VR1, Inc. Shares Launch Year Update: First Commercially Available Non-Prescription CGRP Antagonist Ausanil® Emerges As Go-to Solution for Difficult-to-Treat Headache Patient Population | Business Wire

NEW YORK–()–VR1, Inc. is sharing launch year results, including patient response, of

its non-prescription severe headache and migraine nasal spray ,

the first commercially available CGRP (calcitonin gene related peptide)

antagonist that works to rapidly relieve severe headache and migraine

pain without systemic side effects or adverse drug interactions of

commonly used oral or injectable treatments.

Since its launch in March 2014, Ausanil, which is comprised of a

proprietary formulation using capsicum annuum (capsaicin), has helped

thousands of difficult-to-treat migraine and cluster headache patients

nationwide find rapid pain relief, with many

onset of significant relief within the first three minutes of use.<sup>1</sup>

VR1 founder, lifelong migraine sufferer and neurologist Anjan

Chatterjee, MD worked to develop a formulation that effectively balances

the need for rapid pain relief with patient safety and

tolerability—common challenges for the nearly 12 million migraine

sufferers in the U.S. with a sub-optimal response to currently available

treatment options.

</p>

<p>

“Ausanil was never intended to be a solution for every single person

living with migraines; no one medicine can fill that gap,” said Dr.

Chatterjee. “We developed Ausanil to offer a much needed additional

treatment solution for patients who are crippled by their pain and

unable to function in the midst of their attack for hours or days at a

time. For much of my life, I was that sufferer.”

</p>

<p>

<b>Can CGRP Antagonism Help Address Common Migraine Treatment Challenges?</b>

</p>

<p>

In the past decade, there have been major advances in understanding the

therapeutic management of migraines by blocking the release of or

inhibiting the direct source of the headache pain in the brain—a

build-up of CGRP, a pain modulating neurotransmitter in the human

nervous system which is thought to cause the swelling and inflammation

of blood vessels surrounding the brain.<sup>2</sup> Recent focusing on the development of investigational medicines

that rely on capsaicin pathways to block CGRP and therefore, prevent

migraine, are giving millions of patients hope for a new generation of

treatments to become available in several years.

Currently, Ausanil is the only CGRP antagonist commercially available in

the U.S. specifically formulated to treat severe, debilitating

neuro-vascular headaches. This allows Ausanil’s active ingredient <a rel="wpi" target="_blank" title="" href="">capsicum annuum</a>

(capsaicin) to bind directly to receptors on sensory nerves in the nose,

acting as an analgesic by depleting the build-up of CGRP and reducing

the headache pain within minutes.

</p>

<p>

“Based on intensive, existing clinical research on capsaicin, we

thoughtfully developed Ausanil for intranasal use because it allows the

treatment to work incredibly fast via neural transmission to directly

reduce the headache pain inflammation and thus addresses the biggest

concern for patients—speed of onset of pain relief,” said Chatterjee,

who was involved in the development of CGRP antagonists and antibodies

during his prior roles at Pfizer Inc. and at Merck Research Labs.

“Unlike all other CGRP antagonists and antibodies currently in

development, Ausanil works directly on the nerve to deplete CGRP

build-up—a mode of action that utilizes minute amounts of medicine

locally in the nose—resulting in no meaningful uptake in the

bloodstream. The outcome is a medicine that does not interact with other

medicines or cause side effects in other organs like the heart, liver or

stomach.”

</p>

<p>

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<b>Treatment Accessibility and Affordability: What Does Ausanil’s

Non-Prescription, Homeopathic Classification Mean for Patients?</b>

</p>

<p>

Through decades of clinical practice, and as a researcher of

neuroscience medicines, Dr. Chatterjee was well aware of capsaicin’s

role in pain management from its use in ancient Eastern medicine and

homeopathy to existing clinical research (double blind controlled

trials) from the 1990’s onward on its benefits for treatment of

migraines and cluster headaches.<sup>3,4</sup> Understanding the

connection between an old accepted remedy and its current cutting edge

scientific rationale for use (CGRP antagonism), he spent nearly two

years developing the final formulation of Ausanil using capsicum annuum,

an active natural ingredient approved and regulated by the U.S. Food and

Drug Administration. VR1 manufactures Ausanil in the USA at a

FDA-registered facility that meets GMP (good manufacturing practices)

designations required by the FDA.

