Tuesday, March 18, 2014

AbbVie Hums with Humira

AbbVie (ABBV - $53.10) Chief executive Rick Gonzalez told analysts on the fourth-quarter earnings call that management expects global Humira sales this year will continue growing at a (low) double-digit pace, excluding the impact of foreign exchange. The pursuit of additional indications currently in late stage clinical trials, such as Uveitis (inflammation of the eye and the third leading-cause of blindness), is expected to augment growth too.

Humira – like Johnson & Johnson's (JNJ) Remicade – is a manufactured monoclonal antibody that treats autoimmune diseases by interfering with (blocking) tumor necrosis factor (TNF), an inflammatory protein over-expressed in a wide range of progressive inflammatory disorders that can result in permanent tissue and joint damage over time. 

Could Humira lose share to biosimilars?  Read more at The Motley Fool: AbbVie's Humira Still a Growth Engine

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy. 

Pfizer's Strategic Move into Opioid Analgesics

Pfizer's (PFE-$31.93) management stated during the fourth-quarter 2013 earnings call last month that a move toward opioid analgesics and a promising anti-nerve growth factor (NGF) drug in its pipeline, a monoclonal antibody called tanezumab, could help to mitigate the impact Celebrex's loss of market exclusivity will have on sales going forward.

Looking to capitalize on the growing need for abuse-deterrent formulations, Pfizer is looking to entrench itself in the $5.1 billion market for extended-release (ER) opioid formulations prescribed by physicians to chronic pain sufferers (30% of the $18.1 billion in annual sales for all opioid-based therapies). 

Chief executive Ian Read confirmed on the conference call that Embeda, an ER morphine/naltrexone formulation that was voluntarily benched in 2011, would be back on pharmacy shelves in second-quarter 2014 after the FDA approved both an updated manufacturing process and a risk evaluation and mitigation strategy (REMS) – which is now required for all ER and long-acting opioid medications.

Read more at The Motley Fool: Pfizer Stubs Toe Without Celebrex

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy. 

Ignore the Zogenix Buzz

Though Zogenix (ZGNX-$3.55) is entering a chronic pain market with estimated annual sales worth an estimated $15.5 billion, the market is saturated with reformulations of well-established short and long-acting products that include generic and branded hydrocodone (e.g. Vicodin), oxycodone (e.g. OxyContin), hydromorphone (e.g. Exalgo), morphine (e.g. Avinza), oxymorphone (e.g. Opana ER), and fentanyl (Duragesic transdermal patch).

Undaunted, chief executive officer Roger Hawley judiciously opines that Zohydro ER has the potential to fulfill an unmet clinical need: similar efficacy to a combination-entity hydrocone that contains the analgesic acetaminophen or ibuprofen, such as AbbVie's (ABBV) Vicoden or Vicoprofen – but without the risk of liver toxicity.

Continue reading at The Motley Fool: Zogenix Stockholders Facing World of Pain?

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.