Hot Watch List (comments).
BPAX (buy) updated to neutral or sell
This potential biotech gem wasn't discovered by me, subscriber A. pointed at this small biotech and suggested this idea.
After some analysis I agreed and immediately bought this company. After today news I see that it was a correct pick.
BioSante Pharmaceuticals Reports Positive LibiGel® Safety Data in Phase III Program
"BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA approved product."
“LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD,” said Stephen M. Simes, BioSante’s president & CEO. “We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future,” Mr. Simes continued. “With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women,”
Actually it's true. In 06/18/2010 Boehringer Ingelheim drug flibanserin for hypoactive sexual desire disorder (HSDD) was rejected by advisory panel (10-1) because there was insufficient evidence of overall efficacy.
"BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.
BioSante's lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S.
Also in development is a portfolio of cancer vaccines (GVAX), three of which have been granted orphan drug designation, currently in several Phase II clinical trials, at minimal cost to BioSante. Other products in development are Bio-T-GeI™, a testosterone gel for male hypogonadism, licensed to Teva Pharmaceuticals (NASDAQ: TEVA) and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies.
"In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity."
238% vs. baseline (p<0.0001)... The randomness can't generate such high effect, so these results must be repeated in phase III trial. BioSante’s objective is to submit the LibiGel NDA for a product launch in 2012.
Disclosure: I opened BPAX positions in Feb. 11/11, probably for long-term investment. The current BPAX pps $2.31 is good entry point for this.
May 13, 2011 by BiotechInvest
BPAX is still very valuable stock. So, after some gap I will buy it again. Pps now is $2.64 and recent updates suggest that this stock will continue run up even during this summer.
Recent BioSante Developments
* LibiGel® Phase III Efficacy Trials Enrollment Completed: BioSante completed enrollment of subjects in its two pivotal Phase III LibiGel (testosterone gel) efficacy trials in the first quarter. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
* LibiGel Phase III Safety Study Continues: For the fifth time, unblinded safety data were reviewed by the independent Data Monitoring Committee (DMC) of the LibiGel Cardiovascular and Breast Cancer Safety Study. As per DMC recommendation, the LibiGel safety study continues, with no modifications.
* Bio-T-Gel™ New Drug Application (NDA) Filed by BioSante Licensee, Teva Pharmaceuticals: An NDA for Bio-T-Gel (testosterone gel) for the treatment of male hypogonadism, was accepted for filing by the FDA following submission by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA - News). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
* Pancreas Cancer Vaccine Positive Clinical Results and Melanoma Orphan Drug Designation: BioSante reported positive Phase II clinical results for its Pancreas Cancer Vaccine. The vaccine increased the median survival of resected pancreatic cancer patientsfrom 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. BioSante also received Orphan Drug designation from the FDA’s Office of Orphan Products Development for its Melanoma Cancer Vaccine.
* Closed $25.1 million Registered Direct Financing: BioSante closed a registered direct offering in March 2011, bringing its March 31, 2011 cash balance to approximately $51.3 million. BioSante’s management believes this cash balance will be sufficient to finance operations and LibiGel clinical development well into 2012, without the need for additional funds.
Then there is again this sacramental question: Is BPAX next DNDN? If I know answers for such questions I should be already a millionaire.
But I'm definitely sure that BPAX has a strong science basis and innovative ideas for new drugs (likely DNDN had). It's already a green flag for me to invest in this small cap.
12.18.2011 by BiotechInvest
BPAX pps was crashed by Results from LibiGel(R) Efficacy Trials.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced top-line results from its two pivotal Phase III LibiGel (testosterone gel) efficacy trials. Initial analysis of the data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences in the endpoints, all results were in the appropriate directions. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
Subjects in BLOOM-1 showed an increase in mean sexual desire of 0.03 over placebo, a p value of 0.672, while subjects in BLOOM-2 demonstrated an increase in mean sexual desire of 0.03 compared to placebo, a p value of 0.48. Subjects in both trials demonstrated a decrease in sexual distress when treated with LibiGel (p=0.569 and p=0.26) compared to baseline.
Well, indeed this LibiGel(R) is not good for postmenopausal women. What is about the man?
Bio-T-Gel™ New Drug Application (NDA) Filed by BioSante Licensee, Teva Pharmaceuticals: An NDA for Bio-T-Gel (testosterone gel) for the treatment of male hypogonadism.
