Humira goes off patent next year

[Anonymous]

voyeur dirty troll bags love this thread

Guilty as charged! You guys are screwed.

 

[Anonymous]

My manager has started interviewing and says I should do the same.

is your manager phag troll like you

 

[Anonymous]

It is not the end of the world! We will all find other jobs. Some with Abbvie, most somewhere else. Let's look at the positive side of this story. Thousands of patients will have access to more affordable adalimumab and billions of dollars will be saved in our very expensive healthcare system.

 

[Anonymous]

It is not the end of the world! We will all find other jobs. Some with Abbvie, most somewhere else. Let's look at the positive side of this story. Thousands of patients will have access to more affordable adalimumab and billions of dollars will be saved in our very expensive healthcare system.

You are right. I feel kind of guilty with this stuff costing so much. Maybe they can lower the price like with Synthroid and they can let those guys in metabolics sell it as a branded generic. Thoughts?

 

[Anonymous]

It is not the end of the world! We will all find other jobs. Some with Abbvie, most somewhere else. Let's look at the positive side of this story. Thousands of patients will have access to more affordable adalimumab and billions of dollars will be saved in our very expensive healthcare system.

If that is how you think, then you should definitely get out of pharma. Perhaps a non profit or government job would be more to your liking.

 

[Anonymous]

If that is how you think, then you should definitely get out of pharma. Perhaps a non profit or government job would be more to your liking.

Yes, a job that feels much more ethical.

 

[Anonymous]

You are right. I feel kind of guilty with this stuff costing so much. Maybe they can lower the price like with Synthroid and they can let those guys in metabolics sell it as a branded generic. Thoughts?

Seriously?! Metabolic is going to be laid off just like CV. You can't compare Synthroid with Humira. Who would let go of the best and brightest in immunology and keep the underperforming slugs from metabolic? It just doesn't fit!

 

[Anonymous]

Seriously?! Metabolic is going to be laid off just like CV. You can't compare Synthroid with Humira. Who would let go of the best and brightest in immunology and keep the underperforming slugs from metabolic? It just doesn't fit!

Your just jealous because metabolic is protected for life due to terms of the Solvay acquisition. They hate us cuz they ain't us!

 

[Anonymous]

Your just jealous because metabolic is protected for life due to terms of the Solvay acquisition. They hate us cuz they ain't us!

No way. Heard the protection period is long expired. You dipshits are
hanging on by your shorthairs. Thanks for finding a good chunk of
my dividend increase. Ka-Ching!

 

[Anonymous]

Home office insider here. The OP is indeed correct. Humira does go off patent next year and layoffs are planned. I will try to keep you posted. Stay tuned!

 

[Anonymous]

When Humira goes off patent, what will Abbvie have to replace all of that lost revenue? I imagine that there must be a plan in place to adjust operating costs accordingly.

We need a new drug - stat!!!

Street Authority veteran writer David Sterman has raised serious questions about shares of a large-cap player in the drug space – AbbVie (ABBV). He points out that the Food & Drug Administration has always known that such biologic drugs are hard to engineer and “as a result, has historically kept the door closed to generic competition.” But the FDA has had a change in heart and is now set to open up this market to generics in order to lower the costs faced by consumers and insurance companies. “In coming years, look for bio-similars to grab a huge slice of the market for genetically-engineered drugs,” Sterman writes. “How big a market opportunity are we talking about? Analysts at Citigroup predict that companies such as AbbVie will lose a cumulative $360 billion in revenue over the next 10 years.”

 

[Anonymous]

Home office insider here. The OP is indeed correct. Humira does go off patent next year and layoffs are planned. I will try to keep you posted. Stay tuned!

Thank you, kind sir! We in the field appreciate HQ insiders that are willing to share information with us. Bless your heart!

 

[Anonymous]

We need a new drug - stat!!!

Street Authority veteran writer David Sterman has raised serious questions about shares of a large-cap player in the drug space – AbbVie (ABBV). He points out that the Food & Drug Administration has always known that such biologic drugs are hard to engineer and “as a result, has historically kept the door closed to generic competition.” But the FDA has had a change in heart and is now set to open up this market to generics in order to lower the costs faced by consumers and insurance companies. “In coming years, look for bio-similars to grab a huge slice of the market for genetically-engineered drugs,” Sterman writes. “How big a market opportunity are we talking about? Analysts at Citigroup predict that companies such as AbbVie will lose a cumulative $360 billion in revenue over the next 10 years.”

