Drug Delivery Technologies
In many disease indications, drugs ideally suited to treat a specific indication are not able to be adequately utilized because systemic administration (e.g. oral or intravenous routes) necessitates high doses to achieve efficacious blood plasma concentrations and these systemically efficacious blood plasma concentrations have undesired, systemic side effects. Because of this fact, the healthcare system is left with two choices: (1) discover new, effective drugs or therapeutics with more tolerable side effect profiles, or (2) develop local, drug delivery technologies that limit the systemic side effects to enable the use of the already effective drugs or therapeutics. We have chosen to approach these indications via both paths to deliver cost-effective, efficacious therapeutic approaches to treating these diseases, while creating multiple revenue generating inflection points along the product development timelines.
We are the exclusive licensee of various localized, sustained biodegradable drug-delivery platform technologies for the Indian market. The ability of this technology to appropriately align the material science, biochemistry and biophysics, pharmacology, and route of administration enables us to create proprietary, local drug delivery approaches that permit the use of active pharmaceutical ingredients, or APIs, and biologics ideally suited to treat a disease state or pathology that would otherwise be prohibited from use because of undesired, deleterious systemic side effects. Further, selecting APIs whose mechanisms of action are well-characterized and already indicated in the treatment of the target disease state increases the probability of preclinical and clinical viability and success.
Vulvovaginal atrophy (VVA) is a common, underreported and severely overlooked medical condition whose urogenital symptoms (e.g. dyspareunia, vaginal dryness, vaginal irritation, increased urinary tract infections) will be experienced by most women at some point in their lives. The progression of VVA is directly correlated to declining levels of estrogen with the onset of menopause. Our platform formulation technology comprises the development of an emulsified cream that uniquely combines specific combinations of well-known, generally recognized as safe (GRAS) ingredients that manifest a range of physicochemical properties to mimic the dynamic surface of the vaginal mucosa.
We are the exclusive licensee of paradigm-shifting process improvement technologies to enable cost-effective production of biologics and biosimilar drugs for the Indian market. Biologics, sometimes referred to as large-molecule drugs, are protein-based therapeutics that are produced using unique cell lines, including mammalian cells, yeast, and bacteria. Unlike small-molecule drugs and generics that are manufactured via chemical synthesis, biologics undergo essential post-translational modifications when manufactured in living cells.
The inherent complexity and quality demands on potency and purity impose a substantial burden on commercial scale manufacturing of biologics, as even minor deviations in protein expression, isolation, and purification may lead to differences in the structure, reactivity, stability, and other quality aspects of the end product. Any of these differences has the potential to affect the treatment’s safety, efficacy, and shelf life, and to increase the risk of an unwanted immune response. For these reasons, the cost to reliably manufacture biologics at commercial scale is generally far higher than the cost to manufacture small-molecule drugs.