SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 16, 2021
PhaseBio Pharmaceuticals, Inc.
(Exact name of registrant as specified in its Charter)
(State or Other Jurisdiction of
1 Great Valley Parkway, Suite 30
(Address of Principal Executive Offices)
(Registrant’s Telephone Number, Including Area Code)
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act.
Title of each class
Name of exchange on which registered
|Common Stock, par value $0.001 per share|
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x
Item 1.01 Entry into a Material Definitive Agreement.
On June 16, 2021, PhaseBio Pharmaceuticals, Inc. (the “Company”) entered into a sublicense agreement (the “Alfasigma Sublicense”) with Alfasigma S.p.A. (“Alfasigma”), under which the Company granted to Alfasigma exclusive rights to develop, use, sell, have sold, offer for sale and import any product comprised of or containing bentracimab (the “Licensed Products”) in the European Union and the European Economic Area, as well as the United Kingdom, Russia, Ukraine and certain other countries within the Commonwealth of Independent States, Europe and central Asia (the “Territory”). In addition, the Company granted to Alfasigma an exclusive, royalty-bearing sublicense under certain patent rights and know-how owned or controlled by the Company with respect to bentracimab, including certain patent rights and know-how licensed to the Company from MedImmune Limited (a wholly-owned subsidiary of AstraZeneca) (“MedImmune”) pursuant to a license dated November 21, 2017 (the “AZ License”). The out-licensed patent rights are generally directed to antibodies that bind to ticagrelor and methods of use and include one pending application in the European Patent Office and one pending application in the Russian Federation which, if issued, are expected to expire in 2035.
Under the terms of the Alfasigma Sublicense, Alfasigma will be required to pay the Company:
•an upfront fee of $20.0 million;
•up to $35.0 million upon the achievement of certain regulatory milestones;
•up to $190.0 million upon the achievement of certain commercial milestones; and
•royalty payments in the low double-digit to mid-twenty percentages on net sales of Licensed Products.
With respect to the up to $35.0 million of regulatory milestone payments: (i) $10.0 million is payable following acceptance by the European Medicines Authority (“EMA”) of the filing of the first drug approval application for a Licensed Product; (ii) $12.5 million is payable following achievement of conditional regulatory approval from the EMA; and (iii) the remaining $12.5 million is payable following achievement of unconditional regulatory approval from the EMA allowing for prescribing of a Licensed Product for the reversal of the antiplatelet effects of ticagrelor in both (a) patients with uncontrolled major or life-threatening bleeding and (b) patients requiring urgent surgery or an invasive procedure.
Under the Alfasigma Sublicense, the Company is responsible for developing the Licensed Products and securing regulatory approval with the EMA and the Medicines and Healthcare products Regulatory Agency (the “MHRA”), including in accordance with the Company’s existing Co-Development Agreement (the “Co-Development Agreement”) with SFJ Pharmaceuticals X Limited (“SFJ”), after which any marketing authorizations will be assigned to Alfasigma. Alfasigma is obligated to obtain and maintain any regulatory approvals necessary to market and sell the Licensed Products (including pricing approvals and post-marketing commitments) and is also responsible for securing regulatory approval in countries outside of Europe and the United Kingdom. The Company and Alfasigma will form a joint steering committee to oversee and manage the development and commercialization of the Licensed Products in the Territory. The Company maintains its right, but not obligation, to control prosecution of the out-licensed patents.
The Alfasigma Sublicense excludes any right to manufacture the Licensed Products, and the Company will supply Alfasigma’s requirements for Licensed Product at cost, at a price not to exceed certain agreed amounts. A summary of the terms on which the Company will supply the Licensed Products to Alfasigma is annexed to the Alfasigma License and the Company and Alfasigma will enter into a supply agreement on which the Company will supply the Licensed Product. In the event the Company fails to supply the Licensed Products to Alfasigma, the remedies under the supply agreement will include proportional allocation and potential technology transfer, if such failure is long-term.
Unless earlier terminated, the Alfasigma Sublicense automatically expires, with respect to each Licensed Product and each country in the Territory, on the latest of (1) the tenth anniversary of the first commercial sale of such Licensed Product in such country, (2) the expiration of the last out-licensed patent of such Licensed Product in such country and (3) the expiration of regulatory exclusivity, if any, of such Licensed Product in such country.