I believe they are working on something big but it appear to be hung up in the patent application process.

Read the following:

1) High blood pressure a silent danger in postmenopausal women

http://www.health.harvard.edu/heart...ssure-a-silent-danger-in-postmenopausal-women

2) Patent application for Methods for decreasing cardiovascular risk in postmenopausal women

"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."

http://appft.uspto.gov/netacgi/nph-...D&d=PG01&s1=simes.IN.&OS=IN/simes&RS=IN/simes

This trial over 7300 person years of data from 3656 patients.

Present status (non-final rejection)

Conclusion by examiner – Prior art given to Robert Dudley patent application assigned to Abbvie. Dudley was not awarded the patent due to lack of clinical data in support of claims.
Ani Pharmaceuticals has the clinical data and appears to be refining the scope of the patent application.

If ANI and Abbvie merge patents, Besin gets 50% of Abbvie’s rights. If ANI is successful then Abbvie is clear of the Besin agreement and obtain patent protection to 2031.

3) Abbvie's Patent Application regarding FLUID APPLICATORS FOR USE WITH TOPICAL MEDICATIONS

http://appft.uspto.gov/netacgi/nph-...ND+testosterone&RS=AN/abbvie+AND+testosterone

Note: What product would this patent application be linked to – Androgel is highly unlikely, Libigel on the other hand makes perfect sense .

4) Finally, Abbvie hired Dr Michael Snabes, Study Director of the Libigel trials, as Sr Director of Men and Women’s Health in March 2013. He is also listed as one of the inventors on the CV risk reduction patent application.

 

[Anonymous]

I believe they are working on something big but it appear to be hung up in the patent application process.

Read the following:

1) High blood pressure a silent danger in postmenopausal women

http://www.health.harvard.edu/heart...ssure-a-silent-danger-in-postmenopausal-women

2) Patent application for Methods for decreasing cardiovascular risk in postmenopausal women

"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."

http://appft.uspto.gov/netacgi/nph-...D&d=PG01&s1=simes.IN.&OS=IN/simes&RS=IN/simes

This trial over 7300 person years of data from 3656 patients.

Present status (non-final rejection)

Conclusion by examiner – Prior art given to Robert Dudley patent application assigned to Abbvie. Dudley was not awarded the patent due to lack of clinical data in support of claims.
Ani Pharmaceuticals has the clinical data and appears to be refining the scope of the patent application.

If ANI and Abbvie merge patents, Besin gets 50% of Abbvie’s rights. If ANI is successful then Abbvie is clear of the Besin agreement and obtain patent protection to 2031.

3) Abbvie's Patent Application regarding FLUID APPLICATORS FOR USE WITH TOPICAL MEDICATIONS

http://appft.uspto.gov/netacgi/nph-...ND+testosterone&RS=AN/abbvie+AND+testosterone

Note: What product would this patent application be linked to – Androgel is highly unlikely, Libigel on the other hand makes perfect sense .

4) Finally, Abbvie hired Dr Michael Snabes, Study Director of the Libigel trials, as Sr Director of Men and Women’s Health in March 2013. He is also listed as one of the inventors on the CV risk reduction patent application.

Very interesting. This would provide the protected metabolic reps with job security for years. Metabolic is the place to be!

 

[Anonymous]

Very interesting. This would provide the protected metabolic reps with job security for years. Metabolic is the place to be!

Very interesting indeed, when you also consider that that two former Presidents of the American Association of Hypertension, William B. White, MD, (Chair of the Executive Committee) and Henry R. Black, MD, (Data Monitoring Committee), participated in the safety study. In addition. Libigel safety study was under an FDA SPA which would require post marketing surveillance. They appear to have sufficiently met the safety requirements for an NDA application.

It appears that Solvay and Biosante (Now ANI Pharmaceuticals) had a close working relationship. Biosante's former CEO Stephen Simes was CEO Unimed (acquired by Solvay) during Phase 3 trials for Androgel.

Neither ANI nor Biosante have ever publicly released information of the CV risk reducing discovery.

I believe they felt by now the patent issues would have been resolved.

