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Global Blood (GBT) Thrives on Oxbryta, Overdependence a Woe
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Global Blood Therapeutics, Inc.’s only marketed drug, Oxbryta (voxelotor), is approved in the United States for the treatment of sickle cell disease (“SCD”), a chronic, inherited blood disorder that affects hemoglobin levels.
Oxbryta is approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above. The drug has seen solid uptake since its approval in November 2019. It has also made significant progress on new prescriptions and payer coverage. In the first six months of 2021, Oxbryta generated sales worth $86.6 million, reflecting an increase of almost 90% year over year.
Shares of Global Blood have plunged 34.3% so far this year against the industry’s increase of 1.1%.
Image Source: Zacks Investment Research
In January 2021, the European Medicines Agency (“EMA”) completed the validation of Global Blood’s marketing authorization application for Oxbryta tablets and started its standard review process. The company is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with SCD who are 12 years of age and older.
In July 2021, Global Blood submitted a supplemental new drug application (sNDA) to the FDA seeking accelerated approval of Oxbryta for the treatment of SCD in children aged four to 11 years. The company also submitted a separate new drug application or NDA to seek approval for a pediatric weight-based formulation of Oxbryta.
Global Blood is also evaluating the safety and pharmacokinetics of single and multiple doses of Oxbryta in the phase IIa HOPE-KIDS 1 study in adolescent and pediatric patients with SCD. A potential label expansion of the drug should drive sales in the future quarters.
In July 2021, Global Blood initiated two pivotal phase III studies on inclacumab for the treatment of vaso-occlusive crises (“VOC”) in patients with SCD. The company has an exclusive license agreement with Swiss pharma giant Roche (RHHBY - Free Report) for the development and commercialization of inclacumab.
We note that Global Blood currently has no approved product in its portfolio other than Oxbryta. Hence, due to the lack of a strong pipeline, the company is totally reliant on Oxbryta for growth, which does not bode well. Any regulatory setback for the drug will hurt the company’s prospects.
Also, competition remains tough in the target market as many other companies are also developing treatments for SCD. Novartis’ (NVS - Free Report) new marketed drug, Adakveo (crizanlizumab), an anti-P-selectin monoclonal antibody, is approved for the treatment of VOC in patients with SCD. Editas Medicine (EDIT - Free Report) has commenced the phase I/II RUBY study to assess the safety and efficacy of its experimental CRISPR medicine, EDIT-301, for treating SCD.
Image: Bigstock
Global Blood (GBT) Thrives on Oxbryta, Overdependence a Woe
Global Blood Therapeutics, Inc.’s only marketed drug, Oxbryta (voxelotor), is approved in the United States for the treatment of sickle cell disease (“SCD”), a chronic, inherited blood disorder that affects hemoglobin levels.
Oxbryta is approved by the FDA as an oral, once-daily treatment for SCD in patients aged 12 years or above. The drug has seen solid uptake since its approval in November 2019. It has also made significant progress on new prescriptions and payer coverage. In the first six months of 2021, Oxbryta generated sales worth $86.6 million, reflecting an increase of almost 90% year over year.
Shares of Global Blood have plunged 34.3% so far this year against the industry’s increase of 1.1%.
Image Source: Zacks Investment Research
In January 2021, the European Medicines Agency (“EMA”) completed the validation of Global Blood’s marketing authorization application for Oxbryta tablets and started its standard review process. The company is seeking full marketing approval from the EMA for Oxbryta to treat hemolytic anemia in patients with SCD who are 12 years of age and older.
In July 2021, Global Blood submitted a supplemental new drug application (sNDA) to the FDA seeking accelerated approval of Oxbryta for the treatment of SCD in children aged four to 11 years. The company also submitted a separate new drug application or NDA to seek approval for a pediatric weight-based formulation of Oxbryta.
Global Blood is also evaluating the safety and pharmacokinetics of single and multiple doses of Oxbryta in the phase IIa HOPE-KIDS 1 study in adolescent and pediatric patients with SCD. A potential label expansion of the drug should drive sales in the future quarters.
In July 2021, Global Blood initiated two pivotal phase III studies on inclacumab for the treatment of vaso-occlusive crises (“VOC”) in patients with SCD. The company has an exclusive license agreement with Swiss pharma giant Roche (RHHBY - Free Report) for the development and commercialization of inclacumab.
We note that Global Blood currently has no approved product in its portfolio other than Oxbryta. Hence, due to the lack of a strong pipeline, the company is totally reliant on Oxbryta for growth, which does not bode well. Any regulatory setback for the drug will hurt the company’s prospects.
Also, competition remains tough in the target market as many other companies are also developing treatments for SCD. Novartis’ (NVS - Free Report) new marketed drug, Adakveo (crizanlizumab), an anti-P-selectin monoclonal antibody, is approved for the treatment of VOC in patients with SCD. Editas Medicine (EDIT - Free Report) has commenced the phase I/II RUBY study to assess the safety and efficacy of its experimental CRISPR medicine, EDIT-301, for treating SCD.
Zacks Rank
Global Blood currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.