Drug Development

FDA approval drought despite surge in apps

John Carroll — Tue, 26 Aug 2008 11:09:11 -0400

The long drought of FDA approvals for new molecular entities is occurring despite some big efforts by drug developers to push through new drugs. In a new study examining NME approvals for 2007, Parexel noted that approvals scraped the bottom of the record books at 16. But applications jumped 33 percent last year. Approvals of therapies with a new active substance (an NAS), declined 19 percent last year, while applications jumped from 21 to 28.

"NME and NAS approvals are key measures of new drug productivity in the biopharmaceutical industry, and these measures tend to improve based on the volume of new drug submissions," said Mark Mathieu, Parexel's director of publications and editor of The US Drug Approval Trends and Yearbook 2008/2009. "The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use."

- here's Paraxel's release
- check out the report from the Boston Globe

Pharma giants to collaborate on new discovery tech

John Carroll — Thu, 10 Jul 2008 11:27:36 -0400

Three of the biggest pharma companies on the planet are joining forces to back an unusual venture aimed at developing "breakthrough" discovery technology that can reduce the frequency of trial failures and save them huge amounts of money. Eli Lilly, Merck and Pfizer--which often compete on new therapies--are joining forces with PureTech Ventures to provide $39 million to finance the launch of Enlight Biosciences. Enlight in turn plans to spin off new companies if the technology looks promising enough. Some of the new technologies the collaboration will explore include finding ways to deliver drugs across the blood-brain barrier and new biomarkers.

"Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind," Enlight co-founder Raju Kucherlapati, a genetics professor at Harvard Medical School, told the Wall Street Journal.

"The biopharmaceutical industry has a great need for innovative enabling technologies that will catalyze fundamental transformation of the drug discovery and development process. A collaborative entrepreneurial initiative such as Enlight that is dedicated to such technological innovation in R&D meets that need in an ideal way. We are excited about our partnership with Enlight and its team of world-renowned scientists," said Dr. Steven Paul, the executive vice president, science and technology, at Eli Lilly.

- see this release
- read the article from the Wall Street Journal

GSK looks to gov. agencies for R&D advice

John Carroll — Mon, 07 Jul 2008 10:08:29 -0400

GlaxoSmithKline's newly appointed CEO Andrew Witty has seen the future of drug development, and government healthcare systems will play an even bigger role in it. In an interview with the Wall Street Journal, Witty says that the pharma giant will give government agencies around the world--which pay the lion's share of the drug tab--a bigger voice in deciding which new therapies are advanced in the pipeline. As biopharma giants struggle to win approval for a new generation of therapies at enormous cost, they're showing a rising desire to get regulators' input on their development programs at an earlier stage. Novartis, for example, altered a late-stage trial of an experimental medication to give British regulators more data on cost efficiency. And Glaxo shows every sign of following the same essential path.

"I'm going to deal with the pharmaceutical realities of the next 10 years, and they're very different from those of the 1990s," Witty told the WSJ.

- check out the Wall Street Journal article

Think tank: Industry plays key role in drug dev.

John Carroll — Wed, 25 Jun 2008 10:17:28 -0400

A conservative think tank is riding to the rescue of the drug development industry, insisting that a new study disproves the old argument that drug companies are simply gathering huge windfalls on new drugs without offering any really innovative input into the development process. After examining the fate of 32 drugs, the Manhattan Institute for Public Policy concludes that without the private sector's work the drug research projects funded by the government would have languished, unable to get to the market.

"All or almost all the drugs discussed...would not have been developed or, at best, would have been delayed significantly in the absence of private sector scientific discoveries," says the report.

- read the report from the San Diego Union-Tribune

Expert forecasts revolution in drug dev. work

John Carroll — Fri, 20 Jun 2008 07:14:19 -0400

In the not too distant future drug development work will be revolutionized by new computer technology that will "test" experimental therapies on virtual humans, says a new report from PricewaterhouseCoopers. The new computer-based human model will be instantly adapted to represent every disease, says Steve Arlington. And the cost of drug discovery can be cut by as much as two thirds.

That sort of brave new world would engineer a profound change for drug developers, who take years and hundreds of millions of dollars to advance a drug--often finding out in late-stage trials that they don't work as expected. It's also the kind of model that better suits an approaching age of personalized medicine, when a new generation of therapies will be developed that are more narrowly designed to address disease.

