Updates on products and pipeline candidates are highly-awaited
events in the pharma/biotech sector as these provide investors
information on the current status, efficacy and safety profile of
a candidate. These updates play a crucial role in determining
whether a firm is worth investing in or not. Sometimes, companies
host Investor Days to present such information.
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Ironwood Pharmaceuticals, Inc.
) hosted its Investor Day a few days back to discuss its
strategy. The company intends to work on maximizing revenues from
its sole marketed drug, Linzess (linaclotide). Meanwhile,
Ironwood is also focused on advancing its pipeline.
Linzess (EU trade name: Constella) was launched in Dec 2012 in
Forest Laboratories, Inc.
) for patients suffering from irritable bowel syndrome with
constipation (IBS-C) or chronic idiopathic constipation (CIC).
Forest Labs and Ironwood share Linzess revenues generated in the
U.S. equally. Net sales of the drug, as reported by Forest Labs,
were $34.4 million in the third quarter of 2013 compared to $28.8
million in the preceding quarter.
According to IMS Health data, prescriptions filled till Nov 2013
were more than 500,000 with at least 190,000 being unique
patients. As of Oct 2013, 75% of the Linzess claims were
Initiative to Drive Linzess Sales
Ironwood is focusing on promoting the product by improving the
marketing mix and stepping up the direct-to-consumer campaign
from the first half of 2014. The company also plans to increase
the efficiency of the sales force by focusing on the highest
prescribing physicians. To lower the out-of-pocket cost borne by
patients, the company is looking to improve the reimbursement
rates further and aims to achieve more than an 80% rate of
payment for Linzess claims.
Ironwood along with Forest Labs is looking to broaden Linzess'
label by expanding the targeted patient population and gaining
approval for additional indications. The companies intend to
evaluate Linzess in pediatric patients and for opioid-induced
constipation (phase II study expected to be initiated in the
first half of 2014). The drug is also being evaluated for the
prevention of colorectal cancer (phase I biomarker study
In the second half of 2014, the companies plan to initiate a
co-administration study of Linzess and a proton pump inhibitor
and investigate a fixed-dose combination for symptoms of
gastroesophageal reflux disease (GERD) and IBS-C or CIC.
The companies also plan to initiate a phase II trial in mid-2015
to evaluate the targeted delivery of Linzess to the distal small
intestine and colon for abdominal symptoms in patients with
IBS-C, CIC or other gastrointestinal (GI) disorders (including
ulcerative colitis and diverticulitis).
Other Pipeline Candidates
Ironwood aims to advance seven GI candidates with
proof-of-concept data expected in the next two years. Some of the
interesting pipeline candidates include IW-9179 (phase
IIa-functional dyspepsia ongoing, phase IIa - gastroparesis to be
initiated in the first half of 2015, data expected in 2016) and
IW-3718 (phase IIa - refractory GERD to be initiated in the first
half of 2014, with data expected in the first half of 2015).
For 2014, Ironwood expects total investment in sales and
marketing for Linzess at the $250-$300 million range. The company
is also working on reducing the net cash used in operating
activities through revenue growth and cost control.
Ironwood carries a Zacks Rank #3 (Hold). We expect investor focus
to remain on the market performance of Linzess, which has
blockbuster potential. Some better-ranked stocks include
). Both carry a Zacks Rank #1 (Strong Buy).