The Medicines Company (NASDAQ: MDCO) today announced that it has
entered into a merger agreement with Targanta Therapeutics
Corporation (NASDAQ: TARG) under which The Medicines Company has
agreed to commence a tender offer to acquire 100 percent of
Targanta's outstanding shares.
"The Medicines Company is pleased to announce our agreement to
add the assets and capabilities of Targanta. The addition of
Targanta's oritavancin, a late stage product, will be another step
toward execution of our strategic plan to become a global leader in
critical care medicine," said Clive Meanwell, M.D., Chairman and
Chief Executive Officer of The Medicines Company. "Oritavancin has
the potential to provide important patient outcome and economic
advantages for hospitals. The growing hospital market for gram
positive infections in the U.S. alone reached $1.1 billion in 2007.
We believe that oritavancin can become an important anti-infective
for serious infections involving difficult-to-treat bacteria in
difficult-to-treat hospitalized patients. Many of those critically
ill patients are the same patients treated with our existing
products."
Under the terms of the merger agreement, Targanta shareholders
will receive $2.00 in cash up front for each common share tendered,
or approximately $42 million. Targanta shareholders may also be
entitled to receive additional contingent cash payments upon the
achievement of specified regulatory and commercial milestones
within agreed upon time periods:
-- Upon Food and Drug Administration (FDA) approval of a new drug
application (NDA) for oritavancin for cSSSI (complicated skin and skin
structure infections) using a single dose infusion, $1.20 per share. If
FDA approval does not include single dose infusion labeling, this payment
is reduced to $0.50 per share.
-- Upon European Medicines Agency (EMEA) approval of a marketing
authorisation application (MAA) for oritavancin for cSSSI during 2009,
$1.00 per share. If EMEA approval occurs later, this payment is reduced to
$0.75 per share if it occurs prior to June 30, 2010 or if later, $0.50 per
share.
-- On achievement of worldwide net sales adding up to a total of $400
million or more in the aggregate over four consecutive quarters, a one-time
payment of $2.35 per share.
The transaction has been approved by the boards of directors of
both companies, and Targanta's Board of Directors has recommended
that Targanta's shareholders tender their shares into the tender
offer, adopt the merger agreement and approve the merger.
"We believe that this transaction can create significant value
for our shareholders and further expand our portfolio of critical
care products. It adds a late stage product, with global rights,
and the potential for near-term revenue, and could contribute
significantly to our long-term growth. Oritavancin is a well
characterized Phase 3 asset. We believe the deal terms reflect a
balanced investment to expand our product portfolio and we agreed
to pay for the transaction with cash to avoid share dilution. The
addition of staged payments provides Targanta shareholders
additional value if milestones are achieved and mitigates risk for
The Medicines Company," said Glenn Sblendorio, EVP & Chief
Financial Officer.
Targanta's lead product, oritavancin, is an innovative,
investigational hospital-based antibiotic with potent bactericidal
(killing) activity against a broad spectrum of gram-positive
bacteria including staphylococcal strains with resistance to
methicillin (MRSA) and vancomycin. Oritavancin has the potential to
provide significant clinical advantages, including superior dosing
options over current IV antibiotics that treat serious infections
in the hospital setting. While conventional daily dosing with
oritavancin would provide hospitals with a new treatment option,
the potential for oritavancin to be a single dose product could
deliver significant cost advantages and treatment benefits to the
health-care system. Initial use of oritavancin is expected in
critical care settings within the hospital including the ICU,
surgical suite and the emergency department, where The Medicines
Company sales representatives promote our current products.
Oritavancin has been studied in two pivotal Phase 3 trials in
the treatment of cSSSI (complicated skin and skin structure
infections). Phase 2 trials have successfully studied the compound
in gram positive bacteremia and have examined efficacy and safety
of a single dose infusion in cSSSI (SIMPLIFI trial). Pre-clinical
studies have shown unique anti-microbiological activity in
Clostridium Difficile infection, a rapidly growing problem, which
causes severe and occasionally life-threatening colitis in the
hospital.
Invasive MRSA infection is a serious and growing public health
care concern. In the U.S. over 94,000 patients suffered invasive
infection in 2005, and, of these, almost 19,000 cases were
associated with death (Klevens, RM et al., JAMA. 2007 Oct 17). As a
result of this epidemic, the lack of efficacy provided by existing
older drug treatments, and the availability of novel antibiotics
similar to oritavancin delivered with conventional dosing, the US
market for sales of gram-positive antibiotics grew to more than $1
billion in 2007, up 17% since 2006.
