We have developed stable formulations of over 20 approved but off-patent Active Pharmaceutical Ingredients that are the active substance of drugs addressing large markets. We highlight two of our Lead Programs – one for Dry Eye Disease and one for Alopecia.
Dry Eye Disease (DED) Program: SGN’s DED lead program is based on the following three premises:
- DED is a growing and under-treated disease indication: Incidence of DED is growing worldwide due longer life spans, increased screen usage, cataract surgeries and pollution. Of the total DED population, about 20% would form the moderate to severe DED cohort requiring therapeutic intervention. It is estimated that presently only about 15-20% of the moderate to severe DED population is under treatment, making DED an under-penetrated and under-treated indication that presents a significant market opportunity to novel therapies. Launch of new therapies and increased physician and patient awareness will lead to a greater market penetration.
- Evidence based medicine drives market share: Products that demonstrate superior clinical benefit over existing standard of care, have the potential to cannibalize existing inferior products. The market shares are dependent on relative clinical data, ease of use & frequency of dosing (if clinical benefits are similar) among other things.
- Current standard of care RestasisTM, is a sub-optimal therapy: The current standard of care requires several weeks of treatment before benefit and relief can be experienced. Additionally, RestasisTM is highly irritating to the cornea. Despite its shortcomings, RestasisTM remains the leading therapy for DED.
The objective of our DED drug development program is to devise a cyclosporine formulation that fills a gap in a rapidly growing market with large unmet need by providing a therapy with proven benefits over RestasisTM.
In pursuit of this goal, we designed three proprietary MNP Nanoformulations, that have a high probability of scoring a better clinical benefit profile and hence offer a better alternative to the current #1 brand in Ophthalmic Cyclosprine category (RestasisTM ) and the potential generic iterations thereof, providing SGN with a >$1 BN market target opportunity and a potential blockbuster product.
- The first-generation, preservative containing (0.004% Benzalkonium chloride or BKC) MNP Nanocyclosporine formulation was launched in India in 2015 with a local Indian company Sunways India Private Ltd. under the brand name “NanoTearsTM” (It is noteworthy that we use the least amount of preservative BKC – 0.004% – that has been shown to be active as opposed to almost all ophthalmic formulations which use much higher BKC concentrations. BKC is believed to damage the cornea with long-term use. Hence the lower the amount, the better it is). Within 3 years of launch, “NanoTears” had captured the third largest share of the Indian market and was the fastest growing Cyclosporine A formulation (all Cyclosporine formulations contain Cyclosporine A as the active ingredient) on the Indian market (IMS data). This MNP-Nanocyclosporine formulation (“NanoTearsTM”) was shown to release Cyclosporine much faster than RestasisTM and also to bind 4x more than RestasisTM in pre-clinical studies. Physician polling conducted by Sunways revealed that “NanoTearsTM” was faster acting and far less irritating than the gold standard and Market leader, “RestasisTM” of Allergan (based on RestasisTM historical data). Encouraged by our success we are making continued investments in Cyclosporine, and are in the midst of launching an improved 2nd generation, “preservative-free” MNP Nanocyclosporine formulation in India.
- The 2nd generation, preservative-free (no BKC containing) formulation was developed which binds to cornea ~10 fold more than RestasisTM. This preservative-free, MNP Cyclosporine is being evaluated in a head to head, 150 patient clinical trial to compare its efficacy and safety directly with RestasisTM. The study is being conducted by JSS Medical Research, which is a subsidiary of JSS – Canada’s largest CRO. An Interim data analysis suggests that 2nd generation, preservative-free, MNP Nanocylosporine is likely to compare favorably with RestasisTM on both efficacy and safety. We expect to complete the study by mid-year 2020 and begin Phase III pivotal clinical studies by Year End 2020. We have entered a 15 year, exclusive marketing agreement with a UK based Ophthalmic Company Medicom for launch in India.
The 3rd generation, preservative free combination product of MNP Nano cyclosporine and MNP Nano-cannabinoids is ready to enter Phase I clinical trials in Australia by mid-year 2020.
Alopecia Program: There are two approved pharmaceutical therapies for Alopecia – (1) Rogaine and generic iterations thereof and (2) Oral Finasteride. Both these therapies have significant side effects. The active substance in Rogaine is Minoxidil and the formulation contains 40-50% ethanol and propylene glycol – both of which lead to significant side-effects and poor compliance longer term. Finasteride inhibits the conversion of testestrone to its active form 5HT. When taken orally for long periods, Finasteride can lead to impotence, lower libido and erectile dysfunction as side effects.
We have created (1) transdermal MNP NanoMinoxidil (2) transdermal MNP NanoFinasteride and (3) transdermal MNP Nanominoxidil and MNP NanoFinasteride formulations. These are ready to enter Phase II clinical studies by YE 2020. It is noteworthy that no topical formulation of Finasteride or a combination formulation of Minoxidil and Finasteride are being marketed in regulated markets and for that matter most markets.