Nemaura Pharma Limited Award Write Up

2016 European Transdermal Drug Delivery

Enabling Technology Leadership Award

2016

BEST PRACTICES RESEARCH

© Frost & Sullivan 2016 2 “We Accelerate Growth”

Contents

Background and Company Performance ........................................................................ 3

Industry Challenges .............................................................................................. 3

Technology Leverage and Customer Impact ............................................................. 4

Conclusion........................................................................................................... 7

Significance of Enabling Technology Leadership ............................................................. 8

Understanding Enabling Technology Leadership ............................................................. 8

Key Benchmarking Criteria .................................................................................... 9

Best Practice Award Analysis for Nemaura Pharma Limited .............................................. 9

Decision Support Scorecard ................................................................................... 9

Technology Leverage .......................................................................................... 10

Customer Impact ............................................................................................... 10

Decision Support Matrix ...................................................................................... 11

The Intersection between 360-Degree Research and Best Practices Awards ..................... 12

Research Methodology ........................................................................................ 12

Best Practices Recognition: 10 Steps to Researching, Identifying, and Recognizing Best Practices ................................................................................................................. 13

About Frost & Sullivan .............................................................................................. 14



Background and Company Performance

Industry Challenges

Biologics, or biopharmaceutical drugs, form a rapidly growing drug class characterized by

the advantages of high selectivity, strong therapeutic efficacy, and limited side effects. In

light of these advantages, along with rapid discovery of new targets and advanced

engineering processes, several biologics are either in the late stages of clinical trials or

already marketed for diseases ranging from diabetes to cancer therapeutics. However, due

to their large size and susceptibility to degradation, the formulation and delivery of these

biopharmaceutical drugs pose substantial challenges. The most common way of delivering

biologics is through a parenteral/intravenous (IV) or subcutaneous route, yet drugs

delivered this way are disadvantaged by a short plasma half-life, resulting in more

frequent drug administration. Another challenge associated with biologics is that these

drugs cannot be delivered orally, because the proteins/peptides are digested before

passing through the intestine for absorption. Also, some biologics require IV infusion,

which may last for hours. These factors impede patient compliance to prescribed

medication, which leads to poor health outcomes and even emergency hospitalizations.

To address these multi-faceted challenges, several new technologies enabling the

improved delivery of biologics, such as nanoparticles, smart nanomaterials, and needle-

free devices, have emerged. The needle-free transdermal devices are usually designed as

sub-cutaneous, self-injectable systems for patients. The challenge associated with the

current microneedle transdermal system, however, is optimization of dosage. With self-

administration, often the needles are not uniformly inserted into the skin. Some needles

may not even penetrate the skin, so chances are that the entire drug dose may not enter

the skin, leading to inconsistency in the dosage and risk to patients’ health. This is a

major drawback of the currently available microneedle transdermal patch system.

Moreover, some patches do not have quick drug absorption and may, therefore, require

the microneedles to be embedded into the skin for as long as 30 minutes for the drug to

fully dissolve. These drawbacks affect patient compliance.

Hence for an effective transdermal drug, especially for delivery of biologics, key strategies

such as accurate and controlled drug dosage, fast drug absorption, pain-free drug

delivery, and better patient compliance, all must be implemented to effectively address

the challenges and stay competitive in the transdermal drug delivery market.



Technology Leverage and Customer Impact

Commitment to Creativity

Identifying and understanding the crucial unmet industry need for an effective and

improved transdermal drug delivery system, UK-based company Nemaura Pharma Limited

has developed an enhanced drug delivery technology platform called the Memspatch

technology. Most of the liquid biologic drug formulations are delivered through either

syringes or pen injections. One of the world’s most widely used peptide therapeutical,

insulin, is also delivered through such injectable devices. Worldwide, diabetic patients

number approximately 390 million, and more than $12 billion worth of insulin is sold each

year. Diabetic patients, nonetheless, show treatment non-compliance and dosage

variations with these cumbersome drug delivery devices.

