Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
Amgen: Equity Report And Stock Valuation
Dec. 15, 2015, 4:13 PM
- Amgen (NASDAQ:AMGN) declares $1.00/share quarterly dividend, 26.6% increase from prior dividend of $0.79.
- Forward yield 2.46%
- Payable March 8; for shareholders of record Feb. 16; ex-div Feb. 11.
Dec. 14, 2015, 5:41 PM
Dec. 14, 2015, 5:01 PM
- In a regulatory filing, Coherus BioSciences (NASDAQ:CHRS) reports that it received a $35M milestone payment from development partner Baxalta (NYSE:BXLT) triggered by the successful achievement of certain manufacturing process goals for CHS-0214, the company's biosimilar candidate to Amgen's (NASDAQ:AMGN) Enbrel (etanercept).
- Several Phase 3 studies should wind up in 2016, followed by global regulatory submissions.
- Previously: Coherus Bio and Baxalta's etanercept biosimilar on par with Amgen's Enbrel in late-stage study (Nov. 9)
Dec. 14, 2015, 4:52 PM
- Amgen (NASDAQ:AMGN) reacquires the rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries in Asia, South America, Europe, and other regions from GlaxoSmithKline (NYSE:GSK). The deal includes the new territories of Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand.
- GSK has owned the rights to Prolia and XGEVA since 2009 and Vectibix since 2010 under a license from Amgen. Total sales of the three in 2014 were $111M.
- Under the terms of the new agreement, Amgen will pay GSK undisclosed milestone payments upon signing and on the successful transition of the products back to Amgen. The majority of markets should transition back to Amgen within 12 months. The transaction is expected to be accretive to non-GAAP earnings in 2017.
Dec. 11, 2015, 7:48 AM
- Sanofi (NYSE:SNY) and Regeneron (NASDAQ:REGN) edge out Amgen (NASDAQ:AMGN) for preferred access status for their PCSK9 inhibitor Praluent (alirocumab) in UnitedHealth Group's (NYSE:UNH) OptumRx and UnitedHealthcare for Commercial, Medicare and Managed Medicaid patients. Praluent is now on formularies covering more than 100M patients in the U.S., including Express Scripts and Aetna.
- Amgen's Repatha (evolocumab) is the preferred offering in CVS Health and the exclusive PCSK9 inhibitor for members of Harvard Pilgrim Health System. Express Scripts offers it as well. Patients covered in UnitedHealth's Oxford unit can transition to Repatha if a 12-week regimen of Praluent fails to do the job.
- Previously: Repatha and Praluent go toe-to-toe in PBMs (Dec. 1)
Dec. 10, 2015, 1:31 PM
- A Florida district court grants Amgen (AMGN +1.5%) a preliminary injunction against Toronto, Canada-based Apotex preventing it from launching its biosimilar of Neulasta (pegfilgrastim) for 180 days. Judge James Cohn based his ruling on his interpretation of the Biologics Price Competition and Innovation Act which stipulates that biosimilar makers give the brand holder 180 days notice before bringing their knockoff to market. This provides sufficient time for the original developer to determine if any of its patents are being infringed.
- The same ruling delayed Novartis (NVS +1.4%) from launching Zarxio (filgrastim-sndz). Its U.S. launch commenced in September, six months after being cleared by the FDA.
- Previously: Novartis launches Zarxio in the U.S. (Sept. 3)
- Previously: FDA clears first biosimilar (March 6)
Dec. 5, 2015, 6:57 PM
- Amgen (NASDAQ:AMGN) submits a Variation to the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking clearance for the use of Kyprolis (carfilzomib), in combination with the corticosteroid dexamethasone, in adult multiple myeloma (MM) patients who have received at least one prior therapy.
- The data supporting the application was generated in the Phase 3 ENDEAVOR study that showed patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to patients who received Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone (18.7 months versus 9.4 months, respectively)(p<0.0001).
- The most common treatment-related adverse events (>25%) were diarrhea, anemia, fatigue, dyspnea (difficulty breathing), pyrexia (high temperature) and insomnia.
- Kyprolis is currently approved in Europe for the treatment of MM, in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone, in patients who have relapsed after receiving at least one prior line of therapy.
- Previously: Amgen's Kyprolis cleared in Europe for combo treatment of multiple myeloma (Nov. 19)
Dec. 4, 2015, 9:06 AM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) announce a cancer immunotherapy collaboration to support an open-label Phase 1b/3 clinical trial assessing the combination of BLINCYTO (blinatumomab) and KEYTRUDA (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL).
- Amgen's BLINCYTO is a CD19 bispecific T cell engager (BiTE) that helps the body's immune system to detect and attack malignant cancer cells. The modified antibodies are designed to engage two different targets simultaneously thereby juxtaposing T cells to cancer cells and triggering apoptosis (cell death). Merck's KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
- The companies will also collaborate to support an open-label Phase 1/2 study of the combination of KEYTRUDA and Amgen's AMG 820, an anti-colony-stimulating factor 1 receptor (CSF1R) antibody, in patients with select advanced solid tumors. AMG 820 is a fully human antagonistic IgG2 monoclonal antibody that binds to CSF1R. It helps the body's immune system fight cancer by decreasing the function of tumor-associated white blood cells called macrophages.
Dec. 4, 2015, 7:27 AM
- Amgen (NASDAQ:AMGN) submits its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, its biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab) which is cleared in a range of countries around the world for the treatment of various inflammatory diseases.
- The company submitted in Biologics License Application (BLA) to the FDA on November 25.
