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BioCentury Extra
As published Thursday, August 21, 2014 5:28 PM PST


  • Illumina, pharmas partner for universal cancer assay

    Illumina Inc. (NASDAQ:ILMN) partnered with three pharmas to develop a next-generation sequencing-based system to detect genetic variants linked to cancer that can be used to match patients with targeted therapeutics. The sequencing equipment maker will work with AstraZeneca plc (LSE:AZN; NYSE:AZN), Sanofi (Euronext:SAN; NYSE:SNY) and the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) to develop the system, which initially will be used in clinical trials. Illumina said the ultimate goal is to develop a system that can be used by physicians to help guide treatment decisions.

    Illumina's MiSeqDx genome sequencing system is the only high throughput, next-generation genomic sequencer with FDA approval for broad clinical use (see BioCentury Extra, Nov. 19, 2013).

    Illumina declined to disclose financial details or whether it committed any equipment. Illumina also would not comment on whether it expects to partner with additional pharmas, though it describes AZ, Sanofi and J&J as "initial" strategic partners.

    AZ, Sanofi and J&J's Pharmaceutical Research & Development division also have non-exclusive deals with Foundation Medicine Inc. (NASDAQ:FMI) to identify cancer biomarkers that could lead to companion diagnostics. Foundation Medicine markets next-generation sequencing tests that identify the molecular alterations in a patient's cancer to help match the patient with relevant targeted therapies and trials.

    Illumina slid $0.87 to $172.09 Thursday. Foundation Medicine was down $1.37 to $22.93.

  • Lilly's ixekizumab meets in plaque psoriasis trials

    Eli Lilly and Co. (NYSE:LLY) said subcutaneous ixekizumab (LY2439821) met the co-primary endpoints vs. placebo or etanercept in each of the Phase III UNCOVER-1, -2 and -3 trials to treat moderate to severe plaque psoriasis. Lilly said 78-90% of patients who received ixekizumab achieved a 75% improvement from baseline in Psoriasis Area and Severity Index score (PASI 75) response at week 12. The compound also improved static Physician Global Assessment (sPGA) scores; however, details were not disclosed. Additionally, Lilly said 31-41% of patients who received ixekizumab achieved a PASI 100 response at week 12. The double-blind, international trials enrolled a total of 3,866 patients.

    Next half, Lilly plans to submit worldwide regulatory applications for ixekizumab to treat moderate to severe plaque psoriasis. The humanized mAb against IL-17A is also in Phase III testing to treat psoriatic arthritis.

    At least two other mAbs targeting the IL-17 pathway are in late stage development for plaque psoriasis: brodalumab from Amgen Inc. (NASDAQ:AMGN) and AstraZeneca plc (LSE:AZN; NYSE:AZN) is in Phase III testing; and secukinumab (AIN457) from Novartis AG (NYSE:NVS; SIX:NOVN) is under review in the EU and U.S. Brodalumab is a humpanceanized mAb against IL-17 receptor (IL17R; IL17RA), and secukinumab is a human IgG1 mAb targeting IL-17A.

    Amgen and Pfizer Inc. (NYSE:PFE) co-market Enbrel etanercept in the U.S. and Canada. Pfizer has rights elsewhere.

  • BAX 855 meets in Phase III hemophilia A trial

    Baxter International Inc. (NYSE:BAX) said BAX 855 met the primary endpoint of reducing the annualized bleeding rate (ABR) of patients with hemophilia A when administered as a prophylaxis compared to on demand in the Phase III PROLONG-ATE trial. In the global, open-label, 138-patient study, BAX 855 reduced median ABR by 95% in patients 12 years or older with previously treated severe hemophilia A in the twice-weekly prophylaxis group compared to the on-demand group (1.9 vs 41.5, p=0.0001).

    Baxter expects to submit a BLA to FDA for BAX 855 before year end and an MAA to EMA once it completes a Phase III pediatric study that is expected to start shortly.

    BAX 855 is a pegylated form of Baxter's marketed Advate recombinant Factor VIII. BAX 855 was developed in collaboration with Nektar Therapeutics (NASDAQ:NKTR) and has a longer half-life than Advate.

  • Ampio falls on Ampion update, possible BLA delay

    Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) fell $1.80 (24%) to $5.66 on Thursday after announcing it will report data from the Phase III STEP trial of Ampion to treat osteoarthritis (OA) of the knee later than previously expected. Top-line data from the trial were originally expected this quarter, with a BLA submission slated for 1Q15. Ampio attributed the delay to the discovery by an independent CRO that both Ampion and placebo were exposed to "lower temperatures than permitted by the drug specifications" during shipment to trial sites.

