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Shire (SHPG) Rare Disease Drug Gets Fast Track Designation

Zacks Equity Research

Shire plc SHPG announced that the FDA has granted Fast Track designation for recombinant ADAMTS13 (SHP655) for the treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional deficiency of the von Willebrand factor-cleaving (VWF) protease ADAMTS13.

The candidate was added to Shire’s portfolio through the acquisition of erstwhile Baxalta Inc. in 2016.

We note that the FDA's Fast Track process facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Shire plans to initiate a randomized, open-label, 2-period crossover study with a single arm continuation phase III trial to evaluate the safety and efficacy of SHP655 in the treatment and prevention of acute TTP events in patients with severe hereditary ADAMTS13 deficiency. The trial will be conducted in the U.S., Europe, and Japan.

Shire’s shares have outperformed the Zacks classified Medical-Drugs industry. The stock gained 3.7% in the last three months better than the industry’s gain of 2.2%.

We note that Shire has a dominant position in the rare diseases market, which is growing faster than the broader biopharmaceutical market. Strong performance of Vyvanse, Lialda and Firazyr should continue to drive its top line in the upcoming quarters. The approval of Xiidra has boosted the company’s ophthalmology space.

Shire continues to broaden its product portfolio through acquisitions and partnerships. The acquisition of Baxalta added key products to Shire's hematology, oncology and immunology franchises. These include Oncaspar, a marketed biologic treatment for acute lymphocytic leukemia along with pacritinib, an experimental oral kinase inhibitor for the treatment of myelofibrosis.

Zacks Rank & Stock to Consider

Shire currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the health care sector include Heska Corporation HSKA, Anthera Pharmaceuticals, Inc. ANTH and Retrophin, Inc. RTRX. All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018 over the last 30 days. The company posted a positive earnings surprise in all the four trailing quarters with an average beat of 291.54%. Its share price increased 34.2% year to date.

Anthera’s loss estimates narrowed from $1.49 to $1.17 for 2017 over the last 60 days.

Retrophin’s loss estimates narrowed from 85 cents 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.

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