Mytesi Sales Increased 17.71% Each Month
Over the Prior Month
Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar or the Company), a
commercial stage natural-products pharmaceuticals company focused
on developing novel, sustainably derived gastrointestinal products
for both human prescription use and animals on a global basis,
today provided the following updates regarding commercial,
educational and product development programs and 2017 results.
This press release features multimedia. View
the full release here:
http://www.businesswire.com/news/home/20180122006522/en/
(Graphic: Business Wire)
Mytesi® Sales Update (August 2017 – December of
2017)
Effective July 31, 2017, Jaguar merged with Napo
Pharmaceuticals, Inc. (Napo) and acquired its first-in-class,
FDA-approved anti-secretory human prescription drug product,
Mytesi® (crofelemer). For the period August 1, 2017 through
December 31, 2017, preliminary sales of Mytesi® were approximately
$1.40 million. During the aforementioned period, Mytesi® sales
increased more than 78% relative to average monthly Mytesi® sales
that took place from January through July of 2017, which is before
marketing efforts were deployed in the combined Company and the
deployment in the fourth quarter of Napo’s team of nine dedicated
sales reps. On average during the August 1, 2017 through December
31, 2017 period, sales increased 17.71% each month over the prior
month.
Six of Napo’s nine highly trained Mytesi® sales representatives
are former long-term employees of the HIV portfolio business of
drugmaker Bristol-Myers Squibb, while the remainder of the team
possess extensive experience in drug sales to both HIV healthcare
providers and gastroenterologists.
“Napo has identified a total high-potential prescriber base of
3,500 high-volume ART prescribers (HIV specialists) and 1,500
gastroenterologists who see the highest number of people living
with HIV. The Napo sales force is located in the U.S.
geographies with the highest potential, and is targeting the
prescribers with the highest potential to drive Mytesi®
business. From September 1, 2017 through November 30, 2017,
there was an increase of 86% in new Mytesi® prescribers among
gastroenterologists and 8% in HIV specialists, coincident with the
deployment of our direct sales force,” Lisa Conte, Jaguar's
President and CEO, stated. “According to data provided by IQVIA,
the number of Mytesi® prescriptions written by physicians increased
an average of 9.5% each month over the prior month during the
August 1, 2017 through December 31, 2017 period. Additionally,
patient redemptions of our Mytesi® Copay Savings Card increased an
average of 7% each month over the prior month during the same
period.”
Sales is a measure that is recognized under accounting
principles generally accepted in the United States of America
(“GAAP”), in accordance with new 2018 revenue recognition rules,
still under review by the Company and its auditors. As a result,
the preliminary Mytesi® sales figures provided herein are subject
to revision until the Company reports final fourth quarter fiscal
2017 results no later than March 30, 2018.
Commercialized directly by Napo in the U.S., Mytesi® is the only
antidiarrheal studied in and U.S. FDA-approved for the symptomatic
relief of noninfectious diarrhea in adults living with HIV/AIDS on
antiretroviral therapy (ART). Mytesi® is a prescription treatment
for diarrhea that works differently, by acting locally in the GI
tract to normalize the flow of water. Mytesi® does not have
drug-drug interactions with ART and does not affect GI
motility.
Napo Launches Health Care Practitioner and Patient Advocate
Speaker Bureau – Plans to Conduct More Than 1,400 Educational
Events in 2018
Napo recently completed the training of 29 health care
practitioners (HCPs) and ten patient advocates to serve as members
of the Napo Speakers Bureau. Medical education presentations led by
participating HCPs—a group that includes HIV/AIDS specialists,
infectious disease specialists, gastroenterologists, colorectal
surgeons, and nurse practitioners—will focus on the prevalence and
pathophysiology of gastrointestinal consequences of HIV infection
and on the latest treatment options for HIV-related diarrhea.
Presentations given by patient advocate members will provide
information to people living with HIV (PLWH) about the prevalence
of diarrhea in PLWH and offer guidance about talking to HCPs
regarding diarrhea-related concerns.
As part of Napo’s medical and patient education program, the
Mytesi® direct sales force are planning more than 1,400 live and
virtual educational events for 2018. Live events will largely take
place in the following key geographies covered by the Mytesi® sales
team: Miami/South Florida, Los Angeles/Palm Springs, New York,
Houston, Chicago/St. Louis, Indianapolis, Kansas City, Alabama,
Atlanta, San Francisco, DC, Pennsylvania, New Jersey, Delaware,
Maryland, Mississippi and Louisiana.
