Filed
pursuant to Rule 424(b)(3)
Registration
Statement No. 333-163127
Registration
Statement No. 333-164942
PROSPECTUS
SUPPLEMENT NO. 1
to
Prospectus dated February 16, 2010
This
prospectus supplement No. 1 (“Supplement”) supplements the prospectus dated
February 16, 2010 (“Prospectus”) which forms a part of our Registration
Statement on Form S-1 (Registration Statement No. 333-163127 and No.
333-164942). This Supplement is being filed to update, amend and
supplement the information included or incorporated by reference in the
Prospectus with the information contained in our current report on Form 8-K
filed with the Securities and Exchange Commission on February 3, 2011 (the
“Current Report”). We have attached the Current Report to, and we
incorporate the Current Report by reference into, this Supplement.
The
Prospectus related to the public sale by us of 1,117,800 shares of our common
stock and 372,600 warrants to purchase our common stock, together with 29,160
warrants to purchase our common stock furnished as underwriter’s
compensation. The Prospectus and this Supplement relate to the public
disposition, from time to time, by the warrants holders or their successors in
interest of up to 410,760 shares of our common stock issuable upon exercise of
the foregoing warrants.
Our
common stock is listed on The NASDAQ Capital Market under the symbol
“DSCI”. On February 7, 2011, the last reported sale price of our common
stock on The NASDAQ Capital Market was $10.90.
This
Supplement should be read in conjunction with the Prospectus which is to be
delivered with this Supplement. If there is any inconsistency between the
information in the Prospectus and this Supplement, you should rely on the
information in this Supplement.
Investing
in our common stock involves a high degree of risk. You should review carefully
the risks and uncertainties described under the heading “Risk Factors” beginning
on page 4 of the Prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if the
Prospectus or this Supplement is truthful or complete. Any representation
to the contrary is a criminal offense.
The date
of this Supplement is February 8, 2011.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 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): February 3, 2011
Derma
Sciences, Inc.
(Exact name of registrant as specified
in its charter)
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Pennsylvania
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1-31070
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23-2328753
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(State
or other jurisdiction
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(Commission
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(IRS
employer
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of
incorporation)
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File
Number)
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identification
number)
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214
Carnegie Center, Suite 300
Princeton,
NJ 08540
(609)
514-4744
(Address
including zip code and telephone
number,
of principal executive offices)
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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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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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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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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2
Item
8.01 Other Events
On
February 3, 2011 Derma Sciences, Inc. (the “Registrant”) announced the results
of its Phase 2 clinical trial of DSC127 in patients with diabetic foot
ulcers. A copy of the press release issued by the Registrant in
connection with this announcement is attached as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits
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(d)
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Exhibits:
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||
| 99.1 – |
Press
release dated February 3, 2011 entitled “Derma Sciences Reports Positive
Top-Line Results From DSC127 Phase 2 Trial in Patients with Diabetic Foot
Ulcers”
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||
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
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DERMA
SCIENCES, INC.
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By:
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/s/ John
E. Yetter
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John
E. Yetter, CPA
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Vice
President and Chief Financial
Officer
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Date: February
3, 2011
EXHIBIT
INDEX
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Exhibit
Number
|
Description
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99.1
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Press
release dated February 3, 2011 entitled “Derma Sciences Reports Positive
Top-Line Results From DSC127 Phase 2 Trial in Patients with Diabetic Foot
Ulcers”
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3
Exhibit
99.1
DERMA
SCIENCES REPORTS POSITIVE TOP-LINE RESULTS FROM
DSC127
PHASE 2 TRIAL IN PATIENTS WITH DIABETIC FOOT ULCERS
Drug
meets primary efficacy endpoint
Wounds
up to three times more likely to heal
Conference
call begins at 10:00 a.m. Eastern time today
PRINCETON, N.J. (February 3,
2011) – Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and
pharmaceutical company focused on advanced wound care, today announced positive
results from its Phase 2 clinical trial with DSC127 in patients with diabetic
foot ulcers, including meeting the trial’s primary endpoint, the proportion of
study ulcers healed by 12 weeks as defined by 100% epithelialized with no
drainage, as well as all secondary endpoints measured at this
time. DSC127 is a patented, topically applied novel angiotensin
analog that targets receptors that are up-regulated upon injury to
tissue.
The
double-blind, placebo-controlled, multi-center clinical trial randomized 80
patients to receive one of two dose strengths of DSC127 (0.03% and 0.01%)
or vehicle placebo control. After 14 days of best standard-of-care to
evaluate ulcer healing and ensure the wounds were chronic, those patients
randomized into the study received four weeks of active treatment followed by
eight weeks of observation and assessment.
In the
Intent-to-Treat (ITT) population: Results show that 54% of the diabetic wounds
treated with the 0.03% dose (high dose) of DSC127 achieved 100% closure in 12
weeks or less, compared with 33% of patients receiving placebo control, and 30%
of patients receiving the 0.01% dose (low dose) of DSC127. Based on
odds ratio analysis, patients treated with DSC127 0.03% were 2.3 times more
likely to have their wounds heal completely compared with patients treated with
placebo/standard of care.
In the
Per-Protocol (PP) population: Results show that 65% of the diabetic wounds
treated with the 0.03% dose of DSC127 achieved 100% closure in 12 weeks or less,
compared with 38% of patients receiving placebo control, and 28% of patients
receiving the 0.01% dose of DSC127. Based on odds ratio analysis, patients
treated with DSC127 0.03% were 3.0 times more likely to have their wounds heal
completely compared with patients treated with placebo/standard of
care.
