Titan
Pharmaceuticals, TTNP, Profile
Titan
Pharmaceuticals, TTNP, 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.
Finally,
Titan is also entitled to royalty revenue of 8-10% of net sales of
Fanapt® (iloperidone), an atypical antipsychotic compound being
marketed in the U.S. for the treatment of schizophrenia by Novartis
Pharma AG (“Novartis”) under a sub-license agreement based on a
licensed U.S. patent that expires in October 2016 (does not include a
possible six month pediatric extension). Substantially all of this
future royalty revenue has been sold to Deerfield Management
(“Deerfield”), a healthcare investment fund, in exchange for cash
and debt considerations which have been used to advance the
development of Probuphine and for general corporate purposes.