“Since the merger of Jaguar and Napo, we have both initiated and
dramatically expanded Mytesi®-related commercial, educational and
development initiatives, including the creation of our direct sales
force and our scientific advisory board, the roll-out of
direct-to-consumer advertising campaigns, publication-focused
efforts, government affairs activities regarding neglected
comorbidities of HIV, and the launch of the Napo Speaker Bureau,”
Conte commented. “Mytesi® sales and the awareness of a novel
first-in-class approach to managing diarrhea tested specifically in
the HIV population are clearly benefiting from the programs we’ve
put in place—in addition to the efforts of our recently expanded
team of experienced HIV sales representatives.”
Napo Accepts Request to Support Investigator-Initiated Trial
of Crofelemer
Napo has accepted a request for support submitted by Dr. Mohamad
Miqdady, Chief of Pediatric Gastroenterology, Hepatology and
Nutrition at Sheikh Khalifa Medical City (SKMC) in Abu Dhabi, for
an investigator-initiated trial of crofelemer, the active
pharmaceutical ingredient in Mytesi®, for congenital diarrheal
disorders (CDDs) in children.
CDDs are a group of rare, chronic intestinal channel diseases,
occurring exclusively in early infancy, that are characterized by
severe, lifelong diarrhea and a lifelong need for nutritional
intake either parenterally or with a feeding tube. CDDs are related
to specific genetic defects inherited as autosomal recessive
traits. The incidence of CDDs is prevalent in regions where
consanguineous marriages (related by blood) is part of the culture.
CDDs are directly associated with serious secondary conditions
including dehydration, metabolic acidosis, and failure to thrive,
prompting the need for immediate therapy to prevent death and limit
lifelong disability.
SKMC is the Abu Dhabi public health system’s flagship
institution and the largest hospital in the United Arab Emirates
(UAE), consisting of a 586-bed tertiary hospital, 14 outpatient
specialty clinics, and the Abu Dhabi Blood Bank, all of which are
accredited by Joint Commission International, the oldest and
largest healthcare standards-setting and accrediting body in the
United States. Dr. Miqdady is American Board certified in Pediatric
Gastroenterology, Hepatology and Nutrition, and he is a member of
Napo’s Scientific Advisory Board.
Napo intends to submit documentation in the first half of 2018
to the US. Food and Drug Administration (FDA) for the planned
formulation of crofelemer appropriate for feeding tube
administration to support this investigation.
As announced on June 5, 2017, Napo has received orphan drug
designation from the FDA for short bowel syndrome (SBS). The Orphan
Drug Act provides for granting special status to a drug or
biological product to treat a rare disease or condition upon
request of a sponsor. Orphan designation qualifies the sponsor of
the drug for various development incentives, including extended
exclusivity, tax credits for qualified clinical testing, and relief
of filing fees.
Investigator-Initiated Trials of Crofelemer in Cancer
Therapy-related Diarrhea (CTD)
As previously announced, an investigator-initiated trial titled
HALT-D: DiarrHeA Prevention and ProphyLaxis with Crofelemer in HER2
Positive Breast Cancer Patients Receiving Trastuzumab, Pertuzumab,
and Docetaxel or Paclitaxel with or without Carboplatin is
currently underway in conjunction with Georgetown University. The
primary objective of the study is to characterize the incidence and
severity of diarrhea in patients receiving investigational therapy
in the setting of prophylactic anti-diarrheal management.
As also previously announced, a second study, titled An
Open-Label Study to Characterize the Incidence and Severity of
Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated
with Neratinib and Intensive Loperamide Prophylaxis, is currently
underway in conjunction with the University of California, San
Francisco. The study is designed to evaluate crofelemer as a
salvage anti-diarrheal therapy used with the investigational breast
cancer agent neratinib. The primary objective is to characterize
the incidence and severity of diarrhea in patients with early-stage
breast cancer receiving adjuvant trastuzumab and neratinib followed
by one year of neratinib monotherapy in the setting of prophylactic
anti-diarrheal management.
“Diarrhea continues to be an area of concern for patients
undergoing cancer treatment. Novel targeted agents, such as
epidermal growth factor receptor antibodies and tyrosine kinase
inhibitors (TKIs), may block natural chloride secretion regulation
pathways in the normal gastrointestinal mucosa, thereby leading to
secretory diarrhea,” Conte commented. “We recognize the importance
of future development activities on supportive care for patients
being treated with these cancer-related therapies, analogous to the
supportive care of managing diarrhea in people living with
HIV/AIDS.”
Animal Health Updates
While Jaguar’s commercial and development efforts have evolved
to focus primarily on Mytesi® and human pipeline indications since
its merger with Napo, the Company is continuing animal health
initiatives related to Canalevia™, its drug product candidate for
treatment of various types of diarrhea in dogs, and Equilevia™, its
non-prescription, personalized, premium product for total gut
health in equine athletes.
