MIAMI and NES-ZIONA,
Israel, April 24, 2013 /PRNewswire/ -- OPKO Health, Inc.
(NYSE: OPK) and PROLOR Biotech, Inc. (NYSE MKT: PBTH) today
announced that the companies have signed a definitive merger
agreement under which OPKO will acquire PROLOR, a biopharmaceutical
company focused on developing and commercializing longer-acting
proprietary versions of already approved therapeutic proteins, in
an all-stock transaction. Under the terms of the agreement,
which has been approved by the boards of directors of both
companies, holders of PROLOR common stock will receive 0.9951
shares of OPKO common stock for each share of PROLOR common
stock. Based on a price of $7.03 per share of OPKO common stock, the
transaction is valued at approximately $480
million, or $7.00 per share of
PROLOR common stock. The companies expect the transaction to
be completed during the second half of 2013. Closing of the
transaction is subject to certain conditions including, the
approval of OPKO's and PROLOR's stockholders and other customary
closing conditions.
PROLOR's long-acting version of human growth hormone, hGH-CTP,
has successfully completed four clinical trials, including a Phase
II trial in adults with growth hormone deficiency (GHD). The trials
showed that hGH-CTP has the potential to reduce the required dosing
frequency of human growth hormone from the current standard of one
injection per day to a single weekly injection. hGH-CTP
demonstrated a good safety and tolerability profile in these
clinical trials. A Phase II trial in children with GHD is
currently ongoing, and a Phase III trial in adults with GHD is
planned to begin in the second quarter of 2013. Recombinant
human growth hormone (hGH) is used for the long-term treatment of
children and adults with GHD due to inadequate secretion of
endogenous growth hormone. hGH-CTP has been awarded orphan
drug designation in the U.S. and Europe for both adults and children with
GHD.
PROLOR's long-acting version of human growth hormone and
long-acting clotting factors in preclinical development for
hemophilia are based on the company's proprietary CTP technology.
When attached to a therapeutic protein, CTP significantly extends
the length of time the protein remains active in the body.
Clinical and preclinical studies show that the CTP technology
appears to be safe and effective in extending the duration of all
proteins tested to date. CTP was identified at Washington University in St. Louis and is exclusively licensed to
PROLOR for all proteins and peptides, except for four endocrine
proteins that are licensed to Merck. One of these, the
long-acting fertility drug Elonva®, is already marketed
by Merck & Co. in Europe.
"This transaction is consistent with OPKO's stated objective of
broadening our portfolio of market-transforming therapies in
selected specialty markets," commented Dr. Phillip Frost, OPKO's Chairman and Chief
Executive Officer. "With the inclusion of PROLOR's pipeline,
OPKO will have four significant products in Phase III clinical
development and a robust pipeline of important therapeutic and
unique diagnostic products in various stages of development.
PROLOR's drug-product candidates for growth hormone deficiency,
hemophilia, obesity and diabetes, along with its broadly applicable
technology platforms and efficient research and development center
are highly valuable assets that will complement OPKO's
strategy."
"We believe this transaction recognizes the value we have
created at PROLOR and provides our shareholders with attractive
economic terms, as well as the opportunity to continue to share in
the success of the combined company," commented Shai Novik, President of PROLOR. "We
believe that OPKO's track record of commitment to innovation and
growth, along with its diversified portfolio of innovative
therapeutic and diagnostic products, growing international
presence, ongoing investments in commercial infrastructure and
highly experienced management team make this combination an
excellent fit for PROLOR."
"Leveraging the combined resources of both companies not only
strengthens our various development programs, but also underscores
our commitment to providing patients with next-generation therapies
that may improve their health and quality of life," added Dr.
Abraham Havron, Chief Executive
Officer of PROLOR.
Barrington Research Associates, Inc., acted as the financial
advisor to OPKO Health. Jefferies LLC acted as financial
advisor to PROLOR Biotech and the Strategic Alternatives Committee
on the transaction, and Oppenheimer & Co provided a fairness
opinion to the Strategic Alternatives Committee. Akerman
Senterfitt acted as legal advisor to OPKO Health. DLA Piper
LLP (US) acted as legal advisor to the Strategic Alternatives
Committee and Greenberg Traurig, P.A. acted as legal advisor to
PROLOR Biotech.
Conference Call and Webcast Information
PROLOR will
host a live teleconference and webcast with senior management and a
representative of OPKO management to discuss the acquisition on
Thursday, April 25, 2013 at
8:30 a.m. EDT. To participate in the
conference call, please dial toll-free at 1-866-652-5200 (U.S.),
1-855-669-9657 (Canada),
1-80-9213284 (Israel) or at
1-412-317-6060 for other countries. After placing the call, please
tell the operator you wish to join the PROLOR investor conference
call. A replay of the conference call will be available
through May 1, 2013 at:
1-877-344-7529 (U.S.) and 1-412-317-0088 (international). Ask
for conference number 10028297.
Alternatively, the live webcast of the conference call and slide
presentation can be accessed via PROLOR's website at
www.prolor-biotech.com. Windows Media or Real Player will be
needed to access the webcast. The webcast will be available
on PROLOR's website for at least 90 days.
About OPKO Health, Inc.
OPKO is a
multinational biopharmaceutical and diagnostics company that seeks
to establish industry leading positions in large, rapidly growing
markets by leveraging its discovery, development and
commercialization expertise and novel and proprietary technologies.
For more information, visit http://www.opko.com.
ABOUT PROLOR BIOTECH, INC.
