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
Sep. 14, 2015, 8:25 AM
- NantWorks subsidiary NantPharma inks an exclusive global license deal with Amgen (NASDAQ:AMGN) for its cancer therapy candidate, AMG 337, with the exception of Japan, Russia and certain other Central Asian countries.
- AMG 337, currently in Phase 2 development, is a small molecule inhibitor of the cell surface enzyme called c-Met, which, when dysregulated, stimulates cancer cell scattering, invasion and protection from apoptosis.
- Financial terms are not disclosed.
Sep. 14, 2015, 6:56 AM
- Sanofi (NYSE:SNY) enters into a multi-target peptide discovery and optimization collaboration with Tokyo-based PeptiDream.
- Under the terms of the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System technology to generate certain peptides against multiple targets of interest selected by Sanofi. PeptiDream will receive an undisclosed upfront payment, research funding, preclinical and clinical milestones and royalties of commercial sales.
- PeptiDream also has collaborations with Amgen (NASDAQ:AMGN), AstraZeneca (NYSE:AZN), Bristol-Myers Squibb (NYSE:BMY), Eli Lilly (NYSE:LLY), GlaxoSmithKline (NYSE:GSK), Novartis (NYSE:NVS), Mitsubishi Tanabe (OTCPK:MTZPY), Daiichi Sankyo (OTCPK:DSNKY), Merck (NYSE:MRK) and Ipsen (OTCPK:IPSEY).
Sep. 11, 2015, 9:39 AM
- Amgen (AMGN -0.8%) files an application with the FDA seeking clearance for a single once-per-month 420 mg injection of its cholesterol fighter Repatha (evolocumab). Presently, Repatha is available in a single-use 140 mg/mL prefilled autoinjector which requires three subcutaneous injections for a dose of 420 mg. One injection, obviously, would be much more patient-friendly for those patients requiring/preferring a once-per-month regimen.
- The FDA cleared Repatha, a PCSK9 inhibitor, on August 27, for lowering LDL-C (bad cholesterol).
- Sanofi (SNY -0.2%) and Regeneron's (REGN -0.4%) Praluent (alirocumab), Reptha's competitor, requires a subcutaneous injection every two weeks via a pre-filled syringe/pen.
Sep. 11, 2015, 7:34 AM
- AstraZeneca (NYSE:AZN) purchases a biologics bulk manufacturing facility from Amgen (NASDAQ:AMGN) for an undisclosed sum. The site, located in Boulder, CO, will eventually double AZN's U.S. manufacturing capacity for biologics. It is expected to be licensed and operational by late 2017, after refurbishment and infrastructure improvements are made.
Sep. 3, 2015, 5:05 PM
- Undoubtedly prompted by Novartis' launch of Zarxio (filgrastim-sndz), the first biosimilar commercially available in the U.S., Coherus BioSciences (NASDAQ:CHRS) provides investors with an update on its three lead programs.
- CHS-1701 [biosimilar of Amgen's Neulasta (pegfilgrastim)]: top-line data from pharmacokinetic and pharmacodynamic study should be completed this month; immunogenicity study expected to be completed in Q4; 351(k) BLA submission expected in Q1 2016.
- CHS-1420 [biosimilar of AbbVie's Humira (adalimumab)]: Phase 3 underway in psoriasis; pharmacokinetic bioequivalence bridging study to be initiated by end of H1 2016; BLA expected to be filed in H2 2016.
- CHS-0214: [biosimilar to Amgen's Enbrel (etanercept)]: top-line data from Phase 3 psoriasis study expected next quarter; rheumatoid arthritis data in Q1 2016; MAA filing in the EU in 2016.
- Related tickers: (NYSE:NVS) (NASDAQ:AMGN) (NYSE:PFE) (NASDAQ:EPRS) (NYSEMKT:PFNX) (NYSE:ABBV)
Sep. 3, 2015, 4:41 AM
- Kicking off a new era in American medicine, Novartis (NYSE:NVS) has launched the first "biosimilar" copy of a biotechnology drug approved in the United States, following a green light from a U.S. appeals court.
- Biosimilars have been on the market in Europe since 2006, but the U.S. regulatory pathway for the drugs was only established by a healthcare reform in 2010.
- Novartis' Sandoz unit will now begin selling Zarxio, a knockoff version of Amgen's (NASDAQ:AMGN) Neupogen that was approved by the FDA in March.
Sep. 2, 2015, 4:21 PM
- Amgen (NASDAQ:AMGN) submits its Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval for etelcalcetide (AMG 416) for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on dialysis. If approved, it will be the first calcimimetic agent that can be administered intravenously.
- Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone by binding to the calcium-sensing receptor on the parathyroid gland. It is administered intravenously three times per week at end of each dialysis session.
- Amgen obtained the drug candidate in 2012 via its acquisition of KAI Pharmaceuticals.
- Secondary hyperparathyroidism affects ~2M dialysis patients worldwide.
- Previously: Amgen (AMGN) acquires privately-held KAI Pharmaceuticals for $315M in a deal that will give it... (April 10, 2012)
Sep. 2, 2015, 1:41 PM
- The U.S. Court of Appeals for the Federal Circuit declines to stop Novartis (NVS +0.3%) from launching its biosimilar Zarxio in the U.S. Neupogen (filgrastim) maker Amgen (AMGN +0.7%) sought to extend the injunction by asking the court to clarify federal regulations on when biosimilars may be brought to market. The current injunction expires today.
- Biosimilars have been commercially available in Europe since 2006. Zarxio was approved by the FDA in March.
