Biotech thinking is in. The Big Pharma mindset is out. And you only have to stroll through the halls of GlaxoSmithKline’s shrinking R&D ops to find telltale signs of the shift in development strategies.

The Wall Street Journal’s Jeanne Whalen took a tour and found no shortage of anecdotes about GSK’s move to break its research unit into small groups in order to develop that lean-and-mean biotech attitude needed to move through the clinic quickly. The British scientist Kevin Lee even had new gear made that was emblazoned with the logo of his biotech-like outfit. The gear and the name are intended to demonstrate “that we were biotech-like and not big-pharma-like.”

GSK’s strategy has been to chop 20 percent out of its R&D ops, refocus its drug development strategy and partner up more with outside developers who can help fan the flames of entrepreneurship at the big multinational. Just to ensure that no one forgets how serious this all is, the discovery performance units, or DPUs as they’re known inside the company, were given three-year plans back in 2008. And anyone who doesn’t perform could face the axe next year.

The 500 R&D staffers in Verona, Italy, knew earlier this year that they weren’t part of GSK’s plans, a victim of GSK CEO Andrew Witty’s decision to drop its work in certain areas of neuroscience. Today the company announced that it will sell its Italian R&D operation to Aptuit, which has its own ideas about energizing the R&D field.

“This partnership is an example of the developing new model of outsourced R&D collaborations,” said Tim Tyson, Aptuit’s chairman and chief executive.

Source: FierceBiotech

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The 10-year-old Human Genome Project has only just begun to bring to fruition its promise to transform medicine, its founders said on Thursday.

Francis Collins, who led the U.S. component of the project and is now director of the U.S. National Institutes of Health, said that although it may seem that the revolution promised with the publication of the first draft in 2000 is slow in coming, many early predictions had been prematurely hyped.

Scientists have barely scratched below the surface of the possibilities opened up by having access to the whole human gene map, he said, and when they do, their results will determine the way all people are diagnosed and treated for diseases.

“It’s fair to say that most people have not yet had the experience of having their personal medical care directly affected by the sequencing of the human genome,” Francis told a briefing in London marking the project’s 10-year anniversary.

“So while one might argue that the consequences have not come across in the first 10 years in the most dramatic form that some predictors put forward in the year 2000, I think the predictions … were probably a bit overblown.”

“TRULY TRANSFORMATIVE”

Mike Stratton, another of the project’s founders and now director of Britain’s influential Sanger Institute, pointed to several areas of disease where big medical advances had already come about thanks to the ability to read the map of human life.

Cancer drugs, like so-called BRAF inhibitors for malignant melanoma skin cancers — versions of which are being developed by drugmakers including Switzerland’s Roche and Britain’s GlaxoSmithKline — were examples how quickly gene sequencing had given birth to targeted treatments, he said.

“It has taken (only) eight years for a drug to be developed … then to be put into clinical trials and to be shown to work,” he said. “And it works in a cancer that was otherwise untreatable. That’s an illustration of what is possible.”

The genome founders also noted that scientists had already found more than 800 genetic variants that play a role in risks of common illnesses like heart disease, cancers and diabetes.

“Those are shining new light into the way those diseases come about, with implications for both prevention and (drug) therapies,” said Collins.

The scientists’ comments were echoed in the drug industry, where Glaxo’s chief executive Andrew Witty said that reaping the benefits of genome research was always going to be a long haul.

“The great mistake everybody made was thinking that the decoding of the genome would somehow yield a drug. It’s got nothing to do with yielding a drug — it’s got everything to do with yielding a whole array of components and ways of looking at a problem which, together with other things, will yield drugs. It’s going to take time,” he told reporters earlier this week.

But Collins said he had no doubt the project would live up to its potential:

“When a truly transformative advance occurs in science, inevitably there will be in the short term an overly optimistic set of predictions,” he said. “But in the long term…the consequences will turn out to have been underestimated. I think that will…be true of the Human Genome Project.

“I think we will see in the next 10 or 20 years a virtual revolution in medicine — in prevention, in the choice of the right drug for the right person at the right time, and in the development of entirely new drugs.”

Source: Reuters

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GlaxoSmithKline CEO Andrew Witty has taken over at the European Federation of Pharmaceutical Industries and Associations, and he’s already calling for change. In his first speech as federation chief, Witty set out a to-do list for European governments. First on the list: Get your pricing act together. Next: Work together to assess new medications, rather than duplicating efforts–and contradicting one another.

Witty said that European countries need to look at the big picture when setting drug prices. “If they take a narrow focus … in 10 years’ time they will discover there are not any new drugs being developed,” Witty said. We’ve heard that song before, but Witty offered a new twist, saying that the industry needs to do its part by participating in a “balanced dialogue” about drug prices. Companies shouldn’t run off when price cuts are threatened, as Novo Nordisk did in Greece. “Industry needs to find ways to stay at the table,” he said.

