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
Mon, Jul. 11, 3:35 PM
- Coherus BioSciences (CHRS +25.8%) heads north on more than triple normal volume in response to its announcement of positive pharmacokinetic and pharmacodynamic data for Neulasta (pegfilgrastim) biosimilar CHS-1701. The single-blind 122-subject study met all of its co-primary endpoints and the data were well within the pre-specified confidence intervals.
- Commercial plans and preparations will commence later this year.
- Neulasta generated almost $4.8B in sales for Amgen (AMGN -0.2%) over the most recent four quarters.
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%)
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)
Thu, Mar. 17, 5:21 PM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
- The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
- Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
- Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
- MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
- Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
Wed, Mar. 16, 11:52 AM
- Nasdaq has suspended trading in Regeneron Pharmaceuticals (REGN +2.6%) pending news. One possibility is a ruling on its patent fight with Amgen (AMGN -0.4%) over their PCSK9 inhibitors [Praluent (alirocumab) versus Repatha (evolocumab)].
- Here's an SA article by Markman Advisors for background.
- Update: Amgen patents upheld per report by Evercore ISI's Mark Schoenebaum. Permanent injunction hearing set for March 23 - 24. Regeneron to appeal. Judge ruled that Amgen failed to establish sufficient evidence of willful infringement (win for Regeneron).
- Update #2: Judge ruled that two Amgen patents covering antibodies targeting PCSK9 are valid. Regeneron and development/commercialization partner Sanofi (SNY -1.7%) intend to appeal the decision. The availability of Praluent is not affected at this time. Trading in REGN to resume at 1:00 pm ET. Initial trading has shares down only 1%.
Mon, Feb. 22, 12:03 PM
- Micro cap Unilife (UNIS +14.3%) is up double normal volume in response to its announcement that it has entered into a strategic collaboration with Amgen (AMGN -1.3%) for injectable drug delivery systems centered on its portfolio of prefilled, customizable wearable injectors.
- Under the terms of the agreement, Unilife grants Amgen exclusive rights to its wearable injectors within select drug classes for use with certain Amgen drugs and non-exclusive rights to all Unilife delivery systems within oncology, inflammation, nephrology, cardiovascular and neuroscience. Previously granted rights to other Unilife customers are unaffected.
- Unilife is eligible to receive up to $75M, including an upfront license fee of $20M. It also sold Amgen a $30M senior secured convertible note. Amgen may buy up to an additional $25M in senior secured convertible notes over the next two years ($15M in 2017 and $10M in 2018). These amounts are in addition to the $15M it paid to Unilife in December 2015 in connection with the exclusivity letter.
- Unilife expects to earn additional revenues from Amgen from the development, production and supply of its delivery systems.
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 20, 1:47 PM
Wed, Jan. 20, 11:36 AM
- To point out the obvious, the biotech sector has been unable to fight off the widespread selling. The iShares Nasdaq Biotech Index Fund (IBB -1.8%) is down again, albeit on modestly higher volume. It's down over 21% since late December.
- Representative tickers: (GILD -1.7%)(CELG +0.7%)(BIIB -2.7%)(AMGN -0.6%)(ALXN -2.8%)
Thu, Jan. 14, 5:59 PM
- Amgen's (AMGN +5.3%) efforts to make a biosimilar version of the top-selling prescription medicine get a setback as the U.S. patent office ruled against its petition regarding Humira, AbbVie's drug (ABBV +6.6%).
- Amgen asked the patent office to review two formulation patents on Humira -- a rheumatoid arthritis drug with annual sales near $14B -- with the argument that they shouldn't have been granted.
- The company had filed in November seeking approval to sell a cheaper biosimilar to Humira. It expects the first of its biosimilars in development to hit the market between 2017 and 2019.
- Meanwhile, AbbVie says that based on its patents it doesn't expect biosimilar competition until 2022.
- The patent office said Amgen "has not shown a reasonable likelihood of prevailing on any of its challenges."
- After hours: AMGN is flat; ABBV is up 0.8%.
Mon, Jan. 4, 10:36 AM
- Unilife (UNIS +66.3%) enters into an exclusivity agreement with Amgen (AMGN -2.8%) in effect through the end of the month during which they will negotiable a license deal for Unilife's wearable injector devices. In consideration of the exclusive period, Amgen has paid the company a non-refundable deposit of $15M.
- The license agreement provides for a perpetual, global non-exclusive license to Unilife's technology, know-how and IP for the development, manufacture and sale of wearable injector devices for use with certain large volume Amgen products. Amgen will also receive a perpetual worldwide exclusive license to Unilife's 1mL wearable injector for use with certain small volume drug products. It will pay Unilife an undisclosed price per device.
- Other items under negotiation are: a non-exclusive license to Unilife's other devices, an interest-bearing note to be satisfied through discounted pricing and/or credits against future amounts owed, the purchase by Amgen of up to 19.9% of Unilife's common stock, a preferred right of access to certain new delivery platforms and a manufacturing rights agreement.
Dec. 14, 2015, 5:41 PM
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.
Oct. 28, 2015, 4:06 PM
- Amgen (NASDAQ:AMGN): Q3 EPS of $2.72 beats by $0.34.
- Revenue of $5.72B (+13.7% Y/Y) beats by $400M.
- Shares +1.8%.
Oct. 27, 2015, 10:29 AM
- Cytokinetics (CYTK +4.9%) and collaboration partner Amgen (AMGN) announce positive top-line data from a Phase 2 clinical trial assessing omecamtiv mecarbil in patients with chronic heart failure. Study participants treated with the drug candidate showed statistically significant improvements in several measures of cardiac function at 20 weeks following randomization.
- The study, called COSMIC-HF, was designed to evaluate an oral formulation of omecamtiv mecarbil in chronic heart failure patients with reduced ejection fraction. It consisted of two parts: a dose escalation phase and a longer expansion phase. The latter enrolled 448 subjects who were dosed for 20 weeks and followed for a total of 24 weeks. They were randomized to receive either placebo or omecamtiv mecarbil 25 mg twice daily or 25 mg escalating to 50 mg twice daily. The primary endpoints were an assessment of the maximum and pre-dose plasma concentration of omecamtiv mecarbil. Secondary endpoints included measures of cardiac function including changes from baseline in systolic ejection time, stroke volume. left ventricular end-systolic diameter and heat rate at week 20.
- Final results will be presented at a future medical conference and for publication.
- Omecamtiv mecarbil activates a protein in cardiac muscle cells called myosin, which is directly responsible for converting chemical energy into the mechanical energy that results in cardiac contraction.
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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