- Previously: Amgen shot down in attempt to bar Neupogen biosimilar in U.S. (July 21)
- Previously: FDA clears first biosimilar (March 6)
Sep. 1, 2015, 5:28 PM
- Amgen (NASDAQ:AMGN) and Novartis (NYSE:NVS) enter into a collaboration agreement in neuroscience, specifically Alzheimer's disease (AD) and migraine.
- The agreement combines each firm's BACE (beta-site APP-cleaving enzyme-1) programs in AD into a global co-commercialization and co-development arrangement. Novartis' molecule, the Phase 1/2a-stage BACE inhibitor CNP520, will be the lead product candidate. Each company's preclinical BACE inhibitor programs will generate potential follow-ons. Amgen will make upfront and milestone payments and will be responsible for a majority of the R&D costs for an agreed-upon period. Thereafter, the partners will share costs and profits equally.
- BACE initiates the production of beta amyloid, the primary constituent of amyloid plaques which are believed to play a key role in the development of AD. Inhibiting BACE could potentially reduce the production of amyloid plaques.
- In the migraine space, Novartis will have global co-development rights and commercial rights, exclusive of the U.S., Canada and Japan, to Amgen's investigative molecules in its migraine portfolio, including AMG 334 and AMG 301. It will also have the option to commercialize an additional early-stage Amgen molecule in its territories. Novartis will fund the majority of global R&D expenses for an agreed-upon period and pay Amgen double-digit royalties on commercial sales.
- Specific financial terms of the deal are not disclosed.
Sep. 1, 2015, 4:42 PM
- Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF) announce positive results from a 436-subject Phase 3 clinical trial, called STRUCTURE, that compared their investigational monoclonal antibody, romosozumab, to teriparatide [Eli Lilly's (NYSE:LLY) Forteo] in postmenopausal women with osteoporosis at high risk of fracture. The study met its primary endpoint of a statistically significant difference in percent change of total hip bone mineral density through month 12 versus teriparatide.
- Romosozumab inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. The companies started Phase 3 development for the indication in April 2012.
- The analysis of the results is ongoing. The data will be presented at a future medical conference and for publication.
- Previously: Amgen osteoporosis drug increases bone density in Phase II trial (Jan. 2, 2014)
Sep. 1, 2015, 5:48 AM
- Valeant Pharmaceuticals (NYSE:VRX) is buying rights to AstraZeneca's (NYSE:AZN) late-stage experimental psoriasis drug brodalumab after it was dropped by Amgen (NASDAQ:AMGN) over concerns about the medicine's "suicidal" side effects.
- Valeant will make an upfront payment of $100M to AstraZeneca, with another $170M in prelaunch milestones and up to $175M following launch.
Aug. 31, 2015, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Aug. 27, 2015, 5:56 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Repatha drug for patients with hereditary forms of high cholesterol and those at high risk of cardiovascular disease.
- The scope of the approval was similar to the recent approval given to Regeneron's (NASDAQ:REGN) Praluent, which was approved for patients with cardiovascular disease and those with heterozygous familial hypercholesterolemia.
- Each of the drugs are expected to generate more than $2B/year in sales by 2020.
Aug. 25, 2015, 9:51 AM
- Amgen (AMGN +2.3%) says it submitted a new drug application to the FDA for its intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.
- AMGN says the treatment, if approved, would be the first of its kind that can be administered intravenously at the end of the dialysis session.
- Secondary hyperparathyroidism affects many of the ~2M people throughout the world who receive dialysis, including 450K in the U.S., the company says.
Aug. 18, 2015, 3:53 PM
- Ending an investigation by 48 states and the District of Columbia into its promotional practices related to Aranesp (darbepoetin alfa) and Enbrel (apremilast), Amgen (AMGN -1.2%) agrees to pay $71M to settle the matter. The case pertained to the company's promotion of Aranesp for anemia caused by cancer, its dosing schedule and the promotion of Enbrel for mild plaque psoriasis.
- Aranesp is approved for the treatment of anemia caused by chronic kidney disease and chemotherapy. Per the package insert, it should be dosed every one to three weeks depending on the indication and every four weeks for patients with chronic kidney disease not on dialysis. Prosecutors said the company tried to convince doctors and patients to administer the drug in larger doses once per month in response to the encroachment of a competitor, but there is insufficient evidence that it works when administered this way.
- Enbrel is approved for the treatment of moderate-to-severe plaque psoriasis as well as certain other inflammatory conditions.
- A few years ago, Amgen paid $762M to settle a federal suit pertaining to off-label marketing in addition to pleading guilty to one criminal charge.
Aug. 12, 2015, 12:11 PM
- RBC Capital's Michael Yee maintains his Outperform rating on Amgen (AMGN -1.2%) with a price target of $190 (14% upside). His rationale is based on the potential for a delay in the U.S. launch of the Neulasta (pegfilgrastim) biosimilar from Toronto, Canada-based Apotex, still under FDA review.
- He feels that there is a chance that the product will not be approved (unlikely) or Amgen's litigation will tie matters up until at least mid-2016 (likely). Amgen sued Apotex accusing it of infringing on two patents ('138 and '784). The case is scheduled to be heard in July 2016.
- Amgen is also accusing Apotex of violating the Biosimilar Price Competition and Innovation Act (BPCIA) by failing to provide 180-day effective notice of commercial marketing. Apotex has not provided the notice because its offering has not been cleared yet (FDA filing was December 2014). Amgen successfully employed this delaying tactic in its suit against Novartis' (NVS -0.9%) Sandoz unit over its Neupogen (filgrastim) biosimilar Zarxio, approved by the FDA in March but unable to be launched until September.
- Mr. Yee believes that the legal maneuverings will give Amgen sufficient time to convert many Neulasta customers to its on-body formulation even if it does not prevail in its case against Apotex.
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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