Sandoz Launches generic Revlimid in 19 European Countries, Bringing a Flood of Competition to BMS’ Megablockbuster
Since Bristol Myers Squibb acquired Celgene and its megablockbuster Revlimid, the company has been bracing for the day when the multiple myeloma superstar would face generic competition. Sandoz, a subsidiary of Novartis, announced on Friday that its generic version of the medication has been launched in 19 European countries. Stada Arzneimittel, a German generics manufacturer, has also launched its Revlimid generic in Europe. Lenalidomide will save patients money and also expand treatment options for patients with Multiple Myeloma, previously treated Follicular Lymphoma, or Relapsed or Refractory Mantel Cell Lymphoma.
Celgene has worked hard to keep Revlimid out of the hands of competitors through court battles and settlements since it was approved in 2006. But Alvogen managed to launch its Revlimid generic in a few smaller European markets in 2019.
Sandoz, Novartis’ global generics division, is Europe’s largest generics producer. Last year, the Swiss pharma giant’s division generated USD 9.8 billion in global sales. Sandoz launched generic lenalidomide in Canada last September. Meanwhile, the first Revlimid generics are set to hit the massive US market next month.
According to the company, the drug generated USD 12.8 billion in revenue last year. BMS expects Revlimid sales to fall between USD 9.5 billion and USD 10 billion this year with so much new competition.
FDA Approves Agios’ Pyrukynd, first-in-class PK activator to Treat a Rare Blood Disorder
Agios Pharmaceuticals has received the first FDA approval for its genetically defined diseases portfolio, following the sale of its cancer unit to Servier in 2020. Pyrukynd, an oral medication, was approved by the FDA on Thursday as the first medicine for the treatment of Hemolytic Anemia in adults with pyruvate kinase (PK) deficiency, a rare and debilitating blood disorder. The inherited disease leads to lifelong complications such as gallstones, pulmonary hypertension, osteoporosis, and other conditions. According to the company, it can cause patients to face difficulties at work and in their social lives.
Prior to the approval, the only treatment options were red blood cell transfusions or spleen removal surgery, both of which come with risks and burdens, according to Agios.
The FDA approval was based on two Phase 3 studies, ACTIVATE and ACTIVATE-T. The drug showed a statistically significant increase in hemoglobin in patients who were not regularly transfused in the ACTIVATE study. In the ACTIVATE-T study, the drug reduced the number of people who needed blood transfusions.
Aside from PK deficiency, Agios is testing the drug for Thalassemia and Sickle Cell Disease. Pyrukynd could become a blockbuster if it receives approval in these indications.
Organon Announces 4Q & Full-year Earnings Report and Planning Big Biosimilar Launches
Organon (NYSE: OGN) announced its results for the fourth quarter and full-year ended December 31, 2021. Organon reported revenue of $ 6.4 billion in 2021 with a decrease of 3% as-reported and 6% ex-FX, compared with 2020.
The women’s healthcare segment observed $1.6 billion in revenue in 2021, driven by key products Nexplanon, which observed an increase of 12% ex-FX in 2021. The other major products in the women’s health products, such as Follistim AQ® (follitropin beta injection) and ganirelix acetate injection, also observed a growth over the previous year. The revenue for the Established Brands observed a decline of 10% as reported and a decline of 13% ex-FX for the full year 2021. The major factor is the loss of exclusivity of Zetia in Japan in June 2020.
Organons’s Biosimilars revenue grew by 28% as reported and 25% ex-FX for full-year 2021 compared with 2020. The overall revenue from the Biosimilars stood at $ 424 million. Renflexis® (infliximab-abda) reported positive growth in the United States. Another major product, Ontruzant® (trastuzumab-dttb), also contributed to the Biosimilars portfolio growth driven by sales in the US. The company is expecting some big biosimilar launches in 2023, with its first years as independent operations, after officially splitting from Merck in June 2021.
