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Sun Pharmaceutical Announces First U.S. Approval for Novel Drug

  • Drug approved to treat patients with skin condition psoriasis
  • Developing novel drugs part of plan to diversify from generics

Sun Pharmaceutical Industries Ltd., India’s largest drug maker, has announced its first U.S. approval for an innovative medicine, marking a milestone in the company’s bid to diversify out of generic drugs by building a portfolio of novel ones protected by patents.

Sun’s drug Ilumya was approved by the U.S. Food and Drug Administration to treat adults with moderate to severe cases of the skin condition plaque psoriasis, who are also candidates for systemic therapy or phototherapy, the company said in a statement Wednesday. Phase-3 studies for the drug demonstrated significant clinical improvements, according to the statement.

“We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis,” Abhay Gandhi, the chief executive officer of Sun’s North America business, said in the statement.

The approval comes as Sun’s core business making copies of other companies’ medicines has been squeezed by a wave of competition in the U.S., putting pressure on prices for these generic drugs. Sun has been particularly exposed because its ability to offset the price declines with new revenue has been hampered by a U.S. sanction preventing new product launches from a key plant in western India.

The roll out of innovative medicines has been seen not only as a new revenue stream, but one that will deteriorate less quickly because other generic firms won’t be able to copy them until the patents expire.

Sun licensed Ilumya from Merck & Co. in 2014, agreeing to fund Merck’s efforts to complete the Phase 3 trials and get it approved, and then takeover the commercialization and regulatory upkeep after. Merck is eligible for milestone payments and royalties on the drug.

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