</p>

<p>

According to a 2012 survey conducted among 2,500 migraineurs, nearly

half (45.5%) of the patients noted cost as a reason they did not take

commonly used migraine medications such as triptans (e.g., Imitrex,

Relpax, Zomig).<sup>5</sup> Results of a National Institute of Health

study found that 63 percent of patients saved their triptan use for

“bad” migraines due to cost and insurance issues. Alongside high costs,

insurance plans may not approve enough of a medication dosage to

adequately treat some patients symptoms.<sup>6</sup> In 2014, VR1 made

Ausanil available to millions of patients in pain, as a non-prescription

homeopathic treatment retailing at $34.95 (less than 70 cents a dose) to

address two huge patient challenges—treatment accessibility and

affordability.

</p>

<p>

“Given capsicum annuum has long been clinically acknowledged as an

effective analgesic for migraines and headaches, the homeopathic

designation allowed us to make Ausanil rapidly available to patients

without the need for a prescription and at an affordable price point. It

is important that patients are able to access multiple viable options.”

said Michele Harris, VR1 Chief of Operations and Marketing.

</p>

<p>

This unique approach is paying off for thousands of sufferers, and

patients and professionals alike are sharing their experience with many

others nationwide:

</p>

<p>

<i>“I have struggled with migraines for decades and have tried every

migraine product on the market,” said Ausanil user Cheryl Glace. Simply

put, Ausanil is a life changer. My daily life is no longer defined by

whether or not I have a headache.”</i>

</p>

<p>

<i>“I have recommended Ausanil to dozens of patients,” Bridget Rowan,

RPh, pharmacist and owner of O’Hearns Pharmacy in Cambridge, New York.

It's safe, easy to use, does not require a prescription, no insurance

limits, no drug interactions, convenient, and developed by a

neurologist. It sounded too good to be true! But, as an infrequent

migraine sufferer, I have used the treatment myself and am amazed at the

quick and complete relief. My headache pain is gone in about 4 minutes.

My daughter now uses it and carries it with her. Personally and

professionally, I can say Ausanil is one of my favorites.”</i>

</p>

<p>

<b>Ausanil Launch Year Update; Potential for Migraine Prevention?</b>

</p>

<p>

In calendar 2015, the first full year on the market, sales of Ausanil

have gained fast traction and are set to triple the company’s revenue

from 2014.

</p>

<p>

Available online as well as at hundreds of local pharmacies nationwide,

including Kinney Drugs, VR1 has made it a top priority to educate

thousands of neurologists, family physicians, nurses, pharmacists, as

well as physician assistants and nurse practitioners on the indications

and proper use of Ausanil as an acute treatment. Healthcare teams at the

Mayo Clinic, the University of Southern California, the University of

Kentucky, and others are regularly recommending Ausanil to

difficult-to-treat patients and seeing success.

</p>

<p>

The Atlantic Neuroscience Institute at Overlook Medical Center in

Summit, New Jersey is currently recruiting patients for a

to further examine Ausanil’s effectiveness and tolerability for primary

headache disorders.

“Many of our patients are often limited in treatment options. By

offering relief within minutes, without concerns of drug-to-drug

interactions. Long-term side effects, Ausanil is becoming a preferred

solution for many of them,” said Dr. Seth Stoller, Medical Director of

the Overlook Headache Center and lead study investigator. “We're

optimistic the observational study will provide additional support for

the intranasal use of capsicum annuum for migraine and severe headache

relief.”

Given existing research suggesting the use of CGRP blockade for migraine

prevention, VR1 is also exploring Ausanil’s potential for future use as

a preventative medication for migraine and pain management. If pursued,

such an indication will likely involve a New Drug Application (NDA) with

the FDA.

Visit Ausanil.com

to learn more.

About Ausanil®

Non-prescription, homeopathic Ausanil nasal spray is specifically

formulated to provide symptomatic rapid relief from severe headache and

migraine pain. It's not intended to be a preventative or cure for

migraines or severe headaches.

