FDA sets PDUFA Date for I.V. Triferic Drug on March 28, 2020
As the current healthcare crisis rages on, millions of patients for other conditions still require the attention and innovation of professionals in the space to come to their aid.
While there are calls from leaders to fast-track drug approvals1 to mitigate the crisis, organizations such as the US Food and Drug Administration (FDA) still have potential drugs for other deadly conditions in need of review.
One new drug could potentially come as a relief to more than a billion people worldwide… VERY soon.
After going through all the necessary lead-up phases for FDA approval2, the drug’s future is hinged on what’s known as the ever-important PDUFA date3.
For this particular drug, that PDUFA date is ever so near…. March 28th, to be exact.
So… MARK YOUR CALENDARS, because that date could be the breakthrough for Rockwell Medical Inc. (NASDAQ:RMTI) that investors have been looking for. The company generated $61.3 million in revenue in FY 2019 and with the potential for the next approval so close, 2020 could turn out to be a fantastic year for the company.
This drug is named I.V. TRIFERIC®is attempting to tackle a very serious condition that the CDC acknowledges was the cause of 5,382 deaths (1.7 people per 100,000 population) in 2017.4
The condition is… anemia.
It’s an iron deficiency disorder—often associated with diabetes mellitus or Type 2—that affects more than 2.8 million Americans1 and over 1.62 billion people worldwide5.
And with the growing prevalence of diabetes, which is projected to increase by 54% to more than 54.9 million Americans between 2015 and 2030, and increased societal costs related to the disease to increase at roughly the same rate to more than $622 billion by 20306… this new drug if approved is clearly very needed.
It’s time to take an in-depth look at a company possibly on the cusp of a major drug approval, that’s here to protect those with anemia and kidney disease.
Rockwell Medical Inc. (NASDAQ:RMTI)
Meet Rockwell Medical Inc. (NASDAQ:RMTI) a commercial-stage company with a platform drug technology designed to transform anemia management in a wide variety of disease states across the globe, with an initial focus on ESRD.
Their drug, TRIFERIC, is now before the FDA in the final days ticking down to its PDUFA date of March 28, 2020… the result of which could make or break the company.
Recent activities from the company show that they’re poised to roll with the platform, including having secured a war chest of $35 Million in debt financing, and a MASSIVE partnership with a +$11-Billion company for the rights to commercialize TRIFERIC in India.
The Rockwell Medical Inc. (NASDAQ:RMTI) team consists of winners from within the pharmaceutical sector, including a President and CEO who served as Corporate Officer and VP of Abbott Laboratories, leading its largest global business unit with $600 million of revenues.
Now it’s the potential for Rockwell Medical through Triferic to capture market potential in excess of $1 billion. This potential has not been ignored by the analysts currently covering and targeting Rockwell Medical Inc. (NASDAQ:RMTI).
Rockwell’s analyst coverage has been very favorable:
The potential for upside if the drug is approved this week could be massive.
CLOCK TICKING ON THE PDUFA DATE
In August 2019, Rockwell Medical Inc. (NASDAQ:RMTI) announced that the US Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA) for its Intravenous formulation of TRIFERIC with a PDUFA (Prescription Drug User Fee Act) date of March 28, 20208.
It’s actually quite rare for new drugs to get to this stage of the approval process. Only a select few per year are even deemed eligible for this level approval.
If a company gets its breakthrough drug FDA approved, its stock typically is likely to climb as a result.
Knowing that a PDUFA date is imminent can give investors an edge and help them time their upcoming stock purchases.
STANDOUT COMMERCIAL-STAGE BIOTECH PLAY
What must be taken into account, is that Rockwell Medical Inc. (NASDAQ:RMTI) is already a commercial-stage company, with a platform technology that’s designed to transform anemia management as we know it—with the initial focus on end-stage renal disease (ESRD).
Through its flagship proprietary platform TRIFERIC, Rockwell Medical has already launched into sales and distribution in the USA, in May 2019 with revenues exceeding $61.3 million in FY 2019.
Over this campaign, the company has been collecting real-world data from seven sites totaling 500+ patients—the initial data readout is expected to be delivered in Q1 2020.
For new clinics (clients), that Rockwell Medical Inc. (NASDAQ:RMTI) has launched a 3-month Evaluation Program, which has already resulted in a 75% conversion rate since launch.
FIRST and ONLY FDA-APPROVED PRODUCT
TRIFERIC is one of the most innovative advancements in iron management over the last two decades.
It’s a novel therapy that addresses the daily iron needs of dialysis patients and avoids iron toxicity.
To date, it’s the FIRST and ONLY FDA-approved product indicated to maintain hemoglobin in HD-dependent CKD patients.
The company’s global intellectual property portfolio includes an Orange Book listed patent with expiry in 2029.
Rockwell Medical Inc. (NASDAQ:RMTI) has developed two formulations: Dialysate Triferic – launched May 2019: and I.V. Triferic – PDUFA date: March 28, 2020
The platform replaces recurring iron loss during dialysis, and maintains hemoglobin without increasing ferritin levels.
It’s a unique, physiologic mechanism of action that donates iron directly to transferrin for red blood cell production mimicking the body’s natural process of iron absorption.
