SOUTH SAN FRANCISCO, Calif.,
March 21, 2018 /PRNewswire/
-- 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 Società
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."
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 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.
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.