Rigel Pharmaceuticals Provides Business Update
"Rigel has built a solid foundation for continued growth, anchored by increased revenues from our U.S. commercial business. With European approval of fostamatinib, we expect to generate revenue from royalty payments beginning in the second half of the year, and importantly, we will receive a
Preliminary Financial Update
While Rigel is still in the process of determining final results for the fourth quarter of 2019, the company expects to report net product sales of approximately
Contract revenues from collaborations for the quarter ended
For the fourth quarter 2019, Rigel expects to report total revenues of approximately
The company expects to report cash, cash equivalents and short-term investments as of
The above information is preliminary, has not been audited and is subject to change upon completion of the audit of the company's financial statements as of and for the year ended
Growing TAVALISSE in the U.S. Market
During the fourth quarter of 2019, a total of 1,518 bottles of TAVALISSE were sold in the U.S. of which 1,422 were shipped directly to patients and clinics. The refill rate at month 4 increased to approximately 54%, reflecting the benefit patients are experiencing as TAVALISSE is used more frequently in earlier line treatment and physicians become more experienced with its use.
Heading into 2020, Rigel is poised for further growth with plans to expand its salesforce by six people in key markets. In addition, the company intends to continue its ongoing data initiatives and leverage recently presented post-hoc data showing a 78% response rate in ITP patients who received TAVALISSE in second line use.
EC Approval of Fostamatinib and Product Launch
Rigel today announced that it has received EC approval of its marketing authorization application (MAA) for fostamatinib for the treatment of chronic immune thrombocytopenia in adult patients who are refractory to other treatments. With this approval, the company will receive a milestone payment of
Phase 3 Trial in Warm AIHA
Since the launch of FORWARD (
Clinical Development Pipeline
In the fourth quarter of 2019, Rigel announced results from its Phase 1 clinical trial of R8351, its interleukin-1 receptor-associated kinase 1/4 (IRAK1/4) inhibitor. This novel molecule is the only asset in clinical development that is a dual inhibitor of IRAK1 and IRAK4 and has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. The Phase 1 trial established proof-of-mechanism by demonstrating the inhibition of inflammatory cytokine production in an LPS (lipopolysaccharide) challenge.
In addition, Rigel recently initiated a Phase 1 trial of its receptor-interacting protein kinase (RIP1) inhibitor, R5521. RIP1 is believed to play a critical role in necroptosis, a form of regulated cell death implicated in inflammatory and neurodegenerative diseases. Initial data from Rigel's ongoing Phase 1 suggests R552 has an attractive pharmacokinetic (PK) and safety profile with a half-life of approximately 15 hours. In earlier preclinical studies, the molecule was shown to prevent joint and skin inflammation in a RIP1 kinase-mediated murine model.
Both assets target pathways that are of high interest in the biopharma industry and are widely thought to have significant potential in the treatment of inflammatory and immune-mediated diseases.
38th Annual J.P. Morgan Webcast Presentation Details
Rigel's presentation will be webcast and is scheduled to take place
In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's 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 respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.
The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response, and dysregulation of these pathways can lead to a variety of inflammatory pathological conditions. R835 treatment demonstrates amelioration of clinical symptoms in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the
The investigational candidate, R552, is an orally available, potent and selective inhibitor of receptor-interacting protein kinase (RIP1). RIP1 is believed to play a critical role in necroptosis. Necroptosis is a form of regulated cell death where the rupturing of cells leads to the dispersion of their inner contents, which induces immune responses and enhances inflammation. In preclinical studies, R552 prevented joint and skin inflammation in a RIP1-mediated murine model of inflammation and tissue damage. The safety and efficacy of R552 has not been established by the
TAVALISSE® (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Important Safety Information
Warnings and Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
- Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.
To report side effects of prescription drugs to the
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About Rigel (www.rigel.com)
1The product for this use or indication is investigational and has not been proven safe or effective by any regulatory authority.
Forward Looking Statements
This release contains forward-looking statements relating to, among other things, the commercial success of TAVALISSE in the U.S.; Rigel's ability to broaden its pipeline of assets targeting immune-mediated diseases; Rigel's efforts to expand fostamatinib in
IR Contact: David Burke
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