What makes TRIFERIC different from traditional I.V. iron?
- It’s taken up by reticuloendothelial cells first
- Induces increase in ferritin and hepcidin levels
- High ferritin and hepcidin levels increase iron storage and reduce iron uptake by transferring -> less efficient RBC production
- Side effects may include: oxidative stress, iron overload, infection and cardiovascular disease
MAMMOTH SIZED MARKET POTENTIAL
The opportunity that Rockwell Medical Inc. (NASDAQ:RMTI) has targeted is substantial. There are over two million people worldwide who receive hemodialysis annually.9
This equates to +250 million estimated annual hemodialysis treatments, with growth occurring due to increased rates of diabetes, obesity, and hypertension.
Once they’ve started, patients typically require dialysis for life, at a rate of at least 3x weekly.
The overall hemodialysis and peritoneal dialysis market is projected to reach US$99.2 billion by 2024—up from US$74.2 billion in 2019, at a CAGR of 6.0%.10
As early as 2015, Rockwell Medical Inc. (NASDAQ:RMTI) projected the global market potential for TRIFERIC to be in excess of $1 billion.11
And in May of 2019, that’s when the company started sales of its TRIFERIC platform.
By looking at the other comparables in the space, it’s worth noting that the market is currently giving Rockwell Medical Inc. (NASDAQ:RMTI) the lowest market cap valuation vs revenue.
Within the USA, Rockwell Medical observed a TRIFERIC US Market Overview, that includes more than $4 billion spent on anemia management therapies annually in a concentrated provider market.17
TOP-TIER RELATIONSHIPS WITH LEADING DIALYSIS PLAYERS
Rockwell Medical Inc. (NASDAQ:RMTI) is the #2 supplier of dialysis concentrates in the US; relationships with leading dialysis players.
And earlier this year in January, the company secured a MASSIVE deal with a wholly-owned subsidiary of +$11-Billion pharma giant Sun Pharmaceutical Industries Ltd.—the largest pharmaceutical company in India, with more than $4 billion in annual sales globally.
Sun Pharma will leverage its market leading nephrology franchise to promote TRIFERIC to nephrologists in India.
Domestically, back home in the USA, the upcoming FDA PDUFA date decision could lead to a similarly large partner (or partners) wanting a piece of the action.
TRIFERIC is the FIRST and ONLY FDA-approved therapy indicated to replace iron and maintain hemoglobin levels in adult hemodialysis patients, and it already generates +$60M revenue annually.
The biggest players have already realized the potential of the TRIFERIC platform.
The company is now building upon its long-established existing relationships with other leaders in dialysis… namely Baxter, DaVita.
Backed by the experience of manufacturing and selling dialysis concentrates since the 1990s, Rockwell Medical Inc. (NASDAQ:RMTI) has a stepwise plan to establish TRIFERIC as the new standard of care.
Now with a newly minted cash supply of $35 million in funding on hand, through a debt financing agreement with Innovatus Capital Partners, the company is in a fantastic position moving forward.
“We are pleased to partner with Innovatus on this transaction. This financing will provide flexibility as we continue our mission to advance our novel therapeutic, TRIFERIC, and to transform the way anemia is managed around the world.”
– Stuart Paul, President and Chief Executive Officer of Rockwell Medical
Stacked Management Team with Deep Renal and Pharma Commercial Experience
Rockwell Medical Inc. (NASDAQ:RMTI) is a biopharmaceutical company dedicated to transforming anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company’s initial focus is the treatment of anemia in end-stage renal disease (ESRD). Rockwell Medical’s exclusive renal drug therapy, Triferic (ferric pyrophosphate citrate), is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.
to Examine Rockwell Medical Inc. (NASDAQ:RMTI)
FDA Approval in final stage with PDUFA Date of March 28th:
presenting a rare moment in the sector of a company getting an official yes or no on their drug I.V. TRIFERIC®.
with platform technology extremely close to potential approval that’s designed to transform anemia management across the globe.
3TRIFERIC is one of the most innovative advancements in iron management over the last two decades, and is the FIRST and ONLY FDA-approved product indicated to maintain hemoglobin in HD-dependent CKD patients.
Global TRIFERIC market has massive potential:
with a growing number of diabetes patients worldwide, set to reach nearly 55 million people by 2030 in the US alone.
Major exclusive license and supply agreement:
in India secured with the country’s largest pharmaceutical company with a market cap worth more than $11 billion.
Recent $35M debt financing
has the company well-equipped with a suitable war chest, in order to pursue the next stages of the TRIFERIC story.
7Company’s global intellectual property portfolio includes Orange Book listed patent with expiry in 2029.
#2 supplier of dialysis concentrates in the US;
relationships with leading dialysis players, generating $61M+ revenue annually.
board and advisors with deep renal and pharma commercial experience.
9 For selected countries listed in United States Renal Data System 2018 Annual Data Report. Table N.7.a “Yearly counts of all patients treated with in-center hemodialysis as of the end of the calendar year, 2003-2016.” and European Renal Association.
17 Nephrology News and Issues, September 2018, Mark E Newman, Table 1: The largest dialysis providers in 2018.