One and a half minutes after updating its tozadenant Phase 3 program design with a positively versed stock exchange release, biopharmaceutical company Biotie Therapies (OMXH: BTH1V) announced it plans to list in the United States and triple its stock count in the process to fund the said development program.
The company will issue convertible notes with a conversion price of 0.15 EUR per share and warrants
at a subscription price of EUR 0.17 in a directed issue to U.S. based investors such as Vivo Capital, OrbiMed, Versant Ventures and investment funds managed by the Baupost Group and some existing shareholders. Up to 562 million new shares may result from this. It also plans to conduct an Initial Public Offering in the United States with a maximum number of 530 million new shares from that as well. This might mean the company having more than 1.5 billion shares.
Many traders jumped the gun on the first stock exchange release. Share price of Biotie certainly reflected the need for further financing, and the conversion prices aren’t a whole lot below the current market price, so whether they come out of this unscathed is another matter, but it would certainly be hoof companies to ask for a trading halt rather than to drop one mammoth nugget at a time during market open.
Showing posts with label Biotie. Show all posts
Showing posts with label Biotie. Show all posts
Thursday, 23 April 2015
Thursday, 28 February 2013
Selinco receives EU approval
H. Lundbeck A/S (OMX: LUN) and its partner Biotie Therapies (OMXH: BTH1V) said that Selincro (nalmefene) has been approved as a treatment for the reduction of alcohol consumption in high drinking risk individuals. Predicting sales is an arduous tasks given the pioneering nature of the drug with the new treatment paradigm and the need to administer the drug in combination with continuous psychosocial support. The drug is expected to launch mid-year.
Tuesday, 26 February 2013
UCB keeps tozadenant worldwide rights in a modified deal with Biotie
Biotie Therapies (OMXH: BTH1V) commented after market close that UCB Pharma S.A (Euronext: UCB) has decided to license worldwide agreements for adenosine A2a antagonist tozadenant (SYN115), a candidate for the treatment of Parkinson’s disease. In December it was noted that the product reached primary endpoint in a phase 2b study.
Biotie will receive 20 million USD upfront and in a change to the original license agreement, Biotie will conduct the phase 3 program while UCB will make additional payments towards the running of the trial and regulatory development in the ”low triple digit millions” within the next six years. Biotie later added that the additional funding from UCB will not have a material effect on group profitability during the running of the trial. The global biopharmaceutical noted it has been impressed with Biotie’s performance in running the previous trial and sees it as the ideal party to continue clinical development.
The further remaining milestones are intact with Biotie potentially eligible for a further 340 million USD in future milestone payments upon meeting development and commercial milestones. Patient enrolment for Phase 3 program is estimated to begin in early 2015. This decision is clearly transformational for the Finnish biotech company which now finally has something to show for in regards to phase 3 in-licensing decisions and a vote of confidence from a big pharmaceutical company in regards to running major clinical trials.
Biotie will receive 20 million USD upfront and in a change to the original license agreement, Biotie will conduct the phase 3 program while UCB will make additional payments towards the running of the trial and regulatory development in the ”low triple digit millions” within the next six years. Biotie later added that the additional funding from UCB will not have a material effect on group profitability during the running of the trial. The global biopharmaceutical noted it has been impressed with Biotie’s performance in running the previous trial and sees it as the ideal party to continue clinical development.
The further remaining milestones are intact with Biotie potentially eligible for a further 340 million USD in future milestone payments upon meeting development and commercial milestones. Patient enrolment for Phase 3 program is estimated to begin in early 2015. This decision is clearly transformational for the Finnish biotech company which now finally has something to show for in regards to phase 3 in-licensing decisions and a vote of confidence from a big pharmaceutical company in regards to running major clinical trials.
