Regulatory News:
BioAlliance Pharma SA. (Paris:BIO), the specialty pharmaceutical company
focused on the treatment of opportunistic infections in cancer and HIV,
and APR Applied Pharma Research SA., together with its joint venture
partner Labtec GmbH, today announced that they have entered into an
exclusive licensing agreement under which BioAlliance has acquired the
commercialization rights in Europe to the thin film formulation of
ondansetron from APR/Labtec, leader in oral thin film technology named
RapidFilmTM. Ondansetron thin film formulation
is a new oral formulation for the prevention of chemotherapy-induced
nausea and vomiting, prevention of nausea and vomiting associated with
radiotherapy, and post-operative nausea and vomiting.
Based on the results of a recently completed bio-equivalency study,
BioAlliance will be preparing registration in Europe. The exclusive
license to BioAlliance may total up to € 6.0
million with € 1 million at signature and €
1,25 million at approval and sales milestones up to €
3,75 million; in addition royalties on net sales of the product will
also be paid.
Anti-emetic therapies constitute one of the largest segments of the
supportive care market in Europe, with annual sales of over €
400 million in 2007 in the 5 major EU markets (IMS Midas 2007).
Ondansetron was the prescription leader in the category in 2007, with
about 800 000 prescriptions (as extrapolated from IMS Midas Medical Data
2007).
APR/Labtec´s proprietary RapidFilmTM
technology is a novel, non-mucoadhesive, fast dissolving oral dosage
form. It features a thin film based on a water-soluble polymer. The film
disintegrates rapidly within seconds in contact with water or saliva,
releases the drug in the mouth and promotes gastrointestinal absorption.
The RapidFilmTM dosage form was
especially designed for high patient compliance. The application is
easy. The patient does not have any swallowing difficulty. The fact that
no water intake after administration is needed is very well accepted by
patients with nausea.
Dominique Costantini, CEO of BioAlliance said, "We are delighted
to collaborate with APR/Labtec and expand our pipeline of supportive
care products. With two unique, yet complementary delivery systems of
ondansetron in our portfolio, ondansetron oral spray from NovaDel and
the oral thin film, we are able to offer patients a better opportunity
to find a product that meets their individual needs."
Paolo Galfetti, CEO of APR, stated, "BioAlliance is uniquely
positioned to market and sell our ondansetron thin film product and we
are very excited about the collaboration. Following approval,
ondansetron is expected to be the first prescription drugs to come to
market utilizing thin film drug delivery technology”.
About BioAlliance Pharma
BioAlliance Pharma SA is a specialty pharmaceutical company focused on
the treatment of opportunistic infections in cancer and HIV. The company
develops and commercializes innovative products which address resistance
issues. The company has launched its first portfolio product (Loramyc®)
in France and already received European Marketing Authorizations in UK,
Germany, Belgium, Denmark and Luxemburg. The compound has completed the
pivotal Phase III clinical development in oropharyngeal candidiasis in
the USA. In addition, two other innovative products are currently in
Phase III clinical trials: acyclovir Lauriad®
in oral herpes (based on the same Lauriad®
muco-adhesive technology as Loramyc®, which
enables targeted release at the disease site) and doxorubicin Transdrug®
in primary liver cancer (based on the Transdrug®
nanoparticle technology, designed specifically for intracellular
targeting of resistant cells - this trial is currently suspended on the
advice from the Data Safety Monitoring Board and Steering Committee,
while waiting for additional clinical functional data). The company is
also developing a new therapeutic entities program focused on the
oncology and infectious disease markets.
In 2007, the company has established strategic alliances for
commercializing Loramyc® in Europe (with JV
SpeBio) and in the USA with Par Pharmaceutical. In March 2008,
BioAlliance Pharma signed a partnership agreement with Handok
Pharmaceuticals for commercializing Loramyc®
in Korea, Taiwan, Singapore and Malaysia and with Novamed
Pharmaceuticals in June 2008 for commercialization of Loramyc™
in China. In May 2008, the company expanded its product portfolio via
acquisition of the European commercial rights to ondansetron Oral Spray
(OS) from NovaDel Pharma Inc. (Amex: NVD).
For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com.
About APR Applied Pharma Research s.a.
APR is a private Research & Development company headquartered in
Switzerland. Core business is the development of its own selected drug
candidates (developed using APR proprietary technologies) as well as on
the development under contract of third party pharmaceutical products
and medical devices. Leveraging on its own technology platforms, R&D
know-how, marketing and regulatory expertise, APR is committed to create
new sustainable value on its own as well as on third party products and
projects.
The APR products and technologies are licensed to third parties for
distribution and marketing. R&D activities are carried out directly or
under contract.
Disclaimer 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
otherwise. 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 reference document approved by the AMF on
April 11 2008 under the number R. 08-021, which is available on the AMF
website (http://www.amf-france.org)
or on BioAlliance Pharma S.A.'s website (http://www.bioalliancepharma.com).
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