On September 1, 2022 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and Juniper Biologics Pte Ltd, a science-led healthcare company focused on researching, developing and commercializing novel therapies, reported the signing of an exclusive distribution license and supply agreement to register, distribute, promote, market and sell LEDAGA (chlormethine gel) in Australia, Southeast Asia and the Middle East* as a topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma ("MF-CTCL") in adults (Press release, Juniper Biologics, SEP 1, 2022, View Source [SID1234618864]).

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Giorgio Calderari, Helsinn CEO commented: "I am pleased to announce this agreement with Juniper today which further widens the geographic distribution of LEDAGAmaking this treatment option available to even more patients suffering from MF-CTCL. Juniper is an excellent partner for Helsinn and I’m looking forward to working with them to deliver on our mission to improve the lives of people with cancer all over the world."

Raman Singh, CEO of Juniper Biologics stated: "This latest deal is testament of the shared purpose and strong partnership between Juniper Biologics and the Helsinn Group. The licensing of LEDAGA marks a key milestone in our mission to help improve the treatment for patients suffering from the burden of MF-CTCL. With LEDAGA, we will not only be adding to our growing portfolio of oncology medicines, we will more importantly be providing cancer patients with access to this important treatment option."

Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

*The full list of countries covered by the license agreement includes: Australia, Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan, Brunei, Cambodia, Georgia, India, Indonesia, Iraq, Kazakhstan, Kyrgyzstan, Laos, Malaysia, Mongolia, Myanmar, Nepal, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Tajikistan, Turkmenistan, Uzbekistan and Vietnam.

About Mycosis Fungoides

Mycosis fungoides (MF) accounts for almost 50% of all primary cutaneous lymphomas, a form of non-Hodgkin’s lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance.

About LEDAGA

LEDAGA gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. LEDAGA is a gel which is applied topically once a day. The drug has been approved by the European Commission (for the treatment of MF-CTCL in adult patients). Since June 2019, LEDAGA is commercialized in more than 30 countries including Europe, Canada, Latin America.

On September 1, 2022 Abcam plc (Nasdaq: ABCM; AIM: ABC) ("Abcam" or the "Company"), a global leader in the supply of life science research tools, reported that Alan Hirzel, Chief Executive Officer, will be participating in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare conference at the Sheraton, New York Hotel in New York at approximately 4.10 p.m. BST (11.10 a.m. EDT) on 14 September 2022 (Press release, Abcam, SEP 1, 2022, View Source [SID1234618884]).

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To access the webcast, please use the following link:

View Source

The live audio webcast will also be available in the investor section of Abcam’s corporate website at corporate.abcam.com/investors/reports-presentations/. An archive will be available after the call at that same address.

On September 1, 2022 Moores Cancer Center at UC San Diego Health, the Office of Industry Relations and Alexandria Real Estate reported that the 18th annual Industry/Academia Next Generation Precision Oncology Symposium will be held Thursday, September 15, at The Alexandria at Torrey Pines (Press release, UC San Diego Moores Cancer Center, SEP 1, 2022, View Source [SID1234618917]). The Symposium serves as a forum for sharing scientific and medical advances in cancer research spanning multiple classes of therapies, with sessions focused on immuno-oncology, solid tumors and hematology/oncology.

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As part of the event, Kristen Hege, MD, Senior Vice President of Early Clinical Development, Hematology/Oncology & Cell Therapy at Bristol Myers Squibb, will be honored as the 2022 Duane Roth Achievement Award recipient. Dr. Hege is being recognized for her contributions to advancing cancer treatments over her career, including leading the development of Abecma (idecabtagene vicleucel), the first BCMA-directed CAR-T cell therapy approved by the FDA. In addition, Dr. Hege is a Clinical Professor of Medicine at the University of California San Francisco (UCSF), and continues to see patients with blood cancers.

