting CD33 Acute myeloid leukemia FDA granted orphan drug designation (2/13)
Spectrum
Pharmaceuticals
Inc. (SPPI) and
GPC Biotech AG
(Germany; GPCB)		 Satraplatin Oral platinum compound Prostate cancer GPC completed its submission of the rolling NDA (2/19)
CARDIOVASCULAR
Aastrom
Biosciences
Inc. (ASTM)		 Tissue Repair Cells Consist of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient Dilated cardiomyopathy FDA granted orphan drug designation (2/1)
Cardiome Pharma
Corp. (Canada;
CRME) and Astellas
Pharma US Inc. 		Vernakalant hydrochloride Intravenous formulation For the acute conversion of atrial fibrillation FDA accepted for review the NDA (2/20)
EPIX
Pharmaceuticals
(EPIX)		 Vasovist Blood-pool imaging agent To visualize vascular disease EPIX filed a formal appeal with the FDA seeking approval of Vasovist, following three denials by the agency (2/28)
Gilead Sciences
Inc. (GILD)		 Ambrisentan Once-daily treatment Pulmonary arterial hypertension FDA granted priority review for the NDA (2/20)
ZymoGenetics
Inc. (ZGEN)		 rhThrombin Recombinant human thrombin Hemostasis during surgery FDA accepted for review the BLA (2/19)
CENTRAL NERVOUS SYSTEM
New River
Pharmaceuticals
Inc. (NRPH) and
Shire plc (UK)		 Vyvanse Once-daily treatment that consists of d-amphetamine, covalently linked to l- ysine, a naturally occurring amino acid that is quickly absorbed from the gastrointestinal tract and converted to d-amphetamine Attention deficit hyperactivity disorder FDA approved Vyvanse (2/26)
INFECTION
Advancis
Pharmaceutical
Corp. (AVNC)		 Amoxicillin PULSYS Amoxicillin formulation delivered with once-daily pulsatile Pulsys technology Pharyngitis Company received a refusal to file letter from the FDA for the once-daily NDA; the application did not include a proposed commercial batch record or a detailed commercial process description with process parameters and in-process controls (2/14)
Emergent
BioSolutions
Inc. (NYSE:EBS)		 BioThrax Anthrax vaccine absorbed Postexposure prophylaxis against anthrax infection FDA granted fast-track designation (2/12)
Theravance Inc.
(THRX)		 Tevavancin Lipoglycopeptide; bactericidal injectable antibiotic Complicated skin and skin structure infections caused by Gram-positive organisms FDA accepted the NDA (2/21)
ViroPharma
Inc. (VPHM)		 Maribavir Benzimidazole compound; oral inhibitor of cytomegalovirus To prevent cytomegalovirus viremia Received orphan drug designation from the FDA (2/7)
MISCELLANEOUS
BioMimetic
Therapeutics
Inc. (BMTI)		 rhPDGF-BB Recombinant human platelet derived growth factor Osteonecrosis of the jaw FDA designated rhPDGF-BB an orphan drug (2/21)
Hana
Biosciences
Inc. (HNAB)		 Zensana An oral spray formulation of the 5-HT3 antagonist ondansetron To prevent nausea and vomiting as a result of chemotherapy FDA approval will likely be delayed because stability studies detected small amounts of precipitated material in scale-up batches of Zensana (2/21)
Kuros
Biosurgery AG
(Switzerland)		 I-040302 Bone-repair product Solitary bone cysts FDA granted orphan drug designation (2/22)
Ortec
International
Inc. (OTC BB:
OTCI)		 OrCel Tissue-engineered product Venous leg ulcers Filed a pre-market approval supplement application (2/26)
Notes:
* Privately held.
BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration;
IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act;
SPA = Special protocol assessment.
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.
AMEX = American Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board