"We are not suggesting that drugs be trialed before they are ready but by 2020 we should be living in an environment where technology will allow doctors and patients to do this," says Arlington. Another sensible way to change the approval process, he says, would be to allow regulators to approve a drug for use in small populations and then expand its use as more data becomes available.

- read the article from The Times

Deloitte sees 'fundamental shift' in drug dev. strategies

Tue, 13 May 2008 06:59:58 -0400

Deloitte sees a major shakeup going on in clinical research strategies at the large pharma companies. Instead of focusing on the development of a small portfolio of blockbuster meds, pharma pipelines are shifting to create a host of new therapies that will have higher efficacy in smaller groups--the genotype-basing approach that's been so much discussed in biotechnology. By targeting smaller populations with promises of greater efficacy, says the accounting firm, the pharma industry can still rely on bigger per-treatment revenues.

The shakeup in R&D strategies is coming after the industry marks only mixed results from outsourcing and other efforts aimed at improving efficiency. And it marks a period of high stress for the companies, as they transition from blockbusters to targeted meds. A "fundamental shift in the industry's operating environment is under way."

- check out the report from Seeking Alpha

FDA badly needs more money, staff

Fri, 30 Nov 2007 06:59:54 -0500

It seems that hardly a week goes by without reports of problems at the FDA. And this week is no exception. According to a subcommittee of the Science Board, an independent advisory group, a number of problems plague the FDA. Imports, food inspection, drug manufacturing, and drug development systems within the FDA all need to be overhauled, according to the group's findings. The agency is stretched too thin and it's endangering public health.

"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public," the Science Board was quoted as saying in the Washington Post. "This will damage not only the health of the population of the U.S., but also the health of our economy." The panel recommended modernizing the FDA's computer systems, increasing the agency's funding and increasing participation of scientific leaders. Andrew Von Eschenbach requested the evaluation a year ago.

This year the FDA has endured serious criticism for a number of blunders, including drug safety, food inspection and pet food contamination. It's clearly under-staffed and under-funded, and these issues are likely to continue and worsen if the necessary changes aren't made.

- see this Washington Post article

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A new 'religion' at Schering-Plough

Mon, 26 Nov 2007 06:59:59 -0500

Sometimes the most obvious suggestions for improving drug development work are the hardest to anticipate. My initial knee-jerk response to reading the story on Schering-Plough's approach to drug development included a reflexive kick against getting manufacturing and marketing reps into the R&D discussion early on. Too premature, I thought. What promising new therapies get sidetracked because they don't meet the right marketing criteria?

But the criticism won't stand up to reflection. By getting the manufacturing and marketing people engaged early on, they have a much better chance of understanding the complexities of a new therapy long before it's in their hands. We demand more insight from drug companies at every turn, not less. And the new 'religion' at Schering-Plough has clearly turned out to be a winner--a new model for other biopharma companies to watch closely as they try to develop their own winning approach to pipeline development.

Perhaps the boldest approach to drug discovery includes a willingness to set old prejudices aside. Outdated prejudices have helped create a discovery system that consumes far too much time and money. We need rethink the drug development model. - John Carroll

R&D spending going gangbusters in China

Thu, 15 Nov 2007 06:59:56 -0500

Everything drug related is going gangbusters in China. Last year, China grabbed $2.2 billion of the global action on drug R&D. By 2010, the country expects that to grow to $10 billion, two percent of the planet's total R&D budget. Time dissects the numbers for us, listing AstraZeneca, Novartis, Eli Lilly and GlaxoSmithKline among the leaders in the pharma world who are blueprinting some ambitious expansion plans. It's clear to see what's attracting the drug giants: Lower research costs, expert scientific help and a massive population suffering from the kind of big ailments that can spawn blockbuster therapies. It's also a growing market in its own right. China bought $13.6 billion in pharmaceuticals last year--and that's expected to double by 2010. Natch.

- check out the article from Time

Related Articles:
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Beleaguered Viragen liquidates assets

Wed, 24 Oct 2007 06:59:54 -0400

Everyone knows that the biotech drug development process is a gamble. Small developers spend years and tens if not hundreds of millions of dollars trying to bring drugs to market. The lucky ones will sign rich licensing deals, be gobbled up by a big pharma or, less likely, go public and successfully market their products.

Sweden-based Viragen is one of the unlucky ones. After spending 25 years and almost $200 million, the drug developer is liquidating its assets. The company's only approved drug is Multiferon, first-line treatment for malignant melanoma that it was never able to get approved in the States. Viragen explored the use of multiferon for SARS and avian flu--particularly when those diseases were making headlines--but was ultimately unsuccessful. And after posting huge losses, the company can no longer stay afloat. You win some, you lose some: such is the risk of the biotech industry.

