BioWorld - Lux/ISA Front Page FeatureToday's BioWorld featured Lux/ISA this morning. I took several quotes from the text of the article and pasted them below...
Lux has done what few small, private biotechs have managed in today’s tough economy: get a drug to market without the help of public funding or a big pharma partner.
Both orphan AND fast-track status. “We’re hoping for approval in Q3,” Ulrich Grau, president and CEO, told BioWorld
After approval, Lux will seek funding - “We’ll be exploring options,” he said.
Only one private firm in five years has been able to accomplish the same feat as Lux - Gloucester
Gloucester Pharmaceuticals made it all the way through approval with Istodax (romidepsin) for cutaneous T-cell lymphoma with about $100 million in venture money. Shortly after FDA approval, Gloucester was snatched up by Celgene for $640 Million.
Lux raised just under $100 million in venture capital, most recently closing on an impressive $50 million Series B round in October to support regulatory filings of Luveniq and commercial launch preparations.
The filings alone were a big task – they comprised about 1 million pages, and filing simultaneously in the U.S. and Europe was “a bit of a challenge.”
Lux was helped some by Isotechnika, from which it licensed rights to Luveniq in ophthalmic indications.
Isotechnika retained rights to the drug, a next-generation calcineurin inhibitor known as voclosporin, in autoimmune indications such as psoriasis and organ transplant rejection. The FDA allowed Lux to submit safety data from Isotechnika’s psoriasis trials as part of the Luveniq application. “So our safety database includes 2110 patients”, Grau said.
Upon FDA approval, Lux would owe Isotechnika a $7.1 Million
Upon EMEA approval, Lux would owe Isotechnika a $3.5 Million
Uveitis affects about 300,000 people in the U.S., with 10 percent of those suffering blindness.
Topical drugs are not effective, so patients resort to steroids or require actual injections into the eye. But Luveniq could reduce inflammation, preserve vision and help eliminate the need for steroid treatment.
Lux is working on a nanomicellar formulation of voclosporin for dry eye syndrome, with a Phase I trial completed last year, and may look at moving voclosporin into other chronic inflammatory ocular diseases.
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