3D Signatures Inc. Announces Successful Scoring Model Development and Analytical Validation of the Telo-HL(TM) Test for Hodgkin’s Lymphoma

TORONTO, April 03, 2018 (GLOBE NEWSWIRE) — 3D Signa­­­­­­tures Inc. (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS“), a personalized medicine company with a proprietary software platform (TeloView^TM) based on the three-dimensional analysis of chromosomal signatures, is pleased to announce the successful and on-time development of the scoring model for Telo-HL^TM, the Company’s lead test for Hodgkin’s lymphoma (“HL”), as well as completion of an analytical validation study to confirm the reproducibility of its Telo-HL^TM test.

Powered by the Company’s proprietary TeloView^TM platform, Telo-HL^TM is a predictive test performed on diagnostic lymph node biopsy specimens, intended to provide clinicians with the first biomarker capable of identifying the 15% – 20% of HL patients who will fail standard ABVD chemotherapy, and who should immediately be considered for more advanced treatment or inclusion into clinical trials with an emerging immunotherapy.

The study data from the Company’s multi-parametric telomeric analysis with TeloView^TM was analyzed by an independent statistical provider, BioStat Solutions Inc. (“BSSI”), to develop the Telo-HL^TM scoring model from over 200 potential predictors that included different combinations of the telomeric nuclear organization, cell type, and clinical parameters. BSSI identified that a combination of at least three of the parameters analyzed by TeloView^TM contributed to the scoring model with highly predictive characteristics. This included measures unique to 3DS’s platform, which can only be evaluated through three-dimensional analysis of telomeres, and for which current clinical data alone is insufficient to predict risk of relapse.

In addition, the Company reports it has successfully run an internal analytical validation of the test by processing and analyzing, in triplicate, archived samples from the same patients. This important step demonstrates the consistency of the Telo-HL^TM test and reproducibility of TeloView^TM results under a variety of conditions.

“In keeping with best practices, external scientific peer-review is now essential to confirm our own evaluation of Telo-HL^TM’s strong performance and reproducibility,” notes Dr. Kevin Little, CSO of 3DS. “The detailed findings will be submitted as quickly as possible for presentation in clinician meetings, and then publication in a top-level clinical journal in the latter half of 2018. This will build awareness with key opinion leaders and pharmaceutical companies that Telo-HL^TM is ready and available to be incorporated into clinical trials as a correlative biomarker alongside new therapeutic interventions.”

“This is the most significant accomplishment for the Company yet, and I congratulate everyone involved for achieving this critical milestone as per our plan,” commented Jason Flowerday, CEO of 3DS. “This highly successful study is an important culmination of the work by Dr. Sabine Mai and the 3DS team, to develop the first clinically-compliant and validated test based on telomeric profiling, which can uniquely inform treatment decisions in Hodgkin’s lymphoma. Telo-HL^TM represents a critical proof-of-principle for the Company’s TeloView^TM platform that we believe may establish an entirely new clinical paradigm for genome organization, and accelerate the development of our broader platform of TeloView^TM-based tests in prostate cancer, lung cancer and multiple myeloma.”

About 3DS

3DS (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) is a personalized medicine company with a proprietary software platform, TeloView, that is designed to predict the course of certain diseases and to tailor treatment options for the individual patient. The technology is based on the three-dimensional analysis of telomeres, the protective caps at the ends of chromosomes. 3DS’ TeloView software platform measures the organization of the genome and its correspondence to; the stage of a given disease, the rate of progression of the disease, how different diseases will respond to various therapies, and a drug’s efficacy and toxicity. 3DS’ proprietary imaging software is designed to go beyond identifying whether a patient suffers from a specific disease or condition. Instead, the TeloView^TM platform is designed to inform clinicians and patients with respect to how to personalize treatment and best manage an individual’s disease based on their unique TeloView Score^TM. As healthcare moves increasingly toward better informed, patient-centric approaches, the Company intends for the TeloView^TM platform to deliver personalized medicine that allows for better treatments, leading to better outcomes.

The TeloView^TM platform is supported by 25 clinical studies involving more than 3,000 patients and 20 different cancers, plus Alzheimer’s disease. 3DS benefits from twenty years of research, $25M of non-dilutive investment into its platform and more than 130 supporting publications, and holds a portfolio of patents related to three-dimensional telomere analysis for proliferative diseases, including (but not limited to) hematological disorders such as Hodgkin’s lymphoma, multiple myeloma, and chronic myeloid leukemia. 3DS’ intellectual property portfolio also covers prostate cancer, breast cancer, lung cancer, melanoma, colorectal cancer, and Alzheimer’s disease.

