SAMBRIA

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.

Our Approach

• We have developed a proprietary topical pain relief formula that combines the active ingredient, lidocaine HCl with a blend of skin permeating enhancement drivers widely used in pharmaceutical compounding.

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

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

Potential Applications

We 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. 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

• Co-branding/license availability

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)

• 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

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