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
Aug. 11, 2015, 10:15 AM
- In a letter published in the Journal of the American Medical Association (AMA), CVS Health (CVS -0.5%) urges heart specialists to revamp guidelines for treating patients with high cholesterol to provide clarity on how best to choose the best and most cost effective therapy now that expensive new drugs called PCSK9 inhibitors are now on (or will soon be on) the market.
- PCSK9 inhibitors, led by recently-approved Praluent (alirocumab) (SNY -0.4%)(REGN -0.8%) and soon-to-be-approved Repatha (evolocumab), are, at least initially, more than 20 times more expensive than statins. Pharmacy benefit managers, like CVS, aim to control costs by extracting significant discounts from manufacturers and controlling patient access to the pricier drugs.
- CVS wants the guidelines to include specific LDL targets, which older guidelines did before new ones issued in 2013 did away with them. The emphasis now is on a patient's risk of developing heart disease as the main determinant for more intensive treatment. Unsurprisingly, the American College of Cardiology and the AMA have shown scant enthusiasm for revisiting the issue.
- CVS Chief Medical Officer Dr. Troyen Brennan says that if the guidelines are not changed, then CVS will use its own targets, which will vary depending on each patent's medical history. "We expect patients to first use statins. If they can't use statins or can't make (NYSE:LDL) targets, then they would use PCSK9 inhibitors."
- The PDUFA date for Amgen's (AMGN -1%) Repatha is August 27.
Aug. 10, 2015, 12:25 PM
- CVS Health (CVS +0.8%), the number two pharmacy benefit manager (PBM), says it will wait until a second PCSK9 inhibitor is approved before adding either one to its list of covered drugs and negotiating price discounts, clearly an effective strategy if its hopes to win significant price reductions, which is likely if one firm secures exclusive coverage.
- Last month, the FDA cleared Praluent (alirocumab), co-developed by Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.9%). The PDUFA date for a second PCSK9 inhibitor, Amgen's (AMGN -0.8%) Repatha (evolocumab), is August 27.
- PCSK9 inhibitors are the "next big thing" in lowering bad cholesterol. They ain't cheap, though. Generic statins cost ~$50 per month while Praluent costs ~$1,200 before discounts.
Aug. 6, 2015, 9:41 AM
- Dr. Reddy's Laboratories (RDY +0.8%) enters into a strategic collaboration with Amgen (AMGN -1.5%) to market and distribute Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India.
- Under the terms of the agreement, Dr. Reddy's will be responsible for all regulatory and commercial activities for the three products. Specific financial terms are not disclosed.
Aug. 5, 2015, 7:35 AM
- Nano cap Biocept (NASDAQ:BIOC) launches its proprietary quantitative Target Selector assay targeting KRAS mutations, a predictive biomarker in cancer. The assay is performed on a blood sample (liquid biopsy) instead of a tissue biopsy which allows physicians to more easily monitor cancer patients for response to treatment and progression of disease.
- ~40% of colorectal cancer patients are KRAS mutation positive. KRAS is also present in high frequency in other solid tumor cancers including lung and pancreatic cancers. Patients with the mutation are much more resistant to anti-EGFR monoclonal antibodies such as Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) and Lilly's (NYSE:LLY) Erbitux (cetuximab).
- Investors should keep an eye on the uptake of this test. If robust, then it validates its value proposition of a more convenient, cheaper and much less invasive method of monitoring cancer patients. To date, investors appear to lack confidence in the company's prospects. Shares are down 76% since its IPO at $10 in February 2014.
- Shares are up 10% premarket on light volume.
Jul. 30, 2015, 4:21 PM
- Amgen (NASDAQ:AMGN) Q2 results ($M): Total Revenues: 5,370 (+3.7%); Product Sales: 5,225 (+5.6%).
- Key Product Sales: Enbrel: 1,348 (+8.4%); Neulasta: 1,158 (+2.2%); Epogen: 491 (-4.1%); Aranesp: 479 (-7.4%); Sensipar/Mimpara: 344 (+15.4%); Prolia: 340 (+28.8%); Xgeva: 331 (+10.7%); Neupogen: 256 (-13.5%); Vectibix: 160 (+21.2%); Kyprolis: 119 (+52.6%).
- Net Income: 1,653 (+6.9%); EPS: 2.15 (+7.0%); CF Ops: 2,814 (+26.4%).
- 2015 Guidance: Total Revenues: $21.1B - 21.4B from $20.9B - 21.3B; EPS: $8.06 - 8.35 from $7.48 - 7.87; Non-GAAP EPS: $9.55 - 9.80 from $9.05 - 9.40.
- Shares are up 2% after hours on increased volume.
Jul. 30, 2015, 4:03 PM
- Amgen (NASDAQ:AMGN): Q2 EPS of $2.57 beats by $0.14.
- Revenue of $5.37B (+3.7% Y/Y) beats by $50M.
- Shares +1.72%.
