Regulatory issues!

For past many months there has been issues related GMP production whether it’s Roche, Sanofi and Hospira and the issue was cGMP compliance in manufacturing. For Roche the issue was API production in their API manufacturing in North carolina, US and later Sanofi with their TB drug production in Canada. Why is that developed nations facing the CGMP issues as their regulatory bodies are the most stringent ones in the world?What should be the next steps for this company, third party manufacturing of active API's and products ?

Social Media Bug in Pharma!

Social media in some years has become a hot topic or rather then talk of the town, In FMCG scenario it has worked wonders and made some old products come back into shelf after consumer's persuasion. But I feel for Pharma there is an overall different story. Pfizer had closely watched effort for patient recruitment for clinical trials, One year after launching its so-called clinical-trial-in-a-box.

Pfizer is planning to discontinue enrollment in the first such study that was designed to allow the patients to participate from home by using computers and smart phones rather going back to hospital or doctor's office for medicines and after check-ups. While this effort created lot of Buzz in the virtual world but the drug maker was not able to pursue the patients to come up front to participate in trial, which was for testing the Detrol overactive bladder drug.

Time will say Social media success in Pharma and biopharma sector?

Pharma consolidation!

Good Morning Bangalore!.....India.......i have started loving Bangalore because of many things but majorly because of its climate and good Volvo services :)

Last to last week when Astra zenaca CEO stepped down after series of failures in strategic decisions...there were humors that GSK in eyeing on Astra, Both of then are Europe based companies and if this merger happens, it will help GSK to penetrate Europe and access to R&D in APAC region.......I assume that after 10 years all the Top 20 to 30 companies will be subsidiary of the Top 10 and i am just here to watch the consolidation of the Pharma industry......Might be case that Novartis mights increse its stakes in Roche and might even make it as its Biological subsidiary.......We never know what will be the consequences......but the shrinkage and consolidation of Pharma across the globe has started........

Turkey the next land of oppurtunity!

From the beginning of this year my life has been a roller coaster ride, leaving the hectic life, what I found is Bangalore is better compared to my life in Delhi. From last month I have been looking at a different trend, I started reading about Big pharma investment in emerging markets, what i am looking at is many of the big pharma's in the last 2-3 years have started collaboration with the Turkish companies or rather buying them out,  and some for instance like out of the major top 20, Novartis last month announced that it is going to start its R&D in Turkey and today’s latest news is Amgen bought 95% stakes Turkish Drug maker Mustafa Nevzat for $700 Million. After china being the favorite destination in Asia for big pharma’s emerging market strategy, I feel that likewise Turkey is becoming key destination for penetration into North Africa and middle east emerging market strategy for Big pharma. Amgen of course with this deal has become part of large pharma with generic arm and what I believe that in coming 6-7 years will promote its biosimilar arm through the generic divisions which it will perhaps expand from turkey to other parts of Europe, as from olden days (Biblical era) Turkey was gateway to both Europe, Africa and Asia…………

Reverse merger of Pfizer and Sanofi????

One year back while I was traveling with my boss for a small conference in Delhi. Aditya my boss started telling me about reverse merger of Merck by Schering-Plough, I was surprised to know that as I had a always known that Merck had acquired Schering-plough.....leaving that story apart, in the current scenario if I look into world’s largest pharma Pfizer's current pipeline, it is somewhat dry with its major block buster getting off patented last month,  there are not many revolutionary drugs in its somewhat dry pipeline which will give it a huge ROI in next 10 years and it also do not have a strong biopharma presence .....on the other hand the company which is making mark and has been into lot action in biological for a while is Sanofi Aventis of france.........with Sanofi's strong biological pipeline and Pfizer's strength in world class chemical synthesis...in future can we think of a reverse merger of Pfizer by Sanofi ???

China Incorporation!

Happy diwali to all!
Diwali is the festival of lights in India and one of the important festivals for Indian subcontinent.
I have been enrolled for the strategy management course from Indian institute of management- Kozhikode and this December it’s going to come to end, so for our last semester course on Mergers and acquisition we have been assigned a group course and we out of the blue opted for Automobile industry M&A and the classic case we took into account was Geely and Volvo, the merger looked lucrative for Geely's part but when I looked into external environment nation wise the thing which surprised me was government initiatives for more direct investment by major companies in China. We in India had been into development path for long around 30 years but if I compare the two nations in the automobile segment scenario, China is far ahead in terms of price and quality in all the segments (Low price to premium car segments), we so called democratic nation have to learn a lot from the biggest communist nation of the world  

Eli lilly .....

In US sometime it’s the investor’s  who  turn around the game for  fate of the firm in a given industry, In Pharma from the days of its inception there is lot strong lobby going on which have lead to many decisions in favor of the republican lead lobby such as Biotech drug exclusivity and NDA exclusivity. In India like the Gilead and Pfizer, Eli lilly, Abbott of the world we have Cipla which has replicated the trends in the democracy.

Yesterday I was reading about the article that current CEO of Eli lilly who is veteran for 32 years went against the stake holders opinion of cutting down on R&D budgets , what we have observed  over the last decade is that Eli lilly had around 8 blockbuster molecules in its pipeline

Eli lilly pipeline: One of the Top ten research based companies in the world in terms of sales with block buster products sales exceeding US $1 Billion

Lilly has around compounds Byetta, Cialis, Alimta, and Cymbalta all of which are strong entries to their respective markets. Overall sales is going to rise steadily as mentioned in Epsicom report.

Sales of Major Products (2003A-2013E)

 
As mentioned in http://www.espicom.com/Prodcat2.nsf/Product_ID_Lookup/00000125?OpenDocument

So I second the CEO’s opinion in aspect of allotment of resource for R&D development but also to focus on more licensing deals and mergers and acquisitions in some broad area such as rare diseases and increase in sales in emerging markets

Link: http://www.fiercebiotech.com/story/lilly-outlines-turnaround-strategy-ceo-calls-research-cuts-nuts/2011-06-30

CMO Outlook in India

Last week I was finishing one assignment for CMO (contract manufacturing organizations) growth opportunities in India and this was in regard to the question put by my prof regarding if you are a company who would like to outsource your manufacturing to India, make a case related to it, there were many points which were favorable for India as destination for outsourcing in term of technology, talent pool which includes reverse engineering experts. the trend which shocked me that many Indian companies are out sourcing there manufacturing to China and then later market their product in India due to cheap labor cost and rapid scale up process. Many north India and west India based companies have implemented this process for long and having an annual CAGR of more than 15%