Bio-T-Gel™ is licensed to Teva Pharmaceuticals, USA. A Bio-T-Gel™ NDA is pending with the FDA having a PDUFA date of February 14, 2012. Teva is responsible for all regulatory and marketing activities.
About Hypogonadism
Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone can be caused by a signaling problem that occurs between the brain and the testes that causes the production of testosterone to drop below normal. Low testosterone also can occur when the body can't make normal levels of testosterone and can lead to a medical condition known as hypogonadism that has many symptoms including fatigue, decreased energy, reduced sexual desire and depressed mood.
It is estimated that low testosterone affects more than 4 to 5 million men in the U.S. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.
Will FDA approve Bio-T-Gel™? It's very likely because there is no cure for hypogonadism. And it is a medical condition that usually requires ongoing treatment.
Of course, the female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women is also medical condition but usually it's not requires ongoing treatment.
So, what is positive in LibiGel trial? Safety and efficacy (in term of PK)
1) The trials demonstrated that LibiGel was generally well tolerated with a safety profile that appears to be comparable to placebo.
2) Importantly, and as seen in previous pharmacokinetic data, the LibiGel groups in both trials showed an increase in free testosterone levels compared to baseline and placebo. In BLOOM-1 mean free testosterone at baseline was approximately 1.19 pg/ml and 1.10 pg/ml in the placebo and LibiGel groups, respectively. In month six of the trial, free testosterone levels were approximately 1.35 pg/ml and 4.01 pg/ml in the placebo and LibiGel groups, respectively. In BLOOM-2 mean free testosterone at baseline was approximately 1.06 pg/ml and 1.19 pg/ml in the placebo and LibiGel group, respectively. In month six of the trial, free testosterone levels were approximately 1.09 pg/ml and 3.70 pg/ml in the placebo and LibiGel groups, respectively.
Aapproximately 300-900 ng/dL of total testosteron are given as a normal laboratory range, for men ages 20-70.
For females, this range is 15-70 ng/dL
Both total and free testosterone studies should be measured to adequately evaluate testosterone levels. Depending on the lab used, approximately 300-900 ng/dL are given as a normal laboratory range, for men ages 20-70. For females, this range is 15-70 ng/dL.
Free testosterone levels average approximately 2% of the total, 55-200 pg/ml for men and 1-10 pg/ml for women. Free testosterone is the more valuable of the two, reflecting the amount of hormone available to perform useful work.
So LibiGel increased free testosterone level in females to normal range 3.7-4 pg/ml (from 1.19-1.35 pg/ml)
But for man free testosteron should be 55-200 pg/ml.
Will Bio-T-Gel™ increase free testosteron to this level?
I'm not sure now after LibiGel PK data.
I can't find any published data for Bio-T-Gel™ clinical trials (PK, PD or other).
BioSante is in line to receive certain milestone payments and royalties when the Bio-T-Gel™ is commercialized by Teva.
Upon signing the U.S. development and license agreement, BioSante received an upfront payment of $1.5 million. In addition, Teva will pay BioSante development and sales-related milestone payments plus royalties on sales of the product commercialized in this collaboration. Teva also will be responsible for continued development, regulatory filings and all manufacturing and marketing associated with the product.
And we know that "Abbott Laboratories received U.S. regulatory approval for a new, more potent formulation of its testosterone gel.
The gel is approved for men with hypogonadism or low testosterone, a condition associated with fatigue, depression and various sexual dysfunctions.
The new Androgel 1.62 percent formula delivers 40.5 milligrams of gel in two pumps of the canister. The older, Androgel 1 percent formulation included 50 milligrams in four pumps. The two formulations are not interchangeable and both require a prescription.
The Food and Drug Administration approved the new formula based on a study showing 78 percent of men using the gel had normal testosterone levels after one year of use.
Is TEVA/BPAX Bio-T-Gel™ better than new ABT Androgel?
If it less effective FDA will reject Bio-T-Gel™ and BPAX pps will be at cents range (now $0.48).
Conclusions: I don't have BPAX positions now. I'm not going to buy BPAX in nearest future.
02.14.12 by BiotechInvest
I bought BPAX today because I concluded that FDA approval Bio-T-Gel™ has very high probability. LibiGel failed but it was safest medication and FDA is not so crazy to reject safe medication.
BPAX pps after approval should be >$1.50-2 because of milestone payments and royalties from Teva.