Pharmaceutical company “Imprimis” has just made a subsidiary company that is concentrated on the issue of dry eye disease. Called Surface Pharmaceuticals, the new subsidiary plans to create three formulations in ophthalmology indications that are currently being fought over and under the eye of big companies Allergan and Shire.
This San Diego-based pharmacy provides proprietary compounded formulations.
A compounded formulation, according to the FDA, is “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters the ingredients of a drug to create a medication tailored to the needs of an individual or patient.”
This process has allowed Imprimis to discover certain compounded drugs that it believes have a chance at winning approval under the FDA’s 505 (b)(2) pathway and then moving on to claim market share.
Surface is the proof of this concept.
The spinoff begins with three candidates and aspirations to develop them into five indications. One candidate (SURF-100) uses the immunosuppressant mycophenolic acid as its active ingredient. Another one, SURF-200 or SURF201 (depending on which type of indication was targeted, is based on the steroid betamethasone.
Those two candidates then mix their active ingredients with Klarity, a tropical ophthalmic gel (or solution) technology that Imprimis picked up the rights to back in April. The subsidiary believes that combining Klarity with mycophenolic acid will result in a formulation capable of challenging Allergan’s Restasis and Shire’s XIidra for the chronic eye disease market.
These betamethasone formulations are directed towards patients who suffer from episodic eye dryness (dry eye disease) and post-cataract surgery pain and inflammation.
The third candidate of Surface is made up of low-dose doxycycline (a tetracycline antibiotic) and/or omega-3. This amalgamation is established on the belief omega 3-supplements may prevent symptoms of dry eye disease. Also, adding fatty acids to the antibiotic is sometimes used as a second-line treatment of the disease and may, therefore, improve the outcomes.
Of course, the scientific explanations and rationales behind the candidates still remain uncertain and unproven. However, Surface believes that it can start to address some existing uncertainties comparatively quicker and in a substantially cheaper manner.
The subsidiary believes that it can have phase 2 of the data by the first half of 2020. At $3.4 million to $3.5 million, the development of SURF-100 is forecasted to be the highest valued, and the biggest line item.
Surface’s ability to make that specific investment decision is based on its outgoing funding efforts. Imprimis wants Surface to be outside-funded. At the last count, however, Imprimis had $4.2 million in cash. The creation of Surface came out four months after Imprimis’ first spinoff, Eton Pharmaceuticals.
It put together a Series A of $20 million.
The business practices that have taken place at Imprimis, however, have seen some difficulties on the way. The FDA gave Imprimis a warning letter back in August, after inspectors had found a wood-like material in a product compounded by the pharmacy. They were also put under scrutiny for having cleanliness problems, and inadequate cross-contamination controls. They were also issued a separate warning that same month after a patient died following administration of a curcumin emulsion compounded by Imprimis.
Overall, shares have gone down almost 40% over the past year.