Apomorphine

Supernus Resubmits NDA for SPN-830 Apomorphine Infusion Device

Retrieved on: 
Monday, October 9, 2023

Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).

Key Points: 
  • Working closely with the U.S. Food and Drug Administration (FDA), Supernus believes it has addressed the FDA’s questions related to a Complete Response Letter (CRL) issued in October 2022 for the SPN-830 New Drug Application (NDA).
  • The CRL required additional information and analysis related to the infusion device and drug product across several areas of the NDA.
  • Supernus will continue to work closely with the FDA as it reviews the SPN-830 NDA.
  • “SPN-830 represents a novel and less invasive therapy approach for PD patients who are seeking a convenient option in the form of a continuous subcutaneous infusion of apomorphine,” said Jack Khattar, President and CEO of Supernus.

Parkinson's Disease Market Insights, Epidemiology and Forecasts, 2032 - Focus on United States, Germany, Spain, Italy, France, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 2, 2023

The "Parkinson's Disease - Market Insight, Epidemiology and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Parkinson's Disease - Market Insight, Epidemiology and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering.
  • This report delivers an in-depth understanding of the Parkinson's disease, historical and forecasted epidemiology as well as the Parkinson's disease market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
  • Parkinson's disease market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Parkinson's disease market size from 2019 to 2032.
  • The majority of Diagnosed Prevalent Parkinson's Disease patients were estimated in the US followed by EU4 and the UK, and Japan.

FTC Files Amicus Brief in Sage Chemical vs. Supernus Pharmaceutical Supporting Competition in the Market for Drug Used to Treat Advanced Parkinson’s Disease

Retrieved on: 
Tuesday, March 21, 2023

Apokyn is an injectable drug used to treat patients with symptoms of advanced Parkinson’s Disease.

Key Points: 
  • Apokyn is an injectable drug used to treat patients with symptoms of advanced Parkinson’s Disease.
  • Apokyn’s cost per patient to the Medicare Part D program in 2020 was close to $100,000.
  • According to the FTC’s brief, “This case may have significant implications for patients who rely on apomorphine to treat debilitating symptoms of advanced Parkinson’s Disease.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.

FTC Files Amicus Brief in Sage Chemical vs. Supernus Pharmaceutical Supporting Competition in the Market for Drug Used to Treat Advanced Parkinson’s Disease

Retrieved on: 
Tuesday, March 21, 2023

Apokyn is an injectable drug used to treat patients with symptoms of advanced Parkinson’s Disease.

Key Points: 
  • Apokyn is an injectable drug used to treat patients with symptoms of advanced Parkinson’s Disease.
  • Apokyn’s cost per patient to the Medicare Part D program in 2020 was close to $100,000.
  • According to the FTC’s brief, “This case may have significant implications for patients who rely on apomorphine to treat debilitating symptoms of advanced Parkinson’s Disease.
  • For the latest news and resources, follow the FTC on social media, subscribe to press releases and read our blog.

Oncotelic Reports Q3 2022 Compared to Q3 2021 Financial Results

Retrieved on: 
Monday, November 21, 2022

In comparing the Companys operating results for the three months ended September 30, 2022, and 2021, respectively, our net loss reduced by approximately $1.0 million.

Key Points: 
  • In comparing the Companys operating results for the three months ended September 30, 2022, and 2021, respectively, our net loss reduced by approximately $1.0 million.
  • Further, our general and administrative expenses decreased by approximately $0.6 million primarily due to reduced compensation expense of approximately $0.6 million.
  • We expect our R&D and G&A expense to remain steady or reduce for the remainder of the year 2022.
  • Oncotelic acquired AL-101, during the 4th quarter of 2021, for the intranasal delivery of apomorphine.

EVER Pharma Launches the User-friendly D-mine® Pump Generated Report “DATA-mine®” to Enhance the Therapy Management of Parkinson’s Patients on Apomorphine

Retrieved on: 
Tuesday, September 27, 2022

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220915005029/en/
    The user-friendly DATA-mine REPORT (Graphic: Business Wire)
    EVER Pharma, a specialist in neurology and specialty pharmaceuticals, offers a complete therapy package for PD patients with Dacepton (Dopaceptin, Apomorphine hydrochloride), D-mine Pump , D-mine Pen and now the DATA-mine REPORT , a tool to read out the data of the D-mine Pump.
  • With the DATA-mine REPORT, we continue to optimize our product offering by ensuring the best possible therapy management of Parkinsons patients on Apomorphine and facilitating the follow up of the Healthcare Professional, explains Georges Kahwati, General Manager at EVER Pharma GmbH.
  • The products are developed and manufactured at EU GMP certified facilities in Austria and Germany.
  • EVER markets its products in more than 80 countries around the world through 30 international affiliated companies and strategic partners.