For more information, visit the Company’s website at: https://ift.tt/2k1KFjY.

For further information, please contact:

Jason Flowerday
CEO & Director
416-673-8487
investors@3dsignatures.com

Cautionary Note Regarding Forward-Looking Statements

This news release contains forward-looking statements which constitute “forward-looking information” within the meaning of applicable Canadian securities legislation (“Forward Looking Statements”).  All statements included herein, other than statements of historical fact, are Forward-Looking Statements and are subject to a variety of known and unknown risks and uncertainties which could cause actual events or results to differ materially from those reflected in the Forward-Looking Statements. Often, but not always, these Forward-Looking Statements can be identified by the use of words such as “estimates”, “potential”, “open”, “future”, “assumes”, “projects”, “anticipates”, “believes”, “may”, “continues”, “expects”, “plans”, “will”, “to be”, or statements that events “could” or “should” occur or be achieved, and similar expressions, including negative variations. Statements with respect to 3DS’ scoring model for its Telo-HL^TM test, validation of TeloView^TM, peer-review and publication of its findings and establishing a new clinical paradigm for genome organization, among others, are Forward-Looking statements.

Such Forward-Looking Statements reflect the Company’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by 3DS as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many risk factors could cause the Company’s actual results, performance, achievements, prospects or opportunities to be materially different from any future results, performance or achievements that may be expressed or implied by such Forward-Looking Statements, including risks related to the failure of 3DS’ scoring model for its Telo-HL^TM test and its analytical validation; the risk that the Telo-HL^TM test may not be commercially launched as an LDT or for research use by the first quarter of 2018, or at all; risks that its study results or scoring model may not be peer-reviewed or accepted for publication or presentation; uncertainties related to 3DS’ clinical studies and test development; risks related to the volatility of the price of 3DS’ common shares; risks related to the possibility that 3DS’ shareholders may experience dilution; risks related to 3DS’ requirements for additional financing and future access to capital, including the risk that the proceeds raised under the Private Placement may be insufficient to finance 3DS’ business objectives; the risk that a positive return on an investment in 3DS’ common shares is not guaranteed; risks related to 3DS’ intention to retain earnings and not pay cash dividends on its common shares in the foreseeable future; risks related to 3DS’ early stage of development; the risk that 3DS’ tests will not be successfully deployed; risks related to 3DS’ dependence on third parties, including collaborative partners, licensors and others; risks related to 3DS’ clinical study recruitment; that there is currently no market for 3DS’ products and that such market may be slow to develop if at all; risks related to 3DS’ reliance on key personnel; risks related to the competitive nature of the biotechnology industry; risks related to 3DS’ limited operating history, lack of revenue, history of losses and inability to assure that it will earn profits in the future or that profitability will be sustained; risks related to government regulation; risks related to rapid technological change; risks related to the fact that 3DS’ software may now or in the future contain undetected errors, bugs or vulnerabilities; the risk that 3DS or its directors and officers may be subject to a variety of civil or other legal proceedings, with or without merit, including product liability claims; risks related to the protection of 3DS’ intellectual property rights; risks related to 3DS’ limited sales, marketing and distribution experience; risks related to the possibility that 3DS’ directors and officers may be placed in a conflict of interest as a result of their employment or affiliation with third parties, risks related to 3DS’ use and storage of personal information and compliance with applicable privacy laws, as well as those risks discussed under the heading “Risk Factors” in the Company’s annual management’s discussion and analysis dated October 23, 2017 and filed on SEDAR. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in the Forward-Looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.

In making the Forward-Looking Statements, the Company has made various material assumptions including, but not limited to, 3DS’ scoring model for its Telo-HL^TM test, internal validation of TeloView^TM, peer-review and publication of its findings and establishing a new clinical paradigm for genome organization all being successful, obtaining positive results from 3DS’ current and planned clinical studies and research and development initiatives; that the Telo-HL^TM test will be commercially launched as an LDT or for research use by the first quarter of 2018; obtaining regulatory approvals with respect to 3DS’ clinical studies which are now ongoing or may in the future be commenced; 3DS’ ability to successfully develop its tests; assumptions regarding general business and economic conditions; that 3DS’ current positive relationship with third parties will be maintained; the availability of future financing on reasonable terms; 3DS’ ability to attract and retain skilled staff; assumptions regarding market competition and the products and technology offered by 3DS’ competitors; and 3DS’ ability to protect patents and proprietary rights.

