Endometriosis

A condition resulting from the appearance of endometrial tissue outside the uterus and causing pelvic pain.

EndoRisk® - Companion diagnostic/genetic test for endometriosis

NHP-07 - Therapeutic for the prevention and/or suppression of the disease

The next generation DOES NOT NEED TO SUFFER from Endometriosis

What is endometriosis
  • The World Endometriosis Research Foundation estimates 1 out of every 10 women over the age of 15, or 176 million women worldwide, suffers from endometriosis.
  • Endometriosis is a painful and debilitating disease affecting women of reproductive age (i.e., puberty to menopause). Endometriosis is one of the most common gynecological disorders that can affect women.
  • It is a disorder in which abnormal growths of endometrial-like tissue are present in locations other than the uterine lining.
  • It can occur in various pelvic sites and in distant sites.
  • Endometrial tissue outside the uterus responds to changes in hormones. Beginning at puberty, this inflamed tissue breaks down and bleeds during the menstrual cycle causing scar tissue, called adhesions. Adhesions can bind organs and cause acute pain.
  • Endometriosis is typically diagnosed after more than nine years of disease progression. The results include debilitating chronic pelvic pain, severe PMS, number one cause of infertility.
  • There are regular claims that women with endometriosis have a higher risk of developing ovarian cancer; however, this research in not definitive and the absolute risk is very, very small. (World Endometriosis Research Foundation, January 2012)
Current best treatment of care

Endometriosis is typically diagnosed after more than nine years of disease progression. These nine years of disease progression can not be reversed.

“The market is wide open for novel entrants which show long term safety and efficacy benefits or arrest the progression of the disease.”

“The currently available pharmacological and surgical treatment options primarily target short term symptomatic relief with none of them capable of treating the progression of the disease.”

The drugs available for endometriosis patients are the lowest on efficacy profiles, which can either worsen the condition or cause serious adverse effects.

Endometriosis Therapeutics – Pipeline Assessment and Market Forecasts to 2018, Global Data, Published September 2011

Solution Must Include
  • Diagnostic to predict the patient’s likelihood/predisposition of developing the disease.
  • A safe and effective long term therapeutic that can arrest the progression of the disease or prevent its origination all together.

PRx Solution

EndoRisk®: Predictive genetic companion diagnostic

(in licensed from Juneau Biosciences)

· Fertility clinics launch date expected 1st-half of 2018
· 27,000,000 symptomatic women in the United States
· Greater than $1Billion US Market
· Today, endometriosis is diagnosed through laparoscopy with costs that exceed $15,000
· In over 50% of cases (today’s “gold standard”) diagnosis is NOT confirmed
· Companion diagnostic for therapeutics
· Initial base patent issued in January 2015 by USPTO
· Additional patent applications pending

 

NHP-07: Long term safe and effective therapeutic

(internally developed)
NHP-07 – First pharmaceutical/therapeutic candidate to be developed by PRx. Management believes NHP-07 with EndoRisk® as a companion diagnostic/prognostic is the only treatment protocol that can prevent development of endometriosis and, in women experiencing advanced stages of endometriosis NHP-07, stop the progression of the disease while suppressing the debilitating symptoms.

  • Expected launch 2018
  • Approximately 7.5 million women suffer from endometriosis in the United States with only 2.5 million women currently diagnosed
  • 5 million women are estimated to suffer from endometriosis in the major international markets with 70 million women suffering globally
  • Greater than $1Billion annual US market
  • Tremendous need for new more effective/lower side-effect therapeutics to meet this unmet demand
  • Suppresses the symptoms of endometriosis in women diagnosed with endometriosis
  • Prevents the development of the disease
  • Believed to be superior to all competitive pharmaceuticals currently on the market
  • Combination of two or more existing FDA-approved compounds, whose safety has already been established over decades
  • Coupled with EndoRisk® as a companion diagnostic NHP-07 can be given prior to development of endometriosis or becoming symptomatic to prevent the disease altogether
  • Patent pending for combination of progesterone and NSAIDs (Non Steroidal Anti-Inflammatory Drugs)
  • Patent pending to replace traditional NSAIDs with cannabinoids to reduce the long-term side effects of NSAIDs