Shire says it's sitting on a $3B pipeline with M&A on tap

Shire CEO Flemming Ornskov

Shire, settling into life on its own after a failed merger with AbbVie ($ABBV), believes its in-development drugs can bring in a combined $3 billion in sales by 2020, sharpening its focus on rare diseases and keeping an eye out for bolt-on acquisitions.

At its R&D day in New York, Shire ($SHPG) pulled back the veil on its pipeline, pointing to a company-record 22 candidates in clinical development and heralding a new collaboration that will broaden its work in cystic fibrosis.

Among Shire's most promising assets is SHP607, a protein-replacement therapy for the rare retinopathy of prematurity, which affects premature infants. The treatment, currently in Phase II, received the FDA's fast-track designation, Shire said, guaranteeing a speedy regulatory review if and when it completes pivotal trials. Then there's Lifitegrast (SHP606), star of Shire's $160 million buyout of SARcode Bioscience last year, which is a dry eye disease therapy the company expects to file for approval in the first quarter of 2015.

Shire is also making progress on the liver treatments it acquired in a $260 million deal for Lumena Pharmaceuticals. The company has wrapped up enrollment in two Phase II studies of SHP625, the former LUM001, an oral drug designed to block the body's ability to transport bile acid and thus halt the buildup of fluids that can cause major damage in patients with rare cholestatic liver diseases. And, last month, the company filed an IND for SHP626 (LUM002) with plans to start a Phase I trial in patients with nonalcoholic steatohepatitis early next year.

Separately, Shire has struck up a deal with the Cystic Fibrosis Foundation's nonprofit drug development arm in hopes of developing an mRNA solution for the disease. The nonprofit has committed up to $15 million to support Shire's work in mRNA, through which it hopes to craft a treatment that can correct the errant CFTR gene at the heart of the disease.

Each of those parts plays a role in Shire's plan to effectively double its revenue to $10 billion by 2020, a figure that includes $7 billion from on-the-market products like the ADHD treatment Vyvanse and rare disease therapy Firazyr, the company said.

"Our clinical and scientific capabilities in discovering new therapies for rare diseases are focused on new indications and therapeutic areas," Shire R&D chief Philip Vickers said in a statement. "We have a number of significant clinical milestones anticipated over the next 18 months, and aim to accelerate delivery of therapies to patients from a highly productive internal pipeline, complemented by the acquisition of external assets and innovative collaborations."

Shire is quickly moving on after AbbVie's plot to buy the company for $55 billion fell apart last month, giving the Irish drugmaker a new lease on freedom and a $1.6 billion breakup fee for its trouble. Now CEO Flemming Ornskov, who has presided over 6 acquisitions in his brief tenure, is hinting at more deals to come, pointing to Shire's $4.5 billion deal for ViroPharma last year as a template for the future.

- read the statement

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