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BEST PRACTICES RESEARCH © 2013 Frost & Sullivan 1 “We Accelerate Growth” Investment Opportunity Award Oncology Global, 2013 Frost & Sullivan’s Global Research Platform Frost & Sullivan is in its 50 th year in business with a global research organization of 1,800 analysts and consultants who monitor more than 300 industries and 250,000 companies. The company’s research philosophy originates with the CEO’s 360-Degree Perspective™, which serves as the foundation of its TEAM Research™ methodology. This unique approach enables us to determine how best-in-class companies worldwide manage growth, innovation and leadership. Based on the findings of this Best Practices research, Frost & Sullivan is proud to present the 2013 Global Investment Opportunity Award in Oncology to Sorrento Therapeutics, Inc. Near term revenue potential through strategic acquisition is also noted. Significance of Investment Opportunity Award Strategic Acquisition of Late Stage, Ph3 ready, Oncology Drug Candidate That Is Not Reflected in Current Company Valuation Sorrento Therapeutics, Inc (STI or Sorrento) recently announced a strategic transaction to acquire a privately owned company, Igdrasol, Inc. As part of this acquisition, Sorrento secured access to a next generation, late-stage paclitaxel nanoparticle formulation - Cynviloq™ (paclitaxel in polymeric micelle formulation) with multiple therapeutic indications. Cynviloq™ has PK properties amenable to personalized dosing allowing for improved therapeutic index versus industry leader – Abraxane ® marketed by Celgene Corporation. The development program of Cynviloq™ will benefit from the 505(b)(2) bioequivalence pathway, which could provide for abbreviated development time and near term revenue generation to support further clinical development. STI, through its acquisition of Igdrasol, has obtained the exclusive marketing and distribution rights to Cynviloq™ in the United States and the 27 EU member countries from Samyang Biopharmaceutical Corporation, a South Korean company. Significant upside to be realized with Cynviloq™ acquisition: Celgene paid over US $3.5 Billion for Abraxis Bioscience to acquire the Abraxane ® asset in 2010. Last year, Celgene achieved Abraxane ® sales of $427M mostly in the metastatic breast cancer (MBC) indication. In October, 2012, the FDA also granted Abraxane ® approval for non- small cell lung cancer (NSCLC), an indication with a significantly larger patient population than MBC. Abraxane ® sales are likely to grow because a large global randomized Phase III study (MPACT trial), in which Abraxane ® in combination with gemcitabine demonstrated significantly improved ORR, PFS, as well as a nearly 2-month OS benefit versus

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Page 1: Significance of Investment Opportunity Awardsorrentotherapeutics.com/wp-content/uploads/2013/07/... · 2020. 6. 1. · over US $3.5 Billion for Abraxis Bioscience to acquire the Abraxane

BEST PRACTICES RESEARCH

© 2013 Frost & Sullivan 1 “We Accelerate Growth”

Investment Opportunity Award

Oncology

Global, 2013

Frost & Sullivan’s Global Research Platform

Frost & Sullivan is in its 50th year in business with a global research organization of 1,800

analysts and consultants who monitor more than 300 industries and 250,000 companies.

The company’s research philosophy originates with the CEO’s 360-Degree Perspective™,

which serves as the foundation of its TEAM Research™ methodology. This unique approach

enables us to determine how best-in-class companies worldwide manage growth, innovation

and leadership. Based on the findings of this Best Practices research, Frost & Sullivan is

proud to present the 2013 Global Investment Opportunity Award in Oncology to Sorrento

Therapeutics, Inc. Near term revenue potential through strategic acquisition is also noted.

