SOUTH SAN FRANCISCO, Calif.,
Oct. 15, 2020 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) ("Titan" or the
"Company") today announced a strategic restructuring designed to
position it for future growth. Specifically, the Company plans
to:
- Restructure the Company to focus on ProNeura®-based
product development, specifically a kappa opioid receptor agonist
and nalmefene;
- Discontinue its U.S. Probuphine® (buprenorphine)
implant sales and wind down Probuphine commercialization
activities;
- Make strategic senior management changes;
- Substantially reduce its operating costs; and
- Complete negotiations with its lenders to eliminate outstanding
debt.
Probuphine
Probuphine is the first product based on Titan's ProNeura
technology approved in the U.S., Canada and the European Union ("EU") for the
maintenance treatment of opioid use disorder ("OUD") in clinically
stable patients taking 8 mg or less a day of oral
buprenorphine.
Commercializing Probuphine with the requirements of the current
product label, as well as the Risk Evaluation and Mitigation
Strategy, or REMS, program has proven to be onerous. Other factors
that have negatively impacted Titan's ability to effectively
commercialize Probuphine include the financial constraints that
have limited our sales and marketing capabilities; suboptimal
reimbursement rates; and the complexity of the distribution
channel. The complexity of the changing environment due to the
COVID-19 pandemic has exacerbated these issues. As a result, sales
of Probuphine have been, and would likely continue for the
foreseeable future to be, extremely limited.
Accordingly, Titan's Board has determined to wind down its U.S.
Probuphine business and redirect its focus and resources on its
ProNeura-based product development efforts.
Key ProNeura-Based Product Development Programs
Kappa Opioid Receptor Agonist Peptide Implant
In October 2020, Titan entered
into a non-binding term sheet with JT Pharma for the acquisition
and development of JT-09 for use in combination with Titan's
ProNeura technology. James McNab, a
member of our board of directors, is a principal of JT Pharma.
Several years ago, we began limited laboratory work in
collaboration with JT Pharma to assess the feasibility of
delivering JT-09 through ProNeura implants in animal models. Our
initial work focused on JT-09's ability to activate peripheral
kappa opioid receptors, with the JT-09 ProNeura implants
potentially providing a non-addictive treatment for certain types
of pain. Recently, we have begun exploring the feasibility of using
JT-09 ProNeura implants in the treatment of pruritus. We believe,
based on our early animal data, that subcutaneous administration of
the JT-09 ProNeura implants could potentially deliver therapeutic
concentrations of JT-09 for up to one year.
Cara Therapeutics Inc. (NASDAQ:CARA) has recently demonstrated
in phase 2 and phase 3 clinical trials the efficacy of a selective
kappa opioid receptor agonist peptide, CR845, in the treatment of
pruritus associated with end-stage kidney disease.
Nalmefene Implant
In September 2019, the National
Institute for Drug Addiction ("NIDA") awarded Titan approximately
$8.7 million in a two-year grant for
its nalmefene implant development program for the prevention of
opioid relapse following detoxification. This grant provides funds
for the completion of implant formulation development, cGMP
manufacturing and non-clinical studies required for filing an
Investigation New Drug ("IND") application.
During the first quarter of 2020, the Company met with the U.S.
Food and Drug Administration ("FDA") to review Titan's non-clinical
development plans and obtain guidance regarding filing an IND.
Titan has been making good progress with the IND-enabling
non-clinical studies, which it expects to complete in mid-2021,
followed by filing of the IND.
Strategic Management Changes
As disclosed in August 2020,
Titan's President & CEO, Sunil
Bhonsle, has expressed his desire to retire. Accordingly,
the current Executive Chairman, Marc
Rubin, M.D., will assume the position of Chairman and CEO,
and its current Executive Vice President and Chief Scientific
Officer, Kate Beebe DeVarney, Ph.D.,
will be appointed President and Chief Operating Officer.
Significant Reduction in Operating Costs and Negotiations to
Eliminate Debt
While there will be costs in the near term associated with the
wind down of commercial operations and Titan's transition back to a
development stage company, the change is expected to result in a
lower operating cash burn moving forward. Also, in support of its
efforts to continue as a research and development company, Titan is
in negotiations to eliminate its outstanding debt, which is secured
by a lien on all of its assets. There can be no assurance regarding
the timing or outcome of these efforts, all of which will depend on
the Company's ability to raise additional capital.
