This Week in Biotech

With the SPDR S&P Biotech Index up 40% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.

Despite being in between second- and third-quarter earnings season, it was a monstrously busy week in the biotech world. As such, you get a bit of treat this week as I'm expanding this from the usual top five to the top six stories you should have on your radar, in case you missed them.

Just the two of us ...
As always, let's start the weekend with some good news. Perhaps nothing proved more satisfying than the meeting between the Food and Drug Administration's panel and GlaxoSmithKline (NYSE: GSK  ) /Theravance regarding anoro ellipta on Tuesday. The chronic COPD treatment received a nod of confidence from the FDA panel, which voted 11-2 in favor of recommending approval, noting that its safety and efficacy had been well demonstrated and that new treatment options are sorely needed in long-term COPD maintenance. Although there is no such thing as a sure bet when it comes to the FDA, with anoro ellipta's PDUFA decision expected by Dec. 18, it appears very likely that it will be approved.

Another company making waves this week is small-cap immunotherapy vaccine maker Inovio Pharmaceuticals (NYSEMKT: INO  ) , which on Tuesday announced a global partnership with Roche to develop and commercialize therapies aimed at treating hepatitis-B and prostate cancer. Under the terms of the deal, Inovio gets $10 million upfront and is eligible to receive development and commercial licensing milestones of up to $412.5 million. It also gives Roche immediate licensing access to INO-5150 for prostate cancer, INO-1800 for hep-B, and Inovio's proprietary Cellectra electroporation technology for the delivery of these vaccines. With a big-name pharmaceutical partner, investors may now be required to take Inovio more seriously.

Keeping with the "buddy" theme, Isis Pharmaceuticals (NASDAQ: ISIS  ) also popped nicely this week after announcing an expanded antisense drug development partnership with Biogen Idec on Monday. Under the terms of the deal (its fourth such partnership with Biogen Idec is less than two years), Isis will receive $100 million upfront and has the potential to earn up to $4 billion in milestones and royalties (assuming every last drug they develop is approved) in exchange for Biogen's gaining access to its proprietary antisense drug development platform. With 31 ongoing clinical trials and 12 development partners, Isis remains a must-watch up-and-coming biotech juggernaut.

It's all in the data
And then there were the "three stooges" of the clinical data world that left investors longing for the weekend.

No company had investors wishing for a reset button more than Neurocrine Biosciences (NASDAQ: NBIX  ) , which lost 34% on the week after delivering disappointing mid-stage results for its drug for tardive dyskinesia, or TD, NBI-98854. The drug, which aims to reduce symptoms of TD -- a disease marked by involuntary muscle movements, especially of the lower face -- proved to be not statistically significant from the placebo in the 50mg dose but did reach statistical significance in the 100mg dose. Why this is bad news is Neurocrine expected the 100mg dose to be a max-tolerated dosage and had been looking for solid results in the 50mg dosing category. The good news is that the 100mg dose appears to work; the bad news is that the company needs to run an additional phase 2 trial with even higher doses than 100 mg before it can even consider moving NBI-98854 to a late-stage trial, meaning the need to spend more time and more money.

Trailing not too far behind Neurocrine Biosciences in the loss column was ChemoCentryx (NASDAQ: CCXI  ) , which fell 25% on the week after releasing uninspiring top-line results for CCX140, a mid-stage therapy to treat diabetic nephropathy. The top-line data demonstrated that ChemoCentryx's CCR2 inhibitor delivered a 12% reduction in kidney protein levels at the 5mg dose, compared with a 1% rise in the placebo after 12 weeks, and an 8% reduction at the 10mg dose after 12 weeks. Investors' disappointment in the company comes from ChemoCentryx's failure to meet its own preconceived expectations of achieving a 20% drop in kidney protein levels on the top line. Not all hope is lost, though, as the trial is still ongoing and it may prove successful in helping a predefined subset of patients, but it's nonetheless been an abysmal past couple of weeks for ChemoCentryx shareholders.

Finally, female infertility drugmaker OvaScience did its best double-digit swan dive, shedding 24% of its value on the week, after announcing the suspension of U.S. drug trials for Augment in the United States. The reason behind the halt for its drug, which designed to improve egg quality and in vitro fertilization success, relates to the receipt of an untitled letter from the FDA. In that letter, the FDA questions the status of Augment as a 361 HCT/P (an FDA regulation governing human cells, tissues, and cellular and tissue-based products) and suggested OvaScience file an investigational new drug application for Augment in the United States. A meeting is expected soon between the company and the FDA to hash out what the next step will be for Augment. In the meantime, OvaScience is continuing development of the drug outside the United States. 

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Read/Post Comments (3) | Recommend This Article (2)

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  • Report this Comment On September 14, 2013, at 3:06 PM, jawscclaws wrote:

    You go Sean!

    Long on ISIS. Short term share price range $24 - 52, busting-out range $58 - 85, buyout range $125 - 225, and long shot pipeline infusion range $300 - 400.

    Many happy returns to all!

  • Report this Comment On September 14, 2013, at 6:54 PM, BohicaJohn wrote:

    You still don't get it Sean, do you? INO didn't need Roche to be taken seriously. It was capable of be taken seriously on its own.

  • Report this Comment On September 15, 2013, at 9:51 AM, jamaicanholiday wrote:

    Great article, thank you. Novavax (NVAX) has a big analyst day scheduled for 9/24. NVAX is clinical stage focused on a variety of vaccines for influenza and respiratory disease. Stock is up strongly since June. Could be another INO type deal in the works before the end of the year. Check it out.

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