CivicaScript™ Announces Launch of its First Product, Creating Significant Patient Savings

On August 3, 2022 CivicaScriptTM, a public benefit company dedicated to bringing lower-cost generic medicines to U.S. consumers, reported the availability of its first product: abiraterone acetate 250 mg tablets (Press release, CivicaScript, AUG 3, 2022, View Source [SID1234617432]). Abiraterone is used together with steroid medication (prednisone) to treat prostate cancer that has spread to other parts of the body.

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Starting today, CivicaScript will offer abiraterone 250 mg for sale to pharmacies for $160 per bottle of 120 tablets – typically a month’s supply. CivicaScript recommends that pharmacies charge patients no more than $171 per bottle (CivicaScript’s maximum retail price, or MaxRP).

This is about $3,000 per month less than the average cost2 for someone with Medicare Part D, the type of insurance people with prostate cancer are most likely to have. Part D patients who use CivicaScript’s abiraterone product will significantly reduce their out-of-pocket cost both during the deductible phase, in which they pay full price for drugs, and during the "doughnut hole" phase, when they again face substantial out-of-pocket costs.

Abiraterone was chosen by CivicaScript members as a priority generic medicine based on its high list price from other manufacturers and significant patient need for the product.

"This is a proud day for CivicaScript as we advance our mission to make generic medicines affordable and available to everyone," said CivicaScript President Gina Guinasso. "I want to thank our members for their active participation in our drug-selection process, which ensures we are focusing on the right medications at the right time, and where we believe we can have immediate impact on people’s lives."

CivicaScript was co-founded in 2020 by Civica Inc., the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies to bring affordable versions of common but high-priced generic medicines to market. Its model is to identify select high-priced generic medicines and work with manufacturing partners to bring them to market at a fraction of their current cost. CivicaScript then works with like-minded payors, PBMs and pharmacies across the country who pass along the cost savings to their customers.

While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be due to lack of competition in the market. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. CivicaScript, its members and its manufacturing partners are intent on addressing that problem.

"We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market," said Kim Keck, president and CEO of BCBSA. "This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication."

Initially, CivicaScript’s abiraterone will be available through Lumicera Health Services, a specialty pharmacy that focuses on medicines for chronic and serious conditions, and through Intermountain Healthcare. Additional pharmacies will be listed on the CivicaScript website as they come on board. "We welcome the partnership of other health plans, employers and pharmacies who share our belief that patients come before profits," Guinasso said.

The guiding principle for CivicaScript’s portfolio development is to target both specialty and traditional generics where there is greatest opportunity to substantially reduce prices for patients. The organization is initially focused on six to 10 medications for which there currently is not enough market competition to ensure low, sustainable prices.

Starting in 2024, CivicaScript also intends to distribute low-priced insulin, which will be manufactured by Civica, subject to FDA approval. Civica is building a state-of-the-art manufacturing facility in Petersburg, Virginia, and has entered into a co-development and commercial agreement with GeneSys Biologics for three insulin biosimilars: glargine, lispro and aspart (biologics corresponding to Lantus, Humalog and Novolog, respectively).

Civica plans to set a recommended price to the consumer of no more than $30 per insulin vial and no more than $55 for a box of five insulin pen cartridges, a significant discount to prices charged to uninsured individuals today.3

Sumitomo Pharma Oncology Receives Orphan Drug Designation for DSP-5336, an Investigational Menin and Mixed-Lineage Leukemia Binding Protein for Treatment of Acute Myeloid Leukemia

On August 3, 2022 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for DSP-5336, an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, for the treatment of acute myeloid leukemia (AML) (Press release, Sumitomo Pharmaceuticals, AUG 3, 2022, View Source [SID1234617431]).

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"We are pleased to have received this designation for DSP-5336 which reinforces the need to identify novel therapeutic options to improve outcomes for patients with AML," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "We are excited to contribute to the advancement of research in this hematologic malignancy."

The FDA’s Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. AML is a blood cancer that starts in bone marrow. Bone marrow typically produces white blood cells, red blood cells and platelets. However, in people with AML, the bone marrow makes abnormal cancerous white blood cells called myeloid blasts. AML swiftly moves from the bone marrow into your bloodstream and can even involve other parts of your body.1

"MLL gene rearrangements and nucleophosmin 1 (NPM1) mutations are potent drivers of leukemia growth, and menin is a necessary copilot. DSP-5336 is a small molecule that blocks the MLL-menin partnership which inhibits normal differentiation and promotes leukemia growth."2-5 detailed Jatin J. Shah, M.D., Chief Medical Officer of Sumitomo Pharma Oncology, Inc. "We’re encouraged by preclinical evidence showing that blocking the menin-MLL interaction may stop the development of leukemia and restore normal terminal differentiation in MLL rearranged and NPM1-mutant malignant myeloid cells."2,6

DSP-5336 is currently being evaluated in a Phase 1/2 clinical trial to evaluate the safety and efficacy of DSP-5336 in patients with Relapsed/Refractory AML/ ALL with or without MLL Rearrangement or NPM1 Mutation, which is being conducted in the United States and Japan. To learn more about the study and eligibility for enrollment, visit clinicaltrials.gov (NCT04988555).

