CALT Calliditas Therapeutics AB
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Nefecon (NefIgArd)
IgA nephropathy
|
Phase 3
Phase 3
|
Phase 3 trial met primary endpoint - November 10, 2020.
|
Latest News
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SHANGHAI, China, Dec. 02, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) has recommended Breakthrough Therapy Designation (BTD) for Nefecon for the treatment of IgA nephropathy (IgAN).
Nefecon is a potential first-in-disease, oral, targeted-release formulation of budesonide and is currently being investigated in a Phase 3 global registrational study, NefIgArd, to evaluate its efficacy and safety in patients with primary IgAN. Everest is currently enrolling patients as part of the NefIgArd clinical trial to support approval for IgAN patients in China.
Everest Medicines' licensing partner, Calliditas Therapeutics AB (NASDAQ:CALT) ("Calliditas") reported positive topline results on November 8, 2020 from Part A of the global NefIgArd trial demonstrating Nefecon met its primary endpoint of a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. In addition, Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
"We are thrilled that the CDE has recommended Breakthrough Therapy Designation for Nefecon, reinforcing its potential to serve as the first-ever therapeutic option for an estimated 2 million people living with IgAN in China," said Zhengying Zhu, PhD, Chief Medical Officer for Internal Medicine at Everest Medicines. "We look forward to working closely with the CDE to bring this innovative treatment to patients in China as quickly as possible."
"Nefecon continues to experience rapid global clinical and regulatory advancements, and in just a few short months has achieved positive top-line data from the NefIgArd Phase 3 global registrational study, first patient dosed and continued enrollment and treatment in NefIgArd in China, and now recommendation for Breakthrough Therapy Designation in China," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "We are encouraged by the pace and progress of this important global registrational clinical trial and are committed to accelerating Nefecon's late-stage development in order to bring this novel therapeutic to IgAN patients in China."
BTD, which is part of the recently revised Drug Registration Regulation, is designed to expedite the development and review of therapies in China that are being developed for treatment of serious diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over current available treatment options.
About Nefecon
Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer's patch in the ileum, which is responsible for the production of secretory immunoglobulin A (IgA). Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 3 clinical trial conducted by our partner Calliditas Therapeutics AB (NASDAQ:CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore.
About IgA Nephropathy
IgA nephropathy (IgAN), a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with lgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
Everest Medicines
Media in US and Europe:
Darcie Robinson
Vice President
Westwicke PR
(203) 919-7905
[email protected]Media in China:
Edmond Lococo
Managing Director
ICR Asia
+86 (10) 6583-7510
[email protected]
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STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Calliditas Therapeutics AB (publ.) publishes the nomination committee's composition for the AGM in 2021.
The nomination committee, which is appointed in accordance with the principles adopted by the extraordinary general meeting on September 14, 2017, consists of:
· Patrick Sobocki, appointed by Stiftelsen Industrifonden
· Spike Loy, appointed by BVF
· Karl Tobieson, appointed by Linc AB
· Elmar Schnee (chairman of the board of directors)
The nomination committee shall, before the annual general meeting 2021, prepare a proposal for the election of chairman and other members of the board of directors, the election of chairman of the annual meeting, election of auditors, the determination of fees and matters pertaining thereto.
For more information please visit:
https://www.calliditas.se/en/nomination-committee-2314/
Shareholders who wish to submit proposals to the nomination committee for the annual general meeting on May 27, 2021 can do so by e-mail to [email protected]. Proposals should be submitted to the nomination committee before April 5, 2021.
For further information, please contact:
Fredrik Johansson, CFO at Calliditas
Email: [email protected]
Telephone: +46 703 52 91 90
The information was submitted for publication, through the agency of the contact person set out above, at 4.00 p.m on November 27, 2020.
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
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STOCKHOLM, Nov. 12, 2020 /PRNewswire/ -- "On August 13th, we announced a €19.8m acquisition of a majority stake of 62.7% in Genkyotex, a publicly listed life science company in France. We are very excited about this acquisition, which complements our existing and long-standing focus on inflammatory disease. This provides us with a platform with anti-fibrotic and anti-inflammatory compounds, with which we believe can continue to address unmet medical need in orphan diseases and bring solutions to patients across many different therapeutic areas. We believe that we have significant opportunities to leverage this platform to the benefit of patients suffering from fibrotic diseases. We believe that the late stage development, CMC and regulatory expertise which exists in Calliditas can significantly support and enhance the important fundamentals put in place by Genkyotex. We are confident that this will be value driving, for all the company's stakeholders, over the near and medium term.
