Thursday, April 03, 2014

AbbVie's IV Lifeline Still Humira

Investors in AbbVie (ABBV-$53.34) are reminded each quarterly earnings release of the continued importance of Humira to the drug maker's success.  AbbVie's flagship drug, an efficacious treatment for autoimmune diseases like rheumatoid arthritis (RA) and psoriasis, contributed $10.7 billion in global sales (56% of worldwide revenue of $18.8 billion) last year.

AbbVie is spending more than 16% of annual sales to develop a pipeline -- including promising treatments for multiple sclerosis, blood cancers, and hepatitis-C (across all patient types) - with the goal of reducing its dependence on Humira. Fortunately, the Chicago-based drug manufacturer has a stable of off-patent, legacy drugs that contribute sizable sales to this R&D effort.


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. 

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. 

Thursday, February 20, 2014

Progenics Pharmaceuticals: New Front in War Against Cancer

Investors’ bearish sentiment that further testing of the clinical utility of Progenics Pharma’s (PGNX-$5.00) PSMA-ADC might be pointless due to toxicity concerns is unfounded: Robert Israel, MD, one of the study authors and executive vice president of medical affairs at Progenics, pointed out to Medscape Medical News that both of the patients who died had predisposing conditions.

"One had an indwelling central line [known to increase risk of developing sepsis] and the other had repeated urinary tract infections," said Dr. Israel. "The patients were also heavily pretreated and didn't have much in the way of other options."

As a new class of biological therapeutics, the ADC market is still in its infancy. Nonetheless, skeptics might want to spend a Saturday reading up on the managed benefits of these highly potent drugs in the context of understood off-target toxicities.


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. 

Monday, February 17, 2014

The New Old Yahoo Under Marissa Mayer

Yahoo (YHOO-$38.23) continues to fall further behind Google (GOOG) and Microsoft (MSFT) in organic growth for inquiring eyes (and potential customer dollars). In June 2012, the respective share of the U.S. search engine market held by Google, Bing and Yahoo stood at 66.8%, 15.6%, and 13%; data released by comScore for December 2013 showed Google and Microsoft continue gaining voice at Yahoo’s expense: Google and Microsoft expanded their market shares to 67.3% and 18.2% -- while during Mayer’s tenure, Yahoo’s market has fallen further to a 10.8% share.

Revenue slumped for the fourth consecutive quarter at Yahoo, dipping 6% to $1.27 billion in the last three months of 2013, led by a similar 6% decline in all-important display-ad sales to $491 million (as a price-per-ad decline of 7% offset a 3% increase in total number of ads).


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. 

Monday, February 10, 2014

Lobbying Momentum to Drive Pharmacyclics Success?

In addition to hard science, lobbying momentum could be another catalyst driving sales of Pharmacyclics (PCYC-$131.38) new blood cancer drug Imbruvica significantly higher in coming years. The National Comprehensive Cancer Network (NCCN), which is an alliance of leading global cancer centers, issues recommendation protocols reflecting the consensus standard-of-care practices in oncology. Irrespective of formal FDA regulatory approval, an NCCN endorsement can be highly determinative of which therapies are reimbursed by the Centers for Medicare & Medicaid Services (CMS) and private insurers in a given indication. In other words, forget ICD-9 diagnostics codes.

In addition to the formally approved indication of relapsed/refractory MCL, updated NCCN guidelines now already recommend Imbruvica for the “off-label” treatment of refractory and relapsed CLL and other NHL subtypes, according to JMS Securities. 

See more at YCharts: Pharmacyclics: FactsBehind $10B Market Cap

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. 

Saturday, January 25, 2014

Pharmacyclic's Imbruvica: New Hope for Cancer Patients

Imbruvica, by Pharmacyclics (PCYC-$135.20), received accelerated approval for MCL based on a study where 111 participants were given Imbruvica daily until their disease progressed or side effects became intolerable. Results showed nearly 66 percent of participants had their cancer shrink or disappear after treatment (overall response rate).

Imbruvica blocks the function of Bruton’s tyrosine kinase (BTK), a key signaling protein of the B-cell receptor signaling complexes that stimulate malignant B-cells to grow and divide uncontrollably.

MCL affects the white blood cells called lymphocytes found in the “mantle zone” of a lymph node. A rare form of NHL, and most prevalent in older adults (mean age, 68), MCL is an aggressive B-cell malignancy affecting about 6% of the 72,000 new cases of NHL diagnosed in the U.S. annually.

To date, first-line treatment has usually consisted of Roche’s monoclonal antibody Rituxan (rituximab) – which is directed against the CD20 antigen found on Beta lymphocytes – combined with a multi-agent chemotherapy regimen, most often CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone).

Given the complex pathophysiology of the disease (multiple cell-signaling division triggers), combined with a late-stage diagnosis typically discovered after the spread to the GI tract and bone marrow, MCL is characterized by short median survival times (3 – 5 years).


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. 

Saturday, January 11, 2014

Checking for Signs of Life at Vivus

Led by new chief executive Seth Fischer, Vivus (VVUS-$9.18) is walking a new path with its erectile dysfunction (ED) drug Stendra (avanafil), choosing to outsource promotion via licensing deals: in July 2013, VIVUS announced an exclusive pact worth up to $121 million (plus royalties) with the Italian pharmaceutical group Menarini to commercialize avanafil in Europe; Auxilium Pharma (AUXL), which already markets a portfolio of ED treatments, including testosterone and Xiaflex (recently approved for Peyronie’s disease – painful curvature of the penis caused by plaque buildup), inked a marketing deal worth up to $300 million to Vivus (plus royalties) for rights to Stendra in the U.S. and Canada.  

With ED afflicting up to 30 million men in this country alone, management opines that there remains significant commercial opportunity for Stendra to stake claim to a double-digit share of the $2.9 billion U.S. market. Unfortunately, peak sales estimates of $400 million - $500 million in 2016 (one-year prior to expiration of Cialis’ first key patent), could prove too optimistic.

Notwithstanding marketing claims, after adjusting for proper dosage, no one agent in the class has been shown to be more efficacious or safer than the others. How, therefore, are Vivus’s marketing partners going to surmount reimbursement challenges when therapeutic substitutions -- generic versions of Viagra -- are available at less than $2.00 per pill in most industrialized countries (save the U.S.)? Further, Auxilium has only about 150 sales representatives to sell the drug here at home.  


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.