Alimera Sciences ($ALIM) is facing an uphill battle getting its chronic diabetic macular edema drug on shelves in Europe, and now the company has recruited Quintiles to manage the European launch of Iluvien.
Under the deal, Quintiles will help the drugmaker execute a phased launch of the novel treatment, starting in Germany before moving on to the U.K. and France. Neither company disclosed financial particulars, but the agreement tasks Quintiles with providing marketing, regulatory and brand management services in each target country.
And the CRO has its work cut out for it in the U.K. Last month, Alimera hit a speed bump in its plans to cash in on the eye drug when the National Institute for Health and Clinical Excellence (NICE) rejected the treatment, saying its benefits weren't great enough to excuse a $8,800 price tag. Alimera has said it's putting together a Patient Access Scheme to address NICE's concerns and figure out a different pricing structure, and the company is optimistic that it can appease the regulator.
Now, however, Alimera can lean on Quintiles' European expertise to speed the process along, and Chris Pepler, a senior vice president at the CRO, said his company is more than up to the task.
"As the healthcare landscape has become more complex, it is increasingly important to engage with multiple stakeholders across the patient pathway," Pepler said in a statement. "... As Alimera Sciences enters these critical markets, we are excited to partner with them to help drive the success of Iluvien in the European ophthalmic market."
The deal extends through 2015 and, if all goes well in the EU, Alimera might look for similar help stateside, where the FDA has twice rebuffed Iluvien, sending the shares of Alimera and licensor pSivida ($PSDV) sharply southward.
- here's Alimera's announcement