Significance of Investment Opportunity Award

Strategic Acquisition of Late Stage, Ph3 ready, Oncology Drug Candidate That Is

Not Reflected in Current Company Valuation

Sorrento Therapeutics, Inc (STI or Sorrento) recently announced a strategic transaction to

acquire a privately owned company, Igdrasol, Inc. As part of this acquisition, Sorrento

secured access to a next generation, late-stage paclitaxel nanoparticle formulation -

Cynviloq™ (paclitaxel in polymeric micelle formulation) with multiple therapeutic

indications. Cynviloq™ has PK properties amenable to personalized dosing allowing for

improved therapeutic index versus industry leader – Abraxane® marketed by Celgene

Corporation. The development program of Cynviloq™ will benefit from the 505(b)(2)

bioequivalence pathway, which could provide for abbreviated development time and near

term revenue generation to support further clinical development. STI, through its

acquisition of Igdrasol, has obtained the exclusive marketing and distribution rights to

Cynviloq™ in the United States and the 27 EU member countries from Samyang

Biopharmaceutical Corporation, a South Korean company.

Significant upside to be realized with Cynviloq™ acquisition: Celgene paid

over US $3.5 Billion for Abraxis Bioscience to acquire the Abraxane® asset in 2010. Last

year, Celgene achieved Abraxane® sales of $427M mostly in the metastatic breast cancer

(MBC) indication. In October, 2012, the FDA also granted Abraxane® approval for non-

small cell lung cancer (NSCLC), an indication with a significantly larger patient population

than MBC. Abraxane® sales are likely to grow because a large global randomized Phase III

study (MPACT trial), in which Abraxane® in combination with gemcitabine demonstrated

significantly improved ORR, PFS, as well as a nearly 2-month OS benefit versus

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BEST PRACTICES RESEARCH

© 2013 Frost & Sullivan 2 “We Accelerate Growth”

gemcitabine monotherapy in patients with advanced pancreatic cancer. Analysts estimate

peak year sales potential for Abraxane® of approximately $1.7 billion.

Unlike the Abraxane® formulation where paclitaxel is solubilized in human serum albumin

nanoparticles, Cynviloq™ utilizes a proprietary, non-biologic, chemical polymeric-micellar

nanoparticles to solubilize paclitaxel. Particle dissociation studies have shown that both

highly unstable nanoparticles formulations rapidly disintegrate at physiologic

concentrations (when the drugs are administered intravenously, for example) to release

the cytotoxic payload. Once released into the bloodstream, paclitaxel binds to patient

albumin and preferentially enters into the tumor via the gp60/caveolae transcytosis

pathway. Human PK studies and simulation analyses show that both distinct formulations

are bioequivalent at the approved Abraxane® paclitaxel dose range of 100-260 mg/m2

paclitaxel.

STI plans to exploit an abbreviated and simplified 505(b)(2) NDA submission process on

the basis of bioequivalence versus Abraxane® to get Cynviloq™ to market quickly and at

minimal cost. With this potential approval, STI should be able to launch Cynviloq™ in MBC

and NSCLC indications in H1, 2016. In addition, a supplemental NDA, through a Phase III

registration trial in 2nd line bladder cancer, is planned to start in early 2014. Approval in

bladder cancer, an indication in which Abraxane® is not approved for, will allow Sorrento

to differentiate Cynviloq™ commercially and clinically from Abraxane® and will add

significantly to Sorrento’s revenue streams. Peak year sales for Cynviloq™ for these 3

indications (MBC, NSCLC and bladder cancer) are estimated at over $600M in the United

States alone.

Cynviloq™ is already approved in South Korea as well as other countries where it is

branded as Genexol-PM® and approved for MBC, NSCLC and ovarian cancer. Cynviloq™

has been tested in almost a thousand patients in the US, Russia and Korea in Phase I and

II clinical trials in MBC, NSCLC, ovarian, pancreatic and bladder cancer. Cynviloq™ has

shown comparable clinical activity with historical Abraxane® clinical data in MBC, NSCLC

and ovarian cancer. An open randomized Phase III study in patients with recurrent or

advanced MBC in South Korea showed statistically significant improvement in ORR with

Cynviloq™ administered at 260mg/m2 once every 3 weeks (q3w) versus Cremophor-

paclitaxel (known in US as Taxol®) given at the standard 175 mg/m2 q3w dose. The

superior ORR of Cynviloq™ versus that of Taxol® is comparable with historic data from a

pivotal registration studies submitted for Abraxane® that was the basis for Abraxane®’s

approval in the United States and China in the MBC indication.

