Dec. 17, 2013, 2:46 PM
- Amgen's (AMGN -1%) evolocumab meets its primary endpoints in MENDEL-2 (Phase 3 PCSK9 inhibitor for elevated LDL-C).
- Outcome: The company says mean reductions in LDL-C (week 12) compared to placebo "were consistent with results observed in the MENDEL Phase 2 study."
- In the Phase 2 study, evolocumab "as a monotherapy showed robust reductions in serum LDL-C." More specifically, the "mean decrease in LDL-C from baseline for evolocumab dosed Q2W was 41% in the 70mg group, 44% in the 105mg group, and 51% in the 140mg group" (4% decrease for placebo), while the mean decrease for evolocumab "dosed Q4W was 39% in the 280mg group, 43% in the 350mg group, and 48% in the 420mg group" (5% increase in placebo). For more on the Phase 2 study, see here.
- Details of the AMGN study "will be submitted to a future medical conference and for publication," the company says. (PR)
Dec. 13, 2013, 5:07 PM
Nov. 29, 2013, 11:27 AM
- Goldman is out with an update on IMS data for some of Amgen's (AMGN) key drugs.
- "Sales are tracking slightly ahead of our estimates," analyst Terence Flynn says, adding that "Kyprolis, Epogen and Prolia are particularly strong, while Enbrel and Neulasta are tracking in-line and Aranesp is slightly below."
- Flynn sees Q4 Kyprolis sales coming in at $76M versus consensus of $71M.
- AMGN reiterated at Buy.
- Price target is $130.
Nov. 27, 2013, 10:54 AM
- New guidance from the AHA on how doctors should go about facilitating a reduction in their patients' risk of heart attack and stroke "marks the biggest shift in cardiovascular-disease prevention in 30 years," Johanna Bennett writes.
- In short, the new guidelines could dramatically increase the number of patients eligible for statin therapy.
- This is potentially big news for AstraZeneca (AZN +0.6%) as it's "the only drug maker that still has patent protection on a statin." Crestor is protected until 2016.
- Count Amgen (AMGN -0.3%) and Regeneron (REGN -1.8%) among those who may suffer from the new regime. The FDA has indicated that the companies can gain approval for their PCSK-9 inhibitors without proving they prevent heart attacks and although this means faster approval, it could also limit their uptake among physicians, according to some commentators.
- Also affected by the news: Merck (MRK +0.2%) (think Zetia, Vytorin).
Nov. 27, 2013, 8:55 AM
- Piper starts Celgene (CELG) at Neutral.
- Repros Therapeutics (RPRX) initiated at Overweight at Piper. Price target is $26.
- Piper starts Gilead (GILD) at Overweight. Price target is $91.
- Incyte (INCY) initiated at Overweight at Piper. Price target is $56.
- Piper starts Insmed (INSM) at Overweight. Price target is $34.
- Piper starts MannKind (MNKD) at Neutral.
- Nektar Therapeutics (NKTR) is initiated at Overweight at Piper. Price target is $20.
- Amgen (AMGN) initiated at Overweight at Piper. Price target is $143.
- Vanda (VNDA) started at Overweight at Piper. Price target is $21.
- Piper initiates Pharmacyclics (PCYC) at Overweight. Price target is $160.
- Piper upgrades Isis Pharmaceuticals (ISIS) to Neutral from Underweight.
- Piper starts Alexion (ALXN) at Overweight. Price target is $172.
Nov. 21, 2013, 3:20 PM
- After opening higher, shares of Amgen (AMGN -2.9%) moved into negative territory this morning and have since traded notably lower on above average volume.
- The weakness looks to be attributable to BofA/ Merrill Lynch. Here's what the firm had to say regarding a meeting with Celgene's (CELG +1.8%) management: "The most notable derivative commentary was around AMGN's Kyprolis. CELG is hearing increasing concerns from big myeloma centers on CV events."
- They continue: CELG "has access to the event rate in ASPIRE and believes the full story has yet to fully play out." While BofA says CELG "was not tossing away Kyprolis" they did seem to suggest that "it could be reserved with Revlimid/Dexamethasone for high risk myeloma." ASPIRE combines Kyrpolis, Revlimid, and Dexamethasone.
- Now, Cowen is apparently out defending AMGN, saying any CELG commentary might have been taken out of context.
- Also down sharply are shares of Ligand Pharmaceuticals (LGND -5.7%) which receives tiered royalties tied to the use of Captisol technology in the drug.
