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Online Extra: The Next Wave


Both Big Pharma and small companies have hundreds of biotech drugs in development. Here are some innovative candidates that are approaching the market, listed by drug name, company, for what disease, and how the drug works.

AWAITING FDA APPROVAL:

Abatacept

Bristol-Myers Squibb (BMY)

Rheumatoid arthritis

This drug is the first of a new class of compounds called selective T-cell co-stimulation modulators. Overproliferation of the immune system's T cells lead to the joint inflammation that's this disease's hallmark. Abatacept blocks one of two signals needed for T-cell activation, thereby interrupting the inflammatory process while still allowing the body to respondto infection.

Status:Bristol-Myers completed filing its FDA application in March. The drug was granted Fast Track status by the agency, which means the application must be reviewed within six months after it's filed.

Revlimid

Celgene (CELG)

Myelodysplastic syndrome (MDS), a malignant blood-cell disorder that causes anemia and requires frequent blood transfusions

Revlimid is the lead compound of a new class of immunomodulatory drugs, which modulate a deadly immune system cell called tumor necrosis factor alpha that kills malignant cells. Revlimid is a reengineered and far less dangerous version of thalidomide, the notorious sleeping pill that was pulled off the market in the 1960s after it caused horrific birth defects.

Status: Celgene completed filing its FDA application for the drug in April. It has Fast Track status.

Ranexa

CV Therapeutics (CVTX)

Chronic angina (crushing chest pain)

Ranexa, the first new anti-angina therapy in 25 years, improves the heart's pumping efficiency by inhibiting a cardiac channel that can cause an irregular heart beat.

Status: Ranexa received an "approvable" letter from the FDA in October, 2003, pending the successful completion of another clinical trial. CV has completed that trial and plans to submit the data to the FDA in the third quarter of 2005.

Riquent

La Jolla (LJPC)

Lupus

Blocks the overproduction of immune cells that attack the kidneys

Status: Riquent has Fast Track designation, and the FDA issued an "approvable" letter in October, 2004, pending a further clinical trial. However, La Jolla warned on May 31 that it doesn't have the financial resources to continue that additional trial.

SOON TO BE SUBMITTED TO THE FDA:

Acomplia

Sanofi-Aventis (SNY)

Obesity, nicotine addiction

Acomplia blocks the cannabinoid receptor on the surface of brain cells,which controls how the brain reacts to certain pleasurable sensations. If the drug wins approval it's expected to be a instant blockbuster.

Status: Company plans to file an FDA application this year

Gardasil

Merck (MRK)

Human papilloma virus, the cause of most cervical cancer

Likely to be the first vaccine on the market for this disease, Gardasil targets four strains of the virus. GlasxoSmithkline (GSK) is working on a similar vaccine.

Status: Merck plans to file for FDA approval this year.

Sutent

Pfizer (PFE)

Kidney and stomach cancers

One of a new wave of multitargeted cancer therapies, Sutent blocks a protein that drives tumor growth and stops blood-vessel growth to the cancer cells.

Status: Pfizer plans to seek FDA approval for one type of stomach cancer by yearend.

IN LATE-STAGE TRIALS:

Provenge

Dendreon (DNDN)

Prostate cancer

Provenge is a vaccine that stimulates the body's own immune system to attack cancer cells. A number of cancer vaccines are in development, but Provenge is one of the furthest along.

Status: A Phase 3 clinical trial is ongoing, which will form the basis of an FDA application.

Telcyta

Telik(TELK)

Ovarian and lung cancer

This is the first of a novel class of cancer drugs that targets an enzyme overproduced by many cancer cells. When Telcyta comes into contact with the enzyme, it splits into two parts, one of which is highly toxic. The poisonous half enters the cancer cell and kills it, while the other half dissolves, leaving healthy cells unharmed.

Status: The drug has Fast Track status and is in two Phase 3 clinical trials that will form the basis of an FDA application.

Lucentis

Genentech (DNA)

Macular degeneration (age-related blindness)

This leading cause of blindness in the elderly occurs when excess blood vessels start leaking into the eye. Lucentis is injected directly to the back of the eye, where it blocks an enzyme called VEGF that encourages blood-vessel growth. A similar drug, Macugen, approved in December, stabilizes the disease, but in clinical trials Lucentis appears to be the first drug that actually improves vision.

Status: In late-phase clinical trials that will form the basis of an FDA application


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