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FDA grants orphan status for two drugs

Senesco has won US orphan drug status for a multiple myeloma drug, while Optimer has won orphan status for a potential drug for paediatric CDI

Senesco Technologies has won orphan drug status from the US Food and Drug Administration for a multiple myeloma drug, while Optimer has been granted US orphan status for a potential treatment for paediatric Clostridium difficile infection (CDI).

Orphan drug status, which is designed to encourage the development of treatments for diseases affecting fewer than 200,000 Americans, carries with it a number of benefits to the drug sponsor, including tax credits, access to grant funding for clinical trials, accelerated FDA approval, seven years of marketing exclusivity after drug approval, and potential exemption from the FDA's prescription drug application fee.

Senesco's SNS01-T multiple myeloma drug, the company's lead product candidate, is about to enter clinical studies. The drug was developed using proprietary technology that regulates programmed cell death, or apoptosis.

Optimer's drug for paediatric CDI, called fidaxomicin, is also the company's lead product candidate. The drug has completed phase III trials in adults, and marketing applications have been filed in the US and the EU seeking approval for fidaxomicin for the treatment of CDI and for the reduction of recurrences in adult patients.

Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase. Currently, vancomycin is the only FDA-approved drug for CDI, although metronidazole is used off-label. About 30 per cent of CDI patients who initially respond to these treatments have a clinical recurrence once drug treatment ends, according to Optimer.

5th January 2011

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