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EKR THERAPEUTICS
AND PDL BIOPHARMA SIGN ASSET PURCHASE AGREEMENT FOR CARDIOVASCULAR
PRODUCTS
Cedar Knolls,
NJ and Redwood City, Calif., (February 4, 2008) – EKR Therapeutics,
Inc. and PDL BioPharma, Inc. (Nasdaq: PDLI) today announced that
they have entered into an agreement under which EKR would acquire
the rights to PDL’s cardiovascular products, consisting of Cardene®
I.V. (nicardipine hydrochloride), Cardene SR® and new formulations
of Cardene in development, as well as Retavase® (reteplase) and the
development product ularitide. Under the terms of the agreement, PDL
would receive cash payments of $85 million at closing, up to an
additional $85 million in development and sales milestones for the
new Cardene formulations, as well as royalties on sales of the new
Cardene formulations and ularitide.
Howard Weisman, EKR’s Chairman and CEO said, “In addition to our
core competency in the acute-care setting, EKR is uniquely well
positioned to maximize the market potential of the PDL products, and
we expect our revenues to increase at least ten-fold as a result of
this transaction.” Weisman noted that many of the EKR management
team and several of its investors had previously collaborated on
Cardene and Retavase. “Thus, we have strong operating experience in
that market space which we can leverage in implementing our
long-term strategies for these products and for the Cardene line
extensions.”
L. Patrick Gage, Ph.D., interim chief executive officer for PDL
said, “We are pleased to have executed agreements to sell all of our
commercial and cardiovascular assets, consistent with our stated
goals.” He continued, “Today’s announced transaction represents
another important achievement toward our goal to maximize the value
of PDL’s assets for our stockholders. In connection with our
strategic process, we continue to explore our alternatives for our
remaining assets, including our royalty stream and our biotech R&D
and manufacturing assets, and potential mechanisms to distribute
proceeds from our completed transactions."
At the close of the transaction, EKR would acquire all rights to the
cardiovascular products, including related trademarks, patents,
intellectual property, product inventory and other related assets.
EKR expects to hire a number of PDL’s commercial employees in
support of the expanded product portfolio associated with this
acquisition. In addition, EKR will focus all development efforts on
the launch of the new Cardene formulations and will not pursue
additional development for the product in pediatric patients. PDL
and EKR agree that the long-term value of the Cardene franchise can
be both well protected and substantially enhanced by strategically
focusing lifecycle management programs on the high growth potential
of new formulations for the product.
In addition to the $85 million cash payment at closing, the
agreement provides for potential milestones and royalties payable to
PDL. PDL would receive a $25 million milestone upon the approval of
a new formulation of Cardene, which PDL anticipates will occur well
in advance of the November 2009 Cardene I.V. patent expiry. Two
additional milestones of $30 million each would be payable upon
achievement of $80 million and $150 million of annual net product
sales of the new Cardene formulations. EKR also would pay PDL
royalties of ten percent and five percent on future net sales of the
new Cardene formulations and ularitide, respectively.
The transaction has been approved by the boards of directors of both
companies and is expected to close during the first quarter of 2008,
subject to antitrust clearance under the Hart-Scott-Rodino Act and
satisfaction of financing-related and other customary conditions.
EKR has secured financing commitments from its debt and equity
sources. EKR's equity financing for the transaction is being led by
MPM Capital and LLR Partners. Also participating in the equity
financing are existing EKR investors: Quaker BioVentures and Garden
State Life Sciences Venture Fund managed by Quaker, plus NewSpring
Capital and ESP Equity Partners. As part of the transaction, Steven
St. Peter of MPM and Scott Perricelli of LLR will join the EKR
board.
Cowen and Company, LLC is acting as financial advisor and Milbank,
Tweed, Hadley & McCloy LLP is acting as legal advisor to EKR in
connection with the transaction. Merrill Lynch & Co. is acting as
financial advisor and DLA Piper is acting as legal advisor to PDL in
connection with the transaction.
About Cardene® I.V. (nicardipine hydrochloride)
Cardene I.V. was approved in the United States by the U.S. Food and
Drug Administrator (FDA) in January 1992 for the short-term
treatment of hypertension when oral therapy is not feasible or
desirable. Cardene I.V. is the only intravenous calcium channel
blocker (calcium ion influx inhibitor) for this indication. Cardene
I.V. offers rapid, precise blood pressure control and has been
proven to be as effective as sodium nitroprusside with fewer dose
adjustments (1).
