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Ann: Phosphagenics Signs Japanese License Option and R&D Alliance-POH.AX, page-121

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    I believe you may have hit onto the potential future partners (Daiichi Sankyo)

    Perhaps, although that’s not necessarily the conclusion I've come to.

    Daiichi Sankyo is certainly one of the possibilities. Daiichi draws most of its revenues from the Japanese market (over 60%). These revenues are facing increasing pressure from a government push to contain rising health costs by promoting generic drugs and revising drug pricing biennially. Compared with the rest of the world, Japanese uptake of generics has been slow and low, by doctors and patients alike. From recent low levels of around 30%, the Japanese government is aiming to push generic drug penetration to 60% by 2017 and 70% in fiscal 2025. (1) Daiichi has tried various tactics to respond to the generic threat. Its 2008 purchase of Indian generics firm, Ranbaxy, fared badly. After repeated problems which included regulatory fines and an export ban from the FDA, Daiichi sold out of Ranbaxy last year. It brought an arbitration case against Ranbaxy’s owners for misrepresentation which resulted in a $385 million win which was announced earlier this month.(2,3) Daiichi also purchased a generic injectables facility in the United States in 2010. (4) Another tactic has been for its generics subsidiary, Daiichi Sankyo Espha, to seek differentiation and higher pricing for its drugs, through minor improvements. It brands these drugs as “premium generics”. (5)

    Daiichi Sankyo has recently announced a strategic shift in product focus of its specialist unit to oncology and pain. (6) Its pain portfolio now includes various opioid and opioid-related products.

    In 2014, Daiichi added hydrocodone products to its pipeline when it struck a deal with Charleston Laboratories for various hydrocodone development products. The lead product was a fixed-dose combination of hydrocodone, promethazine and acetaminophen, designed to both relieve pain and reduce opioid-induced nausea and vomiting, which had recently successfully completed Phase 3 trials. This drug is now in the marketing application phase in the US. (7)

    In addition to these hydrocodone products, Daiichi Sankyo has an oral hydromorphone product for cancer pain at the marketing application stage in Japan and another product (DS-1971) for chronic pain which is currently in Phase 1. (8) Daiichi also paid Astra Zeneca last year for US co-marketing rights for Movantik for opioid-induced constipation.

    With respect to Daiichi’s recently announced agreement with Nitto Denko, the drug to be developed for PassPort transdermal patch delivery wasn’t disclosed. However, one can’t rule out it being an opioid product as Altea Therapeutics, the company which onsold the PassPort transdermal delivery system to Nitto Denko, successfully completed a Phase 2 trial in the transdermal delivery of hydromorphone for acute pain using PassPort, albeit it a decade ago. (9)

    Although Daiichi Sankyo would seem to fit the bill of potential POH partner, it is also just possible that the undisclosed Japanese healthcare company is the owner of PassPort, Nitto Denko.

    Strictly speaking, Nitto isn’t a healthcare company but it does have a healthcare division and it is a member of the Nikkei 225. The stated focus of its healthcare division is on developing drugs to meet unmet medical needs. Achieving this through transdermal delivery has been a focus of Nitto Denko’s healthcare division for many years. As well as acquiring the PassPort active transdermal delivery system in 2012, Nitto has developed four passive transdermal delivery patch drugs – for ischemic heart disease (clonidine), for asthma (tulobuterol), for local anaesthesia (lidocaine) and for high blood pressure (Bisoprorol).(10) In the United States, Nitto has a biopharma subsidiary, Avecia, and a San Diego based Life Science Center which has been focused on PassPort transdermal delivery. (11, 12) It is about to open a new facility in San Diego for a newly-created subsidiary (Nitto Biopharma) which will be focused on pharmaceutical development. Nitto Biopharma’s lead program is an siRNA anti-fibrotic therapy which uses a targeted lipid nanoparticle delivery system. (13) Nitto Denko has patented the use of fat-soluble vitamins (A, D, E and K) to target delivery of and enhance activity of therapeutic molecules, including siRNA.(14)

    Of course, none of this answers the question, if Nitto is focused on using its PassPort delivery system to deliver drugs not currently deliverable by patch and if Daiichi Sankyo has signed up to use that system, why would either be wanting to acquire another transdermal delivery system? Also, given that Nitto has had the PassPort transdermal delivery technology for four years now, is it simply coincidence that the Daiichi/Nitto collaboration was announced two weeks after the TPM/Oxymorphone patch license option announcement and one week before the TPM/Oxycodone patch license option announcement?

    Daiichi? Nitto? Or a competitor Japanese pharma?

    1. http://marketrealist.com/2016/04/challenges-pharmaceutical-industry-japan/
    2. http://www.reuters.com/article/us-sun-pharm-daiichi-sankyo-idUSKBN0NB18B20150420
    3. http://www.wsj.com/articles/former-...-pay-385-million-to-daiichi-sankyo-1462473046
    4. http://www.in-pharmatechnologist.com/Ingredients/Luitpold-buys-PharmaForce-for-generic-injectables
    5. http://**i-journal.net/the-refineme...ntic-challenge-for-product-re-innovation.html
    6. http://www.thepharmaletter.com/article/daiichi-sankyo-launches-seven-new-premium-generics
    7. http://www.fiercebiotech.com/partne...ets-up-to-650m-on-charleston-s-pain-potential
    8. http://www.daiichisankyo.com/rd/pipeline/development_pipeline/index.html
    9. http://www.fdanews.com/articles/75908-altea-therapeutics-completes-phase-ii-acute-pain-study
    10. http://www.nitto.com/sea/en/products/group/medical/001/
    11. http://www.avecia.com/Avecia/
    12. http://www.ndtcorp.com/page/transdermal-overview
    13. http://www.nitto.com/sea/en/press/2016/0125_01.jsp
    14. http://www.google.com/patents/WO2012170952A2?cl=en
 
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