Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Good point, El Principe.
Iclight, true their website doesn't mention CV nor has Biosante ever mentioned their patent applications regarding CV benefits or commercial production of Libigel.
I guess, Biosante would be the first company not to advertise everything they are working on. Is Abbott the reason why?
I believe you are making the false assumption that efficacy and safety have to be separated, one measurement can actually prove both and that is exactly what has happened in the Libigel Bliss Trial
The patent applications for CV reduction:
Methods for decreasing the risk of cardiovascular events in postmenopausal women having a high risk for a cardiovascular event are provided. In particular, methods for decreasing the risk of cardiovascular events in postmenopausal woman at high risk for cardiovascular events by administering to the woman a therapeutically effective amount of an androgen, whereby administering the androgen decreases the risk of cardiovascular events in the woman compared to untreated postmenopausal woman at high risk for cardiovascular events are provided.
Patent
In addition to the current primary outcomes of the trial:
"The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects"
Clinical trial
It makes the leap extremely short. The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects showed that Libigel significantly reduced the risk of CV events when compared to placebo, by default efficacy has been demonstrated in several of their patient groups.
Read the Bliss safety trial info, this is not your standard clinical trial and has a dynamic set up with changes on the fly.
Bliss trial
In this trial proving efficacy in reducing CV events could simply equate to a change in the title and determining what ratio would be deemed enough of a reduction to be deemed significant. This would be the efficacy endpoint. It would be a paper exercise as they already have the data to support their claims.
Nice post Dorian, the link between testosterone being an anabolic steroid and the heart being the biggest muscle makes perfect sense.
Yet another employee working at Biosante in 2008 while still employed at Abbott, Jason Moresco, MBA. He worked at Biosante as a Sr CRA for under 1 year.
Jason Moresco
Interestingly the safety trail was first submitted January 23. 2008.
Safety trial
Makes you wonder was this a silent partnership from the beginning?
Pete, don't worry about it.
Iclight, I strongly believe the efficacy portion of the Libigel safety trial as it relates to CV events will produce enough data to support the submission of an NDA for the treatment of Hypertension and Dyslipidemia. The sample size in these groups are approximately three times as big as many cardiovascular related efficacy trials. The data will also be used to support Libigel as a HRT for post menopausal women. Which in the end takes care of the off label prescription issue (which is not strictly limited to HSDD, osteoporosis, muscle loss etc...)
The continued safety trial and post marketing studies will provide sufficient evidence to expand the use to treat Diabetes.
This fall Biosante will be receiving the results of the cognitive study in Australia. If all goes well I expect them to start a Libigel phase II cognitive study in addition to the phase III HSDD trials in 2013.
Shifting the focus from HSDD to CV is the proper strategy and i would question a company that put HSDD a head of the discovery of Testosterone on CV events.
If I am correct this is the best course of action. In all likely hood they already have a partner and this strategy is preventing them from buying more shares.
Professor, I agree, I am curious to see how the AbbVie roll-out takes shape. I know Abbott has been concentrating on global expansion including the purchase of Piramal in India and has a good presence in China.
In any event it gives us something to look for while waiting for news.
Jadite, Biosante sold all US royalty rights for Elestrin. They can still receive up to $140 million in milestone payments based on sales targets, no idea what the targets are.
I believe Elestrin rights were divided with Antares similar to the deal with Libigel. AIS gets Europe and Biosante gets the rest of the world.
AIS royalties
Elestrin is approved for use in Isreal, this was done by PharmaSwiss which was bought out by Valeant. I have yet to see any activity yet from Valeant.
I believe Jazz outsources the manufacturing of Elestrin to DPT Labs
Big pharma shopping for immunotherapies, should be good for Biosante.
BIO 2012
It should just add pressure for a company such as Abbott or Pfizer to make a fair deal or risk another company getting involved and jacking up the price.
Jeff, jadite it is also interesting to see that both Simes and Snabes worked for companies that were acquired by Pfizer.
I got to admit this company is well connected.
Jeff, if a three party agreement has been formed between Pfizer, Abbott and Biosante, I imagine the appointment of Sandra Croak-Brossman, MS, Ph.D., as Biosante's Vice President, Regulatory Affairs and Quality Assurance July 18 , 2011 played an important role.
Dr. Croak-Brossman joins BioSante with over 24 years of experience in the pharmaceutical industry. She has held a variety of regulatory positions and has led operations at both a U.S. and global level. Dr. Croak-Brossman's work experience includes positions at Boehringer Ingelheim, Pfizer and Abbott Laboratories. Importantly, while at Pfizer, Dr. Croak-Brossman was the worldwide regulatory lead for Viagra®
Appointment
Dr. Croak-Brossman is now with Abbott as a Sr Director, at she previously held a similar position.
