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 February
4, 2008 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® 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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