Product Development Pipeline

Burke is developing a pipeline of dermatology products for the treatment of unmet medical needs and first in class products.

Products in Development

BLU901 Wart Eraser

The Wart Eraser™ is a dermatological medical device developed designed to produce controlled depth skin abrasions (dermabrasion) to facilitate the penetration of drugs for the treatment of warts. This is a dermabrasion medical device used as a pretreatment to abrade verrucae or warts prior to application of topical products to improve delivery and absorption of the active drug.

The dermabrasion device is also use to reduce calluses, corns and hyperkerotic skin.

BLU402 Hydrogel Patch Wart Kit

This is a novel prescription patch and a first in class treatment for verrucae or warts.

BLU601 Cream

This is a prescription topical product containing a novel ingredient for treatment of atopic dermatitis.

BLU103 Needle Free Injection

This is a prescription needle-free intradermal injection product and a first in class treatment for verrucae.

BLU104 Needle Injection Pen

This is a prescription needle intradermal injection product and a first in class treatment for verrucae.

Over-the-Counter Drug Products

Burke Pharmaceuticals, LLC. is engaged in the development of improved over-the-counter (OTC) and/or USP Monograph based OTC dermatology drug products. Several improved drug products are being evaluated for registration and marketing in the United States and Canada.

These OTC products include:

• Treatment of verrucae
• Atopic dermatitis
• Personal care including skin-care and anti-acne products

Proprietary Prescription Products

Burke Pharmaceuticals, LLC. is developing proprietary prescription pharmaceutical products for the dermatology market following the 505(b)(2) registration approaches. Burke is seeking strategic partners to co-develop, register, and market improved proprietary drug products for existing drug candidates.

These drug products would offer one or more of the following benefits:

• Enhanced product value through greater safety and efficacy
• Improved compliance through reduced dosing frequency
• New dosage forms for approved drugs
• Possibly expanded indication(s)
• Product line extensions
• Extended patent life

Burke Technologies

Burke is developing proprietary products for improving the delivery of drugs to the skin and epidermis. Dermatologic diseases are typically expressed in the upper dermis and epidermal layers of the skin. The stratum corneum is the rate controlling barrier to effective drug delivery (Figure 1).

Burke has developed a novel dermabrasion device for pretreatment of the skin to disrupt the stratum corneum. This device is utilized prior to application of topical products to improve their absorption.

Burke is also developing improved topical (creams, gels, ointments, patches) formulations combining permeation enhancers for optimized target delivery to the epidermis for treatment of selective dermatological diseases. Burke is developing novel products for intradermal injection in needle-free and standard needle-based injection devices. These products will be a first line treatment for verrucae and other localized skin diseases.

Figure 1: Diagram of skin layers and drug delivery to the skin.

Dermabrasion Device

The Wart EraserTM is a dermatological medical device developed by Burke Pharmaceutical Research, Inc. designed to produce controlled depth skin abrasions (dermabrasion) to facilitate the penetration of drugs for the treatment of warts.

There are several device designs of the wart eraser which are protected by two issued US patents ¹,² The wart eraser designs and method of use with medicaments such as pyruvic acid are further described in three US Patent ²,³,⁴The wart eraser design shown in Figure 2 is intended for commercial development and comprises a handle and a base with a plurality of stainless steel tines arranged similar to bristles of a toothbrush on the end of the handle. A schematic of the dermabrasion device is also shown in Figure 3. The device may be provided in a kit to be used in combination with a medicament to treat warts.

Figure 2: Wart and Wart Eraser

Figure 3: Schematic of Wart Eraser Taken from US Patent 6,585,742,B2

References

1. Stough, DB, Wart Removal Method and Device, US Patent 6,585,742,B2, issued July 1, 2003.
2. Stough, DB, Wart Removal Method and Device, US Patent 7,056,324,B2, issued June 6, 2006.
3. Stough, DB, Wart Removal Method and Device, US Patent Application No. US 2002/0169462A1, published November 14, 2004.
4. Stough, DB, Wart Removal Method and Device, US Patent Application No. US 2004/0138679A1, published July 15, 2004.
5. Stough, DB, Wart Removal method and Device, US Patent Application No. US 2006/0200174 A1, published September 7, 2006.

Burke Intellectual Property

Patents and other proprietary rights are essential to our business. We have filed patent applications in an effort to protect our platform technology and formulations. Burke has been issued patents on its proprietary drug delivery technology.

We have been awarded U.S. and foreign issued patents, with numerous patents pending. Our patents issued date back as early as 2003. The Majority of our patents are recently issued and have considerable patent life remaining.