Followers | 20 |
Posts | 5534 |
Boards Moderated | 0 |
Alias Born | 01/04/2012 |
Monday, April 25, 2022 7:18:19 AM
As for Libigel, there appears to be more to the story. As you stated it did fail to show efficacy for HSDD due to a large placebo effect. But the larger safety trial was also measuring efficacy and had a surgically menopausal population similar in size to the total of the two pivotal efficacy trials. They efficacy her was being measured in similar method used in the Intrinsa trials. The results form this trial have yet to be released. Secondary outcomes for this trial were never disclosed, as well.
It is true that ABBT/ABBV have never publicly owned or expressed an interest in female testosterone. However, I and a few others can attest to the fact that Dr. Michael Snabes' Linkedin profile, at one time, stated that he worked for AbbVie as early as January 2013 while working for Biosante at the same time. His linked in work history now reads as if there was no overlap, with him starting at AbbVie in April 2013.
Additionally up until, ATRS was issued a patent for using Testosterone to treat HSDD, ABBT was seeking a similar patent.
Dr. Snabes discovered that Libigel reduced Cardiovascular events over placebo ( never publicly disclosed). It appears that Libigel safety/efficacy trial or at least the observation of the 3,656 participants went beyond the December 2012 completion date. This became evident on December 19, 2015, when during the patent prosecution for reducing cardiovascular events (Dr. Snabes as inventor) they added the claim that restoring testosterone also reduced breast cancer events. In September 2012, the reduction in breast cancer events by restoring testosterone was not present. Interestingly, the support for the claim that it reduced cardiovascular events is well documented in the specifications of their patent application, but there is no such support for the breast cancer reduction claim. If ANIP had continued the work to make such a claim they would likely provided the supportive information to their claim in the specifications document accessible through the Public Pair. It also would have shown up in their R&D expenses as ANIP is a smaller company and it would be hard to hide the expenses related the follow-up of the participants.
According to the American Heart Journal article titled "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder" which also credits Dr Snabes.
The 3,656 participant trial was an adaptive trial under an FDA Special Protocol Assessment set up in two parts, the first part being pre-commercialization. For which Biosante appears to have met.
ANIP has deflected or stopped responding to shareholder questions related to Libigel development since 2016. The full 5 year, 3,656 participant study would have been completed in August 2016. The Certification/Extension request to delay submission of results on October 27, 2021, is puzzling, unless an NDA has been filed or was about to be filed by a company other than ANIP. Logic dictates that if an NDA is being filed, AbbVie with Dr Snabes, would have been in the best position to take the first FDA approved female testosterone product across the finish line. Especially since AbbVie now owns the Intrinsa data.
Is Libigel's safety/efficacy data, supported by Intrinsa's trial data and the Global Consensus Position Statement on the Use of Testosterone Therapy for Women enough to support an approval?
The position statement issued in September 2019, provides guidelines in administering testosterone considered to be a benchmark. It provides clinical guidance regarding the use of testosterone therapy in women, examining the effect on sexual function; well-being, mood, and cognition; musculoskeletal effects; cardiovascular and breast health; as well side effects and adverse events. This is first time expert global agreement has been provided on how testosterone should be measured in women and how it should be therapeutically prescribed.
The Position Statement is largely based on the findings of the Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomized controlled trial data. The study reviewed 36 clinical trials (excluding all phase 3 LibiGel clinical trials), involving 8,480 participants in total. The Position Statement found that though no established indications for testosterone therapy for women existed, clinicians have been treating women with testosterone for decades, uncertain of the benefits and the risks. In most countries, including the United States, testosterone therapy is prescribed off-label male testosterone or compounded therapies. They also found that further investigation is warranted with respect to an individual's well-being, musculoskeletal and cognitive health and long-term safety. (LibiGel should address the long-term safety issue when the trial data is finally published.)
The Position Statement has been endorsed by the following organizations:
The International Menopause Society,
The Endocrine Society,
The European Menopause and Andropause Society,
The International Society for Sexual Medicine,
The International Society for the Study of Women's Sexual Health,
The North American Menopause Society,
The Federacion Latinoamericana de Sociedades de Climaterio y Menopausia,
The Royal College of Obstetricians and Gynaecologists,
The International Society of Endocrinology,
The Endocrine Society of Australia, and
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
According to the Position Statement, testosterone should only be used to treat HSDD after other options have not proved beneficial and testing shows that a women is testosterone deficient. It only recommends transdermal or cream applications. Where an appropriate approved female testosterone preparation is not available, off label, prescribing of an approved male formulation is considered reasonable. It does not recommend injectables, pellets or formulations that result in supraphysiological blood concentrations of testosterone, or compounded testosterone.
