ValuePickr Forum

VP CHINTAN BAITHAK GOA 2015: Ananth Shenoy: GENERICS PHARMA PIPELINE BASICS

Time now to pay attention to some of the Young Turks, doing exemplary work at VP - Ananth Shenoy
So much so that within 6 months of joining VP he catapulted himself into the top 20 Contributors list through his work on generics pharma pipeline. Now Ankit and Crazymama (like this nickname better) are hotly collaborating to make this job far easier for all of us.

Ananth is the one who gave us the Ammunition necessary to do a great job of quizzing Shilpa Medicare in AGM 2014 - and the rest as they say is History. Allow me to go gaga over this one last time - apart from 15 participants from VP who landed up at Raichur (Karnataka) for the AGM, there were 10 others - analysts & fund managers & HNI Investors.

The really important questions to ask were asked by VP (no guesses, why - we were heavily armed :slight_smile: )

  1. How does one manage a 50% market share - unheard of in Generics (Hint Ans: Non-Infringing Patents)
  2. Why will IMATINIB MESYLATE not be your real blockbuster drug in the Market
    and the like (you get the drift)

No guesses, how we could make some sense of the seemingly complex Oncology pipeline, and bring everyone upto speed quickly. Generics Pharma Pipeline Basics-Ananth Shenoy-VP CHINTAN BAITHAK-GOA 2015.pdf (821.0 KB)

If you (really) want to add Generics Pharma to your circle of competence - it can easily be done, as Ananth has shown.

Over to Ananth Shenoy and you folks!

34 Likes

Ananth,

I’m convinced that you are a detective by profession; unless you are working in a Pharma company and identifying new opportunities. I started getting goosebumps when going through the zauba part; excellent digging. What does IMS stand for?

Congrats @ananth, great work !!! This gives lot of pointers on where/how to get proper data on ANDA, DMF, market size etc.

@chintans

I’am neither a detective nor from pharma company :smile:
I’am a software engineer by profession :smile:

Note that zauba may not be completly accurate - just use to get the trend right

IMS is a company that provides information on the pharma/healthcare industry. They record more accurate information on sales, market share and pricing information for a particular molecule
Mostly pharma companies and analysts use it for finding the above information. Its very expensive
https://en.wikipedia.org/wiki/IMS_Health

7 Likes

@bandlab1
Thanks. Yes, we can hopefully use this to dig more information about our favourite pharma companies and understand them better

@ananth- Very detailed & insightful ppt. Thanks a lot.

1 question-

All this work can be done for US markets only?

Or can we do this analysis for Non-US markets also? Like for Ajanta, hardly anything is coming from US, also for Maksans, UK is biggest contribution.

1 Like

@jk321

Glad you found it useful.
I’am not completely clear about patent regulations/exclusvity expiration in europe/africa etc.

I think in europe each country has its own patent expiry. so for pan-europe launch you need to wait for patent in last country to expire. or you have launch country by country which may be in-efficient

1 Like

@ananth

Thanks for the very insightful presentation.
When i revisit the way i went about trying to dig information for the Pharma Template, it helps to know that i was in the right direction! :smile:
In the process we have uncovered a one-shop site for all pharma-related info from patents, dmf’s, exclusivities, including the export shipment data.

I am still trying to get my head around the exclusivity information.
If we take the example of ARIPIPRAZOLE, there are still some exclusivity listed in favor of Otsuka the innovator with expiration dates ranging from FY17-21.

But, wouldn’t the exclusivity apply for Alembic, Teva , Torrent and other generic cos ?
For instance, ODE is a 7-yr exclusivity period. Does this apply to the Innovator or the Generic co?

2 Likes

Vishnu,

There are layers and layers of details to uncover in the pharma generics puzzle. Take it easy …things will become clearer as we get more hands dirty deeper in the domain. As the Guru says, it is about getting things roughly right…You wouldn’t want to draw very specific conclusions…and end up being precisely wrong.

Try and get hold of a pharma expert in your circle/connected circle. They can unravel in 30 mins for us …what we may take a month to struggle and come to terms…that the smarter way :wink:

2 Likes

Hello Donald,

You have unleashed the Kraken! :smile:
I guess as i keep reading and digging, things will fall into place at its own pace.

I also understand why @ananth was adamant on getting the patent info. also automated. :wink:
It is a vital clue to identify the conversion of an existing DMF to highly probable approved ANDA.
Patent column is included back again :smile:

On the other hand, it makes the additional upcoming ANDA sheet redundant.

