Emerging Drug Developer: Lux Biosciences

Lux banks $50M as it readies new drug launch

Lux Biosciences announced this morning that it has wrapped a $50 million Series B, and the CEO says much of that money will be used to launch its first ophthalmic drug as early as mid-2010.

Lux has several eye therapies in its pipeline, but the primary focus right now is on Luveniq, says CEO Ulrich Grau.

"It's our key product," says Grau. "We reported successful Phase III data from two trials and we are targeting submission (to the FDA) for late December in the U.S. and in Europe in early 2010." If Lux is granted a priority review, he added, the Jersey City, NJ-based developer could see an FDA approval next summer.

Luveniq is designed to target uveitis--an autoimmune disease resulting in chronic inflammation of the eye--in patients who are not responsive to topical steroids, adds Grau. And the CEO says that a sales force of about 30 could successfully market the drug in the U.S., making it likely that Lux will retain the sole rights to the drug, which it obtained in a licensing deal with Isotechnika.

"These are patients treated by uveitis specialists," says Grau. "The current treatment protocol is corticosteroids," and bringing bring them down to less than 10 milligrams a day is usually done with the experimental use of immunosuppressants.

Luvenig, he says, is a first-in-class therapy which researchers demonstrated could be used to taper the use of steroids to 5 milligrams a day, a vital issue for patients who face a potential loss of vision that takes a significant amount of time to recover from.

The developer raised the money from HBM Bioventures, Novo A/S, Prospect Venture Partners and SV Life Sciences (SVLS), as well as SVLS' publicly traded fund, International Biotechnology Trust. The financing, says Grau, will provide funds for Lux Biosciences until late in 2010.

Lux released data from three clinical trials for LX211.

"The available results from the Luminate program demonstrate that Luveniq, if approved, can play a significant role in the treatment of inflammation in certain forms of sight-threatening uveitis," said Eddy Anglade, M.D., Lux Biosciences' chief medical officer. "A significant unmet therapeutic need exists for an approved agent which is not a corticosteroid and allows sparing of those drugs to reduce their associated, serious side effects."

"From the beginning, we believed that Lux Biosciences had great programs that together made a compelling investment case in the ophthalmology field, which we felt was ripe for the development and commercialization of important new therapeutics," said Lutz Giebel, Ph.D., a managing partner at SVLS.

Grau says that it's possible that Lux may sign on partners to market the drug outside of the U.S., but he's quick to note that other countries would also require only a small sales force. And even though Lux is still small, with only 23 staffers, there are still ways for a semi-virtual company to use contract sales groups to market a drug.

Beyond the Series B, Grau adds that really anything is possible for Lux, including a potential IPO or M&A deal. But that's something that only the future will tell. In the meantime, Lux is also pursuing other drug programs.

Its LX201 program is centered on a silicone implant that provides sustained release of cyclosporine A locally to the eye over the course of one year. LX201 is implanted episclerally--beneath the connective tissue covering the white of the eye. The implant is being developed clinically for the prevention of rejection in corneal transplantation.

LX214 is a proprietary topical formulation of voclosporin that has been developed for ophthalmic use in collaboration with the University of Missouri at Kansas City. In late September Luz reported that a Phase I trial of the therapy in 30 healthy volunteers showed LX214 to be well tolerated at the two doses studied, with safety and tolerability measurements indistinguishable from placebo.

Emerging Drug Developer: Lux Biosciences
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