Comments from Management
"Marketing of Probuphine in the U.S. has used considerable
resources over the past two years and would continue to require
additional investments for meaningful growth," commented Dr. Rubin.
"After careful review of the recent sales and marketing results, we
recognize the improbability of near-term indicators of material
revenue growth for Probuphine. Accordingly, we have decided to
discontinue sales and wind down commercialization activities for
Probuphine. Our plan is to focus on our ProNeura-based product
development programs. Of course, we are also open to evaluating
reasonable offers, if any, that we receive from interested
third-parties to continue making Probuphine commercially available
in the U.S."
Commenting on the management changes announced today, Dr. Rubin
said, "On behalf of everyone at Titan, I would like to thank Sunil
for his many contributions over the years and wish him well in his
retirement. At the same time, I am excited that Kate has agreed to
take on an expanded role as President and Chief Operating Officer.
Kate's long-standing leadership across multiple functional areas of
the company has been greatly valued, and I believe she is
exceptionally well qualified to lead Titan's overall
operations."
"While I am deeply disappointed that we can no longer support
the commercialization of Probuphine, I look forward to working with
Marc and the Titan team to strategically advance the ProNeura
delivery platform across key development programs, specifically our
NIDA-funded nalmefene implant program for OUD and our newly
acquired kappa opioid agonist peptide for the treatment of
pruritus," said Dr. DeVarney. "I have greatly enjoyed working with
Sunil over the past 14 years and wish him all the best in his
well-earned retirement."
About Probuphine
Probuphine is the only subdermal implant designed to deliver
buprenorphine continuously for six months following insertion.
Probuphine was developed using ProNeura®, the continuous drug
delivery system developed by Titan that consists of a small, solid
implant made from a mixture of ethylene-vinyl acetate and a drug
substance. The resulting construct is a solid matrix that is placed
subdermally, normally in the upper inner arm in an outpatient
office procedure and removed in a similar manner at the end of the
treatment period. The U.S. Food and Drug Administration ("FDA")
approved Probuphine in May 2016, and
it is the first and only buprenorphine implant available for the
maintenance treatment of opioid addiction in eligible patients.
IMPORTANT SAFETY INFORMATION INCLUDING INDICATION AND BOXED
WARNING
INDICATION
PROBUPHINE is an implant that contains the medicine
buprenorphine. PROBUPHINE is used to treat certain adults who are
addicted to (dependent on) opioid drugs (either prescription or
illegal). PROBUPHINE is indicated for the maintenance treatment of
opioid dependence in patients who have achieved and sustained
prolonged clinical stability on low-to-moderate doses (doses no
more than 8 mg per day) of a buprenorphine-containing product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
It is not known if PROBUPHINE is safe or effective in children
less than 16 years of age.
IMPORTANT SAFETY INFORMATION
WARNING:
COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
See Full Prescribing Information for complete Boxed
Warning
|
Serious
complications may happen from insertion and removal of PROBUPHINE,
including:
- Nerve or blood
vessel injury in your arm
- Movement of implant
(migration). PROBUPHINE or pieces of it can move into blood
vessels, possibly to your lung, and could lead to death
- Implant sticks out
of the skin (protrusion)
- Implant comes out
by itself (expulsion)
|
Call your healthcare provider right away if:
- PROBUPHINE sticks out of the skin or comes out by itself
- You have bleeding or symptoms of infection at the site after
insertion or removal, including excessive or worsening itching,
pain, irritation, redness, or swelling
- You have numbness or weakness in your arm after the insertion
or removal procedure
- You have weakness or numbness in your arm, or shortness of
breath
If the implant comes out by itself, keep it away from others,
especially children, as it may cause severe difficulty in breathing
and possibly death.
Because of the risk of complications of, migration, protrusion,
expulsion and nerve injury with insertion and removal of
PROBUPHINE, it is only available through a restricted program
called the PROBUPHINE REMS Program. Healthcare providers who
prescribe and/or insert PROBUPHINE must be certified with the
program by enrolling and completing live training.
- PROBUPHINE is not available in retail pharmacies
- PROBUPHINE must be inserted or removed only in the facility of
the certified prescriber
Implants may be difficult to locate if inserted too deeply, if
you manipulate them, or if you gain significant weight after
insertion. Your healthcare provider may do special procedures
or tests, or refer you to a surgical specialist to remove the
implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and
life-threatening problems, especially if you take or use certain
other medicines or drugs. Call your healthcare provider right
away or get emergency help if you:
Feel faint or dizzy, have mental changes such as confusion,
slower breathing than you normally have, severe sleepiness, blurred
vision, problems with coordination, slurred speech, cannot think
well or clearly, high body temperature, slowed reflexes, feel
agitated, stiff muscles or have trouble walking.
