Actavis Generics: A 2-Year Ticket To Insolvency?
Graham Osborn • 49 Comments
Graham Osborn • 49 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Wed, Oct. 5, 11:21 AM
- Slingshot Insights is hosting an exert interview today at 2:00 pm ET focused on non-alcoholic steatohepatitis (NASH), a sizable market opportunity for drug makers that many call the "next hepatitis C." The space has heated up recently stoked by Allergan's (NYSE:AGN) $1.7B takeout of Tobira Therapeutics (NASDAQ:TBRA) and $50M acquisition of privately held Akarna Therapeutics.
- SA subscribers should use their 90-day coupon code SA_Sub16.
- NASH-related tickers: (NYSE:PFE)(NASDAQ:GALT)(NASDAQ:BLRX)(NASDAQ:GLMD)(NASDAQ:CNAT)(NASDAQ:MNOV)(NASDAQ:RGLS)(NASDAQ:ICPT)(NASDAQ:SHPG)(NYSEMKT:CANF)(NASDAQ:VBLT)(OTCPK:ISLT)(OTCPK:GNFTF)(NASDAQ:GILD)
Mon, Oct. 3, 4:40 AM
- AstraZeneca (NYSE:AZN) has signed a deal with Allergan (NYSE:AGN) where the latter will pay up to $1.52B for rights to an antibody for Crohn's disease.
- Allergan pays $250M up front, but it might also make payments worth up to $1.27B over a period of up to 15 years, tied to potential sales of the antibody, MEDI2070 -- an anti-IL-23 monoclonal antibody, currently in Phase IIb clinical development.
- That includes launch milestone payments of up to $435M and sales-based milestones of $725M along with tiered royalties. The deal comes via AstraZeneca's global biologics research and development unit.
- AZN is up 0.5% premarket.
Fri, Sep. 30, 3:45 PM
- Depomed (DEPO +4.5%) perks up on increased volume in response to the news that a court has issued an an injunction against potential competitor Allergan (AGN +0.1%) from selling a generic version of NUCYNTA (tapentadol). Actavis (TEVA -0.2%) and Roxane have also lost bids to invalidate NUCYNTA patents, which are valid until 2022 to 2028.
- In the first half of 2016, NUCYNTA products accounted for almost 64% of the company's product sales ($141.3M/221.1M).
Thu, Sep. 22, 11:30 AM
- Thinly traded nano cap Galmed Pharmaceuticals (GLMD +13.1%) enjoys the NASH rally stoked by Allergan's (AGN +1.7%) generous acquisition of Tobira Therapeutics (TBRA +0.9%). Shares have rallied over 46% in a week.
- Today, the company announced that it inked an agreement with the UC-San Diego School of Medicine to conduct a Phase 1/2 study, ARTISAN, assessing Aramchol in a juvenile population with nonalcoholic fatty liver disease (NAFLD). The trial is expected to commence in H1 2017.
- Aramchol, a conjugate of cholic acid and arachidic acid, is in Phase 2 development for the treatment of non-alcoholic steatohepatitis (NASH).
- There is a first-to-market horse race among drug developers for a NASH treatment considering it affects ~5% of Americans. As many as 20% have a milder condition known as "fatty liver."
Thu, Sep. 22, 10:45 AM
- Buoyed in large part by the FDA's approval of Sarepta Therapeutics' (SRPT +4.4%) Exondys 51 for Duchenne muscular dystrophy and Allergan's (AGN +1.9%) over-the-top acquisition of NASH player Tobira Therapeutics (TBRA +0.6%), money flow has turned decidedly bullish for biotechs. On a technical basis, the iShares Nasdaq Biotechnology ETF (IBB +0.6%) is poised for a breakout through 300, a healthy 25% turnaround from the low of ~240 in June.
- There is a laundry list of leaders in the rally, including bluebird bio (BLUE -0.1%), Clovis Oncology (CLVS +5.4%), Puma Biotechnololgy (PBYI +3.8%), Aerie Pharmaceuticals (AERI -2.1%) and CoLucid Pharmaceuticals (CLCD -3.7%).
