From Center for market intelligence
Pharmaceuticals & Biotechnology
Feature Reports
Pfizer Seeks Boost from Copying Biotechnology Drugs
Bloomberg, December 9, 2009
Pfizer Inc., which became the biggest drugmaker selling widely prescribed pills such as the Lipitor heart medicine, is preparing to enter the business of making cheaper copies of pricey, injectable drugs from biotechnology. The company may sell its first copies of medicines like Amgen Inc.’s anemia therapy Epogen or Sanofi-Aventis SA’s blood thinner Lovenox in four to five years, and eventually market 10 to 15 such drugs, said David Simmons, head of Pfizer’s Established Products Business Unit. Pfizer also may ally with or buy companies that possess the technology as part of a strategy that’s still being completed, Simmons said. Pfizer’s $68 billion Wyeth acquisition, completed in October, expanded its ability to make biologic drugs, injectable treatments made in living cells. Health-overhaul legislation, now being debated in Congress, would create the first U.S. regulatory process to copy biotech drugs, opening a market worth $10 billion in the next decade, according to Ronny Gal, a Sanford C. Bernstein analyst in New York. "While the market is young and nascent in its development, it’s going to be big," Simmons said in a telephone interview. Pfizer still needs to complete its plans and appropriate internal funding to take advantage, he said.
Big Pharma's Crime Spree
Bloomberg Markets, December 2009
Pfizer and Lilly lead a parade of U.S. companies that have paid $7 billion in penalties after promoting drugs for uses not approved by the FDA.
Pharma 2020: Taxing Times Ahead
PricewaterhouseCoopers, December 2009
The fifth paper in the PwC Pharma 2020 series, this report discusses the major tax repercussions of the political, economic, scientific and social trends currently shaping the commercial environment, together with the evolution of more collaborative models. It focuses on the challenges ahead but also shows how companies can adapt their tax planning to support the provision of outcomes-based healthcare and remain competitive.
Are You Ready for the Revolution?
Pharmaceutical Executive, October 2009
Each year, IMS Health, a provider of healthcare information and business consulting, surveys the landscape to uncover developments with the biggest potential bottom line impact on the biopharmaceutical industry. These seven Harbingers of Change should be considered in every pharma company's plans for addressing the business and reputational environment in 2010. Of the issues identified, reimbursement challenges in emerging markets dominate the list, with potentially game-changing initiatives underway in Korea and China, and also—surprisingly—in Japan. Each of these can be said to draw inspiration from precedents in other markets, so the value of thinking globally while executing locally is a theme worth teasing out from the mix. This year's list also underscores the search for new business models, evidenced by trends around new therapeutic formulations to serve lower income patients in developing countries, revival of the OTC segment, and the restructuring of in-house R&D operations. In summary, the list shows how "globalized" business risks have become. Big Pharma now lives in a glass house with many doors.
For Profit, Industry Seeks Cancer Drugs
New York Times, September 1, 2009
Pfizer’s fortunes in the past were built on cardiovascular drugs, like the cholesterol buster Lipitor and the blood pressure pill Norvasc. But the future of Pfizer, the world’s largest pharmaceutical company, may rest in a cluster of buildings on a bluff not far from the Pacific Ocean. It is here that Pfizer has amassed about 1,000 researchers for an all-out effort to develop drugs for cancer, a disease the company once largely ignored. Virtually every large pharmaceutical company seems to have discovered cancer, and a substantial portion of the smaller biotechnology companies are focused on it as well. Together, the companies are pouring billions of dollars into developing cancer drugs.
Industry Audit 2009
Pharmaceutical Executive, September 2009
The Eighth Annual Industry Audit analyzes the 2007–2008 performance of 27 publicly traded companies that file 10-K or 20-F reports on an annual basis with the US Securities and Exchange Commission. As in past years, the audit includes a wider array of performance metrics than found in the standard financial and accounting statements. Drawing on this larger set of sources allows for a more meaningful picture of performance, analyzing such key metrics as enterprise value in proportion to sales—a mission-critical driver of future prospects that focuses on profitability growth through product and process innovation. In addition to the 10-K and 20-F reports, the audit relies on proprietary and non-proprietary databases, as well as a broad array of secondary sources ranging from the business press to investor reports.