As previously announced, Jaguar has received MUMS (Minor Use and
Minor Species) designation status from the FDA for Canalevia™ for
the indication of chemotherapy-induced diarrhea in dogs. Jaguar has
completed clinical and manufacturing activity for Canalevia™ for
this indication. MUMS designation is modeled on the orphan-drug
designation for human drug development and offers possible
financial incentives to encourage MUMS drug development, such as
the availability of grants to help with the cost of developing the
MUMS drug.
As announced last month, Jaguar has entered into a collaboration
agreement with Seed Mena Businessmen Services LLC (SEED) for
Equilevia™. Based in Dubai in the UAE, SEED is affiliated with Seed
Group, a diversified group of companies under the umbrella of The
Private Office of His Royal Highness Sheikh Saeed Bin Ahmed Al
Maktoum establishing strategic partnerships with multinational
companies from around the globe in an aim to leverage Seed Group’s
network to support potential business expansion in the MENA (Middle
East and North Africa) region. The UAE has become a global leader
in horse racing, equine endurance competitions, and other equine
athletic activities. Gut health is of critical importance in
competitive horses, as conditions such as ulcers can meaningfully
impair equine athlete performance, and colic can lead to the death
of an otherwise healthy horse in a matter of hours. According to a
third-party 2005 study, as many as 55% of performance horses have
both colonic and gastric ulcers, and 97% of performance horses have
either a gastric (87%) or a colonic (63%) ulcer.1
Net sales in 2017 for Jaguar’s non-prescription Neonorm™ Foal
and Neonorm™ Calf products totaled approximately $422,000.
Collaboration revenue totaled approximately $2.9M. Jaguar continues
to maintain a relationship with the Company’s dairy market
distributor in addition to selling Neonorm™ directly to end users
though neonorm.com.
About Mytesi®
Mytesi® (crofelemer) is an antidiarrheal indicated for the
symptomatic relief of noninfectious diarrhea in adult patients with
HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated
for the treatment of infectious diarrhea. Rule out infectious
etiologies of diarrhea before starting Mytesi®. If infectious
etiologies are not considered, there is a risk that patients with
infectious etiologies will not receive the appropriate therapy and
their disease may worsen. In clinical studies, the most common
adverse reactions occurring at a rate greater than placebo were
upper respiratory tract infection (5.7%), bronchitis (3.9%), cough
(3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are
available at Mytesi.com. Crofelemer, the active ingredient in
Mytesi®, is a botanical (plant-based) drug extracted and purified
from the red bark sap of the medicinal Croton lechleri tree in the
Amazon rainforest. Napo has established a sustainable harvesting
program for crofelemer to ensure a high degree of quality and
ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products
pharmaceuticals company focused on developing novel, sustainably
derived gastrointestinal products for both human prescription use
and animals on a global basis. Our wholly-owned subsidiary, Napo
Pharmaceuticals, Inc., focuses on developing and commercializing
proprietary human gastrointestinal pharmaceuticals for the global
marketplace from plants used traditionally in rainforest areas. Our
Mytesi® (crofelemer) product is approved by the U.S. FDA for the
symptomatic relief of noninfectious diarrhea in adults with
HIV/AIDS on antiretroviral therapy.
For more information about Jaguar, please visit jaguar.health.
For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute
“forward-looking statements.” These include statements regarding
the Company’s plan to conduct more than 1,400 educational events in
2018, the investigator-initiated trial of crofelemer for CDDs, the
Company’s intention to submit documentation in the first half of
2018 to the FDA for the planned formulation of crofelemer to
support this investigation, the Company’s belief that crofelemer
may have considerable potential to help manage the severe diarrhea
and dehydration symptomatic of CDDs, and the Company’s plans to
focus upcoming resources on the development of potentially
important supportive care for patients being treated with
cancer-related therapies. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “potential” or “continue” or the negative of these terms
or other similar expressions. The forward-looking statements in
this release are only predictions. Jaguar has based these
forward-looking statements largely on its current expectations and
projections about future events. These forward-looking statements
speak only as of the date of this release and are subject to a
number of risks, uncertainties and assumptions, some of which
cannot be predicted or quantified and some of which are beyond
Jaguar’s control. Except as required by applicable law, Jaguar does
not plan to publicly update or revise any forward-looking
statements contained herein, whether as a result of any new
information, future events, changed circumstances or otherwise.
1Pellegrini FL. Results of a large-scale necroscopic study of
equine colonic ulcers. J Equine Vet Sci. 2005;25(3):113-117.
Jaguar-JAGX
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Jaguar Health, Inc.Peter Hodgephodge@jaguar.health
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