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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
Dec. 14, 2015, 5:41 PM
Dec. 14, 2015, 5:01 PM
- In a regulatory filing, Coherus BioSciences (NASDAQ:CHRS) reports that it received a $35M milestone payment from development partner Baxalta (NYSE:BXLT) triggered by the successful achievement of certain manufacturing process goals for CHS-0214, the company's biosimilar candidate to Amgen's (NASDAQ:AMGN) Enbrel (etanercept).
- Several Phase 3 studies should wind up in 2016, followed by global regulatory submissions.
- Previously: Coherus Bio and Baxalta's etanercept biosimilar on par with Amgen's Enbrel in late-stage study (Nov. 9)
Dec. 14, 2015, 4:52 PM
- Amgen (NASDAQ:AMGN) reacquires the rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries in Asia, South America, Europe, and other regions from GlaxoSmithKline (NYSE:GSK). The deal includes the new territories of Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand.
- GSK has owned the rights to Prolia and XGEVA since 2009 and Vectibix since 2010 under a license from Amgen. Total sales of the three in 2014 were $111M.
- Under the terms of the new agreement, Amgen will pay GSK undisclosed milestone payments upon signing and on the successful transition of the products back to Amgen. The majority of markets should transition back to Amgen within 12 months. The transaction is expected to be accretive to non-GAAP earnings in 2017.
Dec. 11, 2015, 7:48 AM
- Sanofi (NYSE:SNY) and Regeneron (NASDAQ:REGN) edge out Amgen (NASDAQ:AMGN) for preferred access status for their PCSK9 inhibitor Praluent (alirocumab) in UnitedHealth Group's (NYSE:UNH) OptumRx and UnitedHealthcare for Commercial, Medicare and Managed Medicaid patients. Praluent is now on formularies covering more than 100M patients in the U.S., including Express Scripts and Aetna.
- Amgen's Repatha (evolocumab) is the preferred offering in CVS Health and the exclusive PCSK9 inhibitor for members of Harvard Pilgrim Health System. Express Scripts offers it as well. Patients covered in UnitedHealth's Oxford unit can transition to Repatha if a 12-week regimen of Praluent fails to do the job.
- Previously: Repatha and Praluent go toe-to-toe in PBMs (Dec. 1)
Dec. 10, 2015, 1:31 PM
- A Florida district court grants Amgen (AMGN +1.5%) a preliminary injunction against Toronto, Canada-based Apotex preventing it from launching its biosimilar of Neulasta (pegfilgrastim) for 180 days. Judge James Cohn based his ruling on his interpretation of the Biologics Price Competition and Innovation Act which stipulates that biosimilar makers give the brand holder 180 days notice before bringing their knockoff to market. This provides sufficient time for the original developer to determine if any of its patents are being infringed.
- The same ruling delayed Novartis (NVS +1.4%) from launching Zarxio (filgrastim-sndz). Its U.S. launch commenced in September, six months after being cleared by the FDA.
- Previously: Novartis launches Zarxio in the U.S. (Sept. 3)
- Previously: FDA clears first biosimilar (March 6)
Dec. 5, 2015, 6:57 PM
- Amgen (NASDAQ:AMGN) submits a Variation to the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking clearance for the use of Kyprolis (carfilzomib), in combination with the corticosteroid dexamethasone, in adult multiple myeloma (MM) patients who have received at least one prior therapy.
- The data supporting the application was generated in the Phase 3 ENDEAVOR study that showed patients treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to patients who received Takeda's (OTCPK:TKPHF)(OTCPK:TKPYY) Velcade (bortezomib) plus dexamethasone (18.7 months versus 9.4 months, respectively)(p<0.0001).
- The most common treatment-related adverse events (>25%) were diarrhea, anemia, fatigue, dyspnea (difficulty breathing), pyrexia (high temperature) and insomnia.
- Kyprolis is currently approved in Europe for the treatment of MM, in combination with lenalidomide [Celgene's (NASDAQ:CELG) REVLIMID] and dexamethasone, in patients who have relapsed after receiving at least one prior line of therapy.
- Previously: Amgen's Kyprolis cleared in Europe for combo treatment of multiple myeloma (Nov. 19)
Dec. 4, 2015, 9:06 AM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) announce a cancer immunotherapy collaboration to support an open-label Phase 1b/3 clinical trial assessing the combination of BLINCYTO (blinatumomab) and KEYTRUDA (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL).
- Amgen's BLINCYTO is a CD19 bispecific T cell engager (BiTE) that helps the body's immune system to detect and attack malignant cancer cells. The modified antibodies are designed to engage two different targets simultaneously thereby juxtaposing T cells to cancer cells and triggering apoptosis (cell death). Merck's KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
- The companies will also collaborate to support an open-label Phase 1/2 study of the combination of KEYTRUDA and Amgen's AMG 820, an anti-colony-stimulating factor 1 receptor (CSF1R) antibody, in patients with select advanced solid tumors. AMG 820 is a fully human antagonistic IgG2 monoclonal antibody that binds to CSF1R. It helps the body's immune system fight cancer by decreasing the function of tumor-associated white blood cells called macrophages.
Dec. 4, 2015, 7:27 AM
- Amgen (NASDAQ:AMGN) submits its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, its biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab) which is cleared in a range of countries around the world for the treatment of various inflammatory diseases.
- The company submitted in Biologics License Application (BLA) to the FDA on November 25.
- Previously: Amgen submits first BLA for Humira biosimilar (Nov. 25)
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