PROLOR Biotech, Inc. is a
clinical stage biopharmaceutical company applying unique
technologies, including patented CTP technology, primarily to
develop longer-acting proprietary versions of already approved
therapeutic proteins that currently generate billions of dollars in
annual global sales. The CTP technology is applicable to
virtually all proteins. In addition to its long-acting
version of human growth hormone, which successfully completed a
Phase II clinical trial, PROLOR is also developing long-acting
versions of Factor VIIa and Factor IX for hemophilia and a
GLP-1/Glucagon dual receptor agonist peptide for diabetes and
obesity. For more information, visit
www.prolor-biotech.com.
ADDITIONAL INFORMATION AND WHERE TO FIND IT
This
communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. In connection with the
proposed merger between PROLOR and OPKO, OPKO will file with the
Securities and Exchange Commission (the "SEC") a Registration
Statement on Form S-4 that will include a proxy statement of OPKO
and PROLOR and a prospectus of OPKO. Stockholders of OPKO and
PROLOR are urged to read the joint proxy statement/prospectus
regarding the proposed transaction when it becomes available, as
well as other documents filed with the SEC, because they will
contain important information. Stockholders of OPKO and PROLOR will
be able to obtain a copy of the joint proxy statement/prospectus,
as well as other filings containing information about PROLOR and
OPKO, without charge, at the SEC's website (www.sec.gov).
Stockholders of OPKO and PROLOR may also obtain copies of all
documents filed with the SEC, without charge, by directing a
request to Shachar Shlosberger, PROLOR Biotech, Inc., 7 Golda Meir
Street, Weizmann Science Park, Nes-Ziona, Israel 74140, telephone (+972) 8-930-0051, or
Steven D. Rubin or Juan F. Rodriguez, OPKO Health, Inc., 4400
Biscayne Blvd., Miami, Florida,
telephone (305) 575-4100.
Safe Harbor Statement
This press release
contains "forward-looking statements," as that term is defined
under the Private Securities Litigation Reform Act of 1995 (PSLRA),
which statements may be identified by words such as "expects,"
"plans," "projects," "will," "may," "anticipates," "believes,"
"should," "intends," "estimates," and other words of similar
meaning, including statements regarding the benefits resulting from
the acquisition of PROLOR, including whether the Phase 3 clinical
trials for hGH-CTP will be commenced or completed on a timely basis
or at all, that earlier clinical results may not be reproducible or
indicative of future results, that hGH-CTP and/or any of PROLOR's
compounds under development may fail, may not achieve the expected
results or effectiveness and may not generate data that would
support the approval or marketing of products for the indications
being studied or for other indications, that currently available
products, as well as products under development by others, may
prove to be as or more effective than PROLOR's products for the
indications being studied, as well as other non-historical
statements about our expectations, beliefs or intentions regarding
our business, technologies and products, financial condition,
strategies or prospects. Many factors could cause our actual
activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors
include those described in OPKO's and PROLOR's filings with the
Securities and Exchange Commission, the ability to obtain
regulatory approvals for the transaction on the proposed terms and
schedule; the failure of OPKO's or PROLOR's stockholders to approve
the transaction; the risk that a condition to closing of the merger
may not be satisfied; the time required to consummate the proposed
merger; the focus of management on merger-related issues; the risk
that the businesses will not be integrated successfully; the risk
that any potential synergies from the transaction may not be fully
realized or may take longer to realize than expected; new
information arising out of clinical trial results; and the risk
that the safety and/or efficacy results of existing clinical trials
will not support continued clinical development, as well as risks
inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and
treatments. In addition, forward-looking statements may also be
adversely affected by general market factors, competitive product
development, product availability, federal and state regulations
and legislation, the regulatory process for new products and
indications, manufacturing issues that may arise, patent positions
and litigation, among other factors. The forward- looking
statements contained in this press release may become outdated over
time. OPKO and PROLOR do not assume any responsibility for updating
any forward-looking statements.
You may obtain copies of all documents filed with the SEC
regarding this transaction, free of charge, at the SEC's website
(www.sec.gov). You may also obtain these documents, free of charge,
from OPKO's website (www.opko.com). You may also obtain these
documents, free of charge, from PROLOR's website
(www.prolor-biotech.com).
PARTICIPANTS IN THE MERGER SOLICITATION
PROLOR, OPKO and their respective directors and executive officers
may be deemed to be participants in the solicitation of proxies
from the stockholders of PROLOR and OPKO in connection with the
proposed transaction. Information about PROLOR's directors and
executive officers is set forth in its proxy statement for its 2012
Annual Meeting of Stockholders, which was filed with the SEC on
April 24, 2012, and its Annual Report
on Form 10-K for the year ended December 31,
2012, filed on March 15, 2013.
These documents are available free of charge at the SEC's website
at www.sec.gov, or by going to PROLOR's Investor Relations page on
its corporate website at www.prolor-biotech.com. Information about
OPKO's directors and executive officers is set forth in its proxy
statement for its 2012 Annual Meeting of Stockholders, which was
filed with the SEC on April 27, 2012,
and its Annual Report on Form 10-K for the year ended December 31, 2012, filed on March 18, 2013. These documents are available
free of charge at the SEC's website at www.sec.gov, or by going to
OPKO's Investor Relations page on its corporate website at
www.opko.com. Additional information regarding the interests of
participants in the solicitation of proxies in connection with the
transaction will be included in the joint proxy
statement/prospectus.
OPKO
CONTACT:
|
PROLOR
CONTACT:
|
Steve D.
Rubin, Executive Vice President –
Administration
|
Barbara
Lindheim
|
Juan F.
Rodrigez, Chief Financial
Officer
|
BLL
Partners, LLC
|
OPKO
Heath,
Inc.
|
+1 212
584-2276
|
Tel: +1
305 575-4100
|
blindheim@bllbiopartners.com
|
SOURCE OPKO Health, Inc.; PROLOR Biotech, Inc.