NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of
products based on the NexACT® technology, today provided an update
on ongoing corporate activities and the status of the Company’s
NASDAQ listing.
Product
Pipeline
Topical Alprostadil Treatments
NexMed expects to hear from Health Canada concerning the
approvability of its New Drug Submission (NDS) for Vitaros®, its
topical treatment for erectile dysfunction, sometime in February
2010. As such, management has postponed negotiations with its
potential partner until an approval decision from Health Canada is
received, as partnering negotiations with a marketing approval
would be expected to yield more favorable terms for the
Company.
In the U.S., NexMed is awaiting a response from the Food and
Drug Administration (FDA) regarding the carcinogenicity (CAC)
assessment package, which it expects to occur within the next two
months. Partnering efforts for Femprox®, NexMed’s topical treatment
for female sexual dysfunction, are on hold pending the final
decision by the FDA.
Outside of North America, NexMed is awaiting Health Canada or
the FDA’s response to accelerate partnering efforts and/or filing
for marketing approvals. To date, NexMed has received multiple
indications of interest from international pharmaceutical companies
that might be interested in partnering with NexMed.
In addition, through its Bio-Quant research and development
team, NexMed is running new efficacy studies on the Vitaros
formulation to assess the potential of the compound for other
indications such as wound healing and Raynaud’s Syndrome. NexMed’s
strategy is to take advantage of the development work already
completed for Vitaros and bolster the existing database with new
data and apply it to potentially shorten the path of approval. The
goal includes commencing partnering discussions in mid-2010 for the
new indications, if the pre-clinical data are positive.
NM100060 Onychomycosis Treatment
NexMed is actively engaged in efforts to re-license this product
for the treatment of nail fungus. In the meantime, Novartis
continues to transfer the clinical and regulatory dossiers to the
Company and the data are being shared with potential partners.
Topical Psoriasis Treatment
NexMed’s Bio-Quant R&D team is also proceeding with
extensive pre-clinical efficacy studies to strengthen its psoriasis
candidate while actively engaging in partnering discussions.
Topical NSAID Program
NexMed is also exploring the opportunity to license an early
stage NSAID program, which includes an issued U.S. patent. This
program was not pursued when NexMed chose to focus its resources on
its sexual dysfunction programs. Preclinical data of the
NexACT-based ketoprofen cream has shown more rapid and efficient
delivery of the drug as compared to the currently marketed
products.
NexACT technology, Partnering as a Service
NexMed has initiated discussions with potential partners
regarding the application of its NexACT technology to drugs that
will soon be going off-patent to help create a second-generation
drug that has patent protection through the mechanism of delivery.
The NexACT platform technology has demonstrated the potential to
improve the topical absorption of active therapeutic ingredients
and/or to develop new patient-friendlier routes of administration.
Incorporating older drugs with the NexACT proprietary delivery
system can create new products that not only provide patients with
added therapeutic benefits, but can also extend the product life
for up to an additional 20 years. As such, the Company intends to
aggressively pursue these types of potential partnering
arrangements going forward.
NexACT technology, New Applications
In addition to developing innovative topical treatments,
NexMed’s new scientific team is evaluating the ability of the
NexACT technology to deliver biologics, such as humanized or fully
human antibodies, via transdermal application. The delivery of such
biologics through the skin represents a novel approach to
delivering antibodies to specific areas of the body with limited
systemic exposure – potentially reducing side effects and toxicity.
We are also evaluating the ability of the NexACT technology to
deliver drugs orally, including various first-line oral
chemotherapeutics, which currently have poor bioavailability and
thus require high doses and result in certain toxic side
effects.
NASDAQ Listing
On January 4, 2010, NexMed received an expected notice of
non-compliance from The NASDAQ Stock Market LLC based upon its
failure to solicit proxies and hold an annual meeting for fiscal
2008 by December 31, 2009, as required by NASDAQ Listing Rules
5620(a) and 5620(b), which could serve as an additional basis for
the delisting of the Company’s securities from The NASDAQ Capital
Market. NexMed had discussed this matter with the NASDAQ Listing
Qualifications Panel (the “Panel”) at the hearing on November 12,
2009, and explained that it planned to postpone the 2008 annual
meeting due to the ongoing acquisition of Bio-Quant and would not
be able to incorporate all of the relevant acquisition related
materials in the meeting proxy in a timely manner.
