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BioCentury Extra
As published Thursday, July 30, 2015 8:44 PM PST

  • Galapagos reports additional Phase IIb filgotinib data in RA

    Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) reported 24-week data from the Phase IIb DARWIN 1 trial of filgotinib (GLPG0634) to treat rheumatoid arthritis (RA) that suggested a differentiated safety profile; the data were in line with 12-week results. Galapagos said in April the once-daily 200 mg dose and twice-daily 100 mg dose of filgotinib plus methotrexate met the primary endpoint vs. placebo plus MTX at 12 weeks (see BioCentury Extra, April 14).

    The company reported a higher relative increase in HDL compared to LDL after treatment with filgotinib plus methotrexate over 24 weeks. In April, CSO Piet Wigerinck noted "in general, if your HDL level increased more than your LDL, your risk factors for cardiovascular accidents are improving." Filgotinib led to an increase of up to 23% in HDL and an increase of up to 13% in LDL. The Janus kinase-1 (JAK-1) inhibitor also led to an increase of up to 4% from baseline in hemoglobin levels.

    At 24 weeks, 3.6% of placebo patients discontinued treatment due to safety vs. 3.9% in the filgotinib-treated groups. Treatment-emergent adverse events occurred in 57.1% of placebo-treated patients vs. 52.6% of filgotinib-treated patients.

    Filgotinib plus MTX led to a statistically significant improvement in the secondary endpoint of ARC20 scores at 24 weeks vs. placebo. Galapagos said once-daily doses of 200 mg of filgotinib led to ACR20 responses in 73% of patients (p<0.001 vs. placebo), while twice-daily doses of 100 mg led to responses in 80% of patients (p<0.001 vs. placebo). The company also said all dose regimens led to statistically significant improvements in ACR50 scores, ACR70 scores and Disease Activity Score using 28 joint counts (DAS28).

    Galapagos expects data from the Phase IIb DARWIN 2 trial of filgotinib as monotherapy in the next few weeks. Under a 2012 deal, AbbVie Inc. (NYSE:ABBV) is obligated to pay $200 million to license the candidate if the Phase IIb program meets undisclosed criteria in RA and AbbVie has an option to license the program if the criteria are not met (see BioCentury, March 23).

    Wigerinck said on today's conference call Galapagos will "gladly waive the obligation" and move forward with filgotinib independently if AbbVie does not want to pursue further development.

    Galapagos gained EUR 1.21 to EUR 53.11 on Euronext on Thursday, and rose $0.35 to $57.05 on NASDAQ.

  • Alexion lifts revenue guidance on strong Soliris sales

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) raised its revenue guidance after reporting $636 million in Soliris eculizumab sales in 2Q15, which were up 24% from $512.5 million in 2Q14 and above analyst estimates of $628.5 million. The company also reported non-GAAP diluted EPS of $1.44, up 29% from $1.12 in 2Q14 and above the Street's estimate of $1.38.

    Alexion edged up its 2015 revenue guidance from $2.55-$2.6 billion to $2.6-$2.62 billion to reflect growth in Soliris sales, which CEO David Hallal said compensated for the later

    than expected launch of Strensiq asfotase alfa in the U.S. and EU. Soliris is a humanized mAb targeting complement 5 (C5) marketed to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

    The company plans to launch Strensiq and Kanuma sebelipase alfa this year. Strensiq is under Priority Review in the U.S. and accelerated assessment in the EU to treat hypophosphatasia; the action dates are not disclosed. Hallal said previous guidance had assumed a 1H15 launch for the fusion protein incorporating the catalytic domain of human tissue non-specific alkaline phosphatase (TNSALP; ALPL) and a bone-targeting peptide.

    Kanuma is under review in the U.S., EU and Japan to treat lysosomal acid lipase deficiency. Its PDUFA date is Sept. 8. An EU decision is expected this quarter and a decision in Japan is expected in 1H16. Alexion gained the recombinant human lysosomal acid lipase (LAL) enzyme replacement therapy through its acquisition of Synageva BioPharma Corp. (see BioCentury, May 18).

    The company lowered its 2015 EPS guidance to $4.70-$4.80 from $5.60-$5.80 to reflect effects of the Synageva acquisition.

    Alexion gained $0.53 to $199.29 on Thursday.

  • Amgen gains on elevated guidance

    Amgen Inc. (NASDAQ:AMGN) gained $3.06 to $171.69 in early after hours trading on Thursday after raising its 2015 guidance and reporting 2Q15 earnings. The company now estimates $21.1-$21.4 billion in revenues, up from $20.9-$21.3 billion; and an adjusted EPS of $9.55-$9.80, up from $9.35-$9.65.

    Amgen reported revenues of $5.4 billion, up 4% from $5.2 billion in 2Q14. Amgen said a 6% increase in product sales was offset partially by changes in foreign exchange rates.

