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American College of Cardiology Guidelines for Secondary Prevention Guidelines for Secondary Prevention
One in three American adults has one or more types of cardiovascular disease
Here are some of the statistics:
High Blood Pressure 72,000,000
Coronary Heart Disease 15,800,000
Angina 8,900,000
Heart Failure 5,200,000
Stroke 5,600,000
For the above group secondary prevention becomes essential. You know the a large percentage of these people are post menopausal women. Could Libigel with safety results reducing the risk of cardiovascular events by 71 %, potentially become the optimal medication in secondary prevention?
The key components of secondary prevention include:
cigarette smoking cessation
blood pressure control
lipid management (such as cholesterol lowering)
weight management
diabetes management
optimal use of medications
influenza vaccination
Could it go one better and become a primary prevention for post menopausal women?
Report shows 101 Cancer vaccine in various stages of development
Biosante presently has 7 GVAX type vaccines, breast, clorectal, leukemia, myeloma, pancreatic and prostate.
I note that only a few big pharma are developing cancer vaccines,this supports previous reports that I have read, that companies are farming out R & D.
This should eventually bode well for Biosante with 7% of all cancer vaccines under development and presently in 17 clinical trials. There will be a number of Big Pharma seriously looking at the company. The CEOs are under pressure to improve their R&D and some are being shown the door for failed bids. Cancer vaccines have only been approved since 2010 so this is becoming a large growth market opportunity.
Vaccine development report
Note: the GVAX prostate was listed as Phase III Fast Track. I believe they are referring to Phase III trials that were conducted by Cell Cenesys.
Subset and diary analysis aside, Biosante should be able to present an argument to the FDA that even though Bloom trial demonstrated that Libigel only equaled the placebo results, the safety data showed a 71% reduction in the risk of cardiovascular event. Therefore by not approving Libigel the FDA is encouraging the off label use of male testosterone products (along with the unknown safety issues) or the placebo which has been shown to increase the risk of a life threatening cardiovascular event by 245% over Libigel.
I know the standard for efficacy is a marked improvement over placebo. But it seems to be in the best interest of the patient to accept an equal efficacy that can safely increase their life expectancy.
Should make for some interesting discussions in the FDA meeting.
I fully agree and should it eventually come to a buyout the share prices we have seen since December will be irrelevant. GVAX by itself after being voted as one of the top 5 vaccines this year is worth considerably more then the present market cap.
If AstraZeneca is willing to pay $1.26 Billion for Ardea Bioscience with the following pipeline:
A phase III and Phase I Gout treatments, a phase II Liver Cancer and Phase I Pancreatic cancer treatments. What is Biosante's pipeline worth?
M&A
Ardea Pipeline
WSJ reports that Pharmaceutical Companies Look to Biotech Industry to Combat Losses From Expiring Patents
WSJ Article
As result of the merger with Cell Genesys, Biosante presently owns 95 patents and has 52 patent applications.
In addition, since the merger, The Patent Board has rated Biosante among the top 20 biotech companies in relation to the quality of their science and their patents. In 2010 Biosante was ranked 15th. This February they were ranked as the leader in research intensity.
I realize that for the most part, I am preaching to the choir on this board but I also post to educate the newbies.
I have faith that Biosante has a good idea as to what a fair price for the company would be. Any offer that would be accepted would have to factor in the eventual marketing of Libigel for its CV benefits. The company may be able to get it at a little bit of discount by jumping early. But with over 6000 person years of assessment the financial risk to the purchaser has been greatly reduced.
Considering that last year when GVAX was just coming of a clinical hold, analyst estimated a possible buyout in the $1 Billion range on the strength of Libigel HSDD succeeding alone. Since then GVAX was nominated as one of the top 5 vaccines, a number of cancer trial successes have materialized, Bio-t-Gel was approved and Pill Plus is about to enter Phase III trials and of course the CV benefit of Libigel was discovered.
Interestingly this year a number of companies have been offered deals in the $2.5 to $3.5 range, a number of which have been turned down. All without a doubt, pale in comparison to the sustainable revenue potential of Biosante's pipeline.