After the close of the quarter, on November 8th, we reported positive topline results from Part A of our pivotal Phase 3 trial, NefIgArd. The strong data set confirms the results seen in the successful Phase 2b trial and provides further support for locally treating IgAN at the source, offering patients hope of disease modification. We will now assemble the regulatory file and submit for accelerated approval with the FDA and conditional approval with EMA, which is planned for Q1 and H1 respectively next year."
Renée Aguiar-Lucander, CEO
Summary of Q3 2020
July 1 - September 30, 2020
- No net sales were recognized for the three months ended September 30, 2020 and 2019, respectively.
- Operating loss amounted to SEK 104.9 million and SEK 52.6 million for the three months ended September 30, 2020 and 2019, respectively.
- Loss before income tax amounted to SEK 137.9 million and SEK 50.1 million for the three months ended September 30, 2020 and 2019, respectively.
- Loss per share before and after dilution amounted to SEK 2.77 and SEK 1.30, for the three months ended September 30, 2020 and 2019, respectively.
- Cash amounted to SEK 1,396.9 million and SEK 805.1 million as of September 30, 2020 and 2019, respectively.
Significant events during Q3 2020, in summary
- In July 2020, Calliditas announced the exercise of the partial over-allotment option from the IPO on The Nasdaq Global Select Market. Calliditas was thereby provided with additional gross proceeds of approximately USD 6.9 million (approximately SEK 63 million) before deduction of issuance costs.
- In August 2020, Calliditas announced it has reached an agreement to acquire a controlling interest in Genkyotex SA, a leader in NOX inhibition therapies.
Significant events after the end of reporting period, in summary
- In November 2020, Calliditas acquired a controlling interest in Genkyotex SA representing 62,7%.
- In November 2020, Calliditas announced positive topline results from Part A from the pivotal Phase 3 NefIgArd trial.
Investor Presentation November 12, 14:30 CET
Audio cast with teleconference, Q3 2020, November 12, 2020, 14:30 (Europe/Stockholm)
Webcast: https://tv.streamfabriken.com/calliditas-therapeutics-q3-2020
Teleconference: SE: +46856642707 UK: +443333009034 US: +18332498405
Financial calendar
Year-end report for the period January 1 - December 31, 2020 February 18, 2021
Interim report for the period January 1 - March 31, 2021 May 13, 2021
Interim report for the period January 1 - June 30, 2021 August 19, 2021
Interim report for the period January 1 - September 30, 2021 November 18, 2021
For further information, please contact:
Renée Aguiar-Lucander, CEO at Calliditas
Email: [email protected]Mikael Widell, Investor Relations
Email: [email protected]
Telephone: +46 703 11 99 60The information in the press release is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 07:00 CET on November 12, 2020.
About Calliditas Therapeutics
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which the Company can partially or completely participate in the commercialization efforts. The Company is focused on the development and commercialization of the product candidate Nefecon, a unique two-step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas Therapeutics is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the US. The company is listed on Nasdaq Stockholm (TICKER:CALTX). Visit www.calliditas.com for further information.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas'' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas'' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
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Release
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Press release Q3 2020 ENG
View original content:http://www.prnewswire.com/news-releases/interim-report-q3-2020-301171586.htmlSOURCE Calliditas Therapeutics
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STOCKHOLM, Nov. 11, 2020 /PRNewswire/ -- On November 12, 2020, at 07:00 am CET, Calliditas Therapeutics ("Calliditas") will publish its business update for the third quarter 2020. Calliditas will also host a telephone conference, which will include a presentation of the results, on the same day at 2:30 pm CET. The event will be hosted by the company's CEO, Renée Aguiar-Lucander, and CFO Fredrik Johansson. The presentation will be held in English.
