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Apex NanoPharma is planning to manufacture and market "CurlRelax™"
We are searching for business partners who shares our vision and 
passion to serve the cosmetic needs of the
Black community.

Together, we will successfully take "CurlRelax™" from the bench to the market, under our IP protection. 

Apex NanoPharma is planning to develop "CurlRelax™" as an over-the-counter product claiming textured hair relaxation. According to the FDA regulations (R1) this is possibly considered as both a regulated cosmetic and a drug.  

 

How can a product be both a cosmetic and a drug?

Cosmetics and Over-the-Counter drugs (OTC) are regulated by the Federal Food, Drug, and Cosmetic Act (FD&C Act) that defines cosmetics by their intended use. My simple understanding of how some products meet the definitions of both cosmetics and OTC drugs is described herein. As you know, this is very specialized subject! A product can be both a drug and a cosmetic when it has two intended uses. For example, an antidandruff shampoo is both a cosmetic and a drug. The product intended use may be established according to either the claims stated on the product labeling and advertising, or the ingredients that cause a product to be considered a drug because they have a well-known therapeutic use (to the public and industry). The FDA requires an OTC drug to have labelling details, registration and good manufacturing practice.

What are the approval requirements for an OTC drug?

Under the FD&C Act, drugs must conform to a drug “monograph,” as established by FDA’s Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective (GRAS). Among drug categories covered by OTC monographs are treatment of acne or dandruff, seborrheic dermatitis, and psoriasis. 

 

The good news is that the CurlRelax™ ingredients are GRAS and there is a published monograph for the active ingredients. Our US and international patents have been subjected to a comprehensive international search and examination during 2023. The PCT Search and Examination Report concluded that our claims are: Novel, inventive, and industrially applicable. Accordingly, the expected time to market is estimated to be short! 

The current trend in developing new cosmeceutical products

The pharma industry is developing new products by using the service of specialized Contract Research Organization (CRO), and Contract Manufacturing Organization (CMO). This is the most cost-efficient product development method, as both CRO and CMO have all the required skills and knowledge demanded in this field.

In addition, we might conduct a computer-assisted drug R&D (in-silico molecular docking) to study the interaction of HairelaxRx bioactive phytochemical with its target in the hair follicle. 

Apex Nanopharma plans to enter into long-term

win-win strategic partnership

Apex Nanopharma started an ambitious research program to uncover the root causes of coily hair that led to the discovery of a plant-based nano-drug which "selectively" relaxes the Arrector Pili smooth muscle and relaxes the coily hair from its roots. Our business model has been to do-it-alone similar to the "old school" R&D model, which has been a highly productive approach to discover a treatment target and develop a product based on our curiosity: "For new medicines turn to pioneers," according to Harvard scientists (Ref 2).

Currently, with the goal of taking "HairRelax™" from the bench to the customers, Apex Medical Device Design LLC (Apex) business needs to enter into a strategic partnership that focuses on common goals and complementary strength that can delivers on what their Black customers needs today – and in the future.​

Apex is seeking great partners interested in addressing the coily hair market needs. Together, we will start a value-aligned partnership focused on common goals and complementary strengths to answer Apex current financial and business needs. Together we will deliver benefits and strong offerings to our customers. The partnership will bring successful outcomes and is a win-win strategy. 

"CurlRelax™" Gel Caps development options:

over-the-counter cosmetic drug vs. a branded pharmaceutical drug

When bringing a pharmaceutical drug to market the choices are either to invest resources in developing the product as an Over-the-Counter, or as a branded drug under the FDA regulations. The choice depends on many factors among them are: the company’s technical capabilities, financial considerations, the total market size, the presence of other competitors for the similar products,  future market trends, and the drug's capability to fill this unique niche. These factors will be discussed during partnership negotiations.

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Planning and executing "HairRelax™" development: CROs and CMOs

Apex had successfully completed the drug discovery and development; applied for a patent that covers both the novel process and a product in the United States and internationally. We had completed phase 1; the chosen medicinal herb known for its safety for human consumption (GRAS) according to the Code of Federal Regulations (CFR) (Ref 3), where safety is considered as phase 2.

Under the Apex Medical Device Design LLC partnership, we will progress into phases 3 and 4, where we will outsource  to a Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO). Together we will select CRO and CMO specialized in bringing botanical nano-emulsion to the market and comply with the regulatory requirements. Their plan on cost and timeline will be negotiated and compared against other competitive providers.

In our world of increasingly growing knowledge our main goals will be focusing on cost reduction, flexibility and staying competitive. 

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contact

References:

Ref 1- Is it a cosmetic, a drug, or both? Regulated Product(s), Content current as of: 02/25/2022. Last visited December 5, 2023. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap#Definecosmetic

Ref 2- Mary Todd Bergman (Harvard Correspondent). For new medicines, turn to pioneers. Harvard Gazette, April 25, 2018. https://news.harvard.edu/gazette/story/2018/04/most-transformative-meds-originate-in-curiosity-driven-science-evidence-says/

Ref 3- Code of Federal Regulations (21CFR182.10). Part 182 – Substances Generally Recognized as Safe. Subpart A – General Provisions, Sec. 182.10 Spices and other natural seasoning and flavoring. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=182.10 

 

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