But the biggest change Witty advocated was pan-European co-operation when deciding whether drugs are a good value. Instead of looking at effectiveness country by country–think the National Institute for Health and Clinical excellence in the U.K., and similar groups in Germany and France–the European Medicines Agency could play a larger role. That way, the “rational evidence-based relative efficacy or effectiveness discussion” would happen only once in Europe, “rather than having it 27 times and potentially answered 27 different ways,” he said.

Source: FiercePharma

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Novartis is beefing up its generic division Sandoz with the purchase of U.S.-based Oriel Therapeutics. The deal brings a pipeline of copycat respiratory meds, a welcome addition after the high-profile failure of one asthma-and-COPD project it had going under a partnership with Vectura Group. And it includes an electronic inhaler that may win FDA clearance more easily than the Vectura device could, Reuters says.

Although Novartis wouldn’t put a dollar figure on the deal, it says Oriel investors would get milestone payments as new products get regulatory approvals. Analysts say Novartis, wary after the Vectura trouble, probably structured this deal differently. ”[W]e reckon that the deal is going to be strongly back end loaded, hence a low upfront payment, some milestone upon filing and approval and then royalties,” Bank Vontobel analyst Andrew Weiss tells the Wall Street Journal.

Sandoz is putting lots of emphasis on respiratory drugs these days. “One of our strategic objectives is to offer fully substitutable generic versions of key branded medicines, including respiratory medicines,” Sandoz division chief Jeff George says in a statement. And there are plenty of respiratory drugs to be knocked off over the next few years; half of the $32 billion market is going off patent by 2016, the company says.

But inhaled drugs can be a minefield, because it’s not just the drug itself that needs an FDA approval, but the drug-delivery device as well. That’s the reason that GlaxoSmithKline CEO Andrew Witty says he’s not too worried about generic competition for Advair, the company’s leading asthma and COPD medication. As if to prove Witty right, the drug candidate Sandoz handed back to Vectura was widely believed to be an Advair copycat, Reuters reports.

Source: FiercePharma

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More Indian news from GlaxoSmithKline. CEO Andrew Witty is traveling this week in India, meeting with reporters along the way, and that’s put GSK in the headlines almost daily. Witty’s been talking deals (he’s in favor of them) and drug prices (they have to be flexible) and strategy (grow via deals and organically in poor and middle-income countries).

Now, Witty tells the local Economic Times that he has a long, long time line for his India strategy. After all, he’s seen the country evolve over the last 10 years–he ran India operations around 2000. “This conversation is not about the next quarter but it is about the next 10 or 20 years,” he explains.

Second, he’s not interested in selling generics in the U.S. or Europe. If GSK were to buy a company that has an American generics division, “We will sell it.” He’s more interested in the complete opposite: Branded drugs in emerging markets.

Third, one of the ways he’s planning to make price cuts a reality in India is by cutting the production cost of those products. The company will drive down production costs in part via alliances with local firms, he said, and by driving internal efficiencies. Doing that won’t just enable flexible pricing in India, but allow GSK to export those low-production-cost drugs. Maybe even back home to the U.S. and Europe.

Source: FiercePharma

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GlaxoSmithKline has cut prices to boost sales in the poorest countries on the globe. Now it’s homing in on middle-income countries as another way to grow its revenues. And the company’s strategy in these nations mirrors its approach in the poorer ones: Make medicines more affordable, improve access to them, and higher sales will come.

“Our strategy is to grow our business in middle-income countries by increasing the volume of products we sell,” CEO Andrew Witty tells Bloomberg.

GSK is part of the Big Pharma parade into Asia and other emerging markets. Faced with the prospect of more generic competition and tougher pricing policies, drugmakers have been looking past the slow-growth U.S. and Europe. GSK’s revenue from emerging markets grew by 20 percent in 2009 to about $4.5 billion, and the company is looking for more growth this year.

So, GSK is using flexible pricing models to make drugs more affordable; because middle-income countries have a wide range of socioeconomic groups, the pricing models will allow for different prices in different settings. “[E]conomic status, demography and healthcare infrastructure … can vary significantly,” Witty says. “Taking a single pricing approach would be difficult, inappropriate and inequitable.”

Source: FiercePharma

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Growth in Asia, growth via acquistion, growth via acquisition in Asia: Drugmakers promised investors all these strategies over the weekend. Here’s who plans to use which approach:

• Eli Lilly said it expects its Japanese revenues to grow in the “mid teens” percentage-wise in 2010, the chief of its Japanese unit said today. That’s on top of 19 percent growth in 2009, Bloomberg reports, which put Lilly’s Japanese sales at 109 billion yen for the year, or $1.2 billion.

• Traveling in India, GlaxoSmithKline CEO Andrew Witty pledged to continue expansion in that country via acquistions and organic growth. Speaking on the sidelines of a company event in Nashik, Witty told reporters that India is a crucial market for the company. “[Acquisition] opportunities will be evaluated based on a variety of factors, including the strategic nature of the fit,” he said (as quoted by the Wall Street Journal).