The presentation will be live on the company's website during the call under Financial Reports and Presentations and will also be made available online after the call. To participate in the telephone conference, please use the dial-in details shown below:
Dial-in numbers, SE: +46856642707 UK: +443333009034 US: +18332498405
A link to audio cast can be found on the Calliditas website under Financial Reports and Presentations or here:
https://financialhearings.com/event/12809
The information was released for public disclosure on November 11, 2020 at 11:00 a.m CET.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 7955129845, email: [email protected]
About Calliditas
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (TICKER:CALTX) and the Nasdaq Global Select Market (NASDAQ:CALT). Visit www.calliditas.com for further information.
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
View original content:http://www.prnewswire.com/news-releases/calliditas-therapeutics-to-host-conference-call-to-provide-business-update-and-2020-q3-report-301170783.htmlSOURCE Calliditas Therapeutics
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SHANGHAI, China, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today that its licensing partner, Calliditas Therapeutics AB (NASDAQ:CALT) ("Calliditas"), reported positive topline results from Part A of the global Phase 3 clinical trial NefIgArd, which analyzed the effect of Nefecon® versus placebo in 199 patients with primary IgA nephropathy (IgAN).
The trial met its primary objective of demonstrating a statistically significant reduction in urine protein creatinine ratio, or proteinuria, after 9 months of treatment, with significant continued improvement at 12 months. The trial also met the key secondary endpoint showing a statistically significant difference in estimated glomerular filtration rate or eGFR after 9 months of treatment compared to placebo. The efficacy data indicated a significant and beneficial effect on key factors correlated to the progression to end stage renal disease (ESRD) for IgAN patients. In addition, results showed that Nefecon was generally well-tolerated.
Based on these results, Calliditas plans to submit for accelerated approval with the US Food and Drug Administration (FDA) in Q1 2021 followed by a submission for conditional approval with the European Medicines Agency in H1 2021. An additional 160 patients are being recruited for inclusion in Part B of the trial, which is designed to be a confirmatory post-market approval observational trial to confirm long-term renal protection.
In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore. Everest is currently enrolling patients as part of the global Phase 3 clinical trial to support approval for IgAN patients in China.
"We are very excited to see this strong set of data and look forward to building on these results as we continue to rapidly recruit patients with IgAN in China to support the NeflgArd trial," said Zhengying Zhu, Ph.D, Chief Medical Officer for Internal Medicine at Everest Medicines.
"These encouraging data reinforce the potential for Nefecon to become the first approved treatment option for patients around the world with IgAN," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "There are an estimated 2 million people in China living with IgAN and we are committed to advancing this trial and work to make this important therapy available to patients in China."
About Nefecon
Nefecon, an oral, targeted-release formulation of budesonide, is a potential first-in-disease product for the treatment of IgA nephropathy. This novel formulation delivers budesonide to the Peyer's patch in the ileum, which is responsible for the production of secretory immunoglobulin A. Treatment with Nefecon was previously demonstrated to cause a statistically significant reduction in proteinuria levels and stabilization of eGFR, compared to placebo, in a randomized, double-blind Phase 2b clinical trial conducted by our partner Calliditas Therapeutics AB (NASDAQ:CALT). Nefecon has been granted Orphan Drug Designation for the treatment of IgAN by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon in Mainland China, Hong Kong, Macau, Taiwan and Singapore.
About IgA Nephropathy
IgA Nephropathy(IgAN) a leading cause of chronic kidney disease (CKD) and renal failure, is a chronic, progressive, autoimmune disease associated with progressive renal impairment. A central finding in patients with IgAN is the presence of circulating and glomerular immune complexes comprised of galactose-deficient IgA1, an IgG autoantibody directed against the hinge region O-glycans, and C3. Glomerular sclerosis, renal interstitial fibrosis, renal dysfunction, proteinuria and hypertension are associated with disease progression. 50% of IgAN patients will develop end stage renal disease within 30 years. The standard of care for ESRD is dialysis or kidney transplant, which represents a significant health economic burden as well as a material impact on patients' quality of life. Currently, there are no approved treatments for IgAN in China and globally.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
For further information, please contact:
Everest Medicines
Media in US and Europe:
Darcie Robinson
Vice President
Westwicke PR
(203) 919-7905
[email protected]
Media in China:
Edmond Lococo
Managing Director
ICR Asia
+86 (10) 6583-7510
[email protected]