Nemaura Pharma’s liquid biologic drug delivery system, the Memspatch transdermal drug

delivery technology, is enabled with multiple hollow microneedles in a compact flat box-

like device. The Memspatch’s multiple needles go less deep into the skin compared to

syringes or pen injectors, thereby causing less pain. Going just under the skin, the

Memspatch reaches the microvessel network which absorbs the drug faster than when

delivered through normal syringes or injectors. Unlike injecting the drug through a single

needle, the drug is dispersed over a larger area using multiple hollow needles, which also

helps it to better dissolve and spread into the skin, leading to faster absorption into the

blood stream. This is particularly helpful for diabetic patients. With faster insulin

absorption using Memspatch, the patient can take the insulin dose and his meal

simultaneously, because the absorption is almost instantaneous. This quick- and easy-to-

use Memspatch offers 100% accurate and controlled dosing.

The traditional microneedle transdermal patches available in the market, when pressed at

an angle, leave room for some needles to pierce more than others, causing inaccuracy in

dosage. To address this challenge, Nemaura Pharma’s Memspatch comes with a

disposable drug cartridge and non-disposable applicator. The applicator can be rolled over

the skin, ensuring 100% needle penetration. It can help in rapid or controlled slow

delivery of liquid drug formulations from microlitres to 10's of milliliters. The drug dose

accuracy and easy-to-use features of Memspatch make it more patient-friendly than the

competing solutions and increase patient compliance.



Commitment to Innovation

Innovating in the area of transdermal drug delivery systems, Nemaura Pharma has

developed a transdermal solid dose delivery device called the Micropatch. The Micropatch

device is extremely valuable for delivering a stable, solid form of the drug. Nemaura

Pharma reformulates the liquid biologic into a solid form, making it extremely stable and

requiring no refrigeration, and itis microns or millimeters in size. The Micropatch solid

drug delivery device has a super sharp needle, and the solid drug is pelletized at the tip of

the needle. The needle, when inserted into the skin, is minimally invasive and ensures

immediate delivery of the solid drug. After delivering the drug pellet into the skin, the

needle is then retracted. Through direct and instantaneous delivery into the blood stream,

the low volume of drug can show high potency. Like Memspatch, Micropatch also shows

100% controlled dosing.

Stage Gate Efficiency

Both solid and liquid dose transdermal technologies developed by Nemaura Pharma deliver

drugs just below the surface of the skin, requiring patients endure minimum pain and

discomfort. The transdermal technologies allow for the accurate and controlled

administration of drug doses by the patients themselves. Biologics or peptide therapeutics,

which is degraded by stomach acids if taken orally, are delivered in a minimally-invasive

manner just under the skin. By avoiding the first-pass effect of liver metabolism, Nemaura

Pharma’s transdermal technologies help reduce the side effects associated with oral drug

delivery. Memspatch and Micropatch are aimed to maximize both drug delivery

effectiveness and patient compliance.

One of the most successful examples is using Nemaura Pharma’s Micropatch solid micro-

dose skin delivery system for the delivery of the tetanus vaccine and the DTaP

(diphtheria, tetanus, and pertussis) vaccine. The conventional liquid vaccine has the risks

of contamination and stability associated with it. Nemaura Pharma has re-formulated the

liquid vaccine into a stable solid dose formulation, without any loss of potency.

The Micropatch solid micro-dose skin delivery system, when delivering a vaccine,

eliminates the need for maintaining any cold chain, since the re-formulated solid vaccine

is highly stable and also does not require a specialist to administer it thanks to this easy-

to-use Micropatch system. Nemaura Pharma’s drug delivery technology has certainly

revolutionized the way drugs are delivered in the healthcare system, helping to overcome

several drug delivery issues.

