A Fast-Moving Virus Pits Treating Patients Against Finding a Cure

Bloomberg | April 05, 2020

A Fast-Moving Virus Pits Treating Patients Against Finding a Cure
The frenzied hunt for drugs to ease Covid-19 could make it more difficult for scientists to find lasting treatments. Pharmaceutical-research experts are raising concerns that attempts to offer desperate coronavirus patients some form of treatment may hobble crucial studies of which drugs actually work and which ones don't. More than 100 off-the-shelf and experimental therapies are being tested either formally or informally for the coronavirus disease, including hydroxychloroquine, the antimalarial touted as a treatment by President Donald Trump, and remdesivir, an experimental drug from biotechnology company Gilead Sciences Inc. There are so many even coronavirus experts can barely keep track. The huge field of potential treatments represents a mobilization of medical science that has few historical parallels. But with tens of thousands of patients in the U.S. hospitalized and no proven drugs to treat them, the crisis has exacerbated an always-present tension in the parallel worlds of caring for patients and looking for new therapies: that what might seem best for an individual patient can undercut a research effort that will benefit the greater public good.

Spotlight

Much of the excitement around gene editing is fueled by its potential to treat or prevent human diseases. There are thousands of genetic disorders that can be passed on from one generation to the next; many are serious and debilitating. Genes are the biological templates the body uses to make the structural proteins and enzymes needed to build and maintain tissues and organs. They are made up of strands of genetic code, denoted by the letters G, C, T and A. Humans have about 20,000 genes bundled into 23 pairs of chromosomes all coiled up in the nucleus of nearly every cell in the body.


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BUSINESS INSIGHTS

OPTEL ACQUIRES PHARMA TRACK-AND-TRACE UNIT OF KÖRBER

OPTEL Group | January 12, 2022

OPTEL GROUP, already a world leader in supply chain traceability, is expanding its expertise and global reach with the recent acquisition of the track-and-trace unit of the Körber Business Area Pharma, formerly known as Traxeed, based in Germany. Körber is a leading international technology group. The acquisition, announced today, will allow OPTEL to leverage the unit's expertise in pharmaceutical and agrochemical track-and-trace technologies, provide the company with a second foothold in the European marketplace and contribute to its diversification plans. "Creating a strong presence in the German market is key to the success of our strategic objectives because Germany is a well-established manufacturing hub, with a strong history of developing innovative manufacturing efficiency solutions and Industry 4.0 technologies," Louis Roy, founder and president of OPTEL "We are pleased that we have found a solid and future-oriented new owner with a broad international market access, from whose global network and years of experience in the highly specialized track-and-trace sector customers will clearly benefit. We are furthermore convinced that the new strategic owner can open up attractive development opportunities for the team," said Dr. Jürgen Krebs, Chief Technology Officer and Chief Operating Officer in the Körber Business Area Pharma. The acquisition allows OPTEL to welcome highly skilled pharma track-and-trace experts from Körber, complementing OPTEL's existing strengths in traceability, vision technologies, software and hardware. Furthermore, it will solidify and expand the company's presence in the European market by providing a second base of operations after Limerick, Ireland. In addition to the acquisition, a close collaboration between OPTEL and Körber's Business Area Pharma is planned in the future. The two companies plan to sign a partnership agreement whereby OPTEL becomes Körber's preferred partner for track-and-trace solutions for the pharmaceutical industry. Since its founding in 1989, OPTEL has become the world's foremost provider of track-and-trace solutions to the pharmaceutical industry. Its acquisitions in recent years have positioned it as the only company with the ability to provide complete, full-stack supply chain traceability. The Canadian multinational has since diversified into other industries, including consumer-packaged goods, metals and minerals, and agrochemicals. The acquisition of the track-and-trace unit of the Körber Business Area Pharma is expected to accelerate further expansion. ABOUT OPTEL OPTEL is a leading global provider of traceability systems whose goal is to use its innovative technologies to build a sustainable world through the Intelligent Supply Chain. OPTEL is the only company with the ability to offer complete end-to-end traceability, providing granular data at every step of the supply chain – from raw materials to the consumer and beyond. Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in Ireland, India and Brazil, as well as employees worldwide. ABOUT KÖRBER We are Körber – an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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BUSINESS INSIGHTS

