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

BioDelivery Sciences International Inc. (BDSI) BEMA Fentanyl A dissolvable polymer formulation of the opioid narcotin fentanyl Breakthrough cancer pain Submitted an NDA (10/31)
Imclone Systems Inc. (IMCL) Erbitux (FDA-approved) Cetuximab EGFR-expressing metastatic colorectal cancer FDA approved an sBLA to expand the product labeling to include overall survival data as a single agent following failure of both irinotecan- and oxaliplatin-based regimens (10/3)
Genta Inc. (GNTA) Genasense Oblimersen sodium injection Chronic lymphocytic leukemia Completed its filing of a formal appeal to the FDA regarding the non-approvable letter (10/25)
Innovive Pharmaceuticals Inc. (OTC BB:IVPH) Tamibarotene A fully synthetic retinoid designed to overcome resistance to all-trans-retinoic acid Relapsed or refractory acute promy-elocytic leukemia Received orphan drug designation from the FDA (10/15)
Millennium Pharmaceuticals Inc. (MLNM) Velcade (FDA-approved) Bortezomib Refractory multiple myeloma FDA expanded the label for Velcade to include refractory multiple myeloma patients with impaired kidney function, including those requiring dialysis (10/15)
Telik Inc. (TELK) Telcyta Canfosfamide HCl, TLK286 Advanced ovarian cancer and non-small-cell lung cancer FDA removed the partial hold on clinical trials (10/15)
Lev Pharmaceuticals Inc. (OTC BB:LEVP) Cinryze A C1 inhibitor Hereditary angioedema FDA accepted the filing of the BLA (10/2); amended the filing to include data from a pivotal Phase III trial (10/30)
Cortex Pharmaceuticals Inc. (AMEX:COR) CX717 Ampakine compound Attention deficit hyperactivity disorder FDA rejected a proposal for a Phase IIb trial (10/11)
Hemispherx Biopharma Inc. (AMEX:HEB) Ampligen Toll-like receptor-based therapy Chronic fatigue syndrome Filed an NDA (10/11)
Knopp Neurosciences Inc.* KNS-760704 A small-molecule therapy Amyotrophic lateral sclerosis FDA granted orphan drug designation (10/15)
Noven Pharmaceuticals Inc. (NOVN) Stavzor Delayed release valproic acid capsules Manic episodes associated with bipolar disorder, multiple seizure types and migraine headaches FDA issued an approvable letter (10/24)
Vernalis plc (UK; LSE:VER) and Endo Pharmaceuticals Inc. (ENDP) Frova Frovatriptan Menstrual migraine FDA issued a not approvable letter for the sNDA for Frova (10/1)
Amylin Pharmaceuticals In . (AMLN) Byetta (FDA-approved) Exenatide Type II diabetes FDA issued a warning that Byetta may be linked to pancreatitis and asked Amylin to include information on the current label (10/16)
Amylin Pharmaceuticals Inc. (AMLN) Symlin (FDA-approved) Pramlintide acetate Type II diabetes FDA issued a non-approvable letter for Symlin use with basal insulin in patients who have not achieved desired glucose control (10/1)
Gilead Sciences Inc. (GILD) Viread (FDA-approved) Tenofovir disoproxil fumarate Hepatitis B virus Filed for approval in the U.S. and Europe (10/12)
Sequella Inc.* SQ109 A diamine anti-TB drug Tuberculosis FDA and EMEA granted orphan drug status (10/22)
Theravance Inc. (THRX) Telavancin A once-daily, injectable antibiotic Complicated skin and skin structure infections FDA issued an approvable letter (10/22)
DOR BioPharma Inc. (OTC BB:DORB) orBec A steroid-sparing agent Gastrointestinal graft-vs.-host disease FDA issued a not approvable letter (10/19)
Genzyme Corp. (GENZ) Renvela Sevelamer carbonate To control serum phosphorus in patients with chronic kidney disease on dialysis FDA granted marketing approval (10/22)
MGI Pharma Inc. (MOGN) and Helsinn Healthcare Aloxi (FDA-approved) Palonosetron hydrochloride Postoperative nausea and vomiting Filed an sNDA (10/30)

* 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; OTC BB = Over-the-Counter Bulletin Board