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Significant progress towards
company growth
Paris, September 4, 2007 -
BioAlliance Pharma SA (Euronext Paris - Code Isin : FR0010095596 - BIO), a
specialty pharmaceutical company focused on the development of innovative
therapeutics targeting cancer, HIV, opportunistic infections and drug
resistance, today published its results for the first six months of 2007.
In the first half of 2007,
BioAlliance Pharma successfully implemented its operational plan, in
line with its strategic objectives:
These agreements, the company's three
products in Phase III and its portfolio of cancer and HIV projects mean that
BioAlliance Pharma has never been more confident in its capacity for
growth.
Net sales for the period amounted to
EUR 312,000, compared with EUR 198,000 in the first half of 2006.
Operational expenses increased, reflecting a mature portfolio with three
products in Phase III. Consequently, the company made a net loss in the
first six months in 2007 of EUR 8.761 million, compared with a loss of EUR
5.023 million at June 30, 2006.
Net cash amounted to EUR 19.4 million
at June 30, 2007, compared with EUR 17.6 million at December 31, 2006. The
amount includes the first payments linked to Loramyc(R) in Europe.
"BioAlliance Pharma has
brilliantly achieved its planned milestones," said Dominique
Costantini, President and CEO of BioAlliance Pharma "We have obtained
a manufacturer's price reflecting the innovation inherent in Loramyc(R). We
have set up a European structure that reinforces our financial position and
we have strengthened our international position through the launch of
Loramyc(R) in France, the SpeBio joint venture, and the license agreement
with Par Pharmaceutical in the US (which took place in the second half of
2007)."
Loramyc(R) obtained manufacturer's
pricing and a reimbursement rate for patients covered by social
security, reflecting the value the new treatment brings to patients in
France. For Loramyc(R), the first antifungal mucoadhesive buccal tablet
indicated for oropharyngeal candidiasis in immunocompromised patients, the
Company signed a convention in early June with France's Economic Committee
for Health Products (CEPS - Comité Economique des Produits de Santé Français).
This set a price of EUR 4 for a daily dose of Loramyc(R) on the French
market, or a manufacturer's price of EUR 56 and a patient's price of EUR 70,
for a box of 14 tablets. This price is at the upper end of analyst
forecasts.
This summer, the product was added to
the list of drugs that are reimbursed for patients covered by social
security at 65 per cent and to the list of medicines approved for use by
hospitals. As of September 2007, the sales team of scientific
representatives from the Company's subsidiary, Laboratoires BioAlliance
Pharma, has everything in place to launch the Group's first product in
France.
The Company set up its European
sales operation - SpeBio - under the form of a joint venture focusing on
oncology. Sharing revenues and costs 50/50, this subsidiary based in
Holland markets Loramyc(R) in Europe (outside France). The market
authorizations for each country following the European mutual recognition
procedure are scheduled for 2008. According to the terms of the joint
venture agreement, BioAlliance Pharma will receive up to EUR 29.5 million
from SpePharm, a company also specialized in hospital oncology. The Company
has already received EUR 8 million.
BioAlliance Pharma successfully
concluded its licensing agreement for the US with Par Pharmaceutical
(agreement signed 2 July), an excellent match for BioAlliance Pharma, and a
company that develops, manufactures and markets generic drugs and innovative
branded pharmaceuticals for oncology and HIV markets. In return for the
license, BioAlliance Pharma received an initial USD 15 million payment from
Par Pharmaceutical. PAR will also pay additional sums amounting to USD 50
million, in line with product development.
In addition to royalties, this means
BioAlliance has closed a total of EUR 80 million from commercial
agreements.
Three phase III clinical trials in
progress show the maturity of BioAlliance Pharma's portfolio.
Ongoing clinical pivotal Phase III
trial in the US for Loramyc(R)
The Company expects to finish
recruiting patients at the end of 2007, which will allow it to complete this
clinical trial in 2008 and file for product registration from the FDA (Food
and Drug Administration) in the second half of 2008. FDA approval is
anticipated for the first half of 2009.
Ongoing Phase II/III clinical trial
for doxorubicin Transdrug(R) in Europe for primary liver cancer, which
began in December 2006. Phase III study results are expected in the second
half of 2009.
Initiation of phase III clinical
trial for acyclovir Lauriad(R) in oral herpes in five countries: France,
Australia Germany, the UK and the Czech Republic. The company expects to
file for Marketing Authorization in Europe in the first half of 2009.
For each product, these forecasts depend on whether additional information is requested by agencies. In parallel, BioAlliance Pharma is carrying out development work on its new entities, with the objective of selecting before year end a candidate that is capable of entering Phase I in 2008.
Financial data for the first half
of 2007
Thousands of Euros
Net sales
Operational Income
Financial income
Net income
Earnings per share (Euros)
Cash at 30 June
Shareholders' equity
Cash available at June 30 2007 amounts
to EUR 19.4 million compared to EUR 17.6 million at December 31 2006. This
positive difference comes from payments already made by SpePharm within the
terms of the joint venture agreement, payments that have more than
compensated for the net operating losses.
Sales for the period amounted to EUR 312,000. They derive mainly from services provided by BioAlliance to Eurofins-VIRalliance Inc (EVI) amounting to EUR 237,000, against EUR 198,000 for the first half 2006. Sales also include EUR 75,000 paid to BioAlliance upon signing the SpePharm agreement, as part of the EUR 3 million sum due to be paid over a ten year period. The amount accounted for in the six months to June 30, (EUR 75,000) is pro rata with the six months from January 1 and also consolidates the proportional integration of SpeBio at 50 per cent. Operating costs are made up of the following items:
The net cost of financial debt is a
product which went from EUR 226,000 in 2006 to EUR 141,000 in 2007. These
amounts correspond essentially to the products of the disposal of
investments by the Company using its excess cash.
As a result of the change in activity
reflected in expenditure and product above, the net loss for the six- month
period ending June 30 2007 amounted to EUR 8.761 million against EUR 5.024
million in 2006, an increase of EUR 3.737 million.
About BioAlliance Pharma
BioAlliance Pharma SA (Euronext Paris:
BIO) is a specialty pharmaceutical company focused on the development and
commercialization of innovative therapeutics targeting drug resistance in
cancer, HIV, and opportunistic infections.
The Company is conducting clinical
development of three innovative products. Two products are based on the
Lauriad(R) mucoadhesive technology, which allows an early and prolonged
release of therapeutic agents at the site of the disease: one authorized
product in France and two clinical international phase III trials ongoing (Loramyc(R)
and acyclovir Lauriad(R)). One product is based on the Transdrug(R)
nanoparticle technology designed specifically for intracellular targeting:
one international phase III trial ongoing on primary liver cancer
(doxorubicin Transdrug(R)). The company develops also a New Entities program
focused on new targets in oncology and HIV. The company has concluded two
strategic partnerships in 2007 to sell its Loramyc(R) product in Europe and
in the US.
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 6 April 2007 under the number R. 07-031, which is available on the AMF
website
www.amf-france.org
or BioAlliance Pharma S.A.'s website
www.bioalliancepharma.com.
--
For further information, please contact:
Andrew Lloyd & Associates
Andrew Lloyd / Neil Hunter
Tel: +44 1273 675100
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