REG - Renalytix PLC - Vector Pharma Middle East Distribution Agreement

RenalytixAnnouncement

21/07/2023 07:00

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RNS Number : 7254G  Renalytix PLC  21 July 2023

 

Renalytix plc

("Renalytix" or the "Company")

 

Middle East Distribution Agreement with Vector Pharma

 

Commercial availability of kidneyintelX.dkd™ expanded to an estimated

4 million DKD Patients in the Middle East

 

Distribution agreement opens kidneyintelX.dkd testing to address early-stage
kidney disease in region with one of the highest incidence rates for type 2
diabetes globally

 

LONDON and SALT LAKE CITY, July 21, 2023 (GLOBE NEWSWIRE) -- Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) announces opening the commercial availability of
kidneyintelX.dkd™ testing in Saudi Arabia, Bahrain, Qatar, Oman, Kuwait, and
United Arab Emirates through a distribution agreement with Vector Pharma.
Following the recent announcement of FDA marketing authorization for
kidneyintelX.dkd, Renalytix will take advantage of select opportunities to
expand testing services outside the US market with qualified distribution
partners.

 

In the six markets of the Gulf Cooperation Council (GCC), the International
Diabetes Federation (IDF) has reported high prevalence rates of diabetes, with
more than 20% of the population being diabetic and more than 15% being
pre-diabetic in most GCC countries. These are among the highest reported
incidence rates for diabetes globally(1). Chronic kidney disease (CKD) is a
significant complication of type 2 diabetes (T2D) in this region.  An
estimated 58% of individuals with T2D develop CKD, which concurrently
increases the risk of heart failure and myocardial infarction(2).

 

The agreement with Vector Pharma brings established distribution and market
access capabilities with a strong GCC footprint.  Vector Pharma will
initially focus on building awareness and driving adoption to achieve
specified annual sales targets by territory with kidneyintelX.dkd.

 

"As in the United States, patient care for early-stage diabetes and kidney
disease is in the hands of primary care clinicians," said Tom McLain,
President, Renalytix. "Traditional laboratory distributors do not call on
primary care practices. Our partnership with Vector Pharma, a pharmaceutical
distributor with proven access and contacts in primary care, will accelerate
efforts to introduce kidneyintelX.dkd and expand test adoption."

 

Vector Pharma Chief Executive Officer, Patrick Jordan, commented: "When you
consider the markets in the Middle East are experiencing high rates of T2D and
CKD, diabetic kidney disease management has become a core tenet of many
Ministries of Health in the GCC. Being able to introduce kidneyintelX.dkd™
to complement the current care protocols will not only benefit the management
of individual patients, but it will also address significant objectives to
improve chronic disease diagnosis and treatment for the healthcare ecosystem
as a whole."

 

Notes

(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047189/
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047189/) ;

https://diabetesatlas.org/idfawp/resource-files/2021/11/IDF-Atlas-Factsheet-2021_MENA.pdf
(https://diabetesatlas.org/idfawp/resource-files/2021/11/IDF-Atlas-Factsheet-2021_MENA.pdf)

(2) https://onlinelibrary.wiley.com/doi/10.1111/1753-0407.13266
(https://onlinelibrary.wiley.com/doi/10.1111/1753-0407.13266)

 

For further information, please contact:

 

 Renalytix plc                                                  www.renalytix.com (http://www.renalytix.com)
 James McCullough, CEO                                          Via Walbrook PR

 Stifel (Nominated Adviser, Joint Broker)                       Tel: 020 7710 7600
 Alex Price / Nicholas Moore / Nick Harland / Samira Essebiyea

 Investec Bank plc (Joint Broker)                               Tel: 020 7597 4000
 Gary Clarence / Shalin Bhamra

 Walbrook PR Limited                                            Tel: 020 7933 8780 or renalytix@walbrookpr.com
                                                                (http://renalytix@walbrookpr.com)
 Paul McManus / Lianne Applegarth / Alice Woodings              Mob: 07980 541 893 / 07584 391 303 / 07407 804 654

