Amgen Ends Neuroscience Program
Amgen announced that the company is stopping the vast majority of its neuroscience research. Amgen’s CEO Amgen, Bob Bradway cited the “challenges inherent in developing drugs for major neurologic diseases” as part of the reasoning for backing away from the space.
The company will hold onto several early research and development projects in the neurological space by shifting those involved in neuro inflammation over to its broader inflammation pipeline. Inflammation, cardiovascular disease, and oncology are now going to be the focus of their R&D.
“Upon careful evaluation of our pipeline and the challenges inherent in developing drugs for major neurologic diseases, we’ve made the decision to end our neuroscience research and early development programs with the exception of programs centered on neuro-inflammation,” said EVP of R&D David Reese.
Amgen will continue to support its migraine treatment program, Aimovig, including ongoing clinical development programs.
Biogen to Submit Alzheimer’s Drug to FDA
Biogen announced that it is planning to file for FDA approval for its Alzheimer’s treatment aducanumab after data from more patients in two discontinued studies showed that the drug improved cognition at high doses.
Earlier in the year, Biogen and partner Eisai had decided to end two late-stage trials of aducanumab based on a “futility analysis” of data, which revealed the trials had little hope of succeeding. However, Biogen announced that a new analysis, which included more patients, showed a significant reduction in clinical decline in one trial. Results for some patients in another study support those findings, as well.
The data showed that patients who received aducanumab experienced significant benefits on measures of cognition and function, including memory, orientation and language.
“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s. This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”
Based on discussions with the FDA, Biogen plans to file a Biologics License Application (BLA) in early 2020.
Bristol-Myers Squibb Completes Acquisition of Celgene
Bristol-Myers Squibb (BMS) announced that it had completed its acquisition of Celgene following the receipt of regulatory approval from all government authorities required by the merger agreement.
In connection with the regulatory approval process for the transaction, Celgene entered into an agreement to divest the global rights to Otzela to Amgen following the closing of the merger with BMS.
BMS announced that the FTC accepted the proposed consent order in connection with the pending merger of BMS and Celgene, thereby permitting the parties to close the merger.
BMS stated that with the merger it would build a stronger commercial presence in its key disease franchises of oncology, hematology, immunology and cardiovascular disease and launch new medicines for patients, including five expected near-term opportunities in addition to the recent launches of Inrebic and Reblozyl.
“This is an exciting day for Bristol-Myers Squibb as we bring together the leading science, innovative medicines and incredible talent of Bristol-Myers Squibb and Celgene to create a leading biopharma company,” said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. “With our leading franchises in oncology, hematology, immunology and cardiovascular disease, and one of the most diverse and promising pipelines in the industry, I know we will deliver on our vision of transforming patients’ lives through science. I am excited about the opportunities for our current employees and the new colleagues that we welcome to the Company as we work together to deliver innovative medicines to patients.”
Eli Lilly and Boehringer Begin Jardiance Trial
Eli Lilly and Boehringer Ingleheim announced the start of the Empulse trial, the first ever study to assess Jardiance in stabilized acute heart failure. This will be the sixth Phase III trial of the drug’s program.
The study will see if Jardiance can improve survival and other clinical outcomes in people hospitalized for acute heart failure who have been stabilized on standard therapies.
In the study, Jardiance will be given at a 10mg daily dose to patients with any type of acute heart failure, either with or without type 2 diabetes, to see if it can reduce a composite of all-cause mortality, number of heart failure events, time to first heart failure event and declines in quality-of-life scores.
“Acute decompensated heart failure is one of the fastest-growing diseases in the world and a leading cause of hospital admissions worldwide with high short-term mortality and rehospitalization,” said Adriaan Voors of University Medical Center Groningen in the Netherlands.
“Unlike chronic heart failure, there is no established therapy available that improves clinical outcomes in acute heart failure,” he added.
Empulse is part of the Jardiance heart failure program, which includes studies assessing the effects of Jardiance on heart failure-related outcomes and functional capacity in over 9,500 adults with heart failure, including those with and without diabetes.
Novartis Acquires The Medicines Company
Novartis announced that it is buying The Medicines Company as it seeks to expand its portfolio of medicines against cardiovascular disease.
The Medicines Company is a biotechnology company that focuses on researching treatments for cardiovascular disease, specifically looking at ways to lower cholesterol. Earlier this month, the company published encouraging results at an American Heart Association conference for Inclisiran, a twice-yearly injection treatment that could become the standard of care for patients suffering from high levels of LDL. The company said that it expects to file for FDA approval during the fourth quarter of this year.
“We’re hoping to reimagine treatment of the leading global cause of death. This could be a strong step forward in Novartis’ transformation into a focused medicines company,” Novartis CEO Vas Narasimhan tweeted.
“Our company’s singular, relentless focus and the unwavering commitment of our employees have led to this opportunity to unlock the intrinsic value of Inclisiran for patients and to maximize value for our shareholders,” said The Medicines Company CEO Mark Timney. “We are excited that millions of patients with atherosclerotic cardiovascular disease and familial hypercholesterolemia will potentially benefit from this transformational therapy.”
The deal is expected to close in the first quarter of 2020.
Sanofi Unveils New Company Strategy
Sanofi announced during its Capital Markets Day presentation that it is discontinuing all research into diabetes and cardiovascular disease and said the company would not pursue plans to launch efpeglenatide, a long-acting diabetes medicine currently under development.
Sanofi instead plans to focus on restructuring the company‘s operations under three core global business units: Specialty Care (immunology, rare diseases, rare blood disorders, neurology and oncology); Vaccines; and General Medicines (diabetes, cardiovascular, and established products). Consumer Healthcare will be a standalone business unit with integrated R&D and manufacturing functions.
“Our new strategy positions Sanofi to achieve breakthroughs with our most promising medicines, addressing significant patient needs. We will anchor our efforts in leading-edge science with clearer priorities and a focus on delivering results,” said Sanofi CEO Paul Hudson. “Sanofi gained leadership and changed the practice of medicine in diabetes and cardiovascular diseases. We are now preparing for our next cycle, with a new round of innovative solutions for patients. I’m confident we will achieve long-term growth and value for shareholders while turning innovation into transformative medicines for patients.”
The company also announced plans to acquire Synthorx, Inc. which will bolster its immuno-oncology
(IO) pipeline with both a proprietary IO platform synergistic with Sanofi’s existing therapeutics platforms, and a lead IO candidate (THOR-707) being explored across multiple solid tumor types both alone and in combination with immune checkpoint inhibitors and other future IO combinations.