Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
AbbVie Clearance Sale Going On Now
Chris DeMuth Jr. • 26 Comments
Chris DeMuth Jr. • 26 Comments
Tue, Dec. 6, 12:38 PM
- Results from a Phase 2 clinical trial assessing AbbVie's (ABBV +0.9%) IMBRUVICA (ibrutinib) for the treatment of patients with chronic graft-versus-host-disease (GvHD) showed a significant treatment benefit. The data are being presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- With a median follow-up of 14 months in 42 patients, the overall response rate (ORR) was 67% (n=28/42). A third (n=9/28) of the responders achieved a complete response while 71% (n=20/28) experienced a sustained response of at least five months.
- The GvHD indication has Breakthrough Therapy and Orphan Drug status in the U.S.
- GvHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient receives an allogeneic stem transplant or bone marrow transplant. It can be acute or chronic and can persist for many years. There are no approved therapies to treat GvHD patients who have failed first-line corticosteroid treatment.
Tue, Dec. 6, 10:33 AM
- Results from a Phase 2 clinical trial assessing AbbVie's (ABBV +0.7%) IMBRUVICA (ibrutinib) for the treatment of patients with relapsed/refractory marginal zone lymphoma (MZL) showed an impressive response rate. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- The open-label study involved 63 MZL patients who had received at least one prior line of therapy, including at least one CD20-directed regimen. The overall response rate was 48% (n=30/63). 79% (n=50/63) experienced some tumor reduction.
- IMBRUVICA's safety profile was consistent with earlier studies in B-cell malignancies. Grade 3 (severe) or Grade 4 (life-threatening) adverse events were observed in 63% (n=40/63) of patients, the most common being anemia (14%), pneumonia (8%) and fatigue (6%).
- MZL is a diverse group of slow-growing non-Hodgkin lymphomas (NHL) that comprise ~12% of all NHL cases.
Mon, Dec. 5, 3:47 PM
- AbbVie (ABBV +2.5%) inks a five-year collaboration agreement with Johns Hopkins University School of Medicine with the aim of advancing medical oncology research and discovery at both organizations.
- The partnership allows Hopkins physicians and scientists to explore new therapies developed by AbbVie in a preclinical setting. AbbVie secures an option to exclusively license certain Hopkins discoveries made under the agreement.
- A joint steering committee consisting of representatives of both groups will determine the projects to undertake. Researchers from both organizations will participate in an annual symposium to discuss their joint research and evaluate potential new projects.
Sun, Dec. 4, 2:45 PM
- Results from a Phase 1 study assessing Juno Therapeutics' (NASDAQ:JUNO) JCAR014 in heavily pretreated patients with chronic lymphocytic leukemia (CLL) who failed to respond to AbbVie's (NYSE:ABBV) IMBRUVICA (ibrutinib) showed an encouraging treatment effect. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- The 24 participants in the study had received a median of five previous therapies, including ibrutinib. All failed and had poor prognoses. Three failed prior allogeneic stem cell transplants. All received lymphodepletion therapy prior to receiving JCAR014.
- 88% (n=15/17) of efficacy-evaluable patients experienced a complete bone marrow response determined by flow cytometry while 50% (n=7/14) had no detectable disease. All seven were alive and progression-free during the follow-up period (3 - 26 months).
- Two of 24 (8%) patients developed grade 3 (severe) to grade 5 (death) severe cytokine release syndrome (CRS) while 25% (n=6/24) developed grade 3 - 5 neurotoxicity. The most frequent severe treatment-emergent adverse events were febrile neutropenia (75%), CRS (29%), fever (17%), lung infection (13%), encephalopathy (13%) and hypotension (13%). There was one treatment-related death in a patient who developed CRS and cerebral edema.
- JCAR014, part of Juno's CD19-focused CAR T program, is being co-developed and will be co-commercialized with Celgene (NASDAQ:CELG). A study assessing JCAR014 in combination with ibrutinib in CLL should start in early 2017. The data generated in the JCAR014 studies will support a potential Juno-sponsored study of JCAR017 in CLL.
- The company will host an investor and analyst event and webcast tomorrow, Monday, December 5, at 11:30 am ET to discuss the data.
Wed, Nov. 30, 3:32 PM
- The FDA designates AbbVie's (ABBV -0.8%) IL-23 inhibitor risankizumab (ABBV-066) an Orphan Drug for the treatment of pediatric patients with Crohn's disease. It is currently in Phase 2 development for adults with Crohn's. Other indication being investigated are asthma, plaque psoriasis and psoriatic arthritis.
- Among the benefits of Orphan Drug status is an additional seven-year period of market exclusivity, if approved.
- The company licensed risankizumab from Boehringer Ingelheim in March.
- Previously: AbbVie and Boehringer Ingelheim team up to develop immunology compounds; BI to receive upfront payment of $595M (March 7)
Tue, Nov. 29, 8:18 AM
- Momenta Pharmaceuticals (NASDAQ:MNTA) is up 10% premarket, albeit on only 1,100 shares, in response to its announcement of positive results from a Phase 3 clinical trial assessing M923, a biosimilar to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab), in patients with moderate-to-severe plaque psoriasis. The study met its primary endpoint of demonstrating equivalence between M923 and HUMIRA as measured by the proportion of patients achieving PASI-75 (75% reduction in psoriasis area and severity).