America' Most Medicated States
Forbes, August 17, 2009
Much of the American South is ailing, with West Virginia the worst off--at least, if the rate of prescription drug use is any indication. The state filled 17.7 prescriptions per capita compared to a national average of 11.5, according to Verispan, a health care information company. Dr. Jane Barlow, vice president of medical strategy and clinical quality for Medco Health Solutions, one of the nation's largest pharmacy benefit manager, says there's a reason these states use more medication: Their rates of heart disease, obesity and diabetes are higher than the national average, particularly in West Virginia.
The Next Blockbuster Drugs
Newsweek, July 22, 2009
The top 10 medical conditions, sales estimates for the leading drugs, and the up-and-coming biotech-based candidates.
Costly Drugs Known as Biologics Prompt Exclusivity Debate
New York Times, July 21, 2009
A bitter Congressional fight over the cost of superexpensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition? But what few people in Washington seem to recognize — or publicly acknowledge, anyway — is that this magic number may ultimately not matter as much as the most vitriolic debaters insist.
Questions Swirl Around Avastin
Forbes, June 3, 2009
Cancer researchers are beginning to ask why Roche's very expensive and very lucrative drug Avastin is not providing bigger survival gains for cancer patients. Avastin aims to starve tumors by cutting off their blood supply. It was the biggest prize in Roche's $47 billion deal earlier this year to purchase the 40% of Genentech it did not already own. But on average, Avastin only increases patients' life spans by a couple months. The big sales are partly a result of the high cost--up to $55,000 per patient--and the fact that many people are treated so only a few can benefit. In breast cancer, the drug hasn't extended patients' lives at all in several studies.
2008 Pharm Exec Top 50
Pharmaceutical Executive, June 2009
The world’s top 50 pharmaceutical companies accounted for prescription drug sales of $558 billion in 2008. Though a few more companies dipped into negative growth than last year, more than half of the list achieved double-digit growth, a sign that although recession eventually hits even pharma, it usually hits later than in many other industries.
Is The FDA Easing Up?
Forbes, May 7, 2009
How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.
HIV Deal Shows Need for New Pharmaceutical Models
Reuters, April 16, 2009
The pharmaceutical industry is going back to the lab for its business models as it faces historic challenges. Large drugmakers are experimenting with various collaborations as their major products face revenue declines, research productivity stalls, and governments and health insurers crack down on drug prices and healthcare costs. The new ventures -- from deals on products to mega mergers -- seek to meet these challenges by cutting costs and mitigating the risks of research into new treatments.
One Pill Might Prevent Heart Disease
U.S. News & World Report, March 30, 2009
Create a single pill that contains a statin, three blood pressure drugs and aspirin, and you have an inexpensive medication that can reduce the risk of heart attack, stroke and other cardiovascular problems. Or so researchers hope. A first trial of the polypill (which already has a brand name, Polycap), has been successful, according to a report that was to be presented at the American College of Cardiology annual meeting in Orlando, Fla., and online in The Lancet.
The Drug Mergers' Harsh Side Effects
BusinessWeek, March 23 and 30, 2009
The future of a pharmaceutical company rides on its pipeline—the roster of drugs it hopes to get out of labs and into pharmacies before its previous round of medicines loses earning power. But the recent wave of pharma mergers doesn't bode well for that replacement process. The one part of a drugmaker's operation that never seems to do well in a megamerger is research and development.
The Profit Pill
Forbes, March 23, 2009
When Gilead Sciences started testing the AIDS drug Viread 12 years ago, it didn't look like a potential blockbuster. The drug wasn't a medical breakthrough, and Gilead would be taking on the world's most powerful drug companies in a crowded market. Today Viread is taken by eight out of 10 newly diagnosed AIDS patients, usually as part of two combo pills that Gilead sells.