"The Duane Roth Achievement Award is intended to recognize individuals who overcome significant challenges to improve the lives of patients with cancer," said Ida Deichaite, PhD, director of Moores Cancer Center’s Office of Industry Relations and organizer of the symposium. "This year we are proud to recognize Dr. Hege, whose tireless efforts have led to breakthrough therapeutic advances and who continues to engage directly with patients through her role at UCSF."

The Symposium is a forum for leaders in cancer research to present their latest data and translation of research into clinical applications and lifesaving treatment approaches for patients. The Symposium’s emphasis on translational oncology and drug development unites discovery and clinical development researchers, facilitating alliances and partnerships to ultimately accelerate curative therapies that advance global cancer care. Organizers encourage sharing of unpublished data to accelerate research dissemination and discussions that support exchange of knowledge.

Talks presented at the symposium include:

Presentations by researchers from oncology companies, including Bristol Myers Squibb, Dracen Pharmaceuticals, INHIBRx, Mirati Therapeutics, TRACON Therapeutics, and Viracta Therapeutics
Presentations by academic researchers at Moores Cancer Center and UC San Diego across multiple cancer types
About the Duane Roth Endowed Award Lecture

The Duane Roth Endowed Award Lecture is bestowed upon patient-focused leaders in health care whose work has overcome numerous scientific, financial, institutional, political and cultural obstacles to create new paradigms in research and treatment. Named after Duane Roth, an esteemed leader in the biotech industry who was tragically killed following a bicycle accident in 2013, the award is given to those who demonstrate his deep commitment to innovation and the patient. Past recipients include Dennis Carson, MD, UC San Diego; Susan Band Horwitz, PhD, Albert Einstein College of Medicine; Scott Gottlieb, MD, 23rd Commissioner of the Food and Drug Administration; Carl June, MD, University of Pennsylvania School of Medicine; Sandra Horning, MD, head of global product development and chief medical officer, Genentech; Dennis Slamon, MD, PhD, UCLA Jonsson Comprehensive Cancer Center; Brian Druker, MD, Knight Institute at Oregon Health and Science University; and Laura Esserman, MD, UCSF Helen Diller Family Comprehensive Cancer Center. Biographies of past winners and their accomplishments are available online.

On September 1, 2022 Novo Nordisk and Forma Therapeutics, Holdings Inc. (Nasdaq: FMTX) reported that they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for USD 20 per share in cash, which represents a total equity value of USD 1.1bn (Press release, Novo Nordisk, SEP 1, 2022, View Source [SID1234628159]). Forma Therapeutics is a clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders.

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The acquisition of Forma Therapeutics, including its lead development candidate, etavopivat, is aligned with Novo Nordisk’s strategy to complement and accelerate its scientific presence and pipeline in haemoglobinopathies, a group of disorders in which there is abnormal production or structure of the haemoglobin protein in the red blood cells.

"Novo Nordisk has worked for more than 40 years to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. By adding Forma’s differentiated approach to address unmet needs for patients, we are taking a step forward in enhancing our sickle cell disease pipeline," said Ludovic Helfgott, executive vice president and head of Rare Disease at Novo Nordisk. "We have an ambition to build a leading portfolio with standalone and combination treatments to tackle the complications and underlying causes of sickle cell disease."

Etavopivat, an investigational oral, once-daily, selective pyruvate kinase-R (PKR) activator, is being developed to improve anaemia and red blood cell health in people with SCD, a seriously debilitating, life-threatening and life shortening disease. Etavopivat is currently being evaluated in a global phase 2/3 clinical trial (Hibiscus) in patients with SCD, and in a phase 2 trial (Gladiolus) in patients with transfusion-dependent SCD and another inherited haemoglobinopathy called thalassemia.

"Today’s announcement is an exciting milestone that accelerates Forma’s purpose to transform the lives of patients with sickle cell disease and other serious haematological diseases," said Frank D. Lee, president and chief executive officer of Forma. "Novo Nordisk will partner closely with the sickle cell community to amplify our impact for patients around the world who urgently need new treatment options. We look forward to working together with Novo Nordisk to serve as a trusted partner to our communities and to advance innovation, access and health equity for patients."

