bluebird bio

bluebird bio, Inc.
Type	Public company
Traded as	NASDAQ: BLUE
Industry	Biotechnology; Pharmaceutical industry
Founded	April 16, 1992
Founders	Philippe Leboulch
Headquarters	Cambridge, Massachusetts, U.S.
Key people	Nick Leschly, President & CEO; Chip Baird, CFO
Products	Zynteglo
Revenue	$44 million (2019)
Net income	-$789 million (2019)
Total assets	$1.727 billion (2019)
Total equity	$1.284 billion (2019)
Number of employees	1,090 (2019)
Website	www.bluebirdbio.com
	Footnotes / references; [1]

bluebird bio, Inc., based in Cambridge, Massachusetts, is a biotechnology company that develops gene therapies for severe genetic disorders and cancer.[1]

The company's only - in the European Union (EU) - approved drug is betibeglogene autotemcel (Zynteglo), which treats transfusion-dependent beta thalassemia (TDT), a rare genetic blood disorder, and has been approved for use by the European Medicines Agency.[2] The company has been criticized for the $1.8 million cost of the drug, which is the second most expensive drug in the world.[3][4][5]

The company is developing LentiGlobin gene therapy for the treatment of sickle cell disease and cerebral adrenoleukodystrophy. It is also developing T cell product candidates to treat acute myeloid leukemia, Merkel-cell carcinoma, diffuse large B-cell lymphoma, and MAGEA4 solid tumors.[1]

History

The company was founded as Genetix Pharmaceuticals in April 1992 by Philippe Leboulch.

In September 2010, the company was renamed bluebird bio and Nick Leschy was named chief executive officer.[6]

In June 2013, the company became a public company via an initial public offering, raising $116 million.[7]

In June 2014, the company acquired Precision Genome Engineering Inc. for up to $156 million.[8]

In November 2017, Celgene, now Bristol-Myers Squibb (BMS), announced a collaboration with bluebird bio regarding bb2121 Anti-BCMA CAR-T Cell Therapy.[9] In May 2020 the FDA issued a refusal to file letter to BMS and bluebird bio's marketing application seeking approval of idecabtagene vicleucel (ide-cel) for patients with heavily pre-treated relapsed and refractory multiple myeloma.[10] (US approval of ide-cel by March 31, 2021 is one of the required remaining milestones of the contingent value rights (CVR) issued upon the close of Bristol Myers Squibb's purchase of Celgene in 2019. Ide-cel is a BCMA-directed genetically modified autologous CAR-T-cell immunotherapy.)

In August 2018, the company announced a collaboration with Regeneron Pharmaceuticals to discover, develop and commercialize new cell therapies for cancer.[11]

Products

Zynteglo: In June 2019, the company received approval from the European Commission to market in the EU betibeglogene autotemcel (Zynteglo), a medication for the treatment for beta thalassemia.[12] Bluebird has yet to seek FDA approval for the treatment. The FDA granted Zynteglo orphan drug and breakthrough therapy designations for the treatment of TDT.[12][13][14]

References

"bluebird bio, Inc. 2019 Form 10-K Annual Report". U.S. Securities and Exchange Commission.
"Zynteglo". European Medicines Agency.
Lovelace, Berkeley (June 14, 2019). "Bluebird Bio CEO defends $1.8 million price for gene therapy — 'It's really thinking about it differently'". CNBC.
LaMattina, John (19 June 2019). "What Bluebird Bio Gets Wrong In Pricing For Its $1.8 Million Drug". Forbes.
Kolata, Gina (September 11, 2017). "New Gene-Therapy Treatments Will Carry Whopping Price Tags". The New York Times.
"Genetix Pharmaceuticals Renamed bluebird bio; Announces Appointment of Nick Leschly as Chief Executive Officer" (Press release). bluebird bio. September 9, 2010.
Alspach, Kyle (June 25, 2013). "Bluebird bio IPO closes with $116M raised". American City Business Journals.
Resende, Patricia (July 1, 2014). "Bluebird bio in deal to buy Seattle biotech for up to $156M". American City Business Journals.
Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation from FDA and Prime Eligibility from EMA for Relapsed and Refractory Multiple Myeloma, PM Celgene November 16, 2017, retrieved May 14, 2020
Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma, PM BMS May 13, 2020, retrieved May 14, 2020
"Regeneron and bluebird bio Announce Collaboration to Discover, Develop and Commercialize New Cell Therapies for Cancer" (Press release). PR Newswire. August 6, 2018.
"bluebird bio Announces EU Conditional Marketing Authorization for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia Who Do Not Have β0/β0 Genotype" (Press release). Business Wire. June 3, 2019.
Our Products, Company Website, accessdate: May 9, 2020
"Autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 18 March 2013. Retrieved 8 June 2020.

External links

Official website

Business data for bluebird bio, Inc.:

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[10K-1] "bluebird bio, Inc. 2019 Form 10-K Annual Report". U.S. Securities and Exchange Commission.

[2] "Zynteglo". European Medicines Agency.

[3] Lovelace, Berkeley (June 14, 2019). "Bluebird Bio CEO defends $1.8 million price for gene therapy — 'It's really thinking about it differently'". CNBC.

[4] LaMattina, John (19 June 2019). "What Bluebird Bio Gets Wrong In Pricing For Its $1.8 Million Drug". Forbes.

[5] Kolata, Gina (September 11, 2017). "New Gene-Therapy Treatments Will Carry Whopping Price Tags". The New York Times.

[6] "Genetix Pharmaceuticals Renamed bluebird bio; Announces Appointment of Nick Leschly as Chief Executive Officer" (Press release). bluebird bio. September 9, 2010.

[7] Alspach, Kyle (June 25, 2013). "Bluebird bio IPO closes with $116M raised". American City Business Journals.

[8] Resende, Patricia (July 1, 2014). "Bluebird bio in deal to buy Seattle biotech for up to $156M". American City Business Journals.

[9] Celgene Corporation and bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation from FDA and Prime Eligibility from EMA for Relapsed and Refractory Multiple Myeloma, PM Celgene November 16, 2017, retrieved May 14, 2020

[10] Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma, PM BMS May 13, 2020, retrieved May 14, 2020

[11] "Regeneron and bluebird bio Announce Collaboration to Discover, Develop and Commercialize New Cell Therapies for Cancer" (Press release). PR Newswire. August 6, 2018.

[EU-12] "bluebird bio Announces EU Conditional Marketing Authorization for Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia Who Do Not Have β0/β0 Genotype" (Press release). Business Wire. June 3, 2019.

[13] Our Products, Company Website, accessdate: May 9, 2020

[14] "Autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 18 March 2013. Retrieved 8 June 2020.