Application Diversity

Nemaura Pharma’s transdermal drug delivery system ranges from a minimally-invasive

microneedle system (Memspatch), to an innovative skin insertion platform (Micropatch),

to even transdermal skin patches, delivering solid or liquid drug formulations. Nemaura



Pharma’s transdermal patch system is indicated for central nervous system conditions,

such as Alzheimer's and Parkinson's disease, and other chronic conditions, such as

hypertension. These transdermal patches are particularly useful in elderly patients, who

often forget to take timely medications. Instead of multiple dosage medications that need

to be taken either daily or weekly, a single patch once a week or month can ensure high

patient compliance, and this way, avoid the incident of missing any doses.

Nemaura Pharma’s microneedle drug delivery technologies for different drugs are in

clinical or pre-clinical stages of development for several indications, such as diabetes,

topical pain relief, migraine, chronic pain, osteoporosis, and deep vein thrombosis. It is

also being evaluated for the delivery of human or veterinary vaccines, antibiotics,

oncology drugs, and local anesthetics.

The medical device application of Nemaura Pharma’s microneedle technology spans the

areas of dermatology and diagnostics.

Price/Performance Value

Compared to the other commercially available, expensive microneedle systems in the

market, Nemaura Pharma uses a cheap disposable single-use drug cartridge system. This

system is extremely cost effective as compared to the injectable or other conventional

modes for delivering biologics. For vaccines, Nemaura Pharma re-formulates liquid drugs

into a stable solid form, which in avoiding the cold chain storage, leads to significant cost

savings. Studies have shown that up to 50% of vaccines end up getting wasted due to

degradation because of breakages in the cold chain. The Micropatch system by Nemaura

Pharma can substantially help reduce these unnecessary damages.

The easy-to-use transdermal technologies help patients take their medication more

effectively, avoiding missed doses or taking inaccurate drug dosages. Ultimately, patients

are treated more effectively and the overall healthcare costs are reduced. Also, when

patients administer their own medications, costs otherwise incurred by a nursing staff are

reduced, while also ensuring patients are empowered with the confidence to correctly to

take their medications by themselves, even when not admitted in a hospital.

Commercialization Success

The commercialization success of Nemaura Pharma’s offerings can be clearly gauged from

the enthusiastic reception by multinational pharmaceutical companies as well as by

regulatory authorities. Currently, Nemaura Pharma is working with a multinational

company for developing a solid vaccine formulation as well as the drug delivery device.

Similarly, it is also working with another global company in reformulating a skin cancer

product delivered via its innovative microneedle technology. To date, it has received the

CE mark approval for a microneedle-based skin prep/dermatology medical device, and a

nonsteroidal anti-inflammatory drugs-based microneedle system for joint inflammation. In



2015, Nemaura Pharma submitted the Abbreviated New Drug Application (ANDA) to the

US Food and Drug Administration (FDA) for its transdermal therapeutic system for the

treatment of Alzheimer’s disease. Nemaura Pharma’s promising Memspatch microneedle

transdermal liquid delivery technology platform has received funding of £12 million from

private investors to expand and fast track its approval for market launch.

Conclusion

Nemaura Pharma’s transdermal drug delivery technologies have been designed to address

the challenges and complexities faced by patients using traditional drug delivery

technologies, especially in delivering biologics. The solid and liquid microneedle-based

drug delivery technologies (Memspatch and Micropatch) provide pain-free, minimally-

invasive drug delivery with controlled drug dosage. With superior drug absorption, zero

drug stability or dosage issues, this easy-to-use transdermal technology drives better

patient compliance and outcomes.

With its strong overall performance, Nemaura Pharma Limited has earned Frost &

Sullivan’s 2016 Enabling Technology Leadership Award.



Significance of Enabling Technology Leadership

Ultimately, growth in any organization depends upon customers purchasing from your

company, and then making the decision to return time and again. In a sense, then,

everything is truly about the customer—and making those customers happy is the

cornerstone of any long-term successful growth strategy. To achieve these goals through

technology leadership, an organization must be best-in-class in three key areas:

understanding demand, nurturing the brand, and differentiating from the competition.