 CapComm Partners
 Peter DeNardo                                                  Tel: 415-389-6400 or investors@renalytix.com (http://investors@renalytix.com)

 

About Chronic Kidney Disease

Kidney disease is now recognized as a public health epidemic affecting over
850 million people globally. The Centers for Disease Control and Prevention
(CDC) estimates that 15% of US adults, more than 38 million people, currently
have chronic kidney disease (CKD). Diabetes is the leading cause of kidney
failure, accounting for 44% of new cases. Further, the CDC reports that 9 out
of 10 adults with CKD do not know they have it and one out of two people with
very low kidney function who are not on dialysis do not know they have
CKD.(1) Kidney disease is referred to as a "silent killer" because it often
has no symptoms and can go undetected until a very advanced stage. Each year,
kidney disease kills more people than breast and prostate cancer. Every day,
13 patients in the United States die while waiting for a kidney transplant.

 

About Type 2 Diabetes

More than 37 million Americans have diabetes (about 1 in 10), and
approximately 90-95% of them have type 2 diabetes. Type 2 diabetes most often
develops in people over age 45, but more and more children, teens, and young
adults are also developing the disease(2). Type 2 diabetes symptoms often
develop over several years and approximately 23% of adults with type 2
diabetes are undiagnosed(3). Type 2 diabetes affects many major organs,
including the heart, blood vessels, nerves, eyes and kidneys. Diabetic kidney
disease develops in 30-50% of type 2 diabetes patients(4).

 

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory
services company that is the global founder and leader in the new field of
bioprognosis™ for kidney health. The leadership team, with a combined 200+
years of healthcare and in-vitro diagnostic experience, has designed its
KidneyIntelX laboratory developed test to enable risk assessment for rapid
progressive decline in kidney function in adult patients with T2D and early
CKD (stages 1-3). We believe that by understanding how disease will progress,
patients and providers can take action early to improve outcomes and reduce
overall health system costs. For more information, visit www.renalytix.com
(http://www.renalytix.com) .

 

Sources

1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
(https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/)

2 https://www.cdc.gov/diabetes/basics/type2.html
(https://www.cdc.gov/diabetes/basics/type2.html)

3 https://www.cdc.gov/diabetes/data/statistics-report/index.html
(https://www.cdc.gov/diabetes/data/statistics-report/index.html)

4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/)

 

Forward Looking Statements

Statements contained in this press release regarding matters that are not
historical facts are "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended. Examples of
these forward-looking statements include statements concerning: the commercial
prospects of KidneyIntelX and kidneyintelX.dkd, including whether KidneyIntelX
and kidneyintelX.dkd will be successfully adopted by physicians, inform
clinical guidelines, achieve expanded insurance coverage and be successfully
distributed and marketed, the potential for KidneyIntelX and kidneyintelX.dkd
to be expanded and approved for additional indications and in additional
jurisdictions, our expectations regarding reimbursement decisions and the
ability of KidneyIntelX and kidneyintelX.dkd to curtail costs of chronic and
end-stage kidney disease, optimize care delivery and improve patient outcomes.
Words such as "anticipates," "believes," "estimates," "expects," "intends,"
"plans," "seeks," and similar expressions are intended to identify
forward-looking statements. We may not actually achieve the plans and
objectives disclosed in the forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Any forward-looking
statements are based on management's current views and assumptions and involve
risks and uncertainties that could cause actual results, performance, or
events to differ materially from those expressed or implied in such
statements. These risks and uncertainties include, among others: that
KidneyIntelX and kidneyintelX.dkd are based on novel artificial intelligence
technologies that are rapidly evolving and potential acceptance, utility and
clinical practice remains uncertain; we have only recently commercially
launched KidneyIntelX; and risks relating to the impact on our business of the
COVID-19 pandemic or similar public health crises. These and other risks are
described more fully in our filings with the Securities and Exchange
Commission (SEC), including the "Risk Factors" section of our annual report on
Form 20-F filed with the SEC on October 31, 2022, and other filings we make
with the SEC from time to time. All information in this press release is as of
the date of the release, and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events, or otherwise, except as required by law.

 

 

 

 

 

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