BioAlliance Pharma SA (Paris:BIO) (Euronext Paris - BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, today publishes the major key milestones achieved during the third quarter of 2012.
Two key achievements will reinforce the Company’s capacity to create value:
- The effective start of the Phase III trial with Livatag® in primary liver cancer: at the end of October, recruitment was in line with the planned schedule and ten patients have already been treated. The study, opened in twenty sites in France, should be extended to other European countries in the next weeks.
- The signature, at the end of September, of an exclusive license agreement with Vestiq Pharmaceuticals to commercialize Oravig® (Loramyc® in Europe) in the United-States, the first worldwide market for this product. With the first supply of product planned for mid-November, our new partner will be able to start promoting Oravig® as soon as late 2012. Under this agreement, an amount of $9 million, royalties excluded, should be paid over the next two years.
In parallel, BioAlliance Pharma has pursued the registration procedure of Sitavig® in the US and in Europe for the treatment of recurrent labial herpes, as well as the recruitment of patients in its Phase II clinical trial with Validive® in the radio or chemotherapy-induced oral mucositis in patients with head and neck cancer. The Company has also obtained the regulatory authorizations to start its Phase I/II trial with Amep® in the metastatic melanoma.
“Loramyc®/Oravig® was meant to bring cash reserves on the short term through agreements with international partners,” reminds Judith Greciet, CEO of BioAlliance Pharma. “This has been achieved as more than €53 million have already been received by BioAlliance over five years, to which should be added amounts to be paid by Vestiq and others from expected agreements in emerging countries. As regards operations, we have been reinforcing for several months our focus on our Orphan Oncology portfolio, our strategic and growth driving portfolio with Livatag® ranking first.”
While awaiting the commercialization of Oravig® in the United-States, the turnover for Q3 2012 amounted to €279,000, representing the royalties on Loramyc® sales in Europe by our partner Therabel, as well as the staggering of the payments received under the Asian license agreements.
The consolidated cash reserves stood at €17.3 million as of September 30, 2012, enabling BioAlliance Pharma to pursue as planned its ongoing development activities. Non conditional payments expected from our partners Therabel and Vestiq should reinforce the Company’s resources within the next months.
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About BioAlliance Pharma
Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products, BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.
Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA.
BioAlliance Pharma has developed an advanced product portfolio:
Loramyc®/Oravig® (oropharyngeal candidiasis in immunocompromised patients): Registered in 28 countries (EU, US, Korea)
Sitavir®/Sitavig® (Acyclovir LauriadTM) (labialis herpes): Positive phase III final results; registration status
Fentanyl LauriadTM (chronic cancer pain): Positive preliminary Phase I results
Orphan Oncology products
Livatag® (Doxorubicin Transdrug™) (primary liver cancer): Phase III on going
Validive® (Clonidine LauriadTM) (mucositis): Phase II on going
AMEP® (invasive melanoma): Phase I on going
For more information, visit the BioAlliance Pharma web site at www.bioalliancepharma.com
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 2011 Reference Document filed with the AMF on April 24, 2012, which is available on the AMF website (http://www.amf-france.org) or on BioAlliance Pharma SA's website (http://www.bioalliancepharma.com).
Judith Greciet, CEO, +33 1 45 58 76 00
Nicolas Fellmann, CFO, +33 1 45 58 71 00
Caroline Carmagnol, +33 6 64 18 99 59
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