3DS believes that the assumptions and expectations reflected in the Forward-Looking Statements in this press release are reasonable, but no assurance can be given that these expectations will prove to be correct. Forward-Looking Statements should not be unduly relied upon. This information speaks only as of the date of this press release, and 3DS will not necessarily update this information, unless required to do so by securities laws.  

Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Understanding Validation and Technical Transfer, Part I

EtiAmmos/Shutterstock.comMany new biological entities use unique processing flows and steps that can require non-traditional thinking about process validation. Large-molecule drug products and attendant manufacturing processes often involve complex syntheses and purification steps that differ substantially from those employed for small-molecule pharmaceutical products. In fact, it has been said that for biotechnology products, “The product is the process.” Traditional small-molecule drug products have well-defined chemical structures and can be analyzed to ensure conformance to specifications. Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore, the manufacturing and purification processes become critically important in ensuring the “sameness,” quality, efficacy, and safety of these products.

Process validation is documented process understanding and control that begins when it is determined that a cell, molecule, or compound may have clinical significance and ends when the product is no longer viable in the marketplace. Each product and process may have different validation formats and structures and may not fit the traditional validation models. Validation requires careful thought and planning. It is not a stack of protocols and reports designed to satisfy regulatory expectations. It is not following by rote a series of “qualifications” such as design (DQ), installation (IQ), operational (OQ), and performance qualification (PQ) studies. It is not hiring a validation company to develop the protocols, perform the studies, and write the reports. 

A brief history

The need for formal process validation became evident following a series of incidents beginning in the early 1960s. Thalidomide, a widely prescribed drug for morning sickness in pregnancy, was determined to have caused birth defects, leading to the 1962 Kefauver-Harris Amendment to the US Federal Food, Drug, and Cosmetic Act, which among other provisions, authorized FDA to issue good manufacturing practice (GMP) regulations for “manufacturing, packaging, or holding of finished pharmaceuticals.” Those regulations were finalized in 1963 as 21 Code of Federal Regulations (CFR) 133 “Drugs; Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding” (1).

During the period 1966-1972, a series of incidents at Evans Medical Ltd., Liverpool, England, led to the deaths of five people due to microbially contaminated infusion fluids. The contamination was found to be due to problems with the autoclaves used to process terminally sterilized parenterals (2).

From 1970-1973, a series of septicemia events in hospitals throughout the United States due to contaminated IV fluids were linked to inadequate container-closure systems and terminal sterilization conditions for large-volume parenterals (LVPs) produced by several manufacturers. Following a series of inspections, FDA questioned the manufacturers’ ability to ensure sterility of these products, leading to the promulgation of GMP regulations for LVPs in 1976 (3). Although the LVP GMP regulations were never finalized and were ultimately withdrawn, they established formalized requirements for the validation and monitoring of critical processes such as sterilization.

When the US GMP regulations underwent a major revision in 1978, validation requirements for sterilization processes were included (4). Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals are safe and effective.

 

In May 1987, FDA issued a draft process validation guidance document for comment (5). That draft guidance was followed by two more, one in 2008 (6) and one in 2011 (7). Each of these guidance documents was intended to clarify FDA’s expectations regarding process validation.

The International Council for Harmonization (ICH), an organization composed of regulatory authorities from the US, Europe, Japan, Canada, Switzerland, Brazil, China, and the Republic of Korea, and representatives of pharmaceutical industry organizations, has published a series of documents that, among other things, relate to process validation: Q6B for setting specifications for biotechnological and biological products (8), Q7A for active pharmaceutical ingredients (9), Q8 for pharmaceutical process development (10), Q9 for quality risk management (11), Q10 for pharmaceutical quality systems (12), and Q11 for drug substance development and manufacture (13). 

In 2007, ASTM International published E2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment, which describes an alternative to conventional process validation (14).

The literature is full of references to process validation, and many of them seem to be contradictory. What is process validation, really? To understand this, we need to define “process” and “validation.”

“Process” defined

Process has been defined in a number of ways. One dictionary definition is “a particular method of doing something, generally involving a number of steps or operations” (15). Another definition is “a series of actions that you take to achieve a result” (16). However, these definitions do not adequately consider the factors influencing the operations, actions, and steps that constitute a process. Those factors include the processing system itself, the inputs that drive the system, and the system outputs.

