- Sun Pharmaceutical Industries Ltd. on Wednesday received U.S. approval of its first biologic drug. Though it's a milestone, some analysts noted the generics giant and its new product will face an uphill battle in the fight to carve out market share.
- The Food and Drug Administration cleared tildrakizumab, branded as Ilumya, for adults with moderate-to-severe plaque psoriasis eligible for systemic therapy or phototherapy. The drug inhibits an immune regulating protein called interleukin (IL)-23 from interacting with its receptor, and as a result stifles inflammation.
- Ilumya falls into direct competition with Johnson & Johnson's IL-23 antagonists Stelara and Tremfya, but also has to contend with members of the closely related IL-17 inhibitor class. Novartis AG's Cosentyx, Eli Lilly & Co.'s Taltz and Valeant Pharmaceuticals International Inc.'s Siliq each carry an indication for moderate-to-severe plaque psoriasis.
This new approval means Sun can start recouping some of the big bucks it shelled out for Ilumya.
The India-based company gave Merck & Co. $80 million upfront in 2014 for worldwide rights to the drug across all human indications. Though Ilumya was already in Phase 3 trials when Sun picked it up, the company still ended up spending an additional $250 million to $300 million to advance it through the clinic, according to Jefferies analyst Piyush Nahar.
Sun's main challenge now is finding ways to make its product stand out. The IL inhibitor market is quite crowded, and many of the treatments are as safe and effective as Ilumya, if not more.
"Given the data and the challenges in getting on the formulary list, we believe that market share gain will be slow for Sun. Pricing will be the key criteria in our view. Also, this is Sun's first foray into large [new biologic entity] products," Nahar wrote in a March 21 note.
Post-market studies may improve Ilumya's ability to compete by building its safety and efficacy profile or expanding its label. On that front, the drug is in mid-stage testing as a treatment for ankylosing spondylitis and psoriatic arthritis, and Sun intends to conduct further studies of it in psoriasis, according to the company's Chief Medical Officer Simon Lowry.
Notably, the company doesn't have "defined plans" to do head-to-head studies with Ilumya and competitor IL drugs, but will assess the need for them moving forward, Lowry said in an interview.
That may be problematic for Ilumya, given the indications Sun is pursuing are the same ones Cosentyx (secukinumab) already has under its belt. What's more, Taltz (ixekizumab) holds approvals in plaque psoriasis and psoriatic arthritis, and is closing in on an FDA OK for ankylosing spondylitis. Showing its drug can outperform these heavyweights would pave a major inroad for Sun.
Where Ilumya does hold some advantage, however, is in its dosing. The drug is administered subcutaneously every 12 weeks, whereas other options like Siliq (brodalumab), Taltz and Tremfy (guselkumab) are given more frequently.
Ilumya "fits quite nicely with the schedule for the office, to see the patient every 12 weeks. check them out, check them for side effects, administer the drug, see how they're doing, them bring them back 12 weeks later," Lowry said.
Whether or not Ilumya becomes a major player, Sun intends to dive deeper into biologics, specifically in the fields of dermatology, oncology, ophthalmology and neuroscience.