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
Tue, Jul. 5, 6:44 AM
- The Japanese Ministry of Health, Labor and Welfare approves Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol in certain adult patients with hypercholesterolemia at high cardiovascular risk.
- Amgen's (NASDAQ:AMGN) Repatha (evolocumab) was approved in Japan in January.
- Both products are monoclonal antibodies that inhibit convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
Fri, Jul. 1, 10:08 AM
- Invitae (NYSE:NVTA) initiated with Hold rating with an $8.50 (18% upside) price target by Benchmark.
- Jazz Pharmaceuticals (NASDAQ:JAZZ) initiated with Outperform rating and $190 (33% upside) price target by BMO.
- Pacira Pharmaceuticals (NASDAQ:PCRX) initiated with Underperform rating and $36 (4% upside) price target by BMO.
- Mallinckrodt (NYSE:MNK) initiated with Outperform rating and $84 (35% upside) price target by BMO.
- Horizon Pharma plc (NASDAQ:HZNP) initiated with Outperform rating and $29 (71% upside) price target by BMO.
- Regeneron Pharmaceuticals (NASDAQ:REGN) initiated with an Outperform rating and $400 (13% upside) price target by Bernstein.
- Biogen (NASDAQ:BIIB) initiated with an Outperform rating and $282 (15% upside) price target by Bernstein.
- Amgen (NASDAQ:AMGN) initiated with Market Perform rating and $161 (5% upside) price target by Bernstein.
- Lannett Company (NYSE:LCI) initiated with Hold rating and $26 (5% upside) price target by Deutsche Bank.
- OpGen (NASDAQ:OPGN) initiated with Buy rating and $2.50 (66% upside) price target by Rodman & Renshaw.
- Valeant Pharmaceuticals (NYSE:VRX) initiated with Market Perform rating and $26 (22% upside) price target by BMO.
- Neurocrine Biosciences (NASDAQ:NBIX) initiated with Outperform rating and $80 (75% upside) price target by H.C. Wainwright.
- Healthstream (NASDAQ:HSTM) initiated with Outperform rating and $30 (12% upside) price target by Barrington Research.
- Neurometrix (NASDAQ:NURO) initiated with Buy rating and $4.50 (165% upside) price target by Rodman & Renshaw.
- Vascular Biogenics (NASDAQ:VBLT) initiated with Buy rating and $11 (139% upside) price target by H.C. Wainwright.
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Mon, Jun. 13, 4:43 PM
- The FDA's Arthritis Advisory Committee will review Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) seeking approval of ABP 501, its biosimilar candidate to AbbVie's (NYSE:ABBV) Humira (adalimumab). The specific date has not been announced, but the FDA's action date (PDUFA) is September 25. Advisory committee meetings are typically three months or less beforehand under standard review and two months beforehand under priority review.
- The Arthritis Committee is scheduled to convene on July 13 to discuss Novartis (NYSE:NVS) unit Sandoz's BLA for its Enbrel (etanercept) biosimilar. No other meeting date is listed on the FDA's website.
Fri, Jun. 10, 10:59 AM
- Amgen (AMGN -1.4%) announced expiration and final results of its previously announced private offers to exchange certain specified series of its outstanding senior notes for new 4.563% Senior Notes due 2048 and new 4.663% Senior Notes due 2051.
- The Exchange Offers consist of an offer to exchange any and all 6.375% Senior Notes due 2037; 6.90% Senior Notes due 2038; and 6.40% Senior Notes due 2039 for New 2048 Notes.
- It also consists of an offer to exchange the 5.75% Senior Notes due 2040; 5.65% Senior Notes due 2042; 5.375% Senior Notes due 2043; 5.15% Senior Notes due 2041; for New 2051 Notes provided that the aggregate principal amount of New 2051 Notes shall not exceed $7.1B less the aggregate principal amount of New 2048 Notes to be issued pursuant to the 2048 Exchange Offers.
- The Settlement Date for the Exchange Offers is expected to be June 14, 2016. Amgen expects that it will issue $1.4B aggregate principal amount of New Notes due 2048 and $3.5B aggregate principal amount of New Notes due 2051, in satisfaction of the exchange offer consideration on such tendered Old Notes.
- Source: Press Release
Fri, Jun. 10, 7:00 AM
- An interim analysis of a Phase 3 study, TOWER, showed Amgen's (NASDAQ:AMGN) BLINCYTO (blinatumomab) increased overall survival (OS) to almost eight months in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), the most aggressive type of B-cell cancer. The data were presented at the 21st Congress of the European Hematology Association in Copenhagen.
- Patients treated with BLINCYTO experienced median OS of 7.7 months compared to 4.0 months for standard-of-care chemo with 29% less risk of death (hazard ratio: 0.71).