In December 2008, the U.S. Food and Drug Administration (FDA)
issued a complete response letter to Targanta's New Drug
Application (NDA) indicating that it could not approve the NDA in
its present form and that it would be necessary for Targanta to
perform an additional adequate and well-controlled study to
demonstrate the safety and efficacy of oritavancin in patients with
cSSSI before the application may be approved. A Market
Authorisation Application (MAA) for oritavancin is undergoing
review by the European Medicines Agency (EMEA).
Following consummation of the transaction, The Medicines Company
plans to consult with regulatory authorities with a view to
initiating a confirmatory Phase 3 study, in the United States, of
oritavancin given as a single dose infusion before the end of the
year.
The tender offer will expire at midnight Eastern Time on the
20th business day following and including the commencement date,
unless extended in accordance with the terms of the merger
agreement and the applicable rules and regulations of the
Securities and Exchange Commission. The tender offer, if
successful, will be followed by a second-step merger in which any
shares of Targanta not tendered into the offer will be converted
into the right to receive the same per share consideration paid to
Targanta shareholders in the tender offer. The Medicines Company
has entered into agreements with Targanta shareholders representing
approximately 36% of the voting shares outstanding to tender their
shares in the tender offer.
The consummation of the tender offer is subject to the
satisfaction or waiver of certain conditions, including: (i) a
majority of outstanding Targanta shares on a fully diluted basis
having been tendered into the offer, (ii) the absence of litigation
by any governmental agency relating to the transaction or any other
litigation that would reasonably be expected to succeed and in
which a judgment adverse to Targanta would reasonably be expected
to result in a material adverse change with respect to Targanta,
(iii) there not having been a material adverse change with respect
to Targanta, and (iv) other customary conditions. The tender offer
is not subject to a financing condition.
The Medicines Company plans to announce fourth quarter and full
year 2008 financial results in February 2009. At that time, the
Company will provide expected 2009 full-year net sales and net
income estimates based upon completion of the valuation of the
transaction and transition costs.
The Medicines Company management will host a conference call on
Tuesday, January 13th at 8:30 a.m. Eastern Time to discuss the
proposed Targanta acquisition and its anticipated impact on ongoing
operations. The conference call will be available via phone and
webcast. Dial in details are as follows -- domestic dial in
800-561-2601; international dial in 617-614-3518; participant
passcode 32479308. A replay of the call will be available until
12:00 a.m. EST on January 26 by dialing 888-286-8010 (domestic) or
617-801-6888 (international), passcode 93634023. The webcast can be
accessed at The Medicines Company website at
www.themedicinescompany.com.
Advisors
J.P. Morgan acted as financial advisor and WilmerHale acted as
legal advisor to The Medicines Company for this transaction.
Leerink Swann acted as financial advisor and Ropes & Gray acted
as legal advisor to Targanta Therapeutics Corporation.
About Oritavancin
Oritavancin is a novel, semi-synthetic lipoglycopeptide
antibiotic candidate with potent bactericidal (killing) activity
against a broad spectrum of gram-positive bacteria. The oritavancin
NDA submission included data from 19 clinical trials, including two
pivotal Phase 3 clinical trials examining the safety and efficacy
of oritavancin in the treatment of cSSSI, both of which met their
primary endpoints. The NDA dossier also included the data from more
than 2,100 individuals and in vitro activity data on oritavancin
against more than 9,000 clinical bacterial isolates, including a
broad range of gram-positive strains resistant to commonly used
antibiotics such as oxacillin, methicillin, vancomycin, daptomycin,
and linezolid.
About Targanta Therapeutics
Targanta Therapeutics Corporation (NASDAQ: TARG) is a
biopharmaceutical company focused on developing and commercializing
innovative antibiotics to treat serious infections in the hospital
and other institutional settings. The Company's pipeline includes
an intravenous version of oritavancin, a semi-synthetic
lipoglycopeptide antibiotic currently awaiting EU regulatory
approval, and a program to develop an oral version of oritavancin
for the possible treatment of Clostidium difficile-related
infection. The Company has operations in Cambridge, MA,
Indianapolis, IN, and Montreal, Quebec, Canada. For more
information on Targanta, visit www.targanta.com.
