• Today, 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.
    | Today, 9:17 AM | 6 Comments
  • Tue, Sep. 20, 4:20 PM
    • Shire plc (NASDAQ:SHPG) has apparently lost its enthusiasm for myelofibrosis candidate pacritinib after mixed results in a mid-stage study. Also dampening the mood was a full clinical hold imposed by the FDA in February due to excessive deaths in the test group due to intracranial hemorrhage, cardiac failure and cardiac arrest.
    • Shire inherited the program by way of the Baxalta deal. Baxter International (NYSE:BAX) inked a collaboration with discoverer CTI BioPharma (NASDAQ:CTIC) in 2013 to develop the oral tyrosine kinase inhibitor for certain blood-related cancers. Baxter paid CTI $60M upfront and up to $112M in milestones for the privilege.
    • According to a regulatory filing by CTIC, the companies have entered into a non-binding term sheet regarding the termination of the collaboration agreement and the return of pacritinib to CTIC.
    | Tue, Sep. 20, 4:20 PM | 6 Comments
  • 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, 8:52 AM | 24 Comments
  • Tue, Sep. 20, 6:45 AM
    • Shire plc (NASDAQ:SHPG) prices its public offering of $12.1B of senior notes. Proceeds will fund the repayment of its January 2016 bridge loans that were used to finance the Baxalta transaction and for general corporate purposes.
    • There are four series:
    • $3.3B 1.900% Senior Notes due 2019.
    • $3.3B 2.400% Senior Notes due 2021.
    • $2.5B 2.875% Senior Notes due 2023.
    • $3.0B 3.200% Senior Notes due 2026.
    • The notes should be issued on September 23.
    | Tue, Sep. 20, 6:45 AM
  • Mon, Sep. 19, 6:55 PM
    • Saying "we tried to be reasonable,", Sarepta Therapeutics (NASDAQ:SRPT) CEO Dr. Edward Kaye announces that the annual price of Exondys 51 (eteplirsen) will be ~$300K, apparently a lower price than some analysts predicted for the rare disease drug.
    • The cost is comparable to Vertex Pharmaceuticals' (NASDAQ:VRTX) cystic fibrosis med Orkambi (ivacaftor/lumacaftor), but less than Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab), BioMarin Pharmaceutical's (NASDAQ:BMRN) Naglazyme (galsulfase) and Vimizim (elosulfase alfa) and Shire's (NASDAQ:SHPG) Elaprase (idursulfase).
    • CureDuchenne advocacy group rep Debra Miller says, "Considering the cost of manufacturing, delivering and supporting patients (financial assistance programs), not to mention development costs over a decade, I don't think it's too much." Payer reimbursement should commence in no more than 90 days.
    | Mon, Sep. 19, 6:55 PM | 47 Comments
  • Sat, Sep. 17, 5:33 PM
    • The U.S. District Court for the District of Delaware rules in favor of would-be generic competitor Cadila Healthcare Ltd./Zydus Pharmaceuticals in Shire plc's (NASDAQ:SHPG) lawsuit alleging infringement of its U.S. Patent No. 6,773,720 covering ulcerative colitis med Lialda (mesalamine).
    • Despite the ruling that Cadila's abbreviated New Drug Application (ANDA) does not infringe on the '720 patent, Shire isn't giving up the fight. An appeal is forthcoming.
    • Lialda accounts for ~9% of Shire's product sales.
    • Cadila is headquartered in Western India. Zydus is its U.S. division.
    | Sat, Sep. 17, 5:33 PM | 1 Comment
  • Wed, Sep. 14, 8:57 AM
    • The FDA approves Shire plc's (NASDAQ:SHPG) CUVITRU [Immune Globulin Subcutaneous (Human) 20% Solution] for the treatment of adult and pediatric patients at least two years old with primary immunodeficiency (PI), a group of over 300 genetic disorders in which the body's immune system fails to work properly. It affects ~6M people worldwide.
    • CUVITRU can be infused up to 60 mL per site and 60 mL per hour which minimizes infusion sites and durations.
    • Shire now has the broadest portfolio of intravenous and subcutaneous immunoglobulin (IG) products, including the only once-per-month subcutaneous treatment option.
    | Wed, Sep. 14, 8:57 AM
  • Thu, Aug. 18, 8:46 AM
    • Raptor Pharmaceuticals (NASDAQ:RPTP) is ahead 16% premarket on robust volume on the buzz that several companies are eyeing the Novato, CA firm, including Shire plc (NASDAQ:SHPG) who alleged has already bid $800M and Retrophin (NASDAQ:RTRX), founded by biotech bad boy Martin Shkreli.
    • Raptor focuses its development efforts in rare diseases. Its pipeline includes programs in Huntington's disease, cancer, cystic fibrosis and mitochondrial diseases.
