New drug combination may halt rheumatoid arthritis
November 9, 2008 |
Trial data seems to suggest that a monthly injection may help to halt rheumatoid arthritis in almost half of all patients.
To halt the condition in which the body attacks its own joints, the antibody drug tocilizumb works together with a current treatment methotrexate.
The drug is still awaiting for approval by drugs regulators in the US and Europe and Roche will sell it under the brand name RoActemra after approval.
The study has been presented at a meeting of the American College of Rheumatology.
Though it is said that nothing can be done to reverse the damage that occurs due to RA, the new results indicate that if two drugs are taken together, they can get remission by halting the disease progression.
The trials (involving 1,190 patients) showed that the use of tocilizumab with methotrexate halted the condition in 47% of patients while it was only 8% when methotrexate was given alone.
X-rays revealed that the use of two drugs slowed joints structural damage by 85% on average.
The lead author of the study Professor Paul Emery says: “The results of the study show that tocilizumb can quickly decrease the painful and debilitating effects of RA.”
There are also many other drugs available that help to halt RA disease progression, but there use is restricted in the UK and some other countries
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Cholesterol Drugs
A New Age Of Statins?
Forbes Matthew Herper and Robert Langreth 11.09.08, 9:00 AM ET
A new study could lead millions more Americans to take cholesterol-lowering drugs and generate billions in sales for AstraZeneca, which funded it. But first comes a furious debate.
The study, called Jupiter, gave either AstraZeneca's (nyse: AZN - news - people ) Crestor or placebo to 18,000 patients who received bad scores on a little-known blood test for C-reactive protein (CRP) that is thought to measure inflammation in the arteries. Patients who took Crestor were half as likely to have heart attacks, strokes or operations to open clogged arteries as those getting placebo, an effect that ranks among the best results seen with the two-decade old class of cholesterol drugs called statins, of which Crestor is the most potent.
"It takes prevention to a new level because it applies to a whole group of patients who would not get a statin today," says Douglas Weaver, president of the American College of cardiology. In a statement, Elizabeth Nabel, head of the National Heart, Lung and Blood Institute, says adding CRP tests to those for blood pressure and cholesterol "could identify millions more adults for whom treatments with statins appears to lower the risk of heart attack."
So is every American going to get a CRP test now and, if they get a bad result, take Crestor? Twenty million Americans already take these drugs, and if the results of Jupiter were applied broadly, that number could double. But it won't.
Twenty top cardiologists who reviewed the results for Forbes expect both CRP testing and statin use to increase, but for every one who called the results "huge" or "a home run," there are some who say change will be slow and incremental. The drugs, though very safe, have side effects, and the test can be quite variable.
"I'm convinced CRP is a fad," says Sanjay Kaul, of Cedars-Sinai Medical Center in Los Angeles. "Maybe there will be a little blip in its use, but many physicians have given up on CRP."
Because the patients in the study had a relatively low risk of heart attack, the absolute benefit of taking Crestor was still very small. There were only 400 heart attacks, strokes or heart surgeries among all 18,000 patients in the study. Overall, 95 patients had to be treated with Crestor for two years to prevent one angioplasty procedure, heart attack or other cardiovascular "event."
Patients in the study had average bad cholesterol, or LDL, of 108 milligrams per deciliter, well below levels at which drug treatment is routinely recommended. But their cardiac risk was increased because their CRP levels were elevated (above 2 milligrams per liter). Crestor slashed their LDL levels to 54 and also reduced their CRP levels by 37%.
Crestor did better than experts expected. Statins are among the safest drugs on the market, but in patients at very low risk of heart attack, their potential muscle- and liver-damaging side effects become more worrisome. Howard Weintraub, who directs cardiovascular prevention at NYU Langone Medical Center, calls the results "pretty strong stuff" but worries "people will indiscriminately apply the findings of the study to the wrong group, [and] there may be adverse events." In addition to high CRP, patients in the study were older (around 66), overweight and had borderline high blood pressure.
In Jupiter, there was also an increase in the number of people who developed diabetes while on Crestor. "It's probably chance," says study statistician Robert Glynn of Harvard. "It's an incredibly interesting puzzle."
