Nano Stocks

Elan’s (NYSE: ELN) NanoCrystal^® technology has been approved for use in Japan. The approval comes as part of the approval for EMEND^® a drug treatment for chemotherapy induced nausea. EMEND^® is the first NanoCrystal® based drug to be approved in Japan. The stock traded up over 4.5% on the news today.

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Janssen-Cilag a division of Johnson & Johnson (NYSE: JNJ) has submitted a marketing application for paliperidone palmitate (marketed as Invega Sustenna in the US) a once-montly schizophrenia treatment that utilizes Elan’s (NYSE: ELN) Nanocrystal drug delievery system. The treatment was granted approval by the FDA in August. The monthly injection is seen as having certian advantages over oral drug treatments. Specifically, paliperidone palmitate avoids the potential for relapse as result of individual’s failing to take their medication (a common outcome of oral-based schezophrenia treatments).

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J&J partnered with Elan following a $1 billion investment by the New Jersey health care giant earlier this year. In return for the investment J&J recieved an 18.34% stake in the Dublin based biotech company and rights to teh biotech’s Immunotherapy Program.

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The Michael J. Fox Foundation in partnership with biotech firm Elan (NYSE: ELN) have contributed grants totaling $1.5M towards the Novel Approaches to Drug Discovery for Parkinson’s Disease program. The money goes to six grant winners whose research has shown promising initial results but lacks necessary funding to further development. Of the six winners two researchers use nano-based protein targeting.

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Biogen and Elan’s (NASDAQ: ELN) multiple sclerosis drug Tysabri has been a subject of serious concern as a rare brain infection PML has been a known side effect of the drug. However, more recent reports have shown that the frequency as well as the severity of the side effect is not as grave as originally thought. In fact, initial estimates of the frequency of PML as a side effect was 1/1000. However, data collected over the past 4 years has shown that the frequency is closer to 1/2500.

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The multiple sclerosis drug Tysabri made by Biogen in partnership with nanodelievery maker Elan has been cited by European pharma regulators for potential ties with progressive multifocal leukoencephalopathy (PML). Elan shares were down more than 20% on the news, originally reported on NanoStock here.

An excerpt from recent analyst coverage reads:

“A European panel has started a review of controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. and ELN, citing a much higher number of rare brain infections than previously disclosed. The European Medicines Agency’s Committee for Medicinal Products for Human Use, commonly called CHMP, reported that there are 23 cases of progressive multifocal leukoencephalopathy, or PML, since the drug’s launch. Previously, there had only been 13 confirmed cases of the infection since the drug re-entered the market in 2006, following an 18-month removal that was prompted by a link to three previous cases of PML. The drug is key to the growth of both companies, and this recent news had Biogen shares recently trading down 5.8% to $44.49, while ELN’s American depository receipts fell 20% to $5.17.”

“For the second quarter of 2009, Tysabri in-market net sales increased by 27% to $253.8 million, up from $200.0 million for the same period of 2008. The increase reflects strong patient demand across global markets.”

Elan dropped over 17% in trading on Friday after European pharmaceutical regulators announced plans to look into the safety of Biogen’s Tysabri, a multiple sclerosis treatment. Elan works in partnership with Biogen and provides the delivery mechanism for Tysabri.

Link to full story: here