Understanding Enabling Technology Leadership

Product quality (driven by innovative technology) is the foundation of delivering customer

value. When complemented by an equally rigorous focus on the customer, companies can

begin to differentiate themselves from the competition. From awareness, to consideration,

to purchase, to follow-up support, best-practice organizations deliver a unique and

enjoyable experience that gives customers confidence in the company, its products, and

its integrity.



Key Benchmarking Criteria

For the Enabling Technology Leadership Award, Frost & Sullivan analysts independently

evaluated two key factors—Technology Leverage and Customer Impact—according to the

criteria identified below.

Technology Leverage

Criterion 1: Commitment to Innovation

Criterion 2: Commitment to Creativity

Criterion 3: Stage Gate Efficiency

Criterion 4: Commercialization Success

Criterion 5: Application Diversity

Customer Impact

Criterion 1: Price/Performance Value

Criterion 2: Customer Purchase Experience

Criterion 3: Customer Ownership Experience

Criterion 4: Customer Service Experience

Criterion 5: Brand Equity

Best Practice Award Analysis for Nemaura Pharma Limited

Decision Support Scorecard

To support its evaluation of best practices across multiple business performance

categories, Frost & Sullivan employs a customized Decision Support Scorecard. This tool

allows our research and consulting teams to objectively analyze performance, according to

the key benchmarking criteria listed in the previous section, and to assign ratings on that

basis. The tool follows a 10-point scale that allows for nuances in performance evaluation;

ratings guidelines are illustrated below.

RATINGS GUIDELINES

The Decision Support Scorecard is organized by Technology Leverage and Customer

Impact (i.e., the overarching categories for all 10 benchmarking criteria; the definitions

for each criteria are provided beneath the scorecard). The research team confirms the

veracity of this weighted scorecard through sensitivity analysis, which confirms that small

changes to the ratings for a specific criterion do not lead to a significant change in the

overall relative rankings of the companies.



The results of this analysis are shown below. To remain unbiased and to protect the

interests of all organizations reviewed, we have chosen to refer to the other key players

as Competitor 2 and Competitor 3.

DECISION SUPPORT SCORECARD FOR ENABLING TECHNOLOGY LEADERSHIP AWARD

Measurement of 1–10 (1 = poor; 10 = excellent)

Enabling Technology Leadership

Technology

Leverage

Customer

Impact Average Rating

Nemaura Pharma Limited 10 8 9.0

Competitor 2 8 9 8.5

Competitor 3 7 8 7.5

Technology Leverage

Criterion 1: Commitment to Innovation

Requirement: Conscious, ongoing adoption of emerging technologies that enables new

product development and enhances product performances

Criterion 2: Commitment to Creativity

Requirement: Technology is leveraged to push the limits of form and function, in the

pursuit of “white space” innovation

Criterion 3: Stage Gate Efficiency

Requirement: Adoption of technology to enhance the stage gate process for launching new

products and solutions

Criterion 4: Commercialization Success

Requirement: A proven track record of taking new technologies to market with a high rate

of success

Criterion 5: Application Diversity

Requirement: The development and/or integration of technologies that serve multiple

applications and can be embraced in multiple environments

Customer Impact

Criterion 1: Price/Performance Value

Requirement: Products or services offer the best value for the price, compared to similar

offerings in the market

Criterion 2: Customer Purchase Experience

Requirement: Customers feel like they are buying the most optimal solution that

addresses both their unique needs and their unique constraints

Criterion 3: Customer Ownership Experience

Requirement: Customers are proud to own the company’s product or service, and have a

positive experience throughout the life of the product or service



Criterion 4: Customer Service Experience

Requirement: Customer service is accessible, fast, stress-free, and of high quality

Criterion 5: Brand Equity

Requirement: Customers have a positive view of the brand and exhibit high brand loyalty

Decision Support Matrix

Once all companies have been evaluated according to the Decision Support Scorecard,

analysts can then position the candidates on the matrix shown below, enabling them to

visualize which companies are truly breakthrough and which ones are not yet operating at

best-in-class levels.

