Mon, Aug. 31, 7:53 AM
- The Medicines Company (NASDAQ:MDCO) jumps 20% premarket on average volume in response to development partner Alnylam's (NASDAQ:ALNY) announcement that its investigational RNAi therapeutic, ALN-PCSsc, lowered LDL-C (bad cholesterol) up to 83% with a mean maximum reduction of up to 64% (+-5%) in an early stage study, results comparable to Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent (alirocumab). The data were presented at the ESC Congress in London.
- What's notable in this case is the difference in dosing regimens. ALN-PCSsc was administered in one subcutaneous dose that was effective for over 140 days, giving it the potential for once per quarter or twice per year administration. Praluent is dosed once every two weeks and Repatha once every two weeks or once per month at a higher dose.
- ALN-PCSsc turns off PCSK9 synthesis in the liver. This is a different mechanism of action compared to Praluent and Repatha, both of which bind to PCSK9 in the blood.
- The Medicines Company will take the lead in developing ALN-PCSsc under the ORION Program. A Phase 2 study will commence by the end of the year and a Phase 3 trial is planned for 2017. The clinical development will include comparisons to the anti-PCSK9 monoclonal antibodies.
- The companies will host a conference call this morning at 9:30 am ET to discuss the results and their development plan.
Tue, Aug. 25, 9:51 AM
- Amgen (AMGN +2.3%) says it submitted a new drug application to the FDA for its intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis.
- AMGN says the treatment, if approved, would be the first of its kind that can be administered intravenously at the end of the dialysis session.
- Secondary hyperparathyroidism affects many of the ~2M people throughout the world who receive dialysis, including 450K in the U.S., the company says.
Wed, Aug. 5, 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.
Thu, Jul. 30, 4:03 PM
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.
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, May 26, 4:56 AM
- AstraZeneca's (NYSE:AZN) goal of topping $45B in revenue by 2023 has been dealt a severe blow by a problem with an experimental psoriasis drug that the company had viewed as a potential billion-dollar plus seller.
- Amgen (NASDAQ:AMGN), its partner on the project, announced late on Friday it was ending a collaboration to develop brodalumab after suicidal thoughts were observed in patients taking the medicine.
- AZN -1.6%; AMGN -0.8% premarket
Thu, Mar. 5, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Mon, Mar. 2, 4:05 PM
- Thinly-traded Ligand Pharmaceuticals (LGND +15.5%) jumps on a 5x surge in volume in response to the positive news on Amgen's (AMGN +1.1%) Kyprolis (carfilzomib) study. Ligand is eligible to receive milestone and royalty payments on sales of Captisol, which carfilzomib's IV formulation utilizes. Ligand and Proteolix entered into a collaboration in 2005 to explore the use to Captisol. Onyx Pharmaceuticals acquired Proteolix in 2009 and Amgen acquired Onyx in 2013.
- Captisol is a formulation technology. It is a uniquely modified cyclodextrin, which improves the solubility, stability, bioavailability and dosing of active pharmaceutical ingredients.
- Previously: Amgen's Kyprolis beats Takeda's Velcade in head-to-head study (March 1)
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Wed, Jan. 14, 8:25 AM
- Ziopharm (NASDAQ:ZIOP) jumps 50% premarket on robust volume in response to its announcement of an exclusive license deal with partner Intrexon (NYSE:XON) (+12%) with The University of Texas MD Anderson Cancer Center covering technology and intellectual property related to non-viral adoptive cellular cancer immunotherapies. The technologies originate from two researchers who have pioneered the design and clinical investigation of chimeric antigen receptor (CAR) T cell therapies for the potential treatment of cancer using non-viral gene integration platforms.
- The two researchers are Laurence Cooper, M.D., Ph.D, professor of pediatrics at MD Anderson who has expertise in immunotherapies and Perry Hackett, Ph.D., professor within the College of Biological Sciences at Minnesota, who discovered and developed a system called Sleeping Beauty, a non-viral DNA plasmid-based gene transfer system.
- The deal brings the CAR-T technology together Intrexon's technology suite and Ziopharm's clinically tested RheoSwitch Therapeutic System interleukin-12 modules. Up to five CARs are expected to enter the clinic this year and off-the-shelf programming initiating in 2016.
- Under the terms of the agreement, MD Anderson will receive $100M from the companies in the form of $50M of common stock from each firm. In addition, the companies have committed $15M - 20M over each of the next three years for researching and developing the technologies.
- CAR-T therapies are the "next big thing" in cancer treatment.
- Related tickers: (NASDAQ:KITE) (NASDAQ:JUNO) (NASDAQ:AMGN) (NYSE:NVS) (NYSE:JNJ)
Nov. 14, 2014, 12:00 PM| Nov. 14, 2014, 12:00 PM | 41 Comments
Oct. 27, 2014, 4:05 PM
Oct. 21, 2014, 1:55 PM
Aug. 13, 2014, 5:54 PM
- Amgen's (AMGN) Kyprolis (carfilzomib) failed to achieve its primary endpoint of improving overall survival (OS) in a 315-patient Phase 3 clinical trial (FOCUS) evaluating the safety and efficacy of the product in patients with relapsed and advanced refractory multiple myeloma compared to an active control regimen of low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide.
- Despite the setback, Amgen subsidiary Onyx Pharmaceuticals (ONXX) President Pablo J. Cagnoni says, "While it is unfortunate that the FOCUS study did not meet its primary endpoint, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world."
Jul. 29, 2014, 4:19 PM
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