Organon’s CEO Kevin Ali stated that the company is planning to disclose the pricing approach for the Humira biosimilar very soon. Organon has partnered with Samsung to launch AbbVie’s Humira biosimilar Hadlima. Both are working together, intending to hit the market by June 2023, nearly six months after Amgen is expected to roll out its own copycat Amjevita in January. Apart from biosimilar, Organon is actively looking forward to expanding its business in Women’s Healthcare and contraceptives in the coming years.
FDA Grants Priority Review to Bristol Myers’ CAR-T Drug Breyanzi
Bristol Myers Squibb (NYSE: BMY) updated that the FDA has accepted the Priority Review for Breyanzi (lisocabtagene maraleucel) as a Second-Line Therapy for Relapsed or Refractory Large B-cell Lymphoma (R/R LBCL). BMS received the supplemental Biologics License Application (BLA) for Breyanzi after the first-line treatment failure in the disease type. FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 24, 2022.
In the phase 3 trial, the Breyanzi exceeded the standard of care in second-line LBCL patients with a significant improvement. It enables to clear tumors or staves off the progression of the disease. Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy with a defined and purified composition and 4-1BB costimulatory domain.
The USFDA has already approved Breyanzi to treat adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and follicular lymphoma grade 3B. Similarly, Japan has also approved the treatment for R/R LBCL after two or more lines of systemic therapy. While the Marketing Authorization Applications are under review in the European Union, Switzerland, and Canada for relapsed and refractory LBCL.
E.U. Approves Bayer’s Drug Kerendia for Chronic Kidney Disease
Finerenone has been granted marketing authorization in the European Union (E.U.) under the brand name Kerendia by the European Commission. Kerendia, a non-steroidal, selective mineralocorticoid receptor antagonist, is used to treat Chronic Kidney Disease (CKD) in type 2 diabetes.
“Even with well-controlled blood glucose and blood pressure, the risk of chronic renal disease progression and cardiovascular events remains high in these patients,” stated Professor Peter Rossing, Head of Complications Research at the Steno Diabetes Center Copenhagen. “People with type 2 diabetes should be carefully checked by their doctor for the earliest signs of kidney impairment, as most patients have no symptoms in the early stages. Finerenone is the first non-steroidal, selective M.R. antagonist designed particularly to protect patients from future kidney damage by tackling a critical source of disease progression that is currently ignored by existing medications.”
Finerenone is different from existing CKD in T2D treatments, and it works by preventing overactivation of the mineralocorticoid receptor (M.R.), which contributes to the advancement of CKD and cardiovascular impairment.
Kerendia received FDA clearance after the crucial Phase III FIDELIO-DKD study results were announced at the Kidney Week 2020 (American Society of Nephrology’s) and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020.
Based on the FIDELIO-DKD Phase III research results, the U.S. Food and Drug Administration (FDA) approved Kerendia in July 2021. Kerendia was given Grade A recommendation to treat patients with CKD and T2D in the American Diabetes Association’s (ADA) updated treatment guidelines, “Standards of Medical Care in Diabetes 2022,” in December 2021. They have a higher risk of cardiovascular events or CKD progression or cannot use sodium-glucose cotransporter two inhibitors.
Finerenone has also been submitted for marketing approval in several additional countries worldwide, and these applications are now being reviewed.
Lilly Releases Mirikizumab Data in Ulcerative Colitis as it Prepares to File For Regulatory Approvals.
LUCENT-2, a Phase III maintenance study evaluating the efficacy and safety of mirikizumab for the treatment of patients suffering from moderate to severe active ulcerative colitis, met the primary endpoint of clinical remission and all critical secondary endpoints at one year, according to Eli Lilly and Company. Patients in this trial had previously observed the LUCENT-1 12-week induction study.
In LUCENT-2, a statistically higher proportion of patients who attained clinical response in the 12-week induction study and also were re-randomized to mirikizumab maintenance dosing met the primary endpoint of clinical remission at one year than those who were re-randomized to placebo. Clinical remission occurs when colon inflammation is controlled or resolved, resulting in symptom normalization or near-normalization, such as frequent and bloody feces. All critical secondary endpoints were also met, including significantly higher proportions of patients treated with mirikizumab achieving endoscopic remission, resolution or near-resolution of bowel urgency, corticosteroid-free remission, improvement in endoscopic, histologic intestinal inflammation and maintenance of remission, and a more significant reduction in bowel urgency symptoms from baseline at one-year compared to placebo.