DECISION SUPPORT MATRIX FOR ENABLING TECHNOLOGY LEADERSHIP AWARD

High

Low

Low High

Cu

sto

mer I

mp

act

Technology Leverage

Nemaura

Pharma

Limited

Competitor 2

Competitor 3



The Intersection between 360-Degree Research and Best

Practices Awards

Research Methodology

Frost & Sullivan’s 360-degree research

methodology represents the analytical

rigor of our research process. It offers a

360-degree-view of industry challenges,

trends, and issues by integrating all 7 of

Frost & Sullivan's research methodologies.

Too often, companies make important

growth decisions based on a narrow

understanding of their environment,

leading to errors of both omission and

commission. Successful growth strategies

are founded on a thorough understanding

of market, technical, economic, financial,

customer, best practices, and demographic

analyses. The integration of these research

disciplines into the 360-degree research methodology provides an evaluation platform for

benchmarking industry players and for identifying those performing at best-in-class levels.

360-DEGREE RESEARCH: SEEING ORDER IN

THE CHAOS



Best Practices Recognition: 10 Steps to Researching,

Identifying, and Recognizing Best Practices

Frost & Sullivan Awards follow a 10-step process to evaluate award candidates and assess

their fit with select best practice criteria. The reputation and integrity of the Awards are

based on close adherence to this process.

STEP OBJECTIVE KEY ACTIVITIES OUTPUT

1 Monitor, target, and screen

Identify award recipient candidates from around the globe

Conduct in-depth industry research

Identify emerging sectors Scan multiple geographies

Pipeline of candidates who potentially meet all best-practice criteria

2 Perform 360-degree research

Perform comprehensive, 360-degree research on all candidates in the pipeline

Interview thought leaders and industry practitioners

Assess candidates’ fit with best-practice criteria

Rank all candidates

Matrix positioning all candidates’ performance relative to one another

3

Invite thought leadership in best practices

Perform in-depth examination of all candidates

Confirm best-practice criteria Examine eligibility of all

candidates Identify any information gaps

Detailed profiles of all ranked candidates

4

Initiate research director review

Conduct an unbiased evaluation of all candidate profiles

Brainstorm ranking options Invite multiple perspectives

on candidates’ performance Update candidate profiles

Final prioritization of all eligible candidates and companion best-practice positioning paper

5

Assemble panel of industry experts

Present findings to an expert panel of industry thought leaders

Share findings Strengthen cases for

candidate eligibility Prioritize candidates

Refined list of prioritized award candidates

6

Conduct global industry review

Build consensus on award candidates’ eligibility

Hold global team meeting to review all candidates

Pressure-test fit with criteria Confirm inclusion of all

eligible candidates

Final list of eligible award candidates, representing success stories worldwide

7 Perform quality check

Develop official award consideration materials

Perform final performance benchmarking activities

Write nominations Perform quality review

High-quality, accurate, and creative presentation of nominees’ successes

8

Reconnect with panel of industry experts

Finalize the selection of the best-practice award recipient

Review analysis with panel Build consensus Select winner

Decision on which company performs best against all best-practice criteria

9 Communicate recognition

Inform award recipient of award recognition

Present award to the CEO Inspire the organization for

continued success Celebrate the recipient’s

performance

Announcement of award and plan for how recipient can use the award to enhance the brand

10 Take strategic action

Upon licensing, company may share award news with stakeholders and customers

Coordinate media outreach Design a marketing plan Assess award’s role in future

strategic planning

Widespread awareness of recipient’s award status among investors, media personnel, and employees



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