Biotech Stocks Facing FDA Decision In January 2019

Starpharma

Starpharma’s (SPHRY.OB) New Drug Application for VivaGel BV is under priority review by the FDA – with a decision expected in early January.

VivaGel BV is a non-antibiotic, water-based vaginal gel for the treatment of bacterial vaginosis and prevention of recurrent bacterial vaginosis.

The global market for bacterial vaginosis treatment is estimated to be roughly US$750 million, and about US$1 billion for prevention of recurrent bacterial vaginosis.

The product is already approved in Europe and Australia. VivaGel BV is licensed to Mundipharma in Europe, and to Aspen Pharmacare in Australia where it is marketed under the brand name Fleurstat.

Antibiotics like Flagyl, Cleocin oral or vaginal suppositories, vaginal gel MetroGel-Vaginal, and Solosec are some of the other approved medications for bacterial vaginosis.

In the U.S., VivaGel BV is licensed to ITF Pharma.

Starpharma is entitled to receive up to US$101 million from ITF Pharma in regulatory approval and commercialization milestones in addition to escalating double-digit royalties on sales.

SPHRY.OB closed Friday’s (Dec.21, 2018) trading at $9.55, down 3.44%.

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