- Previously: Amgen submits first BLA for Humira biosimilar (Nov. 25)
Dec. 3, 2015, 1:46 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, thinks Alexion Pharmaceuticals' (ALXN -3.9%) Strensiq (asfotase alfa) is a bit too expensive for its tastes. The enzyme replacement therapy for pediatric-onset hypophosphatasia, affecting only seven people a year there, is priced at a hefty ₤366,912 ($552,000).
- NICE says the company has yet to provide an adequate justification for the high price. Luckily for Alexion, its decision is still in the draft stage and is open to further consultation. The company will, no doubt, take advantage of the opportunity to try to change NICE's opinion.
- Alexion is not alone. A few weeks ago, NICE rejected Amgen's (AMGN -3.4%) Repatha (evolocumab) saying, among other things, that it doubted the company's cost-effectiveness data.
- Previously: Advisor to Britain's NHS gives thumbs down to Amgen's Repatha (Nov. 18)
Dec. 3, 2015, 7:41 AM
- Thinly traded micro cap Foamix Pharmaceuticals (NASDAQ:FOMX) announces positive top-line results from a 24-subject Phase 2 clinical trial assessing FDX104 for the prevention of moderate-to-severe skin rashes in patients receiving epidermal growth factor receptor antibody inhibitors (EGFRI) [Eli Lilly's (NYSE:LLY) Erbitux (cetuximab) or Amgen's (NASDAQ:AMGN) Vectibix (panitumumab)] for the treatment of cancers such as colon and head and neck. The acne-like (acneiform) rash is the most common side effect from EGFRI drugs and, if severe enough, treatment should be withheld, reduced or discontinued.
- Each randomized patient in the study acted as their own control by treating one side of the face with FDX104 and the other with a foam vehicle (placebo) in a blinded manner.
- Results showed the side treated with FDX104 was better overall than the placebo-treated side. The mean maximal rash severity favored FDX104, 1.33 versus 1.71. 37.5% of patients (n=9/24) developed a Grade 3 rash (severe) on the placebo side compared to 16.7% (n=4/24) on the FDX104 side. The difference in the prevention of severe rash was statistically valid (p<0.05) in favor of FDX104 as measured by the Wilcoxon Signed-Rank test. Other exploratory analyses also trended positively.
- FDX104, a doxyocycline foam, appeared safe and well-tolerated with no drug-related systemic adverse events observed. Local reactions were noted in six patients with five resolved before the end of the study.
- The company will host a conference call this morning at 8:30 am ET to discuss the results. Shares are up 9% premarket on light volume.
Dec. 1, 2015, 12:53 PM
- In a shining example of the beauty of competition, Amgen (AMGN +0.5%) is battling fiercely with Sanofi (SNY) and Regeneron (REGN -0.4%) for favored status of its cholesterol fighter Repatha (evolocumab) versus Praluent (alirocumab) in the leading pharmacy benefit managers (PBMs).
- Amgen won preferred listing in CVS Health (CVS +1.4%) and an exclusive deal with Harvard Pilgrim Health System. Express Scripts (ESRX +1.2%) covers both PCSK9 inhibitors while UnitedHealth's (UNH +2.5%) Oxford unit is taking a different approach. Plan members will have to try Praluent first. If it fails to do the job after 12 weeks, then they can try Repatha.
- UnitedHealth and its OptumRx PBM are largest unsigned accounts and are, no doubt, getting substantial exposure to the companies' representatives.
Nov. 25, 2015, 4:23 PM
- Amgen (NASDAQ:AMGN) submits its first biosimilar Biologics License Application (BLA) to the FDA for ABP 501, a biosimilar version of AbbVie's (NYSE:ABBV) Humira (adalimumab).
- EVP of R&D Sean Harper, M.D., says, "The submission of Amgen's first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients. Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen's branded biologic medicines and biosimilars are developed and manufactured according to the same high standards and we are committed to delivering high quality medicines to patients with serious inflammatory diseases."
- Previously: Amgen's ABP 501 equivalent to Humira in late-stage RA study (Nov. 9)
Nov. 24, 2015, 7:23 AM
- As expected, the European Commission grants conditional marketing authorization for Amgen's (NASDAQ:AMGN) Orphan Drug-tagged BLINCYTO (blintumomab) for the treatment of adults with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.
- Conditional marketing authorization requires the annual renewal of the license until post-licensing commitments have been fulfilled. BLINCYTO is subject to additional monitoring in light of its side effects. The data supporting approval was generated in two Phase 2 trials (Study '206 and Study '211) instead of the typical Phase 3s.
- Previously: European Ad Comm gives thumbs up to Amgen's Kyprolis and BLINCYTO (Sept. 25)
Nov. 23, 2015, 9:18 AM
- Round one in the Repatha (evolocumab) versus Praluent (alirocumab) competition goes to Amgen (NASDAQ:AMGN). After evaluating both PCSK9 inhibitors, Pharmacy benefit manager CVS Health (NYSE:CVS) exclusively adds Amgen's Repatha to its commercial formularies, effectively shutting out Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent.
- No word yet on the decisions from other PBMs.
Nov. 20, 2015, 6:51 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Samsung Bioepis' Benepali, a biosimilar version of Amgen's (NASDAQ:AMGN) Enbrel (etanercept), for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
- This is the first time CHMP has backed an etanercept biosimilar. A final decision by the European Commission usually takes ~60 days.
- Samsung Bioepis is a joint venture between Samsung Biologics and Biogen (NASDAQ:BIIB).
Amgen, Inc. is a biotechnology medicines company, which discovers, develops, manufactures and markets medicines for grievous illnesses. The company focuses on human therapeutics and concentrates on innovating novel medicines based on advances in cellular and molecular biology. It markets... More
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