These can be signs of an overdose or other serious
problems.
Coma or death can happen if you take anxiety medicines or
benzodiazepines, sleeping pills, tranquilizers, or sedatives,
antidepressants, or antihistamines, or drink alcohol during
treatment with PROBUPHINE. Tell your healthcare provider if you are
taking any of these medicines or if you drink alcohol.
Who should not use PROBUPHINE?
Do not use PROBUPHINE if you are allergic to buprenorphine or
any of its ingredients, this includes buprenorphine hydrochloride
and the inactive ingredient ethylene vinyl acetate or EVA.
PROBUPHINE may not be right for you. Before starting
PROBUPHINE tell your doctor about all of your medical conditions,
including:
Trouble breathing or lung problems, an enlarged prostate gland
(men), a head injury or brain problem, problems urinating, a curve
in your spine that affects your breathing, liver problems,
gallbladder or adrenal gland problems, Addison's disease, low
thyroid hormone levels (hypothyroidism), a history of alcoholism, a
history of keloid formation, connective tissue disease (such as
scleroderma), or history of MRSA infections, mental problems such
as hallucinations, an allergy to numbing medicines or medicines
used to clean your skin, are pregnant or plan to become pregnant or
are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
What should I avoid while being treated with
PROBUPHINE?
- Do not drive, operate heavy machinery, or perform any other
dangerous activities until you know how this medication affects
you
- You should not drink alcohol during treatment. You
should not take anxiety medicines or benzodiazepines, sleeping
pills, tranquilizers, or sedatives that are not prescribed to you
during treatment with PROBUPHINE, as this can lead to slowed
breathing, drowsiness, delayed reaction time, loss of consciousness
or even death
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
- Infection at the insertion or removal
site. Infection may happen at the implant site during
insertion or removal. Do not try to remove PROBUPHINE implants
yourself
- Opioid withdrawal. If PROBUPHINE comes out of your
arm or if you stop treatment, tell your doctor right away as you
can have symptoms of shaking, sweating more than normal, feeling
hot or cold more than normal, runny nose, watery eyes, goose bumps,
diarrhea, vomiting and muscle aches
- Physical dependency
- Liver problems. Call your doctor right away if you
notice signs of liver problems that may include your skin or the
white part of your eyes turning yellow (jaundice)
- Allergic reaction. If you get a rash, hives,
itching, swelling of your face, or wheezing, low blood pressure,
dizziness or decrease in consciousness
- Decrease in blood pressure. You may feel dizzy when you
get up from sitting or lying down
- Sleep Apnea. Call your doctor right away if you or
someone close to you notices: Observed episodes of stopped
breathing or abnormal breathing patterns during sleep
Tell your healthcare provider if you develop any of the
symptoms listed.
Common side effects of PROBUPHINE include: Headache,
nausea, toothache, constipation, depression, vomiting, back pain,
mouth and throat pain.
Common risks with the minor surgical procedure:
Itching, pain, irritation, redness, swelling, bleeding, or bruising
at the insertion or removal site. Scarring around the insertion
site.
Please read Full Prescribing Information,
including BOXED WARNING regarding IMPLANT MIGRATION,
PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION
AND REMOVAL.
Titan encourages you to report negative side effects of
prescription drugs to the FDA. You can
visit www.fda.gov/safety/medwatch/ or call
1-800-FDA-1088.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is a commercial stage
company developing proprietary therapeutics with its ProNeura®
long-term, continuous drug delivery technology. The ProNeura
technology has the potential to be used in developing products for
treating a number of chronic conditions, where maintaining
consistent, around-the-clock blood levels of medication may benefit
the patient and improve medical outcomes. For more information
about Titan, please visit www.titanpharm.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
product development programs and any other statements that are not
historical facts. Such statements involve risks and uncertainties
that could negatively affect our business, operating results,
financial condition and stock price. Factors that could cause
actual results to differ materially from management's current
expectations include those risks and uncertainties relating to the
commercialization of Probuphine, the regulatory approval process,
the development, testing, production and marketing of our drug
candidates, patent and intellectual property matters and strategic
agreements and relationships. We expressly disclaim any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as
required by law.
CONTACT:
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
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SOURCE Titan Pharmaceuticals, Inc.