Pfizer's Humira is Poised to Become the World’s Biggest-Selling Drug.; Novartis Drug SigniforR Recommended by FDA Advisory Committee Print E-mail
By Staff and Wire Reports   
Wednesday, 07 November 2012 19:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 7, 2012

As the world awaited results from the US presidential election, Pfizer (NYSE:PFE) scored its own victory Tuesday with the approval of a pill that treats rheumatoid arthritis.

With Xeljanz, Pfizer is believed to have a potential blockbuster -- a drug that potentially generates a few billion dollars a year in revenue, according to Wall Street analysts. Speculation by analysts also focuses on how much market share Pfizer can take from existing injected rheumatoid arthritis drugs, including Amgen’s (NASDAQ:AMGN) Enbrel, Johnson & Johnson’s (NYSE:JNJ) Remicade and the big gorilla, Abbott Laboratories’ (NYSE:ABT) Humira. (Pfizer is unwinding a sales partnership with Amgen for Enbrel.)

Humira is poised to become the world’s biggest-selling drug.

RBC Capital Markets analyst Glenn Novarro predicts Humira sales will top more than $9 billion this year and more than $10 billion in 2013. He does not plan to immediately change his forecast for the drug based on the approval of Pfizer’s Xeljanz.

“We do not expect the convenience benefit of an oral to outweigh Humira's long-term efficacy and safety track record,” Novarro says in a note to clients Wednesday. He has a buy rating on Abbott’s stock.

Indeed, Pfizer’s drug carries a number of warnings, including risk of infections, tuberculosis and cancer. As part of its drug approval, Pfizer is required to carry out a plan to evaluate and mitigate the risks to patients. At almost $25,000 a year, the Pfizer drug is priced at a slight discount to the injected therapies.

Xeljanz, also known as tofacitinib, is part of a class of drugs known as JAK inhibitors. The Pfizer drug is approved by the Food and Drug Administration to treat patients with moderate to severe rheumatoid arthritis who are intolerant or can’t be treated with an older drug, methotrexate.

Other companies are studying JAK inhibitors. Eli Lilly (NYSE:LLY) and Incyte (NASDAQ:INCY) are studying a drug to treat rheumatoid arthritis. Incyte’s JAK inhibitor Jakafi was approved by the FDA last year for the blood cancer myelofibrosis. YM Biosciences (NYSEAMEX:YMI) is in the early stages of testing a JAK inhibitor for inflammatory diseases, including rheumatoid arthritis, and cancer. The drugs are designed to inhibit a family of enzymes known as Janus kinases, which are linked to certain diseases.

Considered a promising new therapy, Pfizer’s drug is approved at a crucial point for the company. For years, Pfizer relied on the cholesterol drug Lipitor, which has been the world’s top-selling drug until recent generic competition. Pfizer desperately needs new blockbusters to fill the void of Lipitor and other older drugs.

Shares of Pfizer fell about 1% to $24.30 in morning trading Wednesday as the broader market also dipped. The stock is up more than 12% in 2012. Abbott, which plans to break into two separate companies later this year, fell almost 2% to $63.77. The company’s shares are up more than 13% this year. Incyte gained 1% to $17.89 and Lilly fell 1% to $48.43.


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The US FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted unanimously in support of the use of Novartis' (NYSE:NVS) SigniforR  (pasireotide) for the treatment of patients with Cushing's disease who require medical therapeutic intervention.

"We are encouraged by today's favorable advisory committee recommendation for pasireotide in Cushing's disease and will work closely with the FDA as it completes its review of our application," said Hervé Hoppenot, President, Novartis Oncology. "There is a significant unmet medical need for Cushing's disease patients and Novartis is committed to providing the endocrinology community with a novel therapeutic approach for this rare and debilitating endocrine disorder."

The recommendation was based on data from clinical trials of pasireotide, including PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease), the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease. Although not obliged to follow the recommendation, the FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments.

Results from the PASPORT-CUSHINGS study found that mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was rapidly decreased and sustained in a majority of patients, with a subset of patients reaching normalized levels. The study also showed that, on average, as UFC levels were reduced, clinical manifestations of Cushing's disease improved. The most frequently reported adverse events (AEs) (>10%) by investigators for pasireotide were diarrhea, nausea, hyperglycemia, cholelithiasis, abdominal pain, diabetes mellitus, injection site reactions, fatigue and increased glycosylated hemoglobin (HbA1c), with most events being Grade 1-2. The safety profile of pasireotide was similar to that of other somatostatin analogs (SSA) with the exception of the greater degree of hyperglycemia.



