Tue, Jul. 21, 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)
Tue, Jul. 21, 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)
Thu, Jul. 16, 4:20 PM
- Top-line results from a Phase 2 clinical trial evaluating Amgen's (NASDAQ:AMGN) Blincyto (blinatumomab) in adult patients with relapsed/refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (ALL) show a clinically meaningful number of patients achieved complete remission or complete remission with partial hematologic recovery within two cycles of treatment. The data will be submitted for publication and for presentation at a future medical meeting.
- About 25% of adult ALL patients express the oncogenic protein BCR-ABL1 that results from the mutation known as the Philadelphia chromosome.
- The FDA cleared Blincyto in December 2014 for the treatment of adults with Philadelphia chromosome-negative ALL.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
Fri, Jul. 10, 7:05 AM
- Ultragenyx (NASDAQ:RARE) initiated with Market Outperform rating with a $119 (6% upside) price target by JMP Securities.
- Regeneron Pharmaceuticals (NASDAQ:REGN) downgraded to Sell from Neutral by UBS. Price target maintained at $500 (2% downside risk).
- Amgen (NASDAQ:AMGN) downgraded to Neutral from Buy by UBS. Price target lowered to $165 (9% upside) from $185.
Fri, Jun. 19, 9:02 AM
- A Phase 3 study, called REACH, evaluating Eli Lilly's (NYSE:LLY) Cyramza (ramucirumab) as second-line treatment [after Nexavar (sorafenib)] in patients with hepatocellular carcinoma (HCC) failed to achieve its primary endpoint of a statistically significant improvement in overall survival (OS). Median OS in the Cyramza plus best supportive care (BSC) arm was 9.2 months versus 7.6 months in the placebo plus BSC arm (p=0.1391). The results were published in The Lancet Oncology.
- A prespecified subgroup of HCC patients with elevated baseline alpha-fetoprotein (AFP), a liver enzyme, did show a statistically valid improvement in survival after receiving ramucirumab. Median OS was 7.8 months compared to 4.2 months for placebo (p=0.0059).
- The company plans to conduct an new Phase 3 study, called REACH-2, to assess Cyramza in a second-line setting in patients with elevated AFP. Enrollment will begin shortly.
- Cyramza is currently approved for the treatment of certain colorectal, gastric and lung cancers and gastroesophageal junction adenocarcinoma.
- Related tickers: (NASDAQ:AMGN) (OTCPK:BAYRY)
Thu, Jun. 18, 4:23 PM
- A Phase 3 clinical trial comparing the efficacy of Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) and best supportive care (BSC) versus BSC alone in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) met its primary endpoint of a statistically significant improvement in overall survival (OS) in the Vectibix cohort. All key secondary endpoints were met as well.
- Complete results will be presented at a future medical conference and will be submitted for publication.
- The FDA approved Vectibix in May 2014 as a first-line treatment, in combination with the chemo regimen FOLFOX, in patients with wild-type KRAS (exon 2) mCRC.
Wed, Jun. 10, 3:58 PM| Wed, Jun. 10, 3:58 PM | 7 Comments
Wed, Jun. 10, 1:33 PM
- Eli Lilly (LLY -0.5%) announces the results from two Phase 3 studies, just published in The Lancet, evaluating ixekizumab in patients with moderate-to-severe plaque psoriasis. Both trials, called UNCOVER 2 & 3, met all primary and secondary endpoints, demonstrating superiority to etanercept [Amgen's (NASDAQ:AMGN) Enbrel] and placebo.
- Approximately 90% of patients treated with ixekizumab every two weeks achieved PASI 75 (at least a 75% reduction in severity of psoriasis from baseline) at week 12 while ~50% achieved PASI 75 by week 4. About 40% of patients achieved total skin clearance or PASI 100. Almost 60% of patients reported that psoriasis no longer impacted their quality of life.
- Ixekizumab is a monoclonal antibody that binds to interleukin-17A, a pro-inflammatory cytokine produced by the immune system's T cells. In psoriasis, IL-17A plays a major role in the excess proliferation and activation of skin cells.
- Psoriasis affects nearly 8M Americans. About 17% (~1.4M) have moderate-to-severe plaque psoriasis.
Wed, Jun. 10, 9:30 AM
- Biogen (NASDAQ:BIIB) and Samsung Bioepis announce results from separate Phase 3 trials comparing their biosimilar candidates to their respective reference products. The data were presented at the European League Against Rheumatism Annual Congress in Rome, Italy.
- 24-week data from one Phase 3 study comparing SB4 to the etanercept reference product Enbrel (NASDAQ:AMGN) in patients with moderate-to-severe rheumatoid arthritis (RA) showed equivalent efficacy. 596 patients were randomized to receive either SB4 (n=299) or Enbrel (n=297). The ACR20 (American College of Rheumatology: 20% improvement in RA symptoms) response rate at week 24 in the full analysis set was 73.8% in the SB4 arm versus 71.7% in the Enbrel arm. Full 52-week data will be available at a later date.
- 30-week data from a second Phase 3 comparing SB2 to the infliximab reference product, Remicade (NYSE:JNJ), in patients with moderate-to-severe RA also showed equivalent efficacy. 584 patients were randomized to receive either SB2 (n=291) or Remicade (n=293). The ACR20 response rate at Week 30 in the full analysis set for the SB2 arm was 55.5% compared to 59.0% in the Remicade arm.
- Data from a Phase 1 study assessing the pharmacokinetic equivalency of another biosimilar candidate, SB5, to its reference product, adalimumab [AbbVie's (NYSE:ABBV) Humira], will be presented as well.
- Samsung Bioepis is a joint venture between Biogen and Samsung Biologics.
