The Current Manufacturer of VPRIV: Takeda Pharmaceuticals
Today, the manufacturing and distribution of VPRIV (velaglucerase alfa) are managed by Takeda Pharmaceuticals. This is a direct result of Takeda's significant acquisition of Shire plc, the company that originally developed and launched the medication. The transition brought VPRIV and Shire's other rare disease products into Takeda's extensive portfolio, solidifying Takeda's position in the global rare diseases market. For patients, this change ensured continued access to this critical enzyme replacement therapy (ERT), with Takeda upholding the existing manufacturing standards and supply chain. Takeda continues to oversee the production, quality control, and distribution of VPRIV globally.
The Takeda Acquisition of Shire
The acquisition of Shire by Takeda was one of the largest deals in pharmaceutical history, officially closing in January 2019. This strategic move allowed Takeda to expand its footprint in several key therapeutic areas, including rare diseases, where Shire was a leading player. As a result, former Shire products, including VPRIV, were integrated into Takeda’s operational structure. Takeda emphasized its commitment to a smooth transition and uninterrupted supply of medications for patients worldwide. The integration involved consolidating and leveraging manufacturing facilities, including the ones initially established by Shire for VPRIV production.
VPRIV's Origins with Shire
Before the acquisition, the story of VPRIV was synonymous with Shire plc. Shire was a specialty biopharmaceutical company focused on developing therapies for rare diseases. They were instrumental in developing velaglucerase alfa, an enzyme replacement therapy specifically designed for patients with Type 1 Gaucher disease. Shire's investment in state-of-the-art manufacturing facilities was a crucial part of this process.
Development and Early Approval
- Shire obtained FDA approval for VPRIV in February 2010.
- This approval was a significant milestone, offering patients a new therapeutic option for Gaucher disease.
- The development involved extensive clinical trials to prove its safety and efficacy, demonstrating that velaglucerase alfa could effectively replace the missing enzyme in patients.
Shire's Manufacturing Commitment
In 2014, Shire announced the FDA approval of its manufacturing facility in Lexington, Massachusetts, for producing VPRIV drug substance. This facility was purpose-built to use advanced manufacturing techniques, including single-use technology, to ensure a stable and consistent supply of VPRIV. This investment was a key part of Shire's strategy to reduce manufacturing risks and assure patients of a reliable treatment source. The manufacturing process uses a human cell line to produce the recombinant enzyme, ensuring it has the identical amino acid sequence as the naturally occurring human enzyme.
A Closer Look at VPRIV (Velaglucerase Alfa)
VPRIV, with its generic name velaglucerase alfa, is a hydrolytic lysosomal glucocerebroside-specific enzyme. It is indicated for the long-term treatment of Type 1 Gaucher disease, a rare genetic disorder. Patients with Gaucher disease lack a functional glucocerebrosidase enzyme, leading to a buildup of a fatty substance called glucocerebroside within cells. This accumulation can cause a range of symptoms, including enlarged liver and spleen, bone pain, and low blood cell counts. VPRIV works by replacing this missing enzyme, helping to break down the fatty substance and prevent its accumulation.
Administration and Patient Considerations
VPRIV is administered through intravenous (IV) infusion, typically once every other week. The infusion is overseen by a healthcare professional and can be done in a healthcare facility or at home. For patients who have been on other ERTs, a switch to VPRIV can be managed at the same dosage. The medication has been studied in a broad range of patients, including adults and children aged 4 and older. While generally well-tolerated, side effects like infusion-related reactions, headache, and abdominal pain can occur. In the event of a severe allergic reaction, such as anaphylaxis, immediate medical care is necessary.
Manufacturer Comparison: Shire vs. Takeda
| Feature | Shire plc | Takeda Pharmaceuticals |
|---|---|---|
| Period of Ownership | Initial developer and manufacturer (2010-2019) | Acquired Shire and assumed manufacturing (2019-Present) |
| VPRIV Role | Pioneered the development, clinical trials, and initial market launch of VPRIV. Built specialized manufacturing facilities. | Continued manufacturing and global distribution of VPRIV after acquisition. Integrated the drug into its rare disease portfolio. |
| Therapeutic Focus | Primarily a specialty biopharmaceutical company focused on rare diseases. | A global, diversified pharmaceutical company with a broad therapeutic focus, including a major rare diseases division. |
| Key Milestones for VPRIV | FDA approval (Feb 2010), EMA approval (Aug 2010), Establishment of dedicated manufacturing sites. | Acquisition of VPRIV rights and manufacturing facilities in 2019. Continued supply and support for patients. |
Conclusion
While VPRIV was developed and first brought to market by Shire plc, the company was acquired by Takeda Pharmaceuticals in 2019, making Takeda the current manufacturer. For patients relying on this essential enzyme replacement therapy for Type 1 Gaucher disease, the change in ownership did not interrupt the manufacturing process or access to the medication. Takeda has successfully integrated VPRIV into its rare disease portfolio, ensuring a continued and stable supply. The drug's history, from its initial development by Shire to its current production under Takeda, demonstrates a successful transition of a life-altering treatment. Patients should consult their healthcare provider for any questions regarding their treatment.
List of VPRIV Development and Manufacturing Milestones
- 2010: Shire plc receives FDA approval for VPRIV.
- 2010: Shire receives European Medicines Agency (EMA) approval for VPRIV.
- 2012: Shire receives EMA approval for its Lexington, MA facility for VPRIV manufacturing.
- 2014: Shire announces FDA approval of its Lexington, MA facility for VPRIV manufacturing.
- March 2014: Shire initiates a voluntary nationwide recall of one batch of VPRIV, with unaffected lots continuing in use.
- January 2019: Takeda Pharmaceutical Company completes its acquisition of Shire.
- 2019-Present: Takeda assumes full responsibility for the manufacturing and distribution of VPRIV.
Organizations Involved in VPRIV's Journey
- Shire plc: The UK-founded biopharmaceutical company that developed and commercialized VPRIV.
- Takeda Pharmaceutical Company: The current Japanese multinational pharmaceutical company that acquired Shire in 2019.
- US Food and Drug Administration (FDA): The regulatory body that granted the initial approval for VPRIV in the United States.
- European Medicines Agency (EMA): The European regulatory body that approved VPRIV for use within the European Union.
