On January 9, pSivida (PSDV) held a dinner for analysts and investors in New York. The audience had a large number of retail investors and Dr. Paul Ashton, the CEO, gave a general, introductory overview of the Company. However, Dr. Ashton did provide some information that is very important to the outlook of the stock in 2014. I have written previous articles that provide an in-depth view of the Company for those unfamiliar with the Company
pSivida developed Iluvien and licensed it to Alimera (ALIM). Under this agreement, PSDV has rights to all of the clinical data created by Alimera on the use of this product in over 1000 patients. Also, PSDV has the right to develop this product for other indications. It is developing Iluvien under a different name, Medidur, for a different indication.
Iluvien was developed for diabetic macular edema and Medidur is being developed for posterior uveitis, two very different diseases. Diabetic macular edema is caused by leaky vasculature in the eye and posterior uveitis is believed to be an auto-immune disease. Importantly, the VEGF inhibitors, Lucentis and Eylea, are the hottest ophthalmology drugs on the planet and are extensively used in diabetic macular edema. They are not effective in posterior uveitis.
Dr. Ashton gave an update on Alimera's plans to refile the Iluvien NDA. For background, see my recent reports. His speculation is that the FDA has no questions on the clinical data. The only things standing before its approvals are a few questions on manufacturing and the need to update an instructional booklet on the use of Iluvien. Alimera has indicated that it plans to resubmit the NDA on Iluvien before the end of 1Q, 2014. The FDA will probably set a six month PDUFA date so that the approval of Iluvien is likely to be in September, 2014. Approval requires that Alimera pay pSivida a $25 million milestone within 30 days or return the product rights to PSDV.
In regard to Medidur, Dr. Ashton gave the following timeline for development. The enrollment on the first phase III trial of Medidur will complete by the middle of the year and data will be available in 3Q, 2014. There is a high expectation that the data will be positive based on the efficacy seen with other steroid products in posterior uveitis. However, clinical trials always have a high degree of uncertainty and I have seen drugs fail in a trial because of trial design issues and then succeed in subsequent trials. Acadia (ACAD) and Neurocrine (NBIX) are two outstanding examples. There is no such thing as a sure thing when it comes to clinical trials.
My reading of Dr. Ashton is that he is probably most excited about the Tethadur technology. The product is still in animal studies and we may see the first pre-clinical results in mid-2014. This technology is very unique and was developed for use in the semiconductor industry. The hope is that this will be a way to deliver proteins like monoclonal antibodies in a sustained release formulation. This is a high risk and early stage product, but this type of technology, if successful, would be the Holy Grail for protein drug delivery that could enhance the product characteristics of monoclonal antibodies and extend their patent lives.