Thu, Oct. 6, 3:32 PM
- Biotech investors are sitting on the sell button today. The iShares Nasdaq Biotechnology ETF (IBB -2.4%) is down on increased volume. Shares have retraced over 5% since the recent close of 300 on September 22.
- Alnylam (ALNY -48%) is leading the rout after it announced that it was dropping development of RNAi candidate revusiran.
- Representative tickers: (AMGN -0.3%)(BIIB -1.3%)(GILD -1.9%)(CELG -1.4%)(BMY)(MRK -0.7%)(PFE -1.2%)(VRTX -3%)(ALXN -2.2%)
Tue, Oct. 4, 9:20 AM
- Samsung Bioepis announces that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB3, a biosimilar to Roche's Herceptin (trastuzumab). Herceptin is a monoclonal antibody indicated for the treatment of breast cancer and gastric cancer. The MAA was submitted in August.
- SB3 is Samsung Bioepis’ fifth biosimilar candidate submitted to the EMA, following SB4 (etanercept), SB2 (infliximab), SB9 (insulin glargine) and SB5 (adalimumab). It is the company’s first oncology biosimilar candidate submitted for regulatory review in Europe.
- The marketing and distribution of SB3 in Europe will be handled by Merck (NYSE:MRK) if approved.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB).
Thu, Sep. 29, 10:39 AM
- The Japanese Ministry of Health, Labor and Welfare approves CSL Behring's IDELVION (Albutrepenonacog Alfa) for the prevention of bleeding tendency in patients with hemophilia B (factor IX deficiency). The specific approval includes routine prophylaxis, on-demand control of bleeding episodes and the perioperative management of bleeding.
- IDELVION maintains factor IX activity at an average of 20% when administered prophylactically every seven days and at an average of 12% when administered every 14 days.
- Hemophilia B-related tickers: (NASDAQ:QURE)(NASDAQ:ONCE)(NYSE:NVO)(NYSE:BAX)(NASDAQ:BIIB)(NASDAQ:DMTX)(NASDAQ:SGMO)
Wed, Sep. 28, 12:52 PM
- Micro cap Anavex Life Sciences (AVXL +44.6%) shows some heft on a healthy 14x surge in volume. Investors appear to be excited over its material transfer agreement with Biogen (BIIB -1.2%) under which the latter will test lead product candidate ANAVEX 2-73 in an oligodendrocyte precursor cell differentiation assay. If all goes well, it may lead to an in vivo study using a demyelination model, which may ultimately lead to its development for the treatment of multiple sclerosis (MS).
- The decline in remyelination in chronic MS is attributed to, at least in part, inadequate oligodendrocyte precursor cell migration, a process governed by the extracellular matrix. Oligodendrocytes are responsible for generating myelin, the fatty insulating sheath around nerve fibers. MS is an inflammatory disorder that results in the loss of myelin which disrupts the ability of nerves to conduct electrical impulses to and from the brain.
- Anavex 2-73, an orally available sigma-1 receptor (S1R) agonist, is currently being developed/investigated for the treatment of Alzheimer's disease and Parkinson's disease. S1R plays a key role in modulating neurotransmission.
Tue, Sep. 27, 9:17 AM
- Shire plc (NASDAQ:SHPG) terminates its collaboration agreement with Momenta Pharmaceuticals (NASDAQ:MNTA) to develop and commercialize M923, a biosimilar to AbbVie's (NYSE:ABBV) HUMIRA (adalimumab). It made the decision after an assessment of its product portfolio following the Baxalta acquisition.
- Under the terms of the 2011 collaboration agreement between Baxalta and Momenta, the deal will terminate 12 months following the formal notice. Shire will continue to fund the M923 program until then, although preparations to transfer all clinical, regulatory and commercialization activities to Momenta will begin immediately.
- Momenta better get busy. The FDA just approved Amgen's (NASDAQ:AMGN) version and Samsung Bioepis' version, to be marketed by Biogen (NASDAQ:BIIB), is under regulatory review in Europe. Germany's Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) is also in the mix. Indian outfit Cadila Healthcare launched its HUMIRA biosimilar in India in September 2014.
Mon, Sep. 26, 10:47 AM
- Biogen (BIIB -0.7%) finalizes the rolling submission of its New Drug Application (NDA) with the FDA seeking approval of nusinersen for the treatment of spinal muscular atrophy (SMA) along with a request for Priority Review which, if granted, will shorten the review clock to six months from the usual 10 months.
- The company plans to file a marketing application in Europe in the coming months.
- SMA is an inherited disorder characterized by the loss of motor neurons in the spinal cord and lower brain stem, leading to severe and progressive muscular atrophy and weakness. It is caused by a defect in or loss of the SMN1 gene which results in the insufficient production of survival motor neuron protein, essential for maintenance of motor neurons.
