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Baxalta

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Baxalta
Company typeSubsidiary of Shire plc
IndustryBiotechnology
Founded2015
Spun off from Baxter International
Headquarters
United States Edit this on Wikidata
ProductsHematology, Immunology, Pulmonology
Number of employees
16,000[1]
Websitewww.baxalta.com

Baxalta (Bax, taken from its former parent company and Alta taken from the Latin Altus which translates as 'high' or 'profound'[2]) was a biopharmaceutical company founded on 1 July 2015 after its parent company, Baxter International, spun off biopharmaceutical division.[1][3] with revenue of $6 billion.

Company History

Baxalta inherited all of its parent company's on-the-market treatments, focused on hemophilia, The company aims to launch 20 in-development projects by 2020, heaping $2.5 billion in annual sales. Before being spun off, Baxalta acquired SuppreMol for $225 million. Baxalta also acquired the blockbuster leukemia drug Oncaspar from Sigma-Tau Finanziaria S.p.A. for $900 million.[1][4]

In August 2015, Shire Plc made an unsolicited $30.6 billion stock offer for the company[5][6] sending the Baxalta share price up over 16%. Baxalta investors would be set to receive 0.1687 of Shire's American Depositary Receipts for every share they hold, representing a premium of 36% when compared to the company's stock price as of August 3.[7] This deal would also be set to create the largest global biotech company focused solely on rare diseases.[7]

In January 2016, after 6 months of negotiations, the company agreed to be acquired by Shire for $32 billion.[8] Shareholders have approved of the transaction and the deal is planned to close on 3 June 2016.[9]

As of 3 June 2016, Shire plc has officially acquired Baxalta Inc.

Pipeline

Hematology
  • BAX 855 – long-acting pegylated full-length rFVIII[10] hemophilia A drug awaiting FDA approval in conjunction with Nektar Therapeutics.[11] It is also undergoing Phase II trials for sickle cell.[12]
  • BAX 111 – submitted as a recombinant von Willebrand factor treatment for von Willebrand disease, filed with the FDA in December 2014.[13] In August 2015, data was released and published in the journal Blood,[14] which indicated that 100 percent of the patients treated with BAX 111 were successful in the management of bleeding episodes.[15][16]
  • BAX 817 – Recombinant factor VIIa[12]
  • BAX 335 – FIX gene therapy in Phase II.[12]
  • BAX 930 – Recombinant ADAMTS13[12]
  • BAX 826 – Recombinant, extended half-life Factor VIII[12]
  • BAX 888 – Factor VIII gene therapy in Phase I trials.[12]
Immunology
Oncology
  • MM-398 – Co-developed with Merrimack Pharmaceuticals.[17] Undergoing EU reviews for post-Gemcitabine pancreatic cancer, in Phase III trials for gastric cancer[12] Currently undergoing priority review with the FDA[18] for a new drug application.[19][20]
  • Pacritinib – Phase III trials for Myelofibrosis, Phase I trials for Acute Myeloid Leukemia and pre-clinical for Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome and Polycythemia Vera.[12]
  • Rigosertib – Phase III trials for Myelodysplastic Syndrome.[12]
  • BAX 069 – also known as Imalumab, in Phase II trials for Malignant Ascites and Metastatic Colorectal cancer.[12]

References

  1. ^ a b c Ben Reynolds. "Baxalta: A Rare Undervalued Biopharmaceutical Company". cnafinance.com.
  2. ^ "An Error Occurred Setting Your User Cookie". future-science.com.
  3. ^ "Baxalta: Baxter's newly named biopharma spinout has had its ups and downs". FierceBiotech.
  4. ^ "Baxter Expands Cancer Therapies With $900M Oncaspar Buy". law360.com.
  5. ^ Tess Stynes (4 August 2015). "Shire Makes Unsolicited $30 Billion Bid for Baxalta". WSJ.
  6. ^ "Shire Offers $30B for Baxalta". GEN.
  7. ^ a b Kevin McCoy, USA TODAY (4 August 2015). "Pharma mania: Shire offers $30B for Baxalta". USA TODAY.
  8. ^ http://www.genengnews.com/gen-news-highlights/shire-baxalta-tie-the-knot-in-32b-merger/81252213/
  9. ^ DeMuth, Jr., Chris (27 May 2016). "Facebook Is Watching You". Seeking Alpha. Baxalta. Retrieved 2016-05-27.
  10. ^ "Blood Journal - Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A". bloodjournal.org.
  11. ^ "Baxalta & Nektar Reveal Full Data from Hemophilia Study - Analyst Blog". NASDAQ.com. 17 July 2015.
  12. ^ a b c d e f g h i j k l m n o p "Pharmaceutical Development Pipeline - Baxalta". baxalta.com.
  13. ^ "Baxalta's first-of-its-kind bleeding drug lines up for FDA approval". FierceBiotech.
  14. ^ "Blood Journal - Hemostatic efficacy, safety and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease". bloodjournal.org.
  15. ^ "Blood Publishes Phase III Data on Baxalta's Investigational Treatment for Von Willebrand Disease, the Most Common Type of Inherited Bleeding Disorder". Yahoo Finance. 3 August 2015.
  16. ^ "Blood Publishes Phase III Data on Baxalta's Investigational Treatment for Von Willebrand Disease, the Most Common Type of Inherited Bleeding Disorder - Business Wire". businesswire.com. 3 August 2015.
  17. ^ "MM-398". merrimackpharma.com.
  18. ^ Merrimack Pharmaceuticals, Inc. (25 June 2015). "U.S. FDA Grants Priority Review for MM-398 New Drug... -- CAMBRIDGE, Mass. and DEERFIELD, Ill., June 25, 2015 /PRNewswire/ --". prnewswire.com.
  19. ^ "U.S. FDA Grants Priority Review for MM-398 New Drug Application". merrimackpharma.com.
  20. ^ "Oncology Times". LWW.