Scherkenbach, a student of W. Edwards Deming, defines process broadly yet concisely.  “In its simplest form, a process is a blending or a transformation of inputs such as people, materials, equipment, methods, and environment into outcomes. Some of these inputs do the transforming and some of them are transformed” (17). This definition considers important process influences lacking in dictionary definitions. The keys to the effectiveness of this definition are the identified influences on the inputs and outputs. Those influences must be defined, evaluated, and controlled to ensure the process performs as intended.

Figure 1, based on Scherkenbach’s work, presents a process definition applicable to pharmaceutical and biopharmaceutical validation. Specifically, a process is inputs operating through a processing system to produce outputs. The inputs and outputs are influenced by people, material, equipment, procedures, and the environment in which they operate.

Figure 1. Process definition applicable to pharmaceutical and biopharmaceutical validation. (Figure courtesy of author)

 

 

 

 

 

 

 

Processes may be discrete or linked so that the output of one process becomes the input to another, or multiple process outputs may serve as inputs to another. For example, a drug substance is an input to a process that produces a drug product, along with other components that result from other processes. And the drug substance itself is likely the result of multiple process inputs and outputs.

 

“Validation” defined

Validation of pharmaceutical processes was codified in the mid-1970s. That does not mean that earlier pharmaceutical processes were not validated. Pharmaceutical manufacturers had quality control programs that ensured the robustness of their manufacturing processes and the quality of the pharmaceuticals they produced. However, the scope of those programs depended on individual manufacturers resulting in variable effectiveness. Codification of validation expectations and requirements was intended to reduce that variability.

The 1978 CGMP regulations (4) discussed validation in terms of automatic, mechanical, and electronic equipment (21 CFR § 211.68), validation of supplier’s test results for components, drug product containers, and closures (21 CFR § 211.84(d)(2)), and validation of any sterilization process (21 CFR § 211.113). However, the word validation was not explicitly defined.

FDA’s 1987 process validation guideline defined validation as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes” (5).

In 2000, ICH Q7A defined validation as, “A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria” (9). 

Process validation

The concepts presented in the definitions of validation and process can be combined to form a meaningful definition of process validation applicable to the production of pharmaceuticals and biopharmaceuticals. FDA’s 2008 draft process validation guidance document defined process validation as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products” (6).

 

The 2008 definition falls short in several areas, not the least of which is that the process is capable of delivering quality products instead of that it does deliver quality products—and does so consistently and reproducibly. Also, the term “quality products” is nebulous. Does quality relate to meeting regulatory requirements? Or, does it relate to product safety and efficacy?

ICH Q8(R2) provides an excellent description of process validation vis-à-vis product development (10).

Process validation, based on the combination of the definitions of the words process and validation, is establishing, documenting and verifying that the inputs, operating through the processing system, result in outputs that consistently meet pre-determined acceptance criteria and quality attributes. This definition is remarkably similar to FDA’s original 1987 definition of validation. In essence, process validation is documented process understanding.

Why validate?

Validation is necessary throughout a product’s lifecycle, from initial development through commercialization, to ensure it is safe and effective. The molecule originally identified as possibly having clinical significance must be fully characterized and its synthesis routes developed with the aim of scalability. Formulations to be used in clinical trials must be developed. The clinical formulations must be scalable to commercial production, retaining their effectiveness and safety attributes. Commercial production processes must be robust and reliable to ensure consistent product quality, maximize efficiency, and minimize cost. Process validation should—read must—begin at the very beginning to ensure the finished product can be manufactured and controlled to provide requisite levels of clinical effectiveness and patient safety. Products manufactured with validated processes almost invariably meet all regulatory expectations and quality requirements.

How to validate

Start by thinking about the goals: What is the purpose of the study; what should it show, or prove, or demonstrate? Successful validation efforts often follow the 80-20 rule—80% of the effort should be thinking, evaluating options, and planning, and 20% should be devoted to performing the study. This optimizes the chances of success. Often, however, the reverse percentages are employed, resulting in wasted resources and yielding validation reports that do little to support the effectiveness of the processes they were intended to validate.

A process consists of inputs operating through a processing system resulting in outputs. The inputs, outputs, and the processing system, are influenced by people, materials, equipment, procedures, and the environment in which the process operates. All of these things must be considered and evaluated before developing the validation strategy and writing the validation protocol. Each process is unique, and no validation approach is universally applicable. Validation of a purification process for monoclonal antibodies differs substantially from validation of a steam-sterilization process for a drug product in its final container. Terminal sterilization does not work as a model for validation of a pharmaceutical water system.