Cynviloq™ is well differentiated from its closest competitor, Abraxane® through its

chemical polymer-based, non-biologic formulation which allows for (1) higher MTD of

>300 mg/m2 paclitaxel q3w, as shown in Phase I studies (versus MTD of 175 mg/m2 &

260 mg/m2 paclitaxel doses with Taxol® and Abraxane®, respectively), (2) convenience

through ease of handling versus a biologic formulation, and (3) avoidance of serious

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© 2013 Frost & Sullivan 3 “We Accelerate Growth”

safety issues (prion/viral transmission, etc.) associated with human serum albumin (HSA)

(used for the Abraxane® formulation). Regulatory differentiation will also be achieved

through strategic life cycle management such as label expansion in indications where

Abraxane® is not approved.

STI has access a portable Therapeutic Drug Monitoring (TDM) device that will allow for

personalized paclitaxel therapy with Cynviloq™.

Accelerated time to market with well-defined regulatory/development

strategy: Developing a new product can take almost a decade and cost hundreds of

millions of dollars. Through the FDA 505(b)(2) application process, companies can obtain

FDA approval of new drug applications (NDAs) for reformulations of drugs with the same

active ingredient that is a generic compound with a novel formulation for example, generic

compound paclitaxel, the common active ingredient for both Abraxane® or Taxol®, by

relying, in part, on the agency’s findings for a previously approved but different

formulation, avoiding costly and time consuming clinical trials. According to Section

505(b)(2) guidelines, an NDA approval can be obtained by referencing previously

approved listed drug compounds for safety and efficacy, i.e. both Taxol® and Abraxane®

formulations. In cases where different formulations of the same drug compound are found

to be bioequivalent, a straightforward bioequivalence trial comparing key pharmacokinetic

parameters (i.e., Cmax and AUC) of both formulations may be sufficient to gain FDA

approval.

Human pharmacokinetic (PK) studies and simulation analyses show Abraxane® and

Cynviloq™ formulations to be bioequivalent at the Abraxane® formulation approved

paclitaxel doses of 100-260 mg/m2. This falls within FDA defined criteria for establishing

bioequivalence, (that is 90% confidence intervals for AUCinf and Cmax (total parent

compound) and is within 80-125% of referenced listed drug. Particle dissociation studies

have shown that both formulations are different in the vial in powder form, upon

reconstitution and intravenous administration, both drugs disintegrate within seconds and

distribute the active drug paclitaxel to plasma proteins. Therefore, in the human

circulation, both drugs possess virtually identical PK profiles.

In the third quarter of 2013, STI/Igdrasol will meet with the FDA to discuss Cynviloq’s

clinical development program (“End of Phase 2 Meeting”) to obtain FDA concurrence for

proceeding with 505(b)(2) filings. A single bioequivalence (BE) trial is planned to treat

MBC patients with Abraxane® in a first cycle and with Cynviloq™ (or vice versa) in the

next cycle in a cross-over trial designed to use the patients as their own controls to

measure the pharmacokinetic parameters between the two drug formulations and

establish bioequivalence. A BE trial allows for a relatively small study patient population

and short treatment period (two 3-weekly cycles). The BE study can be completed

relatively quickly (approximately one year study from recruitment to completion) and at

an estimated cost of less than $4M. An NDA filing (under 505(b)(2)) is expected by the

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© 2013 Frost & Sullivan 4 “We Accelerate Growth”

first half of 2015 with approval anticipated in the first half of 2016. If the 2 drug

formulation (Cynviloq™ and Abraxane®) are bioequivalent, approval is often granted.

