{"id":411799,"date":"2021-01-11T07:33:24","date_gmt":"2021-01-11T12:33:24","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=411799"},"modified":"2021-01-11T07:33:24","modified_gmt":"2021-01-11T12:33:24","slug":"rigel-pharmaceuticals-provides-business-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/rigel-pharmaceuticals-provides-business-update\/","title":{"rendered":"Rigel Pharmaceuticals Provides Business Update"},"content":{"rendered":"
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TAVALISSE\u00ae preliminary 2020 net product sales of approximately $61.7 million, a year-over-year increase of 41%<\/h2>\n

U.S. FDA awards Fast Track designation to TAVALISSE\u00ae for warm autoimmune hemolytic anemia<\/h2>\n

Topline data from NIH Phase 2 clinical trial in COVID-19 expected in April ’21<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n SOUTH SAN FRANCISCO, Calif.<\/span>, Jan.\u00a011, 2021 \/PRNewswire\/ —\u00a0Rigel Pharmaceuticals, Inc.\u00a0(Nasdaq: RIGL) today provided a business update, including preliminary total revenue, TAVALISSE\u00ae<\/sup> (fostamatinib disodium hexahydrate) bottles sold for the quarter, Fast Track designation granted for warm autoimmune hemolytic anemia (wAIHA), and the company’s expanding COVID-19 program. The company’s president and CEO, Raul Rodriguez<\/span>, will provide a more detailed company overview during his presentation taking place on Thursday, January 14, 2020<\/span> at 10:00 am ET\u00a0at the 39th Annual J.P. Morgan Virtual Healthcare Conference.<\/p>\n

“Rigel’s accomplishments during the extraordinary global events of 2020 position the company well as we enter the new year,” said Raul\u00a0Rodriguez, Rigel’s president and CEO. “Annual sales of TAVALISSE grew by 41% compared to 2019, and its use as an earlier\u00a0line treatment option for ITP is resonating with both patients and physicians. We are continuing to enroll our Phase 3 trial in wAIHA\u00a0and\u00a0we have received Fast Track designation from the FDA which is intended to expedite the review of a potential regulatory filing. <\/p>\n

“The availability of vaccines is a critical step in managing the COVID-19 pandemic, but we expect there will continue to be a significant need for therapeutics. Our Phase 3 trial in COVID-19 has launched and topline data from the National Institutes of Health\u00a0Phase 2 trial is expected\u00a0in April, which will provide a near-term look at the potential of fostamatinib in this disease.” <\/p>\n

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\n Commercial and <\/u>
\n <\/b>
\n
\n Preliminary Financial Update
<\/u>
\n <\/b>In the fourth quarter of 2020, a total of 1,899 bottles of TAVALISSE were sold in the U.S., of which 1,725 were shipped directly to patients and clinics. While Rigel is still in the process of determining final results for the fourth quarter of 2020, the company expects to report net product sales of approximately $17.7 million<\/span>, compared to $13.8 million<\/span> in the same period of 2019, an increase of 28%.<\/p>\n

Contract revenues from collaborations for the quarter ended December 31, 2020<\/span>, are expected to be approximately $697,000<\/span>, which consists of $500,000<\/span> from Grifols related to an option for commercialization in additional territories and $197,000<\/span> in revenues earned from the performance of certain research and development services from Rigel’s collaboration agreement with Grifols.<\/p>\n

For the fourth quarter 2020, Rigel expects to report total revenue of approximately $18<\/span>.4\u00a0million.<\/p>\n

The company expects to report cash, cash equivalents and short-term investments as of December 31, 2020<\/span> of approximately $57<\/span>.3\u00a0million, compared to $98.0 million<\/span> as of December 31, 2019<\/span>.<\/p>\n

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 December 31, 2020<\/span>.<\/p>\n

\n
\n Portfolio Update
<\/u>
\n <\/b>
\n Phase 3 Trial in wAIHA
<\/b>The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAVALISSE for the treatment of wAIHA based on the significant medical need that exists and the product’s potential in the treatment of these patients. Fast Track designation is designed to enable an expedited review process for any potential regulatory filings. Currently, the study has enrolled 64 of 90, or 71%, of the patients planned for enrollment. <\/p>\n