Current guidelines suggest using CRP as a tiebreaker only if patients have some risk factors like obesity or high blood pressure but don't clearly merit statin therapy. Stanford University's Mark Hlatky argues in an editorial in the New England Journal that these guidelines are about right.
C-reactive protein was first discovered in the 1930s as a protein the body made in response to a sugar (the C polysaccharide) made by bacteria. It came to be seen as a measure of how inflamed tissues all over the body are. In the mid-1990s, researchers started to notice that statins seemed to have benefits, like preventing stroke, that didn't seem to be explained by cholesterol lowering alone.
One explanation: Statins don't just lower blood levels of bad cholesterol, keeping it from sticking to artery walls, but they also reduce the inflammation that causes cholesterol plaques to burst and cause heart attacks and strokes. Paul Ridker, a researcher at Harvard's Brigham & Women's Hospital, thought to test for CRP in a huge database of heart data researchers there had been collecting for decades. He picked CRP because it was the easiest measure to use to test for inflammation.
By 2001, Ridker had presented analyses of CRP's importance from completed studies of statins. He argued that it was at least as good as LDL at predicting heart attack risk, and he published his results in places like the New England Journal. Based mostly on his work, CRP was added to guidelines as a tiebreaker test. The test is made by Siemens (nyse: SI - news - people ), and intellectual property related to it is held by Ridker and the Brigham.
Ridker wanted to conduct a big clinical trial to prove CRP's worth for guiding statin therapy. The National Institutes of Health told Ridker that such an expensive study should be funded by industry. But Pfizer (nyse: PFE - news - people ), seller of top-selling statin Lipitor, rejected his plan for such a study. Bayer (nyse: BAY - news - people ) was going to fund it, but then its statin was withdrawn from the market for side effects. The U.S. division of AstraZeneca agreed to fund the study, but it almost stopped over concern about Crestor's side effects. The trial had to be expanded from just the U.S. and Canada to 26 countries to get it done.
James Stein, a cardiologist at the University of Wisconsin, Madison, thinks the patients in Jupiter all had other risk factors besides CRP, but he's hopeful that the CRP test will get people who are middle-aged with thick middles and slightly high blood pressure on statin drugs.
"They found the sweet spot of risk," says Stein. "They found a way to identify the people doctors look at every day and say, 'This guy's at risk.' But he walks out the door without a prescription."
The patients who get statins, Stein notes, are likely to be men over 50 and women over 60, as in the study. Patients much younger than that have time to protect their hearts by losing weight and exercising.
Many doctors agree that cheaper generic statins may be good enough for many of these patients, although a few say they are a little uncomfortable extrapolating. "If a company is willing to fund the trial and they win, that should be rewarded," says Robert Harrington, a top cardiologist at Duke University.
For AstraZeneca, the competitive benefits of the study come not only from the increase in the size of the statin market, but from the fact that the drug now has hard evidence that it prevents heart attacks and strokes. Vytorin, from Merck (nyse: MRK - news - people ) and Schering-Plough (nyse: SGP - news - people ), the only equally potent cholesterol drug, contains one active ingredient that is not a statin, and there is no evidence it prevents heart attacks or strokes even though it reduces LDL and CRP. Citigroup (nyse: C - news - people ) estimates Crestor sales could double to $6.8 billion by 2012
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Headline findings
•The global pharmaceutical market is forecast to grow to US$897 billion in 2011, an equivalent CAGR of 6.9% over the next five years.
•Strong growth in the 10 European markets that joined the European Union in 2004 will help to boost European sales over the next five years.
•In 2006 the leading therapy areas by sales were cardiovascular with 14.2% share and CNS with 14.1%.
•Continued double-digit market growth in China will make it the seventh biggest drug market by sales in 2010.
•The top 100 blockbuster drugs generated sales of US$232.2 billion accounting for 36% of the total pharma market.
•Total pharmaceutical sales from the top 10 companies accounted for more than 40% of the total market.
Key features of the report
•Comprehensive market trends for key countries, regions, therapy areas, products and companies.
•Country profiles for leading pharma markets with market segment trends and 5 year forecasts.
•Therapy area profiles for leading therapeutic classes and key products and 2010 sales forecasts.
•Detailed profiles of 10 leading pharmaceutical products in 2006, including five year future sales forecasts.