    • It currently markets two products: PROCYSBI (cysteamine bitartrate) delayed-release capsules for nephropathic cystinosis and QUINSAIR (aerosolized form of levofloxacin) for the management of chronic pulmonary infections.
    | Thu, Aug. 18, 8:46 AM | 2 Comments
  • Tue, Aug. 2, 10:35 AM
    • Shire PLC (SHPG +3.8%) Q2 results: Revenues: $2,429.1M (+56.0%); Operating Income: $96.2M (-27.5%); Net Income: $86.6M (-47.2%); EPS: $0.12 (-57.1%); Non-GAAP EPS: $3.38 (+28.5%); Quick Assets: $693.4M; CF Ops: $590.9M (+30.6%).
    • 2016 Guidance: Total Product Sales: $10.8 - 11B; Royalties & Other Revenues: $490M - 530M; GAAP EPS: ($0.40) - $0.00; Non-GAAP EPS: $12.70 - 13.10.
    | Tue, Aug. 2, 10:35 AM | 1 Comment
  • Tue, Aug. 2, 7:15 AM
    • Shire PLC (NASDAQ:SHPG): Q2 EPS of $3.38 beats by $0.39.
    • Revenue of $2.43B (+55.8% Y/Y) beats by $220M.
    • Shares +4.1% PM.
    • Press Release
    | Tue, Aug. 2, 7:15 AM
  • Mon, Aug. 1, 5:30 PM
  • Mon, Jul. 25, 7:08 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merrimack Pharmaceuticals (NASDAQ:MACK) and commercialization partner Shire plc's (NASDAQ:SHPG) ONIVYDE (irinotecan liposome injection), in combination with the chemo  agents fluorouracil (5-FU) and leucovorin, for the treatment of patients with metastatic pancreatic adenocarcinoma  who have progressed after gemcitabine-based therapy.
    • The positive opinion was based on the Phase 3 NAPOLI-1 study that showed pancreatic cancer patients treated with ONIVYDE plus 5-FU and leucovorin achieved overall survival of 6.1 months compared to 4.2 months for those receiving 5-FU and leucovorin alone (p=0.012) with a 33% reduction in the risk of death (hazard ratio: 0.67). One in four patients treated with the ONIVYDE regimen survived at least one year.
    • ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
    • Shire has global development and commercialization rights to ONIVYDE except the U.S. and Taiwan.
    • The FDA approved ONIVYDE for this indication in October 2015.
    • A final decision from the European Commission usually takes ~60 days.
    | Mon, Jul. 25, 7:08 AM | 2 Comments
  • Wed, Jul. 20, 7:02 AM
    • Privately held Chronos Therapeutics Ltd. acquires three pre-clinical programs targeting central nervous system (CNS) diseases from a subsidiary of Shire plc (NASDAQ:SHPG).
    • Under the terms of the agreement, Chronos secures global rights to develop and commercialize programs focused on multiple sclerosis, addictive behaviors and potentially post-traumatic stress disorder. Additional indications may also be possible. Shire will receive milestone payments and royalties on net sales. It will also establish an equity stake in Chronos.
    • Shire has the right of first negotiation for each program on commercial terms and the right to reacquire each if Chronos fails to invest a prespecified minimum amount.
    • Specific financial terms are not disclosed.
    | Wed, Jul. 20, 7:02 AM | 2 Comments
  • Tue, Jul. 12, 9:24 AM
    | Tue, Jul. 12, 9:24 AM
  • Tue, Jul. 12, 8:21 AM
    • The FDA approves Shire plc's (NASDAQ:SHPG) Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. It is the first prescription eye drop indicated for the treatment of both signs and symptoms of this condition. U.S. market launch should commence in Q3.
    • The clinical program supporting the approval of Xiidra is the largest for an investigational-stage dry eye disease candidate to date, including more than 2,500 patients.
    • The safety and efficacy of Xiidra was studied in 1,181 patients (of which 1,067 patients received lifitegrast 5%) in four placebo-controlled 12-week trials. Each of the four studies assessed the effect of Xiidra on both the signs and symptoms of dry eye disease at baseline, week 2, 6 and 12.
    • Shares are up 5% pre-market on robust volume.
    | Tue, Jul. 12, 8:21 AM | 4 Comments
  • Fri, Jul. 1, 10:13 AM
    • Aldyra Therapeutics (NASDAQ:ALDX) initiated with Buy rating and $16 (158% upside) price target by Stifel Nicolaus.
    • Shire plc (NASDAQ:SHPG) re-initiated with Buy rating and 6300p (36% upside) price target by Goldman Sachs.
    • Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $16 (129% upside) price by Baird.
    • Ultragenyx (NASDAQ:RARE) initiated with Buy rating and $72 (41% upside) price target by Bank of America.
    • NantHealth (NASDAQ:NH) initiated with Buy rating and $17 (36% upside) price target by Canaccord Genuity. First Analysis rates it Overweight with an $18 (44% upside) price target. Cowen and Company rates it Outperform with a $19 (52% upside) price target.
    • Clearside Biomedical (Pending:CLSD) initiated with Buy rating and $13 (84% upside) price target by Stifel Nicolaus. Cowen & Company rates it Outperform. Wedbush rates it Outperform with $28 (296% upside) price target.
    • GW Pharmaceuticals (NASDAQ:GWPH) initiated with Sell rating and $40 (57% downside risk) price target by Janney Capital.
    | Fri, Jul. 1, 10:13 AM | 3 Comments