Vascepa’s Amarin Anticipating Label Expansion
A draft report from the Institute for Clinical and Economic Review (ICER) stated that Amarin’s Vascepa is a cost-effective add-on to statins for patients with abnormally high triglyceride levels, compared with statins alone.
Vascepa is a fish-oil derivative drug that is already clinically proven to lower very high triglycerides without raising bad cholesterol. In addition, the recent trials revealed it could also cut cardiovascular risks by 25% in patients with abnormally high triglyceride levels. The FDA will decide on accepting or rejecting this label expansion.
An approval would make Vascepa the first therapy, as an adjunct to diet, proven to reduce cardiovascular events when used to treat patients with persistent elevated triglyceride levels and other cardiovascular risk factors.
Amgen Wins Patent Battle on Enbrel
The U.S. District Court for the District of New Jersey ruled for Amgen in a patent fight against Novartis’ Sandoz unit and its Enbrel biosimilar, Erelzi.
The FDA approved Erelzi in 2016 but Sandoz has been unable to launch the drug due to the patents protecting the Amgen product. Sandoz said it will appeal the decision, but for now, an injunction will keep Erelzi off the market. Currently, Enbrel’s patents do not expire until 2029.
Amgen Chief Executive Officer Robert A. Bradway said that he was pleased with the decision “recognizing the validity of these patents.” He said protecting the intellectual property supporting Enbrel is “critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients.”
“Valid intellectual property should be respected; however, we continue to consider the patents, in this case, to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible,” Carol Lynch, head of Sandoz North America, said in a statement.
Amgen to Buy Celgene’s Otezla
Amgen announced that it has entered into an agreement with Celgene Corporation in connection with its previously announced merger with Bristol-Myers Squibb Company to acquire worldwide rights to Otezla.
Otezla is the only oral, non-biologic treatment for psoriasis and psoriatic arthritis and has patent exclusivity through at least 2028. Currently, Otezla is approved for three indications in the U.S. including moderate-to-severe plaque psoriasis, psoriatic arthritis and its most recent addition, oral ulcers associated with Behçet’s disease. Several ongoing clinical programs could lead to additional label expansions, including mild to moderate psoriasis, scalp and genital psoriasis as well as various pediatric indications.
AstraZeneca’s Farxiga Decreases Heart Failure Risk in Trial
AstraZeneca announced positive results from the landmark Phase III Dapa-HF trial showing that its diabetes drug Farxiga met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalization or an urgent heart failure visit) when compared to a placebo.
Farxiga is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine. The Dapa-HF trial was conducted in patients with reduced ejection fraction (HFrEF) on standard of care treatment. It was the first trial to test an SGLT2 drug against heart failure in patients both with and without type-2 diabetes.
“With the DAPA-HF trial, Farxiga becomes the first in its class to demonstrate efficacy and safety data for the treatment of patients with heart failure, with and without type 2 diabetes, on top of standard of care,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D for AstraZeneca. “Today, half of heart failure patients will die within five years of diagnosis and it remains one of the leading causes of hospitalization. We look forward to discussing the results of DAPA-HF with health authorities as soon as possible.”
“The benefits of dapagliflozin in Dapa-HF are very impressive, with a substantial reduction in the primary composite outcome of cardiovascular death or hospital admission,” noted John McMurray, with the University of Glasgow, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences. “We hope these exciting new findings will ultimately help reduce the terrible burden of disease caused by heart failure and help improve outcomes for our patients.”
AstraZeneca said the full Dapa-HF trial results will be presented at an upcoming medical meeting and they would soon be discussing the results with drug regulators.
Bayer, Bristol-Myers Squibb and Ono Pharma Enter into Clinical Collaboration
Bayer, Bristol-Myers Squibb (BMS) and Ono Pharmaceutical announced that they have entered into a clinical collaboration agreement to evaluate the combination of Bayer’s kinase inhibitor Stivarga and Bristol-Myers Squibb’s / Ono’s anti-PD-1 immune checkpoint inhibitor, Opdivo in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC), the most common form of mCRC.
Encouraging early data have been seen with the studied combination, such as in a Phase Ib investigator sponsored trial from Japan called REGONIVO where the combination of Stivarga and Opdivo showed promising preliminary efficacy results. The detailed data of the study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.
“The data seen in REGONIVO warrant further exploration of the combination of regorafenib and nivolumab in patients with colorectal cancer,” stated Scott Z. Fields, senior vice president and head of Oncology Development at Bayer’s Pharmaceuticals Division. “Regorafenib has proven its efficacy and positive safety profile as a third-line monotherapy and we are excited to enter into a clinical collaboration to evaluate this combination with the hope to deliver an additional therapeutic benefit to patients.”