As NexMed previously announced on December 18, 2009, the Panel
granted its request to remain listed on The NASDAQ Capital Market,
subject to the condition that it evidence stockholders’ equity of
at least $2.5 million or a market value of listed securities of at
least $35 million on or before March 31, 2010. The determination
followed the hearing before the Panel on November 12, 2009, at
which time NexMed presented its plan to evidence compliance with
all requirements for continued listing on The NASDAQ Capital
Market, including the proxy solicitation/annual meeting and bid
price requirements (notwithstanding the fact that NexMed was not
yet deficient with respect to those standards).
As provided by NASDAQ’s most recent notice, NexMed plans to
timely make a formal written submission to the Panel presenting its
plan to evidence compliance with the proxy solicitation and annual
meeting requirements. While it intends to file a proxy statement
for a special meeting of shareholders to be held within the next
sixty days to consider amending its Articles of Incorporation to
authorize more common stock for issuance, that meeting may not be
conducted as an annual meeting since the proxy statement will not
incorporate audited financial statements for the fiscal year ended
December 31, 2009. As a result, in order to satisfy NASDAQ’s annual
meeting requirement, NexMed plans to file a proxy statement for a
joint 2008/2009 annual meeting promptly following the filing of its
Annual Report on Form 10-K for fiscal 2009 in March 2010.
Accordingly, the Company is asking the Panel to modify its
previously issued decision in accordance with the Company’s revised
plan of compliance. However, there can be no assurance that the
Panel will grant the Company’s request.
Also as previously announced, NexMed remains subject to a grace
period through January 25, 2010 to evidence compliance with the
$1.00 bid price requirement for continued listing on NASDAQ. In the
event NexMed does not evidence compliance with the bid price
requirement by that date, NexMed expects to receive an additional
formal notice of non-compliance and to be afforded an opportunity
to request an exception from the Panel to evidence compliance with
the minimum bid price requirement. In that regard, NexMed will
implement a reverse stock split, if necessary, to evidence
compliance with NASDAQ’s minimum bid price requirement, which
action may be taken at any time at the discretion of the NexMed
Board of Directors.
Corporate
Integration
Subsequent to the December 17, 2009 announcement of the lease of
its manufacturing building in New Jersey, NexMed has completed the
relocation of its headquarters to 6330 Nancy Ridge Drive, San
Diego, CA 92121. NexMed now has 34 full time employees, of whom
eight employees hold either Ph.D or MD degrees. NexMed will include
the pro forma financial statements for the combined entity in an
amendment to its December 17, 2009 Current Report on Form 8-K, to
be filed on or before February 26, 2010.
About NexMed
NexMed, due to its recent acquisition of Bio-Quant, is the
largest specialty contract research organization (“CRO”) based in
San Diego, CA and is one of the industry’s most experienced CROs
for in vitro and in vivo pharmacology services and research models.
NexMed has a proprietary product pipeline based on its NexACT drug
delivery technology, including a late stage terbinafine treatment
for onychomycosis, a late stage alprostadil treatment for erectile
dysfunction, a Phase 2 alprostadil treatment for female sexual
arousal disorder, and an early stage treatment for psoriasis. For
further information, go to www.nexmed.com and
www.bio-quant.com.
Forward-Looking Statement Safe
Harbor
Statements under the Private Securities Litigation Reform Act:
with the exception of the historical information contained in this
release, the matters described herein contain forward-looking
statements that involve risks and uncertainties that may
individually or mutually impact the matters herein described for a
variety of reasons that are outside the control of the Company. For
example, and without limitation, there can be no assurance that the
Company will receive favorable approvability decisions from Health
Canada or the FDA within the anticipated time frames or at all, the
Company’s research and development activities will yield the
desired results, the Company will be able to achieve or will
continue to pursue its product development goals, the Company will
be able to execute on its partnering strategies, the Company will
be able to satisfy NASDAQ continued listing standards, and that the
Company will be able to integrate its business following the
Bio-Quant acquisition in a successful manner.
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