Melbourne, Feb 18, 2009 (ABN Newswire) - Biota Holdings Limited (ASX:BTA)(PINK:BTAHY) today announced a half year net profit after tax of A$7.2 million, (1H F08: A$5.5 million), a 31% improvement over first half F08. Profit before tax was A$10.1 million (1H F08: A$7.5 million) and includes A$12.7 million from the GSK litigation settlement in the period.
Commenting on the results today, Biota CEO Peter Cook said "This half has demonstrated strong management of cash and with the resolution of the litigation with GSK, allows Biota to commit optimal resources into its clinical pipeline. The order on GSK, announced in January, from the UK Department of Health for 10.6 million courses of Relenza is encouraging".
Total revenues were A$33.5 million, up 10% from A$30.4 million in the comparable period last year. Total revenues included A$3.8 million of Relenza royalties (1H F08: A$16.5 million), A$6.6 million (1H F08:A$9.6 million) of collaboration income from licensing agreements with AstraZeneca and Boehringer Ingelheim, A$20 million from the litigation settlement with GlaxoSmithKline (GSK) and grant income of A$1.1 million (1H F08 A$2.4 million) from the US National Institutes of Health for the development of LANI.
The result includes a portion of the US$3.5 million payment from AstraZeneca, whilst the comparable period in F08 included a significant milestone payment of A$3.4 million.
Other Significant Events
- The litigation against GSK was concluded in July 2008, following mediation. The agreement provided for a payment to Biota of A$20 million, and the normalisation of commercial relations.
- In January 2009, the UK Department of Health awarded GlaxoSmithKline a contract for the supply of 10.6 million treatment courses of Relenza. This purchase is consistent with recommendations published by the European Medicines Agency (EMEA) and the UK's Royal Society of Medical Sciences to diversify anti-viral stockpiles and include zanamivir (Relenza), especially given the emerging evidence of resistance to Tamiflu (oseltamivir). Biota estimates that the completion of the contract will represent royalty income to Biota of up to A$18 million. Timing of this receipt to Biota is uncertain.
- Biota's co-owned long acting neuraminidase inhibitor (LANI) CS8958 successfully completed its initial Phase II study in Japan and commenced the pivotal Phase III study at a number of centres in Asia. The study involves adult patients who have confirmed, naturally acquired influenza A or B. Enrolments are expected to be complete by the end of the northern hemisphere influenza season.
- Biota expanded the licence of its Respiratory Syncytial Virus (RSV) program with AstraZeneca to include certain Asian and Pacific territories for an additional US$3.5 million payment and future royalties. During the half the 2005 Collaboration agreement, initially with MedImmune Inc., was assigned to AstraZeneca and the supporting research program has been extended. The program's lead compound is completing Phase I clinical trials.
- The Company completed an on-market share buy-back in October 2008. During the half year, 6.6 million shares were purchased and cancelled at a cost of A$4.9 million.
Commenting on the results today, Biota CEO Peter Cook said "This half has demonstrated strong management of cash and with the resolution of the litigation with GSK, allows Biota to commit optimal resources into its clinical pipeline. The order on GSK, announced in January, from the UK Department of Health for 10.6 million courses of Relenza is encouraging".
Total revenues were A$33.5 million, up 10% from A$30.4 million in the comparable period last year. Total revenues included A$3.8 million of Relenza royalties (1H F08: A$16.5 million), A$6.6 million (1H F08:A$9.6 million) of collaboration income from licensing agreements with AstraZeneca and Boehringer Ingelheim, A$20 million from the litigation settlement with GlaxoSmithKline (GSK) and grant income of A$1.1 million (1H F08 A$2.4 million) from the US National Institutes of Health for the development of LANI.
The result includes a portion of the US$3.5 million payment from AstraZeneca, whilst the comparable period in F08 included a significant milestone payment of A$3.4 million.
Other Significant Events
- The litigation against GSK was concluded in July 2008, following mediation. The agreement provided for a payment to Biota of A$20 million, and the normalisation of commercial relations.
- In January 2009, the UK Department of Health awarded GlaxoSmithKline a contract for the supply of 10.6 million treatment courses of Relenza. This purchase is consistent with recommendations published by the European Medicines Agency (EMEA) and the UK's Royal Society of Medical Sciences to diversify anti-viral stockpiles and include zanamivir (Relenza), especially given the emerging evidence of resistance to Tamiflu (oseltamivir). Biota estimates that the completion of the contract will represent royalty income to Biota of up to A$18 million. Timing of this receipt to Biota is uncertain.
- Biota's co-owned long acting neuraminidase inhibitor (LANI) CS8958 successfully completed its initial Phase II study in Japan and commenced the pivotal Phase III study at a number of centres in Asia. The study involves adult patients who have confirmed, naturally acquired influenza A or B. Enrolments are expected to be complete by the end of the northern hemisphere influenza season.
- Biota expanded the licence of its Respiratory Syncytial Virus (RSV) program with AstraZeneca to include certain Asian and Pacific territories for an additional US$3.5 million payment and future royalties. During the half the 2005 Collaboration agreement, initially with MedImmune Inc., was assigned to AstraZeneca and the supporting research program has been extended. The program's lead compound is completing Phase I clinical trials.
- The Company completed an on-market share buy-back in October 2008. During the half year, 6.6 million shares were purchased and cancelled at a cost of A$4.9 million.
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About Biota Holdings Limited
Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.
Biota research breakthroughs have included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, licensed to AstraZeneca and novel nucleoside analogues designed to treat hepatitis C virus (HCV) infections, licensed to Boehringer Ingelheim. Biota has clinical trials underway with its lead compound for human rhinovirus (HRV) infection in patients with compromised respiration or immune systems. In addition, Biota has a key partnership with Daiichi-Sankyo for the development of second generation influenza antivirals.
Relenza(TM) is a registered trademark of the GlaxoSmithKline group of companies. *Further information available at http://www.biota.com.au
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