Full Press Release Details
TITAN EXECUTES AGREEMENT FOR ACQUISITION
PROBUPHINE IN EUROPE AND OTHER SELECT TERRITORIES
Molteni makes upfront payment of
approximately $2.4 million and an indirect strategic
investment through the purchase of $2.4 million of Horizon's debt
SOUTH SAN FRANCISCO, CA - March
21, 2018 - Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that it has entered into a definitive asset purchase,
supply and support agreement with L. Molteni & C. dei F.lli Alitti Societ di Esercizio S.p.A. through which Molteni
has acquired the European intellectual property related to Probuphine, including the Marketing Authorization Application (MAA)
under review by the European Medicines Agency (EMA), and will have 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 (the
"Molteni Territory").
Titan received an initial payment of 2.0
million (approx. $2.4 million) for the purchased assets and will receive potential additional payments totaling up to 4.5
million (approx. $5.5 million) upon the achievement of certain regulatory and product label milestones. Additionally, Titan is
entitled to receive earn-out payments for up to 15 years on net sales of Probuphine in the Molteni Territory ranging in percentage
from the low-teens to the mid-twenties. The agreement supersedes the previously executed term sheet that contemplated a license
arrangement with respect to the intellectual property Titan has sold to Molteni.
As part of the transaction, Molteni also
made an indirect strategic investment in Titan by purchasing $2.4 million of the outstanding $4.0 million principal balance owed
under Titan's July 2017 loan agreement with Horizon Technology Finance Corporation. In connection with an amendment and restatement
of the loan agreement, Molteni was appointed collateral agent and assumed majority and administrative control of the debt and the
interest only payment and forbearance periods were extended to December 31, 2019. Upon meeting certain conditions, including repayment
of the remaining principal amount of $1.6 million to Horizon, the amended and restated loan agreement also includes provisions
for conversion of Molteni's $2.4 million portion of the debt into shares of Titan's common stock at a conversion price
of $1.20 per share, representing a premium of approximately 17% to the average closing price of Titan's common stock for
the last five trading days ended March 20, 2018.
In connection with this transaction, Titan
issued to Molteni and Horizon warrants to purchase an aggregate of 580,000 shares of Titan's common stock at a per share
exercise price of $1.20.
"We are pleased to form this important
partnership with Molteni, a company with a strong track record of success launching and commercializing innovative pain and addiction
pharmaceutical products in Europe, that also shares our enthusiasm about the prospects for Probuphine," said Titan President
and CEO, Sunil Bhonsle. "In addition to providing an opportunity to expand the commercialization of Probuphine beyond the
United States, the additional financial resources and flexibility provided by this transaction enables us to evaluate options to
further strengthen our balance sheet, position Probuphine for commercial success in the U.S., and work to advance our pipeline
of other ProNeura -based product candidates."
Molteni President, Giovanni Seghi, commented,
"There has been close collaboration between the two companies as we plan the process of preparing for the potential European
launch of Probuphine, including our interactions last year with European regulators and our more recent efforts to address their
preliminary questions on the MAA. We remain confident that Probuphine has the potential to become a new paradigm for the treatment
of opioid addiction in Europe, the second largest market for buprenorphine-based products in the world."
In connection with the asset purchase and
amended loan agreements, Titan has granted Molteni board designee and observer rights.
"Our interactions with Molteni management
over the past several months have clearly demonstrated their strong commitment to Probuphine and Titan," said Titan Executive
Chairman, Dr. Marc Rubin. "We know that Molteni shares our vision for Probuphine and we are looking forward to a strong and
successful partnership."
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 30 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.
About Titan Pharmaceuticals
Titan Pharmaceuticals,
Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is developing proprietary therapeutics primarily for the treatment of select
chronic diseases. The company's lead product is Probuphine , a novel and long-acting formulation of buprenorphine for the long-term
maintenance treatment of opioid dependence. Probuphine employs Titan's proprietary drug delivery system ProNeura , which
is capable of delivering sustained, consistent levels of medication for three months or longer. 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 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.
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.