e424b3
Filed Pursuant to Rule 424(b)(3) and Rule 424(c)
Registration No. 333-169385
PROSPECTUS SUPPLEMENT NO. 5
8,140,496 Shares of Common Stock
This Prospectus Supplement No. 5 (the Prospectus Supplement) amends our Prospectus dated May 6,
2011 (the Prospectus). The Prospectus relates to the offer for sale by the existing holders of
our common stock, par value $0.01 per share, named in the Prospectus of 8,140,496 shares of our
common stock, including 3,488,784 shares of our common stock issuable upon exercise of the warrants
held by the selling security holders. These existing holders of our common stock are referred to as
selling security holders throughout this Prospectus Supplement.
All of the shares of common stock offered by this Prospectus Supplement are being sold by the
selling security holders. It is anticipated that the selling security holders will sell these
shares of common stock from time to time in one or more transactions, in negotiated transactions or
otherwise, at prevailing market prices or at prices otherwise negotiated. We will not receive any
proceeds from the sales of shares of common stock by the selling security holders.
On November 14, 2011, Emisphere Technologies, Inc. (the Company) filed with the Securities and
Exchange Commission (SEC) a Current Report on Form 8-K (the Form 8-K) announcing the release by
Novartis Pharma AG (Novartis) of the first interpretable results (FIR) from its three-year
Phase III Study 2303 (Study 2303) assessing the safety and efficacy of oral calcitonin (SMC021)
in the treatment of post-menopausal osteoporosis, conducted by its license partner, Nordic
Bioscience A/S.
According to Novartis, the FIR review found that, while Study 2303 observed the desired biological
effect, a statistically significant treatment effect for the increase in lumbar spine bone mineral
density in the SMC021 treatment group relative to placebo, the study failed to demonstrate a
statistically significant treatment effect between treatment groups on the reduction of the
occurrence of new vertebral fractures at three years, the primary endpoint of the study. In
addition, according to Novartis, no statistically significant response was observed on key
secondary endpoints: e.g. new non-vertebral fractures or new clinical fractures. This preliminary
analysis of data also showed that SMC021 displayed a positive safety profile.
A complete copy of the Form 8-K is attached hereto.
This Prospectus Supplement should be read in conjunction with the Prospectus, as previously
supplemented, and is qualified by reference to the Prospectus except to the extent that the
information in this Prospectus Supplement supersedes the information contained therein.
Our common stock is currently traded on the Over-The-Counter Bulletin Board, commonly known as the
OTC Bulletin Board (OTCBB), under the symbol EMIS.QB As of November 11, 2011, the closing sale
price of our common stock was $1.59 per share.
Investing in our securities involves substantial risks. You should carefully consider the matters
discussed under the section entitled Risk Factors beginning on page 6 of the Prospectus, as
previously supplemented.
Neither the SEC nor any state securities commission has approved or disapproved of these securities
or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a
criminal offense.
The date of this prospectus supplement is November 14, 2011.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): November 14, 2011
EMISPHERE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of incorporation)
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000-17758
(Commission File Number)
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13-3306985
(I.R.S. Employer Identification No.) |
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240 Cedar Knolls Road,
Suite 200, Cedar Knolls, New Jersey
(Address of principal executive offices)
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07927
(Zip Code) |
Registrants telephone number, including area code: 973-532-8000
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 7.01 Regulation FD Disclosure.
Emisphere Technologies, Inc. (the Company) announced on November 14, 2011 that
it has been informed by Novartis Pharma AG ( Novartis) that Novartis has released the first interpretable results (FIR) from its three-year Phase III Study 2303
(Study 2303) assessing the safety and efficacy of oral calcitonin (SMC021) in the treatment of
post-menopausal osteoporosis, conducted by its license partner, Nordic Bioscience A/S.
According to Novartis, the FIR review found that, while Study 2303 observed the desired biological
effect, a statistically significant treatment effect for the increase in lumbar spine bone mineral
density in the SMC021 treatment group relative to placebo, the study failed to demonstrate a
statistically significant treatment effect between treatment groups on the reduction of the
occurrence of new vertebral fractures at three years, the primary endpoint of the study. In
addition, according to Novartis, no statistically significant response was observed on key
secondary endpoints: e.g. new non-vertebral fractures or new clinical fractures. This preliminary
analysis of data also showed that SMC021 displayed a positive safety profile.
A copy of the Companys press release, dated November 14, 2011, announcing this information and
certain other information, is filed as Exhibit 99.1 to this Form 8-K and is incorporated herein by
reference. The information contained herein, including Exhibit 99.1 filed herewith, is intended to
be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following exhibit is filed herewith:
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Exhibit No. |
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Description |
99.1
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Press Release of Emisphere Technologies, Inc. dated November 14, 2011 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Emisphere Technologies, Inc.
