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BioCentury Extra
As published Wednesday, October 22, 2014 7:50 PM PST

  • GSK shuffles top management

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) reshuffled its executive management as it prepares to integrate the vaccines business it is acquiring from Novartis AG (NYSE:NVS; SIX:NOVN) in an asset-swapping deal announced in April. The shake-up was announced along with third-quarter earnings (see BioCentury, April 28).

    Moncef Slaoui, previously chairman of global pharmaceuticals R&D and vaccines, will become chairman of global vaccines. Patrick Vallance will remain president of pharmaceutical R&D and take sole responsibility for GSK's R&D activities in pharmaceuticals. The two executives previously shared pharmaceutical R&D responsibilities. Slaoui remains a member of GSK's board.

    On the commercial side, GSK named Abbas Hussain president of global pharmaceuticals. Hussain, who will head up commercial operations in all regions, including China, previously led GSK's commercial operations in Europe, Japan and emerging markets. Deirdre Connelly will remain in charge of U.S. commercial operations as president of North America pharmaceuticals.

    Finally, Emma Walmsley, president of GSK's consumer healthcare business, became CEO designate for the JV that will combine Novartis' OTC business and GSK's Consumer Healthcare unit. GSK will own 63.5% of the JV.

    As part of the asset swap, GSK sold its cancer portfolio to Novartis for $14.5 billion. The deals with Novartis are expected to close in 1H15.

    GSK shares gained 35p to 1,377p in London and $0.78 to $44.41 in New York on Wednesday.

  • Biogen falls on Tecfidera miss

    Biogen Idec Inc. (NASDAQ:BIIB) fell $17.70 (5%) to $309.07 on Wednesday after reporting that Tecfidera dimethyl fumarate revenues were $787 million in 3Q14, short of the $800 million consensus estimate.

    U.S. sales were $638 million in 3Q14, up 45% from $284 million in 3Q13. Ex-U.S. sales were $149 million in 3Q14, compared to $2.4 million in 3Q13. The company launched the multiple sclerosis drug in the U.S. in April 2013, and in Germany in 1Q14 after the European Commission approved the drug in February.

    On the earnings call, investors noted the product's growth rate had slowed in the third quarter. Tony Kingsley, Biogen's EVP of global commercial operations, said the company "always expected that Tecfidera's growth rate would moderate over time," and that the company believes there is still "meaningful growth in the U.S. market" from both new patients and patients switching therapies. Kingsley also noted that Biogen expects to achieve full reimbursement across most major European markets in 2015.

    CEO George Scangos also announced a patient who had been treated with Tecfidera for over four years developed progressive multifocal leukoencephalopathy (PML) and ultimately died of pneumonia. Scangos said the patient had severe lymphopenia, a risk factor for PML, for 3.5 years. Tecfidera's label states it may cause lymphopenia and suggests lymphocyte screening before and during treatment.

    Scangos said Biogen is discussing with FDA whether the label language appropriately describes the risk.

    Biogen also increased its non-GAAP diluted EPS guidance for 2014 to $13.45-$13.55 from $12.90-$13.10, primarily by lowering is allocation for new early and mid-stage business development opportunities to about $50 million from $150 million guidance in July.

  • GSK mulling ViiV IPO

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it is considering an IPO for ViiV Healthcare Ltd., the HIV joint venture it formed with Pfizer Inc. (NYSE:PFE) in 2009. On GSK's third quarter earnings call, CEO Andrew Witty said the company was considering a "partial IPO or IPO of a minority stake," likely no sooner than 2016.

    GSK holds a 78.3% stake in ViiV, while Pfizer holds 11.7%. Shionogi & Co. Ltd. (Tokyo:4507) obtained the remaining 10% in 2012 when ViiV licensed exclusive, worldwide rights to compounds previously developed under a ViiV-Shionogi joint venture. That deal included Tivicay dolutegravir, which FDA approved in August 2013 and the EC approved in January 2014.

    Sales of Tivicay, an HIV integrase inhibitor, were L78 million in 3Q14. Overall in the quarter, ViiV sales grew 18% to L373 million ($600.6 million), with an operating profit of L246 million.

    GSK CFO Simon Dingemans estimated a standalone ViiV would have an operating margin of roughly 60%.

    Witty did not directly answer an analyst question concerning whether GSK would need Pfizer and Shionogi to consent to the IPO, but said its partners "may or may not choose to participate." Pfizer spokesperson Joan Campion said GSK "made us aware of their intention in advance," while Shionogi did not immediately reply to BioCentury's inquiry.

    GSK also announced changes in senior management (see above) along with a new restructuring program it said would provide cumulative L1 bllion in cost reductions over three years. While the company said the new cuts would affect commercial operations, R&D and support functions, Witty said none of the economies would result in a reduction in the pharma's sales force.

    In answer to questions on the call, GSK noted the sales ramp of Breo Ellipta (Relvar - EU, Japan) fluticasone furoate/vilanterol and the more recently launched Anoro Ellipta umeclidinium bromide/vilanterol were being affected by slower uptake of new drugs in primary care markets. Witty noted a third to 40% of Anoro scripts are being filled with free trials.

