Vivus

Petros Pharmaceuticals to Pursue 505(B)(2) Pathway for H-100, Company’s Novel Topical Investigational Treatment for Peyronie’s Disease Which Impacts More Than 1 in 10 Men in the US

Retrieved on: 
Tuesday, May 3, 2022

H-100 has the potential to be the first FDA-approved, non-invasive topical treatment for Peyronies disease.

Key Points: 
  • H-100 has the potential to be the first FDA-approved, non-invasive topical treatment for Peyronies disease.
  • It is hypothesized that this will better address the inflammatory cascade that leads to the pain, scarring, and penile irregularities associated with Peyronies disease.
  • Currently, Peyronies disease can be treated by invasive surgery, by penile implantation, or by a series of injections or traction devices.
  • Peyronie's (pay-roe-NEEZ) disease is a noncancerous condition resulting from fibrous scar tissue on the penis, causing curved, often painful, erections.

Petros Pharmaceuticals, Inc. Engages Massachusetts General Hospital in a Sponsored Research Agreement for Tissue-Specific Oxygenation Sensor Technology

Retrieved on: 
Tuesday, April 26, 2022

Under the agreement, researchers will evaluate incorporating the use of a tissue-specific oxygenation sensor with the goal of monitoring and understanding the success of Erectile Device Therapy.

Key Points: 
  • Under the agreement, researchers will evaluate incorporating the use of a tissue-specific oxygenation sensor with the goal of monitoring and understanding the success of Erectile Device Therapy.
  • Accompanying the Sponsored Research Agreement, Petros will enter into an Agreement for an option to negotiate an exclusive license of the tissue-specific oxygenation sensor within specific human tissues.
  • The Company plans to apply the technology to potentially enhance its existing erectile device therapy.
  • We believe what Mass General has developed is a truly landmark achievement in immediate and highly-targeted bio-sensor feedback technology, said Fady Boctor, Petros Pharmaceuticals President and Chief Commercial Officer.

Enzymes Global Market Report 2021: COVID-19 Growth, Impacts and Changes to 2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 12, 2021

The "Enzymes Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Enzymes Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Enzymes that are used in medical applications in their isolated or conjugated form with other drugs or therapies are known as therapeutic enzymes.
  • The development of new approaches to treat cancer using enzymes is a key trend gaining popularity in the enzymes market.
  • The growing prevalence of cancer requiring drug-metabolising enzymes (DMEs) for chemotherapy is expected to drive the growth of the enzymes market in the coming years.

VIVUS Receives Court Approval of Joint Chapter 11 Plan of Reorganization

Retrieved on: 
Friday, December 11, 2020

CAMPBELL, Calif., Dec. 11, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (theCompany), a biopharmaceutical company, today announced that it has received approval from the United States Bankruptcy Court for the District of Delaware (theBankruptcy Court) on its Second Amended Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and Its Affiliated Debtors [Docket No.

Key Points: 
  • CAMPBELL, Calif., Dec. 11, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (theCompany), a biopharmaceutical company, today announced that it has received approval from the United States Bankruptcy Court for the District of Delaware (theBankruptcy Court) on its Second Amended Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and Its Affiliated Debtors [Docket No.
  • The Bankruptcy Court approved the disclosure statement and solicitation procedures and confirmed the second amended chapter 11 plan of reorganization, which implements the mediated settlement among the Company, Icahn Enterprises Holdings L.P. (dba IEH Biopharma LLC), and the Equity Committee.
  • Investors also should read the risk factors and accompanying cautionary statements set forth in the Companys the Disclosure Statement for Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and its Affiliated Debtors [Docket No.
  • 14] filed with the Bankruptcy Court on July 7, 2020, as amended by the First Amendment to Disclosure Statement for Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and its Affiliated Debtors [Docket No.

VIVUS Seeks Bankruptcy Court Approval of Second Amended Joint Chapter 11 Plan of Reorganization and Existing Stock Record Date

Retrieved on: 
Saturday, November 14, 2020

Upon confirmation of the Plan by the Bankruptcy Court, only holders of issued and outstanding common stock of the Company as of the Existing Stock Record Date (Existing Stock) will be eligible to participate in the Existing Stock Settlement set forth in Section 5.3 of the Plan and subject to the conditions thereof.

