The GeoTeam has been monitoring developments that might impact REPRO MED SYS INC (OOTC:REPR) and its flagship product, the FREEDOM60 pump (mechanical infusion pump system) and related needle sets used to deliver medication to primary immune deficiency patients.
We noted that the FDA recently approved Baxter’s HQVIA (Immune Globulin Infusion 10% (Human) with Recombinant
Human Hyaluronidase) for subcutaneous treatment for adult patients with primary immunodeficiency (PI). This introduces a new drug to the market for subcutaneous treatment of PI with several advantages over the most wide used drug for this condition, CSL Behring’s Hizentra.
Hizentra treats patients who use and have used REPR’s pump system. HQVIA only has to be administered every 3-4 weeks with one injection site, versus Hizentra which has to be injected every two weeks. If HQVIA gains significant market share, fewer injections would reduce the use of REPR’s needle sets, impacting future revenues, since REPS sell needle sets that are used with its pump system. Part of REPR’s ongoing business is the continued sale of its products made specifically for its pumps.
Additionally, some investors have speculated that if Freedom users and potential PI candidates choose to switch to HQVIA, sales of the Freedom60 Pump could suffer since the Freedom mechanism is not currently approved by the FDA to administer HQVIA.
Optimistic View on the Freedom60 Pump with use of HQVIA
GeoInvesting has taken a more optimistic view on the Freedom60 pump. [hide] If REPR is successful in gaining FDA approval for the use of HQVIA we think the “Baxter” effect will not hurt REPR. In fact, in this scenario, the awareness about PI should be a huge benefit for REPR.
We reached out to REPR’s CEO to learn more about HQVIA and how it might impact REPR’s business:
- Hizentra is estimated to have around 70% (10,000 patients) of the PI subcutaneously treated patient market. HQVIA has not taken the market by storm but is admittedly in the very early stages of its market launch. Baxter is putting significant resources behind HQVIA’s launch in the US and Europe. Anything that gives patients more options and brings broader attention to PI is beneficial to REPR.
- The FREEDOM60 is currently not able to deliver HQVIA due to the drug’s large volume and special flow requirements. REPR is currently working to modify its infusion pump and gain approval for its use with HQVIA so the market opportunity the drug offers will not be missed.
REPR’s primary focus has been, and remains, the expansion of its PI business. According to TreatingPI.com, there are more than 150 different types of primary immunodeficiency disease researchers have identified. Treating PI cites one survey that estimates one in every 1,200 people (267,000 in U.S.) is living with PI, though many remain undiagnosed. Treating PI also references The Immune Deficiency Foundation which estimates that it takes an average of 12.4 years from the time a patient first shows symptoms until he or she is properly diagnosed with a primary immunodeficiency disease. More treatment options and marketing dollars to promote drugs to treat the disease will increase awareness of PI and ultimately accelerate the diagnosis process (to perhaps 5-6 years), thereby expanding the patient population and potential customers for REPR.
REPR’s potential is not limited to PI. The company is also seeking approval for other uses of the FREEDOM60 including antibiotics, pain and other indications. Antibiotics would offer huge market potential and, based on the CEO’s comments, seems to be the furthest along although there is no estimated timeline for ultimate approval of the indication.[/hide]
To learn why we continue to maintain our optimistic view REPR, please go here.
Notes:
- We coded REPR as a GeoBargain on October 6, 2014 and published a related article on October 7, 2014.
- We continue to hold our position in REPR and will consider adding stock as circumstances justify.
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