Published:
EKR Therapeutics and PDL BioPharma Sign Asset Purchase Agreement for Cardiovascular Products


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.
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