The Alfasigma Sublicense contains, among other provisions, representation and warranties, indemnification obligations, confidentiality, publicity, audit and inspection, and intellectual property sharing provisions in favor of each party that are customary for an agreement of this nature.
In connection with the Alfasigma Sublicense, on June 16, 2021, the Company and Alfasigma entered into an Acknowledgement of Grant of Sublicense with MedImmune (the “Acknowledgment of Grant”), which provides for, among other things, a potential assignment of the Alfasigma Sublicense from the Company to MedImmune or a potential assignment of the AZ License from the Company to Alfasigma, in either case in the event that the Company breaches certain obligations under the AZ License that are not cured or remedied and SFJ has grounds to execute a “Program Transfer” (as defined in the Co-Development Agreement) but elects not to do so.
The foregoing summaries of the Alfasigma Sublicense and the Acknowledgement of Grant are not complete and are qualified in their entirety by reference to the text of the Alfasigma Sublicense and the Acknowledgement of Grant, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.
Item 7.01 Regulation FD Disclosure.
On June 17, 2021, the Company issued a press release (the “Press Release”) announcing the Alfasigma Sublicense. A copy of this Press Release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”) and is incorporated herein by reference.
The information contained in this Item 7.01 of the Form 8-K, including Exhibit 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 9.01 Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|PhaseBio Pharmaceuticals, Inc.|
|Dated: June 17, 2021||By:||/s/ John P. Sharp|
|John P. Sharp|
|Chief Financial Officer|
PhaseBio Announces European Licensing Agreement with Alfasigma S.p.A for Commercialization of Bentracimab
Agreement provides PhaseBio with $20 million upfront payment and eligibility to receive up to $245 million in development and commercial milestones in addition to tiered double digit royalties on sales
Collaboration reinforces global bentracimab opportunity
Establishes accessibility to bentracimab, if approved, for the largest pool of ticagrelor patients in the world
PhaseBio to host conference call today at 5:30 am PST / 8:30 am EST
MALVERN, Pa. and SAN DIEGO, June 17, 2021 – PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that it has entered into an exclusive licensing agreement with Alfasigma S.p.A., a privately owned specialty pharmaceutical company focused on commercializing medicines in Europe and other key markets, for the commercialization of bentracimab. The agreement covers countries in the European Union and European Economic Area, as well as the United Kingdom, Russia, Ukraine and other countries within the Commonwealth of Independent States. Bentracimab is a novel, human monoclonal antibody fragment that in earlier clinical trials has shown immediate and sustained reversal of the antiplatelet effects of Brilinta®/Brilique® (ticagrelor).
Under the terms of the license agreement, PhaseBio will receive a $20 million upfront payment and will be eligible to receive up to $35 million in pre-revenue regulatory milestones and up to $190 million in payments contingent upon the achievement of certain sales milestones. PhaseBio will also receive tiered royalties on net sales, with percentages starting in the low double digits and escalating up to the mid-twenties. PhaseBio will be responsible for developing bentracimab and securing approval with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), after which marketing authorization will be assigned to Alfasigma. Alfasigma will be responsible for securing regulatory approval in other territories not covered by EMA or MHRA approvals, and for obtaining and maintaining regulatory approvals necessary to market and sell the product, including pricing approvals and post-marketing commitments.
“The signing of this commercialization agreement with our new partner, Alfasigma, is a truly momentous occasion for PhaseBio,” said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals. “Alfasigma brings deep regional expertise in the hospital environment that we believe will help unlock the value of the global bentracimab brand while enabling PhaseBio to invest in the commercial infrastructure necessary to successfully launch the product in the United States. By establishing
bentracimab in key markets where a significant proportion of the global ticagrelor patient population resides, Alfasigma will play a critical role in our mission to change the way patients on antiplatelet therapy are managed. We are excited to have found a collaborator who shares our enthusiasm for the potential of bentracimab to address critical unmet needs and look forward to a long and mutually-beneficial relationship.”
“This agreement marks another important milestone in our journey to establish Alfasigma as a major international specialty company, and a partner of choice for companies seeking to leverage our expertise in key markets across Europe,” said Pier Vincenzo Colli, Chief Executive Officer of Alfasigma. “The unmet need for bentracimab is clear: we are proud to serve these patients and bring this valuable medicine into the Alfasigma family of specialty products. As one of the leading European-based specialty pharmaceutical companies with a hospital presence and a core focus in the vascular therapeutic area and other cardio-metabolic diseases, Alfasigma is well positioned to commercialize bentracimab. We share a high degree of enthusiasm with PhaseBio as we look forward to building the global bentracimab brand across Europe and other key markets.”