“Treatment with mirikizumab confirmed clinically meaningful and statistically significant improvements in endoscopic, clinical, and histologic measures in this maintenance study, including reduction of bowel urgency – a novel endpoint in the LUCENT program,” said Bruce E. Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at the Icahn School of Medicine “One of the most annoying and disruptive symptoms of ulcerative colitis is bowel urgency, and the LUCENT program assessed patients’ symptoms using an innovative and rigorous patient-centric approach.”
Lilly aims to submit a Biologics License Application for mirikizumab to the FDA in the United States, followed by submissions to other regulatory bodies across the world in the first half of 2022.
“Today’s results are optimistic for patients who have ulcerative colitis,” stated Michael Osso, President and CEO of the Crohn’s & Colitis Foundation. “We’re thrilled about potential new inflammatory bowel disease treatment options that could assist people with ulcerative colitis to regulate their symptoms.”
Mirikizumab is a humanized IgG4 monoclonal antibody that targets interleukin 23’s p19 sub unit. Immune-mediated disorders such as ulcerative colitis and Crohn’s disease are researched with mirikizumab.
Sanofi and Regeneron Abandons the Dupixent Trial in Patients Who Failed Novartis and Roche’s Xolair
Sanofi in collaboration with Regeneron Pharmaceuticals Inc has announced disappointing results from the Phase 3 trial of Dupixent (dupilumab) in patients with Chronic Spontaneous Urticaria (CSU) who were previously refractory to Xolair (omalizumab). In the trial, the patients who were refractory to Xolair treatment as well as uncontrolled on antihistamines received Dupixent plus standard of care compared to standard of care alone for 24 weeks.
Chronic Spontaneous Urticaria is a severe form of hives, causing severe swelling and itching. In the clinical trial study, dupilumab wasn’t able to significantly improve the symptoms in Xolair-refractory patients. The trial is ought to terminate for futility, although the antibody did show “numeric improvements” on itching and hive symptoms. It was observed that the addition of Dupixent to standard-of-care antihistamines significantly reduced itch and hives compared to antihistamines alone. Both the pharma giants are evaluating the next steps.
The sales for Dupixent accounted for a whopping USD 6.2 billion revenue last year for eczema and asthma treatment. Sanofi and Regeneron are said to be still scratching the surface for what they can achieve with the blockbuster drug.
AstraZeneca and Daiichi’s Drug Enhertu Aces in HER2-low Breast Cancer Trial
AstraZeneca and Daiichi Sankyo’s superstar drug Enhertu (trastuzumab deruxtecan) for HER2-positive breast cancer treatment is now making waves for showing efficacy in tumors that express lower levels of HER2 in Breast Cancer patients, potentially making it a very viable option for a much broader group of treatment. Breast cancer classed under HER2-positive holds for about 20% to 25% of all patients with the disease, as per the analysis. Whereas, almost 55% of all patients with breast cancer have tumors with a HER2-low score.
In the clinical trial, Enhertu was administered to patients with HER2-low, unresectable, metastatic breast cancer previously treated with one to two prior lines of chemotherapy. And, this is the very first time ever, when HER2-directed therapy has shown direct benefit in patients with HER2-low breast cancer. AZ’s oncology department head, Susan Galbraith mentioned that the result was “historic news” that it had the potential to “reshape how breast cancer is classified and treated.”
AstraZeneca and Daiichi announced that the newfound data will be shared with global health authorities in the coming future with a view to expanding its usage further. Enhertu reported sales of USD 426 million in 2021, more than double the amount it generated in the previous year, leading to higher anticipated sales in the coming years. Both the pharmaceuticals are continuously working to explore new uses for the drug.