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Business Invite

To: Anthony Alfonso

President & CEO of Clarity Labs, LLC.

Hello Mr. Alfonso:

 

          My name is Orlando Alvarez-Fuentes, Vice President and partner of G&G Petcurae and I am respectfully asking you for 10 to 15 minutes of your time to evaluate a summary of a business plan designed to put on the market a new veterinary drug product that will effectively treat and cure digital dermatitis on dogs, cats, poultry, cattle, sheep, and horses.

          This novel veterinary drug, could potentially cure digital dermatitis in a time no longer than 3 weeks, save several visits to the veterinary, avoid painful and ineffective treatments like surgery, minimize the weakness of the animal’s immune system through antibiotic’s cocktails, minimize economic losses, and have a positive impact in extending the life and quality of life of pets around the World. We are either looking for a loan or, more likely, a business partner, to whom we are willing to transfer 10% of G&G Petcurae.

          Digital dermatitis has as many meanings as species it occurs at; for instance, it is known as Interdigital Cyst Syndrome, Pododermatitis, and Interdigital Furunculosis in dogs, Plasma Cell Pododermatitis in cats and other felines, called Subcutaneous Pododermatitis, “Bumblefoot” or “Footpad dermatitis” in poultry, “Foot Rot” in sheep, “Lameness” in cattle, and in horses and other equids can be known as “Scratches”, “Dew Poisoning”, “Grease”, Equine Pastern Dermatitis, or Pastern Folliculitis.

          Independently of the name for which this disease is known, the reality is that digital dermatitis is the gate to a myriad of dermatological infections on the affected animals and its incidence is at a 1:4 ratio on global population of individuals. Another reality is that this disease has an enormous negative impact in the economy worldwide. Lameness, for example, not only causes significant economic losses, but it has an impact on the health of the animals that suffer from it (Ózsvári, 2017). Only in England, lameness in sheep represent a financial loss of about £ 28 million per year, whereas in dairy cows, is about 190 million of dollars per year (Enting et al., 1997; Ózsvári, 2017). In poultry, broilers to be more specific, the estimated loss is from 80 to 120 million of dollars per year (Aydin, 2018). Animals suffering from lameness not only will show signs of extreme discomfort but also, because the animals tend to spend more time lying on the floor, it is responsible for changes in behavior, stress, and for developing a negative energy balance (NEB) state that leads to a Pleiades of more severe secondary diseases (Ózsvári, 2017). 

NOTE: The data presented here and derived from tangible economic losses, is from studies on First World Countries only; however, the data derived from emotional damages, due to the loss of a companion pet, has not being quantified!

 

          It is apparent that the inefficiency of various treatments obeys to the quick adaptation of the microorganisms by becoming resistant to any battery of antibiotics that have been used against them. Our new product has apparently overcome such difficulties by exposing the lesion via one of the ingredients, which acts as a peeling agent.

 

          Since October 1, 2019, we have been in contact with the Center for Veterinary Medicine (CVM) at the FDA to obtain information about how to effectively evaluate and later commercialize this new product that we have called AsuROCKTM. As mentioned before, AsuROCKTM was invented to treat Interdigital Furunculosis in dogs, for which no cure is currently on the market. The product and labeling material conform with existing monographs for all ingredients used in the formula.

          We have received positive responses from the FDA and CVM compliance officers which had guided us towards the steps needed to be completed to make this drug legal and ready for marketing and distribution in the US. It would be mandatory for us to:

  1. collect first substantial scientific evidence about the effectiveness and safety of AsuROCKTM on the different animal species for which we may have a health claim;

  2. complete a clinical study in at least one (1) species; and

  3. submit all evidence, data, and scientific reports to the CVM at FDA to apply for a NADA (New Animal Drug Application).

 

          We have a great interest in putting AsuROCKTM on the market to provide a cure, that is nonexistent nowadays, to this painful disease that develops in areas with a high number of sensory nerves.

          To achieve this initial goal, we will need to, first and foremost, address steps 1 to 3. Investing in the pharmaceutical industry, especially when trying to put a new drug on the market, is not inexpensive, however, this kind of projects provides a highly appealing Return of Investment (ROI). Moreover, G&G Petcurae is the owner of the patent to this product and will preserve exclusivity for manufacturing, selling, and distribution for the next 18 years.