Cullinan Oncology Forms Strategic Collaboration Agreement with Mount Sinai to Advance Oral HPK1 Protein Degrader for Cancer Treatment

Cullinan Oncology, Inc. | January 10, 2022

Cullinan Oncology, Inc. a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today announced the Company has entered into a collaboration agreement with the Icahn School of Medicine at Mount Sinai to develop novel small molecule immune modulators.​ This exclusive option and multi-year collaboration agreement will be focused on the optimization and development of oral protein degraders targeting hematopoietic progenitor kinase 1 (HPK1), a key regulator of immune cell activation and a high-priority target in immune-oncology. The collaboration aims to accelerate the development of novel, best-in-class HPK1 degraders that stimulate robust anti-tumor immunity. The research will be conducted by leading scientists at both Cullinan and Icahn Mount Sinai. Cullinan will fund the collaboration and has an exclusive option to license the intellectual property for further development and commercialization. The Icahn Mount Sinai team will be co-led by Steven J. Burakoff, M.D., Lillian and Henry M. Stratton Professor of Cancer Medicine, Dean for Cancer Innovation, and Chief, Pediatric Oncology at Icahn Mount Sinai, and Jian Jin, Ph.D., Mount Sinai Professor in Therapeutics Discovery and Director, Mount Sinai Center for Therapeutics Discovery, at Icahn Mount Sinai. “Our team is excited to work with the talented and experienced cancer drug developers at Cullinan. Our research has already demonstrated that a degrader approach to targeting HPK1 may control tumor growth more effectively compared to simply inhibiting HPK1 kinase activity. We believe this collaboration will help us identify novel, differentiated oral HPK1 degraders and can bring future benefit to cancer patients worldwide.” Dr. Jin “We are proud to partner with Icahn Mount Sinai, which is at the forefront of cancer research and patient care,” said Leigh Zawel, Chief Scientific Officer, Small Molecules, of Cullinan Oncology. “We are very excited to build on the synergy between the deep scientific expertise of the Icahn Mount Sinai team and the strong drug development capabilities at Cullinan to advance therapies that have the potential to significantly improve the lives of patients with cancer. We look forward to a fruitful collaboration in this novel area of science.” About Cullinan Oncology Cullinan Oncology is a biopharmaceutical company that is developing a diversified pipeline of targeted therapeutic candidates across multiple modalities in order to bring important medicines to cancer patients. The Company’s strategy is to source innovation through both internal discovery efforts and external collaborations, focusing on advanced stage assets with novel technology platforms and differentiated mechanisms.

