SAMBRIA

NeuroMed7™“A Unique Approach In Topical Pain Management”

Our Mission

Sambria Pharmaceuticals is a developer of

differentiated, highly effective topical pain relief

consumer healthcare products and medications.

Our primary goals are to develop topical

formulations that provide clinicians, patients and

consumers with effective methods to mitigate

pain singularly or in conjunction with other

effective therapies in a regulatory compliant

manner.

Assist healthcare clinicians in improving patient comfort, satisfaction and overall doctor/patient

experience

Our Approach

We have developed a proprietary topical pain relief formula that combines the active ingredient, lidocaine HCl with a blend of trans-dermal penetration enhancers widely used in pharmaceutical compounding.

Clinical applications of our launch product include topical anesthesia particularly for the dermatological, aesthetic/cosmetic, pediatric, podiatric and other specialties where rapid onset of local anesthesia is medically warranted and desired

Clinical studies being conducted around the globe demonstrate the high degree of efficacy applying transdermal delivery of topical lidocaineapplications in a safe manner when applied responsibly.

Current and Potential

ApplicationsWe are researching a broad range of current and potential future uses in an effort to expand applications of this historically effective anesthetic/analgesic.

Dermatologic conditions

Pre-and post-cosmetic/aesthetic procedure applications

Minor surgical procedures

IPL and LASER procedures

Venipuncture

Injections

Immunizations

Cutaneous allergy reactions

Pediatric

Neuropathic pain

Musculoskeletal pain

NeuroMed7TM

A topical anesthetic/analgesic cream that

combines the active ingredient lidocaine HCl 4%

with a proprietary blend of ingredients known in pharmaceutical compounding to enhance

transdermal absorption of a variety of medicinal

therapies

In a topical cream formulation, lidocaine HCl 4% is

applied externally as a local analgesic/anesthetic

medication.

When used properly topical lidocaine demonstrates a very low amount of lidocaine

entering the blood, limiting its systemic effects.

NeuroMed7TM

It can be used to reduce pain locally when applied externally directly to the skin.

Typically will not cause profound, uncomfortable numbing of the skin (lidocaine is known to cause numbing when applied by injection or to mucous membranes),

However, its action is known to desensitize the affected area where applied.

In combination with Sambria’s proprietary penetration enhancement blend, NeuroMed7™ is demonstrating a rapid onset of action and may serve physician needs for trans-dermal and sub-dermal penetration

It is free of counter irritant materials sometimes known to cause localized skin irritation. On the contrary its uses include relief from pain caused by skin irritations.

This product is also free of topical acetaminophen or salicylates, mitigating the risk of reactions in people with sensitivities to those compounds.

Lidocaine HCL 4%

The active ingredient in NeuroMed7™ falls under a class of

medication known as OTC Topical Analgesics and

Anesthetics. See US FDA Monograph CFR 21 348 OTC Topical

Anesthetics and Analgesics

Medications in this class can be used for local pain relief

when applied externally.

When applied topically, Lidocaine HCl 4% has analgesic and

anesthetic properties.

In accordance with Federal Regulations, products in its

category can be used by children and adults 2 years of age

and older without prior consent of a licensed physician when applied externally as an analgesic/anesthetic.

Product differentiators

Rapid onset of action (typically 3 to 5 minutes)

Proprietary blend that includes transdermal

penetration enhancers

Safe concentration of topical anesthetic –

lidocaine HCl 4%

Clinical use dose and patient retail size

packaging availability

Cost effective – affordable price points

throughout the distribution chain; from distributor to end user

Co-branding

Facility Costs and Margins

Sambria wholesales its product for $17.50 per tube.

Tubes contain a blend of materials that include lidocaine HCl 4% in a cream form. Tubes contain 2.2 ounces of cream per tube.

Tubes are sold wholesale in cases of 48 units per case. The case Wholesale Acquisition Cost (WAC) is $840 per case ($17.50 per tube)

By special request, Sambria can package tubes in a 24 units case box WAC is $445 per case ($18.54 per tube)

The manufacturer suggested retail price (MSRP) is $34.95 per tube.

When sold at the MSRP, Neuromed7™ has a nearly 100% markup.

Sambria also produces one use packaging for clinical setting applications – Wholesale Acquisition Cost (WAC) is $1.70 per application dose packet (package includes 3 milliliters of product– 1 milliliter = 40 mgs lidocaine HCl – total application per package = 120 mgs)

Clinic use individual packets are packaged in 100, 500, 1000 and 5000 unit boxes

Regulatory Compliance

NeuroMed7™ is manufactured and marketed in accordance with United States Food and Drug Administration (US FDA or FDA) regulations.

Regulation policies are governed by the US FDA CFR 21 Monograph 348 OTC Topical Analgesic and Anesthetics.

Monograph policy specifically directs marketers of medications in this class to list the uses “topical analgesic”, “topical anesthetic”, “external analgesic”, “external anesthetic” or “for the temporary relief of pain” on its product packaging. ¹ Monograph CFR 21 348.50(a).1

USA FDA NDC# 54723-175-22

Dermatological Safety and Efficacy

References Supporting the Use of OTC 4% Topical Lidocaine

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923950/

http://www.the-dermatologist.com/article/7737

http://www.skinlaser.com/wp-content/uploads/2011/07/2012AnestheticReviewDermSurg-AlsterSobanko.pdf

http://www.hospitalpharmacyeurope.com/featured-articles/topical-anaesthetics-dermatology

http://archderm.jamanetwork.com/article.aspx?articleid=407139

http://www.drugs.com/cdi/lidocaine-cream.html

http://www.iacdworld.org/legal/lidocaine.htm

http://otcsafety.org/en/treatments/topical-pain-relievers/

http://www.webmd.com/drugs/mono-9170-LIDOCAINE+-+TOPICAL.aspx?drugid=8532&drugname=Lidocaine+Top

NeuroMed7™

Thank You!