Dova Pharmaceuticals, Inc. (“Dova”) (NASDAQ: DOVA), a specialty
pharmaceutical company focused on acquiring, developing, and
commercializing drug candidates for diseases where there is a high
unmet need, and Salix Pharmaceuticals (“Salix”), one of the largest
specialty pharmaceutical companies in the world committed to the
prevention and treatment of gastrointestinal diseases and its
parent company, Bausch Health Companies Inc. (NYSE/TSX: BHC), today
announced that they have entered into an exclusive agreement to
co-promote Dova’s DOPTELET (avatrombopag) in the United States
(U.S.). The U.S. Food and Drug Administration ("FDA") approved
DOPTELET on May 21, 2018 for the treatment of
thrombocytopenia in adult patients with chronic liver disease (CLD)
who are scheduled to undergo a procedure. DOPTELET represents the
first thrombopoietin (TPO) receptor agonist approved in the United
States for this indication.
Thrombocytopenia, a condition in which patients have a low
platelet count, is the most common hematological abnormality in
patients with CLD that often worsens with the severity of liver
disease. It is estimated that approximately 15 percent of the 7.5
million patients with CLD have some form of thrombocytopenia. In a
study published in 2010, patients with severe thrombocytopenia
(<75,000/µL) had a 31 percent incidence of procedure-related
bleeding. As a result of the associated increased rate of bleeding,
there is an increased risk for the CLD patient when undergoing
common scheduled medical procedures such as liver biopsy,
colonoscopy, endoscopy, and routine dental procedures.
As part of the co-promotion arrangement, Salix intends to
deploy approximately 100 sales specialists who will promote
DOPTELET to gastroenterology healthcare professionals. The Salix
sales force will begin selling DOPTELET in mid-October 2018. Dova
will continue its commercial efforts targeting primarily
hepatologists and interventional radiologists and certain other
specialties. Pursuant to the agreement, Dova will pay Salix a
quarterly fee based on net sales (as defined in the agreement) of
DOPTELET prescribed by gastroenterologists in the U.S.
“We are delighted to be working with Salix, a company considered
by many to have the preeminent gastroenterology sales force in the
United States,” said Alex C. Sapir, president and chief executive
officer, Dova Pharmaceuticals. “Given Salix’s presence and strong
reputation within large gastroenterology group practices coupled
with the early interest we are seeing among the gastroenterology
community, we are excited to see the impact this partnership will
bring to DOPTELET and to patients.”
“Salix considers liver disease a strategic therapeutic area of
focus, given our history and knowledge with XIFAXAN® (rifaximin),
an innovative medicine indicated for the treatment of overt hepatic
encephalopathy (HE), a condition that is often a consequence of
chronic liver disease,” said Mark McKenna, president, Salix
Pharmaceuticals. “Adding DOPTELET to our portfolio will enable our
sales force to promote yet another innovative product that
addresses a true unmet need in the marketplace.”
About DOPTELETDOPTELET (avatrombopag) is a
second generation, once daily, orally administered TPO receptor
agonist approved for the treatment of thrombocytopenia in adult
patients with CLD who are scheduled to undergo a procedure.
DOPTELET is designed to mimic the effects of TPO, the primary
regulator of normal platelet production.
Two global Phase 3, double-blind, placebo-controlled trials
(ADAPT-1 [N=231] and ADAPT-2 [N=204]), conducted in adults with
thrombocytopenia (platelet count of less than 50,000/µL) and CLD,
supported the FDA approval. Patients were assigned to either 40 mg
or 60 mg of avatrombopag daily for five days based on their
Baseline platelet counts (40 to <50,000/µmL or <40,000/µmL,
respectively). Avatrombopag was shown to be superior to placebo in
increasing the proportion of patients not requiring platelet
transfusions or rescue procedures for bleeding up to seven days
following a scheduled procedure in both trials in both the 40 mg
(ADAPT-1, 88% vs. 38%, p <0.0001; ADAPT-2, 88% vs. 33%;
p<0.0001), and 60 mg (ADAPT-1, 66% vs. 23%, p <0.0001;
ADAPT-2, 69% vs. 35%; p=0.0006) treatment groups. Avatrombopag was
also superior to placebo at the two secondary efficacy endpoints in
each trial. In the avatrombopag treatment groups, there was
an increased proportion of patients achieving the target platelet
count of ≥50,000/µmL on procedure day, and a greater magnitude of
the change in mean platelet count from baseline to procedure day;
all treatment differences between the avatrombopag and placebo
treatment groups for each secondary endpoint were highly
statistically significant with p values <0.0001. The most common
adverse reactions with avatrombopag included pyrexia, abdominal
pain, nausea, headache, fatigue and edema peripheral. Portal vein
thromboses have been reported in patients with CLD and in patients
receiving TPO receptor agonists. One treatment-emergent event of
portal vein thrombosis was reported in the ADAPT trials in an
avatrombopag-treated patient.
