The pharmaceutical industry long ago farmed out much of its human resources, information technology and marketing work. But the research and development (R&D) at the heart of the business remained largely untouched. While other departments shrank, in-house scientists continued as they always had, staring into their microscopes and poring over data in the hunt for the next Lipitor or Prozac.
That is beginning to change.
As the industry comes to grips with the expiration of about $130 billion in patented products over the next four years, its executives can no longer bank on a single drug like Lipitor to drive earnings. Instead, they are aiming to diversify their drug portfolios, hoping to develop products for far less than the $800 million-plus figure often cited as the price of bringing a new drug to market.
"There's a recognition that current models have a lower rate of return than they used to," says David Blumberg, principal and advisory sector leader for KPMG's pharmaceutical industry practice in Philadelphia. Firms are stepping up the pace of smaller acquisitions and licensing deals, outsourcing more R&D work and creating programs to develop so-called "orphan drugs," products that help relatively small numbers of patients.
The biotech industry raised a record $55.8 billion in 2009, an 86% increase over 2008, according to San Francisco investment firm Burrill & Co. Licensing deals -- in which a pharma company pays money for the rights to market a certain compound developed by another firm -- drove much of that jump.
The last few months alone have seen a rush of partnership announcements. In December, Pfizer licensed the worldwide rights to a treatment for Gaucher's disease, a rare genetic enzyme deficiency, from Protalix Biotherapeutics, an Israeli biotech company, for around $60 million. The news caught the attention of the entire industry because it meant the world's largest drugmaker was considering drug candidates that might help just thousands of people at a time -- rather than the millions that were typically targeted under the old blockbuster model.
In January, Swiss drugmaker Roche outsourced some of its drug discovery work to Belgian biotech company Galapagos. Under the deal, Galapagos could get as much as $573 million for applying its discovery technology to identify drugs to fight chronic obstructive pulmonary disease (COPD). At the time, Galapagos CEO Onno van de Stolpe told investors that he was confident big pharmaceutical companies would send more work his way. "We are really in a sweet spot for the pharmaceutical industry [in that] we are providing them exactly what [they are looking for] with regard to discovery research," he said.
Sharing Secrets
Among the more radical experiments, according to industry analysts, is Eli Lilly's decision to allow outside contractors to test the company's promising molecules. For much of the last decade, big drug firms have let outside companies or university scientists conduct clinical trials and do some research. But letting them screen molecules at early stages means sharing company secrets -- a highly unusual strategy for the cautious pharmaceutical industry.
Lilly is not the only company making such moves. GlaxoSmithKline has decided to let its smaller biotech partners do more of its early-stage development work, and it has taken the additional step of mimicking the biotech-venture capital model. Glaxo scientists now must pitch their ideas to panels of company executives and outside industry experts to win funding for new projects. Meanwhile, Swiss drugmaker Novartis AG has jettisoned the old model of pursuing drugs that could fight "big market" diseases, such as Alzheimer's or cancer, in favor of ailments where the science is well understood, improving the chances of finding a treatment that works.
The hope in these new strategies is that by refocusing on the science, instead of on marketing, companies will once again start churning out effective drugs. It's a huge gamble, but pharma firms have little choice."All of this is very different, very unusual," Blumberg notes. "When outsourcing first started popping up in all industries, one of the general maxims was that you don't outsource what's strategic, what's core to your very being.... These guys are outsourcing what look like significant aspects of research and development."
Large pharmaceutical companies will need to analyze outsourced R&D relationships differently than they do other functions -- like information technology -- that other firms have taken on for them, Blumberg adds. "There is a level of risk that feels different and bigger." In the old R&D model, a single scientist or small team may have taken a drug from initial discovery through clinical trials to product launch. Those employees are very invested in getting their idea to work. The downside is that they may not be able to let go of an idea that didn't work early enough. But the upside is that they are passionate and committed, and they understand, for example, that a mistake in data could cost the company millions. Outside researchers, who could have many different clients, may not care as much, Blumberg notes.
"These relationships have to be carefully thought through and navigated to be successful," he says. "You can't just dump everything on an outsourcing partner. You have to create the right incentives. If they're just incented to get the job done on time, does quality suffer? If they are just incented on cost, do time and quality suffer?"
New Organization Models
According to Wharton management professor Larry Hrebiniak, the cultural and organizational issues in creating new partnerships can prove almost as difficult as the science. "What makes it difficult is that you're dealing with very educated people -- research scientists who want to be left alone -- and it's impossible to try to bureaucratize or commoditize innovation, to develop rules," he says. "You can run into trouble. The outside partner may just start doing its own thing and not fit with your organization's strategic needs. You want to somehow have your people working with their people, but you need to give them all some autonomy."