True dionnfr. I get a kick out of trying to solve mysteries, and part of me finds this frustrating but another part of me finds this very fascinating.
Jeff, Pfizer sponsors the newsletter Menopausal Medicine. There have been other issues not covering testosterone. It is possible that that was the topic of the month, especially since it is becoming a bigger issue. Then again they may be putting people in place.
Menopausal Medicine
Iclight, you are probably correct the HR replacement. I was looking at her qualifications. She is probably over qualified for a small company, unless the company intends to significantly expand. Remember she was supporting 1500 employees at Pfizer. Biosante has less then 60 employees. The fact she comes over from Pfizer might benefit Biosante as well.
Jeff, Pfizer leaves the largest footprint. But Abbott appears to have more then just a passing interest in Libigel. You earlier mentioned the possibility Pfizer buying both Abbott and Biosante. It is an interesting possibility but most companies are shying away from the mega-deals including Pfizer
Pfizer CEO has admitted that it is looking for buyout opportunities in the $4 Billion range
Personally, the history between Biosante (Simes) and Abbott and their wholly owned subsidiaries would lead me to believe the plan is for Biosante to become a wholly owned subsidiary of Abbott. This would allow Biosante to continue doing what they do best - concentrating on R&D. Biosante has consistently been the Benchmark for research intensity according to the Patent Board. Interestingly, after the December pps collapse, I remember Simes making an innocuous statement that maybe Biosante should continue sticking to their strength - R&D. In light of what has transpired I have to wonder if it was innocuous statement or a hint.
Looks like Biosante has brought in help for HR expansion.
Lydia Rohn a senior HR manager from Pfizer
Rohn's experience
2008 - Present
Sr. Manager - Pfizer Pharmaceuticals
Provide strategic and tactical ER and HR support nationally for several groups (1500+ employees across Commercial, Clinical, Biologics businesses). Based in local office in Itasca, IL. Complex investigations at all levels. Coach and counsel leaders and employees in performance management, policy, legal considerations, conflict management, etc.
Seems to me Biosante intends to grow.
King, wouldn't being dropped from the Russell Index, the R/S and the low share price make it easy for the big boys to overlook what is really going on. They have many stocks to oversee. This one is easy to dismiss (on the surface).
Think of BPAX as an iceberg, most people (analyst) only see what is above the water - a small portion of the entire iceberg. Fortunately this board has quite a few scuba divers to help paint a picture of the entire iceberg.
Homeslice, you raised a good point. Maybe the division of assets between Abbott and BSM would provide the biggest bang for Biosante shareholders, while suiting the strategic needs of Abbott and BSM at a reduced cost to each company.
Diane Charleston seems to be working simultaneously at a PRA International and Biosante.
Sr. CRA
PRA International
Privately Held; 1001-5000 employees; PRAI; Research industry
2012 – Present (less than a year)
Project Manager
BioSante, Pharmaceuticals, Inc.
Public Company; 51-200 employees; Pharmaceuticals industry
April 2011 – Present (1 year 3 months) Lincolnshire, L
Currently working on an NDA for women's health indication for large phase 3 trials.
Charleston Bio
Is this to support an NDA based on the safety trial data or the new Phase III efficacy trials? They could actually help with both. Personally, I am leaning towards their post-marketing capabilities from an NDA based on safety results..
"PRA is a global expert in the design, management and implementation of post-marketing and minimal risk studies for pharmaceutical, biotech and medical device companies. Our late-phase infrastructure is designed to support your studies throughout the proving process, providing you with a dedicated, effective and knowledgeable partner to smooth the way.
Post-marketing studies are able to identify trends and signals in large, "real life" populations since the number and type of patients and their length of exposure to the product can vary greatly from those studied in the early phase clinical trials.
Our dedicated Late-Phase Services (LPS) group provides a full range of services, including both interventional and non-interventional studies, to demonstrate the effectiveness of a drug or medical device to regulators, healthcare professionals or patients."
PRA international
PRA is a global Clinical Research Organization providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on 6 continents through our global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enable our project teams to deliver consistent and on time performance for our clients
With respect to GVAX, Abbott and Bristol Myers Squibb have collaborated on a number of clinical trials.
