PROLOR Biotech Initiates Pivotal Phase III Trial Of Its Longer-Acting Version Of Human Growth Hormone

PROLOR Biotech Initiates Pivotal Phase III Trial Of Its Longer-Acting Version
                           Of Human Growth Hormone

PR Newswire

NES-ZIONA, Israel, June 4, 2013

NES-ZIONA, Israel, June 4, 2013 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE
Mkt: PBTH), a company developing next-generation biobetter therapeutic
proteins, today announced the initiation of a pivotal Phase III clinical trial
of hGH-CTP, the company's proprietary version of human growth hormone (hGH),
in growth hormone deficient adults.

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and
children with hGH therapy that may require only once-weekly or bi-monthly
injections, rather than the daily injections required by current hGH therapy.
The initiation of the Phase III clinical trial follows a set of successful
Phase II trials showing that hGH-CTP has the potential to be effective when
injected once weekly. In these studies, hGH-CTP was shown to be well
tolerated and safe, and it met all clinical endpoints.

The hGH-CTP Phase III trial is a randomized, placebo-controlled study to
evaluate the efficacy and safety of hGH-CTP injected weekly in adults with
growth hormone deficiency. The primary endpoint is defined as the change in
truncal fat mass from baseline to six months after initiation of treatment.
The trial is being conducted at clinical centers in the U.S., Europe and

Following regulatory review of the hGH-CTP Phase II data, PROLOR obtained
clearance to use a pivotal Phase III trial design that includes a six-month
assessment of efficacy and safety, followed by a subsequent six-month period
of safety assessment. PROLOR's previous estimate and guidance had noted that
a 12-month period of subsequent safety assessment might be required. This
reduction of six months in the length of the required safety assessment and
resulting reduction in the overall trial duration may enable PROLOR to submit
an application for hGH-CTP marketing approval sooner than previously
anticipated, subject to successful completion of the Phase III trial.

In the U.S., the Food and Drug Administration (FDA) has confirmed that the
regulatory pathway for hGH-CTP is via a Biologics License Application (BLA),
which would be submitted subject to the successful completion of the Phase III
trial. The BLA pathway provides the manufacturer with 12 years of data
exclusivity in the U.S., starting at the time of FDA approval. 

"In all studies to date, hGH-CTP has demonstrated excellent safety and the
potential for once-weekly administration," said Abraham Havron, Ph.D., CEO of
PROLOR. "We are delighted now to initiate our pivotal Phase lll trial
designed to provide the definitive data needed to apply for marketing approval
in the U.S. and Europe."

Dr. Havron continued, "We are encouraged by our receipt of regulatory
clearance to use a six-month safety tracking period in the trial, instead of
our anticipated 12 months. This could potentially enable us to accelerate the
timeline for filing for marketing approval and may allow PROLOR to launch
hGH-CTP sooner than originally anticipated. In addition, we are pleased with
the FDA's confirmation of the BLA submission pathway for hGH-CTP, which
provides for 12 years of data exclusivity in the U.S., effectively adding
another layer of potential protection from generic and biosimilar

Update on Status of PROLOR Merger with OPKO Health
Separately, PROLOR today announced the expiration of the 40-day "go-shop"
period pursuant to the terms of its definitive merger agreement with OPKO
Health, Inc. (NYSE: OPK). On April 24, 2013, OPKO Health and PROLOR Biotech
announced that the companies had signed a definitive merger agreement under
which OPKO will acquire PROLOR 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 stock. Under the terms of the
agreement, PROLOR and its representatives had the right to solicit, encourage,
facilitate and engage in discussions and negotiations with third parties with
respect to competing proposals until 11:59 p.m. EDT, on June 2, 2013. PROLOR
did not receive any competing proposals during the "go-shop" period. PROLOR
and OPKO 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 the merger agreement by PROLOR's stockholders, approval of the
issuance of the share consideration by OPKO's stockholders, the receipt of
antitrust approval and other customary closing conditions.

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 ( 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.

Investors may obtain copies of all documents filed with the SEC regarding this
transaction, free of charge, at the SEC's website ( They may
also obtain these documents, free of charge, from OPKO's website
( or from PROLOR's website (

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 2013 Annual Meeting of Stockholders, which was filed with
the SEC on April 25, 2013. These documents are available free of charge at
the SEC's website at, or by going to PROLOR's Investor Relations
page on its corporate website at Information about
OPKO's directors and executive officers is set forth in Amendment No. 1 to its
Annual Report on Form 10-K for the year ended December 31, 2012, which was
filed with the SEC on April 29, 2013. These documents are available free of
charge at the SEC's website at, or by going to OPKO's Investor
Relations page on its corporate website at Additional
information regarding the interests of participants in the solicitation of
proxies in connection with the transaction will be included in the joint proxy

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying
unique technologies, including patented CTP technology and its long-acting
reversible-pegylation 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. PROLOR is developing a long-acting
version of human growth hormone, which is currently being assessed in a Phase
III pivotal trial. It also is 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, all of which are in preclinical
development. For more information, visit

Safe Harbor Statement: This press release contains forward-looking
statements, which may be identified by words such as "expects," "plans,"
"projects," "will," "may," "anticipates," "believes," "should," "would",
"intends," "estimates," "suggests," "has the potential to" and other words of
similar meaning, including statements regarding the results of current
clinical studies and preclinical experiments and the effectiveness of PROLOR's
long-acting protein programs, which are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Investors
are cautioned that forward-looking statements involve risks and uncertainties
that may affect PROLOR's business and prospects, including uncertainties as to
the timing of the merger, the risk that the merger not be consummated for a
number of reasons, the possibility that various closing conditions for the
merger may not be satisfied or waived, including the receipt of the required
approvals by OPKO's and PROLOR's stockholders and the prohibition, delay or
refusal of a governmental authority to grant approval for the consummation of
the merger, the risks that PROLOR may not succeed in generating any revenues
or developing any commercial products, including any long-acting versions of
human growth hormone, erythropoietin, interferon beta, GLP-1 and other
products; that the long-acting products in development may fail, may not
achieve the expected results or effectiveness and/or may not generate data
that would support the approval or marketing of these products for the
indications being studied or for other indications; that ongoing studies may
not continue to show substantial or any activity; that the actual dollar
amount of any grants from Israel's Office of the Chief Scientist is uncertain
and is subject to policy changes of the Israeli government, and that such
grants may be insufficient to assist with product development; and other risks
and uncertainties that may cause results to differ materially from those set
forth in the forward-looking statements. The results of clinical trials in
humans may produce results that differ significantly from the results of
clinical and other trials in animals. The results of early-stage trials may
differ significantly from the results of more developed, later-stage trials.
The development of any products using the CTP platform technology could also
be affected by a number of other factors, including unexpected safety,
efficacy or manufacturing issues, additional time requirements for data
analyses and decision making, the impact of pharmaceutical industry
regulation, the impact of competitive products and pricing and the impact of
patents and other proprietary rights held by competitors and other third
parties. In addition to the risk factors described above, investors should
consider the economic, competitive, governmental, technological and other
factors discussed in PROLOR's filings with the Securities and Exchange
Commission. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not undertake
any obligation to update forward-looking statements, except as required under
applicable law.

Shai Novik, President       Barbara Lindheim
PROLOR Biotech, Inc.     BLL Partners, LLC
Tel: +1 866 644-7811                                   +1 212 584-2276



Press spacebar to pause and continue. Press esc to stop.