1stOncology™: Cancer Intelligence Service – Page 12723 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BIOGEN TO PRESENT AT THE 38TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On December 17, 2019 Biogen Inc. (Nasdaq: BIIB) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Biogen, DEC 17, 2019, View Source [SID1234552474]). The webcast will be live on Monday, January 13, 2020 at 3:30 p.m. PT, 6:30 p.m. ET. To access the live webcast, please visit Biogen’s Investors section at www.biogen.com/investors. An archived version of the webcast will be available following the presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Entry into a Material Definitive Agreement

On December 17, 2019, Ultragenyx Pharmaceutical Inc. (the "Company") reported that it has entered into a Royalty Purchase Agreement (the "Agreement") with RPI Finance Trust ("Royalty Pharma"), pursuant to which Royalty Pharma paid $320 million in cash to the Company in consideration for the right to receive future royalty payments (the "Royalties") due to the Company from Kyowa Kirin Co., Ltd. ("KKC") based on net sales of Crysvita in the European Union, the United Kingdom, and Switzerland under the terms of the Company’s Collaboration and License Agreement with KKC dated as of August 29, 2013, as amended. The Agreement will automatically expire, and the payment of Royalties to Royalty Pharma will cease, in the event aggregate royalty payments received by Royalty Pharma are equal to or greater than $608 million prior to December 31, 2030, or in the event aggregate royalty payments received by Royalty Pharma are less than $608 million prior to December 31, 2030, when aggregate royalty payments received by Royalty Pharma are equal to or greater than $800 million.

The Agreement contains other customary terms and conditions, including representations and warranties, covenants and indemnification obligations in favor of each party. The above description of the Agreement is a summary of the material terms, does not purport to be complete and is qualified in its entirety by reference to the Agreement, which will filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

CNS Pharmaceuticals Partnered with Anthem Biosciences Pvt. Ltd. in Preparation for Upcoming Proposed Phase 2 Clinical Trial

On December 17, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported the completed good manufacturing practice (GMP) reprocessing of its lead drug candidate, Berubicin, with partner Anthem Biosciences Pvt. Ltd. of Banglaore, India, ("Anthem") an internationally recognized Contract Research and Innovation Service Provider specializing in complex medicinal chemistry (Press release, CNS Pharmaceuticals, DEC 17, 2019, View Source [SID1234552453]).

This critical manufacturing step was undertaken pursuant to previously announced positive feedback from the U.S. Food and Drug Administration (FDA) for the Company’s Pre-IND (Investigational New Drug) meeting proposal to use a lyophilized drug product, Berubicin, in Phase II clinical trials.

In its response to the Company’s Pre-IND request, the FDA agreed that CNS’ proposal to use a lyophilized drug product, that was developed previously but not used clinically, is acceptable. The FDA further stated that the Company’s proposal to utilize its existing supply of Berubicin in its proposed Phase 2 clinical trial was reasonable if the Berubicin was reprocessed by batch GMP recrystallization and released under GMP specifications. In response to the FDA’s guidance, CNS contracted with Anthem and completed the GMP reprocessing of CNS’ existing supply of Berubicin.

"We are thankful to have such an experienced partner, Anthem, assist us in completing the critical reprocessing work of our existing Berubicin supply," stated CEO of CNS, John M. Climaco. "The GMP reprocessing was a significant milestone in our continued efforts to prepare a new IND in accordance with the FDA guidance we received. We look forward to our upcoming potential Phase II trial evaluating the efficacy of Berubicin in subjects who have glioblastoma that has recurred or progressed following radiation therapy and temozolomide, as we believe in Berubicin’s potential to demonstrate in clinical trials that it can become the only effective anthracycline against brain cancer."

About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.

Prime Therapeutics announces value-based agreement with Pfizer in oncology

On December 17, 2019 Prime Therapeutics LLC (Prime), a leading pharmacy benefit manager (PBM) serving more than 28 million members nationally, reported that it has entered into a value-based agreement with Pfizer Inc., a global biopharmaceutical company, intended to help improve outcomes for patients being treated for cancer (Press release, Prime Therapeutics, DEC 17, 2019, View Source [SID1234552452]).

"An essential part of Prime’s total drug management strategy is identifying drug therapies that, with the right measures and monitoring, can lead to enhanced member outcomes and yield the best value for patients and insurers," said Kelly Pokuta, vice president, pharmaceutical trade relations for Prime. "Intentionally teaming up with biopharmaceutical companies is one of the many ways we control health plan costs and deliver customer-centered value. Prime’s next-generation analytics and rich drug value assessment experience, combined with Pfizer’s deep expertise in oncology and research, make this agreement a win for patients."

