PARIS -- (Marketwire) -- 08/28/08 -- BioAlliance Pharma publishes its consolidated half-
year accounts to June 30, 2008: increased revenue and reinforced growth via
new licensing agreements
Paris, August 28, 2008 - BioAlliance Pharma SA (Euronext Paris, ISIN code:
FR0010095596-BIO), the specialty pharmaceutical company focused on the
treatment of opportunistic infections in cancer and HIV, has published its
consolidated accounts to June 30, 2008. Notable features include:
Significantly increased revenues from two sources: (i) payments received
under the terms of Loramyc® licensing agreements in the United States,
Europe and Asia and (ii) revenue from direct Loramyc® sales. Over this
accounting period, upfront license fees (spread out over time in the
accounts) amounted to EUR 5,190k. Sales of Loramyc® in France increased
to EUR 330k and are growing steadily, fully in line with BioAlliance
Pharma's objectives.
Contained R&D expenditure at EUR 6,239k, mainly reflecting the company's
investment in late-stage clinical programs and preclinical work.
A healthy cash situation (EUR 43.9 million), combined with a significant
financial profit (EUR 1,067k).
Following a presentation to the French Association of Financial Analysts
(SFAF) at 9.00 am this morning (Paris time), BioAlliance Pharma will host a
conference call in English at 11.30am. Dial-in numbers and connection
information are available on the company's web site.
Summary of key progress in the first half of 2008. Over the first half of
2008, BioAlliance Pharma pursued its business plan in niche markets focused
on oncology and infectious disease. Several significant advances were
achieved, in line with the strategic objectives that the company has set
itself:
- Continuation of Loramyc®'s launch in France, with a significant
progression in the number of prescriptions and the number of patients
treated (+65% between the end of March 2008 and the end of June 2008). End
of July, Loramyc® share in its target OPC market reaches 5%.
- The company has been awarded marketing authorization for Loramyc® in 6
European countries, including the two largest markets after France (the
United Kingdom and Germany) where the product is being launched since July
by the sales & marketing teams at BioAlliance Pharma's SpeBio joint
venture.
- The signature of two new licensing agreements for Loramyc® in Asia,
with Handok Pharmaceuticals (Korea, Malaysia, Singapore and Taiwan) and
NovaMed (China). These two agreements represent a potential total of $16.5
million and feature significant royalties.
- Completion of Loramyc®'s pivotal Phase III trial in the United States
with encouraging interim results, which should enable filing of an NDA at
the FDA by the end of the year.
- Continuation of the company's R&D programs - notably its promising
projects liable to enter clinical phases in 2009 (on AMEP(TM), irinotecan
Transdrug® and new Lauriad® applications) and ongoing clinical trial on
acyclovir Lauriad®.
- In early July, BioAlliance announced the suspension of its Phase II
clinical trial on doxorubicin Transdrug® on the recommendation of the
Drug Safety Monitoring Board and the Steering Committee due to severe
adverse events and is currently making investigations, which are due to be
completed by the end of December 2008.
- Signature of strategic alliances in Europe aimed at completing its
product portfolio, with in-licensing of the commercial rights for Europe to
ondansetron Oral Spray® (indicated in post-chemotherapy and post-
radiotherapy nausea and vomiting). This product reinforces BioAlliance
Pharma's product range in supportive care and is enabling the company to
position itself as a key partner for oncologists and infectious disease
specialists. Earlier this month, the company complemented its supportive
care product portfolio with an additional ondansetron delivery system -
ondansetron RapidFilm(TM). European registration files for both products
are due to be submitted in 2009.
H1 2008 accounts
Available cash and cash equivalents
The company's cash reserves on 30 June 2008 amounted to EUR 43.9 million,
versus EUR 56.3 million on 31 December 31 2007. This drop of EUR 12.4
million is essentially due to R&D investments (particularly the company's
Phase III clinical trials of its three lead products) and promotional
efforts related to Loramyc®'s launch on the French market. Over the
period in question, BioAlliance Pharma paid NovaDel Pharma Inc. EUR 1.9
million for acquisition of the European commercial rights to ondansetron
Oral Spray.
In 2009-2010, BioAlliance intends to reinforce its out-licensing activity
in order to generate revenue.