Monthly Archives: October 2009

Clinical development in disease therapies of interest like Cancer, CVS and CNS in the last 2-3 years has made the researchers of Big Pharma work in the direction of the developing newer drugs in these areas.  Chronic therapies like the one mentioned above drive the investors to invest with Big Pharma/ Big and small bio Pharma to invest in the clinical development of these drugs. The clinical Trials are conducted various sites specified geographic locations based on the patient availability and the protocol design. Sites which are investigator specific are targeted on priority. Regulatory compliance related adherence of GCP guidelines are conducted before and during the course of the trial. The Site specific standard operating procedures are reviewed on an ongoing basis by the relevant regulatory supremacy of the concerned geographic region.

The nature of the clinical results in the Post phase I onwards i.e. Phase II onwards determines the flow of the trial to the next stage. The stage is critical for further progress of the trial form the investor’s perspective especially if the company conducting the trial is a listed company. The Stock rating of the company is likely to be the most affected when the relevant trial results are released to the media and the stock market.

As the boundaries of risk mitigation in clinical development do not “touch” a defined benchmark, clinical trial results would continue to remain the Key point of clinical development.

Veeda Oncology® is dedicated to providing clinical oncology research services internationally for the pharmaceutical and biotech industries. With offices in the US, Europe and India, Veeda Oncology is in the unparalleled position to meet both the regional and global needs of our sponsors. We are one of the few companies whose main focus is oncology. As a result, Veeda Oncology can meet the rigors of local and global requirements of Phase I through Phase IV programs

“The African countries hold the potential to an increasing number of HIV positive patients which are rising at a rapid pace. The rising pace of disease spread is in millions of people in countries like Mozambique. The people of the African countries affording population are a less affording population for treating their “”detectable”” and “”undetectable”” diseases prevailing in their countries. The people of these countries are dependent on subsidized government supplies of anti retroviral drugs which are imported from countries which manufacture the same at subsidized rates. The anti retro viral sent to these countries are sent on a large scale are manufactured by prominent Indian Pharmaceuticals companies and are predominantly generics. The generic anti retroviral drugs are tested for their bio equivalence criterion before they are sent out for export to African nations.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way. ”

The average time duration for CRO selection by a sponsor/ client for outsourcing for various phases is the least in Phase I. This is a recent trend among various global CRO’s hen surveyed for questions relating to CRO selection between preferred and non preferred CRO’s. The difference in negotiation between preferred and non preferred is less than 1.5 days. For all other phases, primarily from Phase II to Phase IIIb, the difference in time duration is on an average of 9 days.
Needless to say, the differentiating criterion for selecting a CRO for a Phase I drug (primarily a generics term for off patent drugs in the EU), the selection criterion is extremely “”specific””/ precise.
CRO’s conducting “”Phase I studies of off patent generic “” need to be develop their capabilities which are specific to their sponsors in order to “”retain “” their presence in the sponsor’s perspective as a preferred CRO for future studies.
CRO’s conducting BA BE studies needless to say need to maintain a niche in the market as these trends are an indication of the “”rising competition “”and shows a tendency of sponsors/ Clients switching CRO’s for “”known and unknown”” reasons.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.

“The dependence of the Asian economies on exports of medicines to the developed world at cost effective pricing drives the growth of their earnings every year. The earnings dependency is related to the outsourcing budgets of Big Pharma and subsequently the healthcare budgets of their respective governments.
With the onset of recession, the budgets of the companies and further the countries would impact the nature of the growth of the outsourcing market. The market for outsourcing of drug studies is the CRO market and CRO markets in cost effective destinations like India have their growths defined by these phenomenon.
Outsourcing of Bio equivalence studies form the western markets to Indian CRO’s has slowed down considerably on account of recession in the western world.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way. ”

Many of the smaller biotech companies have been faced with the aftermath of recession. These companies have been developing and devoting their energies to the development of only 1-2 molecules which may have in the clinical trial phases (Post Phase I scenario). The compounds under study by these companies have been not received favorable results with respect to their end points or faced with results which have not been sufficient enough to invite investor confidence to take the compound to the next stage.
On account of various factors such as the above many small biotech have faced “”bankruptcy”” or faced with issues leading to their closure. These trends are now taking a gentle swing in a different direction which indicate that certain biotech companies are picking up pace in the market and are in the pursuit of “”launching”” new trial expertise in the process. The indications indicate a “”revival”” trend in the biotech market and further outsourcing of clinical research to cost effective geographical locations.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.

Share prices are like swings which once in motion continue to oscillate like a pendulum until external interference or drag brings it to a halt. Similar is the case with the listed Global MNC’s like Merck which gave a after a Goldman Sachs analyst gave the drug developer a “”Buy”” rating, citing the stock’s current value and the company’s pipeline of products. The stock rose 60 cents, or 2 percent, to $30.70 on midday trading. Shares have traded between $20.05 and $36.73 over the last 52 weeks.
However, rating for Elli Lily fell after the ratings for the company by Goldman Sachs gave it a “”sell”” rating, swinging in just the reverse direction. The stock shed $1.07, or 3.1 percent, to reach $33.82 in midday trading. Shares have traded between $27.21 and $49.78 over the last 52 weeks. Goldman Sachs analyst Jami Rubin cut the stock to “”Sell”” from “”Neutral,”” citing the company’s patent cliff as a key factor. The term refers to a period when lucrative drugs lose patent protection, opening the market up to generic competition. When several of these drugs fall off a “”patent cliff,”” the company faces the prospect of shrinking revenue because of tougher competition
Veeda Clinical Research is an Indian CRO which provides cost effective Bio-Equivalence studies for the drug industry.