- According to ClinicalTrials.gov, the estimated study completion date is August. TOWER is the confirmatory study for BLINCYTO. Amgen plans to file for full approval based on the results. The European Commission granted conditional approval of the product for the treatment of Philadelphia chromosome-negative relapse/refractory B-precursor ALL in November 2015 based on the results from two Phase 2 studies.
Wed, Jun. 8, 4:53 PM
- A Phase 2 clinical trial assessing Amgen's (NASDAQ:AMGN) erenumab (AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid change in monthly migraine days compared to placebo. The study compared two doses (70 mg and 140 mg) of erenumab, administered via subcutaneous injection, to placebo. Patients in the treatment arms experienced a 6.6-day reduction in monthly migraine days versus a 4.2-day reduction for placebo.
- The safety profile of both doses of erenumab was similar to placebo. No adverse event occurring in more than 5% of patients was reported.
- Additional analyses are ongoing. Complete results will be presented at a future medical conference and for publication.
- Erenumab inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain.
Thu, Jun. 2, 7:54 AM
- The Medicines Company (NASDAQ:MDCO) completes the enrollment of 501 subjects in its Phase 2 study, called ORION-1, assessing its RNA interference therapeutic targeting PCSK9 (PCSK9si) in patients with high cardiovascular risk and elevated LDL-C ("bad cholesterol") despite receiving the maximum tolerated doses of LDL-C-lowering therapies. The study will compare the effect of different doses of PCSK9si and will evaluate the potential for quarterly or biannual dosing. The primary endpoint is the change in LDL-C from baseline to day 180.
- Interim three-month and six-month data should be available by year end. If all goes well, Phase 3 studies will commence in early 2017.
- PCSK9si is an investigational GalNAc-conjugated RNAi therapeutic targeting PSCK9, a protein regulator of LDL receptor metabolism. In contrast to PSCK9 inhibitors, PCSK9si works by turning off PCSK9 synthesis in the liver. The company is collaborating with Alnylam (NASDAQ:ALNY) on its development.
- Related tickers: (NASDAQ:AMGN)(NASDAQ:REGN)(NYSE:SNY)
Fri, May 27, 7:46 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib), in combination with dexamethasone alone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- The data supporting the application was generated in the Phase 3 ENDEAVOR study which showed MM patients treated with Kyprolis + dexamethasone achieved progression-free survival of 18.7 months compared to 9.4 months for those treated with Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone.
- Kyprolis is currently approved in the EU in combination with lenalidomide and dexamethasone for the treatment of MM patients who have received at least one prior line of therapy.
- A final decision from the European Commission usually takes ~60 days.
- Update: On July 4, the company announced that the European Commission approved the new indication.
Wed, May 25, 9:00 AM
- According to Bloomberg, Celgene (NASDAQ:CELG) is considering a bid for Medivation (NASDAQ:MDVN), currently trying to hold off Sanofi (NYSE:SNY). Other suitors supposedly in the mix are Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN) and Amgen (NASDAQ:AMGN).
- Sanofi is trying to replace Medivation's board after it rejected its per-share offer of $52.50.
- Previously: Amgen another possible Medivation suitor (May 5)
Fri, May 20, 8:04 PM
- New global cardiology guidelines issued by three organizations may give a jump to a struggling heart-failure drug from Novartis (NVS +1.5%).
- Experts from the American College of Cardiology, the American Heart Association and the European Society of Cardiology have agreed that Novartis' Entresto should replace old ACE inhibitors and ARBs, in patients with adequate blood pressure and drug tolerance.
- The groups also said Corlanor, from Amgen (AMGN +1%), may be beneficial when given on top of beta blockers for some heart failure patients.
- Despite a heavy buildup, first-quarter sales of Entresto were just $17M and Novartis sees only $200M in sales this year.
- Now read A New Realm Of Therapeutics Is Emerging: Johnson & Johnson And Novartis Are Key Players »
Thu, May 19, 3:38 PM
- IPO Merus B.V. (Pending:MRUS) is holding its ground on its debut day. Shares are up 5% from the issue price of $10 on modest turnover of 868K shares.
- The Netherlands-based company develops immuno-oncology-focused bispecific antibody therapeutics based on its technology platform called Biclonics. A bispecific antibody has the ability to bind to two or more targets simultaneously. Its lead product candidate is MCLA-128, in Phase 1/2 development in Europe for the treatment of various solid tumors, including breast, colorectal and ovarian cancers. Other pipeline candidates are MCLA-117 for blood cancers, MCLA-158 for colorectal cancer, MCLA-134 for solid tumors and MCLA-145 for solid tumors.
- 2015 Financials (€M): Revenue: 2.0 (+51.7%); Operating Expenses: 25.0 (+33.7%); Net Loss: (23.2) (-33.2%); CF Ops: (23.0) (-57.9%).