- take a look at this South Florida Business Journal report
- see the release on the bankruptcy of Viragen's subsidiary

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FDA, Big Pharma team up on drug research center

Thu, 18 Oct 2007 06:59:56 -0400

In all the hoopla over the new FDA funding-and-reform legislation last month, a key provision was eclipsed--the creation of a new research center paid for by drug makers. The Reagan-Udall Foundation is designed to streamline and improve drug development. But as the Associated Press notes, a research collaboration yoking pharma with the FDA creates an entirely new form of regulator-regulatee relationship--one that might get drugs to market more quickly and more cheaply, but even less safely.

The FDA is fast-tracking nominations to the new center's board, with members slated to be named by October 27. Four of the fourteen members are expected to be pharma executives.

- check out the FDA release seeking nominations for the board
- read the AP's take on the foundation

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Read more on: FDA news

ALSO NOTED: Galapagos gains development grants;Aastrom to sell stock; and much more...

Tue, 16 Oct 2007 06:59:50 -0400

> Galapagos has garnered €5.2 million in grant money to continue its drug development work. Release

> Aastrom Biosciences is raises $13.5 million in a stock offering. Release

> Chutes & Ladders: Fresh from raising $35 million from a Series B of venture capital, Metastatix has named Carol Gallagher as its new president and CEO. Release (.pdf)

> BioSynthema has inked a deal to use Covidien technology to develop a new, targeted radionuclide therapy product. Release

> Boston Scientific is poised to join its healthcare colleagues in laying off thousands of workers. Report

> Last week, the buzz about GlaxoSmithKline's CEO-presumptive Andrew Witty included worries that his internal competitors for the top slot would jump ship. Now Glaxo may sweeten the pot for those also-rans--by putting them on the board of directors. Report

> Here's Exhibit Z in the long list of reasons why Big Pharma wants to make deals with biotech--and why speculation about Biogen and Genzyme is running so high. Roche and Genentech are both reaping a big harvest from their joint cancer drugs this quarter. Report

> Low doses of a human antibody in mice were effective in repairing damaged myelin, a protective shield for nerves that is destroyed by multiple sclerosis. Report

And Finally... Who is most likely to buy Biogen Idec? Poll

The growing power of biotech

Mon, 15 Oct 2007 06:59:59 -0400

Biogen Idec appears to be ready to demonstrate the ever-growing market power of biologics. The report late Friday that the company is exploring its options as Carl Icahn appears anxious to expand his footprint in biotechnology may well demonstrate how much a successful biotech company is worth. The bidding would appear to start at $23 billion in this case. And if Wall Street deal makers can get some big pharma companies to join in the bidding, that could end up looking cheap.

It's all good for biotech. As yet another biotech pulled its IPO last week, it's clear that the big money in the field will come from individuals and corporations who understand the value of these new therapeutics. It's also another indication that biotechnology is maturing as an industry. Buyouts at this level demonstrate just how high the stakes can be in drug development. - John Carroll

Roche won't budge on $3 billion Ventana offer

Thu, 11 Oct 2007 06:59:57 -0400

Hubris can take you a long way in any business, and Roche CEO Franz Humer has plenty to spare. He's been telling the Financial Times that hedge funds have moved in to acquire shares of Ventana, the diagnostic test maker that Roche has firmly set its sights on as it builds up its diagnostics division into a global powerhouse. That's driven up Ventana shares to $85, well past Roche's $75 bid. But Humer has no plans to boost his $3 billion bid, saying that Roche will win out in the end. In an interesting side note, Humer added that he's cooled toward India as questions over IP protection have been raised in recent months. That puts China in the lead as a comer in drug development circles.

- here's the report from the Wall Street Journal

ALSO: Ventana, meanwhile, is sticking to its knitting. The company says it will work with the Critical Path Initiative in Arizona to develop standards and an evaluation process for companion diagnostics. Report

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Read more on: Roche | Diagnostics

China surges past India in drug discovery work

Tue, 09 Oct 2007 06:59:56 -0400

China's willingness to get aggressive in protecting biopharma's intellectual property is being credited with its surge past India in the total number of completed and ongoing clinical trials. An Indian court's ruling against Novartis on Gleevec is helping accelerate a trend away from the subcontinent. There's no sign that India's generic drug industry is flagging, though, with homegrown companies aggressively going after new markets--including biosimilars. We may be seeing a trend here that will take China forward as a new base for drug discovery work based on high quality and low costs while India sees generics grow ever stronger.