INDICATION
DOPTELET (avatrombopag) is indicated for the treatment of
thrombocytopenia in adult patients with chronic liver disease who
are scheduled to undergo a procedure.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO
receptor agonists have been associated with thrombotic and
thromboembolic complications in patients with chronic liver
disease. Portal vein thrombosis has been reported in patients with
chronic liver disease treated with TPO receptor agonists. In the
ADAPT-1 and ADAPT-2 clinical trials, there was one
treatment-emergent event of portal vein thrombosis in a patient
(n=1/430) with chronic liver disease and thrombocytopenia treated
with DOPTELET.
Consider the potential increased thrombotic risk when
administering DOPTELET to patients with known risk factors for
thromboembolism, including genetic prothrombotic conditions (Factor
V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C
or S deficiency).
DOPTELET should not be administered to patients with chronic
liver disease in an attempt to normalize platelet counts.
CONTRAINDICATIONS: None
ADVERSE REACTIONS
Most common adverse reactions (≥ 3%) were: pyrexia, abdominal
pain, nausea, headache, fatigue, and edema peripheral.
Please see full Prescribing Information for DOPTELET
(avatrombopag) www.doptelet.com
About XIFAXANXIFAXAN is a
nonsystemic* antibiotic that slows the growth of bacteria in the
gut that are believed to be linked to symptoms of overt
hepatic encephalopathy (HE). It has been proven to reduce the
risk of overt HE recurrence and HE-related hospitalizations in
adults.
*There is an increased systemic exposure in patients with severe
(Child-Pugh Class C) hepatic impairment. Caution should be
exercised when administering XIFAXAN to these patients.
INDICATIONXIFAXAN (rifaximin) 550 mg tablets
are indicated for the reduction in risk of overt hepatic
encephalopathy (HE) recurrence in adults and for the treatment of
irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
- XIFAXAN is not for everyone. Do not take XIFAXAN if you have a
known hypersensitivity to rifaximin, any of the rifamycin
antimicrobial agents, or any of the components in XIFAXAN.
- If you take antibiotics, like XIFAXAN, there is a chance you
could experience diarrhea caused by an overgrowth of bacteria (C.
difficile). This can cause symptoms ranging in severity from mild
diarrhea to life-threatening colitis. Contact your healthcare
provider if your diarrhea does not improve or worsens.
- Talk to your healthcare provider before taking XIFAXAN if you
have severe hepatic (liver) impairment, as this may cause increased
effects of the medicine.
- Tell your healthcare provider if you are taking drugs called
P-glycoprotein and/or OATPs inhibitors (such as cyclosporine)
because using these drugs with XIFAXAN may lead to an increase in
the amount of XIFAXAN absorbed by your body.
- In clinical studies, the most common side effects of XIFAXAN
were:
HE: Peripheral edema (swelling, usually in the ankles or lower
limbs), nausea (feeling sick to your stomach), dizziness, fatigue
(feeling tired), and ascites (a buildup of fluid in the
abdomen)IBS-D: Nausea (feeling sick to your stomach) and an
increase in liver enzymes
- XIFAXAN may affect warfarin activity when taken together. Tell
your healthcare provider if you are taking warfarin because the
dose of warfarin may need to be adjusted to maintain proper
blood-thinning effect.
- If you are pregnant, planning to become pregnant, or nursing,
talk to your healthcare provider before taking XIFAXAN because
XIFAXAN may cause harm to an unborn baby or nursing infant.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
For product information, adverse event reports, and product
complaint reports, please contact:Salix Product Information Call
Center Phone: 1-800-321-4576 Fax: 1-510-595-8183
Email: salixmc@dlss.comPlease click here for full
Prescribing Information.
