Consensi (amlodipine/celecoxib) / Coeptis, Burke Therap, Purple Biotech - LARVOL DELTA

Estrogen receptor 1 chromatin profiling in human breast tumors reveals high inter-patient heterogeneity with enrichment of risk SNPs and enhancer activity at most-conserved regions. (PubMed, Genome Res) - "ESR1 chromatin binding is extensively studied in cell lines and a limited number of human tumors, using consensi of peaks shared among samples...Finally, in the TCGA breast cancer cohort, we can confirm these variations to associate with differences in expression for the target gene. Cumulatively, we reveal a natural hierarchy of ESR1-chromatin interactions in breast cancers within a highly heterogeneous inter-tumor ESR1 landscape, with the most common shared regions being most active and affected by germline functional risk SNPs for breast cancer development."

Heterogeneity • Journal • Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • FOXA1

"Critical Assessment of the Guidelines-Based Management of Severe Traumatic Brain Injury with the AGREE-II". (PubMed, World Neurosurg) - "The purpose of our study for assessing the quality of CPG and CS was served. We present the strong and weak points of CPG and CS. Our findings support the idea of periodically updating guidelines and improving their rigor of development."

Journal • Review • CNS Disorders • Vascular Neurology

Presentazione della cerimonia per il Centenario di Annali Italiani di Chirurgia. (PubMed, Ann Ital Chir) - "Per una rivista scientifica raggiungere i 100 anni di attività è segno indiscutibile di vitalità e di corretta gestione, ma non sempre equivale ad un miglioramento della qualità delle pubblicazioni e accrescimento del credito e dei consensi...Prof. Nicola Picardi."

Journal • IL10

Purple Biotech Reports Second Half and Full-Year 2021 Financial Results (GlobeNewswire) - "Purple Biotech Ltd...today announced financial results for the year and the six months ended December 31, 2021....Discontinued Operation. As previously reported, COVID-19 adversely impacted the launch of Consensi in the United States. In October 2021, the Company agreed, together with its then U.S distributor for Consensi, Coeptis Pharmaceuticals Inc., to terminate the distribution agreement....we concluded that commercialization of Consensi, both in the U.S market and elsewhere, is not likely to generate significant revenue and achieve profitability in the near term....It was concluded to discontinue Consensi activities and to allocate the funds to our core oncology activities. In parallel, the agreements with Kuhnil Pharmaceuticals Inc.’s for the territory of South Korea and Hebei Changshan Biochemical Pharmaceutical Co., Ltd. for the territory of China were terminated. Consequently, the Company is reporting Consensi as a discontinued operation."

Discontinued • CNS Disorders • Hypertension • Immunology • Osteoarthritis • Pain

Curation Guidelines for de novo Generated Transposable Element Families. (PubMed, Curr Protoc) - "© 2021 Wiley Periodicals LLC. Basic Protocol: Extension and edge polishing of consensi and seed alignments derived from de novo repeat finders Support Protocol: Generating seed alignments using a library of consensi and a genome assembly"

Journal

Fixed-dose combination amlodipine-celecoxib for treatment of hypertension and osteoarthritis pain: an up-to-date evaluation. (PubMed, Expert Opin Pharmacother) - "Introduction: A fixed-dose combination of amlodipine and celecoxib, branded in the USA as Consensi®, was recently granted a US Food and Drug Administration (FDA)-approved indication for treatment of comorbid hypertension and osteoarthritis.Areas covered: A PubMed and Medline search was conducted for clinical trials published through December 2020 in the English language using keywords amlodipine, celecoxib, combination product, consensi, hypertension, osteoarthritis, and pill burden. Although no clinical trials have been published in the peer-reviewed literature, results from two phase 3 clinical trials reported to ClinicalTrials.gov suggest that amlodipine-celecoxib has similar short-term efficacy compared with amlodipine alone in reducing blood pressure and a comparable adverse event profile to the individual components administered alone.Expert opinion: Despite the pill burden reduction and a body of evidence supporting the efficacy and safety of the individual..."

Journal • Hypertension • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Kitov Announces Name Change to Purple Biotech Ltd. (GlobeNewswire) - "Purple Biotech Ltd....today announced that it has changed its corporate name from Kitov Pharma Ltd. to Purple Biotech Ltd. The name change will be effective for trading purposes on the Tel Aviv Stock Exchange (TASE) and the NASDAQ Capital Market (NASDAQ) as of market open on December 22, 2020."

Commercial • CNS Disorders • Osteoarthritis • Pain

"Saving their real efforts for blockbusters like Consensi 🙄" (@PharmD_KS)

Consensi --a fixed dose combination of amlodipine and celecoxib. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hypertension • Immunology • Osteoarthritis • Pain • Rheumatology

"Gunna use Kitov’s Consensi for that?" (@kline_tate)

Kitov Pharma Issues CEO Shareholder Letter Providing Business Update (GlobeNewswire) - "CONSENSI:...We look forward to sales beginning to ramp up in the next few months, which will result in royalty revenue to us of 20% of sales, pursuant to our marketing and distribution agreement with Coeptis. According to the agreement for CONSENSI®, Kitov is eligible to receive up to $99.5 million in milestone and reimbursement payments, in addition to royalties. We expect to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022."