•Detailed profiles of 10 leading pharmaceutical companies in 2006, including 2011 sales forecasts.(AstraZeneca, Eli Lilly, GlaxoSmithKline, Johnson and Johnson, Merck & Co, Novartis, Pfizer, Roche, Sanofi-Aventis Wyeth)
•173 pages long, with 87 figures and 67 tables to illustrate the market trends.
Use this report to:
1. Benchmark your portfolio against key market trends and forecasts in order to plan better for success.
2. Identify key areas of pharmaceutical market growth and key opportunities for delivering successful sales growth over the next five years.
3. Support internal planning and decision-making with an external perspective founded on detailed analysis and transparent market forecasts.
Report coverage
The report methodology provides a detailed but transparent analysis of key pharmaceutical market trends, including key markets, therapy areas, products and companies. Historical trends are formed over a three-year time horizon and future forecasts are made using a five-year future time period. Thus, the data and analysis relate to the nine-year time horizon from 2003 to 2011.
All data used in outlining historical trends is clearly sourced within the report and any data limitations or additional assumptions are explicitly detailed within the text of the report. Future market forecasts are projected based on both historical trends and future expectations over market conditions and events. The assumptions used to form the basis of key market forecasts are outlined in detail within the text of the report.
Table of Contents
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Executive Summary
Introduction
Key global markets
Key therapeutic markets
Key products
Key companies
Key trends and opportunities
Chapter 1 Introduction
Global pharmaceutical market
Report overview
Methodology
Sources
Structure
Chapter 2 Key global markets
Key pharmaceutical markets
US pharmaceutical market
US purchasing channels
US retail drug market
US therapy areas
US market leaders
European pharmaceutical market
European retail drug market
European therapy areas
Japanese pharmaceutical market
Japanese therapy areas
Chapter 3 Key therapeutic markets
Key therapy areas
Retail drug therapy areas
Cardiovascular therapy area
Cardiovascular markets
Cardiovascular blockbusters
Central nervous system therapy area
Central nervous system markets
Central nervous system blockbusters
Alimentary/ metabolism therapy area
Alimentary/ metabolism markets
Alimentary/ metabolism blockbusters
Respiratory therapy area
Respiratory markets
Respiratory blockbusters
Anti-infectives therapy area
Anti-infectives markets
Anti-infectives blockbusters
Musculo-skeletal therapy area
Musculo-skeletal markets
Musculo-skeletal blockbusters
Cytostatics therapy area
Cytostatics markets
Cytostatics blockbusters
Chapter 4 Key products
Leading products
Lipitor (atorvastatin)
Advair/ Seretide (fluticasone/ salmeterol)
Plavix (clopidogrel)
Norvasc (amlodipine)
Nexium (esomeprazole)
Enbrel (etanercept)
Remicade (infliximab)
Zyprexa (olanzapine)
Prevacid (lansoprazole)
Diovan/ Co-Diovan/ Provas/ Miten (valsartan/ hydrochlorothiazide)
Blockbuster trends
Blockbusters by drug type
Blockbusters by therapy area
Blockbusters by company
Chapter 5 Key companies
Major pharmaceutical companies
Major company financials
Major company locations
Top 10 pharmaceutical companies
Top 10 company financials
Top 10 company value drivers
Leading pharmaceutical companies
Pfizer
GlaxoSmithKline
Sanofi-Aventis
Roche
AstraZeneca
Novartis
Johnson and Johnson
Merck & Co
Wyeth
Eli Lilly
Chapter 6 Key trends and opportunities
Global market forecasts
The US market
The European market
The Japanese market
Other markets
Key therapy area forecasts
Cardiovascular market
Central nervous system market
Alimentary/ metabolism market
Anti-infectives market
Respiratory market
Oncology market
Key product forecasts
Lipitor (atorvastatin)
Advair/ Seretide (fluticasone/ salmeterol)
Plavix (clopidogrel)
Norvasc (amlodipine)