Investing in or doing licensing deals with other companies also requires skills that pharmaceutical firms may not have honed, he adds. Cisco, for example, has become famous for its disciplined approach to acquisitions, which focus on understanding which new technologies are likely to pay off. In order to have success in these ventures, "you have to focus on due diligence," Hrebiniak says. "You must find appropriate partners -- solid candidates for acquisition or joint ventures. You must have an absorptive capacity, which is the ability of a company to discover, understand and integrate new technologies that are out there." Some pharma firms have proven they can do this well: Last year, in a move that appeared strategically sound, Roche agreed to acquire 44% of San Francisco biotech Genentech, consummating a partnership between the two companies that had resulted in Roche's three top-selling drugs, the cancer medicines Avastin, Herceptin and Rituxan.
Generally speaking, however, big pharma companies seem to be playing "follow the leader" too much, says Wharton management professor Saikat Chaudhuri, whose work focuses on mergers and acquisitions. "They don't do a good job of portfolio management. They tend to all go after the same things. They tend to be conservative and place their [M&A] bets on [a narrow range] of drugs."
But now big pharma has little choice but to try, Hrebiniak notes. "Competitive pressures in the industry are quite high." Large drug companies simply can't afford to keep spending as much as they are now, when about 10 % to 20% of revenue goes to R&D, he says. Smaller companies are eager for partnerships, too, he adds. Because of the financial crisis, going public is generally not an option for raising capital. "They need cash. They're looking for help, so there's a motivation on the small-firm side to seek cash and relationships with big pharma."
Unsure Science
For large pharma firms, patent expirations aren't the only major problem. The industry's fortunes have changed from the heady days of the 1990s and early 2000s for many reasons, says Patricia Danzon, a Wharton professor of health care management. Many of the drugs that swelled bottom lines in earlier decades treated diseases that affected millions of people. High cholesterol, for example, is almost a rite of passage for anyone entering middle-age -- one reason Lipitor and other drugs that fight it are immensely popular. Similarly, depression has been called the "common cold" of mental illnesses, so there was a huge market for Prozac, Zoloft, Cymbalta and other treatments.
Today, there is an overwhelming need for drugs to treat Alzheimer's disease, but the ailment itself is poorly understood. Scientists don't even know whether Alzheimer's is one disease or many, increasing the difficulty of developing treatments. Cancer, another common illness, also is likely not one disease but many, making a blockbuster cancer drug unlikely. In the wake of scandals over such products as Vioxx -- a Cox-2 inhibitor recalled by Merck & Co. in 2004 after studies indicated the drug was associated with increased risk of stroke and heart attack -- the American public also has grown less tolerant of risk, one reason that the U.S. Food and Drug Administration now approves only about 20 drugs yearly.
"There is the reality that the low-hanging fruit has been picked, that there are a lot of good drugs already on the market to treat the diseases that we know how to treat, so something new has to be superior to the existing drugs," Danzon notes.
Partnering with a smaller company by investing in it or through a licensing agreement can give the larger firm a window into promising technology, says Wharton marketing professor Jagmohan S. Raju. "If you're an investor with $5 million in an early-stage company and ... have someone sitting on the board, you could move earlier than your competitors on a promising development because you would know that much more about it," he says.
Daniel Hoffman, a pharmaceutical consultant in the Philadelphia area, is skeptical that any of the more popular strategies will generate the kinds of revenues the industry is about to lose. Many of these solutions come with their own problems, he says. Pursuing orphan drugs has become all the rage because Novartis took Gleevec, initially developed to treat a rare blood cancer, and found it treated six other life-threatening diseases. Gleevec now generates about $3.7 billion in yearly sales, and some industry executives hope to duplicate that kind of success with their orphan drugs. But that won't be easy. Even if companies can identify broader uses for treatments of relatively rare diseases, they may face political backlash over the drugs' costs, because orphan drugs are generally very expensive to develop and manufacture.
"Is this a means of generating the kinds of revenue for which the sun is setting on a Lipitor or Plavix?" Hoffman asks. "I tend to doubt it. It's questionable whether the scientific paradigm of medicinal chemistry that has resulted in huge successes in areas like cardiovascular drugs can be as productive in the future."
COMMENTARY: I can only offer crocodile tears for these evil, and mostly profit motivated companies, that cried foul over the Obama administrations goal to reform health care.
Last year, I had did some research for a startup with a patent pending antimicrobial agent, and discovered that just in antibiotic drugs alone, Big Pharma will lose over $40 billion in revenues, as numerous patents begin to expire.
Generic drug makers worldwide are positioning themselves to produce generic versions of many of those antibiotic and other drugs as those patents expire.
I actually don't have a lot of pity for Big Pharma, and have taken numerous pot shots at the pharmaceutical industry, because they spend billions through their Washington lobbies to stop legislation that will in any way reform their money-making machine.
Big Pharma has a lot of explaining to do. For instance, why do prescription drugs in other foreign countries cost 30%-50% less than they do in the U.S.? If you have travelled internationally, you know this is true. Also, many drugs that you can only buy through a doctor's prescription can be readily purchased over-the-counter.
So ask me if I care that Big Pharma stands to lose $130 billion due to expiring drug patents.
Courtesy of an article dated February 3, 2010 appearing in KnowledgeAtWharton
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