Just noticed the following about a GVAX Phase II Lung Cancer trial:
June 6th, 2011 Biosante announces that the FDA removed the Clinical hold for GVAX Prostate Cancer vaccine.
June 8th, 2011 the GVAX Lung cancer phase II trial
Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer - changes sponsor from National Cancer Institute to Southwest Oncology Group
July 18th, 2011 the trial name changes to
S0310: Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
Could they be gearing up for a Phase III Lung Cancer Trial. Simes talked about exploring ways to monetize the cancer portfolio? The timing seems to indicate something is up.
This study is ongoing, but not recruiting participants.
Trial
Penny, the products are not the same one treats a chemical imbalance in the brain the other treats low level testosterone.
Now, unless efficacy can be proven with subset data (which is common in the drug approval process) Libigel in all likelihood will not get approved for HSDD. On the other hand if they had stopped the trial in 2010, they would not have the data showing testosterone restoration to pre-menopausal levels, and more importantly they would not have discovered that low dose testosterone reduces the risk of cardiovascular events in post menopausal women by 71%. For these reasons Libigel will become a very profitable product regardless if HSDD is included.
Extra info on the Flibanserin:
According to Medscape, of the women enrolled in the flibanserin trial, 15% stopped treatment because of adverse effects, which included dizziness and fatigue. Potential adverse effects associated with flibanserin include loss of consciousness and depression and were considered unacceptable given the limited benefit the drug offers.
The US Food and Drug Administration's (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 1 on June 18 that flibanserin, 100 mg (Girosa; Boehringer Ingelheim), was not significantly better than placebo for hypoactive sexual desire disorder (HSDD); they also voted unanimously that the benefits did not compensate for its adverse effects. (If safety can be compromised at the expense of efficacy arguably efficacy could be compromised in order to improve safety - eliminating off label use)
It should be noted that flibanserin's is different then Libigel where it tried to restore a chemical balance in the brain. Among the neurotransmitters, the excitatory activity is driven by dopamine and norepinephrine, while the inhibitory activity is driven by serotonin. The balance between these systems is relevant for a healthy sexual response. By modulating these neurotransmitters in selective brain areas, flibanserin, a 5-HT1A receptor agonist and 5-HT2A receptor antagonist, is likely to restore the balance between these neurotransmitter systems,
flibanserin
Which FDA vote are you talking about please provide link. To my knowledge Libigel has never been submitted for FDA approval for them to vote on. All Biosante did was release top level results from the Bloom trial, which caused the big drop in price in December. In addition I find it very hard to believe that FDA would discourage pursuing the CV benefits. In reality the CV benefits described in their patent applications arguably have greater life saving potential then their Cancer vaccines.
Will Libigel get Fast Track approval for CV benefits?
Jeffqdh of Yahoo board had eluded to this possibility a while back. Upon reviewing the Guidance for Industry Fast Track Drug Development Programs — Designation, Development, and Application Review, I believe it is a distinct possibility.
Guidance
The Modernization Act specifically permits FDA to: Approve a marketing application under section 505(c) of the Act or section 351 of the Public Health Service Act "upon a determination that the product has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit." This, in effect, codifies in statute FDA's Accelerated Approval Rule.
In addition Nutsyprofessor from Yahoo Board has indicated that in some cases NDA submission can be made on one 1 clinical trial.
I found this in the Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
Cancer Guidance
In most cases, cases, the FDA recommends at least two adequate and well-controlled clinical trials. In certain cases, evidence from a single trial can be sufficient.
Seeing that heart disease is the leading cause of death in post menopausal women. It is not out of the realm of possibility that a fast track approval is launched on the safety trial data.
To put thing into perspective, there are a number of drugs on the market to address the following:(inclusion criteria)
- Diabetes
- Peripheral vascular disease
- Myocardial infarction
- Stroke,
- Angina
- Acute coronary syndrome
- Revascularization of coronary or peripheral circulations
- Addicted smokers
- Hypertension
- High blood cholesterol-Dyslipidemia
The following is data a few of the drugs that the preventative maintenance of restoring testosterone levels to a pre-menopausal state could greatly reduce their need and or use. I also listed their side effects.
