Natco frets over delay in multiple sclerosis drug’s US launch2 min read . Updated: 01 Oct 2015, 06:09 PM IST
The delay in getting regulatory approvals and launching it in a 20 milligram dose in that key market has dashed those hopes.
Hyderabad: Indian drugmaker Natco Pharma Ltd has invested a hefty sum of ₹ 180 crore—equivalent to one-fifth of its annual revenue in the last fiscal year—to develop a cheaper copy of Israel-based Teva Pharmaceutical Industries Ltd’s blockbuster multiple sclerosis drug Copaxone.
The plan was simple: Launch it in the all-important US market and reap a windfall.
The delay in getting regulatory approvals and launching it in a 20 milligram dose in that key market has dashed those hopes. To add to Natco’s woes, Teva has been able to migrate scores of patients to its 40mg version (which has patent protection) and the US drug regulator has approved another cheaper copy of Copaxone developed by Momenta Pharmaceuticals and the Sandoz unit of Novartis AG.
“It’s disappointing, but it’s the nature of the business," said Rajeev Nannapaneni, vice-chairman and chief executive officer of Natco, addressing shareholders at the company’s annual general meeting (AGM) last weekend.
Copaxone raked up $4.2 billion in sales in 2014 for Teva, representing 21% of its revenue and 50% of its profit. The complex drug is used in the treatment of multiple sclerosis, an auto-immune disorder that damages the central nervous system and affects some 400,000 Americans.
Natco, which filed the abbreviated new drug application (Anda) for the drug as early as October 2009, has teamed up with Mylan NV for its US launch. It has even stocked up the drug anticipating regulatory approval. However, there are few signs of its wait ending any time soon.
Natco got “some queries" from the US Food and Drug Administration (FDA) on Copaxone and the company has answered “all the queries", Nannapaneni said in August, without elaborating.
Following Saturday’s comments at the annual shareholder meeting, analysts have now turned sceptical about the immediate launch of generic Copaxone by Natco and its ability to substantially dent Teva’s sales.
“With uncertainty over the launch, we have discounted Copaxone from our estimates," said Afzaal Mohammed, pharma analyst at Karvy Stock Broking Ltd.
The delay of a second generic entrant gave enough time for Teva to migrate about two-thirds of patients from the once-daily 20mg to thrice-weekly 40mg at a lower cost, making it even difficult for Sandoz-Momenta to grab market share beyond 15%, Mohammed said.
Teva’s 40mg Copaxone version hit the market last year and is covered by patents that don’t expire until 2030.
“US FDA approval is beyond the control of any company, but the delay is worrisome for Natco," said Surjeet Pal, pharma analyst at Mumbai-based Prabhudas Lilladher Pvt. Ltd.
Natco might face more competition, too.
“We can’t even rule out the entry of other players like Dr.Reddy’s Laboratories Ltd and Synthon-Pfizer, though Natco at this point is still ahead,"Mohammed of Karvy said. Pfizer Inc has tied up with Netherlands-based Synthon BV to market generic Copaone in US, following USFDA approval.