Published on February 18, 2009
FOR IMMEDIATE
RELEASE
NOVELOS
THERAPEUTICS AND MUNDIPHARMA SIGN EXCLUSIVE
COLLABORATION
AGREEMENT IN EUROPE AND JAPAN
-
- - -
$95mil
for Cancer Compound through
Equity
Investment, Milestones and Fixed Sales-Based Payments, Plus
Royalties
NEWTON, Mass., February 11,
2009 – Novelos
Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on
the development of therapeutics to treat cancer and hepatitis, announced today
that Novelos signed an exclusive collaboration agreement with Mundipharma
International Corporation Limited to commercialize in Europe and Asia / Pacific
(excluding China) Novelos’ lead compound, NOV-002, which is in a pivotal Phase 3
trial for non-small cell lung cancer under a Special Protocol Assessment (SPA)
and Fast Track. NOV-002 has also
demonstrated positive results in Phase 2 trials for other cancer
indications.
In
parallel, Novelos has also closed a private placement with Purdue Pharma L.P.
resulting in $10 million in gross proceeds through the sale of convertible
preferred stock and warrants to purchase its common stock. Novelos
sold 200 shares of Series E convertible preferred stock, having a stated value
equal to $50,000 per share, a cumulative annual dividend of 9% of stated value
and a conversion price of $0.65 per share of common stock. Purdue
also received warrants expiring on December 31, 2015 to purchase an aggregate of
9,230,769 shares of common stock at an exercise price of $0.65 per
share.
Under the
terms of the collaboration agreement, Novelos may receive up to $25 million of
launch milestones and $60 million of fixed sales-based
payments. Novelos will receive a double-digit royalty, which
increases as the annual sales increase in the licensed
territories. Mundipharma will be responsible for certain development
activities, regulatory submissions and commercialization of NOV-002 in the
licensed territories. Novelos retains all rights and responsibilities
in the U.S.A. and the rest of the Americas.
“I am
very pleased to be collaborating with Mundipharma and Purdue, which are
innovative independent associated pharmaceutical companies with ample resources
and a proven track record of developmental and commercialization expertise,”
said Harry Palmin, President and CEO of Novelos. “This transaction
will provide the remaining capital to complete our pivotal, fully-enrolled,
840-patient Phase 3 lung cancer trial, which is currently expected to conclude
in late 2009.”
According
to Åke Wikström, Mundipharma’s Regional Director – Europe, “NOV-002 is an
important addition to our oncology pipeline and reinforces our commitment to
increasing the treatment options available for cancer patients and improving
their quality of life through the development and commercialization of novel
therapeutics.”
1
Ferghana
Partners (New York, London and Boston) served as financial and strategic
transaction advisor to Novelos. The preferred stock and warrants were
issued in a private placement transaction under Regulation D of the Securities
of Act of 1933 and have not been registered under the Securities Act of 1933, as
amended, or any state securities laws, and may not be offered or sold in the
United States absent registration with the Securities and Exchange Commission
(the “SEC”) or an applicable exemption from the registration
requirements. Novelos has agreed to file a registration statement
with the SEC covering resales of the common stock issuable upon conversion of
the newly issued shares of preferred stock and upon exercise of the
warrants.
About
Mundipharma International Corporation Limited and Purdue Pharma
L.P.
The
Purdue/Mundipharma/Napp independent associated companies are privately owned
companies and joint ventures covering the world's pharmaceutical markets. The
companies have particular expertise in drug delivery systems and these are
applied to a range of analgesics, respiratory treatments, and cardiovascular
drugs. The companies also have a growing presence in the oncology market, and
products in the areas of attention deficit hyperactivity disorder, antiseptics
and laxatives. For more information: www.mundipharma.co.uk
About
Novelos Therapeutics, Inc.
Novelos
Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized
glutathione-based compounds for the treatment of cancer and
hepatitis. NOV-002, the lead compound currently in Phase 3
development for lung cancer under SPA and Fast Track, acts together with
chemotherapy as a chemoprotectant and a chemopotentiator. NOV-002 is
also in Phase 2 development for early-stage breast cancer and
chemotherapy-resistant ovarian cancer. Novelos has a partnership with
Mundipharma to develop and commercialize NOV-002 in Europe and
Japan. Novelos’ second compound, NOV-205, acts as a hepatoprotective
agent with immunomodulating and anti-inflammatory properties. NOV-205
is in Phase 1b development for chronic hepatitis C
non-responders. Both compounds have been partnered with Lee’s Pharm
in China. For additional information about Novelos please visit www.novelos.com
# #
#
|
COMPANY
|
INVESTOR
RELATIONS
|
|
|
Harry
S. Palmin, President and CEO
|
Stephen
Lichaw
|
|
|
Ph:
617-244-1616 x11
|
Ph:
201-240-3200
|
|
|
Email:
hpalmin@novelos.com
|
Email:
slichaw@novelos.com
|
Novelos
Therapeutics, Inc.
One
Gateway Center, Suite 504
Newton,
MA 02458
This
news release contains forward-looking statements. Such statements are
valid only as of today, and we disclaim any obligation to update this
information. These statements are subject to known and unknown risks
and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on
our current beliefs and expectations as to such future outcomes. Drug
discovery and development involve a high degree of risk. Factors that
might cause such a material difference include, among others, uncertainties
related to the ability to attract and retain partners for our technologies, the
identification of lead compounds, the successful preclinical development
thereof, the completion of clinical trials, the FDA review process and other
government regulation, our pharmaceutical collaborators’ ability to
successfully develop and commercialize drug candidates, competition from other
pharmaceutical companies, product pricing and third-party
reimbursement.
2