Bentracimab is currently in late-stage clinical development in the REVERSE-IT (Rapid and SustainEd ReVERSal of TicagrElor – Intervention Trial) trial. REVERSE-IT is a Phase 3, multi-center, open-label, prospective single-arm trial designed to study reversal of the antiplatelet effects of ticagrelor with bentracimab in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or an invasive procedure. The Company expects to complete enrollment of the first 100 patients in the REVERSE-IT trial in mid-2021 and is targeting to submit its Biologics License Application (BLA) for bentracimab in mid-2022, although those timelines could be impacted by the continued scope and duration of the COVID-19 pandemic. To date, nearly all of the patients enrolled have required urgent surgery or an invasive procedure.
Previously, bentracimab has been studied in Phase 1 and Phase 2 clinical trials and has demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of the antiplatelet activity of ticagrelor, potentially mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. Additionally, in a translational study, bentracimab achieved equivalent reversal of branded ticagrelor and multiple ticagrelor generics.
Conference Call and Details
PhaseBio leadership will host a conference call today, June 17, 2021, at 5:30 am PST / 8:30 am EST to discuss today’s announcement. To access the call, please dial 866-221-1776 (domestic) or 270-215-9926 (international) and provide the Conference ID 9369434 to the operator.
To access the audio webcast and subsequent archived recording of this presentation, click here or visit the investor section of the PhaseBio website. The archived call will remain available for replay on PhaseBio’s website for 90 days.
About Bentracimab (PB2452)
Bentracimab is a novel, recombinant, human monoclonal antibody antigen-binding fragment designed to reverse the antiplatelet activity of ticagrelor in major bleeding and urgent surgery situations. In a Phase 1 clinical trial, bentracimab demonstrated the potential to bring life-saving therapeutic benefit through immediate and sustained reversal of ticagrelor’s antiplatelet activity, mitigating concerns regarding bleeding risks associated with the use of this antiplatelet drug. The Phase 1 clinical trial of bentracimab in healthy volunteers was published in the New England Journal of Medicine in March 2019. In April 2019, bentracimab received Breakthrough Therapy Designation from the Food and Drug
Administration (FDA). Breakthrough Therapy Designation may be granted by the FDA when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapy. In September 2019, PhaseBio completed a Phase 2a trial in which bentracimab was investigated in older and elderly subjects on dual antiplatelet therapy of ticagrelor and low-dose aspirin. Additionally, the Phase 2a trial investigated a bentracimab regimen for the reversal of supratherapeutic doses of ticagrelor in healthy younger subjects. In both arms of the trial, bentracimab achieved immediate and sustained reversal of the antiplatelet effects of ticagrelor and was generally well-tolerated, with only minor adverse events reported. These results are consistent with the results observed in healthy younger subjects treated with ticagrelor in the previously published Phase 1 trial. PhaseBio initiated the REVERSE-IT trial, a pivotal Phase 3 clinical trial of bentracimab, in March 2020 to support a Biologics License Application for bentracimab in both major bleeding and urgent surgery indications. There are currently no approved reversal agents for ticagrelor or any other antiplatelet drugs.
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. The company’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including pemziviptadil, and drives both internal and partnership drug-development opportunities.
PhaseBio is located in Malvern, PA, and San Diego, CA. For more information, please visit www.phasebio.com, and follow us on Twitter @PhaseBio and LinkedIn.
Privately owned, Alfasigma is an Italy based multinational pharmaceutical company, present in over 90 countries, through distributors and subsidiaries. The company employs a workforce of around 3,000 people, has in-house R&D capabilities, and several production plants. Alfasigma is known for its strong focus on Gastroenterology and Vascular.
More information is available at the corporate website https://www.alfasigma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements.
Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed, including through our partnership with Alfasigma. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of
future performance, and you are cautioned not to place undue reliance on these forward-looking statements.
Risks regarding our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law.
PhaseBio Investor Contact:
PhaseBio Pharmaceuticals, Inc.
Chief Financial Officer
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Canale Communications, Inc.
Alfasigma Media Relations:
Head of Corporate Communications and Media Relations