ONCOTELIC REPORTS Q2 2022 COMPARED TO Q2 2021 FINANCIAL RESULTS

Retrieved on: 
Monday, August 22, 2022

Comparing Q2 2022 to Q2 2021, we reported a net profit, before non-controlling interests, of approximately $16.0 million compared to a net loss of approximately $3.6 million, respectively.

Key Points: 
  • Comparing Q2 2022 to Q2 2021, we reported a net profit, before non-controlling interests, of approximately $16.0 million compared to a net loss of approximately $3.6 million, respectively.
  • Comparing our research and development (R&D) expenses between Q2 2022 and Q2 2021, our R&D expenses decreased by approximately $0.8 million for Q2 2022 compared to the Q2 2021, primarily due to personnel and operational expenses related to OT-101 being borne by the JV.
  • Comparing our general and administrative (G&A) expenses between Q2, 2022 and Q2 2021, our G&A expenses decreased by approximately $2.6 million, primarily due to lower stock compensation expense of approximately $2.0 million during Q2 2021 as compared to $25 thousand during Q2 2022, and lower compensation and operational expenses of approximately $0.3 million which was borne by the JV.
  • Comparing our interest expense for Q2 2022 and Q2 2021, our interest expense increased by $0.7 million based on approximately $1.1 million for Q2 2022, primarily in connection with debt raised from convertible notes and the JH Darbie Financing, the November 2021 to March 2022 Financing and May/June 2022 financing as compared to $0.4 million for Q2 2021, in connection with debt raised from convertible notes and JH Darbie during 2021.

EVER Pharma Launches a Digital Training App for the D-mine® Pump

Retrieved on: 
Tuesday, July 12, 2022

After successfully launching the D-mine Pump, an infusion device designed to provide precise continuous subcutaneous drug delivery for Parkinsons patients, EVER Pharma developed an App to support the training needs of Healthcare Professionals and caregivers.

Key Points: 
  • After successfully launching the D-mine Pump, an infusion device designed to provide precise continuous subcutaneous drug delivery for Parkinsons patients, EVER Pharma developed an App to support the training needs of Healthcare Professionals and caregivers.
  • View the full release here: https://www.businesswire.com/news/home/20220712005103/en/
    The digital Training App for the D-mine Pump supporting the training needs (Graphic: Business Wire)
    EVER Pharma, a specialist in neurological diseases, offers a complete therapy package for Parkinsons disease with D-mine Pump , D-mine Pen and Dacepton (Dopaceptin, Apomorphine hydrochloride) and with its new D-mine Pump TRAINING APP a simulation tool to support the training and the programing of the D-mine Pump.
  • With the development of the TRAINING APP for the D-mine Pump in Parkinson's therapy, we now have an empowering and interactive tool to support the training of the Healthcare Professionals and caregivers on how to use and program the infusion pump device.
  • The App is an intuitive, easy-to-use simulator and enables training any time everywhere, explains Georges Kahwati, General Manager at EVER Pharma GmbH.

At 6.9% CAGR, Global Erectile Dysfunction Drugs Market Size & Share Will Hit US$ 5.94 Billion | Industry Trends, Demand, Growth, Value, Analysis & Forecast Report by Zion Market Research

Retrieved on: 
Wednesday, June 22, 2022

Key Industry Insights & Finding of the Erectile Dysfunction Drugs Market Reports:

Key Points: 
  • Key Industry Insights & Finding of the Erectile Dysfunction Drugs Market Reports:
    As per the analysis shared by our research analyst, the Erectile Dysfunction Drugs Market is expected to grow annually at a CAGR of around 6.9 % (2022-2028).
  • Erectile dysfunction drugs are majorly sold in developed and emerging economies; however, the percentage of their sale is less in low- and middle-income countries.
  • Furthermore, increased investments in advertisements are also likely to contribute significantly to the expansion of the global erectile dysfunction drugs market.
  • The expanding manufacture of generic erectile dysfunction pharmaceuticals, as well as the growing availability of bogus erectile dysfunction drugs, are two important challenges for the market.

At 6.9% CAGR, Global Erectile Dysfunction Drugs Market Size & Share Will Hit US$ 5.94 Billion | Industry Trends, Demand, Growth, Value, Analysis & Forecast Report by Zion Market Research

Retrieved on: 
Wednesday, June 22, 2022

Key Industry Insights & Finding of the Erectile Dysfunction Drugs Market Reports:

Key Points: 
  • Key Industry Insights & Finding of the Erectile Dysfunction Drugs Market Reports:
    As per the analysis shared by our research analyst, the Erectile Dysfunction Drugs Market is expected to grow annually at a CAGR of around 6.9 % (2022-2028).
  • Erectile dysfunction drugs are majorly sold in developed and emerging economies; however, the percentage of their sale is less in low- and middle-income countries.
  • Furthermore, increased investments in advertisements are also likely to contribute significantly to the expansion of the global erectile dysfunction drugs market.
  • The expanding manufacture of generic erectile dysfunction pharmaceuticals, as well as the growing availability of bogus erectile dysfunction drugs, are two important challenges for the market.