Friday, 14 December 2012
CHMP recommends Selincro approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said it has recommended granting marketing authorization for Lundbeck’s (OMX: LUN) and Biotie’s (OMXH: BTH1V) Selincro (nalmefene) for the reduction of alcohol consumption in adults with alcohol dependence. The aim is to help lower alcohol consumption with high risk drinkers and the recommendation is that the drug should be prescribed in combination with psychosocial support that focuses on treatment adherence and reducing alcohol consumption.
A positive opinion had been rather unanimously expected. The bigger issue was what kind of label would be given. The requirement for psychosocial support wasn't unexpected but it does make sales predictions rather difficult and analysts appear really torn on peak sales guidance. Lundbeck too has referred to the drug as some kind of a wild card with the entire treatment concept being completely novel. Both companies responded with a rather mild positive uptick. Final approval decision is expected in 2-3 months.
A positive opinion had been rather unanimously expected. The bigger issue was what kind of label would be given. The requirement for psychosocial support wasn't unexpected but it does make sales predictions rather difficult and analysts appear really torn on peak sales guidance. Lundbeck too has referred to the drug as some kind of a wild card with the entire treatment concept being completely novel. Both companies responded with a rather mild positive uptick. Final approval decision is expected in 2-3 months.
Tuesday, 11 December 2012
Biotie jumps on SYN115 news
Finnish biopharmaceutical company Biotie Therapies (OMXH: BTH1V) got some much needed positive news with its Synosia Therapeutics acquired product candidates with adenosine A2a antagonist tozadenant (SYN115) meeting primary and numerous secondary endpoints in Parkinson’s disease in patients with Levodopa end of dose wearing off. The 420 patients study compared the off time vs. placebo in 420 patients suffering from advanced parkinson’s. Secondary endpoints included various validated rating scale as well as clinician and patient patient improvement evaluations.
CEO Timo Veromaa exxpressed hope that the study could be considered pivotal. The compound is licensed worldwide to UCB Pharma S.A (Euronext: UCB). The partners will assess following steps with UCB responsible for further development. Decision from the large multinational is expected early next year. More detailed results will be released at a medical conference and in scientific publications. Another important event is expected soon with a decision on European Marketing Approval for the lead drug candidate Selincro (nalmefene) expected soon.
CEO Timo Veromaa exxpressed hope that the study could be considered pivotal. The compound is licensed worldwide to UCB Pharma S.A (Euronext: UCB). The partners will assess following steps with UCB responsible for further development. Decision from the large multinational is expected early next year. More detailed results will be released at a medical conference and in scientific publications. Another important event is expected soon with a decision on European Marketing Approval for the lead drug candidate Selincro (nalmefene) expected soon.
Friday, 3 August 2012
Biotie waits inflection points before making further investments
Finnish biopharmaceutical company Biotie Therapies (OMXH: BTH1V) reported increasing losses this morning as R&D costs climbed to 6.7 million. Net loss of 7 million Euros translates into earnings per share of -0.02. The company now enters a wait and see mode, with Lundbeck-led (OMX: LUN) alcohol dependence drug Selincro (nalmefene) nearing EMA decision on EU approval, with feedback expected by year end. There will also be data from Phase 2b Parkinson’s disease trial with Tozadenant (SYN115) and topline data with Nepicastat (SYN117) in post-traumatic stress disorder (PTSD). CEO Timo Veromaa made it clear, that further investments are on halt prior to the readouts.
The company already has hundreds of millions of shares and further dilution of existing shareholders still looms since the maximum of 20 million Euro Standby Equity Distribution Agreement or SEDA with YA Global Master SPV Ltd was renewed for a further three-year period. Further funds are needed in 2013, with milestones from Selincro or partnering deals possibly lessening that need.
Biotie has been readying fully human antagonist VAP-1 for phase 2 development in fibrotic disease and had been seeking partner for larger indications. Now there has been a reversal and the product candidate known as BTT-1023 will not see further clinical trials initiated unless a partner is found for the time being. In the “what have you done for me lately”- world, confidence in Biotie’s partnering success is currently low. During the quarter two existing deals were terminated. Veromaa said that 5-HT6 antagonist SYN120, an AD/cognitive disorders product candidate ready for phase 2 has attracted interest and he believes a partner for this compound will be found.
The company already has hundreds of millions of shares and further dilution of existing shareholders still looms since the maximum of 20 million Euro Standby Equity Distribution Agreement or SEDA with YA Global Master SPV Ltd was renewed for a further three-year period. Further funds are needed in 2013, with milestones from Selincro or partnering deals possibly lessening that need.
Biotie has been readying fully human antagonist VAP-1 for phase 2 development in fibrotic disease and had been seeking partner for larger indications. Now there has been a reversal and the product candidate known as BTT-1023 will not see further clinical trials initiated unless a partner is found for the time being. In the “what have you done for me lately”- world, confidence in Biotie’s partnering success is currently low. During the quarter two existing deals were terminated. Veromaa said that 5-HT6 antagonist SYN120, an AD/cognitive disorders product candidate ready for phase 2 has attracted interest and he believes a partner for this compound will be found.
Thursday, 5 July 2012
Biotie completes Phase 2b Parkinson’s disease trial enrolment ahead of schedule
Biotie Therapies (OMXH: BTH1V) noted this morning that its week, double-blind, placebo-controlled, dose-finding study with Tozadenant (SYN115) in patients suffering Parkinson’s Disease has reached target enrolment of 420 patients suffering from levodopa related end of dose wearing off ahead of schedule. The trial is conducted in US, Canada, Chile, Argentina, Ukraine and Romania and should report topline data at the end of this year. UCB Pharma S.A. has an exclusive worldwide license for the orally administered adenosine 2a (A2a) antagonist and would be responsible for further development in the indication if results so warrant.
Tuesday, 26 June 2012
Roche again squashes Biotie’s hopes
Biotie Therapies (OMXH: BTH1V) said this morning that Roche (SIX: ROG) has decided against utilizing its one-time option to license SYN120. The drug candidate is a 5-HT6 antagonist targeting cognitive disorders such as Alzheimer’s and schizophrenia. This means Biotie will be left without a substantial milestone payment and now plans to seek an alternative partner to develop the compound more.
Biotie’s CEO Timo Veromaa claimed Roche’s decision was due to strategic portfolio reasons and said it has already received interest from a ”number of reputable companies” and is thus confident of finding a new high quality partner. Back in 2010, when a similar thing took place concerning VAP-1 (BTT-1023), Biotie said essentially a similar thing, although it did not claim it had already been contacted about the product. Now two years on, it is getting ready to go forward with development of the said product, a fully human monoclonal antibody, on its own. Biotie has an upcoming catalyst regarding its lead product candidate Selincro or Nalmefene due shortly.
Biotie’s CEO Timo Veromaa claimed Roche’s decision was due to strategic portfolio reasons and said it has already received interest from a ”number of reputable companies” and is thus confident of finding a new high quality partner. Back in 2010, when a similar thing took place concerning VAP-1 (BTT-1023), Biotie said essentially a similar thing, although it did not claim it had already been contacted about the product. Now two years on, it is getting ready to go forward with development of the said product, a fully human monoclonal antibody, on its own. Biotie has an upcoming catalyst regarding its lead product candidate Selincro or Nalmefene due shortly.
Friday, 8 June 2012
Biotie at Jefferies conference
Biotie Therapies’ (OMXH: BTH1V) Chief Operating Officer Dr. Ian Massey gave a presentations at the Jefferies 2012 Global Healthcare Conference last night in New York, USA. He highlighted the upcoming European MAA decision for Selincro (nalmefene) in alcohol dependence. The company continues to expect approval for the drug by the end of this year and says this will result in a significant milestone and royalties from partner H. Lundbeck (MOX: LUN). There wasn’t any new colour to add to previous announcements regarding to data from the three phase 3 studies and he said that peak sales projections from Lundbeck continues to be around 335 million Euros per year.
Tozadenant (SYN115, an Adenosine A2a receptor antagonist) Phase 2b data in Parkinson’s disease key inflection point is expected in H1 2013. The drug is partnered with UCB Pharma. Biotie company has several compounds that are ready for phase 2 studies and it has been trying to land a partner in order to do so for a couple of those. The track record in partnering talks within the last several years is very poor so investors are hardly expecting many developments on that front any longer. Roche is currently anticipating whether to opt in SYN120, a 5-HT6 inhibitor drug candidate for Alzheimer’s. The company thinks it may the best-in-class agent. Competitors such as Lundbeck and GlaxoSmithKline have their own agents in the class under development. The SYN prefix denotes compounds acquired in the Synosia transaction. The company has been quite active in the M&A front and is trying to build on that.
Biotie does aim to proceed with the development of BTT-1023 (VAP-1) on its own. According to the company’s new focus, it aims to study this initially inflammation indication drug candidate in inflammatory CNS conditions including intractable epilepsy. Furthermore Nepicastat, which is being studied for Post traumatic disorder, will be entering sponsored studies in cocaine dependence later this year. The share has been on a downward trend ever since the announcement that Selincro MAA was filed and it is down around a third for the year. The lone happenings since then have been the apparently ever increasing number of shares. There are now nearly 400 million of those and the company is valued over 130 million at yesterday’s closing price.
Tozadenant (SYN115, an Adenosine A2a receptor antagonist) Phase 2b data in Parkinson’s disease key inflection point is expected in H1 2013. The drug is partnered with UCB Pharma. Biotie company has several compounds that are ready for phase 2 studies and it has been trying to land a partner in order to do so for a couple of those. The track record in partnering talks within the last several years is very poor so investors are hardly expecting many developments on that front any longer. Roche is currently anticipating whether to opt in SYN120, a 5-HT6 inhibitor drug candidate for Alzheimer’s. The company thinks it may the best-in-class agent. Competitors such as Lundbeck and GlaxoSmithKline have their own agents in the class under development. The SYN prefix denotes compounds acquired in the Synosia transaction. The company has been quite active in the M&A front and is trying to build on that.
Biotie does aim to proceed with the development of BTT-1023 (VAP-1) on its own. According to the company’s new focus, it aims to study this initially inflammation indication drug candidate in inflammatory CNS conditions including intractable epilepsy. Furthermore Nepicastat, which is being studied for Post traumatic disorder, will be entering sponsored studies in cocaine dependence later this year. The share has been on a downward trend ever since the announcement that Selincro MAA was filed and it is down around a third for the year. The lone happenings since then have been the apparently ever increasing number of shares. There are now nearly 400 million of those and the company is valued over 130 million at yesterday’s closing price.
Monday, 5 March 2012
Strong placebo effect dulls investor mood over Selincro results
H. Lundbeck A/S (OMX: LUN) announced results of the three large Phase 3 studies with Selincro (nalmefene) for the treatment of alcohol dependence in connection with its presentations at the 2012 European Congress of Psychiatry. The headline statistic shows that patients treated with the drug were able to reduce alcohol intake by 66% on average after six months of treatment.
The drug aims to change treatment paradigm of alcoholism from total abstinence to reduction in consumption empowering the patient to take the drug on as-needed basis when they feel the urge to start drinking. Lundbeck had previously said that not all clinical endpoints were statistically significant albeit they all showed a positive trend vs. placebo. This was what investors were focusing on in today’s results.
Heavy drinking days dipped over 60% in both placebo and Selincro over a 6 month period with a statistically significant improvement at 5% confidence level for Selincro group. It would certainly have been preferable to be able to use a tighter criteria, particularly when it comes to commercial potential of the drug. A further 50% reduction over the next six months was seen in the one longer-term study, which was mainly looking at safety and tolerability, where as placebo group did not show further improvement.
