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, Jan. 25, 7:01 PM
- The FDA accepts for review Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for ABP 501, a biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab). The agency's action date is September 25.
- The company submitted its Marketing Authorization Application (MAA) in Europe on December 4.
- Previously: Amgen submits first BLA for Humira biosimilar (Nov. 25, 2015)
- Previously: Amgen's ABP 501 equivalent to Humira in late-stage RA study (Nov. 9, 2015)
Mon, Jan. 25, 10:00 AM
- The FDA accepts for review the Biologics License Application (BLA) submitted by AstraZeneca (AZN +0.8%), in partnership with Valeant Pharmaceuticals (VRX -0.5%), seeking clearance of brodalumab for the treatment of moderate-to-severe plaque psoriasis. The agency's action date (PDUFA) is November 16.
- Valeant has exclusive rights to develop and commercialize brodalumab worldwide, except in Japan and certain other Asian countries where Kyowa Hakko Kirin owns the rights. It acquired the rights after Amgen (AMGN +0.4%) backed out due to the potential adverse side effect increased suicidal thoughts.
- Brodalumab is a human monoclonal antibody that binds to interleukin-17 (IL-17), thus blocking its binding to its receptor and inhibiting inflammatory signaling.
- Previously: Valeant strikes psoriasis-drug deal with AstraZeneca (Sept. 1, 2015)
- Previously: Amgen terminates brodalumab co-development deal with AstraZeneca (May 22, 2015)
Mon, Jan. 25, 8:29 AM
- Results from a Phase 3 clinical trial assessing Amgen's (NASDAQ:AMGN) Vectibix (panitumumab) in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) who had not responded to chemotherapy showed a statistically significant increase in overall survival (OS), the primary efficacy endpoint, in patients receiving Vectibix plus best supportive care (BSC) compared to those receiving BSC alone . The data were presented at the 2016 Gastrointestinal Cancers Symposium in San Francisco.
- Median OS in the Vectibix + BSC cohort was 10.0 months compared to 7.4 months in the BSC only group (p=0.0096). In addition, patients with wild-type KRAS who lacked mutations in exons 2,3 and 4 of KRAS and NRAS achieved a median OS of 10.0 months versus 6.9 months for BSC alone (p=0.0135). Patients with mutant RAS mCRC did not benefit from Vectibix treatment.
- In December, Amgen reacquired the rights to Vectibix from GlaxoSmithKline (NYSE:GSK), who originally licensed it in 2010. It was cleared by the FDA in May 2014, in combination with the chemo regimen FOLFOX, for the first-line treatment of mCRC patients with wild-type KRAS (exon 2).
- Previously: Amgen regains rights to three drugs from Glaxo (Dec. 14, 2015)
Fri, Jan. 22, 8:23 AM
- Credit Suisse analysts have been very busy lately with a long list of initiations: Acceleron Pharma (NASDAQ:XLRN) Outperform with $50 (47% upside) price target; BioMarin Pharmaceutical (NASDAQ:BMRN) Outperform with $110 (36% upside) price target; Amgen (NASDAQ:AMGN) Outperform with $205 (34% upside) price target.
- Celgene (NASDAQ:CELG) Outperform with $149 (41% upside) price target; Coherus Biosciences (NASDAQ:CHRS) Outperform with $25 (79% upside) price target; Gilead Sciences (NASDAQ:GILD) Outperform with $125 (40% upside) price target.
- Regeneron Pharmaceuticals (NASDAQ:REGN) Neutral with $552 (19% upside) price target; Vertex Pharmaceuticals (NASDAQ:VRTX) Outperform with $151 (59% upside) price target; Alnylam Pharmaceuticals (NASDAQ:ALNY) Outperform with $154 (117% upside) price target.
- Alexion Pharmaceuticals (NASDAQ:ALXN) Neutral rating with $201 (29% upside) price target; Biogen (NASDAQ:BIIB) Neutral with $322 (23% upside) price target; XenoPort (NASDAQ:XNPT) Underperform with $4 (16% downside risk) price target.
- PTC Therapeutics (NASDAQ:PTCT) Outperform with $36 (33% upside) price target; Mesoblast Limited (NASDAQ:MESO) Outperform with $10 (92% upside) price target and Incyte (NASDAQ:INCY) Outperform with $110 (49% upside) price target.
Fri, Jan. 22, 7:22 AM
- The Japanese Ministry of Health, Labour and Welfare approves Amgen's (NASDAQ:AMGN) Repatha (evolocumab) for the treatment of patients with familial hypercholesterolemia or hypercholesterolemia who have a high risk of cardiovascular events and do not adequately respond to statins.
- Repatha was developed in Japan by Amgen Astellas BioPharma K.K., a joint venture between Amgen and Astellas Pharma (OTCPK:ALPMF)(OTCPK:ALPMY). The marketing application was filed in March 2015. It is the first PCSK9 inhibitor approved there.
- Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY) are playing catch up with Praluent (alirocumab). They reported successful Phase 3 data in July.
