• Cells coaxed to produce insulin in diabetes breakthrough
  
• GSK, Valeant ink $820M epilepsy deal
  
• Sanofi-Aventis scores positive data in Multaq trial
  
• Sir Chris prescribes £500M for UK biotech industry
  
• Economy catches up with biotech investing
  
• NexMed tanks after Novartis stalls on fungus drug
• Fish oil beats Crestor for heart failure
• Clinical Trials Update

Cells coaxed to produce insulin in diabetes breakthrough
A team of scientists at the Harvard Stem Cell Institute have reprogrammed normal pancreas cells into insulin-producing cells. The team injected proteins into the cells to activate genes, flipping a switch on their genetic transformation. After 10 days the cells were able to help regulate blood sugar. And the scientists say the same approach could work across a range of diseases.

"We were able to flip the cell from one state into another," Doug Melton said, adding that the approach should be useful in treating disorders in "any case where there's a cell type missing and there are neighboring cells that are still healthy."

- read the report from the Los Angeles Times

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GSK, Valeant ink $820M epilepsy deal
Valeant Pharmaceuticals will pocket a $125 million upfront fee from GlaxoSmithKline in exchange for a collaboration deal on the epilepsy drugretigabine. Altogether the pact could be worth up to $820 million if the drug achieves all of its milestones. Valeant retains up to half of the profits from any sales in the U.S. and several other countries. Glaxo also gains the rights to VRX698 and the other back-up compounds from the potassium channel opener discovery program.

Retigabine has already completed two Phase III trials and is in a study for post-herpetic neuralgia, a painful complication of shingles. The developers say they will file for European approval in early 2009.
"There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications," commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. "We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK's portfolio."

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Sanofi-Aventis scores positive data in Multaq trial
The experimental heart drug Multaq, being developed by Sanofi-Aventis, reduced the risk of stroke by a third among elderly patients suffering from atrial fibrillation. The trial pitted Multaq against a placebo.

"These are extraordinarily impressive trial results," said John Cam, professor of clinical cardiology, at St George's Hospital Medical School. "No other anti-arrhythmic drug has had a positive outcome of this nature in atrial fibrillation. The 34 per cent reduction in relative risk of stroke is amazing for a drug that is not an anti-coagulant."

Researchers say that the positive effect of the drug was seen early in the study and was maintained during the 12 to 30-month follow-up. That data helps underscore the drug's potential, with analysts estimating future revenue from an approved product at around $2 billion a year. The trial involved 4,628 patients over the age of 70.

- read the report from the Telegraph

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Sir Chris prescribes £500M for UK biotech industry
Noted UK biotech investor Sir Christopher Evans has analyzed what ailsthe country's development business and has come up with a cure. Comparing Great Britain's recent success in the Olympics with past failure, he says that a major investment made all the difference. And he's suggesting that the government join with private investors to inject £500 million pounds into biotech companies in the UK.

"People always ask why haven't we got an Amgen or a Genentech when we have brilliant science," says the investor. "There's a lot of reasons for this. There isn't enough world-class management, or enough ability to commercialize drugs. You have a lot of good scientists and academics who can't run a company. Also, if you're any good, you tend to get bought quickly. With these funds, industry experts would be able to direct cash to the right places. This would also encourage underperforming small companies to consolidate. The government has to underpin the consolidation fund because it was responsible for lots of start-ups and it's many of these start-ups that now have to consolidate."

read the article from The Times

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Economy catches up with biotech investing
Early in 2008, life science investment was on a roll. It seemed as though the industry wouldn't be bothered by many problems affecting the rest of the economy, and that it was a safe haven compared to other more volatile markets. But Robert Dellenbach at Genetic Engineering News observes that the poor economy has caught up with the industry.

"Despite an abundance of funding as well as scientific and technological progress, the environment for investing in the life science industry seems to have changed dramatically," said Dellenbach.

In the last quarter of 2007 and the first quarter of 2008, life sciences enjoyed a record level of investment. But by the second quarter of this year, there were only 215 investments totaling $1.9 billion; that's compared to 315 investments totaling $3 billion in the first quarter. For the biotech industry, the numbers are even worse. "The number of biotechnology venture backings fell by nearly 50 percent, and the dollar amount invested fell by more than 40 percent from the first quarter...Outside the U.S., the venture financing value fell nearly 50 percent in the same period." On top of that, the IPO market is downright bleak…. no VC-backed IPOs in the second quarter.

According to Dellenbach, three factors are having a negative impact on the level of life science investment:

• Biotech is notoriously risky and investors may be waiting for a better economy.
• Drug development investments are longer-term than medical device and other healthcare ventures. Investors looking for a quicker return are drawn to these options.
• The emergence of clean and green tech investment opportunities have given VCs an alternative to biotech investment.

Because of the long-term nature of life science investments, the industry should be somewhat insulated from the current economic downturn. But increased caution on the part of life science VCs is causing them to wait for a better time to invest.

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NexMed tanks after Novartis stalls on fungus drug
Shares of NexMed tanked after the company announced late Tuesday that Novartis would not be submitting an NDA for their partnered nail fungus therapy "at this time." According to NexMed, Novartis was persuaded to pull back after considering the results of late-stage studies. NexMed's stock quickly nosedived, losing 96 cents--or a little more than 70 percent of its value.

Novartis took control of the development program for NM100060 back in 2005 after paying $4 million as an upfront fee and agreeing to up to $47 million in milestone payments. But NexMed hasn't given up on the program.

"While this is disappointing," said Vivian Liu, NexMed's president and CEO, "a European comparator study is still ongoing, and those results are expected mid-2009."

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Fish oil beats Crestor for heart failure
The biggest news out of the European Society of Cardiology meeting may be the formal presentation of the SEAS study, which rocked the market when Schering-Plough released preliminary data on an an increase ….. experts have debated ever since. But there's plenty of other significant developments, too. Here's a roundup:

• A prescription fish oil pill--sold by GlaxoSmithKline in the U.S. as Lovaza and in Europe as Omacor--benefited heart-failure patients, cutting their risk of death and their hospital admissions, a 7,000-patient trial found.
• In the same trial, 4,600 heart-failure patients assigned to take a low dose of AstraZeneca's Crestor didn't get any benefits compared with placebo.
• Using Merck's antiplatelet drug Aggrastat in patients with a certain type of heart attack--in addition to the standard combo of aspirin, heparin, and clopidogrel--improves results of angioplasty procedures.
• Eli Lilly and Daiichi Sankyo's new blood thinner prasugrel appears to work better in diabetic patients than the common anti-clotting med Plavix does, according to new analysis of the Triton clinical trial. As you know, however, prasugrel's FDA approval has been delayed n findings of serious bleeding.
• A Boston Scientific-sponsored study found that bypass surgery works better in the long run than stents did, proving to end in fewer deaths within one year of the surgery and preventing repeat procedures. But the surgery patients had a 2 percent risk of stroke, versus zero in the angioplasty patients.

There's sure to be more heart-related pharma news as the week rolls on; the meeting continues through tomorrow.
- see the fish oil news at CNN Money
- get more from the Guardian

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Clinical Trials Update

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