Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc, is shown in a Cambridge, Massachusetts (Photographer: JB Reed/Bloomberg News ) 

SPARC Says It Expects U.S. FDA Nod For Two Key Drugs This Year

Sun Pharma Advanced Research Co. Ltd. expects the U.S. regulator to approve two of its key drugs by the second half of this financial year, as issues at Sun Pharmaceutical Industries Ltd.’s Halol plant, where these will be manufactured, are now resolved.

In its annual conference call with analysts last night, the management of the demerged research and development arm of Sun Pharma, spoke on the PDUFA date--the date by which the U.S. Food and Drug Administration will give its decision--for the drugs Xelpros and Elepsia XR.

While it indicated that the PDUFA date for Xelpros--used for curing chronic eye disease glaucoma--would be November 2018, that for Elepsia--used for epilepsy patients--is likely to be January 2019, according to the investor and conference call presentation filed by SPARC on exchanges.

Here are the other key highlights from the conference call:

  • SPARC has strategically built five distinct platforms that focus on three therapeutic categories which include oncology, neurology and dermatology /ophthalmology.
  • Three lead novel drug delivery system products which are Xelpros, Elepsia XR and Taclantis to be near-term monetisation opportunities.
  • Xelpros and Elepsia XR are in pre-approval stage and expected to reach milestones in the current financial year. Management maintained its peak sales guidance of $50-75 million for both these products over two to three years.
  • SPARC is hopeful about receiving approvals in the near term for Xelpros and Elepsia XR as FDA issues at Sun Pharma’s Halol unit in Gujarat are resolved.
  • Taclantis, PDP 716 and SDN 037 are in late stage clinical state. The cancer drug Taclantis is expected to reach milestones in FY19 with the other two in financial year 2020.
  • Taclantis NDA filing expected in fourth quarter of FY19 and will be filed under the 505(b)(2) route.
  • SPARC envisages a premium pricing due to the niche offering for PDP 716 and SDN 037 and is exploring partnership opportunities for the commercialisation.
  • SPARC has discretion to go with other marketing partners for its products apart from Sun Pharma.

Also read: Sun Pharma Gets First Drug Approval For Halol After Five Years

Brokerage Take

Morgan Stanley analyst Sameer Baisiwala said in a note that SPARC is making steady progress with its innovation-led pipeline and appears to be nearing monetisation of its lead products. “Sun should benefit from the potential FY19 commercialisation of two mid-sized lead assets (Xelpros and Elepsia XR) and contribute in building its speciality pipeline,” he said.

HSBC analyst Damayanti Kerai said in a report: “SPARC’s assets can contribute towards Sun Pharma’s specialty buildup in focused areas such as ophthalmics and oncology. We watch for execution of specialty initiatives where Sun is treading a steep learning curve.”

Shares of the company snapped a two-day decline to gain as much as 4.9 percent in early trade. These were trading 2.06 percent higher at Rs 393.55 apiece on the BSE at 11.55 a.m.

Also read: Sun Pharma Bets On Specialty Products To Drive Growth