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PHARMACY MARKET

CASI PHARMACEUTICALS ANNOUNCES CNCT19 (CD19 CAR-T) GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA

CASI Pharmaceuticals, Inc. | January 19, 2022

CASI Pharmaceuticals, Inc. a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration as granted Orphan Drug Designation for CNCT19, an investigational CD-19 directed CAR-T therapy, for the treatment of patients with Acute Lymphoblastic Leukemia. CNCT19 is currently being developed independently by Juventas to meet the urgent clinical needs of patients with hematologic malignancies globally. The National Medical Products Administration has granted CTA approval for CNCT19 in two indications in Nov. 2019. Currently, the Phase II clinical trials of CNCT19 are in progress. Positive clinical data for adult and pediatric patients with relapsed/refractory B-ALL has been presented at the December 2021 ASH annual meeting, which further demonstrated its safety and efficacy profile. CNCT 19 is expected to be the first domestic CD19 directed CAR-T product in China with independent intellectual property rights. "Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. The Orphan Drug Designation, from the FDA, and the Breakthrough Designation status, granted by the China Center of Drug Evaluation (CDE) in December 2020, represent significant milestones that demonstrate our belief that CNCT19's commercialization will not only be successful in China, but potentially on a global scale. CASI has worldwide co-commercial rights of CNCT19, and will start the global commercialization process according to CNCT19's regulatory progress outside China." Dr. Wei-Wu He, CASI's Chairman, and CEO About Juventas Juventas is a biopharmaceutical company headquartered in China dedicated to the development and commercialization of cell therapies globally. Utilizing innovative and integrated technology platforms, the company has developed a diverse pipeline of cellular immunotherapies for treatment of hematological malignancies, solid tumors, and other non-oncological conditions both in China and globally. At present, the company is conducting two pivotal clinical trials of CNCT19 for treating adult r/r-B-ALL and r/r-B-NHL in China. CNCT19 has the potential to become the first launched domestically developed CD19 CAR-T therapy in China and the first CAR-T product for the treatment of adult R/R B-ALL in China. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based in China.

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PHARMA TECH

CSL Limited announces tender offer to acquire Vifor Pharma Ltd

Vifor Pharma Group | December 15, 2021

Global biotechnology leader CSL Limited and Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in iron deficiency, nephrology & cardio-renal therapies, announced that they have entered into a definitive agreement for CSL to acquire Vifor Pharma for an aggregate equity value for Vifor Pharma of US$ 11.7 / CHF 10.9 billion. CSL has offered to acquire Vifor Pharma in an all-cash tender offer of US$179.25 per share, payable in U.S. dollars.1 The offer assumes a dividend of CHF 2 expected to be declared at the AGM of 26 April, consistent with past practice. The tender offer represents an implied premium of approximately 61% to the unaffected closing price of Vifor Pharma on 1 December 2021 and a 47% premium to Vifor Pharma’s unaffected 1-month VWAP as of 1 December 2021.2 Patinex AG, Vifor Pharma’s largest shareholder holding 23.2% has agreed to tender its shares into the offer. The Transaction remains subject to the conditions and further terms including: Minimum acceptance rate of 80% of all Vifor Pharma shares on a fully diluted basis; and further customary offer conditions, including regulatory approvals. The tender is currently expected to commence around 18 January 2022 and the transaction is expected to complete around mid-2022. The Board of Directors of Vifor Pharma considers that the proposed transaction respects the interests of all stakeholders and is unanimously recommending the offer to shareholders. There is committed financing for the deal and a strong commitment to pursue regulatory clearances. “Vifor Pharma's strategy has been to focus towards continuing being a market leader in iron deficiency, nephrology and cardio-renal therapies. The offer provides an excellent strategic opportunity for Vifor Pharma to optimize future market opportunities from a position of strength and to create substantial value for all stakeholders.” Jacques Theurillat, Chairman of the Board of Directors Vifor Pharma Group The transaction will enable Vifor Pharma to leverage CSL’s global reach, balance sheet and capabilities to bring more products to patients within its key categories. The transaction also enables Vifor Pharma to accelerate growth in cardiovascular-metabolic, renal and transplant. Centerview Partners UK LLP is acting as exclusive financial advisor to Vifor Pharma on the transaction. IFBC have been retained as Fairness Opinion providers by the Vifor Pharma Board of Directors. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

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Spotlight

Much of the excitement around gene editing is fueled by its potential to treat or prevent human diseases. There are thousands of genetic disorders that can be passed on from one generation to the next; many are serious and debilitating. Genes are the biological templates the body uses to make the structural proteins and enzymes needed to build and maintain tissues and organs. They are made up of strands of genetic code, denoted by the letters G, C, T and A. Humans have about 20,000 genes bundled into 23 pairs of chromosomes all coiled up in the nucleus of nearly every cell in the body.

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