Shire PLC (ADR) (NASDAQ:SHPG) Rare Disease Drug Gets Fast Track Designation


Shire PLC (ADR) (NASDAQ:SHPG), a top biotech stock company, has announced that its for recombinant ADAMTS13 (SHP655) has been awarded Fast Track designation by the United States Food and Drug Administration. ADAMTS13 (SHP655) is used in treatment of severe thrombotic thrombocytopenic purpura (hTTP) in patients with shortage of von Willebrand factor-cleaving (VWF) protease ADAMTS13.

Shire added the candidate to its portfolio in 2016 after acquiring erstwhile Baxalta Inc. the Food and Drug Administration’s Fast Track designation is meant to facilitate development of the drug and expedite its review so as to be used in treatment of serious illness as well as fill a big unmet demand in the market.

 The company plans to start an open-label and randomized two-session crossover trial with one arm continuing to the third phase to evaluate the efficacy and safety of SHP655 in the prevention and treatment of severe TTP in patients suffering from heredity deficiency of ADAMTS13.the study will be carried out in Europe, the United States and Japan.

For the last three months, Shire’s biotech stock has performed better than the Zacks classified Medical-Drugs industry. The stock recorded a 3.7% rise in the last three month above the 2.2% the industry gained.

The company occupies a strong and unique position in the market of rare diseases. The rare disease market has been growing much faster than the larger biopharmaceutical market. Impressive performance by Firazyr, Lialda and Vyvanse are expected to be the main drivers of the company’s growth in the upcoming quarters. The company’s ophthalmology space got a boost following the approval of Xiidra.

The company has been and continues to widen its product portfolios through partnerships and acquisitions. The company acquired Baxalta, a key element of its oncology, hematology and immunology offerings. These include Oncaspar which is used in the treatment of severe lymphocytic leukemia together with pacritinib.

The company currently carries the third zacks Rank (Hold). Among the better ranked and top biotech stocks include Anthera Pharmaceuticals Inc (NASDAQ:ANTH), Heska Corp (NASDAQ:HSKA) and Retrophin Inc (NASDAQ:RTRX) which all carry a Zacks Rank #1 (Strong Buy).


Please enter your comment!
Please enter your name here