Nov. 20, 2013, 2:13 PM
- Amgen (AMGN) announces results from an open-label extension study of evolocumab in patients with high cholesterol.
- The company's executive VP of R&D calls the results "encouraging" and says the data "suggest evolocumab may be a promising option to treat hyperlipidemia in a range of at-risk patients."
- The company says the PCSK9 inhibitor "was not associated with a major increase in AEs versus SOC and produced mean LDL-C reductions of 52% in combination with SOC in patients with high cholesterol." (PR)
Nov. 18, 2013, 11:33 AM
- Teva (TEVA -0.6%) is out with an oncology portfolio update.
- Highlights: Lonquex was launched in Germany on November 4, Granix was launched in the U.S. on November 11, and the BLA for balugrastim has been withdrawn "pending the provision of additional confirmatory data." (PR)
- Although Goldman's Terence Flynn didn't "see balugrastim as a significant competitive threat to [Neulasta]," the analyst notes that "many investors did," and therefore, TEVA's move to pull the leukocyte growth factor from the FDA review process "removes a near-term competitive threat" for an Amgen (AMGN +1.9%) and also lifts "an overhang on shares heading into 2014."
- Goldman maintains a CL-Buy on AMGN.
- Price target is $140.
Oct. 22, 2013, 4:10 PM
- Amgen (AMGN) is up 1% AH following its Q3 report.
- Revenues of $4.75B are up 11% Y/Y.
- Adjusted EPS growth comes in at 16%.
- Sales by product: Neulasta/ Neupogen, +18%; Enbrel, +7%; Aranesp, -10%; Epogen, flat; Sensi[ar/Mimpara, +7%; Vectibix and Nplate, +19%; XGEVA, +30%; Prolia, +62%.
- FY 13 outlook: Adjusted EPS of $7.35-7.45 on sales of $18.3-18.5B against consensus of $7.32/share on $18.33B in sales. (PR)
Oct. 22, 2013, 4:05 PM
Oct. 22, 2013, 12:10 AM
Oct. 21, 2013, 5:35 PM
Oct. 16, 2013, 4:56 PM
Oct. 16, 2013, 3:15 AM
- A drug developed by Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) cut levels of the "bad" LDL cholesterol by 47% in a Phase III trial of 103 patients. No major side effects were experienced.
- The treatment, called Alirocumab, is part of a new class of injectable cholesterol medicines that block a protein called PCSK9. Amgen (AMGN) and Pfizer (PFE) are among those developing such drugs, which could each generate sales of $3B or more.
- Regeneron and Sanofi hope to file for authorization of Alirocumab by late 2015 after the results of another 11 studies are released. (PR)
Oct. 14, 2013, 10:01 AM
- Leerink starts Acceleron Pharma (XLRN -0.3%) at Outperform.
- The company is "pushing innovation boundaries with lead compounds for anemia (Sotatercept, ACE-536) and oncology (Dalantercept)," analyst Marko Kozul says.
- Leerink thinks Sotatercept and ACE-536 "have potential to compete directly with ESAs" such as Aranesp and Epogen (AMGN) and Procrit (JNJ).
- As for Dalantercept (ACE-041), Kozul says it "could be used synergistically with any VEGF-inhibitor."
- Finally, Kozul says XLRN "has important catalysts for almost every quarter through YE14."
- Price target is set at $33.
- Leerink starts Acceleron Pharma (XLRN -0.3%) at Outperform.
Oct. 13, 2013, 2:59 AM
- California Governor Jerry Brown has vetoed a bill that would have limited the use of biosimilar pharmaceuticals in the state.
- Brown explained that the legislation was premature, as the FDA hasn't yet set the rules governing such drugs.
- Biosimilars are the copycat versions of biotech drugs - also known as biologics - which are complex proteins developed in living cells. Biosimilars are not called generics, as it's difficult to prove that they're exactly the same as the biologic original.
- The campaign to limit the use of biosimilars has been led by Amgen (AMGN) and Genentech (RHHBY.OB); so far, 10 states have blocked such efforts this year, including Illinois and Texas.
- Companies developing biosimilars include Hospira (HSP), Novartis (NVS), Momenta Pharmaceuticals (MNTA), Baxter (BAX) and Teva (TEVA).
- Healthcare ETFs: XLV, XHE, VHT, FXH, IHF, IHI, IYH, PTH, RYH, PSCH, RXL, RXD, XHS
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