BMS has been the lead in 5 trials
Abbott has been the lead in 3 trials
Both have collaborated on an addition 8 trials where neither was the lead.
trials
Including the following ongoing trials:
Phase III - Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)
Phase III - Relapse or Refractory MM - Open Label With or Without Elotuzumab (ELOQUENT - 2)
Phase II - Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Phase II - Biomarker Study of Elotuzumab in High Risk Smoldering Myeloma
Phase I - Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
Note the following is strictly hypothetical.
If the grand plan is for Abbott to acquire Biosante, it is feasible that BMS would wait until the deal is announced before advancing to the next GVAX Prostate + Yervoy trial. This way Abbott and BMS can share the trial expenses and possibly advance a number of GVAX trials.
Jeff, I am not certain if this is a modification of the L3 position the posted earlier or an additional position
L3
Pete, I mentioned the Ardea / Astrazeneca $1.26 Billion deal in the previous post. Notice they were only starting Phase III trials
Now look at the future global gout market.
GlobalData’s analysis shows that the global gout therapeutics market grew at a compound annual growth rate (CAGR) of 13.4% from $527.4m in 2006 to $988.7m in 2011, and is predicted to grow further at a CAGR of 12.5% to reach $2.5 billion by 2019, providing further incentive for pharmaceutical companies to explore the market in future.
Gout Market up to 2019
Now look at Biosante's potential revenue. (Note this was a previous post and I have since learned that some of the issues around global rights may need adjusting on some products)
Hope this provides a clearer picture of what you would deem as fair market value for Biosante. Homeslice mentioned a $200 + pps target he had in mind. Upon reading what I have provided in this post, I see his target as being very realistic, maybe even on the conservative side.
Pete, I understand your skepticism. Based on the information we as a group have uncovered it appears like management has been less then forthright. However Simes has constantly stated that they want to maximize shareholder value(he didn't say when and where)and for this reason those who remain should be well rewarded. If not, unlike previous lawsuits which were frivolous the one we as group will launch would have teeth.
Now, with everything that has transpired, I believe a buyout is in the works. The buyout would have to pass a shareholder vote. The share holders including institutional shareholders would know if the deal was a low ball offer. Such an offer would get rejected. Abbott and Biosante's Boards & Management teams are not stupid. The offer would have to be fair in order to pass a vote and avoid another big pharma company from stepping in which would end up costing Abbott much more in the long run if they wanted to attain their goal of being lead in expanding the use of testosterone.
A number of companies were offered $2.5 to $3.5 billion this year with much less revenue potential then what we have uncovered. The other deals and their revenue potential will be the gauge for a fair deal.
Love it or hate it we have on our side Tang and he has sued companies in the past who tried to sell for less then what he believed the company was worth.
Use the Ardea Bioscience's sale to Astrazeneca for $1.26 Billion as a guide as to what Tang would believe the company is worth.(Tang was a Director)
Sale
Now look at Ardea's Pipeline
Cee-it, with the limited resource the SEC has and high profile cases such as the Facebook IPO, I wouldn't hold my breath.
Professor, I had noticed Simes was involved in a number of patent applications and patents. I hadn't looked at the earlier ones. Noticed a number of the earlier ones had no assignee.
The story with Biosante is like a good book, hard to put down.
Jeff, you are right that it was pretty close, I hadn't noticed that.
Thanks
The deeper I dig, the more intriguing it becomes.
From 1994 to 1997, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., (currently a wholly owned subsidiary of Abbott Laboratories) a company with a product focus on infectious diseases, AIDS, endocrinology and oncology
June 1999 - Unimed board agreed to become a wholly owned unit of Solvay's U.S. unit, which is based in Marietta, Ga.
Unimed -Solvay
Feb 2000 -Androgel is approved by the FDA to Unimed
Androgel
Feb 2010 - Abbott acquires Solvay.
No doubt Simes had some involvement of Androgel's development from 1994
Androgel 1996.
Thanks professor.
Professor, I agree with your assessment
Notice that Biosante announces Dr. Croak-Brossman to their Management team on July 18th, 2011.
Announcement
Then Biosante files for the following patent applications excluding Antares:
COMMERCIAL SCALE PRODUCTION METHODS FOR TRANSDERMAL HORMONE FORMULATIONS - August 17, 2011
The connection for the following two patent applications are harder to establish. Unless it triggered a response from Abbott as insurance.
Methods for decreasing cardiovascular risk in postmenopausal women - July 20, 2011
Methods for treating sexual dysfunction while decreasing cardiovascular risk - June 29, 2011
Professor it makes the Abbott acquisition of Solvay in 2010 for $6.2 billion a much more interesting development. The announcement of deal being struck was around Sept 28, 2009
Abbott-Solvay deal completion
Abbott-Solvay Deal annoucement
Put this into the context of the trial changes and Linda Andrews coming over to Biosante in November 2009 after being with Abbott from August 2009 and then apparently working for both Abbott and Biosante for 5 months simultaneously.