- here's the research from Seeking Alpha

ALSO: China's generics industry is gearing up for an onslaught on the U.S. market. Report

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Pfizer tops the charts in global R&D spending

Mon, 08 Oct 2007 06:59:56 -0400

It hasn't had a lot to show for it so far, but Pfizer became the world's number one spender on research and development last year, grabbing the top spot from Ford. The list, assembled by the European Commission, looks at the top 50 research budgets on the planet. Biopharma companies ramped up spending big time last year, according to the EU, overtaking technology hardware and equipment makers. Much of that money was poured into programs designed to introduce a new generation of blockbusters as the current top products face a looming loss of patent protection. Merck, for example, increased R&D spending by 24 percent. Pfizer has been regularly held up to criticism that it has been notoriously ineffective in beefing up its pipeline--with the torcetrapib fiasco used as a prime example of its shortcomings. That helped lead the company to announce a major new initiative last week to launch a biotech center in South San Francisco that will be responsible for advancing critical new products--an announcement that left analysts buzzing for days.

- see the EU's press release
- check out the AP report for more info

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Bill could improve funding for small biotechs

Fri, 05 Oct 2007 06:59:55 -0400

In a victory for small biotech, the U.S. House passed a bill that allows small companies to be eligible for federal small-business programs even if they're majority-owned by VC firms. Biotechs can often go for a decade or more before marketing a product, and they rely on investment from VC firms to keep the company going through the early stages of drug development. However, by the time a biotech has a marketed drug, VCs can own a large chunk. This means that the small company isn't eligible for Small Business Innovation Research (SBIR) awards.

The new legislation will lift current restrictions, giving small biotechs access to SBIR awards as long as VC firms own less than half of the company. "Private investment in small business is a good thing and should be encouraged, not discouraged," said Rep. Sam Graves (R-MO), the bill's co-sponsor. However, among other concerns, critics say opening up SBIR awards to more established companies will make competition harder for small start-ups.

- read the Baltimore Business Journal article

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APT lands $22M in first round

Thu, 04 Oct 2007 06:59:55 -0400

Burlingame, CA-based APT Pharmaceuticals has landed $22 million in series A-2 financing. New investors Versant Ventures and Great Point Partners joined existing firms Vivo Ventures and Charter Life Sciences in the round. The money will help APT advance its development pipeline which includes Pulminiq, a Phase III drug for prevention of lung transplant rejection, a novel cardioprotectant and several other projects. The company is focused on finding treatments for significant unmet medical needs.

"APT has all the makings of a premier drug development firm with its experienced and respected team and their keen sense for clinical unmet needs that address sound market segments," said Camille Samuels of Versant Ventures. "APT has a strong, capital-efficient business model encompassing a robust therapeutic drug development strategy," added Samuels.

- check out APT's release

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Roche halts Phase I trial

Fri, 21 Sep 2007 06:59:55 -0400

Roche has halted a trial of MAXY-alpha, also known as R7025, due to an unanticipated reduction of the pharmacodynamic and pharmacokinetic effects in patients who received the drug. Roche and development partner Maxygen are conducting Phase I trials of R7025 for Hepatitis C and Hepatitis B.

"We don't yet know how this will impact the future timing or advancement of the program. Roche has now started additional work to assess the meaning and significance of these results. We will provide an update once all relevant information is collected and evaluated," said Russell Howard, Maxygen's CEO. Back in March Roche opted out of another co-development deal with Maxygen for acute bleeding indications.

- see this release from Maxygen

Wyeth's reports strong Phase III bazedoxifene data

Thu, 20 Sep 2007 06:59:56 -0400

At the American Society for Bone and Mineral Research Annual Meeting, Wyeth presented strong Phase III data for its osteoporosis drug. Bazedoxifene 20 mg and 40 mg significantly reduced the risk of new vertebral fractures by 42 percent and 37 percent, respectively, in a three-year study. Bazedoxifene has already been submitted to the FDA and is awaiting final approval. Earlier this year, Wyeth received an FDA approvable letter for bazedoxifene for the prevention of postmenopausal osteoporosis. In July 2007, Wyeth submitted a separate new drug application to the FDA for bazedoxifene for the treatment of postmenopausal osteoporosis. This new data comes as much-needed good news for Wyeth, which has struggled with its drug development programs as of late.

- see Wyeth's release for more on bazedoxifene

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