- Nusinersen is an antisense drug designed to correct the splicing defect that causes SMA by increasing the production of fully functional SMN protein. Biogen licensed it from Ionis Pharmaceuticals (IONS -1.3%) under their 2012 collaboration agreement. If approved, Ionis could earn up to $225M in total milestones in addition to mid-teen royalties.
Fri, Sep. 16, 5:43 PM
- Perrigo (NASDAQ:PRGO) is exploring a sale of the royalties from its multiple sclerosis drug Tysabri, possibly to privately held Royalty Pharma, Reuters reports.
- The royalty divestment is one of the actions requested by Starboard Value earlier this week when it disclosed a 4.6% stake in PRGO, but the company had been exploring a sale of Tysabri royalties before Starboard's proposals, according to the report.
- Tysabri is marketed through a partnership with Biogen (NASDAQ:BIIB), which paid more than $300M in royalties to PRGO last year and could be worth ~$2.8B in a sale, RBC Capital says.
Tue, Sep. 13, 8:59 AM
- Thinly traded micro cap Applied Genetic Technologies (NASDAQ:AGTC) is down 29% premarket on light volume in response to its earnings announcement yesterday after the close.
- Revenues for fiscal Q4 and fiscal 2016 were up nicely due to its collaboration with Biogen (NASDAQ:BIIB), but investors are hitting the sell button in response to its disclosure of slower-than-expected enrollment in the Phase 1/2 study of lead gene therapy candidate XLRS for the treatment of X-linked retinoschisis. The company says the delays stem from patients not meeting one or more eligibility criteria so it intends to expand the number of clinical trial sites. It also reports that mild-to-moderate ocular inflammation has been observed in most of the study participants which has been resolved by stopping treatment with XLRS or after treatment with topical or oral corticosteroids. AGTC has amended the study protocol to include the use of prophylactic corticosteroids which, in turn, required institutional review board approvals. This also contributed to the delay in patient recruitment. And, finally, there were apparently vendor errors that required the re-testing of the study drug for a process component. The product met all specifications but the company has established several backup vendors as well as internal testing capabilities to ensure uninterrupted supply.
Fri, Sep. 9, 9:59 AM
- Eli Lilly (NYSE:LLY) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $95 (20% upside) from $92.
- Ligand Pharmaceuticals (NASDAQ:LGND) upgraded to Hold from Sell by Deutsche Bank. Price target raised to $110 (2% downside risk) from $105.
- Gilead Sciences (NASDAQ:GILD) upgraded to Buy from Hold by Jefferies. Price target raised to $91 (16% upside). Morgan Stanley rates it Hold with a price target of $100 (27% upside).
- Teva Pharmaceutical Industries (NASDAQ:TEVA) upgraded to Outperform from Market Perform with a $66 price target by Oppenheimer.
- Novo Nordisk (NYSE:NVO) downgraded to Neutral from Overweight by JPMorgan.
- AbbVie (NYSE:ABBV) downgraded to Neutral from Overweight with a $73 (14% upside) price target by JPMorgan.
- Cepheid (NASDAQ:CPHD) downgraded to Neutral from Buy by BTIG Research.
- Tonix Pharmaceuticals (NASDAQ:TNXP) downgraded to Neutral from Buy by Roth Capital.
- Momenta Pharmaceuticals (NASDAQ:MNTA) downgraded to Sell from Hold with a $6 (48% downside risk) price target by Maxim Group.
- Biogen (NASDAQ:BIIB) downgraded to Hold from Buy with a $323 (7% upside) price target by Jefferies.
- Centene (NYSE:CNC) downgraded to Market Perform from Outperform with an $80 (19% upside) price target by Leerink Swann. Wedbush rates it Outperform with an $85 (26% upside) price target.
Fri, Sep. 2, 1:19 PM
- In a factsheet just published on Presidential candidate Hillary Clinton's website, she outlines her plan to reign in rogue drug companies who aggressively increase the prices of their medicines.
- Her plan features three methods for containing runaway drug costs: make alternatives available and increase competition; enable emergency importation of safe treatments and fine drug firms for unjustified price increases.
- Her first action, as President, will be to create a dedicated group of representatives from Federal agencies that oversee health and safety and fair competition that will be charged with protecting consumers from "outlier" price increases. The group will establish criteria for determining if a price increase is justified for a long-available treatment and investigate and consider enforcement in certain situations.
- In cases where the level of competition is light, her plan will enable the emergency purchases of alternative versions and make them available to patients in need while encouraging competition from additional suppliers.
- She also calls for legislation to safely and securely import drugs from foreign nations whose regulatory regimes are as robust as the FDA, with the proviso of a "careful review" by the agency (more temporary than permanent).
- In cases where miscreant drug firms are fined, the funds will be used to support new programs to make lower-cost alternatives available and speed up approvals in order to beef up competition (specifics are not provided).
- In her broader plan to lower prescription drug costs for all Americans, she proposes a cap on out-of-pocket costs, additional funding to support the clearing of the FDA's backlog of generic drug applications, prohibit "pay for delay" deals (long overdue), a moratorium on direct-to-consumer advertising and allowing Medicare to negotiate drug and biologic prices.