ACE Inhibitor drugs for hypertension
The following is a list of the ACE inhibitors that are available in the United States:
• benazepril (Lotensin),
• captopril (Capoten),
• enalapril (Vasotec),
• fosinopril (Monopril),
• lisinopril (Prinivil, Zestril)
• moexipril (Univasc), and
• perindopril(Aceon),
• quinapril (Accupril),
• ramipril (Altace),
• trandolapril (Mavik)
The most common side effects are:
• cough,
• elevated blood potassium levels,
• low blood pressure, dizziness,
• headache,
• drowsiness,
• weakness,
• abnormal taste (metallic or salty taste), and
• rash.
Statins to reduce Cholesterol
Statins are among the most commonly prescribed drugs in medicine.
The Statin Drugs include:
• Lipitor (atorvastatin)
• Lescol (fluvastatin)
• Mevacor (lovastatin)
• Livalo (pitavastatin)
• Pravachol (pravastatin)
• Zocor (simvastatin)
• Crestor (rosuvastatin)
Side effects
Changes in liver function
Myopathy," involving actual damage to muscle tissue, can be very serious
Memory, Thinking and Concentration
Some people report changes in memory, attention, or concentration on statins
Depression and Irritability
Some people report changes in mood on statins
Pain
Although muscle pain is a well-recognized side effect of these drugs (and one that should be reported, so tests can be done), other pain effects have been reported by many people on statins, but have not been studied extensively include headaches, joint pains, and abdominal pain.
Peripheral Neuropathy
Studies have confirmed that peripheral neuropathy (tingling and numbness or burning pain) may occur with statins.
Other Side Effects
Sleep problems, sexual function problems, fatigue, dizziness and a sense of detachment are also reported with these drugs. Additionally, people have mentioned experiencing swelling, shortness of breath, vision changes, changes in temperature regulation, weight change, hunger, breast enlargement, blood sugar changes, dry skin, rashes, blood pressure changes, nausea, upset stomach, bleeding, and ringing in ears or other noises.
You get the idea, there a number of drugs and each come with their own set of side effects. It is very possible that Libigel could eventually be considered as preventative maintenance to ward of cardiovascular disease and reduce the need for the aforementioned drugs plus a list of others. That in a nutshell is the importance of the Libigel CV discovery.
According to the BLISS trial findings, Libigel could very well end up being used to treat the following:
- Diabetes
- Peripheral vascular disease
- Myocardial infarction
- Stroke,
- Angina
- Acute coronary syndrome
- Revascularization of coronary or peripheral circulations
- Addicted smokers
- Hypertension
- High blood cholesterol-Dyslipidemia
Simes strongly stressed, not only that Libigel was alive, but pending FDA meetings they would be moving forward with Libigel or the Testosterone safety data.
Since Biosante has committed to 5 years of further testing for testosterone safety as long as Libigel is alive. The FDA may seriously look at recommending Biosante make an NDA for the Testosterone and HSDD (if subset data or placebo effect cause can elevate efficacy). And modify the follow up safety as a phase IV trail with efficacy being measured on each of the above treatments and HSDD, if required.
Phase IV trials are being used more and more to extend the life of existing drugs where patents are bout to expire. This scenario would be a spin on the an existing practice only at the start of an approved drug patent protected life instead of the end.
Phase IV
Bliss trial excerpt:
Table I. BLISS inclusion criteria
1. Postmenopausal women at least 50 y of age with a clinical diagnosis of HSDD (DSM-IV)
2. CV disease risk score if =2(adapted from Barett-Connor et al7) using the following point scale:
a. Age, 60 to <70 y (1 point) or =70 y (2 points)
b. Diabetes mellitus (2 points)
c. Peripheral vascular disease with ankle-brachial index <0.6 (2 points)
d. Documented CV disease (myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary or peripheral circulations) (2 points)
e. Present smoker of at least 10 cigarettes per day (or the equivalent) (1 point)
f. Hypertension—defined as seated systolic blood pressure =150 mm Hg and/or diastolic blood pressure =95 mm Hg and/or taking antihypertensive medications (for treatment of hypertension)—(1 point)
g. Dyslipidemia—low-density lipoprotein >160 mg/dL and/or high-density liproprotein <45 mg/dL with triglycerides >250 mg/dL and/or taking prescribed lipid-lowering medication (1 point)
First, the study not only is attempting to rule out a preapproval level of risk after an average of 2 years (range, 1-4 years) of treatment but also includes a postapproval commitment to follow participants for a total of 5 years each including a period after the primary regulatory analysis and potential approval. In addition, use of an adaptive design to determine sample size and predictive probability to determine correct enrollment have rarely been used in studies of this nature. Furthermore, the indication for LibiGel will initially be in oophorectomized women, but the study is also enrolling naturally menopausal women to explore the safety of LibiGel in a broader population and is based on agreement with FDA.
