The company is also moving forward in other therapeutic areas. The company’s Open Science research and development model, announced in late 2015, is showing results, Dr. Hashad said.
The concept is based on recognition of a basic shift in innovation. While large pharma companies provide the bulk of the innovation leading to new products and new revenue, the driving source of the innovation comes from smaller biotechnology, specialty pharma companies, and academia. Allergan is refocusing its R&D program to follow innovation to the source.
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“We are becoming more flexible and more open about acquiring new technologies regardless of where the talent and the resources live,” Dr. Hashad explained. “This establishes a stronger relationship with the biotech industry, with healthcare professionals, with regulators and with patient groups.
“This model pushes into and expands an area that has long been a bottleneck in product development, the translational piece. This new model will help us push more products and more innovative technologies into and through this translational area. We are already seeing results in ophthalmology,” he added.
17 potential products
Of the 70-some new products in mid- to late-stage development, about 17 are ophthalmic. Allergan has strong candidates in dry eye and other indications through acquisitions and partnerships.
One of the promising areas is wet age-related macular degeneration (AMD). Wet AMD is a growing problem as the world’s population ages. Swiss biotech company, Molecular Partner, has opened a new therapeutic category–a class of proteins called DARPIns.
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Allergan has acquired global ophthalmologic rights from Molecular Partner, Dr. Hashad reported, including a molecule currently in phase III trials, abicipar pegol. Phase II data suggest the agent is at least as effective as ranibizumab while having a longer duration of action, which could mean fewer injections. Data suggest dosing every 3 months, which could provide an advantage over current anti-VEGF products in clinical use.
The company is also moving forward on a new molecular entity, tavilermide, a small molecule TrkA agonist for dry eye that induces mucin product to treat the dry eye. The product is a collaboration with Mitogen Pharmaceuticals.
Another key product is the first nasal neurostimulation device for dry eye, part of the acquisition of Oculeve. The device induces tear production by stimulating a branch of the trigeminal nerve.
Oculeve has completed four clinical trials in a total of more than 200 patients. Allergan has two pivotal trials in the works and is expecting an FDA submission later in 2016 with a potential commercial launch in 2017.