Commercial production processes must be robust and reliable to ensure consistent product quality, maximize efficiency, and minimize cost.

A few simple guidelines will help to simplify validation planning and execution:

• Define the inputs, the processing system, and the expected outputs.
• Don’t get bogged down in terminology.
• Define critical and non-critical process attributes and parameters.
• Use common sense.
• Demonstrate a state of control.

The second part of this three-part series will provide a generalized example intended to show how a validation plan might be developed to support a process unrelated to biopharmaceutical manufacture, but which demonstrates various points to consider related to the inputs, the processing system, and the outputs that can be applied to biopharmaceutical processes and systems. Part three will cover validation of a non-traditional biopharmaceutical process, and lifecycle and change management.

References

1. FDA, Drugs; Current Good Manufacturing Practice in Manufacture, Processing, Packing, or Holding. In 21 CFR 133, 28 Federal Register 6385, 1963.

2. B. R. Matthews, PDA J. Pharm. Sci. Technol. 56 (3), 137-149 (2002).

3. FDA, Current Good Manufacturing Practice in the Manufacture, Processing, Packing, or Holding of Large Volume Parenterals for Human Use. In 21 CFR 212, 41 Federal Register 22208, 1976.

4. FDA, Current Good Manufacturing Practice for Finished Pharmaceuticals, In 21 CFR 211, 43 Federal Register 45077, 1978.

5. FDA, Guideline on General Principles of Process Validation (CDER, Rockville, Maryland, 1987).

6. FDA, Guidance for Industry, Process Validation: General Principles and Practices Draft Guidance (CDER, Rockville, Maryland, 2008).

7. FDA, Guidance for Industry, Process Validation: General Principles and Practices (CDER, Rockville, Maryland, 2011).

8. ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, Geneva, Switzerland, 1999).

9. ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (ICH, Geneva, Switzerland, 2000).

10. ICH, Q8(R2) Pharmaceutical Development Revision 2 (Step 4 version)(ICH, Geneva, Switzerland, 2009).

11. ICH, Q9 Quality Risk Management (Step 4 version) (ICH, Geneva, Switzerland, 2005).

12. ICH, Q10 Pharmaceutical Quality System (Step 4 version) (ICH, Geneva, Switzerland, 2008).

13. ICH, Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (Step 4 version) (ICH, Geneva, Switzerland, 2012).

14. ASTM, E 2500, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (ASTM International: West Conshohocken, PA, 2007).

15. M. Agnes and D.B. Guralnik, Eds., Webster’s New World College Dictionary, Fourth Edition ed. (Wiley Publishing, Inc., Cleveland, Ohio, 2007).

16. Cambridge Dictionary, https://ift.tt/2Itqbdg (accessed March 10, 2018).

17. W. W. Scherkenbach, The Deming Route to Quality and Productivity Road Maps and Roadblocks, p. 145 (CEEPress Books, George Washington University: Washington, D.C., 1986).

Article Details

BioPharm International
Vol. 31, No. 4
April 2018
Pages: 26-30

Citation

When referring to this article, please cite it as R. Madsen, “Understanding Validation and Technical Transfer, Part I,” BioPharm International 31 (4) (2018).

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3D Signatures Inc. Announces Successful Scoring Model Development and Analytical Validation of the Telo-HL(TM) Test for Hodgkin’s Lymphoma

ATCC and BioAgilytix to host first ’Trends in Cell-Based Assays’ Forum

Shire Pharmaceuticals, Takeda Pharmaceuticals, Visterra, as well as the former senior advisor of Science Innovation and Policy for the Food and Drug Administration (FDA), will partner with ATCC and BioAgilytix to cover topics such as recent advances in the development of in vitro cell models, innovative technologies in antibody-drug conjugate assay development, and discuss the challenges in analytical method transfer in pharmaceuticals.

The forum is designed to benefit scientists currently working in the biopharmaceutical industry who want to improve their awareness of the latest advancements in cell-based assay development, and non-scientists who seek a better understanding of the processes, challenges, regulatory landscape, and opportunities in the industry.

“ATCC is pleased to partner with BioAgilytix to provide scientists with a unique opportunity to hear from some of the most respected and accomplished thought leaders in the discovery, development and commercialization life cycle of cell-based assay advancements,” said Dr. Maryellen de Mars, Vice President, Standards Resource Center, ATCC Global. “We believe this educational forum will generate quality discussions and give participants important access to the latest industry knowledge and key trends,” said Dr. de Mars.