    STEP is one of two pivotal trials required to support the BLA for Ampion in the indication. Ampio said it is pursuing alternatives to be able to submit the BLA in 1Q15, including substituting data from the ongoing Phase I/II MULTIPLE INJECTIONS STUDY of Ampion. According to the company, FDA agreed to analyze STEP as "supportive data" for the BLA. Ampion is a cyclic aspartate-alanine dipeptide cleaved from human serum albumin.

  • Xiaflex meets in Phase IIa cellulite trial

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) said 0.48 and 0.84 mg doses of Xiaflex collagenase clostridium histolyticum each met the primary endpoint in a Phase IIa trial to treat cellulite. The primary endpoint of the 150-patient, U.S. study was assessment of the change from baseline to day 73 in the appearance of cellulite vs. placebo (p<0.05 for both). A 0.06 mg dose missed the endpoint. Patients received up to three treatment sessions of up to 12 injections in cellulite dimples. In 2Q15, Auxilium plans to start a Phase IIb trial in the indication.

    The injectable form of collagenase is approved in the U.S. as Xiaflex and as Xiapex in the EU to treat Dupuytren's contracture in adult patients with a palpable cord, which affects joints in the hand. In the U.S., Xiaflex is also approved to treat Peyronie's disease.

    Auxilium has rights to the product from BioSpecifics Technologies Corp. (NASDAQ:BSTC), which gained $1.88 to $30.92 on Thursday. Auxilium was up $0.78 to $18.55 on the day. The company is merging with QLT Inc. (TSX:QLT; NASDAQ:QLTI), which gained $0.26 to $5.56 on NASDAQ and was up C$0.22 to C$6.06 in Toronto on Thursday.

  • FDA approves Eliquis for DVT, pulmonary embolism

    FDA approved an sNDA for Eliquis apixaban from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) to treat and to reduce the risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE). The direct Factor Xa inhibitor is approved in the EU for the indication, and in the U.S. and the EU to treat DVT and PE in patients undergoing knee or hip replacement surgery and to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).

  • EMA to review Basilea's isavuconazole

    EMA accepted for review an MAA from Basilea Pharmaceutica AG (SIX:BSLN) for isavuconazole (BAL8557) to treat invasive aspergillosis and mucormycosis (zygomycosis). Last month, partner Astellas Pharma Inc. (Tokyo:4503) submitted an NDA to FDA for the broad-spectrum water-soluble azone antifungal. Basilea was down CHF0.10 to CHF100.70 on Thursday.

  • J&J gains option to ViaCyte's VC-01

    ViaCyte Inc. (San Diego, Calif.) granted the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) an option to license rights to VC-01, which is in development for Type I diabetes. J&J's Johnson & Johnson Development Corp. venture arm paid ViaCyte $20 million in an undisclosed payment for the option and a note convertible into equity. ViaCyte plans to start a Phase I/II trial of VC-01 next month. The product comprises insulin-producing pancreatic endocrine cells derived from human embryonic stem cells (hESCs) encapsulated in ViaCyte's Encaptra macroencapsulation device.

  • NeuroDerm raises $16 million

    NeuroDerm Ltd. (Rehovot, Israel) raised $16 million in an undisclosed venture round from existing and new investors including Elias Group. A low-dose version of NeuroDerm's lead program ND0612L is in an Israeli Phase IIa trial to treat moderate Parkinson's disease (PD). The company also plans to begin testing a high-dose version for severe PD. ND0612L is a levodopa and carbidopa liquid formula administered by a subcutaneous belt pump device.

  • R2HC issues call for Ebola research proposals

    The Research for Health in Humanitarian Crises (R2HC) program launched an emergency call for proposals to support research on experimental Ebola therapies and vaccines, with a focus on clinical trials that could begin during the current outbreak. Proposals are due Sept. 8. R2HC was launched last year by the not-for-profit Enhancing Learning and Research for Humanitarian Assistance (ELRHA) and investors the Wellcome Trust and the U.K.'s Department for International Development. The two investors put in L6.5 million ($10.9 million). The goal was to support collaborative research on public health challenges in low- and middle-income countries.

    The Wellcome Trust also committed L40 million ($66.9 million) over five years to Developing Excellence in Leadership, Training and Science Africa (DELTAS Africa), its new program supporting medical research in Africa. The trust also partnered with African philanthropic organization Dangote Foundation to support Ebola research initiatives.

    The call for proposals follows a WHO statement last week that endorsed investigational Ebola compounds that have not yet been evaluated for safety and efficacy in humans. The organization said use of the compounds is ethical as long as certain conditions are met (see BioCentury Extra, Aug. 12).


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