About Dova Pharmaceuticals,
Inc.Dova is a pharmaceutical company focused on acquiring,
developing, and commercializing drug candidates for rare diseases
where there is a high unmet need, with an initial focus on
addressing thrombocytopenia. Dova’s proprietary pipeline includes
one commercial product, DOPTELET, for the treatment of
thrombocytopenia in adult patients with CLD scheduled to undergo a
procedure. About SalixSalix is one of the largest
specialty pharmaceutical companies in the world committed to the
prevention and treatment of gastrointestinal diseases. For almost
30 years, Salix has licensed, developed, and marketed innovative
products to improve patients' lives and arm health care providers
with life-changing solutions for many chronic and debilitating
conditions. Salix currently markets its product line to U.S. health
care providers through an expanded sales force that focuses on
gastroenterology, hepatology, pain specialists, and primary care.
Salix is headquartered in Bridgewater, New Jersey.
About Bausch HealthBausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Dova Pharmaceuticals Cautionary Notes
Regarding Forward-Looking Statements Any statements
contained in this press release that do not describe historical
facts may constitute forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995.
These statements may be identified by words such as “anticipated”,
“believe”, “expect”, “may”, “plan”, “potential”, “will”, and
similar expressions, and are based on Dova’s current beliefs and
expectations. These forward-looking statements include the
potential benefits of the collaboration, the timing of the Salix
sales force beginning to sell DOPTELET and other information
relating to the transaction between Dova and Salix. These
statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, increased regulatory requirements, Dova’s
reliance on third parties over which it may not always have full
control, and other risks and uncertainties that are described in
Dova’s Annual Report on Form 10-K for the year ended December 31,
2017, filed with the U.S. Securities and Exchange Commission (SEC)
on February 16, 2018, and Dova’s other periodic reports filed with
the SEC. Any forward-looking statements speak only as of the date
of this press release and are based on information available to
Dova as of the date of this release, and Dova assumes no obligation
to, and does not intend to, update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
Bausch Health Forward-looking Statements
This news release may contain forward-looking statements, which may
generally be identified by the use of the words "anticipates,"
"expects," "intends," "plans," "should," "could," "would," "may,"
"will," "believes," "estimates," "potential," "target," or
"continue" and variations or similar expressions. These statements
are based upon the current expectations and beliefs of management
and are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks and uncertainties discussed in the
Bausch Health’s most recent annual or quarterly report and detailed
from time to time in Bausch Health’s other filings with the
Securities and Exchange Commission and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
In addition, certain material factors and assumptions have been
applied in making these forward-looking statements, including that
the risks and uncertainties outlined above will not cause actual
results or events to differ materially from those described in
these forward-looking statements. Bausch Health believes that the
material factors and assumptions reflected in these forward-looking
statements are reasonable, but readers are cautioned not to place
undue reliance on any of these forward-looking statements. These
forward-looking statements speak only as of the date hereof. Bausch
Health and Salix undertake no obligation to update any of these
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect actual outcomes, unless
required by law.
Dova Investor
Contacts: |
|
Mark W. Hahn |
Westwicke Partners |
Chief Financial
Officer |
John Woolford |
mhahn@dova.com |
john.woolford@westwicke.com |
(919) 338-7936 |
(443) 213-0506 |
|
|
Salix Investor
Contact: |
Salix Media
Contacts: |
Arthur Shannon |
Lainie Keller |
Arthur.Shannon@bauschhealth.com |
Lainie.Keller@bauschhealth.com |
514-856-3855 |
908-927-0617 |
877-281-6642 (toll
free) |
|
|
Karen Paff |
|
Karen.Paff@salix.com |
|
908-927-1190 |
AkaRx, Inc., a wholly owned subsidiary of Dova Pharmaceuticals,
Inc., is the exclusive licensee and distributor of DOPTELET®
in the United States and its territories. ©2018DOPTELET®
is a registered trademark of AkaRx, Inc.
PM-US-DOP-0072
The Xifaxan 550 mg product and the Xifaxan trademark are
licensed by Alfasigma S.p.A. to Salix Pharmaceuticals or its
affiliates.
SAL.0103.USA.18
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