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
Today, 10:15 AM
- AbbVie (ABBV -0.3%) and privately held X-Chem enter into a multi-target drug discovery partnership with the aim of identifying novel small molecule inhibitors of promising new targets in addition to those already validated but difficult to address. AbbVie has an exclusive option to license active hits and leads generated during the collaboration and is responsible for all further development and commercialization.
- Financial terms are not disclosed.
Yesterday, 5:37 PM
- The FDA approves AbbVie's (NYSE:ABBV) VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets, a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK. The new product is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those patients with compensated cirrhosis (Child-Pugh A). It is used without ribavirin in genotype 1b patients and in combination with twice-daily ribavirin in genotype 1a patients.
- The data supporting the application was generated in Phase 3 studies that showed a 100% cure rate in genotype 1b patients after 12 weeks of therapy without ribavirin and a 95% cure rate in genotype 1a patients when used with ribavirin for 12 or 24 weeks.
- HCV-1 is the most prevalent form of HCV infection in the U.S., representing ~74% of cases. About 2.7M Americans are chronically infected with HCV.
Yesterday, 7:50 AM
- AbbVie (NYSE:ABBV) and Bristol-Myers Squibb (NYSE:BMY) will collaborate in a Phase 1/2 clinical trial assessing the former's antibody-drug conjugate Rova-T (rovalpituzumab tesirine) and the latter's Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) in patients with relapsed extensive-stage small cell lung cancer (SCLC). The objective is to determine if the targeted cell killing and antigen release caused by Rova-T enhances the effect of immunotherapy. Patient recruiting should start later this year.
- Small cell lung cancer, accounting for ~15% of lung cancer cases, is very resistant to treatment. The five-year survival rate is less than 5%.
- Rova-T combines a targeted antibody that selectively binds to delta-like protein 3 (DLL3), expressed in more than 80% of SCLC tumors, with a cytotoxic agent. AbbVie obtained the rights to the product candidate via its acquisition of Stemcentrx.
Yesterday, 7:28 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of a 12-week regimen of AbbVie's (NYSE:ABBV) VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) with ribavirin (RBV) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 infection with compensated cirrhosis (Child-Pugh A). The currently approved regimen is 24 weeks for these patients.
- The data supporting the positive opinion was generated in the Phase 3 AGATE-1 study that showed a 97% cure rate (n=57/59) in HCV-4 Child-Pugh A patients treated with VIEKIRAX and RBV for 12.
- The 12-week VIEKIRAX and RBV regimen was previously approved for all HCV-4 patients except those with Child-Pugh A.
- A final decision from the European Commission usually takes ~60 days.
Tue, Jul. 19, 10:50 AM
- Prompted by moderating growth from traditional drug sales, large cap drug/biotech firms have their sights set on developers of cancer therapies, in particular immunotherapies, to boost both their top and bottom lines. Roche (OTCQX:RHHBY -1.5%), Amgen (AMGN +0.1%), Sanofi (SNY -1.3%) and Gilead Sciences (GILD -1.2%) are all actively on the prowl for acquisitions.
- Medivation (MDVN +0.1%), with its prostate cancer drug Xtandi (enzalutamide), is currently in play. Sanofi has been the most aggressive with two unsuccessful bids, but Pfizer (PFE) and Celgene (CELG -0.6%) are supposedly interested.
- Analysts say Incyte (INCY -0.4%), with polycythemia vera and myelofibrosis drug Jakafi (ruxolitinib), and Seattle Genetics (SGEN -0.8%), with lymphoma drug Adcetris (brentuximab vedotin), are the most attractive takeover targets.
- Recent transactions include AbbVie's (ABBV -0.3%) buyout of Stemcentryx, Jazz Pharmaceuticals' (JAZZ -0.8%) takeout of Celator Pharmaceuticals and Bristol-Myers Squibb's (BMY -0.2%) acquisition of Cormorant Pharmaceuticals.
Mon, Jul. 18, 7:18 AM
- The European Medicines Agency accepts for review Samsung Bioepis' Marketing Authorization Application (MAA) seeking approval of SB5, its biosimilar candidate to AbbVie's (NYSE:ABBV) Humira (adalimumab).
- SB5 is the third anti-TNF-alpha biosimilar candidate submitted for review by Samsung Bioepis. Benepali (etanercept) was approved in January and Flixabi (infliximab) was approved in May. If the MAA for SB5 is approved, Biogen (NASDAQ:BIIB) will be responsible for commercialization.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. It has 13 biosimilar candidates in its pipeline, including six in its first wave. It is responsible for development and manufacturing of all immunology and oncology biosimilar candidates as well as global clinical trials and regulatory submissions. Following approval, Biogen and Merck (NYSE:MRK) are responsible for marketing and distribution.