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November 14, 2011 |
By: |
/s/ Michael R. Garone
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Name: |
Michael R. Garone |
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Title: |
Interim Chief Executive Officer and
Chief Financial Officer |
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Exhibit Index
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Exhibit No. |
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Description |
99.1
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Press release of Emisphere Technologies, Inc., dated November 14, 2011 |
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Exhibit 99.1
Emisphere Technologies, Inc. Reports Notification of First Interpretable Results on
Phase III Study of Oral Calcitonin in Osteoporosis Patients
CEDAR KNOLLS, NJ, November 14, 2011 Emisphere Technologies, Inc. (OTCQB: EMIS) (Emisphere
or the Company) announced today that it has been informed by Novartis Pharma AG (Novartis) that
Novartis has released first interpretable results (FIR) from its three-year Phase III Study 2303
assessing the safety and efficacy of oral calcitonin (SMC021) in the treatment of post-menopausal
osteoporosis, conducted by its license partner Nordic Bioscience A/S (Nordic Bioscience).
According to Novartis, the FIR review found that, while Study 2303 observed the desired biological
effect, a statistically significant treatment effect for the increase in lumbar spine bone mineral
density in the SMC021 treatment group relative to placebo, the study failed to demonstrate a
statistically significant treatment effect between treatment groups on the reduction of the
occurrence of new vertebral fractures at three years, the primary endpoint of the study. In
addition, according to Novartis, no statistically significant response was observed on key
secondary endpoints: e.g. new non-vertebral fractures or new clinical fractures. This preliminary
analysis of data also showed that SMC021 displayed a positive safety profile.
Novartis has not provided Emisphere with any further data from Study 2303 at this time. However,
Novartis did inform the Company that Study 2303 observed fewer overall vertebral fractures than
expected. Novartis also informed the Company that they will further analyze and evaluate the
results of Study 2303 in osteoporosis, as well as data from Phase III Studies 2301 and 2302 in
osteoarthritis, prior to making a decision on the continuation of the SMC021 program in both
indications. In addition, the Company will require additional information from Novartis in order
to further analyze and evaluate the results of Study 2303 in osteoporosis, as well as data from
Phase III Studies 2301 and 2302 in osteoarthritis, in order to fully understand the methodologies
and results of such studies.
The Companys other development programs are continuing with Novo Nordisk A/S (Novo Nordisk)
using Emispheres Eligen® Technology to develop and commercialize oral formulations of
Novo Nordisks insulins and GLP-1 receptor agonists, with a potential GLP-1 drug currently in a
Phase I clinical trial; and with the Companys internally developed oral
formulation of Eligen® B12 (1000 mcg.) for use by B12 deficient individuals undergoing
evaluation of regulatory and commercial development options.
About Emisphere Technologies, Inc.
Emisphere is a biopharmaceutical company that focuses on a unique and improved delivery of
pharmaceutical compounds, medical foods and dietary supplements using its EligenÒ Technology.
These molecules and compounds could be currently available or in development. Such molecules are
usually delivered by injection; in many cases, their benefits are limited due to poor
bioavailability, slow on-set of action or variable absorption. The EligenÒ Technology can be
applied to the oral route of administration as well as other delivery pathways, such as buccal,
rectal, inhalation, intra-vaginal or transdermal. The companys website is: www.emisphere.com.
Safe Harbor Statement Regarding Forward-looking Statements
The statements in this release and oral statements made by representatives of Emisphere relating to
matters that are not historical facts (including without limitation those regarding the timing or
potential outcomes of research collaborations or clinical trials, any market that might develop for
any of Emispheres product candidates, the sufficiency of Emispheres cash and other capital
resources and its ability to obtain additional financing to meet its capital needs) are
forward-looking statements that involve risks and uncertainties, including, but not limited to, the
likelihood that future research will prove successful, the likelihood that any product in the
research pipeline will receive regulatory approval in the United States or abroad, the ability of
Emisphere and/or its partners to develop, manufacture and commercialize products using Emispheres
drug delivery technology, Emispheres ability to fund such efforts with or without partners, and
other risks and uncertainties detailed in Emispheres filings with the Securities and Exchange
Commission, including those factors discussed under the caption Risk Factors in Emispheres
Annual Report on Form 10-K for the fiscal year ended December 31, 2010 (file no. 000-17758) filed
on March 31, 2011, Emispheres Quarterly Report on Form 10-Q for the quarter ended March 31, 2011,
filed on May 10, 2011, Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed on
August 9, 2011, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, filed
on November 8, 2011.
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CONTACT: |
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Michael R. Garone, Interim CEO and CFO
973-532-8005
mgarone@emisphere.com |