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Shire's New Formulation of Oncaspar Gets CHMP Recommendation

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Shire plc announced that the Committee for Medicinal Products for Human Use ("CHMP") has recommended the approval of a freeze-dried formulation of Oncaspar for treating acute lymphoblastic leukemia ("ALL") in Europe. The marketing authorization application ("MAA") aims to get lyophilized Oncaspar approved for pediatric (from birth to 18 years) as well as adult patients.

Presently, the drug is approved in a liquid form for treating the same indication. The potential approval of the new formulation will increase the shelf life of Oncaspar by three times to 24 months.

Shire’s shares have underperformed the industry so far this year. The company’s shares have lost 9.5% compared with the industry’s gain of 2%.

Coming back to the release, we note that the new formulation of Oncaspar is built on research and market data on liquid Oncaspar collected for over a decade. The CHMP recommendation is based on analytical and nonclinical studies, which showed that lyophilized Oncaspar has comparable efficacy to the liquid formulation.

Notably, the CHMP’s positive opinion will now be reviewed by the European Commission and the final decision will be applicable to all 28 the European Union (EU) member countries plus Iceland, Norway and Liechtenstein.

Lyophilized Oncaspar works in a similar way as liquid Oncaspar and has the same dosing regimen as well. Also, the increase in shelf life is expected to help the company improve the supply of this critical drug. Moreover, the new formulation will improve the accessibility of the drug to ALL patients in countries where the liquid form is not allowed.

Shire PLC Price and Consensus

 

Shire PLC Price and Consensus | Shire PLC Quote

Zacks Rank & Stocks to Consider

Shire carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) , Exact Sciences Corporation (EXAS - Free Report) and Adaptimmune Therapeutics PLC (ADAP - Free Report) . While Ligand and Exact Sciences sport a Zacks Rank #1 (Strong Buy), Adaptimmune carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings per share estimates have remained stable for 2017 and increased from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprise in two of the trailing four quarters, with an average beat of 6.19%. Share price of the company has increased 40.8% year to date.

Exact Sciences’ loss estimates have remained stable for 2017 and 2018 over the 30 days. The company came up with positive earnings surprise in three of the trailing four quarters, with an average beat of 38.75%. The share price of the company has increased 254.9% year to date.

Adaptimmune’s loss estimates have narrowed from $1.07 to 95 cents for 2017 and from $1.00 to 90 cents for 2018 over the last 60 days. The company pulled off positive earnings surprise in two of the trailing four quarters, with an average beat of 2.56%. The share price of the company has increased 88.6% year to date.

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