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oxymorphone q &a

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    Q1 How big is the market that POH is now targeting?

    Today’s announcement states that the Opana-dominated global market for oxymorphone is close to US$1 billion. This market can now be added to the OxyContin-dominated global market for oxycodone which Phosphagenics is targeting with its TPM patch. Global OxyContin sales in 2011 were estimated at US$4 billion.

    IMS Health data from 2011 suggests the U.S. market for... extended release opioids accounted for approximately $4.8 billion. Prescription tracking data (IMS Health) suggests Purdue sold over $3.3 billion in OxyContin in the U.S. in 2011. Another $700 million was sold outside the U.S. (1)

    Therefore, the combined global market for extended release oxycodone and oxymorphone, which Phosphagenics is now targeting, exceeds US$5 billion.

    Q2 Is Opana Endo Pharmaceuticals’ only pain product?

    Absolutely not. Other pain products include oxycodone, diclofenac and lidocaine. Endo’s current branded pain portfolio exceeds $2 billion in annual sales. (3)

    Endo’s core business is the development of pain management products. The firm’s business model is to in-licence or acquire pharmaceutical assets with the intent to complete development and commercialise the products. Pain management products include Lidoderm (lidocaine), Frova (frovatriptan succinate), Voltaren (diclofenac sodium), Percodan (oxycodone hydrochloride and aspirin) and Opana (oxymorphone hydrochloride). (2)

    Two years ago, Endo acquired Qualitest Pharmaceuticals, which was a natural fit with Endo’s pain management business.

    Qualitest has the ability to manufacture controlled substances, which make up around 40% of the firm’s portfolio. (2)

    Q3 Who manufactures Opana?

    Novartis is the sole manufacturer of the current formulation of Opana ER. (4)

    Q4 Is Endo’s Opana under threat from generic competition?

    Yes. The original patents supporting Opana ER were due to expire starting from September 2013. (5) Watson Pharmaceuticals won the right to launch its generic version of Opana in September this year. Endo has responded to generics competition firstly by reformulating Opana with Gruenenthal’s abuse deterrent technology, thus extending the Opana patents until 2023. In a second move, last Friday Endo filed suit against the FDA, basically seeking that the FDA immediate suspend all non-abuse deterrent generic versions of Opana for safety reasons.

    The latter (Opana) has been the subject of a great deal of generic interest; in October 2010, Endo reached a settlement with Watson Laboratories to resolve outstanding litigation after Watson filed an ANDA for a proposed generic version of the drug. The settlement will allow Watson to launch its version ahead of the expiration of the patents protecting Opana. (2)

    Endo Health Solutions Inc. announced Friday that its subsidiary, Endo Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration or FDA seeking a formal determination whether the original formulation of OPANA ER, or oxymorphone HCl, was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications or ANDAs for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons.

    The company said that the data show a 59 percent drop in abuse rates of the reformulated OPANA ER which is designed to be crush-resistant. The same data demonstrate a 122 percent increase in abuse rates of non-tamper resistant extended-release oxymorphone HCl.

    Q5 Does Endo perceive opioid delivery via patch to be a threat?

    Endo admitted in late 2010 that it was keeping a close eye on Purdue’s Butrans (buprenorphine) patch, which was to be released in 2011. Although the patch was positioned in the extended release moderate-to-severe chronic pain opioid market, Endo claimed that it didn’t believe the Butrans patch would impact on Opana sales.

    Well, we're obviously following the (BUTRAN's) launch carefully. We believe that it will compete among the more weaker opioid-based therapies, and won't have a direct impact on either OPANA ER or some of our generic competitor's that are categoried to opioid. So, we're going to follow it very carefully, but I believe that our core franchise, OPANA ER in particular, will continue to be very strong and will not be materially affected by this launch.(7)

    However, in January this year, Endo signed a worldwide licensing and development agreement with Biodelivery Sciences International for a BEMA (dissolvable buccal film delivery) twice-daily formulation of buprenorphine. Endo signed the $180 million deal despite the fact that BioDelivery revealed in the previous September that it had missed its primary goal that measured difference in pain intensity among patients with chronic aches in a Phase III study, which compared the drug, BEMA Buprenorphine, with a placebo. (8)

    The financial terms of our agreement with Endo include: (i) a $30 million upfront payment, which we received in January 2012; (ii) $95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events; (iii) $55 million in potential sales milestones upon achievement of designated sales levels; and (iv) a tiered, mid- to upper-teen royalty on net sales of BEMA® Buprenorphine in the United States and a mid- to high-single digit royalty on net sales of BEMA® Buprenorphine outside the United States. We expect to use portions of our Endo milestone payments to fund our development obligations under the Endo agreement with respect to BEMA® Buprenorphine.(3)

    Q6 Is today’s announcement exciting?

    You have been reading, haven’t you?

    (1) http://seekingalpha.com/article/858141-buy-durect-as-visibility-on-remoxy-improves

    (2) http://thepharmaceutical-news.com/tag/endo-acquiring-qualitest

    (3) http://www.faqs.org/sec-filings/120319/BIODELIVERY-SCIENCES-INTERNATIONAL-INC_10-K/#b

    (4) http://online.wsj.com/article/BT-CO-20120109-708046.html


    (6) http://www.rttnews.com/2015421/endo-pharma-sues-fda-to-protect-consumers-from-non-tamper-resistant-oxymorphone.aspx?type=bn

    (7) http://www.morningstar.com/earnings/22732031-endo-pharmaceutical-holdings-inc-endp-q4-2010.aspx?qindex=5

    (8) http://www.fiercebiotech.com/story/biodelivery-sciences-shares-spike-180m-pain-drug-deal-endo-pharma/2012-01-06

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