Cardene I.V. plus Cardene SR net product sales for the 12 months
ended September 30, 2007 were $143.9 million.
References
1 Chest 1991; Vol 99:393-398.
About Retavase
Retavase® (reteplase) is a fibrinolytic agent that was approved by
the U.S. Food and Drug Administration (FDA) in October 1996 for the
management of acute myocardial infarction (AMI) or heart attack in
adults for the improvement of ventricular function following AMI,
the reduction of the incidence of congestive heart failure and the
reduction of mortality associated with AMI. Treatment should be
initiated as soon as possible after the onset of AMI symptoms.
Retavase net product sales for the 12 months ended September 30,
2007 were $21.6 million.
About Ularitide
Ularitide is a synthetic form of urodilatin, a naturally occurring
human natriuretic peptide that is involved in regulating blood
pressure and the excretion of water and sodium from the kidneys.
Urodilatin is produced in the kidney and excreted into the urine,
and thus exists in low levels naturally in the systemic circulation.
When injected intravenously into the blood, ularitide appears to
cause diuresis (urine output) and natriuresis (sodium excretion), as
well as vasodilation. Ularitide is currently in Phase 2 development
as a potential treatment for patients with acute decompensated heart
failure (ADHF). PDL BioPharma holds worldwide development and
marketing rights for all indications.
About EKR Therapeutics
EKR Therapeutics is a privately held specialty pharmaceutical
company that has brought together a highly seasoned team of industry
professionals. The Company focuses on the acquisition, development
and commercialization of proprietary products to enhance patient
quality-of-life in the acute setting, including pain management and
oncology supportive care. From its inception in late 2005, EKR has
been organized to be a class leader in commercializing products to
address unmet and under-satisfied medical needs or to otherwise
enhance the therapeutic value of acute-care prescription products.
EKR’s goal is to be the pre-eminent provider of acute-care specialty
products, backed by a commitment to excellence in customer service
and medical education programs. The Company’s product offerings
include DepoDur® for post-operative pain management and Gelclair®
for treating oral mucositis. For additional information about EKR
visit the Company’s website at www.ekrtx.com. Full prescribing
information for DepoDur and Gelclair are available, respectively, at
www.depodur.com and www.gelclair.com.
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on
discovering, developing and commercializing innovative therapies for
severe or life- threatening illnesses. For more information, please
visit www.pdl.com.
NOTE: PDL BioPharma and the PDL BioPharma logo are considered
trademarks of PDL BioPharma, Inc. and Cardene I.V. and Retavase are
registered U.S. trademarks of PDL BioPharma, Inc.
Forward-looking Statements
This press release contains forward-looking statements, including
regarding the expected closing of PDL's sale of product rights to
EKR and the potential approval of a new formulation of Cardene, each
of which involves risks and uncertainties. Actual results may differ
materially from those, express or implied, in these forward-looking
statements. The consummation of the sale of PDL's product rights to
EKR could be adversely impacted or prevented by failure to satisfy
closing conditions, regulatory delays, EKR’s inability to obtain
adequate financing notwithstanding the commitments it has received
from potential debt sources and equity investors or other
developments. The potential approval of the new formulation and the
payment of royalties and milestones to PDL will depend upon
regulatory actions and the efforts of PDL and EKR. Other factors
that may cause PDL's actual results to differ materially from those
expressed or implied in the forward-looking statements in this press
release are discussed in PDL's filings with the Securities and
Exchange Commission (SEC), including the "Risk Factors" sections of
its annual and quarterly reports filed with the SEC. Copies of PDL's
filings with the SEC may be obtained at the "Investors" section of
PDL's website at http://www.pdl.com. PDL expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in PDL's expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statements are based for any reason, except as required by law, even
as new information becomes available or other events occur in the
future. All forward-looking statements in this press release are
qualified in their entirety by this cautionary statement.
Contacts:
EKR Therapeutics:
Stuart Z. Levine, Ph.D.
877-435-2524 x 107
s.levine@ekrtx.com
PDL BioPharma:
Kathleen Rinehart (Media) Jean Suzuki (Investors)
(650) 454-2543 (650) 454-2648
kathleen.rinehart@pdl.com jean.suzuki@pdl.com
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