Nexium (esomeprazole)
Enbrel (etanercept)
Remicade (infliximab)
Zyprexa (olanzapine)
Prevacid (lansoprazole)
Diovan/ Co-Diovan (valsartan/ hydrochlorothiazide)
Key company forecasts
Pfizer
GlaxoSmithKline
Sanofi-Aventis
Roche
AstraZeneca
Novartis
Johnson and Johnson
Merck & Co
Wyeth
Eli Lilly
Appendix
Proprietary data sources
Product Trends Database
Company Trends Database
Top 100 pharmaceutical products
Top 62 pharmaceutical companies
LIST OF FIGURES
Figure 1: Global pharmaceutical market, 1999-2006
Figure 2: Report structure
Figure 3: Global pharmaceutical market share by region, 2006
Figure 4: Global pharmaceutical market by region, 2003-2006
Figure 5: US pharmaceutical market, 2003-2006
Figure 6: US pharmaceutical market share by purchasing channel, 2006
Figure 7: US pharmaceutical market by purchasing channel, 2003-2006
Figure 8: US retail pharmaceutical market, 2003-2006
Figure 9: US retail pharmaceutical market share by therapy area, 2006
Figure 10: US retail pharmaceutical market by therapy area, 2003-2006
Figure 11: Top 10 products by US pharmaceutical sales, 2006
Figure 12: Top 10 companies by US pharmaceutical sales, 2006
Figure 13: Top 10 companies by share of US pharmaceutical sales, 2006
Figure 14: European pharmaceutical market, 2003-2006
Figure 15: European pharmaceutical market share by country, 2006
Figure 16: European top 5 retail pharmaceutical market, 2003-2006
Figure 17: European top 5 retail pharmaceutical market share by country, 2006
Figure 18: European top 5 retail pharmaceutical market by country, 2003-2006
Figure 19: European top 5 retail pharmaceutical market share by therapy area, 2006
Figure 20: European top 5 retail pharmaceutical market by therapy area, 2003-2006
Figure 21: Japanese pharmaceutical market, 2003-2006
Figure 22: Japanese pharmaceutical market share by therapy area, 2006
Figure 23: Japanese pharmaceutical market by therapy area, 2003-2006
Figure 24: Global pharmaceutical market by therapy area, 2006
Figure 25: Top 10 product classes by global pharmaceutical sales, 2006
Figure 26: Global retail pharmaceutical market share by therapy area, 2006
Figure 27: Global retail pharmaceutical market by therapy area, 2003-2006
Figure 28: Cardiovascular retail pharmaceutical market, 2003-2006
Figure 29: Cardiovascular retail pharmaceutical market share by country, 2006
Figure 30: Cardiovascular retail pharmaceutical market by country, 2003-2006
Figure 31: Central nervous system retail pharmaceutical market, 2003-2006
Figure 32: Central nervous system retail pharmaceutical market share by country, 2006
Figure 33: Central nervous system retail pharmaceutical market by country, 2003-2006
Figure 34: Alimentary/ metabolism retail pharmaceutical market, 2003-2006
Figure 35: Alimentary/ metabolism retail pharmaceutical market share by country, 2006
Figure 36: Alimentary/ metabolism retail pharmaceutical market by country, 2003-2006
Figure 37: Respiratory retail pharmaceutical market, 2003-2006
Figure 38: Respiratory retail pharmaceutical market share by country, 2006
Figure 39: Respiratory retail pharmaceutical market by country, 2003-2006
Figure 40: Anti-infectives retail pharmaceutical market, 2003-2006
Figure 41: Anti-infectives retail pharmaceutical market share by country, 2006
Figure 42: Anti-infectives retail pharmaceutical market by country, 2003-2006
Figure 43: Musculo-skeletal retail pharmaceutical market, 2003-2006
Figure 44: Musculo-skeletal retail pharmaceutical market share by country, 2006
Figure 45: Musculo-skeletal retail pharmaceutical market by country, 2003-2006
Figure 46: Cytostatics retail pharmaceutical market, 2003-2006
Figure 47: Cytostatics retail pharmaceutical market share by country, 2006
Figure 48: Cytostatics retail pharmaceutical market by country, 2003-2006
Figure 49: Blockbuster drug sales share by drug type, 2006
Figure 50: Blockbuster drug sales share by lifecycle stage, 2006
Figure 51: Blockbuster drug sales share by therapy area, 2006
