QIDP

Microbion Corporation Announces Granting of a US Patent for a Pharmaceutical Composition of Pravibismane

Retrieved on: 
Tuesday, October 4, 2022
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BOZEMAN, MT, and VANCOUVER, BC, Oct. 4, 2022 /PRNewswire/ - Microbion Corporation today announced that the US Patent and Trademark Office (USPTO) issued to Microbion, United States Patent No.

Key Points: 
  • BOZEMAN, MT, and VANCOUVER, BC, Oct. 4, 2022 /PRNewswire/ - Microbion Corporation today announced that the US Patent and Trademark Office (USPTO) issued to Microbion, United States Patent No.
  • 11,324,715 on May 10, 2022, with claims to a pharmaceutical composition of pravibismane.
  • The patent, titled "Bismuth-thiol compositions and methods for treating wounds," adds to Microbion's growing portfolio of intellectual property on the pravibismane program with this latest patent providing protection through to 2039.
  • "We are pleased that the USPTO has granted this new patent that provides additional protection for the pravibismane program," said Karim Lalji, CEO of Microbion Pharma Corp. "This new patent with granted pharmaceutical composition claims is a key patent in our growing patent portfolio."

Cidara Therapeutics Receives $11.1 Million Milestone Payment from Mundipharma

Retrieved on: 
Tuesday, October 4, 2022
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SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) --  Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019. The payment was made in association with the European Medicines Agency (EMA) acceptance of the marketing authorization application (MAA) for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients.

Key Points: 
  • SAN DIEGO, Oct. 04, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today announced receipt of an $11 million milestone payment from Mundipharma under the licensing agreement established between the two companies in September 2019.
  • With the $11 million milestone payment from Mundipharma, Cidara remains eligible to receive additional non-dilutive capital of up to approximately $108 million in development and regulatory milestones from our existing partnerships based on successful completion of activities planned for the next two years, said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara.
  • Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma Medical in all other geographies.
  • Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases.

PolyPid Announces Eligibility for European Medicines Agency Centralized Procedure for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Surgery

Retrieved on: 
Wednesday, September 28, 2022
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PETACH TIKVA, Israel, Sept. 28, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application (MAA) in the European Union (EU) under the Agency’s centralized procedure.

Key Points: 
  • The centralized process eligibility is granted to D-PLEX100 under the Therapeutic Innovation criteria which underscores that D-PLEX100 provides a new alternative to patients in preventing post abdominal surgical site infections (SSIs).
  • This decision by the EMA allows us to potentially pursue registration of D-PLEX100 through the more efficient centralized review process.
  • D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
  • PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal surgical site infections.

Evofem Announces Issuance of U.S. Patent Covering Phexxi® Composition of Matter

Retrieved on: 
Friday, September 23, 2022
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SAN DIEGO, Sept. 23, 2022 /PRNewswire/ -- Evofem Biosciences (OTCPK: EVFM) today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,439,610, which covers the composition of matter of Phexxi® (lactic acid, citric acid, potassium bitartrate).  

Key Points: 
  • 11,439,610, which covers the composition of matter of Phexxi (lactic acid, citric acid, potassium bitartrate).
  • "We are extremely pleased with the continued development of the Phexxi patent portfolio, which comprises more than 40 patents.
  • Top-line data from EVOGUARD, Evofem's registrational Phase 3 clinical trial evaluating Phexxi for these two potential new indications, are expected in mid-October.
  • Evofem now has the sole right in the United States to make, have made, market, and sell for any commercial purpose the composition of matter that comprises Phexxi.

GSK and Spero Therapeutics Announce Exclusive License Agreement for Late-Stage Antibiotic Asset, Tebipenem HBr

Retrieved on: 
Thursday, September 22, 2022
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LONDON and CAMBRIDGE, Mass., Sept. 22, 2022 (GLOBE NEWSWIRE) -- GSK (LSE/NYSE: GSK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced they have entered into an exclusive license agreement for Spero’s late-stage antibiotic asset, tebipenem HBr. Tebipenem HBr is being developed as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain bacteria.