    Enbrel etanercept, Prolia denosumab, Sensipar cinacalcet, Kyprolis carfilzomib, and Xgeva denosumab all saw increased sales. Combined Xgeva and Prolia sales were $671 million, up 19% from $563 million in 2Q14; sales of Xgeva, marketed to prevent bone metastatis, increased 11%, while osteoprosis treatment Prolia grew 29%.

    Kyprolis sales increased 53% over 2Q14. Earlier this month, FDA expanded the indication for Kyprolis to include multiple myeloma patients who have received 1-3 prior therapies in combination with Revlimid and dexamethasone.

    The company reported adjusted EPS of $2.51, an 8% increase from $2.37 in 2Q14 and beating analyst estimates of $2.43.

    EVP of global commercial operations Anthony Hooper said Amgen is prepared to launch PCSK9 inhibitor Repatha in the U.S. "imminently." The drug, which was approved in the EU last week, has an Aug. 27 PDUFA date. The company is also anticipating an EMA decision on Kyprolis to treat relapsed MM, and FDA and EMA decisions on talimogene laherparepvec to treat metastatic melanoma.

  • Zai licenses preclinical cancer candidate from Sanofi

    Zai Laboratory Inc. (Shanghai, China) obtained an exclusive, worldwide license from Sanofi (Euronext:SAN; NYSE:SNY) to develop, manufacture and commercialize a preclinical multi-kinase inhibitor for oncology indications including non-small cell lung cancer (NSCLC). Sanofi is eligible for undisclosed development and regulatory milestones, plus tiered sales royalties.

    Zai holds rights to two preclinical compounds from Sanofi to treat chronic respiratory diseases under a 2014 deal. The company in-licenses China or global rights to compounds that may have a competitive advanage in China and greater Asia (see BioCentury Extra, Aug. 12, 2014).

  • Foundation Medicine sinks after cutting guidance

    Foundation Medicine Inc. (NASDAQ:FMI) lost $7 (24%) to $22.30 on Thursday after lowering its 2015 guidance as part of its 2Q15 earnings, which it reported after market close Wednesday (see BioCentury Extra, July 29). The company now expects $85-$95 million in revenue, rather than $105-$115 million.

    On a conference call Wednesday, CEO Michael Pellini said Foundation Medicine had expected to have local coverage determinations (LCDs) in place for a portion of Medicare cases during 1H15, but that progress was slower than expected and the company no longer assumes it will receive any Medicare payments this year. He said Palmetto GBA LLC issued an LCD July 6 for the company's FoundationOne in a subset of patients with non-small cell lung cancer (NSCLC), but that the "next phase" of obtaining coverage decisions from regional Medicare administrative contractors "is going to take more time to play out."

    FoundationOne is a laboratory-developed test (LDT) that identifies all somatically altered genes that are validated targets for therapy or drivers of oncogenesis. The test covers multiple cancers.

    The company's shares are down 59% from their 52-week high of $54.28 on Jan. 12, when Roche (SIX:ROG; OTCQX:RHHBY) took a majority stake in Foundation, and now trades below their close of $23.93 on Jan. 9 before the deal was announced.

  • Tesaro licenses rolapitant China rights to Hengrui

    Tesaro Inc. (NASDAQ:TSRO) licensed exclusive Chinese rights for its lead candidate, oral rolapitant (SCH 619734), to Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276). FDA accepted an NDA for rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV) in November; the PDUFA date is Sept. 5.

    Tesaro declined to disclose the financial details of the agreement, but said Hengrui will be responsible for all development, registration and commercialization activities in China. Tesaro will receive an undisclosed upfront payment, as well as milestones and royalties on net rolapitant sales in China.

    Tesaro has rights to rolapitant, a neurokinin 1 (NK1) Substance P receptor (TACR1) antagonist, from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK).

    Tesaro shed $1.81 to $57.43 on Thursday; Hengrui lost RMB2.18 to RMB42.81.

  • Astellas antifungal misses in Phase III

    Astellas Pharma Inc. (Toyko:4503) released top-line results from the Phase III ACTIVE trial of Cresemba isavuconazonium to treat Candida infection, saying that the broad-spectrum water-soluble azole antifungal missed its primary endpoint.

    Cresemba failed to show non-inferiority to Cancidas caspofungin in an intent-to-treat analysis of 400 adult patients with candidemia and other invasive Candida infections (a total of 440 patients were enrolled). There was a 60.3% treatment response after 10 days in the Cresemba group vs. 71.1% in the caspofungin group (-10.8%; 95% CI: -19.9%, -1.8%). The lower bound of the confidence interval exceeded the pre-specified non-inferiority margin of -15%.

    Cresemba's safety profile was consistent with previous studies.

    Astellas spokesperson Christina Noland told BioCentury that Astellas is still analyzing the top-line data, and declined to give a timeline for releasing the full results. Nolan said it was too early to comment on the company's next steps in developing Cresemba for the indication.

