Company* |
Product | Description | Indication |
Status |
| ||||
AUTOIMMUNE | ||||
Genentech |
Rituxan |
Rituximab; antibody that targets and selectively depletes CD20- positive B cells |
Rheumatoid arthritis |
Filed supplemental BLA seeking approval in patients with active RA who inadequately respond to an anti-TNF therapy (8/31) |
CANCER | ||||
Amgen Inc. |
Panitumumab |
Fully human monoclonal antibody directed against the epidermal growth factor receptor |
Metastatic colorectal cancer |
The FDA granted fast-track designation to the product; a BLA filing is planned before the end of 2005 (8/1) |
AmpliMed |
Amplimexon |
Imexon injection; a cyanoaziridine compound believed to disrupt mitochondria |
Ovarian cancer |
The FDA granted orphan designation to the product in that indication; it already had orphan status in three other cancer indications (8/30) |
Antisoma plc |
AS1411 |
Anti-nucleolin aptamer |
Renal cancer |
The FDA granted orphan designation to the Phase I product in that indication (8/17) |
Ariad |
AP23573 |
Oral form of agent designed to inhibit cell-signaling protein mTOR |
Soft-tissue and bone sarcomas |
The FDA granted orphan designation to the drug in both indications (8/18) |
Genentech |
Rituxan (FDA-approved) |
Rituximab; antibody that targets and selectively depletes CD20-positive B cells |
Non-Hodgkin's lymphoma |
Filed supplemental NDA seeking approval in previously untreated patients with intermediate-grade or aggressive, CD20-positive, B- cell NHL, in combination with other chemotherapy regimens (8/17) |
ImClone |
Erbitux (FDA-approved) |
Cetuximab; antibody that blocks the epidermal growth factor receptor |
Head and neck cancer |
Filed supplemental BLA seeking approval for use with radiaiton in advanced squamous cell carcinoma of the head and neck and as a monotherapy in platinum-based failures (8/30) |
CARDIOVASCULAR | ||||
CoTherix Inc. |
Ventavis (FDA-approved) |
Inhaled formulation of iloprost, a prostacyclin analogue |
Pulmonary arterial hypertension |
The FDA expanded the drug's label to include use with Tracleer and for use with the hand-held I-neb AAD device (8/30) |
CENTRAL NERVOUS SYSTEM | ||||
Cognetix Inc.* |
CGX-1160 |
Broad-spectrum non-opioid analgesic based on peptide synthesized from marine cone snails |
Neuropathic pain |
The FDA granted orphan status to the Phase Ib product for the intrathecal treatment of neuropathic pain associated with spinal cord injury (8/30) |
CytRx Corp. |
Arimoclomol |
Small molecule designed to provide cellular protection by activating molecular chaperone proteins |
Amyotrophic lateral sclerosis |
The FDA requested additional information in order to release a clinical hold it placed on planned Phase II trials (8/10) |
Pozen Inc. (POZN) |
Trexima (MT400) |
Single-tablet combination of sumatriptan (5-T1B/1D agonist) and naproxen |
Migraine |
Pozen filed an NDA with the FDA seeking approval of the agent (8/8) |
Pozen Inc. |
MT 100 |
Metoclopramide hydro- chloride combined with naproxen sodium |
Migraine |
FDA advisory panel voted that potential risk for tardive dyskinesia would outweigh benefits; the FDA issued a not-approvable letter in June 2004; Pozen ended development of the drug (8/5) |
TheraQuest |
TQ-1017 |
Abuse-deterrent, once-daily, extended-release tramadol |
Postherpetic neuralgia |
The FDA granted orphan designation to the product in that indication (8/11) |
INFECTION | ||||
Arpida Ltd. |
Iclaprim |
Capsule formulation of broad- spectrum antibiotic infections |
Complicated skin and skin- structure |
The FDA granted fast-track status to the product in that indication (8/23) |
Chiron Corp. |
Fluvirin (FDA-approved) |
Influenza vaccine |
Influenza |
The FDA OK'd Chiron's manufacturing facility in the UK, allowing the company to provide the vaccine for the 2005-06 flu season (8/31) |
Vicuron |
Anidulafungin |
Broad-spectrum agent from the echinocandin class |
Invasive candidiasis/candidemia |
Filed NDA with the FDA seeking approval in that indication (8/18) |
MISCELLANEOUS | ||||
BioMarin |
Orapred ODT |
Prednisolone sodium phosphate tablets; new formulation of Orapred |
Inflammation reduction |
Submitted an NDA with the FDA (8/1) |
CollaGenex |
Oracea |
Non-antimicrobial tetracycline derivative |
Rosacea |
Filed NDA with the FDA seeking approval in that indication (8/1) |
Discovery |
Surfaxin |
Engineered version of natural human lung surfactant |
Respiratory distress syndrome in premature infants |
The FDA said Discovery needed to provide more information in its response letter to the approvable letter received in February (8/15); the questions center on chemistry and manufacturing (8/19) |
Tercica Inc. |
Increlex |
Mecasermin injection; recombinant human insulin-like growth factor-1 |
Short stature caused by IGF deficiency |
The FDA approved the drug for long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone (8/31) |
Large Scale |
-- |
Recombinant human lysosomal acid lipase |
Various diseases |
The FDA granted orphan designation to the product, which is targeted toward the metabolism of certain lipids (8/1) |
Neurochem |
Fibrillex |
Glycosaminoglycan mimetic with anti-amyloid properties |
Amyloid A amyloidosis |
Initiated rolling NDA submission with the FDA; complete filing is expected around year-end (8/22) |
Unigene |
Fortical |
A nasal calcitonin product |
Osteoporosis |
The FDA approved the product for treating postmenopausal osteoporosis; Upsher-Smith Laboratories Inc. will market it (8/15) |
| ||||
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; SPA = Special protocol assessment. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange. |