Cynviloq™ will receive the same label indications as Abraxane®, including MBC and

NSCLC, plus all future indications for which Abraxane® may be approved for, such as

advanced pancreatic cancer (upon expiration of marketing exclusivity). A Phase III

registration trial in 2nd line bladder versus best supportive care is also planned for

separate supplemental NDA application if Cynviloq™ is approved under 505(b)(2) or a

stand-alone NDA application in the absence of bioequivalent 505(b)(2) FDA approval.

Either way, approval is targeted first half of 2017.

First step towards true personalized chemotherapy: STI/Igdrasol is also

developing a portable Therapeutic Drug Monitoring (TDM) device that will allow clinicians

and patients to measure blood paclitaxel drug concentrations easily in the clinic or at

home. This allows for optimal Cynviloq™ dose titration for each individual patient.

Incorporating TDM into Cynviloq™ will allow for personalized dosing to (1) expand the

therapeutic window, and (2) balance maximum efficacy versus tolerability. TDM will

enhance commercial viability and competitiveness of Cynviloq™ versus other

chemotherapy agents.

Cynviloq™ chemical polymer patent provides US product protection until 2028 and

STI/Igdrasol believes that it is non-infringing on Abraxane® biologic polymer patents. In

addition, incorporation of the TDM device will allow extension in the IP of the product

beyond 2028.

Highly experienced management team: With the acquisition of Igdrasol, STI also

brought in significant expertise in the area of nanomedicine, clinical development,

regulatory and commercial know-how. The key persons behind the approval and launch of

Abraxane® are now leading the development and commercial efforts. These skills

complement STI’s expertise in drug discovery and research.

Key Industry Challenges Addressed by a Diverse mAb (fully human monoclonal

antibody) Library and Drug Conjugation Process

The number of therapeutic drug targets of interest for novel therapies is in the thousands.

For this reason, Frost & Sullivan feels that it is quite important to have an antibody library

with the diversity needed to develop therapies for drug targets with the highest potential for

clinical development success. The biotech industry is also crowded with many competitors;

therefore, Frost & Sullivan notes that differentiation and fast developmental turnaround

time are paramount, starting with the conception of novel therapies.

The ability to generate fully human mAbs has become a necessity, as humanized and

chimeric mAbs are being marketed as outdated mAbs with potential greater immunogenicity

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© 2013 Frost & Sullivan 5 “We Accelerate Growth”

concerns. The traditional approach of targeting and inhibiting cellular signals implicated in

the immune cascade of various diseases has led to fruitful success. However, in certain

instances, inhibiting a drug target is just the beginning. A new approach of targeting and

killing cells with an antibody linked to a cytotoxic agent, so-called “antibody drug conjugate”

(ADC), is an increasing trend in the development of novel therapies. A high degree of

expertise is also required to select antibodies against difficult target antigens, such as

G protein-coupled receptors (GPCRs), which are the target for ~40% of all FDA-approved

drugs, with high specificity and potency. Lastly, there are geographic challenges that can

create barriers to entry for companies into overseas markets.

The diversity of Sorrento’s fully human G-MAB® antibody library enables efficient

developmental turnaround for an almost limitless numbers of drug targets, through the use

of Sorrento’s proprietary G-MAB® library technology. Currently, Sorrento has multiple fully

human mAbs in preclinical development against promising targets, such as PD-L1, PD-1,

CCR2, CXCR3, EGFR, VEGFR2, c-Met, ErbB3, CXCR5, and others. In the future, Frost &

Sullivan expects that this diverse platform will enable Sorrento to be an innovative industry

leader in the development of novel biologics and to improve currently existing biologics.

As one example, PD-L1/PD-1 are thought to be some of the most promising future drug

targets in oncology and are being pursued by industry behemoths such as BMS,

Roche/Genentech, and Merck. The mAbs against PD-L1, CTLA-4, PD-1 targets are projected

to be an important immunotherapy drug class in the fight against cancer. This class of

immunotherapy mAbs may approach $35 billion market potential in the next 10 years as

projected by a Citibank analyst. Sorrento was able to quickly identify and develop fully

human mAbs targeting PD-L1 as well as PD-1, which exhibit higher in vitro potency than the

competitors’ lead compounds targeting PD-L1 or PD-1. This nicely positions Sorrento on the

forefront of oncology drug development.