PS: Not much of a people person.
Prefer to be the number-cruncher and data-miner for the super analysts to process.
Analysis is not my strong-suit yet.

2 Likes

Sure.
Love it that you know yourself well :smile:
And now we know of your formidable strengths …to broaden our bandwidth

What’s the progress on GDUFA? Have the ANDA processing times come down/ likely to?

Hi Chintan,

Although lot of funds have been accumulated under GDUFA, ANDA approval timeline hasn’t come down and the ANDA applications have piled on. As per one of the reports I read, the median approval time for ANDA is 48 months. Pre-GDUFA, due to limited resources, the USFDA inspected manufacturing sites in the US every 2.5 years, while foreign sites were inspected once every nine years.Given reliance on imported drugs, one of the goals of GDUFA was to bring US-based and foreign manufacturers on the same level-playing field. I think this is happening now with increased inspections for Indian companies.

5 Likes

Great work, @ananth! Tremendous accelerated learning for people like me who, though invested in pharma companies, never understood these arcane acronyms and their implications :thumbsup:

1 Like

@Donald- sir. where is your presentation. eagerly waiting for your presentation too.

This is one of the most practical and informative presentation I have come across at ValuePickr. @ananth, take a bow!

I have infinitely struggled while reading ARs and information on Pharma companies and many times gave up in the middle. But now with new arsenal at my disposal, I’ll give it another shot.

Thanks again!

1 Like

Same question

When aripiprazole is in exclusivity period till year 2021 (in favor of Otsuka), then how are Alembic, torrent etc selling in US market?

There is a Drug Price Competition and Patent Term Restoration Act also called Hatch-Waxman act which incentives generic drug manufacturers to launch a generic before the patent expires so that price of the drug falls and patients are benefited.

There are several nitty gritties involved but this is my understanding of basic flow:
a) The patent (of the innovator) lasts for 10 years. The patents for the molecule are mentioned in the orange book
b) A generic company can challenge this by saying that either the patent is invalid or they have found a novel way of producing this molecule by filing para IV with USFDA any time.
c) The innovator gets notified of this para IV challenge and has to file a patent infringement case with the court within 45 days
d) if the innovator does not sue with in 45 days, FDA will approve this para IV ANDA taking its usual time.
e) if innovator sues within 45 days, FDA will not grant the ANDA for 30 months

There is a Hatch-Waxman law which explains this:
To incentivize generic drug makers to “challenge suspect Orange Book listed patents,” Hatch-Waxman gives the first such filer of a Paragraph IV Certification a marketing “bonus”: a “180-day period of generic marketing exclusivity during which time [the] FDA will not approve” a later filed ANDA based on a Paragraph IV Certification based on the same NDA. Even more interesting, this first Paragraph IV Certification ANDA filer is entitled to this 180-day marketing exclusivity period “regardless of whether it establishes that the Orange Book patents are invalid or not infringed by the drug described in its ANDA.”

This is a primer on this which I found very useful in understanding
http://www.ipwatchdog.com/2013/04/03/a-primer-on-paragraph-iv-certifications-into-the-belly-of-the-hatch-waxman-beast-part-1/id=38384/

https://www.equitymaster.com/detail.asp?date=09/21/2012&story=3&title=Indian-pharma-A-walk-through-Para-I

14 Likes

@ananth I also have a question regarding exclusivity period for aripiprazole The Exclusivity data shows 3 different expiration data. Can we get an idea regarding which of the following patent has been challenged because according to my understanding (Is it correct?) if the patent is only in early stage(expiry date is far into future) then the addressable market size for generic player would be much bigger

Hi Aman,

We are not 100% sure about this patent and exclusivity expiration, but I had read an interview by an USFDA employee that the generic get launched at around expiration of exclusivity period. Remember that for Aripiprazole, Otsuka also has an orphan drug status for treatment of a rare disease and that most probably would be this exclusivity expiration (for treatment of different diseases, there would be different patents). On that basis, Otsuka was trying to push the generic launch of abilify. Also, just look at the patent expiration data:

So if you see the generic was launched on April 28, 2015 near to the one patent expiration on April 20, 2015. To predict product launch date is not that simple and wish we knew all the answers to it. One key thing we also track is by listening to a competitor’s concall and their press releases and reading as many research reports as possible. Just to give you an example gAbilify was also launched by Torrent along with Alembic. So to get a sense on pricing and other important data, we did go through its concall. We try to just connect the dots and see how the whole picture evolves. However, there will still be few pieces missing in the jigsaw puzzle :smile:.

7 Likes