Archive for the 'Drug Trials' Category

Milestones Mitigate Risk in Biotech Deals

Milestone payments are becoming an increasingly familiar aspect of many biotech deals, as buyers try to mitigate the risks inherent with big purchases. Take Celgene’s $2.9 billion buyout of Abraxis; the biotech giant set aside $650 million in milestone payments if Abraxis’ key drug Abraxane hit certain goals. “These structures are a great way for buyer and seller to share the risk that’s related to drug development,” says analyst Brett Skolnik. Milestones also encourage buyer and seller to look beyond the merger, making it more likely the deal will be beneficial to both sides in the long term.

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Fastest Growing Therapeutic Classes (by Sales)

Oncologics, lipid regulators, respiratory agents, antidiabetics and anti-ulcerants are the five largest drug classes by sales. But annual sales are only half the story. Which drug classes are booming, and which have plateaued–or even dropped? IMS Health has released top-line industry data revealing the 15 largest drug classes, and we’ve crunched the numbers to take a closer look at the average sales growth of the 15 largest therapeutic classes over the last five years.

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Pipeline to Soften Lilly Patent Losses

Eli Lilly (NYSE: LLY) is looking to its pipeline to fill the gaps left by a number of high-profile drugs coming off patent. In October 2011, blockbuster Zyprexa will fall to generic competition; additionally, about three-quarters of Lilly’s current revenue comes from eight drugs that will lose patent protection between now and 2017. ”We have the challenge of replenishing our product portfolio from our pipeline,” says CEO John Lechleiter in a USA Today interview. “Fortunately, we have the most exciting pipeline today in our history.”

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Merck KGaA’s Pancreatic Cancer Vaccine Ready for Testing

In the quest for a cancer vaccine, Merck KGaA is again stepping into the ring. Vaximm Holding AG, the company’s joint venture with a Switzerland’s BB Biotech Ventures III, will start testing a therapeutic cancer vaccine in patients next year. The vaccine, VXM01, harnesses the body’s immune system to fight cancer by using T-cells to close off the tumor’s blood supply. Roche’s Avastin also focuses on the tumor’s blood supply, but it focuses on eliminating a protein that creates the blood vessels to the tumor.

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Pfizer’s Litany of Pipeline Snafus Cause Analysts to Fret

The clock is ticking on Pfizer’s final, 18-month countdown on its $11.5 billion Lipitor franchise, but analysts are growing increasing fretful about the pharma giant’s ability to find new drugs to fill the looming revenue chasm. Pfizer had to admit that it suspended a slate of osteoarthritis trials after its highly touted pain drug tanezumab–billed as the world’s first likely biologic for pain–was linked to potentially perilous safety issues. And that came just two days after the company had to pull the cancer therapy Mylotarg from the market.

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Importance of Human Genome Sequencing Still Debated – 10 Years Later

Craig Venter has never been reluctant to credit himself for a lead role in sequencing the human genome. And he’s certainly not the least bit shy about placing a high value on the overall significance of the work. “I think it’s far more important than walking on the Moon; not much has happened since walking on the Moon,” he tells the BBC on the tenth anniversary of the grand achievement, which took 2,000 scientists more than 10 years and $2.7 billion to accomplish.

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Synthetic Flu Virus Opens Door to Safer Vaccines

A group of molecular biologists and computer scientists at Stony Brook University have created a synthetic flu virus that can be used to develop a safer type of vaccine.  The virus–A/PR/8/34–contains a scrambled genetic code generated by computer algorithms. The resulting mutations–what they describe as death by a thousand cuts–are arranged so the resulting viral genome will produce fewer proteins, which weakens it. And the researchers say that the flu vaccine they created worked in mice.

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FDA Imposes Hurdle for Cytori Breast Repair Device

Cytori Therapeutics may need to spend $10 million more than anticipated to get clearance for its first product because of a stricter-than-anticipated regulation. Cytori had laid out $200 million in eight years on the device and was seeking ”fast-track” clearance for the body-tissue repair device. But now it must take the slower regulatory path used for about one in every 10 experimental devices.

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Pharma Trifecta: Generics, New Markets and Personalization

What three trends are most important to pharma these days? Generics, emerging markets and personalized medicine, according to the Harvard Business Review. Branded generics are the wave of Big Pharma’s future, HBR says. These branded versions of off-patent meds sell at higher prices than regular generics do, but are cheaper than the branded meds themselves. They give a measure of assurance to patients worried about counterfeit meds–and to those concerned that unbranded generics won’t work as well as their branded counterparts. They also offer drugmakers a niche in emerging countries.

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Tetraphase Hauls in $45M to Back Antibiotic Work

Tetraphase Pharmaceuticals has hauled in a $45 million C round–a hefty chunk of cash that will open a development runway stretching out up to two-and-a-half years. Over that time, CEO Guy Macdonald says the company will put its technology for developing a better breed of tetracycline antibiotics to the clinical development test, taking a lead program–TP-434–through Phase II and ushering two more into the clinic. By the end of this stretch, the biotech should be able to position itself for a collaboration deal and possibly even an IPO.

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