Another challenging area in which Sorrento provides solutions is the development of

antibody formulated drug conjugates (AfDC) as the next generation of antibody drug

conjugates (ADC). An emerging market is in place with the recent FDA approval of the two

ADC drugs: the Adcetris™ from Seattle Genetics and Kadcyla™ from Roche/Genentech and

ImmunoGen. Kadcyla™ is a Herceptin®-DM1 conjugate with potential peak sales of $6

billion. AfDC provides multiple oncolytic small molecule drugs as payload and with multiple

mAbs as targeting moieties. The ability to link a targeted antibody with a cytotoxic drug

conjugate provides a promising approach to increase the efficacy of already targeted

approaches - such as Her2 and EGFR antibodies - and novel future drug targets. Sorrento is

currently working on next generation AfDC versions of Herceptin® and Erbitux® by linking

proprietary Sorrento mAbs with stable nanoparticles containing paclitaxel or other oncolytic

drugs. The addition of a cytotoxic conjugate holds the promise to increase efficacy in breast,

colorectal, and lung cancer. The Phase I/IIa proof of concept study is due to initiate as early

as 2015. The opportunity here is the recent acquisition of TOCOSOL®-Paclitaxel asset

(TOCOSOL®-PAC) from OncoGenex Pharmaceuticals. Learning from the clinical development

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© 2013 Frost & Sullivan 6 “We Accelerate Growth”

of TOCOSOL® – a stable paclitaxel nanoparticle- and the clinical development of Abraxane®

- an unstable paclitaxel nanoparticle- the STI/Igdrasol team has defined pitfalls for stable

targeted nanoparticle. Using its proprietary algorithm to define a functional targeted

paclitaxel nanoparticle, STI/Igdrasol is poised to launch a platform poised to garner large

Pharma interest.

Another important challenge that Sorrento is able to overcome are limits on geographic

outreach. The corporate HQ for Sorrento is based in San Diego, California and very few of

the company's peers in the US are able to successfully develop their pipeline on the global

scale. The company has successfully established a China presence with an office in Hong

Kong. Sorrento is also adding to their global late-stage clinical and regulatory expertise with

the FDA, EMEA, sFDA, and KIKO through the addition of the Igdrasol team.

Key Benchmarking Criteria for Investment Opportunity Award

For the Investment Opportunity Award, the following criteria were used to benchmark

Sorrento Therapeutics’ performance against key competitors: • Strength of Intellectual Property

• Experience and Expertise of Management Team (successful track record,

ability to execute, industry experience)

• Funding History, Strength and Quality of Other Investors

• Market Growth and Positioning

• Product Differentiation Capabilities

• Expansion Strategy

Decision Support Matrix and Measurement Criteria

To support its evaluation of best practices across multiple business performance categories,

Frost & Sullivan employs a customized Decision Support Matrix (DSM). The DSM is an

analytical tool that compares companies’ performance relative to each other with an

integration of quantitative and qualitative metrics. The DSM features criteria unique to each

Award category and ranks importance by assigning weights to each criterion. The relative

weighting reflects current market conditions and illustrates the associated importance of

each criterion according to Frost & Sullivan. Fundamentally, each DSM is distinct for each

market and Award category. The DSM allows our research and consulting teams to

objectively analyze each company's performance on each criterion relative to its top

competitors and assign performance ratings on that basis. The DSM follows a 10-point scale

that allows for nuances in performance evaluation; ratings guidelines are shown in Chart 2.

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© 2013 Frost & Sullivan

Chart 2: Performance-Based

This exercise encompasses all criteria, leading to a weighted average ranking of each

company. Researchers can then

final step, the research team confirm

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

overall relative rankings of the companies.