Jul. 29, 2015, 5:35 PM
- AIV, AMCC, AMGN, ATEN, AUY, AVD, AXTI, BAS, BCOR, BCOV, BRCM, BVN, CALD, CATM, CLW, CMLS, COHR, COLM, CPSI, CPT, CRAY, CTRL, CXP, DCT, DECK, DGI, DLR, DTLK, EA, EEP, EGO, EIX, ELLI, ES, ESS, EVHC, EXPE, FE, FEIC, FEYE, FLR, FLS, FR, FRGI, GB, GMED, HBI, HK, HME, HTCH, IM, IMMR, INT, ISBC, KAMN, KLAC, LEG, LNKD, LRE, LSCC, MOH, MTD, MTSN, MWA, MXWL, NGVC, NR, NSR, OLN, OMCL, OUTR, PCCC, PDFS, PKI, PODD, PTCT, PXLW, QLGC, QTM, RGC, RMD, RNG, ROVI, SAM, SB, SGEN, SKYW, SPF, SPN, SYA, SYNA, SZYM, TCO, TEP, TMST, TNAV, TNDM, TPX, TSYS, TXTR, UHS, VCRA, VVUS, WAGE, WBMD, WU, WWWW, YRCW, ZLTQ
Jul. 29, 2015, 12:44 PM
- Amgen (AMGN -1.4%) will report Q2 results tomorrow after the close. Consensus view is EPS of $2.43 (+2.5%) on revenues of $5.3B (+2.3%).
Jul. 28, 2015, 5:47 PM
- Amgen (NASDAQ:AMGN) declares $0.79/share quarterly dividend, in line with previous.
- Forward yield 1.83%
- Payable Sept. 8; for shareholders of record Aug. 17; ex-div Aug. 13.
Jul. 28, 2015, 12:57 PM
- Privately-held Boehringer Ingelheim (BI) enters into an exclusive license and collaboration agreement with Seoul, Korea-based Hanmi Pharmaceutical to develop and commercialize HM61713, a third generation epidermal growth factor receptor (EGFR)-targeted therapy for the treatment of EGFR mutation-positive lung cancer.
- Under the terms of the agreement, Hanmi will receive an upfront payment of $50M, milestones up to $680M and tiered double-digit royalties on net sales. BI will have exclusive global commercialization rights to HM61713 except South Korea, China and Hong Kong.
- HM61713 is an orally active, irreversible EGFR mutation-selective tyrosine kinase inhibitor (TKI). It is currently in Phase 2 development for the treatment of patients with non-small cell lung cancer with T790M mutations who have developed resistance to other EGFR-targeting agents. A Phase 3 study will commence next year.
- EGFR-related tickers: (AZN +0.3%)(OTCQX:RHHBY +1.3%)(OTCPK:ALPMY) (OTCPK:ALPMF) (BMY +0.1%)(LLY +1.4%)(GSK -0.1%)(AMGN +4.3%)
Jul. 28, 2015, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Jul. 28, 2015, 2:38 AM
- So what's Allergan (NYSE:AGN) doing with all that cash from the Teva deal? CEO Brent Saunders plans to use the money to increase the size of the firm's existing drug business, expand into new therapy areas and pursue larger deals.
- When asked if Allergan planned to spend the cash within 18 months, Saunders replied that he would, as long as the company could maintain its investment-grade credit rating.
- Possible targets: Biogen (NASDAQ:BIIB), AbbVie (NYSE:ABBV) and Amgen (NASDAQ:AMGN).
- Previously: Teva to buy Allergan Generics for $40.5B (Jul. 27 2015)
Jul. 24, 2015, 12:53 PM
- The FDA approves Amgen's (AMGN -0.8%) sNDA for Kyprolis (carfilzomib) for patients with relapsed multiple myeloma who have received at least one prior line of therapy. The approval was based on results from the ASPIRE Phase 3 study.
- Kyprolis was originally approved for the treatment of MM patients who have received at least two prior lines of therapy.
Jul. 23, 2015, 1:47 PM
- Tomorrow is the FDA's action (PDUFA) date for its review of regulatory filings submitted by Amgen and Sanofi.
- Sanofi's (SNY +1.2%) NDA for cholesterol-lowering Praluent (alirocumab), co-developed with Regeneron Pharmaceuticals (REGN -0.2%). On June 9, the Ad Comm voted 13 - 3 supporting approval.
- Amgen's (AMGN -0.4%) sNDA for Kyprolis (carfilzomib) for the second-line treatment of relapsed multiple myeloma. Filing accepted for review on March 30.
Jul. 21, 2015, 12:36 PM
- The U.S. Court of Appeals for the Federal Circuit rejects Amgen's (AMGN -0.5%) attempt to block Novartis' (NVS -1.7%) Sandoz unit from launching Zarxio (filgrastim - sndz), a biosimilar to Neupogen (filgrastim), in the U.S. The current injunction will remain in place until September 2.
- A district court rebuffed Amgen in March. The FDA approved Zarxio on March 6.
- Previously: Court rejects Amgen's bid to block Neupogen biosimilar (March 20)
- Previously: FDA clears first biosimilar (March 6)
Jul. 21, 2015, 8:03 AM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximum tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated. It is also approved to the treatment of adults and adolescents at least 12 years old with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies.
- Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the world. Regulatory clearance for Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab) should happen shortly, however. PCSK9 inhibitors are poised to dominate the post-statin cholesterol-lowering market.
- Previously: Amgen gets EU backing for Repatha (May 22)
- Previously: Regeneron up 1.1% as trading reopens after Ad Comm approval (June 9)
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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