BRISTOL, Tenn. and CRANBURY, N.J., Aug. 13 /PRNewswire-FirstCall/ -- King
Pharmaceuticals, Inc. (NYSE: KG) and Palatin Technologies, Inc. (Amex: PTN)
announced today that they have entered into a strategic alliance to jointly
develop and, on obtaining necessary regulatory approvals, commercialize
Palatin's PT-141 for the treatment of male and female sexual dysfunction.
PT-141 is the first compound in a new drug class called melanocortin
receptor agonists under development to treat sexual dysfunction. This new
chemical entity is being evaluated in phase II clinical trials studying the
efficacy and safety profile of varying doses of this novel compound in men
experiencing erectile dysfunction ("ED") and women experiencing female sexual
dysfunction ("FSD"). The mechanism of action of PT-141 may offer important
benefits over currently available products for the treatment of ED because it
acts on the pathway that controls sexual function without acting directly on
the vascular system. Clinical data indicates that PT-141 may be effective in
treating a broad range of patients suffering from ED. The nasal formulation of
PT-141 currently under development is as convenient as oral treatments, is
more patient-friendly than invasive treatments for ED, such as injections and
trans-urethral pellets, and appears to result in a rapid onset of action.
Although the current ED market is primarily served by PDE-5 inhibitors
which target the vascular system, a substantial unmet medical need for
alternative sexual dysfunction therapies exists. Many patients are
contraindicated for, or non-responsive to, PDE-5 inhibitors. For example,
unlike PDE-5 inhibitors which are contraindicated in patients taking nitrates,
primarily for the treatment of cardiovascular disease, current clinical data
indicates that PT-141 should not have any drug interactions with nitrates.
Current literature indicates that about one half of all patients who receive
an initial prescription for a PDE-5 inhibitor do not renew the prescription
due chiefly to adverse side effects, drug interaction issues, and/or the lack
of an acceptable level of responsiveness.
The companies believe that PT-141 will benefit from the success King has
achieved in marketing Altace(R) (ramipril), the leading branded ACE
(angiotensin converting enzyme) inhibitor according to IMS America
prescription data, to a similar male patient population with its experienced
sales force.
In connection with the transaction, King and Palatin entered into a
collaborative agreement for the purpose of developing and commercializing PT-
141. Pursuant to the terms of the agreement, Palatin has granted King a co-
exclusive license with Palatin to PT-141 in North America and an exclusive
right to collaborate in the licensing or sublicensing of PT-141 with Palatin
outside North America. Palatin has the option to create a urology specialty
sales force to co-promote the product in the U.S., upon commercialization.
This transaction is expected to close before the end of this quarter.
King will pay Palatin $20.0 million at closing, $5.0 million of which will
consist of an equity investment in Palatin. In addition, upon achieving
certain milestones, King could pay Palatin up to $100.0 million for achieving
certain ED and FSD development and regulatory approval targets, a portion of
which could consist of additional equity investments in Palatin, at King's
option. After regulatory approval and commercialization of PT-141, King may
also pay potential one-time milestone payments to Palatin totaling up to
$130.0 million upon achieving specified annual North American net sales
thresholds.
Under the terms of the agreement, King and Palatin will share all
collaboration development and marketing costs and all collaboration net
profits derived from net sales of PT-141 in North America based on an agreed
percentage. King and Palatin will seek a partner for PT-141 for territories
outside of North America and will jointly share in collaboration revenues
generated from those territories.
Brian A. Markison, King's President and Chief Executive Officer, stated,
"We are very excited to announce our collaborative agreement with Palatin to
jointly develop and commercialize PT-141. This transaction exemplifies our
strategy to in-license promising novel branded prescription pharmaceutical
products in development that have considerable market potential. PT-141
provides an excellent strategic fit, complementing our established primary
care and cardiovascular franchises. Additionally, when considering our pending
merger with Mylan Laboratories, Inc. and the potential strength of the
combined core competencies of King and Mylan, our ability to optimize the
commercial potential of PT-141 should be substantial. Moreover, with a
composition of matter patent that extends through 2020, PT-141 has the
potential to significantly enhance our company's long-term shareholder value."
Mr. Markison explained, "PT-141's fast-acting nasal-spray delivery method
and potentially superior drug interaction and safety profile, combined with a
unique mechanism of action that targets the central nervous system, highly
differentiates the product from currently marketed ED therapies. The vast
size of the sexual dysfunction market is well recognized and we believe PT-141
has the promise to meet the substantial unmet needs of patients who are not
able to successfully treat their ED with currently available products."
Carl Spana, Ph.D., President and Chief Executive Officer for Palatin,
commented, "This strategic alliance with King Pharmaceuticals is a validation
of our company's outstanding accomplishments in research and development and
represents a major milestone in value creation for our stockholders. In
particular, this opportunity to jointly develop and commercialize PT-141 with
King Pharmaceuticals will serve as a foundation for the continued development
of Palatin as an emerging biopharmaceutical company."
Dr. Spana continued, "This is a smart alliance that leverages each
company's strengths. By combining Palatin's first-in-class ED product and
melanocortin research and development expertise with King's demonstrated
regulatory and manufacturing capabilities, plus its well-established primary
care-physician and cardiovascular-specialist sales force, we believe the
companies can truly maximize PT-141's potential."
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to attain and maintain an
erection sufficient for sexual intercourse. The condition is correlated with
increasing age, cardiovascular disease, hypertension, diabetes, hyperlipidemia
and smoking. In addition, certain prescription drugs and psychogenic issues
may contribute to ED. It is estimated that one half of all men over the age
of 40 suffer from ED. About 150 million men worldwide and 30 million
American men suffer from ED.
