Swings and Roundabouts at Biota – LANI and RSV
Biota released the following two significant announcements today, LANI is a success and RSV a dud. The market continues to digest the news in volatile fashion. Initial infatuation is currently giving way to fear of rejection. Putting this in perspective RSV was in P1, the likelihood of getting a P1 compound to market is low, so the RSV failure should come as little surprise and barely move the valuation needle on Biota. The LANI results are excellent news and it should beget more excellent news in the coming months; approval, licencing and prophylaxis.
Biota will now receive royalties from what should be the world’s two leading influenza anti-virals. The LANI results are excellent for the stockpiling market and with a clinical study for prophylaxis of influenza expected to commence in Japan in late 2009 an expanded retail market could eventuate.
LANI Phase III clinical trials in Asia prove successful
Biota Holdings Limited (ASX:BTA) today announced successful results from the Asian Phase III clinical trials of CS-8958, its second generation influenza treatment. CS-8958 now has been assigned the new name of ‘laninamivir’ by the World Health Organization under its International Non-proprietary Names (INN) drug identification system. Laninamivir is a long acting neuraminidase inhibitor (LANI) and is co-owned with Daiichi Sankyo.
In the Phase III trial in adults, a single inhaled dose of laninamivir was shown to be as effective as oseltamivir (Tamiflu) administered orally twice daily for 5 days (total of 10 doses). A parallel Phase II/III trial of CS-8958 in paediatric patients also met the primary and secondary endpoints compared to oseltamivir.
“The success of the multifaceted Phase III trials in Asia is significant. Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications” said Peter Cook, Biota’s Managing Director. read more it gets even better
RSV program returned to Biota
Biota Holdings Limited (ASX:BTA) and AstraZeneca UK Limited (AstraZeneca) today announced the completion of its Phase Ia clinical trial for Biota’s respiratory syncytial virus (RSV) anti-viral drug, BTA9881 and that further development of this compound has been halted.
BTA9881, the first representative of a novel class of fusion inhibitors developed by Biota, to enter clinical trials, exhibited approximately 100% oral bioavailability in humans and a safety profile in humans comparable to placebo at the doses examined. The pharmacokinetic profile indicated a very long plasma half life in humans. However, the BTA9881 drug profile overall did not meet the desired safety margin required to continue development of this compound.
AstraZeneca’s primary interest in Biota’s RSV program was the clinical candidate BTA9881. As development of BTA9881 has halted, AstraZeneca has provided notice to Biota that it will terminate the License and Collaboration Agreement as soon as practical. All rights in the Biota RSV program revert to Biota.
Biota intends to invest approximately $3 million in F2010 for the development of promising back-up compounds and to re-licence the program in the future.
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