Attack of the Monster Merger
Pharmaceutical Executive, March 2009
What will Pfizer do? That question has been asked almost daily by Wall Street and the business media since late 2006, when then-new CEO Jeffrey B. Kindler announced the death of torcetrapib, the company's would-be savior. The No. 1 pharmaceutical company with the best-selling drug in history—and the steepest patent cliff—has come to symbolize the "crisis" of the drug industry and its bankrupt blockbuster model. Could this drug colossus fail? Just go under, like a glacier into the sea? Or like Lehman Brothers, GM, the state of California.
A Push to Spell Out a Drug’s Risks and Benefits
New York Times, February 25, 2009
What if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbs and calories of an Oreo cookie? Inspired by the nutrition fact panels on food packaging, researchers at the Dartmouth Medical School are urging federal regulators to adopt a similar concept — numerical tables that quantify the benefits of taking a drug compared with a placebo, and that list the odds of having side effects. These drug fact boxes or benefit boxes, as the Dartmouth team calls them, would appear on magazine advertisements for drugs as well as on the Food and Drug Administration’s Web site, if the researchers have their way.
Pharma 2020: Marketing the Future
PricewaterhouseCoopers, February 2009
The third paper in the PwC Pharma 2020 series, this report explores how the industry's approach to sales and marketing will change as it moves towards providing products and services to improve the health of patients.
Brand of the Year: Crestor
Pharmaceutical Executive, February 2009
For the third annual Brand of the Year, Pharmaceutical Executive is honoring AstraZeneca's Crestor (rosuvastatin) -- a selection that struck some as eccentric. After all, Crestor is not a medical breakthrough, first in class, or even new. Cynics asked if its recent success is anything more than a marketing marvel. Crestor's sales are a marvel -— and something of a mystery. Since generic simvastatin (Zocor) hit in 2006, it has wreaked havoc on the $34 billion cholesterol market, long a leading engine of the blockbuster economy. Copycats immediately crushed sales of Zocor with a 97 percent switch rate in the first 12 months, according to Datamonitor. Sales of Pfizer's Lipitor -— the fattest pharma cash cow ever -— plunged 20 percent from Q1 2005 to Q2 quarter 2008. Crestor, alone among branded statins, has made gains—big ones. According to the drugmaker, in 2005, the superstatin recorded $1.2 billion in global sales; in 2006, $2.1 billion; in 2007, $2.8 billion; and in 2008, an estimated $3.5 billion.
Medicare Widens Drugs It Accepts for Cancer
New York Times, January 26, 2009
Medicare, with little public debate, has expanded its coverage of drugs for cancer treatments not approved by the Food and Drug Administration. Cancer doctors had clamored for the changes, saying that some of these treatments, known as off-label uses, were essential if patients were to receive the most up-to-date care. But for many such uses there is scant clinical evidence that the drugs are effective, despite costing as much as $10,000 a month. Because the drugs may represent a patient’s last hope, though, doctors are often willing to try them. The new Medicare rules are the latest twist in a protracted debate over federal spending on off-label drugs — drugs prescribed for uses other than those for which they have been specifically approved.
Drug Making’s Move Abroad Stirs Concerns
New York Times, January 19, 2009
Experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States. "The lack of regulation around outsourcing is a blind spot that leaves room for supply disruptions, counterfeit medicines, even bioterrorism," said Senator Sherrod Brown, Democrat of Ohio, who has held hearings on the issue. Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the Food and Drug Administration in 2007, only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India. Some of these medicines are lifesaving, and health care in the United States depends on them. Half of all Americans take a prescription medicine every day.
Researchers Report Progress in Fight Against Fat
Washington Post, January 6, 2009
Researchers are reporting in two new studies that they seem to be moving closer to the holy grail of new treatments for obesity. In one study, scientists managed to coax the brains of obese mice to process a hormone called leptin that helps control appetite. "It's very exciting, because leptin was being talked about as a dead end, that it will never work," said study co-author Dr. Umut Ozcan, assistant professor at Harvard Medical School. In the other study, researchers gained new insight into a genetic trait that's linked to leanness in skinnier people but seems to make the obese pack on extra weight. Both studies were published in the Jan. 7 issue of the journal Cell Metabolism.