Figure 52: Blockbuster drug sales share by company, 2006
Figure 53: Major companies pharmaceutical sales, 2004-2006
Figure 54: Major companies revenue share allocation, 2006
Figure 55: Major companies revenue allocation, 2004-2006
Figure 56: Major companies pharmaceutical sales by location, 2006
Figure 57: Top 10 pharma companies pharmaceutical sales, 2004-2006
Figure 58: Top 10 pharma companies by global pharmaceutical sales, 2006
Figure 59: Top 10 biotechnology companies by global revenues, 2006
Figure 60: Top 10 pharma companies revenue share allocation, 2006
Figure 61: Top 10 pharma companies revenue allocation, 2004-2006
Figure 62: Key value drivers for top 10 pharma companies (income), 2006
Figure 63: Key value drivers for top 10 pharma companies (sales), 2006
Figure 64: Key value drivers for top 10 pharma companies (sales/ R&D), 2006
Figure 65: Pfizer therapy area sales, 2004-2006
Figure 66: GlaxoSmithKline therapy area sales, 2004-2006
Figure 67: Sanofi-Aventis blockbuster therapy area sales, 2004-2006
Figure 68: Roche therapy area sales, 2004-2006
Figure 69: AstraZeneca therapy area sales, 2004-2006
Figure 70: Novartis therapy area sales, 2004-2006
Figure 71: Johnson and Johnson blockbuster therapy area sales, 2004-2006
Figure 72: Merck & Co blockbuster therapy area sales, 2004-2006
Figure 73: Wyeth blockbuster therapy area sales, 2004-2006
Figure 74: Eli Lilly therapy area sales, 2004-2006
Figure 75: Global pharmaceutical market forecast, 2003-2011
Figure 76: Global pharmaceutical market forecast by regions, 2003-2010
Figure 77: Top 10 pharmaceutical drugs by forecast sales, 2011
Figure 78: Lipitor (atorvastatin) forecast sales, 2003-2011
Figure 79: Advair/ Seretide (fluticasone/ salmeterol) forecast sales, 2003-2011
Figure 80: Plavix (clopidogrel) forecast sales, 2003-2011
Figure 81: Norvasc (amlodipine) forecast sales, 2003-2011
Figure 82: Nexium (esomeprazole) forecast sales, 2003-2011
Figure 83: Enbrel (etanercept) forecast sales, 2003-2011
Figure 84: Remicade (infliximab) forecast sales, 2003-2011
Figure 85: Zyprexa (olanzapine) forecast sales, 2003-2011
Figure 86: Prevacid (lansoprazole) forecast sales, 2003-2011
Figure 87: Diovan/ Co-Diovan (valsartan/ hydrochlorothiazide) forecast sales, 2003-2011
LIST OF TABLES
Table 1: Global pharmaceutical market trends by region, 2004-2006
Table 2: US pharmaceutical market trends by purchasing channel, 2004-2006
Table 3: US retail pharmaceutical market trends by therapy area, 2003-2006
Table 4: Top 10 products trends by US pharmaceutical sales, 2004-2006
Table 5: European top 5 retail pharmaceutical market trends by country, 2004-2006
Table 6: European top 5 retail pharmaceutical market trends by therapy area, 2004-2006
Table 7: Japanese pharmaceutical market trends by therapy area, 2004-2006
Table 8: Top 10 product classes trends by global pharmaceutical sales, 2005-2006
Table 9: Global retail pharmaceutical market trends by therapy area, 2004-2006
Table 10: Cardiovascular retail pharmaceutical market trends by country, 2004-2006
Table 11: Cardiovascular blockbuster drug sales, 2004-2006
Table 12: Central nervous system retail pharmaceutical market trends by country, 2004-2006
Table 13: Central nervous system blockbuster drug sales, 2004-2006
Table 14: Alimentary/ metabolism retail pharmaceutical market trends by country, 2004-2006
Table 15: Alimentary/ metabolism blockbuster drug sales, 2004-2006
Table 16: Respiratory retail pharmaceutical market trends by country, 2004-2006
Table 17: Respiratory blockbuster drug sales, 2004-2006
Table 18: Anti-infectives retail pharmaceutical market trends by country, 2004-2006
Table 19: Anti-infectives blockbuster drug sales, 2004-2006
Table 20: Musculo-skeletal retail pharmaceutical market trends by country, 2004-2006
Table 21: Musculo-skeletal blockbuster drug sales, 2004-2006
Table 22: Cytostatics retail pharmaceutical market trends by country, 2004-2006
Table 23: Cytostatics blockbuster drug sales, 2004-2006
Table 24: Top 20 products by global pharmaceutical sales, 2004-2006
