Sun Gets a Shot in the Arm as USFDA Gives Nod to Eye Drug
Approval for non-steroidal anti-inflammatory BromSite opens up access to a $400-m market in the US
Mumbai: Sun Pharmaceutical Industries has received the US Food and Drug Administration (USFDA) approval for BromSite, used to relieve post-operative inflammation and prevention of eye pain in patients undergoing cataract surgery, a significant boost to the company’s strategy of stepping up its specialty branded drugs play in the world’s biggest pharmaceuticals market. It’s the first non-steroidal anti-inflammatory drug (NSAID) approved for such conditions, the company said. Sun Pharma said the approval opens access to a $400-million market growing at 8% as of January, according to data from research provider IMS, based on the moving annual total (MAT). BromSite was developed by InSite Vision, a US company that the Indian drug maker acquired in November.
The product will be commercialised through New Jersey-based Sun Ophthalmics, a division that Sun formed recently to route its specialty branded offerings in eye care. The company said in a release that it aims to provide
used to treat post-operative inflammation and prevention of ocular pain after cataract surgery
to start marketing the drug in second half of 2016
Sun’s JV with Intrexon will give edge through targetted biologic therapies for eye care
products that enhance treatment options and deliver them through a concierge-level approach to customer care.
With BromSite’s approval and additional late-stage candidates in its pipeline, Sun Ophthalmics is positioned to offer a range of beneficial products, the company said.
Sun’s other pipeline candidates in the area of eye care include Xelpros, which is latanoprost ophthalmic solu- play includes dermatology brands; progress of Phase III trial data for MK3222 being watched closely
spend was in FY15, six-fold jump over
tion that seeks to treat reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. DexaSite is a dexamethasone that’s being explored for the treatment of blepharitis. Of total sales of $4.5 billion in 2015, Sun Pharma’s US operations contributed $2.2 billion. Sun spends more than 7% of its sales on R&D, which amounted to .₹ 1,960 crore last year, a six-fold jump from .₹ 330 crore in 2009.
In 2013, Sun formed a JV with Intrexon, a leading US drug maker in the area of synthetic biotechnology, for developing gene-based novel therapies for ocular diseases. Among the areas of research, the venture is working on platform technology RheoSwitch Therapeutic System that, when commercialised, will help patients receive a targeted biologic therapy without having to endure long-term use of injections. The joint venture had planned an expansion of the pipeline to target ocular diseases that include wet AMD (age-related macular degeneration), macular edema, non-infectious uveitis and diabetic retinopathy.
Besides eye care, Sun is ramping up its pipeline of dermatology drugs in the US, where it is ranked third among branded companies in the segment, helped by a portfolio of products from Taro and DUSA, the second of which it acquired in 2012 to broaden its presence in the skin-related segment. The progress of Sun’s late-stage compound MK-3222 (in-licensed from US drug maker Merck) to treat chronic plaque psoriasis is being watched closely by investors.
BromSite: Sun Gets USFDA Nod