Chart 3: Frost & Sullivan

Recipients

Best Practice Award Analysis for Sorrento Therapeutics

The Decision Support Matrix, shown in

criterion for the Investment Opportunity Award and the ratings for each company under

evaluation. To remain unbiased while also protecting the interests of the

organizations reviewed, we have chosen to refer to the other key players as Competitor 1

and Competitor 2.

BEST PRACTICES RESEA

7 “We Accelerate Growth”

ased Ratings for Decision Support Matrix

all criteria, leading to a weighted average ranking of each

. Researchers can then easily identify the company with the highest ranking.

final step, the research team confirms the veracity of the model by ensuring that small

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

overall relative rankings of the companies.

t & Sullivan’s 10-Step Process for Identifying

est Practice Award Analysis for Sorrento Therapeutics, Inc.

The Decision Support Matrix, shown in Chart 4, illustrates the relative importance of each

criterion for the Investment Opportunity Award and the ratings for each company under

evaluation. To remain unbiased while also protecting the interests of the

organizations reviewed, we have chosen to refer to the other key players as Competitor 1

BEST PRACTICES RESEARCH

“We Accelerate Growth”

ecision Support Matrix

all criteria, leading to a weighted average ranking of each

identify the company with the highest ranking. As a

by ensuring that small

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

Identifying Award

Inc.

4, illustrates the relative importance of each

criterion for the Investment Opportunity Award and the ratings for each company under

evaluation. To remain unbiased while also protecting the interests of the other

organizations reviewed, we have chosen to refer to the other key players as Competitor 1

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© 2013 Frost & Sullivan 8 “We Accelerate Growth”

Chart 4: Decision Support Matrix for the

Investment Opportunity Award

Measurement of 1–10 (1 = lowest; 10 = highest) Award Criteria

Strength

of

Intellectual

Property

Experience and Expertise of

Management Team

Funding History,

Strength

and

Quality

of

Other

Investors

Market

Growth

and

Positioning

Product

Differentiation

Capabilities

Expansion Strategy

Weighted Rating

Relative Weight (%) 25% 15% 15% 15% 15% 15% 100%

Sorrento Therapeutics, Inc. 9.9 9.8 9.8 9.5 9.8 9.8 9.8

Competitor 1 9.9 7.5 7.0 7.0 7.0 7.0 7.8

Competitor 2 9.9 7.0 7.5 7.0 7.0 6.5 7.7

Criterion 1: Strength of Intellectual Property

Intellectual property is paramount to a drug’s success. Intellectual property rights protect

novel therapeutics from competitive entry, and the duration of protection may be as long as

18 years. Drug companies file patents for innovative compounds in order to block

competitors from entering the market. The strength of the patent is of high importance in

order to prevent competitors from creating ‘me too’ or generic products.

Sorrento has an extensive patent portfolio enabling the development of next generation

targeted therapeutics and nanomedicines. The portfolio includes issued and filed patents for

TOCOSOL®-PAC, Cynviloq™, recombinant intravenous immunoglobulin (rIVIG), and G-

MAB® library and its derived mAbs as well as their groundbreaking platform technologies

such as AfDC. The lead Cynviloq™ product candidate is patent protected worldwide till 2028.

These patents will provide Sorrento with the necessary protection to prevent competitors

from using similar processes to create competitive therapeutics. Intellectual property is a

business component which almost all companies have best in class business practices; thus,

this is a difficult area in which to differentiate.

Criterion 2: Experience and Expertise of Management Team (successful track

record, ability to execute, industry experience)

The management team of a company guides the success of a company. Development of

products is integral to a company’s success, but without proper management, valuable

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products are unlikely to reach their full market potential. Management is also responsible for

hiring and forming the right team to drive success.

