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Relypsa Reports Fourth Quarter and Full Year 2015 Financial Results and Announces Other Corporate Updates

  • Relypsa reports encouraging initial demand for Veltassa
  • Veltassa added to CMS 2016 Formulary Reference File and agreements signed with Express Scripts and CVS Caremark, the two largest pharmacy benefit managers in the United States
  • Relypsa plans to submit a supplemental New Drug Application (sNDA) by mid-2016 requesting a label change for Veltassa based on positive results of Phase 1 drug-drug interaction studies
  • Relypsa and VFMCRP on track to submit European application for Veltassa in first half of 2016
  • Relypsa management to host conference call/webcast this afternoon at 5:00 p.m. ET/2:00 p.m. PT

REDWOOD CITY, Calif., Feb. 24, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc. (RLYP), a biopharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2015 and announced other corporate updates.

“2015 was a pivotal year for Relypsa with the FDA approval of Veltassa marking our transition to a fully integrated commercial-stage company. We are proud to be among those who have the privilege of delivering a new medicine to people in need and the opportunity to transform the treatment of a condition that has long been a challenge for doctors,” said John A. Orwin, president and chief executive officer of Relypsa. “We are looking forward to another exciting year. We are very pleased with the initial demand for Veltassa and, following a positive meeting with the FDA, plan to submit a sNDA requesting a label change based on the results of the Phase 1 drug-drug interaction studies.”

2015 Business Highlights

  • Veltassa® (patiromer) for oral suspension was approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia on October 21, 2015 and became available for prescription to patients on December 21, 2015.
  • In August 2015, Relypsa announced an exclusive collaboration and license agreement with Vifor Fresenius Medical Care Renal Pharma (VFMCRP) for the development and commercialization of Veltassa outside the United States and Japan. Relypsa also announced a co-detailing agreement with Sanofi for promotion of Veltassa in the United States.
  • The company experienced significant growth during this transformative year, adding almost 300 employees, including a sales force of 133 representatives, to support the launch of Veltassa.


Encouraging Initial Demand for Veltassa

Initial demand for Veltassa has been encouraging. Since Veltassa became available on December 21, 2015 through February 12, 2016, 1,229 new outpatient prescriptions were written for Veltassa and received by the company’s hub, Veltassa Konnect. The number of patients who received a free starter-supply of Veltassa, outpatient prescriptions filled and hospital units sold since the launch on December 21, 2015 through February 12, 2016 are detailed below.

December 21-31,
2015
(partial month)
January 1-31,
2016
(full month)
February 1-12,
2016
(partial month)
Total launch
through
February 12, 2016
Patients who
received free
starter-supply of
Veltassa
26409
(average 102/
week)
380
(average 190/
week)
815
Outpatient
prescriptions filled
(retail TRx)
099
(average 25/week)
133
(average 67/week)
232
Hospital/institution
units sold (non-
retail)
356
(average 14/week)
41
(average 21/week)
100


These numbers have not been verified by any third party and represent Relypsa’s estimates as of the date indicated. The company assumes no obligation to update them.

Progress With Payers
On February 11, 2016, the Centers for Medicare and Medicaid Services (CMS) published its Current Year (CY) 2016 Formulary Reference File (FRF) and Veltassa had been included. This was a significant development as it provides confirmation that CMS will reimburse Medicare Part D plans for Veltassa.

In addition, agreements have been signed with Express Scripts and CVS Caremark, the two largest pharmacy benefit managers in the United States.

Upcoming Milestones

  • Relypsa has shared and discussed the results of the recently announced Phase 1 drug-drug interaction studies with the FDA. Based on the discussion, Relypsa plans to submit a sNDA by mid-2016 to the FDA requesting a label change for Veltassa.
  • Relypsa and VFMCRP are on track to submit a Marketing Authorization Application (MAA)...

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