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Transcript of Sambria presentation-1
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!