Key Points: 
  • Upon confirmation of the Plan by the Bankruptcy Court, only holders of issued and outstanding common stock of the Company as of the Existing Stock Record Date (Existing Stock) will be eligible to participate in the Existing Stock Settlement set forth in Section 5.3 of the Plan and subject to the conditions thereof.
  • The Company today announced that, subject to confirmation of the Plan, the Existing Stock Record Date shall be Friday, November 13, 2020.
  • Eligibility to participate in the Existing Stock Settlement does not trade or transfer with Interests in the Company, including, without limitation, common stock, after the Existing Stock Record Date pursuant to the Plan.
  • 14] filed with the Bankruptcy Court on July 7, 2020, as amended by the First Amendment to Disclosure Statement for Joint Prepackaged Chapter 11 Plan of Reorganization of VIVUS, Inc. and its Affiliated Debtors [Docket No.

VIVUS Announces Updated Agreement with Icahn Enterprises Holdings L.P.

Retrieved on: 
Tuesday, June 2, 2020

CAMPBELL, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS; the Company), a biopharmaceutical company, today announced that it has updated its agreement regarding its corporate debt with Icahn Enterprises Holdings L.P. (dba IEH Biopharma LLC), which holds a principal amount of approximately $170.2 million of the Companys Convertible Senior Notes.

Key Points: 
  • CAMPBELL, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS; the Company), a biopharmaceutical company, today announced that it has updated its agreement regarding its corporate debt with Icahn Enterprises Holdings L.P. (dba IEH Biopharma LLC), which holds a principal amount of approximately $170.2 million of the Companys Convertible Senior Notes.
  • If the Company is unable to refinance on or before June 30, 2020, the Company and IEH Biopharma shall exclusively pursue an in court plan of reorganization.
  • The agreement is subject to, among other things, IEH Biopharmas due diligence and the Companys preservation of its tax attributes.
  • VIVUSdoes not undertake an obligation to update or revise any forward-looking statements, except as required by law.

VIVUS to Host First Quarter Business Update and Financial Results Conference Call on Wednesday, May 6, 2020

Retrieved on: 
Friday, May 1, 2020

VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.

Key Points: 
  • VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.
  • There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.
  • VIVUS does not undertake an obligation to update or revise any forward-looking statements.
  • VIVUS does not undertake an obligation to update or revise any forward-looking statements.

VIVUS Announces Agreement with IEH Biopharma LLC Granting the Company a 30-Day Grace Period to Restructure its Corporate Debt

Retrieved on: 
Friday, May 1, 2020

The Company does not currently have the ability to pay the principal amount of the Convertible Senior Notes held by IEH Biopharma.

Key Points: 
  • The Company does not currently have the ability to pay the principal amount of the Convertible Senior Notes held by IEH Biopharma.
  • As part of the agreement, VIVUS will settle or otherwise satisfy the remaining $11.3 million in principal and $253,373 in accrued and unpaid interest held by other holders.
  • VIVUS is a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs.
  • These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements.

VIVUS Accelerates the Launch of Telemedicine and Remote Monitoring Modules to Facilitate Effective Patient Care During “Social Distancing”

Retrieved on: 
Tuesday, March 31, 2020

CAMPBELL, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS; the Company), a biopharmaceutical company, today announced the accelerated launch of the telemedicine and remote monitoring modules of the VIVUS Health Platform.

Key Points: 
  • CAMPBELL, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq: VVUS; the Company), a biopharmaceutical company, today announced the accelerated launch of the telemedicine and remote monitoring modules of the VIVUS Health Platform.
  • We have rapidly accelerated the launch of our telemedicine and remote monitoring modules to facilitate communication during this unprecedented pandemic and ensure that patients can receive optimum care without leaving their homes.
  • The telemedicine and remote monitoring modules are designed to leverage normal clinical practices without disrupting routine clinical operations.
  • There are no upfront or monthly fees, and physicians pay a fee only for each telemedicine visit and/or for remote patient monitoring.

VIVUS Completes Enrollment in Phase 4 Safety and Efficacy Study of Qsymia® in Adolescents

Retrieved on: 
Monday, March 2, 2020

Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.

Key Points: 
  • Completing enrollment in this study is an important milestone in our ongoing efforts to expand the clinical use of Qsymia based on robust safety and efficacy data, said Santosh T. Varghese, MD, Senior Vice President, Chief Medical Officer at VIVUS.
  • We believe that Qsymia has significant clinical and commercial potential, and we are committed to capturing a larger share of the global market for anti-obesity medications, said John Amos, Chief Executive Officer at VIVUS.
  • In December 2019 , VIVUS reported that data from a pharmacokinetic (PK) and pharmacodynamic (PD) study (NCT# 02714062)conducted in order to establish dosing levels for the ongoing Phase 4 post-marketing study demonstrated that Qsymia has favorable PK, efficacy, and safety/tolerability profiles when used for eight weeks to treat adolescents with obesity.
  • Food and Drug Administration(FDA) required as part of the approval of Qsymia in 2012, enrolled approximately 200 patients at 26 clinical sites inthe United States.