Bliss trial
FDA Generally Accepted as Safe (GRAS, a good point made by ctla_4_play of yahoo board.
I think they are allowed to administer it if its GRAS but they can't advertise it for the purpose (sexual dysfunction) that didn't prove via data. They might be allowed to market it but they will not be able to use the term "clinically proven with respect to increase libido", but might be able to say "clinically proven to be safe when taken as directed".
This would permit revenue generation while working on phase 4 efficacy trials to refine efficacy.
As the only proven safe testosterone restoration therapy it still has a lot of value.
Former FDA Commissioner: Approve Drugs Based on Safety, Prove Efficacy Later. Very positive argument for Libigel being submitted for NDA this year. His concept is bang on and can neutralize some of the placebo effect problems.
Former FDA Commissioner
Biosante has enough information to justify approval of Libigel for one or more treatments and can conduct a Phase IV trial to prove the efficacy, optimization of the drug and any additional uses. This may include cognitive function enhancement in a couple of years time.
It will be interesting to see if the CV data can be deemed surrogate endpoints in application allowing for marketing the CV benefit and obtaining additional info in a phase IV trial
Just like GVAX is versatile in it's treatment of multiple forms of cancers, Libigel and it's ability to restore testosterone to pre-menopausal levels will no doubt expand treatment possibilities in the future (HSDD, CV, Cognitive function is a start).
I noticed in Simes interview he was still holding back on the CV Risk reduction benefit today. Though he stressed the 5 years of proven safety for testosterone use for women, he left out the most important benefit. Following the FDA meetings, we will probably get a PR. I wonder if they will do the same as the did with Libigel, and commission an independent survey of cardiologists and family physicians to identify an estimated commitment for adoption of Libigel for the CV benefit. This will give us more accurate revenue potential and value (ie, partnership, etc..). It also demonstrates due diligence in estimating future revenue and provides a good defense against frivolous lawsuits.
I agree Senderos and once the initial bump occurs to reflect the true value of the company, the pipeline will ensure a long steady climb for a number of years.
Nice to know that BPAX has a huge head start in the CV benefits of testosterone, including patent applications. This study is still toying with delivery methods and dosages. At least it is supportive evidence.
Testosterone Supplements May Help Heart Failure Patients
Good point Nutsy, I read the office visit comment but didn't make the connection until you pointed it out.
Generally reverse splits don't work. But that is for companies that are trouble.
You have to ask yourself do you believe in BPAX, their pipeline and management? I do! This wouldn't be an issue if the stock wasn't so heavily manipulated which begs one to wonder if this is part of a bigger plan to force a takeover. If so, you know we will not get anywhere near what the company is worth.
What Biosante has encountered, is bad timing, in that the finish of trial and time to analyze the data may go beyond the July 31st. The 10 consecutive days above $1 has to start by the beginning of the 3rd week of July. In order to get a second 180 day extension, it is my understanding that they need to show that they have a plan to bring the Stock above $1.
I believe we are voting on giving them the option to R/S if needed. Not that we want a R/S.
Since management and the board of directors are large shareholders and have considerable options they can exercise. It is also in their best interest to do what it takes to elevate pps without a R/S.
If they can't show that a R/S is on the table we have tied their hands. If they can not show a plan is in place, they may not get the second 180 extension. Then we may de-list August 1st. Something we don't want.
