The uptake from Active Biotech’s (OMX: ACTI) Mapital Markets Day held yesterday in Stockholm is that there is plenty to look forward to in the immediate future. The Swedish biotechnology firm has three late-stage assets targeting large indications and a market cap of around 2.7 billion SEK or under 400 million USD.
President & CEO Tomas Leanderson presented the project portfolio while Chief Business Officer Göran Forsberg dug deeper into the presentations given at ASCO. Company said that around half of the patients in the Tasquinimod or TASQ phase 3 study for advanced metastatic castrate resistant prostate cancer have now been recruited, with complete recruitment expected by year-end. The drug is partnered with Ipsen (Euronext: IPN) and Active Biotech is entitled significant milestone payments and double-digit royalties based on success. Active Biotech funds the global phase 3 trial with 1200 patients since the partnership was struck after the trial started and Ipsen will fund a supportive prostate cancer study. Some of the milestone payments accrue from recruitment numbers. The study is expected to take 2-3 years.
Active Biotech retains rights in North and South America and Japan, and the company aims to seek a partner in these remaining regions. The drug shows effect on tumour blood supply and metastasis in pre-clinical models. The phase 2 study data that was again highlighted as ASCO this year still has 4 patients being treated over three years on. That study was skewed in favour of the placebo arm due to differences in baseline variables but the trial still showed statistically significant effect on the primary endpoint of PFS. An effect on symptomatic progression was also shown. The competitive landscape may become rather crowded as several competitors targeting similar patient population are also in late-stage studies, including a couple from other Nordic companies as well but the compound from Active Biotech might compare very well to the competition. The drug is about to enter studies in other indications as well.
Oral Multiple Sclerosis treatment candidate Laquinimod, which has been licensed to Teva Pharmaceuticals (NYSE: TEVA, TASE: TEVA) has completed two phase 3 studies. The immunomodulator failed to show statistical significance in the second (BRAVO) one of the studies but when the data is pooled with the successful ALLEGRO study, the numbers are statistically significant. The relapse rate control was disappointing according to the company but disability control effect was described as promising and effect on brain atrophy was said to be very impressive.
Teva is talking another Phase 3 study with the U.S. FDA under Special Protocal Assessment, which will also include a higher doze arm and still plans to submit a Marketing Application in the EU based on the existing data with possible approval in late 2013. There shall be an announcement from the new study most likely within the next couple of months and it might have effect on disability as an endpoint. Laquinimod is also being studied in other indications, with Lupus data due next year. The royalty agreement with Teva consists mainly of rather attractive double-digit royalty payments. Currently the drug appears unlikely to reach a high market share in this indication, with plenty of other drugs coming to market as well, but the indication calls for life-time treatment so there is room for many options.
ANYARA for renal cell cancer is in phase 3 phase of phase 2/3 study involving altogether over 500 patients. The compound headed directly into late-stage studies meaning that there isn’t your typical earlier stage data available, somewhat adding to the risk. The fusion protein has orphan drug status in Europe and the primate endpoint is overall survival. It is also in early stage studies in other cancer indications. The data will be analyzed once 384 out of 512 patients have died. This will happen during the second half of this year as previously said, but more likely closer to the end of the year.
In other matters Laquinimod delay led to some layoffs that will be completed this summer, with number of employees coming down somewhat. Both Tasquinimod and Laquinimod composition matter patents expire in 2019 but obviously there is seven year market exclusivity upon approval. Tasquinimod development was delayed looking back; by under financing and thus delaying development in Phase 1 years ago, something that the presenters think is a common mistake within Swedish biotech. Regarding other assets, 57-57 is studied in systemic sclerosis with an orphan drug status. An exploratory study is expected to finish early next year and the drug could then go into pivotal trial in 2013/2014. The company seeks to out-license all the compounds in the clinic and has preclinical projects that its scientists will continue work with.
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