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hugbu
Geregistreerd op: 21 Jan 2010
Berichten: 16
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 Geplaatst: 01-02-2010 21:21:15 Onderwerp: Biotech algemeen |
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Hou Pharming, Ablynx, Thrombogenics en Galapagos in het oog de komende weken :
Big drug groups urged to buy in test products
By Andrew Jack in London
Published: January 31 2010 22:46 | Last updated: January 31 2010 22:46
Large pharmaceutical groups should abandon their own early stage drug development and switch to less costly licensing from biotech companies, according to a new analysis.
Shifting from developing chemical-based drugs from scratch in-house to purchasing experimental products from smaller rivals would boost success rates, lower costs and triple returns, says the report from analysts at Morgan Stanley.
The study is the latest assessment of an industry trend to “externalisation” in large pharmaceutical groups driven by limits on their internal capacity to innovate. This is leading to a greater focus on later-stage development, regulatory approval and marketing of medicines.
The trend was highlighted by AstraZeneca’s decision to cut research and development costs by $1bn over the next four years and cut thousands of jobs as it switches more effort to externally generated experimental drugs.
The report highlights the spiralling difficulties of developing medicines, with high failure rates pushing up the cost of each drug that reaches market from an estimated $150m a decade ago to up to $2bn today.
Most large groups have in-licensed a growing proportion of their pipelines in recognition of the fact that they only have the capacity to work on a fraction of all significant science in any therapy area.
But they resist axing early-stage in-house drug research entirely, arguing that they need the expertise to assess the potential of projects developed by others.
The Morgan Stanley study says large companies should in-license experimental drugs once they have reached mid-stage phase 2 clinical trials in humans, by which time the data allow far greater understanding of safety and efficacy.
It estimates large companies spend more than a third of their total research and development studying prospective drugs at earlier stages, which still have a very high probability of failure.
Only 1 in 10,000 drugs yet to be tested in humans make it to market and only one in 10 in early, phase 1, trials, rising to 20 per cent in phase 2 and 50 per cent in late-stage phase 3 trials.
GlaxoSmithKline said that Andrew Witty, its chief executive, had pledged early after his appointment in 2008 to ensure he achieved the maximum returns from research and development, and had accelerated in-licensing of experiment medicines as well as partnerships with academic institutions and a review board to scrutinise projects.
.Copyright The Financial Times Limited 2010. |
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hugbu
Geregistreerd op: 21 Jan 2010
Berichten: 16
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| Geplaatst: 04-02-2010 22:48:49 Onderwerp: |
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Laat maar komen :
Pfizer to chop up to $3B from R&D budget
February 4, 2010 — 9:14am ET | By John Carroll
Signaling that Pfizer's "monolithic" approach to drug R&D is over, CEO Jeffrey Kindler laid out plans to carve $3 billion out of the newly merged company's budget for R&D as the pharma giant shifts away from its traditional reliance on in-house projects and opens itself more to partnerships and collaboration.
Pfizer has been an industry leader when it comes to R&D spending, but like many of its Big Pharma brethren the company has had little to boast of despite all its high-price efforts. In 2008 Wyeth and Pfizer spent a combined $11 billion on research. By 2012, though, the merged company plans to whittle that figure back to $8 billion to $8.5 billion.
"The days of a monolithic approach to either research or commercialization are behind us," Kindler told investors. And Pfizer executives outlined a total of $7 billion in savings that it plans to make in the near future.
Pfizer's plans to significantly scale back R&D spending comes as GlaxoSmithKline, AstraZeneca, Sanofi-Aventis, Bristol-Myers Squibb and others are also rethinking how to go about the enormously expensive task of discovering and advancing new therapies to the marketplace. A number of consultants have been hammering away at the Big Pharma R&D empires, saying that the companies' investments have never paid off properly. And more and more experts say that the big marketing groups would be better off partnering with smaller discoverers who are more nimble and efficient at early-stage work.
Read more: http://www.fiercebiotech.com/story/pfizer-chop-3b-r-d-budget/2010-02-04#ixzz0ebdGehYH |
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hugbu
Geregistreerd op: 21 Jan 2010
Berichten: 16
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| Geplaatst: 06-02-2010 18:06:32 Onderwerp: |
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Pharma Is at Pains to Replace Blockbusters: Has It Found the Cure?
Published: February 03, 2010 in Knowledge@Wharton
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%increaseover 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." |
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hugbu
Geregistreerd op: 21 Jan 2010
Berichten: 16
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| Geplaatst: 02-03-2010 23:46:40 Onderwerp: |
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Speciaal voor de TIGGERS :
('t is maar om te zeggen dat er nog andere biotechs bestaan)
De parels van de Belgische Biotech.
(en ja, TIG wordt vermeld)
Uit De Tijd van 20 februari.
www.mediargus.be/ng/p...tion=. |
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