“We have been actively engaged in the development of nivolumab including combination therapies with other agents,” stated Kiyoaki Idemitsu, corporate officer, executive director, Clinical Development, Ono. “We are excited to initiate the clinical collaboration with Bayer and Bristol-Myers Squibb to investigate this combination therapy as a new treatment option for patients with colorectal cancer and other types of cancer.”
GSK’s Dovato Meets Primary Study Endpoints
GlaxoSmithKline’s HIV subsidiary, ViiV Healthcare announced that the late-stage study evaluating it newly approved, single-tablet two-drug combination of dolutegravir and lamivudine HIV regimen, Dovato, met the primary endpoint.
The phase III TANGO study assessed the antiviral efficacy and safety of switching to Dovato in HIV-1 infected patients, who are virally suppressed and stable on a three-drug tenofovir alafenamide fumarate (TAF)-based regimen.
The 48-week data from the study showed that Dovato was non-inferior in maintaining viral suppression in such patients compared with the TAF regimen, thereby achieving the study’s primary goal. The study also confirmed that no patients met virologic withdrawal criteria or developed any treatment resistance with Dovato.
“When we developed the TANGO study, we asked if virally suppressed people living with HIV could reduce the number of medicines in their HIV treatment regimen while maintaining viral suppression. These Week 48 data clearly indicate that they can – individuals who are already on treatment can maintain viral suppression if they switch from a 3-drug, TAF-containing regimen to a 2-drug regimen of dolutegravir plus lamivudine.” said Kimberly Smith, head of global research & medical strategy at ViiV Healthcare.
Full results from the study will be presented at the 10th International AIDS Society Conference on HIV Science.
J&J’s Erleada Receives New Indication
Johnson & Johnson announced that the FDA approved Erleada as an add-on to androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mCSPC).
The approval follows the FDA’s real-time review of the drug’s phase 3 Titan trial data, which showed Erleada plus ADT cut the risk of death over placebo plus ADT by 33%. After nearly two years, 84% of patients on Erleada-ADT were still alive, compared with 78% of the placebo-ADT group.
“Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone, is often not enough,” said Dr. Kim Chi, Medical Oncologist at BC Cancer – Vancouver and principal investigator of the Titan study. “Results from the Titan study showed that, regardless of the extent of disease, patients with metastatic castration-sensitive prostate cancer have the potential to benefit from treatment with apalutamide in addition to ADT.”
“Erleada has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history, by delaying disease progression and prolonging survival,” said Margaret Yu, M.D., Vice President, Prostate Cancer Disease Area Leader, Janssen Research & Development. “This milestone highlights Janssen’s commitment to improve the standard of care for patients with prostate cancer as we continue to develop innovative treatments across the disease continuum.”
The new indication will make Erleada available for the approximately 40,000 people in the United States diagnosed with mCSPC annually.
FDA Approves New Use for Merck’s Keytruda
The FDA approved Merck’s PD-1 inhibitor Keytruda as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
“Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed,” stated Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “With this approval, Keytruda is now the first anti-PD-1 therapy approved for the treatment of previously-treated patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1, providing an important new monotherapy option for physicians and patients in the United States.”
There are currently more than 1,000 clinical trials ongoing involving Keytruda in a variety of cancers and treatment settings. It is presently approved for a variety of indications in melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merckel Cell Carcinoma, and renal cell carcinoma.
Merck’s Mavenclad Shows Sustained Efficacy
Merck presented new data for Mavenclad in which 75% of patients showed no disability progression at five years post-treatment, supporting the drug’s long-term efficacy and safety profile. The results were shared at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Results were from a retrospective analysis of real-world follow-up data, consisting of patients with clinically isolated syndrome or relapsing forms of MS who received at least one course of Mavenclad in the original clinical trial program. At five years after receiving the last dose of the treatment, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse.
“Our commitment to further understand the long-term efficacy and safety of Mavenclad goes beyond the safety profile seen in its clinical development programme, which includes up to 10 years of safety follow-up in some patients,” said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. “The data we are presenting at ECTRIMS 2019 exemplify this. They include key insights from real-world follow-up of patients from our clinical trials and the post-approval setting for Mavenclad, further validating it as an important treatment option available to patients in 69 countries worldwide.”
“These data show us that Mavenclad continues to display sustained efficacy in a majority of patients at five years after starting treatment and that these results are consistent with data we are seeing from real-world experience,” said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. “As a neurologist, this is important for me to see, as it shows that findings from the clinical development programme of Mavenclad will be borne out in clinical practice.”