The null-hypothesis for superiority of the drug over placebo in lessening total alcohol consumption could not be rejected at 5% level in ESENSE 2. In ESENSE1 the p value was below 0.05 in that endpoint as well. Statistically significant improvement in secondary endpoint of liver enzymes over placebo group is positive sign toward approval. Biotie Therapies (OMXH: BTH1V), which stands to gain a milestone from approval and royalties from sales has gained 6% for the day. Lundbeck is down slightly.
The drug aims to change treatment paradigm of alcoholism from total abstinence to reduction in consumption empowering the patient to take the drug on as-needed basis when they feel the urge to start drinking. Lundbeck had previously said that not all clinical endpoints were statistically significant albeit they all showed a positive trend vs. placebo. This was what investors were focusing on in today’s results.
Heavy drinking days dipped over 60% in both placebo and Selincro over a 6 month period with a statistically significant improvement at 5% confidence level for Selincro group. It would certainly have been preferable to be able to use a tighter criteria, particularly when it comes to commercial potential of the drug. A further 50% reduction over the next six months was seen in the one longer-term study, which was mainly looking at safety and tolerability, where as placebo group did not show further improvement.
The null-hypothesis for superiority of the drug over placebo in lessening total alcohol consumption could not be rejected at 5% level in ESENSE 2. In ESENSE1 the p value was below 0.05 in that endpoint as well. Statistically significant improvement in secondary endpoint of liver enzymes over placebo group is positive sign toward approval. Biotie Therapies (OMXH: BTH1V), which stands to gain a milestone from approval and royalties from sales has gained 6% for the day. Lundbeck is down slightly.
Monday, 20 February 2012
Biotie up slightly on heavy volume after coverage on Bloomberg
Small Finnish biotech company Biotie (OMXH: BTH1V) made Bloomberg’s front-page as Biotie’s potential Alzheimer medicine SYN120 has been attracting interest. Roche has a one-time option to take back the rights after early-stage data prints later this quarter. Biotie’s investors have been vary of that since they were hoping a similar scenario to take place with the company’s fully human antibody couple years ago but Roche chose not to exercise its option for that compound, which is soon set to enter further clinical studies in orphan indications.
Biotie acquired SYN120 when it merged with Synosia Therapeutics last year. With this the company decided to focus even more on central nervous system drugs and its lead product Selincro (nalmefene), which has been out-licensed to H. Lundbeck A/S (OMX:LUN) has completed an extensive phase 3 program and the results will be presented at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic, 3-6 March 2012.
The stock is up 2% on an unusually high volume in Helsinki stock exchange. Veromaa mentioned about the interest for SYN120 last week in a presentation at the 14th Annual BIO CEO & Investor Conference. When interviewed by Bloomberg he was much more direct, saying that “A number of reputable, highly interested pharma companies” have approached Biotie about the drug should Roche decline the option. The Bloomberg article is available here.
Biotie acquired SYN120 when it merged with Synosia Therapeutics last year. With this the company decided to focus even more on central nervous system drugs and its lead product Selincro (nalmefene), which has been out-licensed to H. Lundbeck A/S (OMX:LUN) has completed an extensive phase 3 program and the results will be presented at the 20th European Congress of Psychiatry (EPA) in Prague, Czech Republic, 3-6 March 2012.
The stock is up 2% on an unusually high volume in Helsinki stock exchange. Veromaa mentioned about the interest for SYN120 last week in a presentation at the 14th Annual BIO CEO & Investor Conference. When interviewed by Bloomberg he was much more direct, saying that “A number of reputable, highly interested pharma companies” have approached Biotie about the drug should Roche decline the option. The Bloomberg article is available here.