Frost & Sullivan firmly believes that Sorrento has an industry leading management team

with an impressive track record of long term visions and timely execution. STI’s President

and Chief Executive Officer is also a co-founder of Sorrento and the inventor of the G-MAB®

library technology. The Chief Business Officer and Chief Financial Officer have impressive

track records in the biopharmaceutical space and most recently were jointly involved in the

$430 million acquisition of Elevation Pharmaceuticals, Inc. by Sunovion Pharmaceuticals,

Inc., a transaction ranked as a top 10 US venture backed acquisitions in 2012 by the Wall

Street Journal. The Chief Scientific Officer and Chief Commercial Officer were instrumental

in the invention, development, approval, and commercialization of Abraxane®, a highly

successful oncology therapeutic. Other competitors lack a management team with such

extensive expertise and experience to bring potential multi-billion dollar therapeutics to the

market.

Criterion 3: Funding History, Strength and Quality of Other Investors

The cost of bringing a pharmaceutical drug to market can be in the range of $100s of

millions. Novel therapies require Phase III studies, with upwards of thousands of patients

participating in order to establish the risk/benefit of a therapy. There are also indirect costs

associated with drug development, such as failures of other drugs in the company portfolio,

which weigh on successful compounds in the portfolio. Due to this costly development

process, securing proper funding to conduct clinical trials is of utmost importance.

STI is unique in its ability to have potentially an approved oncology product within the next

few years using an abbreviated 505(b)(2) BE pathway that is a fraction of what is needed

by traditional drug development companies. Partnership with large pharma could also

accelerate its development program as well as broaden its portfolio into inflammation and

infectious diseases. Access to the public investment market due to the fact that it is a

publicly traded company is a plus, however, given the near term revenue generation

potential of Cynviloq™ - it is likely that shareholder dilution will be constrained.

Frost & Sullivan independent analysis confirms that other competitors to Sorrento lack a

near-term approvable therapy which may be able to generate revenues in the next 3 to 4

year time window.

Criterion 4: Market Growth and Positioning

Market growth is driven by targeting therapeutic areas with an unmet need. In order to

garner market uptake, products must be positioned with compelling clinical data in order to

justify usage among physicians and patients.

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Sorrento is selecting antibody candidates that have immense market potential, such as

PD-L1, PD-1 and G protein-coupled receptor (GPCR) antibodies for targeted therapy in

oncology, and is also improving upon already approved therapies through their proprietary

antibody formulated drug conjugate (AfDC) process. This enables Sorrento to capitalize on

the familiarity and success of predecessors, such as Herceptin® or Erbitux®, while

competitors are developing therapies from scratch, thus creating greater difficulty in

establishing familiarity.

Acquisition of the late-stage asset, Cynviloq™ allows STI to become a commercial stage

company by 2016. Cynviloq™, based on conservative estimates, can realize sales upwards

of $500M in the United States alone. STI/Igdrasol also controls EU rights which allow STI

the flexibility to strike alliances/collaborations with multinational companies seeking to get

their hands on a late-stage drug to fill in a gap in their pipeline.

In addition, STI is moving forward in the field of true personalized medicine with the

development of TDM (Therapeutic Drug Monitoring) which will complement and expand the

Cynviloq™ franchise in the market.

Criterion 5: Product Differentiation Capabilities

The pharmaceutical industry is crowded with many branded and generic treatment options

for oncology. In order to successfully enter the market with a new therapy, proper

differentiation must be established during the planning of product positioning in order to

remain competitive.

Sorrento is on the forefront of developing mAbs with formulated drug conjugation to

cytotoxic agents, such as paclitaxel. Other competitors benchmarked by Frost & Sullivan

against Sorrento either do not have the capabilities to generate drug conjugates with

cytotoxic agents, or are using cytotoxic agents that lack the familiarity of paclitaxel.