Norvartis – SMA Drug Trials Data Presented
Novartis presented data regarding Zolgensma, its gene therapy for spinal muscular atrophy (SMA) from an ongoing phase 3 trial that showed six of 10 patients with two copies of the gene SMN2 could sit for 30 seconds without assistance. Three of the patients were ultimately able to stand. The company also stated that the death of the infant previously reported in the phase 3 European trial was determined to be unrelated to the gene therapy but rather was caused by inflammation in the patient’s central nervous system, which can occur in patients with SMA.
JPMorgan analysts recently surveyed 26 physicians who treat SMA and stated that the physicians raised concerns about the effectiveness of Zolgensma. As a result, they said they expect to use the gene therapy in just 56% of newborn Type 1 SMA patients and 42% of those with Type 2 SMA.
Roche and PTC Therapeutics are currently developing an oral therapy for SMA called risdiplam. In May, the companies provided data from a small trial at the American Academy of Neurology annual meeting showing seven of 17 infants who received the drug were able to sit unassisted for five seconds or more and nine were able to hold their heads upright after 12 months on the drug. Phase 2 trials are currently being analyzed.
“Overall, the survey data underscore our view of risdiplam having broad competitive positioning within the SMA treatment landscape, drawing from its oral delivery and competitive efficacy profile across Type 1/2/3 subtypes and various age segments,” JPMorgan analysts wrote.
Novartis and Microsoft Announce Collaboration
Novartis and Microsoft announced a new strategic collaboration with a multi-year research and development effort. Novartis is not new to the use of AI, but this collaboration expands beyond previous efforts. The project, called Data42, will mine 2 million patient years of clinical trial data to attempt to uncover new insights,
Microsoft’s AI technology will influence Novartis’ entire medicine path to market, from research and manufacturing to clinical trials and marketing. Along with revamp of the drug discovery process, Novartis will use Microsoft AI to review the clinical data from hundreds of its drug studies over the past two decades. All Novartis employees, including those without data science training, will be able to use the solutions to cull Novartis data troves.
Vas Narasimhan, CEO of Novartis, said: “As Novartis continues evolving into a focused medicines company powered by advanced therapy platforms and data science, alliances like this will help us deliver on our purpose to reimagine medicine to improve and extend patients’ lives. Pairing our deep knowledge of human biology and medicine with Microsoft’s leading expertise in AI could transform the way we discover and develop medicines for the world.”
Microsoft CEO, Satya Nadella, said: “Our strategic alliance will combine Novartis’ life sciences expertise with the power of Azure and Microsoft AI. Together, we aim to address some of the biggest challenges facing the life sciences industry today and bring AI capabilities to every Novartis employee so they can unlock new insights as they work to discover new medicines and reduce patient costs.”
Pfizer Combining Off-Patent Drug Business with Mylan
Pfizer will spin off its Upjohn business, which runs a portfolio of drugs that are no longer protected by patents, and combine the company with Mylan, which manufactures generic and name-brand drugs.
Both drugmakers recently lost exclusive rights to manufacture drugs: Teva Pharmaceuticals introduced a generic version of Pfizer’s erectile dysfunction drug Viagra in 2017 and the first generic competitor to Mylan’s EpiPen, the emergency treatment for allergic reactions, gained FDA approval last year.
Other drugs in Pfizer’s Upjohn portfolio include anxiety medication Xanax, depression drug Zoloft, and Lipitor, which treats high cholesterol.
Dr. Albert Bourla, Pfizer CEO, stated, “We are creating a new champion for global health—one poised to bring world-class medicines to patients across a wide range of therapeutic areas. I believe that Mylan’s unique profile and strategy has made it the obvious partner of choice in creating this powerful combination. By bringing Mylan’s growth assets to Upjohn’s growth markets, we will create a financially strong company with true global reach. I’m also excited about the management team, which combines strong executive talent from both companies, whose commitment to improving global health for patients and to delivering returns to shareholders are great assets for the new company. For Pfizer, this transaction represents our sharpened focus on innovative medicines and is a testament to our purpose – breakthroughs that change patients’ lives. At the same time, we’ll maintain the financial flexibility to advance our strong pipeline, invest for growth and continue to return capital to our shareholders.”
Pfizer shareholders would own 57% of the new company and Mylan’s shareholders would own 43%.
The new company will have a new, yet-to-be-announced name and the management team will include people from both Mylan and Upjohn. The transaction is anticipated to close in mid-2020, subject to approval by Mylan shareholders and customary closing conditions, including receipt of regulatory approvals. No vote is required by Pfizer shareholders.