- Equivalence was also demonstrated in all secondary endpoints.
- Complete results will be submitted for presentation at future conferences and for publication.
Tue, Nov. 29, 7:44 AM
- Galapagos N.V. (NASDAQ:GLPG) initiates a Phase 1 clinical trial in the Netherlands assessing a novel C2 corrector drug for the treatment of cystic fibrosis (CF) called GLPG2737. The aim of the trial is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses of GLPG2737 in 64 healthy volunteers. Top-line results should be available in Q2 2017. The action triggers a $10M milestone payment from collaboration partner AbbVie (NYSE:ABBV).
- The companies are developing a portfolio of candidates that address three complementary components of CF. GLPG2737, the first of multiple C2 correctors under development, is the final component in a planned triple combination therapy. Potentiators GLPG1837 and GLPG2451 and C1 corrector GLPG2222 are already being evaluated in the clinic.
- In preclinical testing, triple combinations of the compounds have restored healthy activity levels in human bronchial epithelial (HBE) cells of CF patients with the F508del mutation. In addition, they have demonstrated an increase in chloride transport compared to Vertex Pharmaceuticals' (NASDAQ:VRTX) ORKAMBI (lumacaftor/ivacaftor) in HBE cells with homozygous F508del (two copies of the mutation).
- The company says it expects to start testing a triple combination therapy in humans by mid-2017.
Mon, Nov. 28, 1:20 PM| Mon, Nov. 28, 1:20 PM | 2 Comments
Mon, Nov. 28, 7:11 AM
- Johnson & Johnson's (NYSE:JNJ) Janssen Research & Development, LLC initiates an open-label Phase 2b study assessing the combination of simeprevir, odalasvir and JNJ-4178 (AL-335) in treatment-naive and treatment-experienced patients with chronic hepatitis C virus infection genotypes 1,2,4,5 and 6 without cirrhosis.
- Subjects will receive the triple combination for either six or eight weeks. The primary endpoint is the percentage of patients who achieve clinical cure (SVR12) at the end of treatment. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is August 2017. The estimated study completion date is October 2017.
- An ongoing Phase 2b study is evaluating the triple combo regimen in HCV patients with or without compensated cirrhosis.
- Simeprevir (Olysio) is an NS3/4 protease inhibitor. Odalasvir is an NS5A inhibitor. JNJ-4178 (AL-335) is a novel uridine nucleotide analog polymerase inhibitor.
- Related tickers: (NASDAQ:GILD)(NYSE:ABBV)
Mon, Nov. 21, 4:16 PM| Mon, Nov. 21, 4:16 PM | 2 Comments
Mon, Nov. 21, 9:22 AM
- Halozyme Therapeutics (NASDAQ:HALO) eases 10% premarket on light volume in response to its announcement that collaboration partner AbbVie (NYSE:ABBV) has terminated a development program involving Halozyme's ENHANZE platform and the tumor necrosis factor alpha (TNF-alpha). It decided to nix development after a failed Phase 1 study.
- Other work will continue under the companies' 2015 Global Collaboration and Licensing Agreement. TNF-alpha was the first nominated target of nine included in the agreement.
Wed, Nov. 16, 9:13 AM
- Results from a Phase 3 clinical trial, SARIL-RA-MONARCH, assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NYSE:SNY) sarilumab compared to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) in adult patients with rheumatoid arthritis (RA) showed sarilumab to be superior in improving RA symptoms. The data will be presented today at the American College of Rheumatology Annual Meeting in Washington, D.C.
- SARIL-RA-MONARCH enrolled 369 adults with active RA who failed to respond adequately or were intolerant of or were inappropriate candidates for methotrexate. They were randomized to receive either sarilumab monotherapy (200 mg every two weeks subcutaneously) or adalimumab (40 mg every two weeks subcutaneously). The primary endpoint was the change from baseline to week 24 in a scale called DAS28-ESR, a measure of RA activity via the evaluation of 28 joints for tenderness and swelling, a general health assessment and ESR (erythrocyte sedimentation rate), a simple laboratory test for inflammation.
- Sarilumab demonstrated superiority to adalimumab as measured by DAS28-ESR (-3.28 vs. -2.20; p<0.0001). The rates of DAS28-ESR remission also favored sarilumab (26% vs. 7%; p<0.0001).
- It also beat adalimumab in terms of the proportion of patients who achieved ACR20 (20% improvement in RA symtoms) (72% vs. 58%; p<0.01), ACR50 (45% vs. 29%; p=0.0017) and ACR70 (23% vs. 11%; p=0.0036).
- The incidence of adverse events were 64% for both groups. Serious adverse events were observed in 5% of the sarilumab subjects and 7% in the adalimumab subjects. The incidence of infections were similar (29% for sarilumab vs. 28% for adalimumab). Neutropenia (low level of a type of white blood cell called neutrophils) was more common with sarilumab (14%) than adalimumab (1%).