Table 25: Lipitor (atorvastatin) profile, 2006
Table 26: Advair/ Seretide (fluticasone/ salmeterol) profile, 2006
Table 27: Plavix (clopidogrel) profile, 2006
Table 28: Norvasc (amlodipine) profile, 2006
Table 29: Nexium (esomeprazole) profile, 2006
Table 30: Enbrel (etanercept) profile, 2006
Table 31: Remicade (infliximab) profile, 2006
Table 32: Zyprexa (olanzapine) profile, 2006
Table 33: Prevacid/ Zoton (lansoprazole) profile, 2006
Table 34: Diovan/ Co-Diovan/ Provas/ Miten (valsartan/ hydrochlorothiazide) profile, 2006
Table 35: Top 10 blockbuster products by global pharmaceutical sales growth, 2004-2006
Table 36: Top 10 blockbuster products by declining global pharmaceutical sales, 2004-2006
Table 37: New blockbuster products, 2004-2006
Table 38: Major companies revenue allocation trends, 2004-2006
Table 39: Top 10 pharma companies by global pharmaceutical sales, 2004-2006
Table 40: Top 10 biotechnology companies by global revenues, 2004-2006
Table 41: Top 10 pharma companies revenue allocation trends, 2004-2006
Table 42: Pfizer profile, 2006
Table 43: Pfizer blockbuster sales, 2004-2006
Table 44: GlaxoSmithKline profile, 2006
Table 45: GlaxoSmithKline blockbuster sales, 2004-2006
Table 46: Sanofi-Aventis profile, 2006
Table 47: Sanofi-Aventis blockbuster sales, 2004-2006
Table 48: Roche profile, 2006
Table 49: Roche blockbuster sales, 2004-2006
Table 50: AstraZeneca profile, 2006
Table 51: AstraZeneca blockbuster sales, 2004-2006
Table 52: Novartis profile, 2006
Table 53: Novartis blockbuster sales, 2004-2006
Table 54: Johnson and Johnson profile, 2006
Table 55: Johnson and Johnson blockbuster sales, 2004-2006
Table 56: Merck & Co profile, 2006
Table 57: Merck & Co blockbuster sales, 2004-2006
Table 58: Wyeth profile, 2006
Table 59: Wyeth blockbuster sales, 2004-2006
Table 60: Eli Lilly profile, 2006
Table 61: Eli Lilly blockbuster sales, 2004-2006
Table 62: Global pharmaceutical market forecast by regions, 2003-2011
Table 63: Global pharmaceutical market forecast by therapy area, 2006-2011
Table 64: Top 10 pharmaceutical drugs forecast, 2003-2011
Table 65: Top 10 pharmaceutical companies forecast, 2006-2011
Table 66: Top 100 products by global pharmaceutical sales, 2004-2006
Table 67: Top 62 companies by global pharmaceutical sales, 2004-2006 |
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What Obama means for pharma (In pharmacologist)
Following Barack Obama’s victory in the race to the White House, in-PharmaTechnologist.com examines what this could mean for the pharmaceutical industry.
Obama laid out his some of his policies that will affect the pharmaceutical industry in Science Debate 2008, which took place in August and September.
Stem cell research is an area in which a seismic shift should be seen when the new administration takes office, with Obama promising to overhaul George W Bush’s policy of restricting funding.
Obama said: “I believe that the restrictions that President Bush has placed on funding of human embryonic stem cell research have handcuffed our scientists and hindered our ability to compete with other nations.”
As well as lifting the ban Obama intends to establish a federally supported stem cell research programme. This forms part of a doubling of basic research budgets that Obama has said will occur over the next decade, with “increased support for high-risk, high-payoff research”.
Although these reforms all carry significance, the approach Obama takes to the US Food and Drug Administration (FDA) may shape his legacy to pharmaceutical manufacturers.
Concrete policies as to how the FDA is to be reformed are thin on the ground, with a lot resting on who Obama appoints as the agency’s Commissioner.
Obama has said that senior management positions where decisions rely on science and technology advice will be filled on a non-partisan basis by people: “with strong science and technology backgrounds and unquestioned reputations for integrity and objectivity.”