Additionally, STI/Igdrasol is leveraging its personalized dosing approach to differentiate

itself from other pharmaceutical companies. STI/Igdrasol is moving forward in the field of

true personalized medicine with development of TDM which will complement and expand the

Cynviloq™ oncology franchise in the market. This unique concept will be the next evolution

in oncolytic therapy, which STI/Igdrasol is pioneering. This in the long run would give it the

“first mover” advantage.

Criterion 6: Expansion Strategy

The expansion strategy of pharmaceutical companies hinges on successful clinical

development. Early stage companies typically focus on developing promising agents from

pre-clinical through Phase II development. Progression into Phase III development is a

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much higher expense in contrast to Phase II development, and global Phase III studies

typically require enrolling patients from multiple geographical locations.

Sorrento possesses the proper funding to solely develop pipeline candidates through

registration trials for Cynviloq™ and Phase II development for its mAbs and AfDC product

candidates. However, Sorrento is focused on attracting a partner to develop their pipeline

beyond Phase II, a strategy similar to competitors. Sorrento clearly differentiates from

competitors based on their ability to run global clinical studies and attract global partners.

Conclusion

The pharmaceutical industry is crowded with many early stage competitors aiming to

develop mAbs or other novel therapeutics in oncology. Sorrento Therapeutics is definitely

able to differentiate themselves from the competition through their novel AfDC process,

which may produce targeted cytotoxic agents with familiar agents and drug targets, such as

Her2 with paclitaxel. The Company's diverse mAb library, experienced management team,

secure cash position, and superior ability to select and rapidly develop promising drug

targets, such as Cynviloq™, fully human anti-PD-L1 and anti-PD-1 mAbs in oncology, make

Sorrento Therapeutics the rightful recipient of the 2013 Frost & Sullivan Global Investment

Opportunity Award.

Notes:

Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is a

trademark of Celgene; Taxol® (paclitaxel) is a trademark of BMS, Herceptin® (trastuzumab) is a

trademark of Roche/Genentech, Erbitux® (cetuximab) is a trademark of Eli Lilly/Imclone, Genexol-

PM® is a trademark of Samyang, , Adcetris™ is trademarked by Seattle Genetics, Kadcyla™ is

trademarked by Roche/Genentech, TOCOSOL® and G-MAB® are a trademarks of Sorrento

Therapeutics, and CynviloqTM is trademarked by Igdrasol.

The CEO 360-Degree PerspectiveTM

- Visionary Platform for Growth

Strategies

The CEO 360-Degree Perspective™ model provides a clear illustration of the complex

business universe in which CEOs and their management teams live today. It represents

the foundation of Frost & Sullivan's global research organization and provides the basis on

which companies can gain a visionary and strategic understanding of the market. The CEO

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The CEO 360-Degree Perspective™ model enables our clients to gain a comprehensive,

action-oriented understanding of market evolution and its implications for their companies’

growth strategies. As illustrated in Chart 5 below, the following six-step process outlines

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BEST PRACTICES RESEARCH

© 2013 Frost & Sullivan 12 “We Accelerate Growth”

how our researchers and consultants embed the CEO 360-Degree Perspective™ into their

analyses and recommendations.

Chart 5: The CEO's 360-Degree Perspective™ Model

Critical Importance of TEAM Research

Frost & Sullivan’s TEAM Research methodology represents the analytical rigor of our

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integrating all seven of Frost & Sullivan's research methodologies. Our experience has

shown over the years that companies too often make important growth decisions based on

a narrow understanding of their environment, leading to errors of both omission and

commission. Frost & Sullivan contends that successful growth strategies are founded on a

thorough understanding of market, technical, economic, financial, customer, best

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BEST PRACTICES RESEARCH

© 2013 Frost & Sullivan 13 “We Accelerate Growth”

practices, and demographic analyses. In that vein, the letters T, E, A and M reflect our

core technical, economic, applied (financial and best practices) and market analyses. The

integration of these research disciplines into the TEAM Research methodology provides an

evaluation platform for benchmarking industry players and for creating high-potential

growth strategies for our clients.

Chart 6: Benchmarking Performance with TEAM Research

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