MDCO-G
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the
treatment of critical care patients through the delivery of
innovative, cost-effective medicines to the worldwide hospital
marketplace. The Company markets Angiomax� (bivalirudin) in the
United States and other countries for use in patients undergoing
coronary angioplasty, and Cleviprex� (clevidipine butyrate)
injectable emulsion in the United States for the reduction of blood
pressure when oral therapy is not feasible or not desirable. The
Company also has an investigational antiplatelet agent, cangrelor,
in late-stage development and a serine protease inhibitor, CU-2010,
in early-stage development. The Company's website is
www.themedicinescompany.com.
Cautionary Note regarding Forward-Looking Statements
Statements in this press release regarding the proposed
transaction between the Company and Targanta, the expected
timetable for completing the transaction, future financial and
operating results, benefits and synergies of the transaction,
future opportunities for the combined company, new product
development, including obtaining regulatory approvals, and any
other statements about the Company managements' future
expectations, beliefs, goals, plans or prospects constitute
forward-looking statements. Any statements that are not statements
of historical fact (including statements containing the words
"believes," "plans," "anticipates," "expects," "estimates" and
similar expressions) should also be considered to be
forward-looking statements. These forward-looking statements
involve known and unknown risks and uncertainties that may cause
the Company's actual results, levels of activity, performance or
achievements to be materially different from those expressed or
implied by these forward-looking statements. Important factors that
may cause or contribute to such differences include uncertainties
as to the timing of the tender offer and merger; uncertainties as
to how many of Targanta's stockholders will tender their stock in
the offer; the risk that competing offers will be made; the
possibility that various closing conditions for the transaction may
not be satisfied or waived; the effects of disruption from the
transaction making it more difficult to maintain relationships with
employees, licensees, other business partners or governmental
entities; transaction costs; whether results obtained in clinical
studies or in preclinical studies such as the studies referred to
above will be indicative of results obtained in future clinical
trials; whether, if the Company consummates the acquisition, the
Company can advance oritavancin through the contemplated Phase 3
trial on a timely basis or at all and receive approval from the
United States Food and Drug Administration or equivalent foreign
regulatory agencies for the product; whether, if oritavancin
receives approval, the Company will be able to successfully
distribute and market the product and in that regard, whether
physicians, patients and other key decision-makers will accept
clinical trial results; whether the Company will be able to obtain
regulatory approvals and such other factors as are set forth in the
risk factors detailed from time to time in the Company's periodic
reports and registration statements filed with the Securities and
Exchange Commission including, without limitation, the risk factors
detailed in the Company's Quarterly Report on Form 10-Q filed on
November 10, 2008, which are incorporated herein by reference. The
forward-looking statements are made only as of the date of
publication. Except as otherwise required by law, the Company
specifically disclaims any obligation to update any of these
forward-looking statements.
Additional Information
This press release is neither an offer to purchase nor a
solicitation of an offer to sell shares of Targanta. Boxford
Subsidiary Corporation (the "Merger Sub"), a wholly owned
subsidiary of The Medicines Company, has not commenced the tender
offer for the shares of Targanta stock described in this press
release.
Upon commencement of the tender offer, the Merger Sub will file
with the SEC a tender offer statement on Schedule TO and related
exhibits, including the offer to purchase, letter of transmittal,
and other related documents. Following commencement of the tender
offer, Targanta will file with the SEC a tender offer
solicitation/recommendation statement on Schedule 14D-9. These
documents will contain important information about The Medicines
Company, Targanta, the transaction and other related matters.
Investors and security holders are urged to read each of these
documents carefully when they are available.
Investors and security holders will be able to obtain free
copies of the tender offer statement, the tender offer
solicitation/recommendation statement and other documents filed
with the SEC by The Medicines Company and Targanta through the web
site maintained by the SEC at www.sec.gov. In addition, investors
and security holders will be able to obtain free copies of these
documents from The Medicines Company or Targanta by contacting:
Robyn Brown of The Medicines Company at 973-290-6000 or
investor.relations@themedco.com, or Susan Hager of Targanta at
617-577-9020 x217 or shager@targanta.com.
Contact: Emily Poe WeissComm Partners Phone: (212) 301-7183
Email Contact Robyn Brown The Medicines Company Phone: (973)
656-1616 Email Contact
Targanta Therapeutics Corp (MM) (NASDAQ:TARG)
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