About Female Sexual Dysfunction (FSD)
FSD consists of four components, including hypoactive sexual desire
disorder, female sexual arousal disorder, dyspareunia or painful intercourse
and anorgasmia. A February 10, 1999 study published in the Journal of the
American Medical Association, JAMA, titled, "Sexual Dysfunction in the United
States: Prevalence and Predictors," states that some form of FSD is prevalent
in approximately 43 percent of the female population.
Conference Call Information
King Pharmaceuticals and Palatin Technologies will host a joint conference
call and webcast today at 11:30 am E.D.T. to discuss the collaborative
agreement between the companies. Interested persons may listen to the
conference call at
http://phx.corporate-ir.net/playerlink.zhtml?c=93939&s=wm&e=927763 or by
dialing 800-795-1259 (US only), or 785-832-1508 (International), pass code KG.
If you are unable to participate during the live webcast, the call will be
archived on King's web site at http://www.kingpharm.com and Palatin's website
http://www.palatin.com for not less than 15 days following the call. In
addition, a replay of today's conference call will be available for 15 days
beginning today, by dialing 800-839-4017 (US only) or 402-220-2984
(International).
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing and product life-cycle management. As previously
reported, Mylan Laboratories Inc. and King have signed a definitive agreement
under which Mylan will acquire King in a stock-for-stock transaction, creating
a leading diversified specialty pharmaceutical company.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. (Amex: PTN) is a biopharmaceutical company
focused on discovering and developing melanocortin (MC)-based therapeutics.
NeutroSpec(TM), the Company's proprietary radiolabeled monoclonal antibody
product for imaging and diagnosing infections, has been approved by the FDA as
an imaging agent for the diagnosis of equivocal appendicitis. NeutroSpec is
marketed and distributed by Palatin's strategic collaboration partner,
Mallinckrodt Imaging, a business unit of Tyco Healthcare. The Company is
currently conducting clinical trials with its lead drug PT-141, an MC receptor
agonist, for the treatment of male and female sexual dysfunction. Palatin's
patented drug discovery platform, MIDASTM, streamlines the drug design process
with an efficient approach to identify lead compounds from protein targets for
drugs. For further information, visit the Palatin web site at
http://www.palatin.com.
Forward-looking Statements
This release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements reflect
managements' current views of future events and operations, including, but not
limited to, statements pertaining to the potential development and
commercialization of PT-141; statements pertaining to patent protection for
PT-141; statements pertaining to the potential market for PT-141; statements
pertaining to the potential safety and efficacy benefits of PT-141; statements
pertaining to the potential value of this transaction to shareholders of King
and Palatin; statements pertaining to the ability of King to market PT-141
following regulatory approval; and statements pertaining to Mylan's
anticipated acquisition of King. Some important factors which may cause
results to differ materially from such forward-looking statements include
dependence on the companies' abilities to carry out their respective business
plans; dependence on the successful development and commercial acceptance of
PT-141; dependence on the companies' abilities to fund development of PT-141;
dependence on whether a commercial product results from PT-141 development
activities; dependence on the extent of intellectual property protection for
PT-141; dependence on the companies' abilities to establish and successfully
complete clinical trials necessary for approval of PT-141 as a treatment for
sexual dysfunction; dependence on the companies' abilities to successfully
collaborate in the development and commercialization of PT-141; dependence on
King's ability to successfully market PT-141; dependence on the availability
and cost of raw materials; dependence on the unpredictability of the duration
and results of the U.S Food and Drug Administration's ("FDA") review of
Investigational New Drug Applications ("IND"), New Drug Applications ("NDA"),
and supplemental New Drug Applications, ("sNDAs") and/or the review of other
regulatory agencies worldwide; dependence on compliance with FDA and other
government regulations that relate to King's and Palatin's respective
businesses; dependence on King's and Palatin's abilities to successfully
manufacture PT-141; dependence on the occurrence of all contingencies
necessary to complete the closing of Mylan's acquisition of King; and
dependence on changes in general economic and business conditions; changes in
current pricing levels; changes in federal and state laws and regulations;
changes in competition; unexpected changes in technologies and technological
advances; and manufacturing capacity constraints. Other important factors
that may cause actual results to differ materially from the forward-looking
statements are discussed in the "Risk Factors" section and other sections of
King's Form 10-K for the year ended December 31, 2003 and Form 10-Q for the
second quarter ended June 30, 2004, and Palatin's Form 10-K for the year ended
June 30, 2003 and Form 10-Q for the third quarter ended March 31, 2004, which
are on file with the U.S. Securities and Exchange Commission. The companies
do not undertake to publicly update or revise any of their forward-looking
statements even if experience or future changes show that the indicated
results or events will not be realized.
SOURCE King Pharmaceuticals, Inc.
 back to top
Related links:
http://www.kingpharm.com
http://www.palatin.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green (for King investor or media
inquiries,) Executive Vice President, Corporate Affairs,
+1-423-989-8125, of King Pharmaceuticals, Inc.; or Stephen T.
Wills, CPA, MST, Chief Financial Officer of Palatin Technologies,
+1-609-495-2200, or info@palatin.com; or Janet Dally (for Palatin
institutional investor inquiries) of MontRidge, LLC,
+1-203-894-8038, or jdally@montridgellc.com, or Tony Loke (for
Palatin media inquiries) of Rx Communications Group,
+1-212-322-2164, or tloke@rxir.com, both for King
Pharmaceuticals, Inc.
|