Wed, Sep. 21, 1:04 PM
- As previously reported, Bayer (OTCPK:BAYRY) aims to jettison its dermatology business in order to help fund its Monsanto buy. Although discussions are in the early phase, there appears to be plenty of interested parties. In addition to skincare-focused players like Allergan (NYSE:AGN), Almirall (OTC:LBTSF) and Nestle (OTCPK:NSRGY)(OTCPK:NSRGF), Teva Pharmaceutical Industries (NASDAQ:TEVA), Perrigo (NASDAQ:PRGO) and Sun Pharma (OTC:SMPQY) are also reportedly in the mix.
- On the institutional investor side, KKR (NYSE:KKR), Nordic Capital, Bain Capital, Blackstone Group (NYSE:BX) and Cinven may also be eyeing the unit which, analysts say, could fetch $1.1B.
- Previously: Bloomberg: Bayer eyes sale of $1.1B dermatology business (Sept. 8)
Wed, Sep. 21, 11:20 AM
- The SEC just charged Leon Cooperman with insider trading over Atlas Pipeline Partners, and Omega holdings such as Alitsource Portofolio, Navient, Aercap, and Tribune Media have knee-jerked sharply lower.
- A check of other top Omega holdings: First Data (FDC -1.3%), Allergan (AGN -0.9%), AIG (AIG +0.4%), Walgreens (WBA -0.6%), Dow Chemical (DOW), United Continental (UAL -0.7%), Ashland (ASH +0.3%), Chimera Investment (CIM -0.4%), Motorola (MSI +0.1%), HRG Group (HRG -1%), Microsoft (MSFT +1%), E*Trade (ETFC), New Residential (NRZ -1%), OneMain Holdings (OMF -2.3%), PVH (PVH +0.4%), UnitedHealth (UNH +0.7%), MGM Resorts (MGM -0.5%), New Media (NEWM -1.9%), Dish Network (DISH +0.5%), Synchrony Financial (SYF +1%), Eastman Chemical (EMN +0.3%).
- Previously: Cooperman holdings head south after insider trading charge (Sept. 21)
- Previously: Leon Cooperman charged with insider trading (Sept. 21)
Tue, Sep. 20, 4:39 PM
- Allergan (NYSE:AGN) reinforces its commitment to the NASH space with its second acquisition in a day. It has acquired privately held Akarna Therapeutics for $50M in upfront cash plus unspecified milestones.
- Akarna develops small molecule drugs for the treatment of inflammatory and fibrotic diseases. Its lead product candidate is AKN-083, a preclinical-stage FXR agonist in development for the treatment of NASH. FXR (farnesoid X receptor) is a master regulator of carbohydrate and lipid metabolism, bile-acid homeostasis, inflammation and fibrosis. FXR agonists reduce the expression of certain genes that control the synthesis of triglycerides in liver cells. They reduce liver steatosis (infiltration of liver cells with fat), lower the release of free fatty acids from fat tissue and reduce their uptake by the liver and improve tissues' responsiveness to insulin.
- Allergan announced its takeover of Tobira Therapeutics (NASDAQ:TBRA) this morning.
Tue, Sep. 20, 3:20 PM
- H.C. Wainwright analyst Ed Arce is doing a bit of chest thumping today after his bullish call on Tobira Therapeutics (TBRA +722.8%) paid off in spades when Allergan (AGN -2.2%) announced its intent to acquire the company for up to $1.7B. He raised his price target on the tiny biotech to $31 last month based his confidence that NASH candidate cenicriviroc will be successful in late-stage studies. TBRA shares plummeted to a low of $3.76 on August 2 after the company released the results from a failed mid-stage trial that used an endpoint that the company said will not be necessary to support regulatory applications. The trial met the endpoint that will be used in Phase 3 studies.
- In an interview with StreetInsider, Mr. Arce said he likes other players in the NASH space, specifically Galectin Therapeutics (GALT +13.8%), with top-line data from a mid-stage study of NASH candidate GR-MD-02 due this month, and Conatus Pharmaceuticals (CNAT +20.6%), with lead candidate emricasan about to enter a Phase 2 trial using Exalenz Biosciences' BreathID Methacetin Breath Test to monitor patients during the study.
- GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a protein that plays a key role in the pathogenesis of fatty liver disease and fibrosis.
- Emricasan inhibits a family of enzymes that modulate essential cellular functions called caspases. The functions include those involved in apoptosis and inflammation. Caspases 3 and 7 are major players in apoptosis. These enzymes cleave a key protein called CK18 (cytokeratin-18), part of which is the small fragment cCK18, which correlates to the magnitude of hepatocyte apoptosis. Emricasan inhibits apoptosis regardless of the stimuli that causes it.