Deep Brain Stimulation Helps Those with Advanced Parkinson's
U.S. News & World Report, January 6, 2009
The largest study of its kind finds that deep brain stimulation improves both physical function and quality of life after six months in patients with Parkinson's disease. Deep brain stimulation (DBS) performed better than currently available drug treatments, but it did carry some risks, including one death, according to a study in the Jan. 7 issue of the Journal of the American Medical Association.
No Mug? Drug Makers Cut Out Goodies for Doctors
New York Times, December 30, 2008
Starting Jan. 1, the pharmaceutical industry has agreed to a voluntary moratorium on the kind of branded goodies — Viagra pens, Zoloft soap dispensers, Lipitor mugs — that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs. Some skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians. But proponents welcome it as a step toward ending the barrage of drug brands and logos that surround, and may subliminally influence, doctors and patients.
Winds of Change
The Economist, December 13, 2008
Dick Clark is no stranger to hard times. The chairman of Merck got the top job after a safety scandal caused Vioxx, the firm’s blockbuster painkiller, to be pulled from the market in 2004. The soft-spoken Mr. Clark has won praise for his handling of that crisis and for being quicker than his rivals to start restructuring his firm in preparation for leaner years. He was also appointed head of Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s lobbying arm. But Mr. Clark is not celebrating.
Vaccines Get New Scrutiny
U.S. News & World Report, December 11, 2008
The battle cries both defending and attacking vaccines have risen in recent years along with the number of immunizations children face: 38 shots against 15 diseases before kindergarten, compared with 11 shots against eight diseases 15 years ago. There's no question that vaccines have been lifesaving: If every American child followed the recommended schedule, some 33,000 lives would be saved, 14 million infections prevented, and $10 billion slashed from healthcare costs every year, according to the Centers for Disease Control and Prevention. But plenty of parents are unconvinced by the public-health mission, given other data—also from the CDC—showing that about 30,000 "adverse events" are reported every year by doctors and patients, of which 3,000 to 4,500 are serious enough to cause hospitalization, life-threatening illness, or even death. While the CDC's associate director for immunization safety, John Iskander, insists that "vaccines are extraordinarily safe medical products," he also acknowledges that the "trade-off between risks and benefits can be very difficult for parents."
Survey Documents Popularity of Alternative Treatments
Washington Post, December 10, 2008
More than one-third of U.S. adults and nearly 12 percent of children use alternatives to traditional medicine, according to a large federal survey released that documents how entrenched acupuncture, herbal remedies and other once-exotic therapies have become.
Merck Bets on Generic Biotech in Strategic Shift
Reuters, December 9, 2008
Merck & Co plans to break into biotechnology medicine, including a major push into the developing market for generic biotech, as it confronts challenges to its product line. The move into generic biologics marks a significant shift for the drugmaker into territory primarily targeted by generic companies, and underscores the growth hurdles Merck faces.
British Balance Benefit vs. Cost of Latest Drugs
New York Times, December 2, 2008
When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. If the Hardys lived in the United States or just about any European country other than Britain, Mr. Hardy would most likely get the drug, although he might have to pay part of the cost. A clinical trial showed that the pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000. But at that price, Mr. Hardy’s life is not worth prolonging, according to a British government agency, the National Institute for Health and Clinical Excellence. The institute, known as NICE, has decided that Britain, except in rare cases, can afford only £15,000, or about $22,750, to save six months of a citizen’s life.
Care to Compare?
Hospitals & Health Networks, December 2008
A national program to identify which medical devices, drugs and treatments are most effective would be massive and costly. Can we afford not to do it? If the term "comparative effectiveness research," doesn’t grab you, consider this: Proponents say that if put into practice, this type of research could help to bring the nation’s health care spending under control and improve quality at the same time. At its most fundamental, the idea is simple: Compare medical treatments, devices and drugs to find out which is most effective for particular conditions. Providers, payers and patients could use the findings to pick treatment options. But that’s the only simple thing about it.