If the companies future plans involve raising large amounts of capital to finance a marketing arm to sell their approved products then the R/S makes total sense as the higher price will allow them to raise more funding and in the end we keep all the profits and no longer rely on royalties agreements. This would be a plan that I fully support.
Though proper shorting (not naked) is legal, it doesn't mean it is a good thing. It is one of the reasons the US is in such a financial mess. The following is a well written article explaining the global repercussions of shorting. The US just went through the housing bubble for which they are still recovering. What if the same happens to the stock markets,take a good look at what is happening in Europe Spain, Greece etc.... US unemployment topped 10% due to the housing crisis what happens when it closes in on 20%.
Biosante is considered a global leader in the Gene Therapy Industry
This report analyzes the Global market for Gene Therapy in US$ Million. Annual estimates and forecasts are provided for the period 2009 through 2017. The report profiles 98 companies including many key and niche players such as AnGes MG, Inc., BioSante Pharmaceuticals, GenVec, Oxford BioMedica, Shenzhen SiBiono GeneTech Co., Ltd., Transgene, and Vical Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
13. FOCUS ON SELECT GLOBAL PLAYERS II-65
AnGes MG, Inc. (Japan) II-65
BioSante Pharmaceuticals (US) II-65
GenVec (US) II-66
Oxford BioMedica (UK) II-67
Shenzhen SiBiono GeneTech Co., Ltd (China) II-67
Transgene (France) II-67
Vical, Inc. (US) II-68
Report outline
It would be nice to see what the report says. Anybody with access feel free to share.
I am hoping they will consider a phase IV trial and let them submit an NDA application and get it to market. Come June they will have enough safety data to make an application for the HSDD (original purpose of the trials) providing the efficacy issue has been resolved. In addition they had agreed to a follow up study for 5 years to assess long term benefits and safety.
If the FDA was willing to let it on the market safety seems to have been addressed and is much less an issue. In the phase IV trial, once Libigel is in the market place in addition to what ever agreement they had for continued monitoring for HSDD just add a series of targets they wish to monitor (i.e., cholesterol, etc..) for CV reduction. This will determine drug use optimization.
This may be overly simplistic but a fairly logical approach.
Had they not given the go ahead to make the NDA submission pending the passing of the next safety review and when the last patient has been enrolled for 1 year. Then a phase III trial would most likely be needed.
Because it can proven to save a significant number of lives the FDA will not want to drag their feet on this discovery. It comes down to risk vs rewards.
Here is a previous post i submitted on CV disease
CV
Two very good reasons to fast track Libigel
In 2008, CVD was the cause of death in 419,730 females. Females represent 51.7% of deaths from CVD.
In 2009, CVD was the first listed diagnosis of 2.9 million females discharged from short-stay hospitals.
What are thee savings by reducing 71% of the 2.9 million short hospital stays that apply to post menopausal women. You got to figure they account for the majority.
I earlier reported that the CV benefit of Libigel targeting postmenopausal women has a potential (non exclusive)market of $50 billion in the US
BPAX Revenue potential
What do you think the potential of this product is for a company with a global sales network? Remember Intrinsa was using a patch, not as efficient as the transdermal technology used in Libigel.
Just something to ponder. I know that any government providing universal health care will see this as a no brainer. Medication vs Admission not a hard sell.
Firstly thanks for the kind words.
When Biosante decides to come out of CV closet this is what they will be trumpeting it is item #0104 in their Patent application.
There were eight adjudicated cardiovascular events determined from this Phase 3 clinical trial after greater than 4,000 woman-years of therapy. A comparison of the observed number of cardiovascular events to the expected rate of cardiovascular events revealed that the number of observed events was only about 29% of those expected, resulting in a 71% reduction in cardiovascular events.
Postmenopausal Patent
With 4000 women-years examined closer to 6000 women years by now, the CV reduction rate should remain close to 71 % regardless of the size of population. This is solid data which the street should eat up.
If you are not convinced that the government wants this to succeed. Consider the financial savings through the reduction of hospital admissions.
Adam has been complicit in more then one scam. The person who wrote this post did a good job of surfacing the warts in the investment community including politicians and Adam.