About ATCC
ATCC is a leader in biological materials management, providing the worldwide scientific community and U.S. government with research and development, standardized products, and services in support of global health issues. With a history of innovation spanning more than 90 years, ATCC offers the world’s largest and most diverse collection of human and animal cell lines, microorganisms, biological products, and standards. ATCC is a non-profit organization with headquarters in Manassas, VA, and an R&D and services center in Gaithersburg, MD. For more information about ATCC, visit us at www.atcc.org.

About BIOAGILYTIX
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, GCP, and GCLP, as well as product release testing under GMP.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.

View full agenda online at www.atcc.org/forum

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CURE Pharmaceutical Reports Strong Progress and Sets Growth Roadmap for Remainder of Year

CURE Pharmaceutical Reports Strong Progress and Sets Growth Roadmap for Remainder of Year

Tuesday, April 3, 2018 12:57 PM UTC

OXNARD, Calif., April 03, 2018 — CURE Pharmaceutical (OTC:CURR), an innovative drug delivery company, today reported the company’s Q1 2018 accomplishments. The company strengthened its leadership team with biopharmaceutical expertise, secured additional financing, and boosted nutraceutical product distribution, while advancing towards the launch of its first pharmaceutical CUREfilm product.

“We see solid growth this quarter that offers a strong jumping off point for the year ahead,” said Rob Davidson, CEO CURE Pharmaceutical. “We are already seeing benefits from the additional operational and manufacturing talent that has streamlined manufacturing to support growth in production. Each step is vital to our company’s growth to make medications easier to take, more efficient, and with fewer side effects.”

In the first quarter of 2018, CURE Pharmaceutical has reported developments in the following key areas:

• Financing: Dr. Gene Salkind was named to CURE Pharmaceutical’s Advisory Board and invested $1 million in the company. Additionally, Alexander Capital raised a $1 million bridge financing transaction for working capital to expand production capabilities and accelerate product development.
• Three Strategic Hires: The company bolstered its leadership team with the addition of Jessica Rousset as Chief Operating Officer, Dr. Vered Gigi as its VP of Business Development and Strategy, and former Amgen executive, Steven Ruhl as the VP of Manufacturing.
• Nutraceutical Sleep Demand Increase: The company grew product demand this quarter, including two new purchase orders worth more than $500,000 in the nutraceutical sleep category. Due to leadership additions and improvements in manufacturing this quarter, the company has increased its shipments by more than 300 percent over the average quarterly shipments.
• Advanced ED CUREfilm product development: The company has advanced its erectile dysfunction (ED) CUREfilm product through manufacturing validation. CURE Pharmaceutical anticipates launching this product in Asia in Q2 2019. The global ED drugs market is expected to reach USD 3.2 billion by 2022, according to a report by Grand View Research Inc.
• Research: The first year of sponsored research at Israel’s Technion Institute of Technology has concluded. Specific cannabis extracts and extraction methods that result in tumor cell death in vitro have been identified, demonstrating that specific combinations of actives in the cannabis plant are responsible for the observed therapeutic effects, and that those therapeutic effects are specific to the type of cancer.

About CURE Pharmaceutical
CURE Pharmaceutical is a vertically integrated drug delivery and development company committed to improving drug efficacy, safety and the patient experience through its proprietary drug dosage forms and delivery systems. CURE has a full-service cGMP manufacturing facility and is a pioneering developer and manufacturer of a patented and proprietary delivery system (CUREfilm), one of the most advanced oral thin film on the market today. CURE is developing an array of products in cutting-edge delivery platforms and partners with biotech and pharmaceutical companies. CURE has positioned itself to advance numerous therapeutic categories, including the pharmaceutical cannabis sector with partnerships in the U.S., Canada, Israel and Germany, among other markets. The company’s mission is to improve people’s lives by redefining how medicines are delivered and experienced.

For more information about CURE Pharmaceutical, please visit its website at https://ift.tt/2lZPSq4.

Forward-looking Statement
This press release contains forward-looking statements, which are subject to risks and uncertainties. All statements, other than statements of fact, including those statements with respect to the Company’s business development, are forward-looking statements. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly update or revise any forward-looking statements.

Contact: Ashley Ray
(310) 824-9000
[email protected]

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