The high
dose of DSC127 exceeded the trial’s primary endpoint measurement target of an
improvement of 15 percentage points in complete healing of wounds within the
12-week duration of the study for both the ITT (21 percentage point increase)
and PP (27 percentage point increase) populations, compared with
placebo.
The trial
was not powered for statistical significance, however there was a statistically
significant (p=0.049) improvement in the rate of ulcer depth reduction in the PP
high-dose population through 12 weeks of treatment compared with the control
arm, using covariate analysis.
The drug
was well-tolerated and there were no significant adverse events associated with
DSC127 treatment. Further data on the durability of the healing effect is
expected to be available late in the second quarter of 2011 after all patients
with 100% closed wounds have completed a subsequent 12 weeks of follow-up
monitoring.
4
David
Armstrong, M.D. of Southern Arizona Limb Salvage Alliance (SALSA) at the
University of Arizona and the study's lead investigator, said, "The clinical
results from this trial are very impressive as application of 0.03% DSC127
appears to increase healing rates at a level greater than has been previously
reported by drugs currently on the market and in development. Although
further testing in a pivotal study is required, it seems that DSC127 has the
potential to be an important therapy for the treatment of diabetic
wounds.”
Derma
Sciences Chairman and Chief Executive Officer Edward J. Quilty said, “Results
from this Phase 2 trial exceeded our expectations and we are delighted to be
reporting such compelling results. Our next step in the development
process is to discuss these results with the FDA in an end-of-Phase 2 meeting,
and to advance development into Phase 3. These results are
transformational for Derma Sciences and we are looking forward to sharing these
data with potential development and commercial partners, and to determining how
best to maximize the considerable potential of DSC127 for our
shareholders. We are hopeful that a Phase 3 study will show
comparably robust results and that, in due course, DSC127 will be brought to
market to alleviate the suffering of millions of patients with these
debilitating and stubborn wounds.”
About
Diabetes and Diabetic Foot Ulcers
Diabetes
is common, disabling and deadly. In the U.S., diabetes has reached epidemic
proportions. According to the American Diabetes Association, about 24
million people (8% of the U.S. population) have diabetes, and nearly 2 million
new cases are diagnosed in people age 20 years or older each year. Up to 25% of
people with diabetes will develop a diabetic foot ulcer, resulting in 3 million
diabetic foot ulcers annually in the U.S. alone. A recent study by researchers
at the University of Chicago suggested that treatment costs for diabetes in the
United States would reach $336 billion by the year 2034. According to the World
Health Organization, at least 220 million people worldwide have diabetes, a
number that is expected to more than double by 2030, due mainly to obesity and
aging.
About DSC127
DSC127, a
novel angiotensin analog, has been shown to improve epithelialization,
granulation and vascularization, accelerating wound healing in a variety of
normal and diabetic animal models. This finding suggests that
DSC127 produces different actions at the wound site during various stages of
healing. There were no safety concerns observed in the preclinical and human
Phase 1 studies of DSC127.
Conference
Call and Webcast
Derma
Sciences management will hold a conference call to discuss this press release
and answer questions at 10:00 a.m. Eastern time today. To access the
conference call, from the U.S. please dial (888) 563-6275 and from outside the
U.S. please dial (706) 634-7417. All listeners should provide the following
passcode: 41467730. Individuals interested in listening to the live
conference call via the Internet may do so by logging on to the Company’s
website, www.dermasciences.com.
Following
the end of the conference call, a telephone replay will be available through
February 10, 2011, and can be accessed by dialing (800) 642-1687 from the U.S.
or (706) 645-9291 from outside of the U.S. All listeners should
provide the following passcode: 41467730. The webcast will be
available for 30 days.
Derma
Sciences is a medical technology company focused on three segments of the wound
care marketplace, traditional dressings, advanced wound care dressings, and
pharmaceutical wound care products. Its MEDIHONEY® product is the
leading brand of honey-based dressings for the management of wounds and
burns. The product has been shown to be effective in a variety of
indications, and was the focus of a positive large-scale, randomized controlled
trial involving 108 subjects with leg ulcers. Other novel products
introduced into the $14 billion global wound care market include XTRASORB® for
better management of wound exudate, and BIOGUARD® for infection prevention.
Derma Sciences has successfully completed the treatment phase of a Phase 2
clinical trial in diabetic foot ulcer healing with DSC127, a novel
pharmaceutical drug under development for accelerated wound healing and scar
reduction. For more information please visit www.dermasciences.com.
5
Forward-Looking
Statements
Statements
contained in this news release that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the generality of the
foregoing, words such as "may," "will," "expect," "believe," "anticipate,"
"intend," "could," "estimate" or "continue" are intended to identify
forward-looking statements. Readers are cautioned that certain important factors
may affect the Company's actual results and could cause such results to differ
materially from any forward-looking statements that may be made in this news
release or that are otherwise made by or on behalf of the Company. Factors that
may affect the Company's results include, but are not limited to, product
demand, market acceptance, impact of competitive products and prices, product
development, completion of an acquisition, commercialization or technological
difficulties, the success or failure of negotiations and trade, legal, social
and economic risks. Additional factors that could cause or contribute to
differences between the Company's actual results and forward-looking statements
include but are not limited to, those discussed in the Company's filings with
the U.S. Securities and Exchange Commission.
Contacts:
Derma Sciences,
Inc.
Barry
Wolfenson
Executive
Vice President, Global Marketing and Business Development
bwolfenson@dermasciences.com
(609)
514-4744
Lippert/Heilshorn &
Associates
Investors
Kim
Sutton Golodetz (kgolodetz@lhai.com)
(212)
838-3777
or
Bruce
Voss (bvoss@lhai.com)
(310)
691-7100
Media
Megan
Rusnack (mrusnack@lhai.com)
(212)
838-3777
# # #