Medical Device Daily
Alimera Sciences (Alpharetta, Georgia) reported closing a Series C financing round of $30 million, allowing the company to acquire a majority stake in Medidur FA, a drug delivery device, from partner pSivida (Perth, Australia).
The proceeds also will fund remaining development obligations for Medidur FA, which delivers the drug fluocinolone acetonide for the treatment of diabetic macular edema (DME). Two Phase III studies of the product completed enrollment last October, and top-line results are expected at the end of 2009, said Ken Green, Alimera’s chief scientific officer.
The company plans to file a new drug application in the first part of 2010, Green told Medical Device Daily.
Alimera said it will assume pSivida’s development responsibilities for the product and increase its share of future profits from 50% to 80%. For its increased equity in Medidur FA, Alimera has paid pSivida $12 million in cash and has issued a $15 million note (which would accrue interest of up to $6 million over the life of the note). Alimera also will make an additional $25 million milestone payment upon FDA approval of the product.
In connection with the acquisition, Alimera will complete the licensing of Medidur technology for use with NADPH (nicotinamide adenine dinucleotide phosphate reduced form) oxidase inhibitors, licensed from Emory University (Atlanta). Alimera is pursuing a treatment for dry age-related macular degeneration with these NADPH compounds.
The pivotal Phase III trial for Medidur FA involved about 900 patients around the world, evaluating the safety and effectiveness of injecting the device into the vitreous of the eye to treat DME.
Alimera says the tiny insert is small enough to be injected into the eye via a 25-gauge injector system and is expected to provide delivery of drug to the back of the eye for up to three years.
The company says many other systemic compounds for DME will not produce a therapeutic effect in the back of the eye, and those currently under clinical investigation must be injected often due to a lack of long-term release characteristics.
DME, which involves retinal thickening of the macular area, affects as many as 1 million Americans, and 200,000 people are diagnosed with it each year, according to Alimera’s data. The condition is a major cause of vision loss in people suffering from diabetic retinopathy, a complication of diabetes mellitus.
There are no FDA-approved products for treating DME; however, laser photocoagulation therapy is the current standard of care, Green said. Although it can slow the disease, laser photocoagulation is destructive to the retina, leaving irreversible blind spots, and it is somewhat costly, he said.
It “slows the decay of vision as opposed to leading to vision improvement.”
Medidur would not be destructive to the retina, and such steroids may provide vision improvement, Green said.
IntelliDx (Santa Clara, California reported that it raised $21.5 million in a Series D preferred stock financing, co-led by HLM and 3i Ventures.
IntelliDx is a development-stage company focused on commercializing an automated point-of-care blood analyzer for use in hospital intensive care units (ICU). The device, called Optimuso, uses electro-chemical sensor technology and is first being applied to automate the measurement of blood glucose levels in the many ICU patients with hyperglycemia.
Patients with sustained high blood glucose levels are at a high risk of developing other complications and their length of hospital stay is often prolonged. The company said it expects to launch its product in mid-2009.
In other financing news: Stentys (Clichy, France), a company developing a new approach to the treatment of lesions in bifurcated vessels, reported that it has completed an $18 million Series B round of venture financing.
Lead investor was Scottish Equity Partners. Series A investor Sofinnova Partners also participated in the B round. Aelios Finance served as financial advisor to Stentys.
Brian Kerr, a founding director of Scottish Equity Partners and a partner in the firm’s Healthcare Group, will join the Stentys board.