Relypsareports 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
Relypsaplans 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
Relypsaand VFMCRP on track to submit European application for Veltassa in first half of 2016
Relypsamanagement to host conference call/webcast this afternoon at 5:00 p.m. ET/ 2:00 p.m. PT
"2015 was a pivotal year for
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, 2015and became available for prescription to patients on December 21, 2015.
August 2015, Relypsaannounced an exclusive collaboration and license agreement with Vifor Fresenius Medical Care Renal Pharma(VFMCRP) for the development and commercialization of Veltassa outside the United Statesand Japan. Relypsaalso 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
units sold (non-
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
In addition, agreements have been signed with Express Scripts and CVS Caremark, the two largest pharmacy benefit managers in
Relypsahas shared and discussed the results of the recently announced Phase 1 drug-drug interaction studies with the FDA. Based on the discussion, Relypsaplans to submit a sNDA by mid-2016 to the FDArequesting a label change for Veltassa.
Relypsaand VFMCRP are on track to submit a Marketing Authorization Application (MAA) for Veltassa for the treatment of hyperkalemia to the European Medicines Agency(EMA) in the first half of 2016.
Relypsais initiating a new Phase 4 clinical study of Veltassa called the TOURMALINE study, which will evaluate Veltassa's safety and efficacy when given with and without food.
- The company is also considering additional Phase 4 studies assessing Veltassa's safety and efficacy in other patient populations, potentially including a study with patients with resistant hypertension and a study with hemodialysis patients.
Relypsaalso has a post-marketing commitment to conduct pediatric studies with Veltassa and expects to begin the first pediatric study in late 2016.
2015 Financial Results
Net loss for the fourth quarter 2015 was
Cash, cash equivalents and short-term investments totaled
Collaboration and license revenue for the fourth quarter and full year 2015 was
Research and development expenses for the fourth quarter of 2015 were
Selling, general and administrative expenses for the fourth quarter 2015 were
For the full year 2016, based on its current plans and expectations,
Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia.
Made in powder form consisting of smooth, spherical beads, this new medicine is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
IMPORTANT SAFETY INFORMATION
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components. The Prescribing Information for Veltassa includes Warnings and Precautions for worsening of gastrointestinal motility and hypomagnesemia. The most common adverse reactions (incidence ≥ 2 percent) observed in clinical trials with Veltassa were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa's full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.
To the extent that statements contained in this press release are not descriptions of historical facts regarding
-see attached financial tables-
|Consolidated Statement of Operations Data|
|(In thousands, except share and per share amounts)|
Three Months Ended
|Collaboration and license revenue||$||11,960||$||-||$||18,550||$||-|
|Research and development||26,500||16,596||93,298||50,227|
|Selling, general and administrative||44,056||10,486||103,138||27,914|
|Total operating expenses||70,556||27,082||196,436||78,141|
|Loss from operations||(58,596||)||(27,082||)||(177,886||)||(78,141||)|
|Interest and other income (expense), net||613||69||915||149|
|Net loss per share, basic and diluted||$||(1.40||)||$||(0.80||)||$||(4.39||)||$||(2.43||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||41,785,176||34,368,776||40,697,896||32,837,508|
|Condensed Consolidated Balance Sheet Data|
|Cash, cash equivalents and short-term investments||$||240,716||$||135,757|
(1) Derived from the audited financial statements
Vice President, Corporate Communications
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