- Sarilumab in a human monoclonal antibody that inhibits the inflammatory activity of RA by binding to the interleukin-6 (IL-6) receptor. IL-6 is the most abundant cytokine in the serum and synovial fluid of RA sufferers and is correlated with disease activity and joint destruction.
- Sanofi's U.S. marketing application is currently under review. The FDA issued a CRL last month citing manufacturing deficiencies at the Sanofi site that will "fill and finish" the product. Sanofi has responded to the agency and is working with the regulator to promptly address the issues.
Tue, Nov. 15, 9:17 AM
- Results from a Phase 3 clinical trial, EXPEDITION-4, assessing AbbVie's (NYSE:ABBV) investigational pan-genotypic HCV regimen of glecaprevir/pibrentasvir (G/P) in patients with severe chronic kidney disease (CKD) chronically infected with the hepatitis C virus (HCV) showed a cure rate of 98%. The data will be presented today at The Liver Meeting in Boston.
- EXPEDITION-4 enrolled 104 subjects including 85 who were receiving dialysis at enrollment, 20 with compensated cirrhosis and 44 who were not cured with sofosbuvir with ribavirin or interferon with ribavirin, with or without sofosbuvir.
- The study showed treatment with G/P delivered a 98% (n=102/104) cure rate (SVR12) following 12 weeks of treatment. In a modified intent-to-treat analysis (excluding subjects who did not achieve SVR for reasons other than virologic failure), the cure rate was 100% (n=102/102).
- HCV is common in CKD patients, with a prevalence of up to 80% in some regions of the world. As many as 500K Americans have both chronic HCV and CKD.
- G/P is a once-daily fixed-dose combination of 300 mg of glecaprevir, an NS3/4A protease inhibitor and 120 mg of pibrentasvir, an NS5A inhibitor. Its development is ongoing.
Mon, Nov. 14, 7:02 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of AbbVie's (NYSE:ABBV) HUMIRA (adalimumab) for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adolescents at least 12 years old.
- HS, also called acne inversa, is an acne-like skin disease characterized by pimple-like bumps that appear in places where acne typically does not such as the underarms and groin.
- The European Commission approved the use of HUMIRA in adults with HS in July 2015. If approved in adolescents, it will be the first biologic available for this patient population.
- A final decision from the European Commission usually takes ~60 days.
Sun, Nov. 13, 8:33 PM
- Results from three Phase 2 clinical trials assessing Merck's (NYSE:MRK) MK-3682B (MK-3682/grazoprevir/ruzasvir) for the treatment of chronic hepatitis C virus (HCV) infection showed virologic cure (SVR12) rates as high as 100%. The data were presented at The Liver Meeting 2016 in Boston, MA.
- In patients with HCV genotypes 1a, 1b, 2 and 3 treated with MK-3682B with and without ribavirin (RBV) for eight weeks, the cure rates were 93% (n=39/42); 98% (n=45/46); 86% (n-54/63) and 95% (n=98/103), respectively.
- The same categories of patients treated with MK-3682B with/without RBV for 12 weeks showed cure rates of 98% (n=47/48); 100% (n=40/40); 97% (n=60/62) and 97% (n=155/159), respectively.
- In HCV genotypes 2 and 3 treated with MK-3682B with/without RBV for 16 weeks, the cure rates were 100% (n=26/26) and 96% (n=72/75), respectively.
- In the HCV-3 cohorts, 28%, 36% and 81% of the 8-week, 12-week and 16-week groups, respectively, were previously treated with peginterferon/RBV.
- The most common adverse events (AEs) in patients receiving at least one dose of MK-3682B with/without RBV were headache (22%), fatigue (19%) and nausea (13%). There were two serious treatment-related AEs, both attributed to RBV only. There were nine discontinuations due to AEs, four from RBV only. One patient died due to AEs unrelated to the study drug.
- MK-3682B is a fixed-dose combination of an NS5B polymerase inhibitor (MK-3682), an NS3/4A protease inhibitor (grazoprevir) and an NS5A inhibitor (ruzasvir).
- Clinical development of MK-3682B is ongoing.
- Related tickers: (NASDAQ:GILD)(NYSE:ABBV)(NYSE:JNJ)
Sat, Nov. 12, 5:00 PM
- Johnson & Johnson (NYSE:JNJ) says experimental sirukumab treatment for rheumatoid arthritis showed mixed results against AbbVie (NYSE:ABBV) top-selling Humira in a large trial.
- By one measure, patients with moderate to severe disease who took sirukumab showed significantly greater improvement in the Phase III study than those taking Humira. But another comparison showed no significant benefit of one drug over the other.
- Results of the study were reported today at the annual meeting of the American College of Rheumatology in Washington.
- Humira, and other older medicines such as Amgen (NASDAQ:AMGN) Enbrel and J&J's Remicade, works by blocking a protein called tumor necrosis factor ("TNF") that is involved in inflammation. Sirukumab is a member of an emerging new class of treatments that work instead by blocking IL-6, another protein involved in the inflammation process.