 

[Anonymous]

Very interesting indeed, when you also consider that that two former Presidents of the American Association of Hypertension, William B. White, MD, (Chair of the Executive Committee) and Henry R. Black, MD, (Data Monitoring Committee), participated in the safety study. In addition. Libigel safety study was under an FDA SPA which would require post marketing surveillance. They appear to have sufficiently met the safety requirements for an NDA application.

It appears that Solvay and Biosante (Now ANI Pharmaceuticals) had a close working relationship. Biosante's former CEO Stephen Simes was CEO Unimed (acquired by Solvay) during Phase 3 trials for Androgel.

Neither ANI nor Biosante have ever publicly released information of the CV risk reducing discovery.

I believe they felt by now the patent issues would have been resolved.

?...sounds like a "no go"

 

[Anonymous]

Sorry, this will never fly. Testosterone for women approved by FDA will never happen.
Remember estrogen? Greatest thing in the world but oops! discovered to increase CV risk and fuel breast cancer and now its usage is a mere fraction of original.
Recent studies have shown testosterone to be a CV risk in men. Dr. Nissen has called men on testosterone "guinea pigs". No way in hell will this ever fly. They may get their patent on an application devise, but it doesn't come close to getting indication approved by FDA.

Big pipedream. Not even listed with any sources as a possibility. Not a biologic. RG specifically has stated that Metabolics in not in the strategic interests of AbbVie.

 

[Anonymous]

Sorry, this will never fly. Testosterone for women approved by FDA will never happen.
Remember estrogen? Greatest thing in the world but oops! discovered to increase CV risk and fuel breast cancer and now its usage is a mere fraction of original.
Recent studies have shown testosterone to be a CV risk in men. Dr. Nissen has called men on testosterone "guinea pigs". No way in hell will this ever fly. They may get their patent on an application devise, but it doesn't come close to getting indication approved by FDA.

Big pipedream. Not even listed with any sources as a possibility. Not a biologic. RG specifically has stated that Metabolics in not in the strategic interests of AbbVie.

RG also specifically stated that he does not have any college degree.

 

[Anonymous]

Don't Panic - - - HCV will make up for the revenue loss. Sincerely, Ricky G.

 

[Anonymous]

Sorry, this will never fly. Testosterone for women approved by FDA will never happen.
Remember estrogen? Greatest thing in the world but oops! discovered to increase CV risk and fuel breast cancer and now its usage is a mere fraction of original.
Recent studies have shown testosterone to be a CV risk in men. Dr. Nissen has called men on testosterone "guinea pigs". No way in hell will this ever fly. They may get their patent on an application devise, but it doesn't come close to getting indication approved by FDA.

Big pipedream. Not even listed with any sources as a possibility. Not a biologic. RG specifically has stated that Metabolics in not in the strategic interests of AbbVie.

It is because of estrogen that the large safety study for Libigel was initiated under an FDA SPA, The SPA included agreements to conduct post marketing surveillance regarding the longer term effects of testosterone use.

As for breast cancer, initially the safety/efficacy study was looking at cardiovascular and breast cancer SAEs as primary outcomes. When the trial inclusion criteria was changed to include women who were at an even higher risk of a CV event, breast cancer was no longer a primary outcome. In fact an independent Data Monitoring Committee (DMC) had completed nine unblinded reviews of the LibiGel Phase III cardiovascular events and breast cancer safety study, in each review the independent DMC recommended that the safety study should continue as per the FDA-agreed protocol, without modifications.

I assume you are referring to the same RG who said the Shire deal still made sense even without the reduced tax benefits, the RG who embellished his level of education. Is it a stretch to think that he might keep something like this close to the vest.

Then again you may be right, if so, then it is a clear sign that Abbvie will be sold and the acquirer will probably pursue it. Especially when you consider with over 7656 patient years of data collected, of which over 4000 yrs has been analyzed showing that post menopausal women who are at risk of CV events including:" a cardiovascular death, a non-fatal stroke, a non-fatal myocardial infarction, hospitalized unstable angina (including acute coronary syndrome), angioplasty, coronary bypass surgery, a pulmonary embolism and deep vein thrombosism, are 245% more likely to suffer a CV event, if they do not restore their t-level to pre-menopausal levels. Best of all there is no competition in this field.