Calliditas promotes Andrew Udell to President, North America
Calliditas Therapeutics AB (Nasdaq: CALT) announced the promotion of Andrew Udell to President, North America, effective immediately. Udell, who has been with the company since 2019, will manage US activities, including sales and marketing. The move comes as the FDA has accepted the New Drug Application for Calliditas' product candidate, Nefecon, for IgA nephropathy, with a PDUFA goal date of September 15, 2021. This positions Calliditas for potential commercialization of Nefecon, addressing a significant medical need.
- Promotion of Andrew Udell to President, enhancing leadership in North America.
- FDA acceptance of Nefecon's New Drug Application, facilitating potential commercialization.
- None.
STOCKHOLM, May 3, 2021 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that former Head of North America Commercial, Andrew Udell, has been promoted to President, North America, effective immediately.
"Andrew has been instrumental in the growth of the US operations over the last 12 months and has done a great job of creating a strong connection between the US and European teams throughout this period of high growth. He is an experienced leader, and I am delighted to continue to work with him in this new role," said CEO Renee Aguiar-Lucander.
In his new role, Mr. Udell will oversee all of Calliditas' US related activities, with direct reports including sales, marketing and market access. Mr. Udell joined Calliditas in 2019 and has over 20 years of broad commercial experience in the pharmaceutical industry, working with both established and growing pharma companies.
"I am thrilled for the opportunity to lead and continue to work with such a strong, talented, and rapidly growing team as we build upon the foundation created in these last few years. It is an exciting and critical time at Calliditas as we prepare for the commercialization of the first potential treatment for patients suffering with IgA nephropathy," expressed Mr. Udell.
As previously reported, the FDA has accepted the submission of and granted Priority Review for the New Drug Application (NDA) for Calliditas' lead product candidate, Nefecon, setting a PDUFA goal date of September 15, 2021. Subject to approval by the FDA, Calliditas intends to commercialize Nefecon for IgA nephropathy on its own in the United States.
For further information, please contact:
Marie Galay, IR Manager, Calliditas
Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com
The information was sent for publication, through the agency of the contact persons set out above, on May 3, 2021 at 2.30 p.m. CET.
About Calliditas
Calliditas Therapeutics is a biopharma 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 successfully reported top line data of its global Phase 3 study in IgAN in November of 2020 and, if approved, aims to commercialize Nefecon in the United States on its own and partner elsewhere. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: 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:
Andy Udell Promotion Eng |
View original content:http://www.prnewswire.com/news-releases/calliditas-promotes-andrew-udell-to-president-north-america-301282125.html
SOURCE Calliditas Therapeutics
FAQ
What is the recent announcement about Calliditas Therapeutics (CALT)?
When is the PDUFA goal date for Nefecon's New Drug Application?
What role will Andrew Udell have at Calliditas?
What is Nefecon and its significance for Calliditas?