Commercial • CNS Disorders • Osteoarthritis • Pain

Kitov Announces U.S. Commercial Launch of Consensi™ (GlobeNewswire, Kitov Pharma Ltd.) - "Kitov Pharma Ltd...today announced the U.S. commercial launch of Consensi™, a fixed-dose combination of celecoxib and amlodipine besylate, designed for the simultaneous treatment of hypertension and osteoarthritis pain. Consensi™ is being sold in the U.S. by Burke Therapeutics, the marketing partner of Kitov’s U.S. distributor, Coeptis Pharmaceuticals."

Launch US • Osteoarthritis • Pain

Kitov Pharma Provides Update on Planned U.S. Launch of Consensi™ and Provides Three-Year Revenue Forecast (GlobeNewswire, Kitov Pharma Ltd.) - "Kitov Pharma Ltd...today provided an update on the planned U.S. commercial launch of Consensi™, a fixed-dose combination of celecoxib, and amlodipine besylate, designed for the simultaneous treatment of osteoarthritis pain and hypertension, that was approved for marketing by the U.S. Food & Drug Administration. The Company’s manufacturing partner is completing the packaging, release and shipment of Consensi™ to Kitov’s marketing partners, that is expected to begin selling Consensi™ in the U.S. in May 2020....The Company expects to receive aggregate milestone and royalty revenues of between $28 million and $36 million from 2020 through 2022."

Commercial • Launch • Reimbursement

Burke Therapeutics, LLC signs exclusive US marketing and supply agreement with Coeptis Pharmaceuticals, Inc. for Consensi (Businesswire) - "Burke Therapeutics, LLC...today announced it has signed an exclusive marketing and supply agreement with Coeptis Pharmaceuticals, Inc. for the U.S. market. Burke will market the fixed-dose combination drug, Consensi®, a prescription medicine for adults who need both treatment with amlodipine for hypertension, to lower blood pressure, and celecoxib for the management of the signs and symptoms of osteoarthritis. Commercial launch is anticipated in May of 2020."

Launch US • Licensing / partnership

CURE Pharmaceutical [OTCQB:CURR] Takes First Step to Acquire Coeptis Pharmaceuticals and its Combination Drug for Osteoarthritis Pain and Hypertension (GlobeNewswire, Cure Pharmaceutical Holding Corp.) - "CURE Pharmaceutical...today announced that it purchased a $200,000 convertible promissory note issued by Coeptis Pharmaceuticals, Inc, a biopharmaceutical company engaged in the acquisition, development and commercialization of branded 505(b)(2) pharmaceutical products. This note represents an initial step toward a potential acquisition of the company and the exclusive rights to Coeptis’ approved drug Consensi®, the first fixed-dose combination drug for the treatment of comorbid osteoarthritis and hypertension....'The planned acquisition has the potential to accelerate our 505(b)(2) drug pipeline and expedite our growth with a planned 2020 launch of Consensi...'"

Commercial • Launch • M&A

Fixed-dose combination amlodipine/celecoxib (Consensi™) for hypertension and osteoarthritis. (PubMed, Am J Med) - "The U.S. Food and Drug Administration recently granted an approved indication for the first fixed-dose combination antihypertensive (amlodipine) and non-steroidal anti-inflammatory drug (celecoxib) for treatment of comorbid hypertension and osteoarthritis. This review summarizes available data on this combination product, to be marketed as Consensi™ (Kitov Pharmaceuticals, Ltd, Tel Aviv, Israel), and discusses its potential place in therapy."

Journal • Review

Kitov Pharma announces amended marketing and distribution agreement with Coeptis and provides update on the upcoming launch of Consensi in the U.S (GlobeNewswire) - "Kitov Pharma Ltd....today announced the amendment of the marketing and distribution agreement with Coeptis Pharmaceuticals and provided an update on the upcoming launch of Consensi in the U.S:...Under the terms of the amended agreement Kitov will receive 20% in royalties on net sales of ConsensiTM with minimum royalties of $4.5M over the next 3 years."

Commercial • Launch US • Licensing / partnership

Kitov Pharma Reports First Half 2019 Financial Results and Provides Business Update (GlobeNewswire, Kitov Pharma Ltd.) - With the recent successful completion of the IND-enabling studies to advance NT-219 into the clinic and the almost completed acquisition of CM-24, we will soon initiate clinical trials with both candidates which we believe have a great potential to provide effective and long-lasting treatments for patients.”. Israel added, “We have additionally achieved significant milestones with Consensi™ during this period.

Clinical • Commercial • New trial

Administrative enforcement agreement finalized between Kitov Pharma and the Israeli Securities Authority (GlobeNewswire) - "Kitov Pharma Ltd....today announced that a settlement agreement with the Israel Securities Authority (ISA) was approved, resulting in the termination of ISA’s investigation against Kitov...The investigation arose in connection with Kitov's Phase 3 clinical trial for Consensi™ as part of its development program."

Corporate lawsuit

Kitov Pharma Reports First Half 2019 Financial Results and Provides Business Update (GlobeNewswire, Kitov Pharma Ltd.) - With the recent successful completion of the IND-enabling studies to advance NT-219 into the clinic and the almost completed acquisition of CM-24, we will soon initiate clinical trials with both candidates which we believe have a great potential to provide effective and long-lasting treatments for patients.”. Israel added, “We have additionally achieved significant milestones with Consensi™ during this period. Expected Milestones for 2H19: Submit IND for the initiation of Phase 1/2 study with NT-219 in combination with cetuximab in patients with recurrent and metastatic SCCHN; Complete closing of transaction for the acquisition of FameWave and its CM-24 candidate.

Clinical • Commercial • Launch • New trial • Regulatory