• Fresh off his deal to buy the biotech-equipment company Millipore, Merck KGaA CEO Karl-Ludwig Kley tells a German newspaper that more acquisitions are on the way. “We have indeed a few ideas,” he says. “Acquisitions are part of our strategy … And so it should continue.”

Obviously, these companies aren’t unique; almost everybody in pharma is either looking to buy or be bought these days, and the list of companies targeting Japan for growth gets longer by the day.

Source: FiercePharma

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Fueled by windfall profits from swine flu vaccine sales, GlaxoSmithKline reported a big spike in revenue for the fourth quarter. But the extra money hasn’t stopped the pharma giant from sharpening its budget-cutting axe once again. Glaxo executives this morning outlined an additional 500 million pounds ($791.6 million) of budget cuts as it scales back on R&D.

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Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer’s, Parkinson’s and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.

“We are allocating capital to areas where we can get the best return on investment,” the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company’s workforce that would amount to the “hundreds rather than thousands” in the U.K.

“In addition to our existing discovery effort, alternative opportunities need to be explored to make treatments available for rare diseases,” says Marc Dunoyer, GSK’s president of Asia Pacific and chairman of Japan, who will head the new rare diseases unit. “This complementary approach will combine our existing global expertise with specialist partners. Over time, this new unit has the potential to deliver multiple therapies responding to high medical needs of underserved populations of patients.”

Source: FierceBiotech

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GlaxoSmithKline CEO Andrew Witty swung by Health Blog HQ this week. Given all the M&A action in the industry in the past year (Pfizer-Wyeth & Merck-Schering Plough, to name a few biggies), we asked him about GSK’s acquisition strategy.

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“We’re not in the market for traditional, large-scale, premium acquisitions,” he said.

He didn’t focus on the pipeline drugs or growing franchises that acquirers often cite. Instead, he waded into the ramifications of making a big acquisition at a moment when many segments of the industry are contracting.

“People are buying companies and taking costs down,” he said. “You’re paying a 30% or 35% premium to have the opportunity to fire people.”

Instead, he’s looking for “bolt-on acquisitions” — under $5 billion — that add to growing businesses such as vaccines or consumer products, or to key emerging markets. And even those have to be at a the right price; the company walked away from a few deals in the second quarter of last year, because they were too expensive.

Source: The Wall Street Journal

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Pharmaceutical company GlaxoSmithKline (GSK) is to reveal previously confidential data on thousands of potential anti-malaria compounds.

In addition to this, the company is to pump millions into an ‘Open Lab’ for independent research teams.

The company has 13,500 molecules which have been tested against the parasite which causes malaria.

One expert said more sharing of data could trigger advances like those that came from the human genome project.

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The way in which pharmaceutical firms guard the secrets of their drugs and research has long been cited as an obstacle to disease research.

The latest announcement by GSK chief executive Andrew Witty, follows an earlier decision to set up a “patent pool” where information about patented drugs could be shared.

In a speech in New York, he said that it was important to “earn the trust” of society.

“The measures we have announced today are characterised by a determination to be more flexible, open and willing to learn.

“GSK has the capability to make a difference and a genuine appetite to change the landscape of healthcare for the world’s poorest people.”

Millions scanned

The data in question is the result of a year’s effort by GSK scientists to study a disease which still claims almost a million lives a year, mainly in sub-Saharan Africa.

The company holds a “library” of millions of different molecules, and each of these was tested against the Plasmodium falciparum parasite which causes malaria.

The result was 13,500 which appeared to have an effect on it, although extensive further research would be needed to narrow down this list into those most likely to succeed as new drugs.

Dr Timothy Wells, Chief Scientific Officer of the Medicines for Malaria Venture, which has worked with GSK on the project, said it had the potential to “dramatically alter” the way the world approached malaria research.

“By sharing the data, the research community can start to build up a public repository of knowledge that should be as powerful as the human genome databases and could set a new trend to revolutionise the urgent search for new medicines to tackle malaria.”

Dr Mallika Kaviratne, from the Malaria Consortium, a not-for-profit organisation, said it could boost access to medicines for developing countries, as resistance to existing drugs was an important issue.

She added: “The release of 13,500 molecules made to the public is very important – we have nothing else in the pipeline – and new drugs need to be developed, but they’re expensive.”

Professor Peter Winstanley, from the Liverpool School of Hygiene and Tropical Medicine, said that the decision was a “step in the right direction”.

He said: “It looks like the chief executive has said: ‘What’s the sense of sitting on 13,500 molecules which perhaps have antimalarial properties when other people might be more interested in them than we are?’.

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“How, while there’s a slight possibility that we may have new drugs from this in the next five years, it is more likely to happen over the next 10 to 20 years, and that will take a lot of work, some luck, and a lot of money.”

Source: BBC NEWS

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