Stada Arzneimittel

Calliditas announces filing with UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Tuesday, October 3, 2023
EEA, CET, Health care, EGFR, Medication, Glomerular filtration rate, Immunoglobulin A, Budesonide, Person, Proteinuria, Sustainability, European Economic Area, CALT, Risk, Kidney, United Kingdom, Stada Arzneimittel, Lancet, UPCR, MHRA, Disease, Pharmaceutical industry, IgA nephropathy

STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.

Key Points: 
  • STOCKHOLM, Oct. 3, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization for Kinpeygo®, a treatment for primary IgA nephropathy (IgAN), to standard, or "full", marketing authorization.
  • Kinpeygo is an orphan medicinal product and the first and only treatment approved in the UK for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need.
  • Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • : +46 76 403 35 43, email: [email protected]
    The information was sent for publication, through the agency of the contact persons set out above, on October 3, 2023 at 09:20 a.m. CET.

Alvotech Reports Financial Results for First Six Months of 2023 and Provides Business Update

Retrieved on: 
Wednesday, August 30, 2023
External commercial borrowing, US Foods, Partnership, Teva, RSU, Adalimumab, Research, Business analyst, R, Patient, Investment, Administration, Advanz Pharma, Webcast, Stada Arzneimittel, Johnson & Johnson, Biosimilar, CRL, Research and development, FDA, Ustekinumab, BLA, Food, Pharmaceutical industry, Flour, Generic drug, Security (finance), G&A

Product Revenue: Product revenue was $22.7 million for the six months ended June 30, 2023, compared to $3.9 million for the same six months of 2022.

Key Points: 
  • Product Revenue: Product revenue was $22.7 million for the six months ended June 30, 2023, compared to $3.9 million for the same six months of 2022.
  • Revenue for the six months ended June 30, 2023 consisted of product revenue from sales of AVT02 in select European countries and Canada.
  • Research and Development (R&D) Expenses: R&D expenses were $99.6 million for the six months ended June 30, 2023, compared to $86.9 million for the same six months of 2022.
  • Alvotech will conduct a business update conference call and live webcast on Thursday, August 31 at 8:00 am ET (12:00 noon GMT).

Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Thursday, February 2, 2023
Medication, Conditional, IgA nephropathy, European Commission, Immunoglobulin A, ESRD, United Kingdom, CMA, Kidney disease, MHRA, Civil service commission, UPCR, Patient, European Economic Area, CET, Risk, Person, Health care, EC, Disease, Stada Arzneimittel, CALT, Kidney, Pharmaceutical industry, EEA, Budesonide

STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

Key Points: 
  • STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • The MHRA authorization follows the European Commission (EC) authorization in July of 2022.
  • Calliditas will transfer the CMA to its partner STADA Arzneimittel AG, which is commercializing Kinpeygo in the European Economic Area (EEA) member states, Switzerland and the UK.
  • STADA launched Kinpeygo in its lead launch market, Germany, in October 2022.

Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

Retrieved on: 
Thursday, February 2, 2023
Medication, Conditional, IgA nephropathy, European Commission, Immunoglobulin A, ESRD, United Kingdom, CMA, Kidney disease, MHRA, Civil service commission, UPCR, Patient, European Economic Area, CET, Risk, Person, Health care, EC, Disease, Stada Arzneimittel, CALT, Kidney, Pharmaceutical industry, EEA, Budesonide

STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

Key Points: 
  • STOCKHOLM, Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
  • The MHRA authorization follows the European Commission (EC) authorization in July of 2022.
  • Calliditas will transfer the CMA to its partner STADA Arzneimittel AG, which is commercializing Kinpeygo in the European Economic Area (EEA) member states, Switzerland and the UK.
  • STADA launched Kinpeygo in its lead launch market, Germany, in October 2022.

EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

Retrieved on: 
Thursday, February 9, 2023
Marketing, Safety, Adalimumab, BAD, European Medicines Agency, Physician, Patient, Stada Arzneimittel, Partnership, EMA, Biosimilar, Ustekinumab, Fine chemical, Pharmaceutical industry, Generic drug

The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.

Key Points: 
  • The companies anticipate that the EMA could recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.
  • “We are pleased to be able to move closer to making AVT04 available to patients in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech.
  • As of December 2022, the companies had launched marketing and sales of the first biosimilar in the partnership, high-concentration adalimumab, in 16 countries in Europe .
  • Earlier in May 2022 , Alvotech also announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.

Calliditas CEO acquires shares through the exercise of Calliditas' warrant program 2019/2022

Retrieved on: 
Wednesday, December 21, 2022
Security (finance), Nasdaq Stockholm, Royal commission, Head, CET, Primary biliary cholangitis, FDA, Safety, Stada Arzneimittel, Therapy, CALT, Risk, American depositary receipt, NOX, European Commission, Pharmaceutical industry

Calliditas' lead product, Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name Kinpeygo®.

Key Points: 
  • Calliditas' lead product, Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name Kinpeygo®.
  • Kinpeygo is being commercialized in the European Union Member States by Calliditas' partner, STADA Arzneimittel AG.
  • Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
  • Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

Calliditas CEO acquires shares through the exercise of Calliditas' warrant program 2019/2022

Retrieved on: 
Wednesday, December 21, 2022
Security (finance), Nasdaq Stockholm, Royal commission, Head, CET, Primary biliary cholangitis, FDA, Safety, Stada Arzneimittel, Therapy, CALT, Risk, American depositary receipt, NOX, European Commission, Pharmaceutical industry

Calliditas' lead product, Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name Kinpeygo®.

Key Points: 
  • Calliditas' lead product, Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and conditional marketing authorization by the European Commission under the trade name Kinpeygo®.
  • Kinpeygo is being commercialized in the European Union Member States by Calliditas' partner, STADA Arzneimittel AG.
  • Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
  • Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

Correction to Total Amount in Announcement About Private Placement Published 2022-12-16 09:00 GMT to headline field

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$70 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), which consists of two tranches, Tranche A and Tranche B, convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • Reference is made to the announcement issued earlier today about the completion of a private placement of subordinated convertible bonds.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • In accordance with the Alvogen Facility agreement, associated rights by Alvogen to procure warrants representing up to 4.0% of Alvotech’s ordinary share capital will no longer apply.
  • Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended.

Alvotech Completes $59.7 Million Private Placement

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • Alvotech will issue the Bonds in an aggregate principal amount of approximately US$59.7 million, at today’s exchange rate, in the form of subordinated convertible bonds, with a maturity of 36 months and in two tranches.
  • Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.

Alvotech Completes $59.7 Million Private Placement

Retrieved on: 
Friday, December 16, 2022
Osteoporosis, Stada Arzneimittel, PIK, Communication, Partnership, Marketing, Offering, Degenerative disease, Sale, Cancer, DKSH, ISK, USD, Biosimilar, Teva Pharmaceuticals, Respiratory disease, COVID-19, Patient, Security (finance), EU, Bond, Alvogen

REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.

Key Points: 
  • REYKJAVIK, Iceland, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced completion of a private placement of approximately US$59.7 million, at current exchange rates, of subordinated convertible bonds (the “Bonds”), convertible into new fully paid ordinary shares of Alvotech.
  • Alvotech intends to use the majority of the net proceeds from the private placement offering to replace a US$50 million unsecured subordinated loan from Alvogen (“Alvogen Facility”) which was announced on November 16, 2022 .
  • Alvotech will issue the Bonds in an aggregate principal amount of approximately US$59.7 million, at today’s exchange rate, in the form of subordinated convertible bonds, with a maturity of 36 months and in two tranches.
  • Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide.