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Humira goes off patent next year

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Anonymous said:
?...sounds like a "no go"
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Even if ANI is unsuccessful on their own, they could merge the patent information and negate the justification for denial used by each examiner. It would shorten the patent lifespan and Abbvie would most likely have to share rights with Besin. However, in the end it would still prove very profitable.
 




Anonymous said:
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.
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CORRECTION : It should read over 7300 patient years of data (not 7656).
 




























Fast forward to 2017 and this will be the mandated algorithm for most PBMs for inflammatory disease:

generics
apremilast
biosimilars
branded biologics

we have the expertise selling biologics - we need to acquire the best biosimilar
 




Anonymous said:
Fast forward to 2017 and this will be the mandated algorithm for most PBMs for inflammatory disease:

generics
apremilast
biosimilars
branded biologics

we have the expertise selling biologics - we need to acquire the best biosimilar
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That's exactly what Pfizer did. They now own the 1st Remicade biosimilar pending FDA approval. Pfizer is forward thinking, we were all about tax inversion and look where that landed us. Nice move Gonzo.
 
















Anonymous said:
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.”
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Sell you RSUs and options and look for another job. AbbVie will loose billions in revenue and the slack will be made up by massive layoffs. Teva and others are working on the generic as I write.
 
























Anonymous said:
We can stop worrying bout our jobs now. RG just bought Pharmacyclics. That is for Humira folks. As for Metalolics, yous guys are screwed!
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By the time this deal closes, the new sales dynamic will be kicking in. These are experienced Onc rep jobs. There are some with the new company and plenty from external. Don't think pizza and bagel time with these docs. Limited and very succinct access. Its one drug with currently only a handful of indications, all of which are Onc. Not derm, GI, Rheum, etc. Their future products are a ways off and also will be same Oncologists. Some solid tumor and hemo.
This acquisition will require little, if any, internal AbbVie reps. Metabolics and Humira both stand to gain almost no salvation.
Look in your territory at the total number of onc's, not relatively big and centralized in handful of combined practices. Nagging and food are out.
 




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