- Representative tickers: (NASDAQ:IBB)(NASDAQ:AMGN)(NASDAQ:BIIB)(NASDAQ:GILD)(NASDAQ:CELG)(NYSE:BMY)(NYSE:ABT)(NYSE:MRK)(NYSE:PFE)(NASDAQ:MYL)(NYSE:VRX)(NASDAQ:TEVA)(NASDAQ:PRGO)(NYSE:AGN)
Thu, Sep. 1, 4:37 PM
- The FDA designates Biogen's (NASDAQ:BIIB) investigational Phase 3-stage aducanumab for Fast Track review for the treatment of early-onset Alzheimer's disease.
- Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
- Aducanumab is a human recombinant monoclonal antibody derived from a library of B cells collected from healthy elderly subjects with no signs of cognitive impairment. In a Phase 1b study, patients receiving aducanumab showed a statistically significant reduction in beta amyloid in the brain. It is being developed under a global deal with Neurimmune inked in November 2007.
Wed, Aug. 24, 3:08 PM
- She's at it again. Democratic nominee for President Hillary Clinton takes a dim view of Mylan's (MYL -5.4%) bullish pricing for its EpiPen (epinephrine injection), an auto-injector used to treat allergic reactions in an emergency. The company has raised the price five-fold since 2007.
- In a statement, she says, "Over the last several years Mylan Pharmaceuticals has increased the price of EpiPens by more than 400%. They're now charging up to $600 for a two-EpiPen set that must be replaced every 12 - 18 months. This both increases out-of-pocket costs for families and first responders and contributes to higher premiums for all Americans and their employers. This is outrageous - and it's just the latest troubling example of a company taking advantage of its customers. I believe our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it's wrong when drug companies put profits ahead of patients, raising pricing without justifying the value behind them. I am calling on Mylan to immediately reduce the price of EpiPens."
- Her comments have stoked selling in the biotech/pharma sector, just like it did when Ms. Clinton had Valeant Pharmaceuticals (VRX -1.3%) in her sights a few months ago.
- Previously: Mylan slumps on senator's inquiry into EpiPen price hikes (Aug. 23)
- Representative tickers: (IBB -2.6%)(AMGN -1.8%)(VRX -1.3%)(BIIB -2.5%)(PFE -0.6%)(BMY -1.9%)(MRK -1.2%)(GILD -1%)(AGN -3%)
Wed, Aug. 3, 12:17 PM
- The report from David Faber echoes one from the network's Meg Tiffell last night, but perhaps with more conviction.
- As for Merck (MRK -1.4%) - also rumored to have interest in Biogen (NASDAQ:BIIB) - Faber has nothing new to report.
- Biogen is lower by 4% today, but remains about 5% higher than the price it was at prior to yesterday's WSJ report of buyout interest.
- Allergan (AGN +1.7%)
Tue, Aug. 2, 5:32 PM
- Lumped in with Merck earlier on chatter that it would consider taking over Biogen (NASDAQ:BIIB), Allergan (NYSE:AGN) is unlikely to pursue such a deal, CNBC biotech/pharma reporter Meg Tirrell says.
- Biogen -- which finished the day up 9.4% after earlier news broke -- is down 2.5% after hours. Allergan, meanwhile, has turned up 0.5% in the late session after declining 1.6% today.
- Biogen saw its market cap rise to just over $75B today. It's looking for a new chief after CEO George Scangos said last month he was departing following six years in the post.
Tue, Aug. 2, 2:46 PM
- Biogen (NASDAQ:BIIB) has jumped 5.6% into a trading halt as chatter centers on a potential takeout from Allergan (NYSE:AGN) or Merck (NYSE:MRK).
- IShares Nasdaq Biotech index (NASDAQ:IBB) jumped from the red to a 0.8% gain.
- Biogen might not go for a deal, but the two suitors have tested the waters, the WSJ reports.
- The company's worth more than $68B, setting up what could be the sector's next blockbuster deal.
- Updated 2:51 p.m.: Back on the move, Biogen is now up 7.3%.
Mon, Aug. 1, 11:18 AM
- Leerink analyst Geoffrey Porges weighs in on the big rally in Biogen (BIIB +5.3%) after the company announced positive news on commercializing the spinal muscular atrophy trial with Ionis Pharmaceuticals (IONS +38.3%).
- Snippets from Porges' note are posted below.
- "We currently estimate global revenues of nusinersen of $123mm in 2017 increasing to $2.1bn in 2022, currently adjusted by a probability-of-success of 65% in our Biogen company model."
- "We estimate that there are currently (2016) a combined (Types I-IV) 9,800 patients in the US with 544 Type I; our revenue estimates reflect treatment of ~520 total patients in 2017 growing to 5,500 in 2022."
- "Our revenue forecasts require significant adoption in patients with later onset forms of the disease, in addition to the Type I patients included in this initial study."