Embattled device maker Allergan (NYSE:AGN) hopes it can keep unwelcome buyer Valeant Pharmaceuticals from getting its hands on the company’s advancing R&D pipeline.
Allergan just announced FDA approval for its implantable sustained-release eye drug and is making headway on a trio of other products, saying in a separate shareholder presentation that Valeant represents a risk to this product pipeline.
The California Botox-maker won expanded FDA approval for the Ozurdex implant for treatment of diabetic macular edema, an eye condition affecting more than 560,000 patients, damaging vision and potentially resulting in blindness.
"The approval of Ozurdex for certain patients with DME further strengthens Allergan’s leadership position in ophthalmology and the retina subspecialty," chief scientific officer and R&D executive vice president Scott Whitcup said in prepared remarks. "In addition to receiving this important FDA approval, we are also pleased that two of our innovative pipeline programs are advancing to Phase 3 clinical development. These therapies involve novel molecules or innovative drug delivery systems which may help to improve patient outcomes."
The Ozurdex expansion is an important one for reaching more patients with the implantable drug-delivery product, by analysts were much more enthused by progress in Allergan’s DARPin treatment for neovascular, or "wet," age-related macular degeneration. The product is making its way toward FDA approval, with topline analysis now completed from the Stage III, Phase II study, showing strong results.
DARPin has been dubbed by many analysts as the company’s "most important value driver," Allergan noted. Analysts at UBS and Stifel seemed to agree.
Read more of MassDevice.com’s coverage of the Allergan hostile takover saga
"Based on our 2013 survey, docs would still use DARPin 20% of the time even if it turned out to be a ‘me too’ prod and yet it seems like it could be better than that," UBS analyst Marc Goodman wrote. "Investors may be tired of hearing about the DARPin, but the reality is that this product/Dual DARPin has an excellent chance of being a material new franchise."
The progress with DARPin could mean that Valeant will have to again bump its offer for Allergan if it aims to remain viable, another analyst wrote.
"We believe DARPin advancement alone could force another round of discussions regarding valuation, and we look for a response from VRX regarding these pipeline developments," Stifel’s Annabel Samimy wrote.
It’s for those reasons that Allergan said it needs to ensure that Valeant doesn’t take control of the company through the highly contested $52 billion hostile takeover bid.
"Valeant would have control but not the expertise over the development of DARPin – missteps are likely and would have meaningful impact on the regulatory trajectory of the drug," according to an Allergan shareholder presentation.
Allergan further provided updates on its bimatoprost sustained-release implant, saying that the product was found comparable with topical versions in data from a Phase II study. Finally, the company received a Complete Response Letter from the FDA about its New Drug Application for the Semprana migraine treatment (formerly called Levadex), adding that Allergan will meet again with the FDA to work out concerns about labeling.