Table of Contents
Opportunities Exist for Tamper-resistant Formulations
This research service focuses on the current status of candidates for opioid therapeutics with a focus on current Phase 3 candidates, detailed timelines, rational for pivotal program design, Phase 2 data review and key opinion leader (KOL) commentary. A pipeline assessment is provided for all active candidates in development. The information contained in this research service was derived from published sources including the following: disease organization Web sites; Frost & Sullivan publications, including annual reports; Securities and Exchange Commission (SEC) filings and press releases; United States government public sources; and scientific journals.
Methodology and Scope
• This research service focuses on the global opioid therapeutics market with a focus on current Phase 3 candidates, detailed timelines, rational for pivotal program design, Phase 2 data review and key opinion leader (KOL) commentary.
• A pipeline assessment is provided for all active candidates in development.
• The information contained in this research service was derived from published sources including the following: Disease organization Web sites; Frost & Sullivan publications, including annual reports; Securities and Exchange Commission (SEC) filings and press releases; United States government public sources; and scientific journals.
• Approximately X million Americans suffer from moderate-to-severe chronic pain that interferes with their daily lives.
• The current leader in the opioid therapeutics market is Purdue Pharma with its lead product, Oxycontin, estimated to generate $X billion in 2012 sales.
oEndo’s Lidoderm and Opana products generated $ billion in 2012 US sales.
oThe 3rd and 4th largest pain companies are Teva and Johnson & Johnson (J&J), respectively.
• There are X+ orally-delivered, marketed products with the majority of prescriptions for immediate-release generic opioids.
oBranded products—such as tamper-resistant formulations (TRFs)—that lack generic formulations continue to succeed in capturing significant market share.
• The pain therapeutics pipeline is dominated by TRFs, predominately because these new formulations are endorsed by the Food and Drug Administration (FDA), deter abuse, and enable previously genericized products to remain branded.
oThere areX+ TRF formulations in Phase 2 and later stages of development.
In January 2013, the FDA issued a draft of abuse-deterrence study requirements for inclusion in product labeling.
• There is potential for pain-reducing drugs without TRF technology to be removed from the market, thus creating significant market opportunity for new TRF therapies to remain branded.
• New labeling is falls into X suggested tiers to describe abuse-deterrent properties including.
oFormulation with physicochemical barriers
oReduction/blockage of opioid effect when the product is manipulated
oMeaningful reduction in abuse
oDemonstrated reduced abuse in the community
• All safety categories will likely be required for all tiers, with Tier III requiring clinical abuse potential studies and Tier IV requiring post-marketing data.
Purdue Pharma is the leader in the opioid therapeutics market with an estimated X percent of market share in 2012, led by Oxycontin.
• Oxycontin is Purdue’s oxycodone ER TRF, which holds an estimated % of total prescription share value or $X billion in US sales.
• Purdue Pharma also competes in the transdermal patch market with Butrans, which generated 2012 US sales of $X million.
Endo strongly competes both in the oral and transdermal patch markets.
• Endo’s flagship product, a transdermal patch, Lidoderm, generated $ billion in US sales. Generic competition is expected in 2014.
• Opana ER’s US sales were $ million in 2012, slipping from 2011 sales of $ million.
By 2020, Pfizer is projected to be the new leader in the pain market with a diverse portfolio including orally delivered, transdermal, and IV candidates.
• This is heavily dependant upon the success of their pipeline products.
• Remoxy was originally submitted for FDA approval in 2008; however, multiple setbacks persist due to FDA concerns regarding manufacturing of its tamper-resistant technology. Pfizer stated a development path forward is still active but has not provided details.
• Embeda is another Pfizer pain therapy with abuse-deterrence technology to suffer a setback as it was withdrawn from the market; however, re-launch could be expected by H1 2014.
• In June 2011, Pfizer gained approval for the first immediate release oxycodone designed to deter abuse, Oxecta; however, 2012 US sales were disappointing at approximately $X million.
• Pfizer also has a 3-day bupivacain transdermal patch in development which is expected to compete with J&J’s Duragesic.
J&J competes strongly both in the transdermal patch space and orals.
• Nucynta immediate release and extended-release (ER) formulations had combined US sales of $X million in 2012. J&J is currently conducting clinical trials to show the abuse-deterrence of Nucynta ER and plans to meet with the FDA in H2 2013—possibly providing a label update in 2014 or 2015.
• Ultram ER US sales peaked in 2008 with $Xmillion; however, 2012 sales have declined to $X million due to entry of generic competition.
• J&J’s transdermal patch generated 2012 US revenues of $ million.
Teva’s lead branded product is Fentora, which accounted for $X million in US revenues, but sales growth has been relatively flat since 2008—partly due to a dear doctors letters in 2007.
• Fentora is a effervescent tablet formulation of fentayl, launched to address cancer pain in 2006.
• Patent expiration is not until 2019, providing a wide opportunity for sales growth for other indications including breakthrough back pain, neuropathic pain, and non-cancer-related pain.
• Teva’s pain franchise is also supported by their generics division.
Nektar currently has X products in their pipeline for pain.
• NKTR-181 is a mu-opioid analgesic in Phase 2 development—it is designed to reduce side effects such as respiratory depression, sedation, and abuse potential associated with conventional opioids.
• Nektar has plans to combine their novel mu-opioid analgesics with naloxegol, a Phase 3 candidate indicated to reduce opioid-induced constipation.
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