Key Points: 
  • In connection with the license agreement and pursuant to a stock purchase agreement between GSK and Spero, GSK has agreed to make a $9 million common stock investment in Spero, purchasing 7,450,000 shares of Speros common stock at a purchase price of approximately $1.20805 per share, not to exceed 19.99% beneficial ownership of Spero by GSK and its affiliates.
  • The closing of the equity investment is conditioned upon the effectiveness of the license following Hart-Scott-Rodino clearance.
  • As of June 30, 2022, Spero had cash, cash equivalents, and marketable securities of $45.4 million.
  • If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States.

Cidara Therapeutics Announces FDA Acceptance for Priority Review of New Drug Application for Rezafungin for the Treatment of Candidemia and Invasive Candidiasis

Retrieved on: 
Tuesday, September 20, 2022
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QIDP designation is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections.

Key Points: 
  • QIDP designation is reserved for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections.
  • Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the treatment of candidemia and invasive candidiasis, as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplant.
  • Todays announcement is an important step forward for patients fighting difficult-to-treat and often deadly candidemia and invasive candidiasis, and represents a critical milestone for Cidara's rezafungin development program, said Jeff Stein, President, and CEO of Cidara Therapeutics.
  • Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.

Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem

Retrieved on: 
Monday, September 19, 2022
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This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.

Key Points: 
  • This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed.
  • Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

PolyPid Announces Peer-Reviewed Publication of Phase 2 Clinical Trial Results for D-PLEX₁₀₀ in the Prevention of Surgical Site Infections in Abdominal Surgery

Retrieved on: 
Monday, September 19, 2022
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PETACH TIKVA, Israel, Sept. 19, 2022 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the peer-reviewed publication of positive clinical data from the previously completed Phase 2 study of D-PLEX100 for the prevention of surgical site infections (SSIs) in abdominal surgery. The paper, entitled, “A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections,” was published in Techniques in Coloproctology, and can be found here.

Key Points: 
  • SSIs were adjudicated by the endpoint adjudication committee, all of whom were blinded to study-group assignments.
  • We are pleased by the publication of the positive results from our Phase 2 study of D-PLEX100, said Dikla Czaczkes Akselbrad, PolyPids Chief Executive Officer.
  • D-PLEX100 received Breakthrough Therapy Designation from the U.S. FDA for the prevention of SSIs in patients undergoing elective colorectal surgery.
  • PolyPids lead product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of soft tissue abdominal and sternal surgical site infections.

SCYNEXIS Presents Positive Interim Data of Ibrexafungerp for Refractory Candida Infections from Ongoing Phase 3 FURI Study During the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting

Retrieved on: 
Thursday, September 8, 2022
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Data from the ongoing Phase 3 CARES study will also be presented demonstrating positive outcomes of ibrexafungerp in 89% of patients with Candida auris, complete/partial response (78%) and no disease progression (11%).

Key Points: 
  • Data from the ongoing Phase 3 CARES study will also be presented demonstrating positive outcomes of ibrexafungerp in 89% of patients with Candida auris, complete/partial response (78%) and no disease progression (11%).
  • The new interim analyses are being presented during the Mycoses Study Group Education and Research Consortium (MSGERC) Biennial Meeting being held in Albuquerque, N.M., September 7-9, 2022.
  • The interim analysis included 64 patients from the FURI study with refractory Candida infections, including failure of or resistance to previous standard-of-care antifungal therapy.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

Iterum Therapeutics to Present at the H.C. Wainwright 24th Annual Global Investment Conference

Retrieved on: 
Wednesday, September 7, 2022
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Management will also host investor meetings on September 13-14, 2022.

Key Points: 
  • Management will also host investor meetings on September 13-14, 2022.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.