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Boston Scientific's Voraxaze's MAA Accepted by EMA for Review
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Boston Scientific Corporation’s (BSX - Free Report) business arm, BTG Specialty Pharmaceuticals, announced the acceptance of its Marketing Authorisation Application (MAA) review plea for Voraxaze (glucarpidase) by the European Medicines Agency (EMA). The review application has been submitted with the aim of seeking marketing authorization of Voraxaze to treat adults and children (from 28 days of age) who are at risk of methotrexate toxicity due to a delay in methotrexate elimination.
For investors’ note, the FDA had approved glucarpidase in 2012, which was subsequently launched in the United States. Further, the MAA for Voraxaze is based on clinical data along with real-world experience in the United States.
Boston Scientific aims to strengthen its Specialty Pharmaceuticals business on a global scale once the EMA approves the use of Voraxaze.
Significance of the Approval
Per management, Voraxaze has been available in Europe on a named patient basis for the past few years. However, the company aims to expand the use of Voraxaze for the treatment of cancer patients worldwide, who have been suffering from the toxic effects of methotrexate. To achieve this aim, Boston Scientific plans to educate physicians about the potential for Voraxaze. Hence, the company believes that the filing is the stepping stone toward a marketing authorization which would allow it to speak with European clinicians about treating the condition.
The MAA will be reviewed by the EMA under the centralized marketing authorization procedure. If approved, Voraxaze would receive marketing authorization in all member states of the European Union as well as in Iceland, Liechtenstein and Norway.
Notably, independent study about Voraxaze is being simultaneously conducted. This study explores whether routine application of Voraxaze in combination with high-dose methotrexate might lessen the toxicity, manage the risk to patients and enable them to complete therapy.
Industry Prospects
Per a report by 360iResearch, the global Specialty Pharmaceuticals market is projected to rise from a worth of $24,619.70 million in 2019 to $175,441.60 million by 2025, at a CAGR of approximately 38.7%. Factors like rising demand for specialty drugs for the treatment of complex or serious chronic conditions and increased reimbursement through the medical and pharmacy benefits are expected to drive the market.
Given the market potential, the acceptance of the MAA will provide a significant boost to the company’s business.
Other Regulatory Approvals
Of late, Boston Scientific has been receiving a slew of regulatory clearances for products across its business arms.
In July, the company’s WATCHMAN FLX Left Atrial Appendage Closure Device was cleared by the FDA, indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF).
Boston Scientific received the FDA’s 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System in June. Following the approval, the company began limited market release of the LUX-Dx ICM System to detect arrythmias associated with conditions such as AF, cryptogenic stroke and syncope.
The same month, the company received the Centers for Medicare & Medicaid Services’ approval for its application for a transitional pass-through payment category to describe single-use endoscopes, including the EXALT Model D Single-Use Duodenoscope, under the Medicare hospital outpatient prospective payment system.
In April, Boston Scientific received the FDA’s clearance for its DIRECTSENSE Technology, which it subsequently launched in the United States in June.
Some other notable recent clearances include the receipt of the U.S. approval for the SYNERGY XD Bioabsorbable Polymer (BP) Drug-Eluting Stent (DES) System, the next-generation SYNERGY BP-DES platform with the only 48 mm length DES available in the United States and enhanced deliverability features to enable improved arterial navigation in percutaneous coronary intervention cases. The system was recently launched in Japan following approval from the Japanese Pharmaceuticals and Medical Devices Agency.
The company’s Eluvia Drug-Eluting Vascular Stent System received regulatory approval from China's Center for Medical Device Evaluation and it has plans to begin a limited market release by the end of 2020.
Boston Scientific also received CE Mark for its INTELLANAV STABLEPOINT Ablation Catheter enabled with DIRECTSENSE Technology and subsequently began limited European release. Another CE Mark obtained by the company is for its POLARx Cryoablation System.
Price Performance
Shares of the company have lost 7.9% in the past year compared with the industry’s 4.4% fall and the S&P 500’s 15.8% growth.
Zacks Rank & Key Picks
Currently, Boston Scientific carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Hologic, Inc. (HOLX - Free Report) .
Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).
Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.