In the end AbbVie may not be interested in female testosterone. But they appear miles ahead of any competition should they want to enter a market with potentially no competition until December of 2033.
Recent ABBV News
- AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer • PR Newswire (US) • 09/20/2024 11:32:00 AM
- Allergan Aesthetics Launches BOTOX® Cosmetic (onabotulinumtoxinA) for Masseter Muscle Prominence (MMP) in Adults in China • PR Newswire (US) • 09/11/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/10/2024 07:30:45 PM
- Health Canada Approves AbbVie's CONSTELLA® (linaclotide) for the Treatment of Functional Constipation in Pediatric Patients 6 to 17 Years of Age • PR Newswire (Canada) • 09/10/2024 11:00:00 AM
- AbbVie reçoit l'approbation de Santé Canada pour l'emploi de CONSTELLA® (linaclotide) dans le traitement de la constipation fonctionnelle chez les enfants âgés de 6 à 17 ans • PR Newswire (Canada) • 09/10/2024 11:00:00 AM
- AbbVie Showcases Advancement of Solid Tumor Pipeline at ESMO 2024, with New Data in Tumor Types with High Unmet Needs • PR Newswire (US) • 09/09/2024 01:00:00 PM
- AbbVie Declares Quarterly Dividend • PR Newswire (US) • 09/06/2024 02:13:00 PM
- AbbVie reçoit une recommandation favorable de la part de l'Agence des médicaments du Canada pour le remboursement de VRAYLAR® (cariprazine) dans le traitement de la schizophrénie • PR Newswire (Canada) • 09/04/2024 12:00:00 PM
- AbbVie's VRAYLAR® (cariprazine) Receives Positive Reimbursement Recommendation by Canada's Drug Agency for the Treatment of Schizophrenia • PR Newswire (Canada) • 09/04/2024 12:00:00 PM
- AbbVie Awards Scholarships to 45 U.S. Students Living With Chronic Immune-Mediated Diseases • PR Newswire (US) • 08/27/2024 12:15:00 PM
- SkinMedica® Revolutionizes Skin Hydration with the Introduction of HA5® Hydra Collagen Replenish + Restore Hydrator • PR Newswire (US) • 08/27/2024 12:05:00 PM
- European Commission Grants Second Indication Approval for TEPKINLY® (epcoritamab) for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma • PR Newswire (US) • 08/19/2024 06:05:00 PM
- AbbVie annonce les premiers remboursements provinciaux, en Ontario et au Québec, d'EPKINLY(MC) (epcoritamab) administré par voie sous-cutanée pour le traitement du lymphome diffus à grandes cellules B en vertu d'un nouveau processus d'accès rapide • PR Newswire (Canada) • 08/15/2024 01:14:00 PM
- AbbVie Announces Ontario and Quebec are First Provinces to Reimburse Subcutaneous EPKINLY™ (epcoritamab) for the Treatment of Diffuse Large B-Cell Lymphoma Under New Early Access Process • PR Newswire (Canada) • 08/15/2024 01:13:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/14/2024 08:09:27 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/08/2024 09:40:43 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 08/07/2024 08:22:53 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/07/2024 07:00:51 PM
- AbbVie Completes Acquisition of Cerevel Therapeutics • PR Newswire (US) • 08/01/2024 12:23:00 PM
- Allergan Aesthetics Celebrates the Second Annual JUVÉDERM® Day • PR Newswire (US) • 07/30/2024 12:00:00 PM
- Toyota Reports Another Global Production Decline, Delta Sues CrowdStrike, Meta Launches AI Studio for Custom Chatbots • IH Market News • 07/30/2024 10:00:51 AM
- Alector Presents Baseline Characteristics for INVOKE-2 Phase 2 Clinical Trial of AL002 at the Alzheimer's Association International Conference® 2024 (AAIC®) • GlobeNewswire Inc. • 07/28/2024 12:05:00 PM
- AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis • PR Newswire (US) • 07/26/2024 06:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/25/2024 11:41:17 AM
- AbbVie Reports Second-Quarter 2024 Financial Results • PR Newswire (US) • 07/25/2024 11:36:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM