20.05.2008 05:00:00
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BioAlliance Acquired European Rights for Ondansetron Oral Spray to Complement its Franchise in Cancer Supportive Care from NovaDel Pharma Inc.
Regulatory News:
BioAlliance Pharma SA (Paris:BIO) a specialty pharmaceutical company
focused on the treatment of opportunistic infections in cancer and HIV,
today announced that it has acquired the European commercial rights to
ondansetron Oral Spray (OS) from NovaDel Pharma Inc. (Amex: NVD).
Ondansetron is the leading 5-HT3 antagonist largely used to prevent
nausea and vomiting after chemotherapy, radiation, and surgery (tablets
or intravenous forms). Upon successful development and approval,
ondansetron OS could be the first anti-emetic to be available in Europe
in an oral spray formulation. The convenience of drug delivery via an
oral spray may be an alternative to improve the quality of life of
patients suffering from severe nausea and vomiting. Anti-emetic
therapies constitute the largest segment of the supportive care market
in the EU and Ondansetron is, by far, the prescription leader in the
category.
Under the terms of the Agreement, BioAlliance paid NovaDel a license fee
of $3 million upon closing. NovaDel is eligible for additional milestone
payments totalling $24 million (an approval milestone of $5 million and
sales-related milestone payments of $19 million) as well as a royalty on
net sales. BioAlliance and NovaDel anticipate collaborating in the
completion of development activities for Europe, with BioAlliance
responsible for regulatory and pricing approvals and then
commercialization throughout Europe. NovaDel will be responsible for
supplying the product.
"This first in class spray drug
delivery system aligns well with BioAlliance’s
strategy to expand its presence in supportive care for oncology patients
and to focus on patient convenience,” said
Dominique Costantini, President and CEO of BioAlliance. "NovaDel’s
expertise to design spray formulations will allow us to bring this
unique delivery system to market. Strativa, Par Pharmaceutical’s
branded division, is responsible for the clinical development of this
product in the US and BioAlliance will use their US dossier for European
registration. ”
Steven B. Ratoff, Chairman and Interim President and Chief Executive
Officer of NovaDel said, "I am very
pleased to enter into this agreement with BioAlliance. Ondansetron OS is
an excellent fit with BioAlliance and is an excellent alternative for
patients having difficulties taking tablets and other forms of
ondansetron.” About Ondansetron OS
Ondansetron OS is NovaDel’s proprietary
investigational oral spray formulation of ondansetron, the leading 5-HT3
anti-emetic therapy indicated for chemotherapy and radiotherapy induced
nausea and vomiting (CINV and RINV), and post-operative nausea and
vomiting. NovaDel and Strativa are jointly developing ondansetron OS in
the United States under the brand name Zensana™.
Par/ Strativa recently initiated bioequivalence studies in man.
BioAlliance expects to file the European dossier in 2009-2010. If
BioAlliance has to complement the US dossier for EU registration, it
will pay 100% of the costs of the additional studies up to a certain
amount, after which the development costs are shared 50:50. Anti-emetic
therapies constitute the largest segment of the oncology supportive care
market. According to IMS, in 2007:over two million prescriptions for
ondansetron were written in the US, and, in Europe, ondansetron unit
growth was 19% representing about one million prescriptions in Europe in
retail and hospital (800,000 prescriptions in the top five countries).
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). 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.
For more information, visit BioAlliance Pharma's website at www.bioalliancepharma.com.
About NovaDel Pharma
NovaDel Pharma Inc. is a specialty pharmaceutical company developing
oral spray formulations for a broad range of marketed drugs. The Company’s
proprietary technology offers, in comparison to conventional oral dosage
forms, the potential for faster absorption of drugs into the bloodstream
leading to quicker onset of therapeutic effects and possibly reduced
first pass liver metabolism, which may result in lower doses. Oral
sprays eliminate the requirement for water or the need to swallow,
potentially improving patient convenience and adherence.
NovaDel’s oral spray technology is focused on
addressing unmet medical needs for a broad array of existing and future
pharmaceutical products. The Company's most advanced oral spray
candidates target angina, nausea, insomnia, migraine headaches and
disorders of the central nervous system. NovaDel plans to develop these
and other products independently and through collaborative arrangements
with pharmaceutical and biotechnology companies. To find out more about
NovaDel Pharma Inc. (AMX: NVD), visit our website at www.novadel.com.
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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