Professor, one possible connection for Abbott is their footprint in China in relation to diabetes.
Abbott China
Their diabetes medication combined with Libigel presents a growth opportunity in most places but none with as much explosive potential as China. If this part of the plan, then additional trials would be required.
Professor, since the safety trial had the following Primary Outcome Measures:
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
and
Libigel Safety Study has 3656 patients enrolled of which as of April 2011, out of 2899 enrolled patients,including:
Hypertension - number of patients in the trial = 1962
Dyslipidemia - number of patients in the trail = 1870
Diabetes mellitus - number of patients in the trial =608
If the enrollment ratio remained the same. The following would be the final estimated enrollment.
Hypertension - number of patients in the trial = 2474 approx.
Dyslipidemia - number of patients in the trail = 2358 approx.
Diabetes mellitus - number of patients in the trial = 767 approx.
Do you not believe that they would have enough clinical data to support an NDA for at least two CV treatments, Hypertension and Dyslipidemia? The population size for these two conditions approximately triples the Abbott male trial.
Good observation Jeff, I didn't notice who had sponsored the newsletter (Pfizer). It may just be a coincidence and Testosterone Therapy was the topic of the month.
Pfizer sponsored
I searched clinical trials for Pfizer and Testosterone and the only one involving women was this trial on obesity
The Abbott, Biosante, Pfizer is an interesting spin. Something to watch for in future research.
It appears that Abbott left their people in place at Bioisante to ensure the safety trials made it through.
Alfreda Boreika Clinical - Trial Safety Manager, Pharmacovigilance remained until May 2012. Before going back to Abbott.
Alfreda Boreika
It was obviously timed at the close as they knew the share would be available due to the Russell dump. That works out to almost just under 5% of the company. Tang? Abbott??
Professor, what do make of the positions Linda Andrews held at Biosante and Abbott.
To put this context for the others I have attached your previous post
Biosante Abbott connection
Now look at Linda Andrews resume, you will notice that August 2009 she is hired by Abbott. Then between November 2009 and March 2010 (5 months) she apparently worked for both Abbott and Biosante and not as a contractor. Then from March 2010 onward she has remained with Abbott and moved upward in the company.
Linda Andrews
Linda Andrews was responsible for FDA documentation and submissions and had worked for Biosante as a contractor from Nov 2008 to March 2009.
When Linda returns to work with Biosante November 2009 to March 2010 the following trial modifications were recorded
Safety trial change
Bloom 1 trial change
Bloom 2 trial change
Now remember, Linda had been working at Abbott since August 2009 before coming over to Biosante the second time. Given the timeline of events and the short time between Linda's arrival at Biosante and the trial modifications (approx. 2 weeks). I strongly believe Abbott's fingerprints are all over these trials.
Sandra Croak-Brossman new bio makes no mention of leaving Abbott to work for Biosante. It should be noted that in the end of year SEC filing they mention that in order to preserve cash, management and support staff went from 13 to 12.
If that doesn't smell of partnership or takeover, I don't know what does.
The timing of the following two facts seems peculiar. By themselves it is just a coincidence but when you consider everything else in this post you have to ask yourself is this really a coincidence or part of a greater plan.
1) Abbott is splitting into 2 companies this fall and they are battling bio-equivalence legislation for fear of losing a good chunk of profit from Humira if it passes.
2) Biosante will states the primary data analysis of safety trial will be available by end of year.
On a side note: I can't help but think that Teva - Abbott agreement on Bio-t-gel is somehow mixed up in this as well.
Medicaz, Russell Index Reconstitution
Reconstitution
Kinghelldaddy's explanation seems the most logical. Bpax was not the only stock where similar activity was experienced.
Professor, from the Bliss trial.
"To calculate sample size, we assumed that the CV event rate in the BLISS placebo group would be 2% per year and that the event rates in each group would be equivalent."
Bliss trial
Some subsets groups fared better then others. From the patent application
[0090] In certain embodiments the decrease in the risk of a cardiovascular event in the treated women compared to the risk of cardiovascular events in untreated women is at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 99%.
CV patent
If the release on the safety data review is consistent with February's release. We can expect the release around the first week of August.
In accordance with Bliss trial clinical contact and visit schedule it looks like the 8th Safety Review PR was two months after the last enrolled patient's clinical visit. (Around the 1st week of December)
Since, the last clinical visits would have been around the 1st week of June, the 1st week of August is most likely when we will hear the result of the 9th review.