|[March 19, 2014]
BioAlliance Pharma: Sitavig® Licensing Strategy
PARIS --(Business Wire)--
BioAlliance Pharma SA (Paris:BIO), an innovative Company dedicated to
the development of orphan oncology products, announced major
advancements in the licensing strategy of Sitavig® (acyclovir Lauriad®)
for the treatment of recurrent labial herpes, with the execution of a
licensing agreement with Innocutis Holding LLC to commercialize Sitavig®
in North America. In Europe, the Company received a positive opinion
from the Health Authorities in France and Germany for the Market
Authorization of the drug.
Innocutis, based in Charleston (South Carolina), is a pharmaceutical
company dedicated to Dermatology, with "best-in-class" branded
prescription products in skin related therapies. Innocutis deploys a
direct sales force to promote its products to the fastest-adopting,
highest-prescribing dermatologists in the United States, providing
clinicians with improved solutions for managing the challenges presented
in their daily practice.
Innocutis will promote Sitavig® to dermatologists and top tier general
practitioners alone, or with a sublicensee, allowing coverage of the
largest panel of patients in the U.S. Product launch in the U.S. is
expected as early as early third quarter 2014.
Under this agreement, BioAlliance Pharma is eligible to receive a total
of $5 million in upfront and milestones payments. The agreement also
includes double-digit royalties which should represent significant
downstream revenues. In addition, Innocutis shall fund a major portion
of the pediatric clinical study required by the FDA, as well as U.S.
regulatory taxes. Locust Walk Partners, LLC served as transaction
advisor to BioAlliance Pharma.
"Sitavig® represents a unique opportunity for Innocutis corporately
and will change the way clinicians will treat herpes labialis. In order
maximize Sitavig® opportunity, Innocutis will pursue sublicensing
opportunities in multiple specialty fields while the Innocutis sales
force focuses on dermatology. As an organization, Innocutis couldn't be
more pleased with the partnership that has been develop with BioAlliance
Pharma and we look forward to a successful launch of Sitavig® in North
America", commented Joe Pecora, CEO of Innocutis Holdings LLC.
Regarding Europe, Sitavig® had already been registered in 8
countries through a decentralized procedure successfully achieved in
December 2012. As its registration strategy, the Company had filed in
these countries first to ensure optimized registration timelines, and
then filed a mutual recognition procedure in France and Germany, which
are two major European countries with the greatest commercial potential
in the European herpes labialis market.
This second procedure is now finalized and both Health Authorities have
issued a positive opinion for the registration of Sitavig®.
"Obtaining the opinion from these two countries was key, as they
together represent more than 60% of the total European market, estimated
to €90 million. Indeed, these will significantly accelerate the
discussions with potential European partners, which are our priority now
that Sitavig® is licensed in the US.", declared Aude Michel, Head
of Corporate Development of BioAlliance Pharma.
"These 2 steps are key advancements in our licensing strategy for
We are delighted with this agreement with Innocutis, a strategic U.S.
partner with a highly skilled management team and a dedicated sales
force, and we trust this collaboration will ensure the rapid and
successful commercialization of Sitavig® in the U.S., the largest sales
potential market, estimated up to $500M", commented Judith Greciet,
CEO of BioAlliance Pharma.
In Europe, regulatory procedure has been finalized with success and
Sitavig® is now approved in all key countries. Indeed, we are confident
that it will significantly help licensing discussions with potential
European partners, already fairly well advanced".
Based on proprietary Lauriad® technology,
Sitavig®, patented until 2029 in the major territories and 2031 in the
U.S., comes in the form of a mucoadhesive tablet which the patient
places on the gum and which delivers a high concentration of acyclovir
directly to the lip, the site of the cold sore infection. In addition to
its efficacy, Sitavig® offers the major advantage of a particularly
unobtrusive and simple formulation with a single application for the
episode's entire duration, representing major advantages for patients
suffering from recurrent herpes sores.
Herpes labialis is an extremely widespread condition. Between 20% and
40% of Americans suffer from recurrent cold sores (1), namely between 60
and 120 million people in the U.S., representing a significant market
potential of hundreds of million dollars.
(1). Young TB, Rimm EB, D'Alessio DJ. Cross-sectional study of
recurrent herpes labialis: prevalence and risk factors. Am J Epidemiol.
Innocutis is a pharmaceutical company
specializing in the development and commercialization of therapies
focused on medical treatment of dermatological conditions. Innocutis'
current portfolio of products consists of established branded
prescriptions. At Innocutis we believe our focus on medical dermatology
sets us apart as a company that understands the growing needs of the
dermatology specialty. Our commitment is to be "best-in-class" in
skin-related therapies, providing clinicians with improved solutions for
the management of daily challenges experienced in their practice. Our
"search and development" efforts are designed to identify and acquire
late-stage and/or marketed proprietary pharmaceutical products for the
treatment of dermatological diseases that have an existing base of
safety and efficacy data.
About BioAlliance Pharma
Dedicated to cancer treatments with
a focus on resistance targeting and orphan products, BioAlliance Pharma
conceives and develops innovative products for orphan or rare diseases.
The Company has also successfully developed products based on its
innovative muco-adhesive Lauriad® technology both registered in Europe
and in the United States.
Created in 1997 and introduced to the Euronext Paris market in 2005,
BioAlliance Pharma's ambition is to become a leading player in these
fields by coupling innovation to patient needs. The company's teams have
the key competencies required to identify, develop and register drugs in
Europe and the U.S.
BioAlliance Pharma has developed an advanced product portfolio:
Orphan Oncology products
Transdrug™) (primary liver cancer): Phase III on going
(Clonidine Lauriad®) (mucositis): Phase II on going
(invasive melanoma): Phase I on going
Products from the Lauriad® platform
(oropharyngeal candidiasis in immunocompromised patients): Registered in
21 countries (EU, U.S., Korea), commercialized in Europe and in the U.S.
(Acyclovir Lauriad®) (labialis herpes): Registered in the U.S. and in 10
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
This communication expressly or implicitly contains certain
forward-looking statements concerning BioAlliance Pharma SA and its
business. Such statements involve certain known and unknown risks,
uncertainties and other factors, which could cause the actual results,
financial condition, performance or achievements of BioAlliance Pharma
SA to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
BioAlliance Pharma SA is providing this communication as of this date
and does not undertake to update any forward-looking statements
contained herein as a result of new information, future events or
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of BioAlliance
Pharma SA to differ from those contained in the forward-looking
statements, please refer to the Risk Factors ("Facteurs de Risque")
section of the 2012 Reference Document filed with the AMF on April 18,
2013, which is available on the AMF website (http://www.amf-france.org)
or on BioAlliance Pharma SA's website (www.bioalliancepharma.com).
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