    Breo is approved for COPD in the U.S., for COPD and asthma in Europe, and for asthma in Japan. Anoro is sold in the U.S. to treat COPD. The products are partnered with Theravance Inc. (NASDAQ:THRX), which fell $1.66 (9%) to $16.98 on Wednesday.

    The pharma's shares gained 35p to 1,377p in London and $0.78 to $44.41 in New York.

  • Bavarian Nordic gains on J&J Ebola deal

    Bavarian Nordic A/S (CSE:BAVA) gained DKK36.50 (24%) to DKK186.50 after the Crucell Holland B.V. unit of Johnson & Johnson (NYSE:JNJ) paid $25 million up front to license exclusive, worldwide rights to Ebola vaccine MVA-BN Filo. Bavarian Nordic is eligible for $20 million in milestones, plus royalties on commercial sales outside Africa. Concurrently, J&J Development Corp. will acquire a 6.4% stake in Bavarian Nordic for DKK251 million ($43 million) via a private placement of new shares.

    J&J is responsible for further development and commercialization of MVA-BN Filo, a modified vaccinia Ankara (MVA) multivalent vaccine for the Zaire and Sudan strains of Ebola as well as Marburg virus. J&J and NIH have conducted preclinical tests of the combination Ebola vaccine, and J&J said it expects to begin a Phase I trial in January. MVA-BN Filo is a prime-boost Ebola virus vaccine comprising two vaccine components based on Crucell's AdVac technology and Bavarian Nordic's MVA-BN technology.

    Bavarian Nordic said Janssen will pay it $99.3 million for more than 1 million doses of the vaccine, via a $70.8 million upfront payment and $28.5 million to be paid pro rata upon delivery in 2015. It anticipates that at least 250,000 doses will be ready for use in clinical trials by May 2015.

    Later in the day, the partners expanded the deal to include evaluation of MVA-BN against three additional, undisclosed infectious disease targets. Janssen has an exclusive option to collaborate on one or more of the targets.

  • NICE draft recommends Xarelto in ACS patients

    The U.K.'s NICE issued draft guidance recommending use of Xarelto rivaroxaban from Bayer AG (Xetra:BAYN) in combination with aspirin plus clopidogrel or aspirin alone to prevent blood clots in patients who have acute coronary syndrome (ACS) with elevated cardiac biomarkers.

    The committee noted the bleeding risk associated with the direct Factor Xa inhibitor and recommended that clinicians assess patients' risk of bleeding before treating them with Xarelto. NICE also advised clinicians to consider carefully treatment beyond 12 months.

    The base case incremental cost-effectiveness ratio (ICER) for Xarelto compared to clopidogrel plus aspirin or aspirin alone was L6,203 ($9,988) per quality-adjusted life year (QALY) gained. The recommended dose of Xarelto is 2.5 mg twice daily and the drug's list price is L58.88 ($94.80) per 2.5 mg, 56-capsule pack.

  • WuXi licenses Foundation's cancer genomics test

    Foundation Medicine Inc. (NASDAQ:FMI) has licensed the laboratory component of its FoundationOne genomic profiling test for solid tumors to WuXi PharmaTech Inc. (NYSE:WX). Oncologists use the laboratory-developed test to identify patients' somatically altered genes and match them with targeted therapies and clinical trials. WuXi's Genome Center in Shanghai, the only CLIA-certified lab in China, will offer the test to companies conducting clinical trials in the country. The companies did not disclose financial terms.

    Foundation closed down $1.25 to $22.28 on Wednesday. WuXi was off $0.13 to $36.30.

  • Regulus doubles on interim HCV data

    Regulus Therapeutics Inc. (NASDAQ:RGLS) surged $6.98 (103.1%) to $13.75 on Wednesday after announcing interim results from a Phase I trial in which a single 2 mg/kg injection of antisense therapy RG-101 led to significant and sustained viral reductions in HCV-infected patients.

    The company reported that RG-101 monotherapy produced mean viral load reduction of 4.1 log10 at day 29 in 14 HCV patients with genotypes 1, 3 or 4. Six of the 14 treated patients (43%) had no detectable HCV RNA at day 29. The trial included 8 patients who were treatment-naive and 6 who had relapsed after treatment with an interferon-containing regimen.

    Regulus said it would report full data from the trial, including those from a cohort receiving a higher 4 mg/kg of RG-101, at an unspecified medical meeting in 2Q15. The company plans to submit an IND in 1Q15 and begin a Phase II trial combining RG-101 with a direct-acting antiviral agent to treat HCV in 2Q15. RG-101 is a GalNAc-conjugated antagonist targeting miR-122.

  • NIH begins second trial of NewLink's Ebola vaccine

    NewLink Genetics Corp. (NASDAQ:NLNK) gained $4.01 (12%) to $38.51 on Wednesday after NIH's National Institute of Allergy and Infectious Diseases (NIAID) said it had begun the second Phase I trial of its investigational Ebola vaccine VSV-EBOV (BPSC1001).