This is the third recently announced Orphan Drug Designation from SMP Oncology. TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, was granted Orphan Drug Designation for the treatment of myelofibrosis (NCT04176198) as well as DSP-0390, an investigational emopamil-binding protein (EBP) inhibitor, was also granted Orphan Drug Designation for the treatment of brain cancer (NCT05023551). These designations support the strength and diversity of SMP Oncology’s pipeline and commitment to oncology research and development.

About DSP-5336
DSP-5336 is an investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein. Menin is a scaffold nuclear protein that plays various key roles in biological pathways, including cell growth regulation, cell cycle control, genomic stability, bone development, and hematopoiesis.2,3 In preclinical studies DSP-5336 has shown selective growth inhibition in human acute leukemia cell lines with MLL rearrangements or NPM1 mutations.2,6 DSP-5336 is currently being evaluated in a Phase 1/2 dose escalation/dose expansion study of DSP-5336 in patients with relapsed or refractory AML (NCT04988555).

Elevation Oncology to Participate at the Wedbush PacGrow Healthcare Conference

On August 3, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported that Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology, will participate in a fireside chat at the Wedbush PacGrow Healthcare Conference on Tuesday, August 9, 2022, at 10:55 am ET (Press release, Elevation Oncology, AUG 3, 2022, View Source [SID1234617430]).

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A live webcast and replay of this event will be available on the Events page of the Company’s Investor Relations website at View Source

Theseus Pharmaceuticals to Participate Virtually in Wedbush PacGrow Healthcare Conference

On August 3, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported that it will participate virtually in the 2022 Wedbush PacGrow Healthcare Conference, taking place August 9-10, 2022 (Press release, Theseus Pharmaceuticals, AUG 3, 2022, View Source [SID1234617429]).

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Presentation Details:
Event: Wedbush PacGrow Healthcare Conference
Date / Time: Wednesday, August 10th, 2022, at 10:20am ET
Format: Panel Discussion

A live webcast will be available in the Events section of the company’s investor relations website at ir.theseusrx.com and archived for 30 days following the presentation.

Management will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Theseus management team should contact their Wedbush representative.

Jubilant Therapeutics Inc. announces US FDA clearance of IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor, for treatment of solid tumors with brain metastases and primary brain tumors

On August 3, 2022 Jubilant Therapeutics Inc., a biopharmaceutical Company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported U.S. Food and Drug Administration (US FDA) clearance of the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, for the treatment of solid tumors with brain metastases and primary brain tumors including high-grade glioma (Press release, Jubilant Radiopharma, AUG 3, 2022, View Source [SID1234617428]).

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Jubilant Therapeutics Inc. announces US FDA clearance of& IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor,& for treatment of solid tumors with brain metastases and primary brain tumors
Jubilant Therapeutics Inc. announces US FDA clearance of& IND for JBI-778, an Oral, Brain Penetrant and Selective PRMT5 Inhibitor,& for treatment of solid tumors with brain metastases and primary brain tumors
The Phase I/II trial is an open-label, two-part dose escalation and expansion study designed to define the safety profile, pharmacokinetics, optimal dosing and preliminary activity of JBI-778. The study population in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts will include patients with active brain metastases and high-grade gliomas.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics’ proven discovery engine and structure-based drug discovery expertise."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumors and brain metastases which currently have limited treatment options. The incidence of brain metastasis is increasing due to improved therapies, increased imaging of neurologically asymptomatic patients and patients living longer. Our team has developed a unique capability to optimize brain penetration for precision oncology therapeutics. In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others."

About JBI-778

JBI-778 is a potent and selective brain penetrant inhibitor of protein arginine methyl transferase 5 (PRMT5), which is overexpressed in many cancers. JBI-778 is in development for the treatment of patients with advanced cancer with brain metastasis, and patients with high-grade glioma all of whom have limited treatment options. It has a unique mechanism of action compared to existing PRMT5 inhibitors by being substrate-competitive and S-adenosylmethoinine (SAM) cooperative, combined with a high brain exposure that enables targeting of both primary brain tumors and CNS metastasis. The substrate competitive profile appears to provide enhanced selectivity in the biological system by not interfering with the functions of SAM and shows a good tolerability profile in toxicological studies.