Prime will utilize real-world patient pharmacy data to support a value-based agreement related to patients’ adherence to their cancer treatment. Interruptions in oncology therapy can not only have a negative impact on patient outcomes but can also drive up associated health care costs.

"We are pleased to work with Prime on this agreement using real-world data with the aim to improve patient outcomes and ultimately lower health care costs," said Justin McCarthy, senior vice president, patient and health impact group, Pfizer. "As we move from a volume- to a value-based health care system, this collaboration is a great example of the partnerships we are creating across the health care sector to help patients access innovative medicines."

As a pioneer in value-based contracting since 2010, Prime’s manufacturer contracts analyze the value of a selected medicine when taken appropriately, with the goal of improving outcomes and lowering total cost of care. As an integral part of its value and health outcomes strategy, Prime is transforming value-based contracting through analysis of integrated pharmacy and medical data, showing members’ total health picture and providing actionable information to design high-touch interventions. Prime continues to leverage value-based contracts to help ensure emerging and high-cost therapies are priced according to the member value they deliver.

Herantis Pharma Plc Completes Patient Recruitment and Treatment in Phase 2 AdeLE Trial in Breast Cancer Associated Lymphedema

On December 17, 2019 Herantis Pharma Plc ("Herantis" or "Company") reported that patient recruitment in the Company’s Phase 2 clinical trial AdeLE ("Adenoviral gene therapy for the treatment of LymphEdema") has been completed (Press release, Herantis Pharma, DEC 17, 2019, View Source [SID1234552451]). All of the 39 patients with breast cancer associated lymphedema have been randomized to receive either Lymfactin or placebo treatment, and their treatments have been completed according to the study protocol. The AdeLE trial will continue with a 12-month blinded follow-up to evaluate the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. Herantis expects to unblind the study and announce its top-line results in the first quarter of 2021.

"The rapid enrolment completion demonstrates not only that there is a significant need for novel treatment options in lymphedema, but it is also an important milestone for our Lymfactin program as we are advancing into late-stage clinical development. We are truly grateful to the patients who participated in the AdeLE study, the supporting physicians and staff at the study sites, and to the international patient organization LE&RN, which fights to raise awareness for lymphedema as a significant unmet clinical need," commented Pekka Simula, CEO of Herantis. "Based on the cumulated safety data and assessments of the trial’s independent Data Safety Monitoring Board, we are encouraged by the established safety profile of Lymfactin. We look forward to the efficacy read-outs that could bring new hope to lymphedema patients all around the world."

Study Design

The AdeLE study is a multi-center, randomized, double-blind, placebo-controlled Phase 2 trial that evaluates the safety and efficacy of Lymfactin in the treatment of breast cancer associated lymphedema, when combined with a conventional lymph node transplantation surgery. In total, 39 patients with breast cancer associated lymphedema have been recruited in the study and randomized 1:1 to receive a single dose of either Lymfactin or placebo as an adjunct to surgery. The active patient treatment period was completed with last dosing in December 2019 and the study continues with a 12-month blinded follow-up.

Study Objectives

The primary endpoint of the AdeLE study is efficacy in the treatment of breast cancer associated lymphedema. Efficacy will be assessed by changes in the volume of the affected arm compared with the unaffected arm, quality of life of the patient based on the Lymphedema Quality of Life Inventory and the assessment of the lymph flow of the affected arm by quantitative lymphoscintigraphy.

Further Information:

Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358-40-7300-445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358-9-25-380-225

About Lymfactin

Lymfactin is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication. Based on cumulated data from a Phase 1 clinical study in 15 patients with breast cancer associated lymphedema, Lymfactin is safe and well tolerated. The efficacy of Lymfactin is currently studied in the Phase 2 clinical study AdeLE in Finland and Sweden.

Lymfactin, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki. For more information please see View Source

About Breast Cancer Associated Lymphedema

Approximately 20% of breast cancer patients who undergo axillary lymph node dissection develop secondary lymphedema: a progressive, disabling, and disfiguring disease that severely affects the quality of life. Symptoms include a chronic swelling of an upper limb, thickening and hardening of skin, loss of mobility and flexibility, pain, and susceptibility to secondary infections. Secondary lymphedema is currently treated with compression garments, special massage, and exercises. While these therapies may relief the symptoms in some patients, they do not address the underlying cause of lymphedema, which results from damage to the lymphatic system. There are currently no approved medicines for the treatment of secondary lymphedema.