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Impax will Commercialize up to Nine Products in 2012
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Expected to be Accretive to Impax’s EPS in 2012
HAYWARD, Calif. & FORT COLLINS, Colo.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) and TOLMAR, Inc. today
announced that they will collaborate on a multiproduct agreement for the
development, supply and distribution of generic topical prescription
drug products. As part of the Development, Distribution and Supply
Agreement (the “Agreement”), TOLMAR will supply up to nine currently
approved and marketed products, and Impax’s generics division, Global
Pharmaceuticals, will commercialize these products following a short
transition period. According to Wolters Kluwer Health, total U.S. brand
and generic sales of these nine multi-source products were approximately
$378 million in the 12 months ended May 2012. The Agreement also
includes two additional generic topical prescription drug products of
which one is currently in development and one is a first-to-file
Abbreviated New Drug Application (ANDA) pending approval at the U.S.
Food and Drug Agency (FDA).
Under the terms of the Agreement, Impax will pay TOLMAR $21 million upon
the closing and up to $25 million in milestone payments, if certain
commercialization and ANDA approval targets are met. In addition, Impax
will pay TOLMAR a profit share for each product commercialized. The
transaction is expected to be accretive to Impax’s earnings per share
(EPS) in 2012.
“We are excited to further enhance our relationship with TOLMAR on these
products as we continue to diversify our generic product portfolio,”
said Larry Hsu, Ph.D., president and CEO of Impax Laboratories. “This
represents Global Pharmaceuticals first opportunity to commercialize
alternative dosage form products alongside our existing portfolio of
tablets and capsules. Our business development activities will continue
to focus on delivering growth from high-value products, technologies,
and businesses in complementary dosage forms.”
Mike Duncan, CEO of TOLMAR, said: “We are very excited about this
expansion of our already strong relationship with Impax Laboratories.
This agreement is aligned with our long term strategy and we firmly
believe that Impax Laboratories is the right partner for these products.
From its inception in 2006, TOLMAR has been developing and introducing
new products to the market through strategic partnerships. We look
forward to working with Impax Laboratories as we continue to expand our
product offerings in the generic dermatology space.”
Agreement Product Details
Approved ANDA products:
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Betamethasone Dipropionate Cream (Augmented) 0.05%
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Calcipotriene Topical Solution 0.005%
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Fluticasone Propionate Cream 0.05% (not currently marketed)
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Imiquimod Cream 5%
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Lidocaine 2.5% / Prilocaine Cream 2.5%
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Metronidazole Topical Gel 0.75%
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Mometasone Furoate Lotion 0.1%
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Mometasone Furoate Ointment 0.1%
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Mometasone Furoate Cream 0.1%
Pending and Under Development ANDA products:
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Diclofenac Gel 3% (generic to Solaraze®) – According to Wolters Kluwer
Health, U.S. sales of Solaraze® 3% gel were approximately $131 million
in the 12 months ended May 2012.
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One ANDA topical product under development.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a
technology based specialty pharmaceutical company applying its
formulation expertise and drug delivery technology to the development of
controlled-release and specialty generics in addition to the development
of branded products. Impax markets its generic products through its
Global Pharmaceuticals Division and markets third-party branded products
through the Impax Pharmaceuticals Division. Additionally, where
strategically appropriate, Impax has developed marketing partnerships to
fully leverage its technology platform. Impax Laboratories is
headquartered in Hayward, California, and has a full range of
capabilities in its Hayward, Philadelphia and Taiwan facilities. For
more information, please visit the Company's Web site at: www.impaxlabs.com.
About TOLMAR, Inc.
TOLMAR, Inc. is a northern Colorado based
pharmaceutical research, development, manufacturing and commercial
operations company. TOLMAR develops and manufacturers both proprietary
and generic pharmaceutical products. TOLMAR provides its customers with
a competitive and sustainable combination of product development and
commercial services. The company’s strengths include a proven
development, clinical, regulatory and manufacturing infrastructure with
a highly trained and experienced staff. Several of its marketed products
are still in an early stage growth mode. TOLMAR products are
commercialized through marketing partners in over fifty five countries
worldwide, including North America and Europe.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this
news release contain information that is not historical, these
statements are forward-looking in nature and express the beliefs and
expectations of management. Such statements are based on current
expectations and involve a number of known and unknown risks and
uncertainties that could cause the Company’s future results, performance
or achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Such risks and uncertainties include, but are not limited to, the effect
of current economic conditions on the Company’s industry, business,
financial position and results of operations, fluctuations in the
Company’s revenues and operating income, the Company’s ability to
successfully develop and commercialize pharmaceutical products,
reductions or loss of business with any significant customer, the impact
of consolidation of the Company’s customer base, the impact of
competition, the Company’s ability to sustain profitability and positive
cash flows, any delays or unanticipated expenses in connection with the
operation of the Company’s Taiwan facility, the effect of foreign
economic, political, legal and other risks on the Company’s operations
abroad, the uncertainty of patent litigation, increased government
scrutiny on the Company’s agreements with brand pharmaceutical
companies, consumer acceptance and demand for new pharmaceutical
products, the difficulty of predicting Food and Drug Administration
filings and approvals, the Company’s inexperience in conducting clinical
trials and submitting new drug applications, the Company’s ability to
successfully conduct clinical trials, the Company’s reliance on third
parties to conduct clinical trials and testing, the availability of raw
materials and impact of interruptions in the Company’s supply chain, the
use of controlled substances in the Company’s products, disruptions or
failures in the Company’s information technology systems and network
infrastructure, the Company’s reliance on alliance and collaboration
agreements, the Company’s dependence on certain employees, the Company’s
ability to comply with legal and regulatory requirements governing the
healthcare industry, the regulatory environment, the Company’s ability
to protect the Company’s intellectual property, exposure to product
liability claims, changes in tax regulations, the Company’s ability to
manage the Company’s growth, including through potential acquisitions,
the restrictions imposed by the Company’s credit facility, uncertainties
involved in the preparation of the Company’s financial statements, the
Company’s ability to maintain an effective system of internal control
over financial reporting, any manufacturing difficulties or delays, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines and other risks described in the Company’s
periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and Impax undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
Source: Impax Laboratories, Inc.