Avanir attack
The whole idea of shorting a stock is detrimental to growing the economy. It slows or stops innovation and research. And as long as it persists the US will continue to slide in its standard of living. Those who counter that shorting creates liquidity are creating a false liquidity. Lack of liquidity can be addressed by paying more for a stock. Simple as supply an demand.
Forgot to add that the estimate by Piros never factored a phase III trial for the Pill Plus which should start later this year.
Below is the inclusion criteria and the point system they used.
Table I. BLISS inclusion criteria
1. Postmenopausal women at least 50 y of age with a clinical diagnosis of HSDD (DSM-IV)
2. CV disease risk score if =2(adapted from Barett-Connor et al7) using the following point scale:
a. Age, 60 to <70 y (1 point) or =70 y (2 points)
b. Diabetes mellitus (2 points)
c. Peripheral vascular disease with ankle-brachial index <0.6 (2 points)
d. Documented CV disease (myocardial infarction, stroke, hospitalization for unstable angina/acute coronary syndrome, revascularization of the coronary or peripheral circulations) (2 points)
e. Present smoker of at least 10 cigarettes per day (or the equivalent) (1 point)
f. Hypertension—defined as seated systolic blood pressure =150 mm Hg and/or diastolic blood pressure =95 mm Hg and/or taking antihypertensive medications (for treatment of hypertension)—(1 point)
g. Dyslipidemia—low-density lipoprotein >160 mg/dL and/or high-density liproprotein <45 mg/dL with triglycerides >250 mg/dL and/or taking prescribed lipid-lowering medication (1 point)
I noticed family history of heart disease was an omitted criteria, probably out of fairness as the focus of the drug was HSDD
My wife is Congestive Heart failure nurse who often states that regardless of lifestyle choices (i.e, proper diet, exercise, etc..) family history often catches up with you. If you come a from a family with a history of heart disease it will probably get you.
Just a thought, but it would be very interesting if the restoration of testosterone levels to pre-menopausal levels could be proven to counter the family history issue. A future trial tackling that issue could be an amazing discovery for the medical community. This would be one of the carrots I would use to have the FDA support a phase IV trial. Allowing Libigel to move market and using a larger trial group which would be available once marketed.
Interesting article regarding Biosante as a potential takeover target. Though dated Jul. 19, 2011. it contains key info to help in your analysis.
The following is an excerpt referring to Libigel licensing agreement and a potential buyout.
"Simes told Bloomberg that a "very conservative" estimate for a licensing deal would be $100 million plus royalties, or an acquisition of BioSante within $300 to $500 million. Analyst at Rodman & Renshaw Elemer Piros believes the company’s acquisition price could reach $1 billion, contingent on successful Phase III results. To put these numbers into perspective, BioSante’s (BPAX) market cap was $356.62 million as of July 12."
Takeover Target
Firstly, in addressing potential lawsuits over overstated claims regarding Libigel. The statement Simes makes here would be exactly the opposite. He obviously understates the value of a potential buyout. The market cap at the time was higher then his low end figure.
Secondly, analyst Elemer Piros of Rodman & Renshaw estimates the buyout price could reach $1 billion.
Note: Piros' estimated price did not factor the following:
- the importance of the GVAX hold being removed,
- Gvax pancreas phase II trial with Aduro
- Gvax prostate phase I trial results with Ipi (Yervoy)
- that GVAX was nominated as one of top five vaccines.
- Bio-T-Gel was approved by FDA
- Azur and Jazz have merged creating a larger exposure for Elestrin in the US.
- PharmaSwiss was acquired by Valeant creating a larger client base for Elestrin in Isreal.
- the surprise discovery of a 70 % reduction in the risk of cardiovascular events for postmenopausal women using Libigel.
It would be interesting to see what estimate Piros gives as a buyout price for Biosante with the added information.
And go think today I have to cash in three share for a cup of coffee. Even more if I wanted Starbucks.
Accidentally exchanged the trail names, it should read Bloom trial when referring to efficacy and Bliss trial when referring to CV and breast cancer safety.
Another FDA possibility for Libigel drug advancement is discussed the following yahoo thread.