The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2022 or the ongoing share buy-back programme. Novo Nordisk will fund the acquisition from financial reserves.

About the transaction
Under the terms of the agreement, Novo Nordisk will initiate a tender offer to acquire all outstanding shares of Forma Therapeutics’ common stock at a price of USD 20 per share in cash (or aggregated value of USD 1.1bn) and a premium of 92% to Forma Therapeutics’ volume-weighted average price per share over the past 30 days ended August 31, 2022.

The transaction has been unanimously approved by the Forma Therapeutics Board of Directors. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing a majority of Forma Therapeutics’ outstanding shares, receipt of applicable regulatory approvals and other customary conditions. Upon the successful completion of the tender offer, Novo Nordisk’s acquisition subsidiary will merge into Forma Therapeutics, and any shares of common stock of Forma Therapeutics not tendered into the offer will receive the same USD per share price payable in the tender offer. The transaction is expected to close in the fourth quarter of 2022.

In addition, certain affiliates of RA Capital Management, L.P., which collectively own approximately 19% of Forma Therapeutics’ outstanding shares, have entered into a support agreement pursuant to which they committed to tender their shares in the tender offer.

Novo Nordisk is represented by Moelis & Company UK LLP as financial advisor and Davis Polk & Wardwell LLP as legal advisor. Forma Therapeutics is represented by Centerview Partners LLC as financial advisor and Goodwin Procter LLP as legal advisor.

About sickle cell disease
Sickle cell disease (SCD) is a chronic and progressive inherited disorder associated with a decrease in the health and lifespan of red blood cells. People living with SCD have red blood cells that are crescent shaped, rendering them inflexible, fragile, and unable to effectively deliver oxygen. The health of these sickle red blood cells is impaired and characterized by reduced cellular energy, poor deformability, decreased membrane repair, and increased adhesion.

Around 17 million people worldwide live with SCD, including approximately 100,000 people in the United States, as well as approximately 30,000 in France, Germany, Italy, Spain, and the United Kingdom. SCD can cause serious health problems, including anemia, fatigue, episodes of pain known as vaso-occlusive crises (VOCs), and chronic, progressive end-organ damage. Despite recent advances in treatment, most patients with SCD still suffer from pain crises, lifelong disability, reduced quality of life, and shortened life expectancy.

About etavopivat
Etavopivat is an investigational, once-daily, selective pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy with the potential to improve red blood cell health and transform the lives of people living with SCD. Employing a multimodal approach, etavopivat works by activating the red blood cell’s natural PKR activity to decrease levels of the metabolite 2,3-DPG, allowing sickle hemoglobin to hold on to oxygen longer, resulting in decreased polymerization, haemolysis, and sickling. Etavopivat-mediated PKR activation also increases adenosine triphosphate (ATP) levels, to improve red blood cell function, which can lead to improved deformability, capacity for membrane repair, red blood cell health, and lifespan. Together, these effects are anticipated to improve the health of sickle red blood cell and lead to a reduction in anaemia, haemolysis, vaso-occlusive crises, and end organ damage.

In a phase 1 trial, etavopivat improved anaemia and red blood cell health and appeared to have a safe and well-tolerated profile, demonstrating a potential to improve the lives of patients with SCD, including increases in haemoglobin, improvements in red blood cell health, and decreases in vaso-occlusive crises (VOCs).

The U.S. Food and Drug Administration (FDA) has granted etavopivat Fast Track, Rare Pediatric Disease and Orphan Drug designations. Additionally, etavopivat was granted Orphan Drug designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

On September 1, 2022 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will participate in a Fireside Chat at the H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 12:00 PM ET at the Lotte New York Palace Hotel (Press release, Mannkind, SEP 1, 2022, View Source [SID1234618865]).

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Interested parties can access a link to the on demand webcast of the presentation from the Events & Presentations section of the Company’s website at View Source The webcast replay may be accessed at the same location for 14 days.