Titan
Pharmaceuticals, Inc. is a biopharmaceutical Company developing
proprietary therapeutics primarily for the treatment of serious
medical disorders.
Titan’s
principal asset is Probuphine®, the first slow-release implant
formulation of buprenorphine hydrochloride (“buprenorphine”),
designed to maintain a stable, round-the-clock blood level of the
medicine in patients for up to six months following a single
treatment. The outpatient treatment of opioid dependence with daily
dosed sublingual buprenorphine formulations represents a $1.3 billion
market in the U.S., and a seven day transdermal patch formulation of
buprenorphine for the treatment of chronic pain was launched in the
U.S. in 2011. This novel implant formulation is inserted subdermally
in a patient’s upper arm providing continuous medication, and has
the potential to enhance patient compliance to treatment, and limit
diversion for illicit use and accidental exposure to the sublingual
formulations.
The
New Drug Application (NDA) was submitted to the FDA in October, 2012
seeking approval for treatment of opioid dependence. In December
2012, Titan entered into a license agreement with Braeburn
Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive
commercialization rights to Probuphine® in the United States and
Canada. Titan received a non-refundable up-front license fee of
$15.75 million and will receive a $50 million milestone payment upon
the approval of the NDA by the FDA. Additionally, Titan will be
eligible to receive up to $130 million upon achievement of specified
sales milestones and up to $35 million in regulatory milestones in
the event of future NDA submissions and approvals for additional
indications, including chronic pain. Titan will receive tiered
royalties on net sales of Probuphine ranging from the mid-teens to
the low twenties.
Probuphine
is the first product to utilize ProNeura™, a novel, proprietary,
long-term drug delivery technology. The ProNeura technology has the
potential to be used in developing products for the treatment of
other chronic conditions, such as Parkinson’s disease, where
maintaining stable, round-the-clock blood levels of a drug can
benefit the patient and improve medical outcomes.
Continuous
Drug Delivery Technology
The
continuous drug delivery system consists of a small, solid rod made
from a mixture of ethylene-vinyl acetate (“EVA”) and a drug
substance. The resulting product is a solid matrix that is placed
subcutaneously, normally in the inner part of the upper arm in a
simple office procedure, and is removed in a similar manner at the
end of the treatment period. The drug substance is released slowly,
at continuous levels, through the process of dissolution. This
results in a stable blood level similar to intravenous
administration. Such long-term, linear release characteristics are
generally desirable as this avoids peak and trough level dosing that
poses problems for many Central Nervous System (“CNS”) and other
disease settings.
This
continuous drug delivery technology was developed to address the need
for a simple, practical method to potentially provide continuous drug
administration on an outpatient basis over extended periods of up to
6-12 months. In addition to Probuphine, which is the first product to
complete clinical testing that has utilized this proprietary
continuous drug delivery technology, Titan has conducted initial
non-clinical studies with long-term delivery of dopamine agonists
demonstrating the potential of this product in the treatment of
Parkinson’s disease in non-clinical models of the disease.
Strategic
Alliances
In
December 2012, Titan entered into a license agreement with Braeburn
Pharmaceuticals Sprl (“Braeburn”) that grants Braeburn exclusive
commercialization rights to Probuphine® in the United States and
Canada. Titan received a non-refundable up-front license fee of
$15.75 million and will receive a $50 million milestone payment upon
the approval of the NDA by the FDA. Additionally, Titan will be
eligible to receive up to $130 million upon achievement of specified
sales milestones and up to $35 million in regulatory milestones in
the event of future NDA submissions and approvals for additional
indications, including chronic pain. Titan will receive tiered
royalties on net sales of Probuphine ranging from the mid-teens to
the low twenties.
Novartis
Pharma, AG, has licensed the rights to commercialize Fanapt in the
U.S. and Canada, and commenced marketing the product in the U.S. in
Q1, 2010. Titan is entitled to receive a royalty of 8-10% on the
global net sales of this product. Titan does not incur any expenses
related to this product.
Source:
Titan Pharmaceuticals, OxBridge
Research, Daily
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