Views on Prescription Drugs and the Pharmaceutical Industry
Kaiser Family Foundation, April 2008
Prescription drugs play a role in the daily life of more than half of all Americans, and most agree that these medications have had a positive impact on their life. Over half (54%) of adults say they currently take prescription medicine and one in five (19%) say they take four or more medications a day. On the whole, a majority of Americans agree that prescription drugs developed in the past 20 years have improved the lives of people in the US in general (73%) as well as their own and their family members’ lives (63%). Although the public has a positive impression of the value of prescription drugs to society on the whole, they have much more mixed views of pharmaceutical companies themselves. While a plurality (47%) of adults have a favorable impression of pharmaceutical companies overall, a significant minority (44%) say their impression of these companies is unfavorable.
Pharmaceutical Industry Profile 2008
Pharmaceutical Research and Manufacturers of America (PhRMA), March 2008
This annual report details the industry's R&D process, the fight against chronic diseases, and its growing role in the nation's health care system. The appendix includes a membership roster, membership survey, and definition of terms.
Pharma 2020: The Vision -- Which Path Will You Take?
PricewaterhouseCoopers, June 2007
By 2020 the pharmaceutical market is anticipated to more than double to US$1.3 trillion, with the E7 countries — Brazil, China, India, Indonesia, Mexico, Russia and Turkey — accounting around for one fifth of global pharmaceutical sales. Further, incidence of chronic conditions in the developing world will increasingly resemble those of the developed world. But Pharma 2020: The vision - which path will you take? indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.
Web Resources
News Sites & Portals
Pharmaceutical Business Review
Industry news and feature articles, as well as abstracts of research report, with full-text available for purchase.
Pharmaceutical Executive
This monthly magazine covers industry issues such as product development and management, marketing, and regulatory affairs.
IPT Online
An archive of published papers from Innovations in Pharmaceutical Technology and her sister journal Innovations in Clinical Trials.
Pharmaceutical Technology
Covers applied research and development, scale-up, and manufacturing technologies for the pharmaceutical industry.
Pharmafocus
Industry news and analysis from the U.K.
Associations & Organizations
Pharmaceutical Research and Manufacturers of America (PhRMA)
Represents the country's leading research-based pharmaceutical and biotechnology companies.
American Pharmacists Association (APhA)
APhA provides professional information and education for pharmacists and acts as an advocate for improved health of the American public through the provision of comprehensive pharmaceutical care.
American Association of Pharmaceutical Scientists (AAPS)
A professional, scientific society of more than 12,000 members employed in academia, industry, government, and other research institutes worldwide. The AAPS Journal and AAPS PharmSciTech are Open Access publications and are freely accessible on the Web.
U.S. Pharmacopoeia (USP)
USP establishes standards to ensure the quality of medicines for human and veterinary use. It also issues information about the appropriate use of medicines.
Drug Information Association (DIA)
The DIA’s goal is to provide a neutral forum for the exchange and dissemination of information on medicines and related healthcare technologies. Its website includes access to the Association’s publications, news, event information, and more. Some sections of this site require paid membership.
European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA members comprise 29 national pharmaceutical industry associations and 43 leading pharmaceutical companies involved in the research, development, and manufacturing of medicinal products in Europe for human use.
European Directorate for the Quality of Medicines (EDQM)
EDQM is responsible for issuing the European Pharmacopoeia, a collection of standardized specifications that define the quality of pharmaceutical preparations.
Canada's Research-Based Pharmaceutical Companies (Rx&D)
Representing employees of Canadian pharmaceutical companies, this organization helps in the discovery of new medicines. Its website includes backgrounders, annual industry reviews, special reports, and information for patients.
Association of the British Pharmaceutical Industry (ABPI)
The trade association for about a hundred companies in the U.K. producing prescription medicines. The site includes industry statistics and association publications.
Japan Pharmaceutical Manufacturers Association (JPMA)
JPMA represents more than 70 research-based pharmaceutical manufacturers. The site includes industry statistics and association publications.
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
A non-profit, non-governmental organization representing national industry associations and companies from both developed and developing countries. Member companies of the IFPMA are research-based pharmaceutical, biotech, and vaccine companies.
National Pharmaceutical Council (NPC)
The NPC sponsors and conducts analyses of the appropriate use of pharmaceuticals. More than 20 research-based pharmaceutical companies are members of the Council.