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Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Boston Scientific's Voraxaze's MAA Accepted by EMA for Review
Boston Scientific Corporation’s (BSX - Free Report) business arm, BTG Specialty Pharmaceuticals, announced the acceptance of its Marketing Authorisation Application (MAA) review plea for Voraxaze (glucarpidase) by the European Medicines Agency (EMA). The review application has been submitted with the aim of seeking marketing authorization of Voraxaze to treat adults and children (from 28 days of age) who are at risk of methotrexate toxicity due to a delay in methotrexate elimination.
For investors’ note, the FDA had approved glucarpidase in 2012, which was subsequently launched in the United States. Further, the MAA for Voraxaze is based on clinical data along with real-world experience in the United States.
Boston Scientific aims to strengthen its Specialty Pharmaceuticals business on a global scale once the EMA approves the use of Voraxaze.
Significance of the Approval
Per management, Voraxaze has been available in Europe on a named patient basis for the past few years. However, the company aims to expand the use of Voraxaze for the treatment of cancer patients worldwide, who have been suffering from the toxic effects of methotrexate. To achieve this aim, Boston Scientific plans to educate physicians about the potential for Voraxaze. Hence, the company believes that the filing is the stepping stone toward a marketing authorization which would allow it to speak with European clinicians about treating the condition.
The MAA will be reviewed by the EMA under the centralized marketing authorization procedure. If approved, Voraxaze would receive marketing authorization in all member states of the European Union as well as in Iceland, Liechtenstein and Norway.
Notably, independent study about Voraxaze is being simultaneously conducted. This study explores whether routine application of Voraxaze in combination with high-dose methotrexate might lessen the toxicity, manage the risk to patients and enable them to complete therapy.
Industry Prospects
Per a report by 360iResearch, the global Specialty Pharmaceuticals market is projected to rise from a worth of $24,619.70 million in 2019 to $175,441.60 million by 2025, at a CAGR of approximately 38.7%. Factors like rising demand for specialty drugs for the treatment of complex or serious chronic conditions and increased reimbursement through the medical and pharmacy benefits are expected to drive the market.
Given the market potential, the acceptance of the MAA will provide a significant boost to the company’s business.
Other Regulatory Approvals
Of late, Boston Scientific has been receiving a slew of regulatory clearances for products across its business arms.
In July, the company’s WATCHMAN FLX Left Atrial Appendage Closure Device was cleared by the FDA, indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF).
Boston Scientific received the FDA’s 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System in June. Following the approval, the company began limited market release of the LUX-Dx ICM System to detect arrythmias associated with conditions such as AF, cryptogenic stroke and syncope.
The same month, the company received the Centers for Medicare & Medicaid Services’ approval for its application for a transitional pass-through payment category to describe single-use endoscopes, including the EXALT Model D Single-Use Duodenoscope, under the Medicare hospital outpatient prospective payment system.
In April, Boston Scientific received the FDA’s clearance for its DIRECTSENSE Technology, which it subsequently launched in the United States in June.
Some other notable recent clearances include the receipt of the U.S. approval for the SYNERGY XD Bioabsorbable Polymer (BP) Drug-Eluting Stent (DES) System, the next-generation SYNERGY BP-DES platform with the only 48 mm length DES available in the United States and enhanced deliverability features to enable improved arterial navigation in percutaneous coronary intervention cases. The system was recently launched in Japan following approval from the Japanese Pharmaceuticals and Medical Devices Agency.
The company’s Eluvia Drug-Eluting Vascular Stent System received regulatory approval from China's Center for Medical Device Evaluation and it has plans to begin a limited market release by the end of 2020.
Boston Scientific also received CE Mark for its INTELLANAV STABLEPOINT Ablation Catheter enabled with DIRECTSENSE Technology and subsequently began limited European release. Another CE Mark obtained by the company is for its POLARx Cryoablation System.
Price Performance
Shares of the company have lost 7.9% in the past year compared with the industry’s 4.4% fall and the S&P 500’s 15.8% growth.
Zacks Rank & Key Picks
Currently, Boston Scientific carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Hologic, Inc. (HOLX - Free Report) .
QIAGEN’s long-term earnings growth rate is estimated at 22.3%. It currently flaunts a Zacks Rank #1. (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).
Hologic’s long-term earnings growth rate is estimated at 15.5%. The company presently sports a Zacks Rank #1.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>