Full Press Release Details
TITAN RECEIVES APPROVAL FOR SECOND YEAR
OF NIDA GRANT FUNDING FOR DEVELOPMENT OF A NALMEFENE IMPLANT
Changes in Grant Terms Result in Additional
$2 Million Available to
Titan for Nalmefene Project Expenses
SOUTH SAN FRANCISCO, CA - September
18, 2019 - Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced that the National Institutes of Health's National
Institute on Drug Abuse (NIDA) has approved approximately $6.1 million in second-year funding for Titan's non-clinical development
of a ProNeura based six-month implantable formulation of Nalmefene, an opioid antagonist, intended for the prevention of
relapse to opioid addiction, following opioid detoxification.
NIDA awarded Titan a two-year grant in
the amount of $6.7 million in September 2018 for the project, subject to satisfactory project progress, fund availability and certain
other conditions. The award for the first year, which ended August 31, 2019, was approximately $2.7 million. As a result of a change
in the grant award terms regarding company matching funds, the second-year award covers both the Federal and company match amounts
of the original year two award, thereby increasing the aggregate potential expense reimbursement to approximately $8.7 million.
"We believe our ProNeura technology
is well-suited to this approach to treating opioid addiction, so we are grateful for NIDA's ongoing support," said
Titan's President and CEO, Sunil Bhonsle. "As we continue to execute on the program's development milestones, we are
encouraged by the potential for additional NIDA grant funding for clinical development activities beyond the current grant's
end date of September 2020."
This second-year grant award provides funds
for the completion of implant formulation development, cGMP manufacturing and non-clinical studies which, if successful, are expected
to support the Company's submission of a Nalmefene six-month implant Investigational New Drug Application to the U.S. Food
and Drug Administration. Titan retains full commercial rights to the Nalmefene implant product.
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 U.S.
Food and Drug Administration 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.
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
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:
Call your healthcare provider right away if:
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.
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
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?
What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
Tell your healthcare provider if you develop any of the symptoms
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