It is possible that Obama will make an appointment such as Steve Nissen or Bruce Psaty, who were outspoken on Avandia and Vioxx respectively, and usher in significant reforms at the FDA.
However, such reforms may upset more moderate stakeholders in the FDA, which could lead Obama to appoint a Commissioner more inclined to tweak than overhaul the agency.
Big pharma’s generic threat
An aspect of the FDA reforms will be to facilitate the more widespread use of generics, with Obama’s advisors saying the creation of an approval pathway for follow-on biologics is a top priority.
Early in the Democratic primaries Obama spoke out against pharmaceutical companies: “explicitly paying generic drug makers not to enter the market so they can preserve their monopolies and keep charging Americans exorbitant prices for brand name products.”
Obama’s has promised to put a stop to this practice and ensure that market power does not push up prices for consumers. This could potentially reduce the lifespan of a branded product, be it a biologic or small molecule.
Similarly, Obama is also looking to reform the patent application process, based on the belief that they are awarded too easily and that previous inventions are given insufficient attention during the approval process.
To counter this Obama proposes opening up the patent process to citizen review and creating a “gold-plated” patent, which would be less vulnerable to court challenge.
This proposal has been accused of being unfair because the more expensive and time consuming “gold-plated” approval process would favour large companies. However, this issue could be solved through the adoption of reduced fees for smaller companies.
The change we need?
Beyond these issues Obama has the prospect of reforming the healthcare system and laws governing direct-to-consumer advertising, both of which could have significant implications for pharma’s US operations.
However, implementing these changes could prove challenging despite the Democrats commanding majorities in the House and the Senate, as Bill Clinton discovered in 1994 when his healthcare plan was scuppered.
Obama campaigned with the slogan “one voice can change the world”; whether it can pass reforms remains to be seen.
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Demographic Trends Creating Opportunities for Inhaled Drug Delivery
Greystone Associates Analyzes Demand Drivers and Therapeutic Opportunities
Last update: 7:00 a.m. EDT Oct. 29, 2008NASHUA, NH, Oct 29, 2008 (MARKET WIRE via COMTEX) -- Faced with an aging patient population that is placing greater emphasis on compliance, less-frequent dosing, and ease-of-use, drug developers continue to examine inhalation as a potential drug delivery method. While the technology associated with pressurized metered dose inhalers (MDIs) has been evolving to address the replacement of CFC propellants and device 'proper use' issues, the design and development capabilities of this class of inhalation devices are fairly well dispersed among inhaled therapeutic sector participants.
For dry powder inhalers, with its reliance on particle engineering and dependence on deep lung inspiratory flow characteristics, the situation is quite different. With the exception of a handful of very large inhaled drug players with captive capabilities, there is a broad reliance on a core group of device developers and technology consultancies specializing in drug particle development and dry powder inhaler design.
Over the next four years, we expect the value of systemic drugs delivered via inhalation to increase at an average annual rate of thirty-three percent. During the same period, inhaled drugs for upper respiratory conditions including asthma, and COPD will increase at a rate of between eight and nine percent. Systemic inhaled drugs will represent just under nine percent of all inhaled drugs worldwide in 2011, up from less than five percent in 2007.
Significant developments over the next four years will include new dual drug inhalers that combine the actions of two distinct drug classes to treat upper respiratory diseases, and device designs that eliminate dosing errors related to differences attributable to patient usage factors. For systemic inhalation, we expect at least one approved drug to emerge for a number of new therapeutic indications that will represent first-in-class products for drug inhalation. Indications in this area include cardiovascular medicine, metabolic diseases, sexual health, neurology (other than migraine) and pain management.
Survey results are contained in a recently published report: Delivering Drugs by Inhalation. The report analyzes emerging inhalation drug products, market participants, and key demand and technology factors influencing the commercial market and shaping growth in this sector. |
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Basel (Oct. 21)—Novartis will acquire the pulmonary drug-delivery business unit of Nektar Therapeutics for $115 million in cash. Novartis will gain Nektar’s capabilities in product formulation, its delivery expertise, and a broad device platform. This transaction excludes Nektar's inhalation programs for insulin, vancomycin, ciprofloxacin and amikacin. Approximately 140 Nektar associates will join Novartis and remain in San Carlos, California. |
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