Thu, Jan. 21, 5:30 PM
- The FDA has approved a supplemental new drug application (sNDA) for the use of Amgen's (NASDAQ:AMGN) Kyprolis multiple myeloma drug "for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy."
- Kyprolis has also been approved "as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy."
- Amgen EVP Sean E. Harper: "Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs. Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."
- Last month, Amgen filed an application with the European Medicines Agency for the expanded use of Kyprolis. Amgen's Q3 Kyprolis revenue totaled $137M (+45% Y/Y).
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%)
Sun, Jan. 17, 6:02 PM
- The European Commission approves the first biosimilar referencing Amgen's (NASDAQ:AMGN) Enbrel (etanercept). The product, branded as BENEPALI, was developed by Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB).
- Samsung Bioepis and Biogen established their partnership in 2012 with the aim of developing affordable biologics. Biogen will lead the commercialization and distribution of BENEPALI in the 28 EU member states in addition to Norway, Iceland and Liechtenstein. The product launch will commence in the next few weeks.
- Samsung Bioepis is also partnering with Merck (NYSE:MRK) on developing biosimilars in certain territories under a February 2013 agreement. Their Enbrel biosimilar, branded as BRENZYS (formerly SB4), was cleared in South Korea in September. Merck has global rights to SB4 except in the U.S., EU and Japan.
- Enbrel is Amgen's top seller, generating $5.3B in sales over the most recent four quarters.
- Previously: Merck's Enbrel biosimilar cleared in Korea (Sept. 8, 2015)
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. 11, 4:18 PM
- Coherus BioSciences (NASDAQ:CHRS) and co-developer Baxalta (NYSE:BXLT) announce that a Phase 3 clinical trial comparing their biosimilar candidate to Amgen's (NASDAQ:AMGN) Enbrel (etanercept), CHS-0214, in patients with moderate-to-severe rheumatoid arthritis (RA) met its primary endpoint of demonstrating equivalence to the branded product as measured by the proportion of patients achieving a 20% improvement (ACR20) in their RA symptoms. Additionally, there were no significant differences in the safety and immunogenicity profiles of the two products.
- The study was the second of two large confirmatory trials that will support regulatory applications. The first, in plaque psoriasis, was also successful.
- Enbrel is one of Amgen's top sellers, generating $5.3B in sales over the past four quarters.
- Previously: Coherus Bio and Baxalta's etanercept biosimilar on par with Amgen's Enbrel in late-stage study (Nov. 9, 2015)
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. 24, 2015, 9:45 AM
- Spark Therapeutics (ONCE) initiated with Neutral rating and $45 (1% upside) price target by Chardan Capital.
- Eyegate Pharmaceuticals (EYEG) initiated with Buy rating and $6 (115% upside) price target by Chardan Capital.
- Pfizer (PFE +0.1%), Amgen (AMGN -0.2%) and Eli Lilly (LLY -0.6%) initiated with Overweight ratings by Atlantic Equities. Price targets are $39 (20% upside), $202 (24% upside) and $100 (17% upside), respectively.
- Bristol-Myers Squibb (BMY -0.5%) initiated with Underweight rating and $57 (17% downside risk) price target by Atlantic Equities.
- Cerus (CERS +2.5%) downgraded to Neutral from Outperform by Wedbush. Price target maintained at $6.50 (6% upside).
Dec. 18, 2015, 12:18 PM
- Biogen (BIIB +0.2%) initiated with Overweight rating and $344 (16% upside) price target by Atlantic Equities.
- CVS Health (CVS -0.1%) initiated with Overweight rating and $110 (16% upside) price target by Barclays.
- Clovis Oncology (CLVS +0.9%) initiated with Buy rating and $50 (48% upside) price target by Janney.
- Relypsa (RLYP +2.6%) initiated with Buy rating and $63 (123% upside) price target by H.C. Wainwright.
- HCA Holdings (HCA -0.2%) initiated with Outperform rating and $75 (16% upside) price target; LifePoint Health (LPNT +0.4%) with an Outperform rating and $79 (13% upside) price target; Tenet Healthcare (THC +1.2%) with a Neutral rating and $33 (18% upside) price target and Universal Health Services (UHS +0.4%) with a Neutral rating and $129 (11% upside) price target by Credit Suisse.
- Amgen (AMGN -0.1%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $193 (20% upside) from $160.
- Valeant Pharmaceuticals (VRX -1.8%) downgraded to Neutral from Buy by Mizuho Securities. Price target raised to $130 (19% upside) from $111.
Dec. 18, 2015, 6:45 AM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) oncolytic immunotherapy IMLYGIC (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.
- The FDA approved it in late October.
- Previously: European Ad Comm backs Amgen's IMLYGIC for treatment of melanoma (Oct. 23)
Dec. 15, 2015, 4:13 PM
- Amgen (NASDAQ:AMGN) declares $1.00/share quarterly dividend, 26.6% increase from prior dividend of $0.79.
- Forward yield 2.46%
- Payable March 8; for shareholders of record Feb. 16; ex-div Feb. 11.
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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