Also Wednesday:



AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG)
today announced that Frank Thomas, AMAG’s Chief Operating Officer, will present a company overview and business update at the Lazard Capital Markets 9th Annual Healthcare Conference on Tuesday, November 13, 2012 at 8:00 am ET in New York, NY.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA)
today reported financial results for the third quarter and nine months ended September 30, 2012 and provided an update on corporate developments.

Array BioPharma Inc. (NASDAQ: ARRY)
today announced that as part of its continued evolution toward late-stage development and commercialization, John A. Orwin, chief executive officer of Affymax, Inc., joined the Company's board of directors, effective November 6, 2012.

AtheroNova Inc. (OTCBB: AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Fred Knoll, the principal and portfolio manager of Knoll Capital Management, has been named to the Board of Directors of AtheroNova Inc.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading dental laser manufacturer and distributor, announced today that Chairman and CEO Federico Pignatelli is scheduled to present at the Lazard Capital Markets 9th Annual Healthcare Conference

Celgene Corporation (NASDAQ: CELG)
today announced its presentations at two upcoming investor conferences will be webcast live and will be available in the investor relations section of the company’s web site at www.celgene.com.

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX)
today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for a second patent relating to its new formulation of Acetadote®(acetylcysteine) Injection, which is used to treat acetaminophen overdose.

Dyax Corp. (NASDAQ: DYAX)
announced today that executive management will participate in two upcoming conferences.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the Credit Suisse 2012 Healthcare Conference at the Arizona Biltmore Hotel in Phoenix, Arizona on Wednesday, November 14, 2012.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that hypertension data from a subgroup analysis of the EMPOWER trial were presented today at the American Heart Association's 2012 Scientific Sessions, held on November 3-7, 2012 in Los Angeles, CA.

Exact Sciences Corp. (Nasdaq: EXAS)
today announced that it will present at two investor conferences during November.

Genomic Health, Inc. (Nasdaq: GHDX)
today reported financial results and business progress for the quarter ended September 30, 2012.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today reported recent business highlights and financial results for the third quarter and nine months ended September 30, 2012.

InterMune, Inc. (NASDAQ: ITMN)
today announced results from operations for the third quarter and nine months ended September 30, 2012.

Life Technologies Corporation (NASDAQ: LIFE)
today announced Ion AmpliSeq™ Community Panels, a community-driven solution to gene panel sequencing that leverages the expertise of scientific thought leaders and the Ion Community to create gene panels for conditions ranging from cancer to inherited diseases.

NXP Semiconductors N.V. (NASDAQ: NXPI)
today announced that its secure microcontrollers represent the major share in Germany's eHealthcard deployment.

Oncothyreon Inc. (Nasdaq: ONTY)
announced today that management will be presenting at the following upcoming investment conferences in November.

Organovo Holdings, Inc. (OTCQB: ONVO)
("Organovo"), a developer and manufacturer of functional human tissues using a novel three-dimensional  bioprinting technology, today announced that Keith Murphy, Chairman and Chief Executive Officer, will present at the upcoming Lazard Capital Markets 9th Annual Healthcare Conference in New York.

PAREXEL International Corporation (NASDAQ: PRXL)
announced today that it will be presenting at the Lazard Capital Healthcare Conference in New York, NY.  Josef von Rickenbach, Chairman and Chief Executive Officer, will be making a presentation on PAREXEL at 2:00 p.m. ET on Tuesday, November 13, 2012.  

Quidel Corporation (NASDAQ: QDEL)
, a leading provider of diagnostic testing solutions and cellular-based virology assays, announced today that it will present at the Credit Suisse 2012 Healthcare Conference to be held at the Arizona Biltmore hotel in Phoenix, Arizona on Wednesday, November 14, 2012.

Rapid Fire Marketing (PINKSHEETS: RFMK)
announced today that the Company has filed its 3rd quarter financial statement with OTC Markets.

Rapid Fire Marketing (PINKSHEETS: RFMK)
announced today that as a result of the elections in 3 states, the landscape has been altered with regard to the marijuana business as well as the medical marijuana business.

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today the appointment of Douglas E. Williams, Ph.D. to its Board of Directors.

Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

Tengion, Inc. (OTCQB: TNGN)
, a leader in regenerative medicine, today announced that John Miclot, President and Chief Executive Officer of Tengion, will present at the upcoming Lazard Capital Markets 9th Annual Healthcare Conference on Wednesday, November 14, 2012, at 11:30 a.m. EST in New York City.

Thermo Fisher Scientific Inc. (NYSE:TMO)
, the world leader in serving science, today announced that Klaus Lindpaintner, MD, MPH, and Edison T. Liu, MD, have joined its Scientific Advisory Board.

Zynex, Inc. (OTCQB: ZYXI)
, a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announces its third quarter 2012 unaudited financial results.



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