UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 15, 2019
RIGEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
0-29889 |
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94-3248524 |
(Commission File No.) |
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(IRS Employer Identification No.) |
1180 Veterans Boulevard
South San Francisco, CA
(Address of principal executive offices)
94080
(Zip Code)
Registrants telephone number, including area code: (650) 624-1100
Not Applicable
(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 Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 o
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. o
Securities pursuant to Section 12 (b) of the Act:
Title of Each Class |
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Trading Symbol(s) |
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Name of Each Exchange on Which |
Common Stock, par value $0.001 per share |
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RIGL |
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The Nasdaq Stock Market LLC |
Item 8.01. Other Events.
On November 15, 2019, Rigel Pharmaceuticals, Inc., or Rigel, issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the Marketing Authorization Application for fostamatinib disodium hexahydrate for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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Description |
99.1 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: November 18, 2019 |
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RIGEL PHARMACEUTICALS, INC. |
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By: |
/s/ Dolly A. Vance |
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Dolly A. Vance |
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Executive Vice President, General Counsel and Corporate Secretary |
Rigel Receives Positive CHMP Opinion for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe
SOUTH SAN FRANCISCO, November 15, 2019 /PRNewswire/ Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion for Rigels Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib) for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments.
The CHMP reviews medical product applications and provides their opinion to the European Commission (EC), which has the authority to approve medicines for use in Europe. The positive opinion will now be reviewed by the EC, which will issue a decision on the approval of fostamatinib in Europe within approximately 70 days.
We are extremely encouraged by the CHMPs positive opinion and look forward to the final decision on our MAA from the European Commission, said Raul Rodriguez, Rigels president and CEO. We are excited by the potential to provide adult chronic ITP patients in Europe with a new treatment option that addresses the primary cause of their disease. Our European partner, Grifols, is preparing diligently for a prospective commercial launch in 2020.
The CHMP based its opinion on data provided from the FIT Phase 3 clinical program, which included two randomized placebo-controlled trials (FIT1 and FIT2) and an open-label extension trial (FIT3). The MAA included data from 163 ITP patients and was supported by a safety database of more than 4,600 subjects across all other indications in which fostamatinib has been evaluated.
Fostamatinib is commercially available in the U.S. and is the first and only spleen tyrosine kinase (SYK) inhibitor indicated for the treatment of thrombocytopenia in U.S. adult patients with chronic ITP who have had an insufficient response to a previous treatment. Europe is the second largest market for adult chronic ITP treatments after the United States.
About ITP
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the bodys own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. Rigels pioneering research focuses on signaling pathways that are critical to disease mechanisms. The companys first FDA approved product is TAVALISSE® (fostamatinib disodium hexahydrate) tablets, the only oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Rigels current clinical programs include a Phase 3 study of fostamatinib in autoimmune hemolytic anemia (AIHA); a recently completed Phase 1 study of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program; and an ongoing Phase 1 study of R552, a proprietary molecule from its receptor-interacting protein kinase (RIP1) inhibitor program. In addition, Rigel has product candidates in clinical development with partners Aclaris Therapeutics, AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
Forward Looking Statements
This release contains forward-looking statements relating to, among other things, the CHMP opinion and the potential approval and subsequent 2020 commercial launch in Europe of fostamatinib for the treatment of chronic ITP, and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as potential, will, may, expect, prospective, and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on Rigels current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of TAVALISSE; risks that the FDA, EMA or other regulatory authorities may make adverse decisions regarding fostamatinib; risks that TAVALISSE clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that TAVALISSE may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop Rigels product candidates; market competition; as well as other risks detailed from time to time in Rigels reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. Rigel does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
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Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com