Interesting FDA meeting next week on product development & CVE's
I agree, the scientific community is objective in their assessment and not only are they more knowledgeable, they are privy to the latest research and the quality of the research. I can't say the same about AF as it is obvious that he will only state what supports his or his puppeteer's agenda.
I see I am not the only one that he company is mysteriously quiet on the GVAX nominations. Something must be up.
GVAX nomination
Don't be surprised if the meeting results in a recommendation to submit an NDA application addressing HSDD and CV with the intent of bringing them to market. Along with an agreement to conduct a phase IV trial for drug optimization.
PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
This trial can further narrow down the intent to treat optimal group for HSDD and examine additional criteria for CV (cholesterol reduction etc..)
Since testosterone is already being used off label, this would seem the most logical course of action.
It appears that adding all naturally post menopausal women to the Bloom safety study was method to help the FDA get the info on the low dose testosterone and didn't originally fit into the plans of Biosante. Even though the placebo effect hammered the Bliss efficacy trials it too seemed to be used as a tool for the FDA getting safety data beyond what the drug was intended to do. Going beyond the Intent to treat population.
Fortunately the Bloom safety trial discovered that low dose testosterone reduces the risk of Cardiovascular events by over 70%.
The FDA meeting will be very interesting, Biosante has gone above and beyond with these trials. I believe the Biosante and FDA agreement will be highly favorable to Biosante and this will materialize when they come out of the meetings. If so it will encourage other companies to tackle safety issues on other unmet needs.
The following video supports Biosante working with the FDA to get the data they want.
What is Libigel Video
Reassurances that the FDA wants to help Libigel succeed.
I highly recommend reading the Bliss Safety Trial
If you read the discussion section it shows that Biosante was asked to do a lot outside the scope of a normal trial. Reason is that the FDA want the info on the low dose testosterone.
What happens if they make Biosante walk away. They will not get the 5 year follow up information that they desperately want. This also explains why the Bloom efficacy trails were set up the way they were. I have added an excerpt from the discussion section.
"There are additional aspects of the BLISS study that make it unique among recent women's health studies. First, the study not only is attempting to rule out a preapproval level of risk after an average of 2 years (range, 1-4 years) of treatment but also includes a postapproval commitment to follow participants for a total of 5 years each including a period after the primary regulatory analysis and potential approval. In addition, use of an adaptive design to determine sample size and predictive probability to determine correct enrollment have rarely been used in studies of this nature. Furthermore, the indication for LibiGel will initially be in oophorectomized women, but the study is also enrolling naturally menopausal women to explore the safety of LibiGel in a broader population and is based on agreement with FDA. Finally, the CV composite outcome in the BLISS study is expanded compared with other recent studies of CV safety of noncardiac agents, including venous thromboembolic events, because testosterone is an obligate precursor of estradiol, a molecule that can be thrombogenic."
The FDA knows that it has asked a lot. If they aren't going help, no one will ever put themselves out there in the future and stick to the normal clinical trial standards, which overall puts the public at risk.
Though Biosante sold it's US royalty rights for Elestrin. Jazz is getting recognized for their internet marketing strategy of Elestrin. We could see milestone payments yet (up to $140 million if it takes off)
Elestrin Web awards
Elestrin site
According to Chimera Research group, NDA filed for Israel 6/09 by PharmaSwiss (company to be acquired by Valeant Pharma). 2010 10K: elestrin has been approved in Israel.
Since Elestrin initially in the hands of 2 smaller companies and are now in the hands of Jazz and Valeant larger companies. This should end up creating an increased revenue stream from earlier projections. As I understand it Biosante will still get royalties from Valeant.
There are a number of possible catalyst. The problem is all the positive news hasn't clarified when revenue and how much can be expected. The market has written off Libigel and we have not seen any revenue to speak of. News allowing them properly project future revenues is required. That is where a Libigel NDA allowed for a large projected revenue stream bringing in buyers.
I believe positive PR regarding FDA meeting on Libigel would get us to there. Info on the Teva deal would be nice to allow for projected revenue(ie.Teva will launch generic Bio-t-gel with a date) Any revenue from Teva for approval or side deal with Abbott?
