 Resistance
to drugs leads to therapeutic failure and is recognized as
a growing public health problem. The company is active in
major markets where there is a pressing need for improved
therapeutic management. Cancers, fungi, bacteria and viruses
continuously out-innovate the drug industry, by becoming insensitive
to therapy and creating an ongoing demand for new products.
The most practical reasons for new drugs or drug delivery
development are improving patient compliance and reducing
the toxicity of present regimens.
Since its foundation, the Company has concentrated on the
development of three ranges of products, based on:
- Lauriad® technology, which targets the site
of the infection via the adhesion of a mucoadhesive
gingival tablet to the buccal mucous membrane. This innovative
technology allows rapid and prolonged delivery and release
of the therapeutic agents to the actual site of the disease;
- Transdrug® technology, which is used for
intracellular targeting. This technology, based
on nanotechnologies, is specially designed to attain the
heart of the cell, thus bypassing drug resistance mechanisms
and improving drug efficacy and drug tolerance; and
- New Entities aimed at new targets. These entities
constitute a portfolio of new medicines capable
of inhibiting new pharmacological targets. These products
are intended for oncology and the human immunodeficiency
virus (HIV).
Lauriad® Drug Delivery Platform
A first product ready to enter the market: Loramyc®
The company’s lead product, Loramyc® - miconazole Lauriad® 50 mg mucoadhesive buccal tablet, that uses the patented Lauriad® technology, has been developed as an anti-infective for local oral treatment. It obtained its first marketing authorization in France in October 2006. The Company plans to launch Loramyc® in France in 2007 via its operating subsidiary Laboratoires BioAlliance Pharma.
Loramyc® has completed two Phase III clinical trials
in Europe for treatment of oropharyngeal candidiasis, a potentially
life threatening oral fungus frequently contracted by immune,
compromised patients, including cancer patients who have undergone
chemotherapy or radiotherapy, HIV patients, diabetics and
the elderly.
The company has filed for registration in the EU in 3Q05.
The French marketing authorization is the first step towards
obtaining regulatory approval across Europe under the European
Mutual Recognition Procedure. France will present the application
in 2007 as the reference Member State. The Company anticipates
receiving the first marketing authorizations in certain European
countries at the end of 2007, with marketing in Europe being
started in 2008 trough its subsidiary SpeBio (JV 50:50 with
Spepharm).
BioAlliance Pharma is currently carrying out a pivotal phase
III clinical trial in the United States, authorized by the
FDA, with regard to Loramyc® in oropharyngeal candidiasis
for immunocompromised patients (with HIV). It is expected
that recruitment for this trial will terminate at the end
of 2007, with the filing of the dossier being envisaged in
2008, subject to any additional regulatory requirements.
A near term follow-on product, acyclovir Lauriad® for
treatment of oral herpes, utilizing the same delivery platform,
has completed a Phase I clinical study in the EU. In 1S07,
the Company obtained the authorizations from the relevant
authorities in Australia, France, Germany, the United Kingdom
and the Czech Republic, enabling it to enter Phase III clinical
trials for this product.
A third product, fentanyl Lauriad® for treatment of severe
resistant cancer pain, is under consideration as the next
candidate for development using this platform.
Transdrug® Nanotechnology Drug Delivery Platform
The lead product in the BioAlliance nanoparticle program,
doxorubicin Transdrug®, has completed in 2006 a Phase
I/II study in the EU for treatment of primary liver cancer,
hepatocellular carcinoma (HCC), via the intra-arterial route
of administration.
This product has received 'Orphan Medicinal Product' designation
from the European Medicines Agency (EMEA) and Orphan Drug
Designation in the U.S. from the U.S. Food and Drug Administration.
BioAlliance Pharma is currently carrying out a phase III
clinical trial with regard to doxorubicin Transdrug® in
primary liver cancer.
Follow-on products based on this technology are under development.
New Entities
The Company’s new entities program currently focuses
on three different projects in HIV and cancer. These projects
include development of a novel integrase inhibitor designed
to disrupt a key viral replication process in HIV. The integrase
enzyme plays a key role in HIV infection by acting on multi-resistant
viral strains that develop in response to other drugs. This
product is expected to enter clinical development in 2007.
In oncology, the company has focused on the cytoskeleton
region involved in resistance and metastasis through selection
of an anti-invasive peptide (AMEP) targeting the entry of
the cytoskeleton cascade and acting on metastatic cancers.
While still in preclinical development, it is possible that
this product may also be ready to move into the clinic in
2007. A second NCE under development in oncology is a key
gene target (Zyxin), also involved in the cytoskeleton cascade
and whose under-expression is involved in the tumour phenotype.
It represents a key to phenotypic reversion in oncology and
is the basis of a new screening test for drug candidates.
The ultimate goal of this NCE program is the development
new drugs targeting large and growing markets in cancer and
infectious disease.
While still in preclinical development, one of these projects
is expected to enter phase I in 2008.
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