Thu, Jul. 14, 6:50 AM
- Amgen (NASDAQ:AMGN) inks an exclusive deal with Tokyo-based Daiichi Sankyo (OTCPK:DSKYF)(OTCPK:DSNKY) to commercialize nine biosimilars in Japan, including adalimumab [AbbVie's (NYSE:ABBV) Humira], bevacizumab [Roche's (OTCQX:RHHBY) Avastin] and trastuzumab (Roche's Herceptin).
- Under the terms of the agreement, Amgen will be responsible for development and manufacturing and Daiichi will manage regulatory submissions and handle distribution and commercialization while Amgen will have a limited rights to co-promote the products.
- Amgen will retain all distribution and commercialization rights outside of Japan. Financial terms are not disclosed.
Mon, Jul. 11, 11:57 AM
- The FDA's Arthritis Advisory Committee will meet tomorrow to review and discuss Amgen's (AMGN -0.1%) Biologics License Application (BLA) seeking approval of ABP 501, a biosimilar to AbbVie's (ABBV +1.1%) Humira (adalimumab). A thumbs up appears likely.
- Draft Questions
- FDA Briefing Doc
- Errata to FDA Briefing Doc
- Amgen Briefing Doc
- Update: On June 12, the committee voted 26-0 backing approval.
Mon, Jul. 11, 9:49 AM
- AbbVie (NYSE:ABBV) announces that the FDA has granted Rare Pediatric Disease Designation for Phase 2-stage ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma, highly aggressive and difficult to treat brain tumors found at the base of the brain.
- The FDA granted the Rare Pediatric Disease Designation based on a proposed pediatric sub-study "nested" within the ongoing Phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma, conducted in collaboration with the European Organization for Research and Treatment of Cancer.
- The big benefit of Rare Pediatric Disease Designation is the granting of a Rare Pediatric Disease Priority Review Voucher if and when ABT-414 is approved for sale. The voucher, which can be used for accelerated review of a future submission or sold to a third party, is quite valuable. In 2014, AbbVie bought one from United Therapeutics for $350M.
Thu, Jul. 7, 11:32 AM
- Ghent, Belgium-based Ablynx (OTC:ABLYF) announces positive top-line results from a Phase 2b clinical trial assessing vobarilizumab (ALX-0061) in 251 patients with moderately to severely active rheumatoid arthritis (RA) who are intolerant to methotrexate or for whom methotrexate is inappropriate. The primary objective of the study was to investigate the safety and efficacy of various dose regimens for vobarilizumab monotherapy to guide further clinical development. The primary endpoint of the study was the proportion of subjects achieving ACR20 (20% improvement in RA symptoms) at week 12.
- Participants were randomized to receive one of three subcutaneous regimens of vobarilizumab (150 mg every four weeks, 150 mg every two weeks or 225 mg every two weeks) or open-label tocilizumab [Roche's (OTCQX:RHHBY) Actemra] every one or two weeks (the comparator drug).
- Subjects in the vobarilizumab 225 mg (n=63) responded the best with 81% achieving ACR20, 49% ACR50 and 21% ACR70. The corresponding results in the Actemra arm were 78%, 45% and 23%. The proportion of the subjects in the 225 mg group who achieved remission as measured by an RA activity score called DAS28 was 41% compared to 27% for Actemra. The proportion achieving low disease activity or remission, determined by DAS28, also favored vobarilizumab 225 mg (60% versus 44%).
- Top-line results from a Phase 2b study of vobarilizumab combined with methotrexate should be available in Q3.
- Vobarilizumab inhibits the activity of the proinflammatory cytokine interleukin-6 (IL-6) by binding to the IL-6 receptor (IL-6R). It is comprised of an anti-IL-6R Nanobody linked to an anti-human serum albumin Nanobody which increases the half-life of the molecule. According to the company, its small size may enable it to penetrate more effectively into tissues.
- Ablynx inked a collaboration deal with AbbVie (ABBV) in 2013 to develop vobarilizumab for the treatment of inflammatory diseases.
- Previously: Abbvie in $840M deal to license arthritis, lupus drug (Sept. 23, 2013)
Thu, Jul. 7, 8:52 AM
- AbbVie (ABBV) (NYSE:ABBV) will present initial data from a Phase 3 study of patients with moderate-to-severe fingernail psoriasis demonstrating that nearly half of adult patients treated with HUMIRA (adalimumab) achieved at least a 75% improvement in their symptoms compared to placebo. The results will be presented at Psoriasis 2016 - 5th Congress of the Psoriasis International Network in Paris, France.