Tue, Jun. 9, 6:51 PM
- Regeneron (NASDAQ:REGN) has reopened for trading, up 1.1% to $532, after an FDA Ad Comm ruling in favor of its and Sanofi's Praluent (alirocumab) cholesterol-lowering drug.
- Shares had been halted since just before 7 a.m.
- The vote was 13-3. On Wednesday, the committee turns its attention to Amgen's (NASDAQ:AMGN) drug evolocumab.
- Sanofi estimates that 11M Americans might qualify for the drugs, which could run up to $10K/year in cost. Amgen estimates that 8M Americans might qualify.
Mon, Jun. 8, 8:25 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Wednesday, June 10 to discuss Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for Repatha (evolocumab) injection as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) either alone or in combination with a statin.
- Draft questions
- Briefing doc
- Addendum to briefing doc
- Errata to briefing doc
- Amgen briefing info
- The committed meets tomorrow, June 9 to discuss the BLA submitted by Sanofi for Praluent.
- Previously: Ad Comm approaches for Sanofi/Regeneron cholesterol-lowering med (June 5)
Fri, Jun. 5, 11:02 AM
- The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Tuesday, June 9 to discuss the Biologics License Application (BLA) submitted by Sanofi (SNY -2.7%) seeing approval for Praluent (alirocumab) for the treatment of adult patients with high cholesterol (hypercholesterolemia) or mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) as monotherapy or in combination with a statin. Sanofi and Regeneron Pharmaceuticals (REGN +1.9%) co-developed Praluent.
- FDA Briefing doc
- Sanofi/Regeneron briefing doc
- Addendum to Sanofi/Regeneron briefing doc
- The committee will review Amgen's (AMGN +0.1%) BLA for Repatha on Wednesday, June 10 (briefing docs not yet posted).
Fri, Jun. 5, 9:23 AM
- Amgen (NASDAQ:AMGN) announces the completion of enrollment of ~27,500 patients in the Phase 3 study, called FOURIER, assessing whether treatment with Repatha (evolocumab) reduces the risk of cardiovascular (CV) events in patients with high cholesterol and clinically relevant CV disease. The trial will compare Repatha in combination with statin therapy to placebo plus statin therapy. Results are expected no later than 2017.
- Evolocumab is an investigational fully human monoclonal antibody that inhibits 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.
- PCSK9 inhibitors are posed to dominate the post-statin cholesterol-lowering market. Amgen is neck-and-neck with Regeneron (NASDAQ:REGN) and Sanofi's (NYSE:SNY) Praluent (alirocumab). Europe's CHMP recommended Repatha for approval several weeks ago. A final decision by the European Commission usually takes ~60 days. The EMA accepted the MAA for Praluent in January 2015. An FDA advisory committee will meet on June 9 to discuss Praluent's BLA and June 10 to discuss Rapatha's. The PDUFA date for Repatha is August 27 while Praluent's is July 24.
Tue, Jun. 2, 9:44 AM
- Aveo Pharmaceuticals (AVEO +11.4%) is set for a gap up this morning stoked by positive data on its lead product candidate, tivozanib, that was presented yesterday at ASCO (abstract #4557).
- In a Phase 3 study, TIVO-1, patients with metastatic renal cell carcinoma were randomized to receive either tivozanib or sorafenib (Bayer (OTCPK:BAYRY) and Amgen's (AMGN -1.1%) Nexavar). Progression-free survival (PFS) and overall survival (OS) in the tivozanib arm were 14.6 months and 29.0 months, respectively. For the sorafenib arm, PFS and OS were 9.7 months and 34.1 months, respectively.
- In the 163 patients that crossed over from sorafenib to tivozanib, median PFS and median OS were 11.0 months and 21.6 months, respectively, from the start of tivozanib therapy.
Tue, Jun. 2, 7:31 AM
- Amgen (NASDAQ:AMGN) and Roche (OTCQX:RHHBY) collaborate on a Phase 1b study to assess the former's talimogene laherparepvec (T-Vec) in combination with the latter's MPDL3280A (atezolizumab) in patients with triple-negative breast cancer and colorectal cancer with liver metastases. The partnership is another example of the rationale that combining immunotherapies with different mechanisms of action may be more effective in treating certain cancers.
- T-Vec is an investigational oncolytic immunotherapy that works in two ways. First, it is injected into tumors where it replicates inside tumor cells causing them to rupture and die in a process called lysis. The ruptured cells then release tumor-derived antigens, along with a white blood cell growth factor called GM-CSF (granulocyte-macrophage colony-stimulating factor) that can stimulate a system-wide immune response.
- Atezolizumab is an investigational monoclonal antibody that binds to PD-L1 (programmed death-ligand 1), a protein found on the surface of cancer cells that enable them to avoid detection by the immune system.. Binding to the protein enables T cells to recognize and kill cancer cells.
Fri, May 29, 4:17 PM
- OPKO Health (NYSE:OPK) submits a New Drug Application (NDA) to the FDA seeking approval for Rayaldee, an oral vitamin D prohormone, for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. If approved, it will be the first therapy approved for this disease.
- Rayaldee's proprietary modified-release formulation is designed to gradually raise serum vitamin D prohormone levels while avoiding upregulating CYP24A1, an enzyme which reduces vitamin D's parathyroid hormone-lowering efficacy. Gradually increasing the level of vitamin D prohormone, called 25-hydroxyvitamin D, prevents excessive elevation of serum calcium and related vascular and renal calcification.
- About 20M Americans live with stage 3 or 4 CKD, SHPT and vitamin D insufficiency.
- Related ticker: (NASDAQ:AMGN)
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