The Zacks Analyst Blog Highlights: Ironwood Pharmaceuticals, AstraZeneca, Forest Laboratories, Questcor Pharmaceuticals and Allergan
CHICAGO, Sept. 17, 2013 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Ironwood Pharmaceuticals, Inc. (Nasdaq:IRWD-Free Report), AstraZeneca (NYSE:AZN-Free Report), Forest Laboratories, Inc. (NYSE:FRX-Free Report), Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR-Free Report) and Allergan, Inc. (NYSE:AGN-Free Report)
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Here are highlights from Monday's Analyst Blog:
Ironwood, AstraZeneca Initiate Study
Ironwood Pharmaceuticals, Inc. (Nasdaq:IRWD-Free Report) and partner AstraZeneca (NYSE:AZN-Free Report) recently announced that a phase III trial (n ~ 800) on linaclotide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) has been initiated in China.
The double-blind, randomized, placebo-controlled study will evaluate the safety and efficacy of linaclotide in patients suffering from IBS-C. Top-line data from the study is expected in the first half of 2015. Linaclotide is expected to reach the market in 2017, subject to China Food and Drug Administration approval.
In Oct 2012, Ironwood and AstraZeneca entered into an agreement for the development and commercialization of linaclotide in China.
We note that the product is already available in the U.S. under that trade name Linzess. Ironwood Pharma launched Linzess in Dec 2012 in collaboration with Forest Laboratories, Inc. (NYSE:FRX-Free Report) for patients suffering from IBS-C or chronic idiopathic constipation (CIC).
The companies are looking to broaden the Linzess label by incorporating additional patient populations and indications. To further analyze the effect of Linzess on abdominal symptoms in patients suffering from CIC, Forest Labs and Ironwood Pharma have initiated a phase IIIb clinical trial. Results from the trial are expected shortly. Forest Labs and Ironwood plan to evaluate the use of Linzess in the pediatric population and in opioid-induced constipation patients in the first half of 2014.
Net sales of the drug, as reported by Forest Labs, came in at $28.8 million in the second quarter of 2013 as compared to $4.5 million in the previous quarter. For 2013, Ironwood expects total investment in sales and marketing for Linzess in the range of $250 – $300 million.
In the EU, approval came in Nov 2012 under the trade name Constella. Ironwood is collaborating with Almirall, S.A. in the EU for the drug. The product is now available in Germany, the UK and the Nordic countries and is expected to be launched across Europe in 2013 and 2014.
Ironwood carries a Zacks Rank #3 (Hold). We expect investor focus to remain on the market performance of Linzess. Stocks which currently look attractive in the pharma space include Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR-Free Report), carrying a Zacks Rank #1 (Strong Buy).
Another Indication for Allergen's Botox
Allergan, Inc. (NYSE:AGN-Free Report) recently gained approval for using its key drug, Botox, for another indication. The FDA granted approval to Botox Cosmetic for the temporary treatment of moderate to severe lateral canthal lines, which are commonly known as "crow's feet" lines.
The FDA approval makes Botox the first and only product of its kind to gain approval for this indication. Allergan had conducted two randomized, multi-center, placebo-controlled studies to establish Botox' safety and efficacy for this indication.
Botox is approved for therapeutic as well as aesthetic use. Therapeutic indications include treatment of overactive bladder symptoms (adults), prevention of chronic migraine headaches (adults), treatment of increased muscle stiffness in elbow, wrist, and fingers in adults with upper limb spasticity, treatment of abnormal head position and neck pain related to cervical dystonia (age ≥16), treatment of certain types of eye muscle problems or abnormal spasm of the eyelids (age ≥12) and treatment of the symptoms of severe underarm sweating (adults).
Cosmetic indications include the temporary improvement of glabellar lines (frown lines between the brows) in adults below 65 years of age.
Botox is a major contributor to Allergan's top line. First half 2013 sales came in at $970.9 million, up 12.9% from the year-ago period. Allergan expects Botox sales of $1.94 billion - $2.00 billion in 2013. Botox' label expansion should help Allergan achieve the guidance. The chronic migraine, bladder and upper limb spasticity indications represent significant potential.
Allergan currently carries a Zacks Rank #3 (Hold).
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