Keytruda wins FDA approval in head and neck cancer

pharmatimes | June 12, 2019

MSD’s blockbuster cancer drug Keytruda (pembrolizumab) has won approval from the US Food and Drug Administration (FDA) to treat a type of head and neck cancer. It was approved in the Indication of first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma as monotherapy for patients whose tumours express PD-L1 or in combination with platinum and fluorouracil (FU) regardless of PD-L1 expression. The approval is based on results from the pivotal Phase 3 KEYNOTE-048 trial, where Keytruda demonstrated a significant improvement in overall survival (OS) compared with the current standard of care, the EXTREME regimen which consists of cetuximab with carboplatin or cisplatin plus FU. The results mean that the drug is the first anti-PD-1 therapy approved in the first-line setting as monotherapy in patients whose tumours express PD-L1, and also  the first anti-PD-1 therapy to demonstrate a statistically significant improvement in OS in these patients. The approval marks a “very exciting milestone in the treatment of head and neck cancer and has the potential to transform the way we treat patients with this debilitating disease by offering important new therapeutic options,” said Dr. Barbara Burtness, professor of medicine.

Spotlight

A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical research and the marketing tactics of the pharmaceutical industry, turnin


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PHARMACY MARKET

Medison Pharma Announces Extension of Multi-territorial Agreement with Immunocore and Expansion into Australia and New Zealand

Medison Pharma | May 30, 2022

Medison Pharma a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced the addition of new markets to its multi-territorial agreement with Immunocore Holdings plc a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. The multi-territorial agreement to help seek regulatory authorization and commercialize Immunocore's KIMMTRAK® for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma that affects the eye, which covers Canada, twenty markets across Central Eastern Europe and Israel, will now extend to Australia and New Zealand. KIMMTRAK has been approved by both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where it is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma. "We are delighted to deepen our partnership with Immunocore and proud to further grow the reach of their breakthrough treatment, as part of our mission that knows no borders. We believe that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies. By adding new countries and continents, we are continuing in our efforts to turn our mission into a reality." Meir Jakobsohn, Founder and CEO of Medison "It can be challenging for biotechs to commercialise in a large number of countries, often resulting in delayed access to highly innovative therapies in many areas of the world. Medison's global platform is designed to address this challenge," said Gil Gurfinkel, VP Corporate Development at Medison. "Immunocore's novel therapy for unresectable or metastatic uveal melanoma and our ability to treat patients suffering from this rare and aggressive form of cancer in additional countries is a win-win outcome of our partnership." Medison's expansion of its commercial presence to Australia and New Zealand is the latest addition to its geographic growth, enabling Medison to capitalize on growing market opportunities for its commercial partners. Medison is further enlarging its footprint in Europe with a new office location for its international headquarters in Zug, Switzerland, and operations in Greece and Cyprus, which enlarge its European offering of Central Eastern Europe, the Baltic states, and Balkans. In Canada, the team is also growing and recently moved into larger office space in downtown Toronto. With this latest growth, Medison increases its commercial presence across 25 locations around the world. Medison is hiring across all locations and in key functions. About Medison Pharma Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. About KIMMTRAK® KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. KIMMTRAK is currently approved in 31 countries, including the United States and European Union.

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PHARMACY MARKET

Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

Sunovion Pharmaceuticals Inc. | February 10, 2022

Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development And Commercialization, Inc. announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride is being jointly developed and commercialized as part of a collaboration between Sunovion, its parent company Sumitomo Dainippon Pharma and Otsuka Pharmaceutical Co., Ltd. SEP380-301, named RELEASE 1 is a six-week, global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the efficacy, safety and tolerability of non-racemic amisulpride in adults with bipolar depression. Patients will be randomized to receive fixed-dose, non-racemic amisulpride or placebo. The primary endpoint for RELEASE 1 is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared to placebo, after six weeks of treatment. Following participation in the six-week study period, patients who complete RELEASE 1 may enroll in RELEASE 3, a 12-month, open-label extension study assessing the long-term safety, tolerability and effectiveness of non-racemic amisulpride. “Major depressive episodes associated with bipolar I disorder have a profound impact on those living with the condition. Depressive episodes are associated with mood impairment, fatigue, loss of interest in activities or social situations and, in some cases, suicidality. We are encouraged by our Phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression.” Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at Sunovion “Randomizing the first patient in the RELEASE Phase 3 clinical development program is a significant step in our collaboration with Sunovion and our shared goal of expanding neuropsychiatric treatment options to patients living with serious mental conditions,” said John Kraus, M.D., Ph.D., Vice President, Clinical Development Therapeutic Head, CNS, Otsuka Pharmaceutical Development & Commercialization, Inc. “Through our collaboration with Sunovion, we hope to advance SEP-4199, which we believe shows promise for the treatment of people with bipolar depression.” About Non-Racemic Amisulpride (SEP-4199) Non-racemic amisulpride is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride was designed to enhance 5-HT7 receptor antagonist activity and reduce dopamine D2 receptor antagonist activity compared to racemic amisulpride. Lower D2 receptor occupancy associated with non-racemic amisulpride is intended to maintain overall effectiveness for patients with mood disorders, including bipolar depression, while reducing the burden of D2-related side effects, including movement-related symptoms, such as extrapyramidal symptoms and akathisia.1 About Bipolar Disorder Bipolar disorder affects approximately 12.6 million individuals in the United States and an estimated 29 million people worldwide.2,3 A person is usually diagnosed with bipolar disorder after experiencing at least one manic/hypomanic episode, with symptoms that are not better explained by another mental health condition, such as schizophrenia.4 Bipolar disorder is characterized by debilitating mood swings, interspersed with periods of stable mood and behavior.5 When individuals with bipolar disorder are experiencing symptoms, most tend to be depressed rather than manic.4 Bipolar disorder is associated with significant impairment in personal and professional relationships, quality of life and ability to function. About Sunovion Pharmaceuticals Inc. (Sunovion) Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate

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PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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BUSINESS INSIGHTS

Cedars-Sinai Medical Center and AIkido Pharma Inc. to Codevelop Novel Immuno-Oncology Cancer Treatment

AIkido Pharma Inc. | March 15, 2022

AIkido Pharma Inc. announced that the Company and Cedars-Sinai Medical Center have agreed under their Master Collaboration Agreement to co-fund and codevelop a novel immuno-oncology treatment designed to promote the destruction of cancer cells by a patient's own "killer" T-cells. The Company and Cedars-Sinai will share costs, expenses and management of the drug co-development and will leverage the talent of Cedars-Sinai Technology Ventures and the lead scientists who originated the novel treatment. The parties will also share in the proceeds of any commercialization of the treatment. The compounds to be codeveloped target the cellular pathway that causes CD8+ T-cells to enter an "exhausted state," rendering them ineffective against cancer cells. The new treatment targets and blocks recently discovered transcription factors essential for T-cells to enter the "exhausted state," the goal of which is to strengthen the ability of a patient's T-cells to retain their capacity to destroy cancer cells. "Our agreement with Cedars-Sinai to collaborate in the funding and monetization of novel disease treatments is a major step for the Company. I am thrilled that Cedars-Sinai will be co-funding this project and providing its exceptional staff of scientists to advance this new cancer treatment, which I believe speaks volumes about its potential." Anthony Hayes, CEO of AIkido About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV MERS-CoV, Ebolavirus and Marburg virus.

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Spotlight

A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical research and the marketing tactics of the pharmaceutical industry, turnin

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