I can't see them holding it down any longer, if the PR makes reference to FDA outlining a path forward for the Libigel targeting cardiovascular disease in menopausal women (this would be huge). Heart Disease is a market of approx. $50 billion. It would pop up to a point where a larger number of serious institutional investors would be buying.
A phase II GVAX trial with BMS. This partnership would give it the legitimacy it needs to get over the hump.
Remember analyst were estimating a 1 year target of $6.00 pps primarily on the back of Libigel. In the meantime GVAX has resurrected and was nominated as one of the 5 best vaccines. If Libigel is revived and the CV benefit is added, the stock is definitely worth a lot more then $6 pps. Investors will be clamoring to get in which will push up the price rapidly.
They may be waiting for guidance by FDA and are cautious before announcing anything.
In all honesty I believe something is going on behind the scenes. Contrary to what many believe this company has a very capable management team and a well experience Board. Especially when you consider the following:
1- The silence on the part of the company regarding 70 % reduction CV. They have two patent applications in relation to it. They also have a patent application for mass production of Libigel. All filled in 2012.
2- They have not said anything about the vaccine nominations for best vaccine and best licensing agreements.
3- A number of larger companies are looking for acquisitions. Ealier this year Bristol Myers Squibb bought Inhibitex for $2.5 billion and a few weeks ago Amylin share holders turned down a $3.5 billion offer from BMS.
4 Since management has a number of shares and options anything they do that impacts share price also impacts them.
For all we know a deal may be in place and the results of the FDA meeting will be used to dictate the price.
Nice read, I agree, if Biosante had cash problems I would be concerned. The right news will be too powerful for any type of short attack.
I agree with Double Die, well written.
In addition to avoiding delisting an R/S could make sense even if we go above a buck.
Hypothetically if Biosante wanted to take a serious run at the NDA application and market Libigel and any future drug products itself. It would require a serious infusion of money to create a marketing department. By elevating the share price above $5 it can attract more serious institutional investors. With this infusion of cash they can bring in the right people and have the marketing department ready to hit the ground running around the time Libigel is approved.
The lawsuits are frivolous ambulance chasers and will not succeed for the following reasons.
- Libigel is still alive and in all likely hood will surpass original estimation in the target audience (CV) benefit.
- Management has not sold a single share since early 2007 and a board member bought shares as late as mid November 2011.
- The claims by management were sound based on independent surveys, the phase I & II clinical trials and scientific results of other approved products (not in US)like Intrinsa.
- The phase III clinical trial was double blinded, so management could not of been aware of the top level results and that placebo effect would be that drastic.
- Biosante's forward looking statement indicates that there is no guarantees.
- Investors, those who have done their research and didn't sell as a knee jerk reaction still own their shares and have accumulated more, seeing this as an opportunity.
- You will notice that even real investment firm analyst had down graded BPAX to a hold (not a sell). When the stock price rises above pre-December levels. Those suing will have contributed to their own losses by selling or having a stop loss in place which triggered the sale.
Nutsyprofessor put a good assessment of what happened this week. Many margin calls got triggered because of the global markets going down.
Margin calls
I still believe this stock is a sleeping giant. And that run up to 2013 gives it lots of time to wake up. There are a number of upcoming catalyst. The one which intrigues me is the CV drug play. I find it hard to believe that they haven't received partnership offers on the CV benefit, yet. News in the biotech community like most communities must travel rather fast.
For all we know something may be in the works. This would explain why they have not trumpeted this discovery. Normally discovering your drug reduces the risk of cardiovascular events by over 70% is not something you usually sit on unless you have a very good reason.
As for the $250 market cap. They already have 2 approved drugs Elestrin marketed to Jazz and Bio-t-gel to be marketed by Teva. What they are waiting on revenue to be generated. Once they show that they are generating revenue. Wall Street Investment firms will jump back in. The next drug they have in the pipeline is Libigel and it was estimated as create a $1 billion type market cap if HSDD was a go. I would say triple that (at least) if the get the CV drug is a go. I haven't even touched the impact of GVAX phase three trial or the Pill plus phase 3 trial.