- The study also showed 48.9% of HUMIRA-treated patients achieved Physician's Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a 2-point improvement from baseline versus 6.9% for placebo.
- Fingernail psoriasis occurs in up to 55% of people living with psoriasis and up to 70% of people living with psoriatic arthritis. It is associated with pitting, deformation, thickening, discoloration and separation of the nail from the nail bed.
Tue, Jul. 5, 5:38 PM
Tue, Jul. 5, 9:20 AM
- Biogen (NASDAQ:BIIB) and AbbVie (NYSE:ABBV) announces that the European Commission (EC) has granted marketing authorization for ZINBRYTA (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). ZINBRYTA is a once-monthly, self-administered, subcutaneous injection.
- ZINBRYTA has an immunomodulatory mechanism of action that regulates inflammation without broadly depleting the immune system and immune cell effects are reversible within six months. It offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease.
- The EC approval of ZINBRYTA is supported by results from two studies, Phase 3 DECIDE and Phase 2b SELECT involving 2,400 subjects.
- Daclizumab is a new form of humanized monoclonal antibody that selectively binds to interleukin-2 (IL-2) receptor subunit CD25, a protein that is over-expressed on T cells that become abnormally activated in MS. It modulates IL-2 signaling without causing general immune cell depletion. One negative is a boxed warning that daclizumab can cause liver injury. Patients are required to have liver function tests performed prior to starting therapy, before each monthly dose and up to six months after the last dose.
- Previously: Europe Ad Comm backs AbbVie and Biogen's MS drug Zinbryta (April 29)
Fri, Jul. 1, 7:19 AM
- AbbVie (NYSE:ABBV) announces that the FDA has approved HUMIRA (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis, a group of inflammatory eye diseases and can impact vision. The expanded label, an Orphan Drug indication, marks the 10th approved use for HUMIRA in the U.S. for immune-mediated diseases.
- HUMIRA is also approved in the European Union for the treatment of adult patients with the same types of uveitis who have had an inadequate response to corticosteroids, are in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
- HUMIRA targets and helps block TNF-α, a specific source of inflammation that can have a role in uveitis. The FDA approval is based on results from two pivotal Phase 3 studies, VISUAL-I and VISUAL-II, which demonstrated that adult patients treated with HUMIRA had a significantly lower risk for treatment failure compared to placebo.
Fri, Jul. 1, 7:07 AM
- Micro cap OraSure Technologies (NASDAQ:OSUR) fell 16% yesterday on more than 8x normal volume as informed investors ran for the exits before today's announcement that AbbVie (NYSE:ABBV) has backed out of its co-promotion agreement regarding OraSure's OraQuick HCV Rapid Antibody Test. The deal will now end on December 31 of this year instead of December 31, 2019.
- OraSure was supposed to receive up to $75M in exclusivity payments from AbbVie over the term of the partnership. It has been ratably recognizing the payments since the deal was inked in June 2014 and will book $5.4M for the remainder of this year.
- When the agreement ends, AbbVie will have no further obligations to co-promote the test or any other obligations to OraSure.
- OraSure will host a conference call this morning at 8:30 am ET to discuss the situation. Shares are down 11% premarket this morning.
- SA Contributor Richard Pearson nailed the call: Expect OraSure To Drop 35% (Or More) Next Week
Wed, Jun. 29, 9:36 AM
- Janssen Research & Development (JNJ +0.5%) announces that the FDA has granted a fourth Breakthrough Therapy Designation (BTD) for Ibrutinib (IMBRUVICA) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.
- The FDA also granted the therapy Orphan Drug Designation (ODD) for cGVHD. This marks the first time ibrutinib has been granted BTD or ODD for an indication beyond hematologic malignancies.
- GVHD is a life-threatening condition in which the body is attacked by donor immune cells after a patient undergoes an allogeneic stem cell or bone marrow transplant.
- BTD status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA). Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
- Related ticker: (ABBV +0.4%).
AbbVie, Inc. is a research-based biopharmaceutical company. It engages in the discovery, development, manufacture and sale of a broad line of proprietary pharmaceutical products. The company's products are used to treat rheumatoid arthritis, psoriasis, Crohn's disease, HIV, cystic fibrosis... More
Industry: Drug Manufacturers - Major
Country: United States
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