    The trial's 39 healthy adults will receive two injections of the same dose of the vaccine, 28 days apart. Initial safety and immune response data are expected by YE14, and participants will be re-evaluated 11 times over one year.

    VSV-EBOV is a recombinant vesicular stomatitis virus (VSV) vaccine expressing an Ebola Zaire virus outer protein. Researchers at the Public Health Agency of Canada's National Microbiology Laboratory developed the vaccine. BioProtection Systems Corp., a wholly-owned subsidiary of NewLink, licensed exclusive, worldwide rights to it in a 2010 deal.

    On Oct. 13, the Walter Reed Army Institute of Research (WRAIR) began a Phase I trial of VSV-EBOV using single injections at different doses.

    In August, the Canadian government said it would donate 800-1,000 doses of VSV-EBOV to WHO for applied research and clinical trials.

  • Forendo closes EUR 12M series A

    Forendo Pharma Oy (Turku, Finland) closed a EUR 12 million ($15.3 million) series A round led by new investors Novartis Venture Fund and MS Ventures. Existing investors including Karolinska Development AB; Novo Seeds; and Finnvera also participated.

    Forendo said it will use the funds to advance lead candidate FP-5677, a hydroxysteroid 17-beta dehydrogenase 1 (HSD17B1) inhibitor, through proof-of-concept testing to treat endometriosis. The company acquired a portfolio of HSD17B1 inhibitors last year from the Hormos Medical subsidiary of QuatRx Pharmaceuticals Co. (Ann Arbor, Mich.).

    The company also partnered with Apricus Biosciences Inc. (NASDAQ:APRI) to develop and commercialize fispemifene, a selective estrogen receptor modulator (SERM) in Phase II testing to treat secondary hypogonadism. Apricus plans to begin a Phase IIb trial of fispemifene in this indication in 2H15.

    Anja Koenig from Novartis Venture Fund and Hakan Goker from MS Ventures joined Forendo's board.

  • Proteon raises $61.1M in IPO

    Proteon Therapeutics Inc. (NASDAQ:PRTO) closed up $0.03 to $10.03 in its first day of trading Wednesday after raising $61.1 million by selling 6.1 million shares at $10 in an IPO on NASDAQ. The price valued Proteon at $149.9 million. Stifel; JMP Securities; Baird; and Oppenheimer are underwriters.

    Earlier this month, Proteon proposed to sell 4.7 million shares at $12-$14. At $13, the company would have been valued at $182.6 million while raising the same amount.

    Proteon started Phase III testing of PRT-201, its recombinant human elastase, in August to improve arteriovenous fistula (AVF) outcomes in chronic kidney disease. Data are expected in 2017. The company plans to start a second Phase III trial in 1H15. PRT-201 has both Fast Track and Orphan Drug designations from FDA.

  • Molecular Partners postpones big Swiss IPO

    Ophthalmic and cancer company Molecular Partners AG (Schlieren, Switzerland) postponed plans for a big IPO on the SIX Swiss Exchange, citing "adverse market conditions." The company had begun bookbuilding on Oct. 8 and was scheduled to begin trading today. Last month, it filed to raise CHF125 million ($133.1 million) in the offering.

    The deal would have been the fourth largest IPO in the past five years. Molecular Partners also would have been the third European company to break the $100 million IPO threshold in 2014, joining the $337.5 million deal by Circassia Pharmaceuticals plc (LSE:CIR) and two NASDAQ flotations: $220.5 million by Forward Pharma A/S (NASDAQ:FWP) and the $112.2 milllion by ProQR Therapeutics N.V. (NASDAQ:PRQR).

    Molecular Partners' lead candidate is Abicipar pegol (AGN-150998, MP0112), which is in Phase II testing to treat wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Partner Allergan Inc. (NYSE:AGN) expects to start a Phase III trial in wet AMD in 2015.

    Abicipar is a designed ankyrin repeat protein (DARPin) that antagonizes VEGF-A. The company's most advanced cancer therapy, a DARPin called MP0250, is in Phase I/II testing to treat solid tumors.

  • DBV Technologies launches ADSs

    American Depository Receipts for DBV Technologies S.A. (NASDAQ:DBVT; Euronext:DBV) added $1.26 to $22.90 on NASDAQ Wednesday after the allergy company sold 4.3 million ADSs at $21.64 each in a follow-on that, combined with a private placement outside the U.S. and Canada, will raise about $115.8 million.

    The company is selling an additional 534,728 ordinary shares at EUR 34 in the private placement. Each ADS represents one-half of an ordinary share.

    DBV said it would use proceeds in part for clinical development of Viaskin Peanut (DBV-712), which has completed Phase IIb studies, and Viaskin Milk, which is slated to begin Phase I/II studies this quarter in pediatric patient populations with IgE-mediated cow's milk protein allergy. Both products use the company's Viaskin patch technology to deliver proteins epicutaneously.

    On Euronext, DBV closed at EUR 35.74, down EUR 0.42.

    Citigroup Global Markets, Leerink; and Bryan, Garnier are joint global coordinators and joint book-running managers of the global offering. Trout Capital is a U.S. underwriter.

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