Past Meets Present

I track the Healthcare sector. During one of my thousand searches I came across an interesting picture, that I thought is worth sharing. See the picture.

Guess who is being scanned. Source: HES website

The person being CT scanned is dead and 2,500 years old. Interesting isn’t it. The corpse is an Egyptian mummy which was being examined by radiologists of City University, London. The finding that came out was that the mummy had a “post-mortem fracture of the left thigh bone but her brain was intact and had been left in her body”.

The university intends to “scan historical artefacts such as medieval daggers found embedded in centuries of River Thames mud and a Roman cremation urn too fragile to open”.

Welcome to the Pharma World

I had an opportunity to chat with Anand Bayes over a cup of tea. Anand has built his expertise in the pharma space. He is a MBA (Finance) and a graduate from College of Engineering Pune. Though he has a relentless gaze at PEs and prescriptions forecasts, he was ready to contribute to my blog. Below is shared an interesting insight on the market protection strategies employed by branded and Generic companies. Welcome to the pharma world. Read on….

Q:  Hi Anand! Can you throw some light on the market protection a branded drug gets in your sector?

A:  Hi Ankit! There are two forms of market protection. A) Exclusivity and B) Patent Protection

To understand this let me tell you in brief about the approval process of a new branded drug.

The drug approval process is regulated by Food and Drug Administration (FDA). Consider a branded drug company such as Pfizer or Eli Lilly comes out with a new drug and wants it to get market protection. In such a case it would go to Food and Drug Administration (FDA) and file a New Drug Application (NDA). This NDA contains all the data / statistics from at least their two clinical studies. FDA studies the data and approves or disapproves the drug.

When approved the drug has “Exclusivity” which means that the drug has monopoly in the market for defined number of years (usually 5 years). No new generic variant of the drug can show itself in the market during the period of exclusivity.

The patent protection is another form of market protection for the drug that comes into the market. The time period for patent protection is greater than the “Exclusivity” period ( the average period of patent protection is around 12 years from the time it is launched). In US, the patent protection is granted by the US Patent and Trademark office and listed in the FDA Orange Book. The FDA orange book is an agency publication with all the approved drugs along with all the patents associated with the drug. These patents ensure that no generic versions come to the market before their expiration.

Q:  So a generic variant of the branded drug can not come into the market during the time these protections are present?

A:  One needs to understand that “Exclusivity” protection is by law. So there is no chance for the generic to come into the market during the exclusivity period. But when the exclusivity expires the generic company can challenge the patents of the branded company as invalid, unenforceable or not infringed by the generic company’s product. For this the Generic company files Abbreviated New Drug Application (ANDA) with FDA and gets a Paragraph IV certification. If it prevails in the lawsuit, the generic company is granted 180 days of market exclusivity.

Q:  Does challenging the branded drug patent a viable strategy for the generic companies?

A:  The 180-day exclusivity incentive can be significant for a generic company as it would be the only generic version in the market.   So, it can price the product slightly below the branded version for six months, take market share from the branded product, and maintain its price point before other generics enter the market and erode the price and segment margins. The additional profit for a generic firm can be enormous if the product it challenges is a so-called blockbuster or megabrand

Q: Can you tell us about some recent PIV opportunities?

A: The most famous I can think of is the opportunity with Lipitor which was won by Ranbaxy after years of litigation. Ranbaxy being the first company to file a paragraph IV ANDA for Lipitor, won the 180 days marketing exclusivity starting Nov 2011.

———————x——————————–x——————————x—————————x—————————–

A Wednesday

No No – I am not writing a review of the film “A Wednesday” but I intend to discuss a more serious and contemplating event that started on “A Wednesday”. This was a Wednesday that saw Mumbai being held hostage by madmen. This was a Wednesday which saw country’s security system fail once again. This was a Wednesday which brought out “again” the utter inability or should I say impotence of the politicians to the fore.

Media has already given it a name 26/11 but this was not a single day event like 9/11. This was when Mumbai was raped, mauled, mutilated continuously for more than 50 hrs. It seemed that it would not end. I was shocked to see the attack persist throughout the day. The shock then took the form of anger. An anger mingled with sorrow for my people who were in the middle of this. My family and friends were worried about me. But all I was thinking like the rest of the mumbaikars was of South Bombay.

Now when the city is breathing again, I am sombre. I am thinking and there are certain opinions, I am beginning to form. First that our politicians are inept at their jobs. They lack administrative skills evident from the slow deployment of NSG on the scene. Second there is a disconnect between our intelligence agency and various security groups otherwise we would not have had so many bombings/ terror attacks in the year. And Third we people fail to learn from our mistakes. We forget and forgive. We will again wake up in the morning and dress up for office. We would again follow the routine. We would again take solace in the “Mumbai Spirit”. We would again be comfortable.

We can not be Gandhiji’s three monkeys. We can not afford to stay mum at this time. We want answers from the government. Why did they let this happen? What are they doing about this? And how would they ensure that this will not happen again? We can not stay blind. We have to be vigilant, eyes wide open staring at the world saying that we are watching and we will reply. We can not stay deaf. We can not let this noise pass into oblivion. Those bullets are still firing in my head. We have to think and react. Till we believe that enough is enough, “A Wednesday” will come and haunt us again.

What Jim Roger says?

What Jim Roger says?

That America is bankrupt. The American government bonds are a bloating bubble which would burst and the world will see that the bubble had nothing but air.

Why does he says so?

Becuase he feels that the bonds are overvalued. Because America on average has added debt at a rate of 1 billion dollar a year in the past few years and has currently more than 13 trillion dollars in debt.

What I feel ?

That America will continue to pass its debt to its coming generations. And till the time America can cut forests (be its own or of Iraq) to print money, America will not go bankrupt 🙂

Jim Roger Quote (on the bailout of U.S. banks):

“The Bail-out plan is a disaster. In 1929 we had a recession but after the government interfered, it became a depression. You should not interfere.”

Source: EuroBench.com