“Yes the title is definitely good and very true. In the First 18 days of September 2009, there has been at least 18 captured happenings in the world of outsourcing to CRO’s and their related activities in a major way. The dashboard for the first 18 days says it all. The News happening in the CRO world dominates September 2009 by capitalizing on a presence of greater than 21% of the total happenings. The trends in the Global Pharma are continuously moving in the direction of the more outsourcing to CRO’s. The Global Pharma happening on the news dashboard occupy the pie presence week on week and month to an extent of always greater than 15% of the total.
The world prepares to move out of recession and trends work towards the emerging markets like India and its Pharmaceutical Industry, constant positioning of Indian Pharma in the event dashboard places itself to an extent of at least 10% of the total happenings. As the laws in the Regulatory platforms move towards stringency and better compliance, looking at them in the times of recession on the news dashboard are gradually show their relevant significance.
Regulatory collaborations are now being sought at global levels within regulatory authorities with the involvement of respective governments of countries in the western and the developing world.

Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.”

The Drug industry playground has been occupied by a large number of players in the last 10-15 years. The Big companies and their outsourcing providers have been driving their businesses in their conventional ways. Most of the drug companies have their presence in all major markets and also their outsourcing providers. The list of preferred outsourcing providers of most of the major pharma companies is available in their operating procedures with a certain set of guidelines for costing and reasons for preference.
As recession has taken its swing on the Pharma with rising pressure on their branded drugs sales from off patent copy cat versions of their drugs, growing stringent regulatory guidelines for new drug approvals, rising investor pressure on their drug development pipeline, the market has been “”activated with a lot of merger and acquisition activity in the last 1.5-2 years.
A market which gave “”bulky”” look in the year 2007 gives a more “”trimmed””/slimmer look after the recession struck the world economy particularly the Western markets of the USA and Europe. The recessed economies have made the big Pharma companies to take a look at emerging markets of Asia particularly India and china to outsource their clinical research (Clinical trial and generic studies) to the cost effective markets in a major way.
Veeda Clinical Research is a leading Indian CRO which caters to cost effective bio-equivalence studies for the Global Pharma and biotech industry in a major way.

The global diabetic market has been forecasted to grow to an estimated size of US$45bn growing at 8.5-9%. The reins of the overall market are vested with the USA and the EU where the combined geographic regions are forecasted to have a market share of 75% of the total market by the year 2015. The remaining market share would be occupied by the Rest of the world (primarily India) which accounts for 82% of the total world’s diabetic population and which would have a premium forecasted growth by the year 2015 despite a very low “”awareness””/””undetected “”diabetic population. For the US and the EU, although the awareness levels of the populations are extremely high, the known diabetic population numbers are less than 20% of the total population.
The conventional Diabetic drugs are the PPAR agonist which accounts for 46% of all oral /non –insulin diabetic drugs. DPP-4 inhibitors are novel class of inhibitors which accounts for 11.5% of the of all oral /non –insulin diabetic drugs in terms of revenue for the year 2008 and this scene is likely to dominate the forecasted revenue till the emergence of the “”newer”” therapies for diabetes in the next 10 years.
The total market for diabetes is dominated particularly insulin market is dominated by Novo Nordisk (50%), Elli Lilly (25%) and Sanofi Aventis (25%). The total market for Diabetes as a whole ( Insulin and non –insulin ) is dominated by Novo Nordisk ( 23%), Takeda ( 18%) , Sanofi Aventis( 15%), Elli Lilly( 12%), Merck (8%) and GSK (7%) i.e. in all a total of 6 major global players.
A graphical representation of the same is as follows:
Total Insulin Market Global

Total Diabetes Market Global

Veeda CR unit is familiar with a wide range of diabetology studies including euglycaemic and hyperglycaemic glucose clamping and assays such as insulin and glucagon, DPP inhibition and other enzymatic assays. We have access to populations of diabetics and pre-diabetics and the obese, clinically non-diabetic population.
Visit http://www.veedacr.com/Diabetology.asp for more details.
 

“Indian Pharma P/E is indicative
The Indian Pharma listing based on MCAP and MCAP/Sales speaks of the following- for the period April-September 2009
THE MNC PREDOMINANCE MAY RISE in INDIAN PHARMA
The valuations are indeed interesting because Sun Pharma has the highest MCAP/SALES of 6.7 and its nearest competitor Cipla is 2.3% away from the leader with a margin of approx Rs 7000 crs of MCAP.
 Sun Pharma export run is on the USA whereas Cipla’s export run is on the African market (anti-retrovirals nad government allotments which are subsidized for semi regulated markets which may be impacting its MCAP value). It can be seen that the EBITDA and P/E is higher for Cipla than Sun Pharma.. The P/E is almost double for Cipla as compared to Sun Pharma.
Wockhardt is in negotiation process with PSU banks for corporate debt restructuring programme which has been unsuccessful. Part of the Wockhardt group has been sold off to Abbott (Non Pharma) to recover for the losses it is facing. This may be on still because Wockhadt is facing difficulties in convincing investors for an asset buy. 
2 out of the top 5 Indian HC stocks are are showing negative P/E and that is Ranbaxy and Dr. Reddy’s. (Ranbaxy stake is with Daichi and Dr Reddy stake is ready to go to GSK). 
Aurobindo and Orchid drugs products are licensed to Pfizer. Novartis India has hiked its stake in its Indian subsidiary from 71% to 91% in the last few months.
Piramal Life Sciences has a miniscule presence in the listed market with negative P/E. Amongst competition, Vimta labs shows  a P/E of 18.3 but with avery low MCAP. ”