          Table 1 illustrates projected revenue, initial investment, net profit, and ROI for the product. It is included in the analysis two proposed forms of packaging for the finished product with two brackets for selling prices. It is also included the analysis of two phases for the development of the business; Phase I includes the initial investment, which is excluded from Phase II. Expenses related to insurance, advertising, and marketing campaign are not included here; however, logistics and storage of finished products is somewhat included. To maximize ROI, the manufacturing batches are for 10,000 units each; this plan optimizes reduction of expenses while, at the same time, guarantees full compliance with Federal regulations regarding good manufacturing practices (GMP).

           Table 1.  Return of Investment (ROI) for products AsuROCKTM (labelled as: for Dogs, Cats, and Poultry) and AsuROCKTM (labelled as: for Cattle, Sheep, and Equine). Phase I covers Year 1, which should end with a full payoff of the initial investment, and Phase II covers Year 2, and it represent a non-ambitious manufacturing plan using a contract manufacturer. ROI has been calculated as: ROI = (Net Profit / Cost of Investment) x 100%.

          In terms of market availability and opportunities it is worth to mention that the global number of affected individuals is around 6,640 million, which represents 25% of the worldwide population of the six (6) targeted animal species. Fig. 1 shows the 1% and 0.1% of worldwide individuals that can benefit from the use of AsuROCKTM. A similar graph, that is showing the 1% and 0.1%, is also presented for the US market, where the total number of affected individuals with digital dermatitis is of around 2,185 million.

Fig. 1. Potential worldwide market for AsuROCKTM when targeting digital dermatitis in six (6) animal species.

Fig. 2. Potential USA market for AsuROCKTM when targeting digital dermatitis in six (6) animal species.

          If we take a look at Table 1, notice that we are calculating ROI based on a manufacturing plan that will supply 30,000 units per year, which, when compared with the market availability for AsuROCKTM, represents a small fraction of the total market size (~ 0.0005% for Global market and ~ 0.0015% for US market). It would be naive to think that our goal is to remain stagnant at 30,000 units per year when in reality, our ultimate goal is to be able to meet all the global demands that our product may have. Figs. 3 and 4 illustrate that, in the course of five (5) years, the manufacturing of 2.5 Million units of AsuROCKTM could be possible; these manufacturing plans will continue to use the services of a contract manufacturer, e.g., Clarity Labs.

Fig. 3. Five (5) years projection for the manufacturing of AsuROCKTM using a contract manufacturer.

Fig. 4. Five (5) years projection revenue through the manufacturing of AsuROCKTM using a contract manufacturer.

          Table 2 illustrates projected revenue, investment, net profit, and ROI for AsuROCKTM at Year 5. The analysis shown here includes two proposed forms of packaging for the finished product with the lowest bracket for selling prices; do not forget that what is shown on Table 2 is part of an exercise similar to the one practiced for Table 1 where all expenses related to insurance, advertising, and marketing campaign are not included but logistics and storage of finished products are somewhat included. Once again, ROI is maximized through the manufacturing of 10,000 units’ batches, which optimizes reduction of expenses while, at the same time, guarantees full compliance with Federal regulations regarding GMP.

           Table 2.  Return of Investment (ROI) for products AsuROCKTM (labelled as: for Dogs, Cats, and Poultry) and AsuROCKTM (labelled as: for Cattle, Sheep, and Equine). Year 5 showing a manufacturing plan using a contract manufacturer. ROI has been calculated as: ROI = (Net Profit / Cost of Investment) x 100%.

          This novel medicine has been used successfully by the owner of G&G Petcurae and tested on her own dogs, English bulldogs, for the last 11 years. There are almost no pictorial or written evidences from before 2019 to document the progress of her dogs towards complete elimination of the cysts; this has been greatly due to the lack of scientific background of the owner of G&G Petcurae, however, up to today we have pictorial evidences of progress on two separate events of Interdigital Furunculosis on English bulldogs (see Fig. 5 and attached movies). Moreover, her association with me is bringing the scientific element to the company, to which I am giving almost 30 years of experience in the field of biological sciences and over 10 years working with OTC, dietary supplements, and cosmetics’ manufacturers in the area of regulations and GMP compliance.

Fig. 5. Successful elimination of cyst using AsuROCKTM on English bulldogs.

Video 1. Owner of G&G Petcurae, Msr. Griselle García, showing a cyst on the right foot of her English bulldog, Rocky, and demonstrating how to apply the cream on the lesion.

