Portola Pharmaceuticals

Portola Pharmaceuticals is an American clinical stage biotechnology company that researches, develops, and commercializes drugs. The company focuses primarily on drugs used in the treatment of thrombosis and hematological malignancies.[2] Founded in 2003 and headquartered in South San Francisco, California, Portola Pharmaceuticals is a member of the NASDAQ Biotechnology Index.

In May 2020, Alexion Pharmaceuticals and Portola announced that they had entered into a definitive merger agreement for Alexion to acquire Portola.[3]

History

The company was founded on September 2, 2003,[4] and named after Gaspar de Portolà, who was the first European to see San Francisco Bay. It completed an IPO on NASDAQ in May 2013.[5]

The company developed P2Y12 inhibitor Elinogrel, transferring rights to Novartis in 2009.[6] The rights were returned in 2012 to Portola, which decided not to continue development.

Portola Pharmaceuticals has collaboration agreements with SRX Cardio, Dermavant, Millennium Pharmaceuticals, Daiichi Sankyo, Bayer, Janssen, BMS, and Pfizer.[7]

In the class action lawsuit of Hayden v. Portola Pharmaceuticals in U.S. District Court, in the Northern District of California, before U.S. District Judge Vince Chhabria, plaintiffs sued under Section 11 of the Securities Act of 1933 alleging that the company and its underwriters misrepresented its financial position ahead of a 2019 securities offering.[8][9] In November 2022, Judge Chhabria entered an order granting preliminary approval of the proposed settlement of the case in the proposed settlement amount of $17.5 million.[10][11][12]

Products

  • Andexanet alfa (Andexxa), a coagulation factor Xa (recombinant), inactivated-zhzo, the first and only antidote for patients treated with the new oral anticoagulants (NOACs) rivaroxaban and apixaban when a reversal of anticoagulation is required due to life-threatening or uncontrolled bleeding. Andexanet is not indicated for the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban. Approved by FDA in May 2018.[13] In February 2019, the European CHMP of EMA recommended the granting of a conditional marketing authorisation for Andexanet alfa (in EU: Ondexxya).[14] In April 2019 the European Commission granted the authorisation (approved) Andexanet for the 28 countries of the EU.[15]
  • Betrixaban (Bevyxxa), an oral direct FXa inhibitor for prevention of thrombosis; approved by FDA in June 2017.[16]
  • Cerdulatinib, an investigational - not approved - oral multikinase SYK/JAK inhibitor for hematological malignancies and topical use; granted Orphan drug status for PTCL by FDA in September 2018.[17]

References

  1. FORM 10-K For the Fiscal Year Ended December 31, 2018 portola.com, retrieved 13 May 2019^
  2. Corporate site portola.com, retrieved 11 May 2019^
  3. Alexion to Acquire Portola, businesswire.com, Retrieved 5 May 2020.^
  4. EX-3.2 sec.gov^
  5. "Portola Pharmaceuticals prices upsized IPO at $14.50, within the range"^
  6. Novartis gains worldwide rights to elinogrel, a Phase II anti-clotting compound pharmanews.eu, retrieved 2018-11-03^
  7. Collaborations, Portola Website retrieved 11 May 2019^
  8. Jody Godoy. Portola Pharmaceuticals, underwriters lose bid to toss shareholder lawsuit Reuters, August 11, 2021^
  9. Judge Dismisses Securities Claims As Lacking In Drug Company's Stock-Drop Suit - Lexis Legal News lexislegalnews.com^
  10. REMOTE HEARINGS apps.cand.uscourts.gov^
  11. Securities Settlement Approved in Class Action Against Portola Pharmaceuticals | Law Street Media November 1, 2022^
  12. Paul Hayden, et al., v. Portola Pharmaceuticals Inc., et al.,^
  13. FDA Approval Letter - ANDEXXA, May 3, 2018 fda.gov, retrieved 11 May 2019^
  14. EMA Positive Opinion - ONDEXXYA, March 1, 2019 ema.europa.eu, retrieved 11 May 2019^
  15. European Commission Grants Conditional Marketing Authorization for Portola Pharmaceuticals' Ondexxya™ (andexanet alfa), the First and Only Antidote for the Reversal of Factor Xa Inhibitors, PM Portola, April 26, 2019 portola.com, retrieved 11 May 2019^
  16. FDA approved betrixaban (BEVYXXA, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients, FDA, June 23, 2017 fda.gov, November 3, 2018, retrieved 11 May 2019^
  17. NASDAQ: Portola's (PTLA) Lymphoma Candidate Gets Orphan Drug Status, September 26, 2018 nasdaq.com, retrieved 11 May 2019^