BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
BUSINESS INSIGHTS, PHARMACY MARKET
Accord Healthcare | March 14, 2023
On March 13, 2023, Accord Healthcare informed that it has expanded its portfolio with Teriflunomide, a film-coated tablet equivalent to Sanofi Genzyme's Aubagio. The drug treats relapsing forms of MS in adults, including clinically-isolated syndrome and active secondary progressive disease. The company offers Teriflunomide in 14 mg and 7 mg tablets, now available for shipping.
Teriflunomide has been granted FDA approval as an immunomodulatory agent for patients aged 18 and above. Its purpose is to reduce the frequency and severity of relapses, which can lead to new or worsening neurological symptoms associated with the disease.
Accord Healthcare US Vice President of Sales Jim Brown stated, "We're proud to add Teriflunomide to our portfolio. This is an important oral therapy for the millions of patients living with relapsing MS." He added, "Generic medicine allows broad access to effective therapy, to help improve disease course and potentially slow progression of MS."
(Source – Cision PR newswire)
Teriflunomide is an immunomodulatory medication that inhibits an enzyme critical to a metabolic pathway that supports lymphocyte proliferation. This results in fewer activated lymphocytes, which minimizes inflammation and immunological reactivity, resulting in lower recurrence rates and protection of brain volume against inflammatory nerve cell attacks.
Around 2.8 million people globally have multiple sclerosis, with the majority diagnosed with relapsing-remitting MS that typically begins in their twenties or thirties. Diagnosis involves experiencing two or more attacks or relapses while maintaining stability. New or exacerbated symptoms characterize relapses, and the immune system attacks the myelin sheath surrounding nerve fibers, ultimately causing long-term damage. Symptoms include numbness, fatigue, double vision, and balance problems. Besides, relapsing-remitting MS can also progress to active secondary progressive disease.
About Accord Healthcare
Accord Healthcare, a subsidiary of Intas Pharmaceuticals, is recognized as a prominent player in the generic pharmaceutical industry. The company's vision is to enhance patient access to medicines and revolutionize the pharmaceutical experience for healthcare providers and patients. With an emphasis on advanced manufacturing technology and in-house research, Accord Healthcare delivers a wide range of affordable, complex, and essential medicines. The company's dedication to forward-thinking and innovative solutions remains at the core of its mission. Headquartered in Durham (North Carolina), its products are marketed in 80 countries through the Intas network.
Lantheus | February 07, 2023
On February 6, 2023, Lantheus Holdings, Inc. (Lantheus), a company dedicated to improving patient outcomes through radiotherapy, diagnostics, and AI solutions that help clinicians to Find, Fight, and Follow® diseases, announced the acquisition of Cerveau Technologies, Inc. (Cerveau).
Cerveau's primary asset is MK-6240, which is a second-gen F 18-labeled positron emission tomography (PET) imaging agent that targets Tau tangles present in Alzheimer's disease.
Alzheimer's disease is a neurodegenerative condition that causes a steady and gradual deterioration in cognition and function. Alzheimer's disease affects an estimated 6.5 million people in the United States. As the population ages, the frequency of this disease is expected to climb further, and by 2050, the number of persons 65 and older with Alzheimer's disease may reach 12.7 million.
MK-6240 is a clinical-stage PET development candidate that is designed to identify Tau protein that accumulates as neurofibrillary tangles in the brains of individuals suffering or suspected of Alzheimer's disease. MK-6240 has the potential to help in Alzheimer's disease diagnosis, staging, treatment selection and response to therapy. Despite being in clinical development, MK-6240 is now being employed in over 60 academic and industrial clinical studies worldwide for various late-stage Alzheimer's disease therapeutic candidates, being explored by more than 16 pharmaceutical firms.
Following the terms of the agreement, Lantheus will make an upfront payment as well as potential further development and commercial milestone payments. It will also pay double-digit royalties on research revenue and commercial sales. In addition, the deal, which is structured as a stock acquisition, stipulates, among other things, that the seller would offer transition and clinical development services for a specified period after the conclusion of the transaction.
In this transaction, Chestnut Partners, Inc. served as the exclusive financial advisor to Cerveau. At the same time, Lantheus was advised by Foley Hoag LLP in connection with the acquisition.
Founded in 1956, Lantheus offers novel diagnostics, targeted medicines, and artificial intelligence (AI) solutions to help clinicians Find, Fight, and Follow® diseases. It has been delivering life-changing research to patients and clinicians for over 60 years, going above and beyond to enhance lives and outcomes. Lantheus Holdings is the parent company of Progenics Pharmaceuticals, Lantheus Medical Imaging, Inc., Inc. and EXINI Diagnostics AB. Headquartered in North Billerica, Massachusetts, the company has offices in New Jersey, Canada and Sweden.