When used as directed, Ausanil is safe to use several times daily for

migraine and cluster headaches, tension headaches and medication overuse

headaches.

Ausanil shouldn't be used for mild or infrequent headaches, atypical

migraines, basilar migraines, migraines with abdominal symptoms. Any

new onset severe headaches that are unusual for the sufferer. Ausanil

shouldn't be used in people with an active nasal infection, active and

symptomatic asthma or upper respiratory tract infection. With a

severely deviated nasal septum. Ausanil isn't recommended for women who

are pregnant or breastfeeding. For patients under age 18. Individuals

allergic to any of the listed ingredients shouldn't use Ausanil.

Though non-prescription, it’s important that patients always discuss

using Ausanil and its incorporation into their current treatment

regimens with their doctors.

About VR1, Inc.

VR1 is committed to meeting the needs of patients by providing

therapeutic solutions that are effective, safe and accessible. Founded

by neurologist

and lifelong migraine sufferer Anjan Chatterjee, MD, MPH, MBA, FAAN,

FAHS, FAPA, VR1 is a privately held company that focuses on

providing treatments to address acute pain associated with migraine and

other severe headache conditions.

Forward Looking Statement

This press release contains “forward looking statements” within the

meaning of Section 27A of the Securities Act of 1933 as amended.

Section 21E of the Securities Exchange Act of 1934 and are made pursuant

to the safe harbor provisions of the Private Securities Litigation

Reform Act of 1995. Forward looking statements reflect the current view

about future events. Using the words “plan,” “likely,” “explore,”

“intend,” “set to” and similar expressions as they relate to VR1’s

products identify forward looking statements. Such statements, include,

but aren't limited to, statements relating to our business, products

and services we may offer in the future, sales and marketing strategy

and capital outlook. Forward looking statements are based on our current

expectations and assumptions regarding our business, the economy and

other future conditions. Because forward looking statements relate to

the future, they're subject to inherent uncertainties, risks and

changes in circumstances that are difficult to predict. Our actual

results may differ materially from those contemplated by the forward

looking statements. they're neither statement of historical fact nor

guarantees of assurance of future performance. We caution you therefore

against relying on any of these forward looking statements. Important

factors that could cause actual results to differ materially from those

in the forward looking statements, including a decline in general

economic conditions in the U.S. or globally. Decreased demand for our

products. Market acceptance of our products. The ability to protect our

intellectual property rights. Impact of any litigation or infringement

actions brought against us. Competition from other providers and

products’ risks in product development. Inability to raise capital to

fund continuing operations. Changes in government regulation. The

ability to complete customer transactions and capital raising

transactions. Other factors relating to our industry, our operations

and results of operations and any businesses that may be acquired by us.

Should one or more of these risks or uncertainties materialize.

should the underlying assumptions prove incorrect, actual results may

differ significantly from those anticipated, believed, estimated,

expected, intended or planned.

Factors or events that could cause actual results to differ may emerge

from time to time. It's not possible for us to predict all of them.

We can't guarantee future results, levels of activity, performance or

achievements. Except as required by applicable law, including the

securities laws of the United States, we undertake no obligation to and

don't intend to update any of the forward looking statements to conform

these statements to actual results.

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1 Alexianu M., Chatterjee A. “Intranasal capsaicin (IC)

rapidly relieves the pain of migraine and other severe headaches.” 66th

Annual meeting of the American Academy of Neurology. 2014.

2 Bigal ME, Water S, Rapoport, AM. Calcitonin gene related

peptide (CGRP) and migraine. Current understanding and state of

development. Headache. 2013. 53(8):1230-44.

3 Fusco, BM, Barzoi, G, Agro, F. Repeated intranasal

capsaicin applications to treat chronic migraine. British Journal of

Anaesthesia. 2003. 90(6):812.

4 Fusco, BM, Giacovazzo M. Peppers and pain. The promise of

capsaicin. Drugs. 1997 Jun;53(6):909-14.

5 Migraine.com Migraine in America 2012 survey. Available at: http://migraine.com/mia2012/mediaction-cost-issue/.

6 Insurance limitations and cost of triptans negatively

influence use of patterns, quality of life. Medscape. June 18,

2007.