\n COVID-19 Program
<\/b>The Phase 2 clinical trial sponsored by NIH\/NHLBI, in collaboration with Inova Health System, to evaluate the safety of fostamatinib for the treatment of COVID-19 has enrolled 44 of the 60 patients planned for enrollment. In this trial, patients are being randomized to fostamatinib plus standard of care (SOC) or matched placebo plus SOC (1:1), administered orally twice daily for 14 days. There will be a follow-up period to day 60. The primary endpoint of this study is cumulative incidence of serious adverse events (SAE) through day 29, with multiple secondary endpoints designed to assess the early efficacy and clinically relevant endpoints of disease course\u00a0as well as in vitro biological correlatives evaluating the effects of the drug on pathways involved in the pathophysiology of COVID-19, including NETosis. Rigel anticipates topline data to be reported in April\u00a0of this year.<\/p>\n

In addition, Rigel has launched its Phase 3 clinical trial to evaluate the safety and efficacy of fostamatinib in hospitalized COVID-19 patients without respiratory failure that have certain high-risk prognostic factors. The multi-center, double-blind, placebo-controlled, adaptive design study is expected to enroll over 300 evaluable patients that will be randomly assigned to either fostamatinib plus SOC or matched placebo plus SOC (1:1). Treatment will be administered orally twice daily for 14 days with a follow-up period to day 60. The primary endpoint of this study is the proportion of subjects who progress to severe\/critical disease within 29 days. <\/p>\n

In December, the Journal of Infectious Diseases (JID) published research from NIH which demonstrated that R406, the active metabolite of fostamatinib, was able to inhibit NETosis ex vivo in donor plasma from patients with COVID-19. NETosis is a unique type of cell death resulting in the release of neutrophil extracellular traps (NETs). NETs contribute to thromboinflammation and have been associated with mortality in COVID-19. These data provide insights for how fostamatinib may mitigate neutrophil-associated mechanisms contributing to COVID-19 immunopathogenesis.1<\/sup><\/p>\n

\n Clinical Development Pipeline
<\/b>Rigel’s IRAK1\/4 program includes R835, an orally available, potent and selective inhibitor and the only molecule in clinical development that inhibits both IRAK1 and IRAK4. The company plans to pursue this\u00a0program’s potential in hematology\/oncology and rare diseases, where it believes there are areas of significant unmet medical need.\u00a0 <\/p>\n

Rigel has an extensive RIPK1 inhibitor program. \u00a0This program includes R552, an oral systemic RIPK1 inhibitor which has completed a Phase 1 study, as well as RIPK1 inhibitor candidates that cross the blood-brain barrier (CNS-penetrants). RIPK1 inhibitors have broad potential in numerous large indications. In order to fully develop these assets, Rigel intends to enter into a collaboration for this program.<\/p>\n

\n
\n 39th Annual J.P. Morgan Webcast Presentation Details
<\/u>
\n <\/b>Rigel’s presentation will be webcast and is scheduled to take place Thursday, January 14<\/span> at 10:00 am ET<\/span>. To access the live and subsequently archived webcast, go to the Investor Relations section of the company’s website at www.rigel.com<\/a>. Please connect to the website several minutes prior to the start of the live webcast to ensure adequate time for any software download that may be necessary.<\/p>\n

\n
\n About ITP
<\/u>
\n <\/b>In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body’s\u00a0own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP include fatigue, 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. In addition to fostamatinib, 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.<\/p>\n

\n
\n About AIHA
<\/u>
\n <\/b>Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that recognize and mediate 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. Warm 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. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.<\/p>\n

\n
\n About COVID-19 & SYK Inhibition
<\/u>
\n <\/b>COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).\u00a0 SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.2<\/sup> Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.3<\/sup><\/p>\n

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (Fc\u03b3R) and c-type lectin receptor (CLR) mediated drivers of pathology, such as inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.4,5,6<\/sup> Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thromboinflammation, alleviating organ dysfunction in critically ill patients with COVID-19.<\/p>\n

\n
\n About TAVALISSE
<\/u>
\n <\/b>
\n Indication
<\/b>TAVALISSE\u00ae<\/sup> (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.<\/p>\n

\n Important Safety Information
<\/b>
\n Warnings and Precautions<\/b>\n <\/p>\n