SOUTH SAN FRANCISCO, Calif.,
April 29, 2019 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced
that the Committee for Medicinal Products for Human Use ("CHMP") of
the European Medicines Agency ("EMA") has adopted a positive
opinion recommending the granting of a marketing authorization for
the medicinal product Sixmo, the brand name for Probuphine
(buprenorphine) implant in the European Union ("EU"). Sixmo is
indicated for substitution treatment for opioid dependence in
clinically stable adult patients who require no more than 8 mg/day
of sublingual buprenorphine, within a framework of medical, social
and psychological treatment.
The CHMP is a scientific committee composed of representatives
from the EU, Iceland, Norway and Liechtenstein. The CHMP reviews medical
product applications on their scientific and clinical merit and
provides advice to the European Commission ("EC"), which has the
authority to approve medicines for the EU.
The CHMP's positive opinion of Sixmo will now be transmitted to
the EC, which is expected to issue the Commission Decision for
Sixmo for all 28 member states of the EU around the end of
June 2019. The translations of the
Product Information Annexes, which include the Summary of Product
Characteristics (SmPC), will be provided and reviewed in parallel
in all EU official languages.
In March 2018, Titan entered into
a definitive asset purchase, supply and support agreement with
Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
("Molteni") through which Molteni acquired the European
intellectual property related to Probuphine, including the MAA
under review by the EMA, and gained the exclusive right to
commercialize the Titan supplied Probuphine product in Europe, as well as certain countries of the
Commonwealth of Independent States, the Middle East and North Africa.
"Obtaining this positive CHMP opinion is an important step
toward bringing this unique six month buprenorphine treatment to
people in Europe living with
opioid dependence, and represents a significant milestone for
Titan, as well as for our commercialization partner, Molteni," said
Titan's President and CEO, Sunil
Bhonsle. "With Probuphine already approved and commercially
available in the United States and
Canada, we are looking forward to
supporting Molteni as it prepares for Sixmo's pending European
launch, while we also continue to work together to evaluate
pursuing opportunities to commercialize the product in additional
regions around the world to help reduce the significant social,
economic and health burden associated with opioid dependence."
Molteni's Managing Director, Giuseppe Seghi Recli, commented,
"We are pleased that our close collaboration with Titan over the
past year has resulted in this positive CHMP opinion for Sixmo. In
the world's second largest market for buprenorphine-based products,
we believe Sixmo's unique six-month treatment period will offer
European healthcare providers and patients with opioid dependence
an attractive, novel treatment option. This significant achievement
is in line with our European strategy of growth along our main
therapeutic areas."
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 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 transmucosal buprenorphine-containing
product.
PROBUPHINE is part of a complete treatment program that also
includes counseling and behavioral therapy.
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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 and to your lung,
and could lead to death.
- Implant sticks out of the skin
(protrusion)
- Implant comes out by itself (expulsion)
|
Contraindications
Hypersensitivity to buprenorphine or any other ingredients in
PROBUPHINE (e.g., EVA).
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
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
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.
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 U.S. Full Prescribing Information, including
BOXED WARNING.
Titan encourages you to report negative side effects of
prescription drugs to the FDA. You can click here 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 company's lead product is Probuphine®
(buprenorphine) implant, a novel and long-acting formulation of
buprenorphine for the long-term maintenance treatment of opioid
dependence. Approved by the FDA in May
2016, Probuphine is the first and only commercialized
treatment of opioid dependence to provide continuous,
around-the-clock blood levels of buprenorphine for six months
following a single procedure. The ProNeura technology also has the
potential to be used in developing products for treating other
chronic conditions such as Parkinson's disease and hypothyroidism,
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.
About Molteni
Founded in Florence in 1892, Molteni is a privately-held
specialty pharmaceutical company developing, manufacturing and
marketing pharmacological treatments for addictions and moderate to
severe pain. Molteni is a leader in the field of drug
dependence. Molteni operates both directly and through its network
of specialized partners in more than 50 countries and it is a
preferred and qualified partner of International Organizations and
Non-Governmental Organizations such as UNICEF, UNDP, IDA Foundation
and Global Fund. For more information, please visit
www.moltenifarma.it.
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 commercialization and 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.
CONTACTS:
Sunil Bhonsle,
President & CEO
(650) 244-4990
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
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SOURCE Titan Pharmaceuticals, Inc.