Demand for New Glaucoma Therapies Has Greatest Potential to Drive Value for Q BioMed’s Shareholders Print E-mail
By Staff and Wire Reports   
Friday, 08 February 2019 02:51

icon_pipelineprogressQ BioMed (OTCMKTS: QBIO) has announced that it is bringing innovation to the treatment of Glaucoma- the the leading cause of irreversible blindness globally.

The illness often remains undetected long after significant vision loss has already occurred and in the most common form, known as open-angle glaucoma, there are usually no symptoms and no pain associated with the increase in intraocular pressure that leads to optic nerve damage.

A 2014 study published in Ophthalmology, the journal of the American Academy of Ophthalmology, by Y.C. Tham et al. of the Singapore Eye Research Institute projected that the number of people worldwide, aged 40 to 80 years, with glaucoma would grow from an estimated 64 million in 2013 to 76 million in 2020 and nearly 112 million people by the year 2040.

Q BioMed acquires, develops and finances undervalued biomedical assets in order to accelerate development and shorten the path to commercialization. While the company has made demonstrable progress in 2018 across the breadth of its pipeline, it is the glaucoma therapeutic development program that may have the greatest potential to drive value for the company’s shareholders in 2019 and beyond, given the size of the addressable market and the growing demand for effective treatments that will not only reduce intraocular pressure—as current therapies do—but that also it may slow the progression of the disease.

Unique Mechanism of Action

Q BioMed’s MAN 01 program for primary open-angle glaucoma is targeting the Schlemm's canal—the eye’s primary drainage pathway—and its role in regulating interocular eye pressure. We’re aware of no other company that is targeting this unique vessel that is responsible for 70% to 90% of the fluid drainage in the eye. Preclinical testing on mice has consistently delivered positive results in relieving intraocular pressure.

MAN 01 Program in Lead Optimization Stage for Glaucoma

Open SlideThe MAN 01 program, licensed from Mannin Research of Canada in 2015, is currently in the lead optimization stage of pre-clinical testing—one of the final stages before Q BioMed’s planned Phase 1 clinical trial. In January 2019, Mannin initiated a collaboration with McMaster University and focused on ophthalmic drug delivery and formulation experiments for MAN-01. This program will be led by Heather Sheardown, PhD, Professor of Chemical Engineering at McMaster and a world-renowned thought leader in biomaterials, tissue engineering and ophthalmic drug delivery.

Using the formulation and drug delivery expertise of Dr. Sheardown’s laboratory, the collaboration partners are developing novel ways to increase the ability for the Mannin small molecule compounds to lower intraocular pressure to more effectively treat glaucoma. Extended and sustained release formulations of the compounds will also be explored for the treatment of other vascular related diseases. The company expects the data from this collaboration to inform its planned Investigational New Drug (IND) application with the FDA in 2019 or early 2020.

Demand for New Glaucoma Therapies Driving Market Values and Pharma Collaborations

Multiple big pharma household names including Abbott, J&J, Novartis, Pfizer and Regeneron have devoted significant resources, internally and through acquisitions and collaborations, toward capturing a share of the ophthalmic drugs market, estimated to grow to nearly $35 billion by 2024, according to Zion Market Research.

“Large pharma is constantly looking for ways to be more efficient in pipeline development,” said Q BioMed CEO Denis Corin. “They can’t afford to limit themselves to internal paths and are increasingly seeking to partner with specialty companies or acquire assets with significant potential. We believe we are building a stable of development assets that will prove extremely valuable as pharma continues to explore alternate avenues of bringing therapeutics to market.”

From 2001—which brought the FDA’s approval of Allergan’s Lumigan (bimatoprost) and Alcon’s Travatan (travoprost) for reduction in intraocular pressure—until 2017, there were no new approvals for glaucoma medications despite dozens of companies pouring billions of dollars into their ophthalmic development programs.

In 2015, Allergan had a busy year, acquiring dry eye disease company Oculeve for $125 million plus milestone payments, then subsequently acquiring AqueSys, a developer of ocular implants to reduce intraocular pressure associated with glaucoma, for $300 million plus milestones.

In 2017, Aerie Pharmaceuticals received FDA approval for Rhopressa (netarsudil), and Bausch + Lomb got approval for Vyzulta (latanoprostene). Aerie is now a $2.1 billion market capitalization company, and Bausch + Lomb is part of the $9 billion Bausch Health group of companies.

Aerie, which went public in 2013 at a market capitalization of one-tenth of its current value, also filed a New Drug Application (NDA) with the FDA for its second compound, a combination of netarsudil and latanaprost, that in Phase 3 trials showed statistical superiority to either of those drugs as monotherapy.

Glaukos, which went public in 2015 at a $546 million market capitalization, is now trading at nearly five times that value on the back of its iStent micro invasive glaucoma surgery devices.

2018 and the early part of 2019 have been a particularly active period for collaborations in the field of ophthalmic therapeutics development, with companies including Aldeyra, Aequus, Nicox, Ironwood, ProQR and Ascentage all initiating new r&d deals. As Q BioMed approaches Phase 1 clinical trials, we believe the company will be a prime target of interest for pharmaceutical companies as well as other ophthalmic specialists seeking to collaborate and optimize their developmental pathways.

“As we continue to see positive reception and multi-billion dollar demand for companies and therapies that are largely tackling the same symptomatic issue of intraocular pressure, we’re very excited at Q BioMed to be approaching glaucoma from a unique mechanism of action,” continued Corin. “Further, we believe that our approach has the potential to be a true platform technology, and we’re evaluating opportunities to treat other vascular diseases such as acute kidney injury, cardiovascular ischemic damage, pediatric glaucoma, influenza and others.”

 

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