Monday, 13 February 2012
Nordic companies at 14th Annual BIO CEO & Investor Conference
Several Nordic biopharmaceutical companies are presenting at the 14th Annual BIO CEO & Investor Conference in New York today and tomorrow. These two companies are presenting shortly:
Zealand Pharma A/S (OMX: ZEAL) 2.00 PM EST 20.00 CET
Biotie Therapies Corp. (OMXH: BTH1V) 2.30 PM EST 20.30 CET
Their presentations should be webcasted here (available for review later).
Other companies presenting today include Azanta A/S and Novozymes A/S (OMX: NZYM B). Bavarian Nordic A/S (CPH: BAVA) and Veloxis Pharmaceuticals (OMX: VELO, formerly LifeCycle Pharma A/S) are scheduled to present tomorrow.
Zealand Pharma A/S (OMX: ZEAL) 2.00 PM EST 20.00 CET
Biotie Therapies Corp. (OMXH: BTH1V) 2.30 PM EST 20.30 CET
Their presentations should be webcasted here (available for review later).
Other companies presenting today include Azanta A/S and Novozymes A/S (OMX: NZYM B). Bavarian Nordic A/S (CPH: BAVA) and Veloxis Pharmaceuticals (OMX: VELO, formerly LifeCycle Pharma A/S) are scheduled to present tomorrow.
Tuesday, 13 December 2011
Biotie finding other legs to stand on
Biotie Therapies (OMXH: BTH1V) said this morning that US National Institute on Drug Abuse (NIDA) will conduct a phase 2b clinical study on Biotie's dopamine β-hydroxylase inhibitor Nepicastat (SYN-117) in Cocaine Dependence. Under the Collaborative Research and Development Agreement with NIDA, the parties will investigate the drug candidate in 180 treatment-seeking cocaine-dependent subjects for the treatment of drug dependance.
Biotie got the rights to the compound when it merged with Synosia Therapeutics AG in the beginning of the year. Previously a phase 2a study with Nepicastat in cocaine addicts who did not feel they needed treatment was done and the conclusion from that was that the drug is safe and well tolerated (also in combination with cocaine) and that it lessens the pleasure that subjects feel when taking cocaine. Biotie's stock is up 7% in today's trading. The stock has a near-term catalyst with the expected MAA filing of Nalmefene for alcohol dependance.
Biotie got the rights to the compound when it merged with Synosia Therapeutics AG in the beginning of the year. Previously a phase 2a study with Nepicastat in cocaine addicts who did not feel they needed treatment was done and the conclusion from that was that the drug is safe and well tolerated (also in combination with cocaine) and that it lessens the pleasure that subjects feel when taking cocaine. Biotie's stock is up 7% in today's trading. The stock has a near-term catalyst with the expected MAA filing of Nalmefene for alcohol dependance.
Monday, 25 July 2011
Biotie's SYN-120 enters Phase I trial
Biotie Therapies Corp (OMXH: BTH1V) announced that the company will start a Phase 1 clinical study with SYN120, a potential treatment cognitive disorders such as Alzheimers disease and schizophrenia. The stock opened up 6% and is now up by 4% at 51 cents a share 15 minutes into today's session.
SYN120 is orally administrated antagonist of 5-Ht6 receptors originally discovered at Roche, which has an opt-in right after the imaging study is completed. The study, which will be conducted at Hopkins University School of Medicine in healthy volunteers, will use PET imaging to investigate brain concentrations of the compound.
This news alone does not such an advance warrant, but the stock has been beaten down after the much expected news regarding the completion of the company’s flagship product Nalmefene for alcohol dependence came out last month, so traders had been waiting to get back in for some short-term action.
SYN120 is orally administrated antagonist of 5-Ht6 receptors originally discovered at Roche, which has an opt-in right after the imaging study is completed. The study, which will be conducted at Hopkins University School of Medicine in healthy volunteers, will use PET imaging to investigate brain concentrations of the compound.
This news alone does not such an advance warrant, but the stock has been beaten down after the much expected news regarding the completion of the company’s flagship product Nalmefene for alcohol dependence came out last month, so traders had been waiting to get back in for some short-term action.
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