    FDA approved Cresemba in March to treat adults with invasive aspergillosis and mucormycosis (see BioCentury Extra, March 6).

    Astellas has U.S. and Canada rights to Cresemba from Basilea Pharmaceutica AG (SIX:BSLN), which lost CHF15.60 (13%) to CHF103.50 on Thursday.

  • Ascendis announces Phase II results for ACP-001

    Ascendis Pharma A/S (NASDAQ:ASND) announced top-line results from a Phase II study of TransCon Growth Hormone (ACP-001) to treat growth hormone deficiency (GHD). The study's primary endpoints were related to pharmacokinetics and safety; Ascendis was unable to confirm whether it met all five. The therapy was also comparable to Genotropin somatropin in increasing height velocity, a secondary endpoint.

    The 53-patient, six-month study compared weekly 0.14, 0.21 and 0.30 mg/kg doses of TransCon Growth Hormone to 0.21 mg/kg/week Genotropin administered daily in pre-pubertal children with GHD. Ascendis said there were no drug-related serious adverse events, and blood concentrations of human growth hormone (hGH) were comparable between equivalent weekly doses of the hormones.

    Ascendis said height velocity ranged from 11.9-13.9 cm among the three doses of TransCon Growth Hormone compared to 11.6 cm for Genotropin.

    The company expects to release full study results at the European Society for Paediatric Endocrinology meeting in October, and plans to start a Phase III study in mid-2016.

    TransCon Growth Hormone is a once-weekly hGH prodrug that uses TransCon prodrug technology for sustained release.

    Ascendis gained $0.94 to $20.87 on Thursday.

  • vTv falls after $117.2M IPO

    vTv Therapeutics Inc. (NASDAQ:VTVT) lost $4.17 (28%) to $10.83 in its first day of trading Thursday after raising $117.2 million through the sale of 7.8 million shares at $15 in an IPO underwritten by Piper Jaffray; Stifel; Canaccord; and Janney Montgomery Scott. The price valued vTv at $492.2 million, based on 32.8 million shares outstanding. vTv priced at the bottom of its $15-$17 range; at $16 it would have raised $125 million and been valued at $525 million. The company filed last month to raise up to $172.5 million.

    vTv is enrolling patients in the Phase III STEADFAST trial of azeliragon (TTP488) to treat mild Alzheimer's disease, with top-line data expected in late 2017. The trial has an SPA from FDA. The oral small molecule receptor for advanced glycation endproducts (RAGE) antagonist has Fast Track designation from FDA to treat AD.

    Pfizer Inc. (NYSE:PFE) had licensed azeliragon from vTv predecessor company TransTech Pharma Inc. in 2006, but returned rights in 2011 after halting a Phase IIb study to treat mild to moderate AD for futility. vTv said that in a subsequent analysis after correcting errors, the study's 5 mg/day low dose of azeliragon met the trial's primary endpoint of significantly impeding progression of AD vs. placebo, as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-COG11) (p=0.008), and showed greater efficacy in patients with mild AD than moderate disease.

    Former Pfizer CEO Jeffrey Kindler is vTv's executive chairman. The company's principal equity holder is MacAndrews & Forbes Inc., owned by investor Ronald Perelman.

  • Zogenix raises $85.5M in follow-on

    Zogenix Inc. (NASDAQ:ZGNX) raised $85.5 million through the sale of 4.8 million shares at $18 in a follow-on underwritten by Leerink; Stifel; Oppenheimer; and Brean Capital. The company proposed the offering after market on Tuesday, when its shares closed at $20.14. Zogenix gained $0.82 to $19.31 on Thursday.

    Zogenix plans to begin two Phase III trials in 4Q15 of ZX008 to treat Dravet syndrome and submit an NDA and an MAA in 2H16. The low-dose fenfluramine has Orphan Drug designation in the U.S. and EU to treat Dravet. Zogenix gained ZX008 through its 2014 acquisition of Brabant Pharma.

  • Genocea raises $50.1M in follow-on

    Genocea Biosciences Inc. (NASDAQ:GNCA) raised $50.1 million through the sale of 3.9 million shares at $13 in a follow-on underwritten by Cowen; Piper Jaffray; Stifel; and Needham. Genocea proposed the offering after market close Wednesday; it lost $1.02 to $12.89 on Thursday.

    In May, six dosing combinations of Genocea's GEN-003 met the primary endpoint of a Phase II dose optimization trial to treat herpes simplex virus type 2 (HSV-2) infection. The company expects additional data this year. GEN-003 is a T cell vaccine consisting of the infected cell polypeptide 4 (ICP4) and gD2 antigens from HSV-2 combined with the saponin-derivative adjuvant Matrix-M2.

    Genocea also expects data in 4Q15 from a Phase IIa study of GEN-004, a T cell vaccine against Streptococcus pneumoniae containing SP0148, SP1912 and SP2108 protein antigens.

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