- Related tickers: (AMGN -1.5%)(MGNX +1.2%)(JNJ -0.7%)(AFMD +0.3%)(PIRS -7%)(OTC:GNMSF)
Wed, May 18, 3:50 PM
- Thinly traded micro cap MacroGenics (MGNX +16.5%) is up on more than triple normal volume in response to its announcement of a collaboration and license deal with Janssen Biotech (JNJ -0.3%) to develop and commercialize MGD015, a preclinical bispecific molecule based on its proprietary Dual-Affinity Re-Targeting (DART) technology, for the treatment of range of blood cancers and solid tumors.
- Under the terms of the agreement, MacroGenics will receive an upfront license fee of $75M, up to $665M in milestones and double-digit royalties on global net sales. It also has the option to co-promote MGD015 with Janssen in the U.S. and may choose to fund a portion of late-stage development in exchange for a share of the profits in the U.S. and Canada. Janssen will be responsible for completing IND-enabling activities and future clinical development.
- The collaboration builds on Janssen's experience with MGD011, a DART molecule targeting CD19 and CD3.
- MGD015 is designed to redirect T cells, via their CD3 component, to eliminate cells that overexpress an undisclosed antigen in various blood cancers and solid tumors. It is manufactured using a conventional antibody platform which avoids the complexity inherent in patient-specific approaches like chimeric antigen receptor T-cells (CAR-T).
- The DART platform enables the creation of molecules that simultaneously bind to two or more targets. According to the company, a 2011 study showed DART molecules were consistently more potent in eliminating CD19-positive cells than a competing platform, bispecific T cell engager (BiTE), commercialized by Amgen (AMGN +0.3%) via Blincyto (blinatumomab).
- Previously: MacroGenics teams up with Janssen in blood cancer (Dec. 22, 2014)
- Previously: Amgen collaborates with leading cancer center on BiTE technology (Jan. 12, 2015)
Fri, May 13, 6:25 PM
- Third Point's 13F filing shows it took new positions in EMC (EMC, 7M shares), Google (GOOGL, 700K shares) and Baxalta (BXLT, 6M shares) while selling out of eBay (EBAY, 4M shares), and Morgan Stanley (MS, 3M shares).
- Like Appaloosa, the firm also took a new stake in Twenty-First Century Fox (FOXA, for 1.45M shares).
- Third Point trimmed its stake in Amgen (NASDAQ:AMGN) by two-thirds, selling 6.04M shares, and cut its holdings in J M Smucker (NYSE:SJM) by 875,000. It did boost holdings in Yum Brands (NYSE:YUM) with 5.4M additional shares, as well as 1.5M in calls.
Wed, May 11, 9:12 AM
- Health insurer Cigna (NYSE:CI) enters into new value-based agreements with Amgen (NASDAQ:AMGN) and Sanofi (NYSE:SNY)/Regeneron Pharmaceuticals (NASDAQ:REGN) covering their cholesterol-lowering medications, Repatha (evolocumab) and Praluent (alirocumab), respectively. The contracts modify the cost of the pricey meds based on how well patients respond to the drugs. If they meet or exceed the expected reduction in LDL-C (the "bad" cholesterol) the original negotiated price remains as is. If they fall short of the expected LDL-C reduction, the discount increases.
- Repatha lists for $14,000 per year while Praluent lists for $14,600. Cigna will also determine whether there are cardiovascular improvements related to treatment by analyzing medical and pharmacy claim data.
- Cigna is the first payer to close this type of agreement with the drug makers covering their PCSK9 inhibitors. It also has value-based contracts in place covering drugs for heart failure, diabetes, multiple sclerosis and hepatitis C.
Thu, May 5, 12:07 PM
- The anticipated rapid ramp of Regeneron Pharmaceuticals (REGN +5.3%) and Sanofi's (SNY -3%) cholesterol fighter Praluent (alirocumab) and Amgen's (AMGN +0.2%) Repatha (evolocumab) remains elusive in the face of headwinds from insurers over the high costs of the PCSK9 inhibitors. The companies and bullish analysts have touted both meds as blockbusters that will eventually generate well over $1B a year in sales. When is anyone's guess considering Repatha's Q1 sales of $16M and Praluent's $13M, both shy of expectations.
- Regeneron says that 74% of U.S. commercially insured lives and 91% of Medicare insured lives have access to its drug (as of April 1). The premium list price of $14,600 per year, significantly more expensive that other therapies like statins, has prompted insurers to restrict access via specific utilization criteria and burdensome paperwork. The company expects payers to loosen the strings a bit when when upcoming data are released on Praluent's cardiovascular benefits.
- Amgen is in the same boat. Repatha is priced at $14,000 per annum before discounts.
- Another cloud hanging over Praluent's prospects is a patent dispute versus Repatha, currently under appeal after Amgen prevailed in March.
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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