- Mr. Arce has an $8 (315% upside) price target on GALT and $15 (608% upside) on CNAT, both rated Buy.
Tue, Sep. 20, 8:52 AM
- Once investors catch their collective breath over Allergan's (NYSE:AGN) wildly bullish takeout of Tobira Therapeutics (NASDAQ:TBRA), they may want to keep an eye on other NASH players. Some, of course, have more credibility than others.
- Premarket movers: MediciNova (NASDAQ:MNOV) +3.3%; Regulus Pharmaceuticals (NASDAQ:RGLS) +3.1%; Intercept Pharmaceuticals (NASDAQ:ICPT) +6.0%; Conatus Pharmaceuticals (NASDAQ:CNAT) +38.3%; Galectin Therapeutics (NASDAQ:GALT) +24.0%; Shire plc (NASDAQ:SHPG): +1.0%; Can-Fite BioPharma (NYSEMKT:CANF) +23.1%.
- Others: Galmed Pharmaceuticals (NASDAQ:GLMD); Vascular Biogenics (NASDAQ:VBLT); Islet Sciences (OTCPK:ISLT); Genfit (OTCPK:GNFTF).
Tue, Sep. 20, 8:23 AM
- Allergan (NYSE:AGN) inks an agreement to acquire nano cap Tobira Therapeutics (NASDAQ:TBRA) for $28.35 in upfront cash, a whopping six-fold premium to yesterday's close of $4.74. The potential consideration paid to TBRA shareholders could rise to $1.695B based on the successful completion of certain milestones [up to $49.84 in Contingent Value Rights (CVRs)] related to Tobira's lead product candidate cenicriviroc, in development for the treatment of non-alcoholic steatohepatitis (NASH).
- The extraordinary premium is even more surprising considering the failure of cenicriviroc in an earlier NASH study, although the company said the primary endpoint would not be required to support a marketing application. Allergan clearly agrees.
- Cenicriviroc is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis.
- Previously: Tobira's lead product candidate flunks mid-stage NASH study; shares plummet 54% premarket (July 25)
- Update: Allergan will host a conference call tomorrow, September 21, at 8:30 am ET to discuss the transaction and other recent R&D acquisitions.
Tue, Sep. 20, 8:02 AM| Tue, Sep. 20, 8:02 AM | 5 Comments
Wed, Sep. 14, 8:27 AM
- Allergan plc (NYSE:AGN) inks a deal to acquire Vitae Pharmaceuticals (NASDAQ:VTAE) for ~$639M in cash or $21 a share, almost a 160% premium to yesterday's close of $8.10.
- The transaction beefs up Allergan's dermatology pipeline with the addition of VTP-43742, a retinoic acid receptor-related orphan receptor gamma inhibitor for the treatment of psoriasis and other autoimmune disorders and VTP-38543, a topical Liver X receptor beta selective agonist for the treatment of atopic dermatitis.
- The deal should close by year end.
- Read now Vitae Pharmaceuticals: Go Long?
Thu, Sep. 8, 2:11 PM
- Monsanto (MON +1.3%) moves higher following a Bloomberg report that Bayer (OTCPK:BAYRY) is exploring the sale of its dermatology business, as the German company seeks to sell peripheral businesses to boost its pursuit of MON.
- The business could attract interest from existing makers of skincare products such as Nestle’s (OTCPK:NSRGY, OTCPK:NSRGF) Galderma, Allergan (NYSE:AGN) and Almirall (OTC:LBTSF) of Spain, as well as P-E firms, according to the report.
- Analysts say a sale of the unit could fetch more than €1B ($1.1B).
Tue, Sep. 6, 9:36 AM
- Allergan (AGN +0.5%) acquires Ann Arbor, MI-based RetroSense Therapeutics for $60M in upfront cash plus milestones related to lead product candidate RST-001, a gene therapy for the potential treatment of retinitis pigmentosa, an inherited disorder characterized by the gradual loss of vision due to retinal degradation. It affects ~100K Americans.
- RST-001 potentially restores vision via the use of a photosensitivity gene called channelrhodopsin-2 which creates new photosensors in retinal ganglion cells.
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)