Now that Rockwell Medical Inc.’s intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate) is FDA-approved, the nod coming a day before its PDUFA date of March 28, the company plans putting evaluation programs into action during the third quarter of this year. Only after those programs’ completion will the formulation be available commercially.

The programs are designed to give clinics direct experience with the formulation for treating adult hemodialysis patients who need iron replaced and their hemoglobin maintained. Piper Sandler analysts said Friday that the evaluations won’t be complete until probably the fourth quarter of this year. The analysts also see disclosure of real world I.V. iron/erythropoiesis-stimulating agent-sparing data as key to validating the drug’s pharmacoeconomic rationale.

Piper Sandler estimates revenue from the I.V. formulation to bring in $1.9 million during the fourth quarter of 2020, rising to $21 million in 2021, more than doubling to $44 million in 2022, then escalating to $62 million by 2025.

The news didn’t inspire buyers on Friday’s market, a day in which the Nasdaq index dropped 3.79%. The Wixom, Mich.-based company’s stock (NASDAQ:RMTI) dramatically sagged 10.6% to $2.19 per share. Rockwell’s stock has struggled in the past year, dropping incrementally in the last 12 months, having traded at $5.49 per share on March 29, 2019.

Triferic AVNU now takes its place next to Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease. Triferic was developed under a special protocol assessment in which the FDA agreed that an equivalence approach to Triferic delivered via hemodialysate (Triferic Dialysate) would be acceptable for review. The NDA was supported by data from Rockwell’s equivalence study demonstrating that Triferic I.V. delivers the same quantity of iron to patients as the dialysate formulation. An open-label, randomized, multiple-period single-dose study established the equivalence of doses between dialysate and I.V. administration.

The I.V. formulation works via dialysate during each dialysis treatment. Triferic AVNU can be administered directly by I.V. no matter what mode of bicarbonate delivery a dialysis center might use. Many dialysis centers in international markets now use dry bicarbonate bags or cartridges and on-line generation, which Rockwell said is incompatible with Triferic Dialysate. The method is increasingly in use in the U.S. The approval of Triferic AVNU increases the flexibility to deliver intravenously to a broader group of patients than before.

With each hemodialysis treatment, Tiferic is designed to deliver 5 mg to 7 mg of iron to bone marrow and to maintain hemoglobin without increasing iron stores or inflammation.

Little more than a week ago, the company entered a debt financing agreement with an affiliate of Innovatus Capital Partners LLC for up to $35 million in term loans, with $22.5 million funded at closing, and another $5 million drawn upon hitting milestones, such as the FDA approval for I.V. Triferic. A third tranche of $7.5 million is available to the company upon achieving milestones, including hitting certain Triferic sales thresholds.

Triferic Dialysate was launched in the U.S. in May 2019, according to Cortellis, the same month Rockwell submitted an NDA for the I.V. formulation. The FDA accepted the NDA filing in August 2019.

In January, Sun Pharmaceutical Industries Inc. agreed to develop and commercialize Triferic in India. The payment in the deal was unspecified. Rockwell Medical's subsidiary, Rockwell Medical India, had marketing rights in India and Biorenal has commercialization rights in Chile, according to Cortellis. Aram Medical is investigating the drug in certain Middle Eastern countries, including Saudi Arabia.

No Comments