Video 2. Owner of G&G Petcurae, Msr. Griselle García, showing the elimination of the cysts and explaining how she invented the product.

          Nowadays exist, around AsuROCKTM, a strong Quality System that covers every single aspect of the manufacturing process, including formulation, blending procedure, critical control points throughout blending and packaging stages, research protocols for stability studies, validations of processes and sanitization, and qualification of suppliers, laboratories, and contract manufacturers. For example, Fig. 6 corresponds to a draft design of the outer or shelf box in which the cream should be packed. On this label draft you will find, from top to bottom, the following:

  • Name of Product.

  • Intended specific use and health claims.

  • Warning # 1 (FOR USE IN DOGS AND CATS ONLY).

  • Promotional information regarding the product with emphasis to its active ingredients (which have been modified to avoid reveal any proprietary information).

  • Net weight.

  • Sample (mock) Barcode and intended place on the label for Barcode to be.

  • Information of Distributor and product owner (Name of company, address, phone number for quick communication).

  • Patent ID with the US Patent Office for further information.

  • Drug Fact panel including:

  1. List of Active ingredients, dosage, and purpose (actions) on the product (this information has been modified to avoid reveal any proprietary information).

  2. Use of product.

  3. Warnings including route of application (i.e., topical).

  4. Detailed Directions.

  5. Storage information.

  6. List of inactive ingredients (alphabetical) [which have been modified to avoid reveal any proprietary information].

 

          The labeling material conforms with existing monographs for Antibiotics, Antihistamine, Antifungal, and Dequamifier. Labeling material is also compliant with US FDA 21 CFR part 201 (labeling of drugs and finished pharmaceuticals) and with FDA regulations for labeling OTC Animal Drugs.

Fig. 6. Shelf box draft label for 1 Oz AsuROCKTM product.

          To finalize, Fig. 7 shows not only the roadmap to successfully launch AsuROCKTM in January 2022, but also highlights risks and how to manage them. In an optimistic scenario, AsuROCKTM can be successfully launch by January or February 2022; this can only be possible by the injection of $1,273,903.42 from an investor, and by overcoming the risks associated with the completion of stages 2 through 5. Investment risks become smaller and smaller as we successfully move from one stage to the other, being the most critical stages 2 and 3. We at G&G Petcurae, are confident that my training and experience as scientist (over 25 years) together with my expertise in compliance with Federal regulations, and in the manufacturing of OTC drugs and cosmetic products, are assets to overcome any setback that may compromise the smooth path depicted in Fig. 7, while at the same time will guarantee the movement of this product forward and in compliance with all current applicable laws and regulations.

Fig. 7. Roadmap, detailed stages, risks, and risks management to launch the first installment of AsuROCKTM.

          At this point, we are at a halt because we lack enough monetary power to continue. As I mentioned at the beginning of the letter, we are either looking for a loan or, more likely, a business partner, to whom we are willing to transfer 10% of G&G Petcurae.

          I sincerely like to thank you in advance for your attention to this letter and am looking forward to hearing from you.

 

Have a great day.

Sincerely,

 

 

Orlando

 

Orlando Alvarez, Ph.D.

Vice President

G&G Petcurae, Inc.

President and Main cGMP Consultant

The SAR Group, LLC

Gainesville, FL 32605

Phone: (786) 514-6171

Web site: https://www.theSARgroup.com

Email: orlando.alvarez.fuentes@gmail.com

 

 

REFERENCES:

 

          Aydin, A. 2018. Leg Weaknesses and Lameness Assessment Methods in Broiler Chickens. Archives of Animal Husbandry & Dairy Science DOI: 10.33552/AAHDS.2018.01.000506.

          Enting H., D. Kooij, A. A. Dijkhuizen, R. B. M. Huirne, and E. N. Noordhuizen-Stassen. 1997. Economic losses due to clinical lameness in dairy cattle. Livestock Production Science 49: 259-267.

          Ózsvári, L. 2017. Economic cost of lameness in dairy cattle herds. Journal of Dairy, Veterinary & Animal Research 6: 283-289.

 

 

          This letter and associated attachments, references and information are confidential information, and such confidentiality cannot be violated. This information can only be handled by the following entities: the author, G&G Petcurae, The SAR Group, and the recipients at Clarity Labs, LLC and Anthony Alfonso.

Gainesville, FL 32605 U.S.A.

info@theSARgroup.com

Tel: 786.514.6171

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