How much is a new treatment for pink eye worth? For one on the verge of Phase 3 testing, about $300 million.
That’s the figure Shire, the Ireland and Lexington, MA-based based rare disease specialist, has agreed to pay for a small New York-based biotech called Foresight Biotherapeutics, Shire announced this morning. Few details about Foresight are publicly available, other than it’s based just a few blocks south of Central Park in Manhattan and was established to develop drugs for eye and ear conditions. Shire’s interest is in a prospective drug called FST-100, an eye drop for pink eye that combines the steroid dexamethasone with povidone-iodine, which has been used as an off-label treatment for the disease.
Regulatory filings show Foresight raised about $17 million total—$2 million in 2011, and $15 million a few years after that—and was formed by Michael Weiser and Jason Stein, the co-founders of a New York-based healthcare investment firm called Actin Biomed. Weiser is also on the board of Ziopharm Oncology and had been a director of Chelsea Therapeutics before Lundbeck acquired it last year.
Shire is touting FST-100 as a potential treatment for pink eye caused by viruses (which are to blame for about half of all pink eye infections) and bacteria. Viral pink eye is easily spread and has no effective FDA-approved treatment; people who get it simply have to stay home and wait for it to go away. Bacterial pink eye can be effectively treated with antibiotics, but it can be difficult to determine whether the infection is caused by a virus or a bacterium, meaning sometimes patients can be given the wrong treatment and antibiotics can be overused. There are about 11 million cases of pink eye in the U.S. and Europe every year.
“In our discussions with experts in the field, we’ve heard their enthusiasm for the possibility of a treatment that could reduce inflammation while killing virus and bacteria without the risk of unnecessary antibiotic use,” Weiser said in a statement.
Though Shire wants to test FST-100 in both types of pink eye, its development as a viral pink eye treatment is much further along, on the verge of a Phase 3 trial. Foresight has yet to test the drug in humans for bacterial pink eye. Shire says the drug was tested in two Phase 2 studies for viral pink eye, and that, in one of those trials, while there was a “trend toward efficacy,” the drug didn’t meet its goal because there weren’t enough patients who tested positive for a virus in the eye. Shire will lead the Phase 3 study, which will include “investigation” for the treatment of bacterial pink eye.
One thing to watch going forward is that iodine stings the eye and can cause corneal defects, which is why existing iodine preparations have to be rinsed out quickly after being administered and why doctors typically prep a patient with numbing agents beforehand. Shire said in a mid-stage trial that the most commonly seen side effects were inflammation in the eye and swelling in the eyelid. Both are painful, and something to keep an eye on in further testing.
Shire is sliding FST-100 into fairly recently created ophthalmics unit, which it’s built up over the past few years with the help of some acquisitions. The most advanced drug in that group is lifitegrast, a potential drug for dry eye disease that Shire snared when it bought Brisbane, CA-based SARcode Biosciences for $160 million in late 2013. Shire has also added companies like Premacure AB and BIKAM Pharmaceuticals to the eye drug unit, which also candidates for glaucoma, retinitis pigmentosa, and other diseases that affect the eye.