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BioCentury Extra
As published Wednesday, July 29, 2015 6:08 PM PST


  • Mereo raises $119M, acquires three Novartis programs

    Mereo BioPharma Group Ltd. (London, U.K.) debuted on Wednesday with $119 million (L76.7 million) and three clinical-stage programs acquired from Novartis AG (NYSE:NVS; SIX:NOVN). Woodford Investment Management and Invesco Perpetual invested in Mereo; Novartis also has an equity stake.

    The start-up aims to acquire and develop validated, mid-stage development programs from large biopharmas before partnering the programs at key inflection points. Mereo is focused on rare and specialist diseases.

    The initial three programs are all in Phase II testing. BPS-804 is a human mAb for the Orphan bone disease osteogenesis imperfecta; BCT-197 is an oral inhibitor of p38 mitogen-activated protein kinase (p38 MAPK; MAPK14) for acute exacerbations of chronic obstructive pulmonary disease (COPD); and BGS-649 is an oral aromatase inhibitor for first-line therapy of obese men with hypogonadotrophic hypogonadism.

    Mereo has also partnered with CRO ICON plc (NASDAQ:ICLR) to develop its pipeline.

    Denise Scots-Knight is co-founder, CEO and a director of Mereo. She was a managing partner at Phase4 Partners, which was founded when Nomura's life sciences team spun out in 2010.

  • GSK discusses pipeline expectations, growing HIV sales

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) CEO Andrew Witty said on the company's 2Q15 earnings call that the company has about 40 drug candidates in its pipeline, with 20-25 that could be approved in the next five years. The company expects to unveil more details at its R&D day in November.

    GSK also said ViiV Healthcare, its HIV-focused joint venture with Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd. (Tokyo:4057), had L559 million ($867 million) in 2Q15 sales, up 59% from L352 million ($545.9 million) in 2Q14. GSK opted to retain its stake in ViiV after considering a spin-off via an IPO (see BioCentury Extra, May 6).

    GSK reported core EPS of 17.30p in 2Q15, above the Street's estimate of 16.67p. Its L5.9 billion ($9.2 billion) in revenues were in line with analyst estimates.

    The company expects a 2015 core EPS decline in the high teens at constant exchange rates due to continued pricing pressure on asthma and chronic obstructive pulmonary disease (COPD) drug Advair salmeterol/fluticasone propionate, which is set to lose patent protection in 2016, and the dilutive effects of its asset swap with Novartis AG (NYSE:NVS; SIX:NOVN). However, it expects core EPS to reach double-digit growth in 2016.

    Global sales of Advair were L960 million ($1.5 billion) for the quarter, down 13% from L1.1 billion ($1.7 billion) in 2Q14. GSK markets the adrenergic receptor beta 2 (ADRB2) agonist (LABA) and corticosteroid in the EU as Seretide.

  • Foundation Medicine lowers guidance

    Foundation Medicine Inc. (NASDAQ:FMI) shed $3.80 (13%) to $25.50 in early after-hours trading on Wednesday after the precision medicine company lowered its 2015 revenue guidance to $85-$95 million from $105-$115 million.

    On a conference call, CEO Michael Pellini said Foundation had "slower-than-expected progress with Medicare and certain national commercial payers" and that the company is "no longer assuming any Medicare payments for the rest of 2015."

    Revenues in 2Q15 were $22.5 million, up 55% from $14.5 million in 2Q14 but short of analysts' consensus estimate of $24.4 million.

    The company's clinical tests include FoundationOne, a laboratory-developed test (LDT) for profiling genomic alterations in solid tumors; and FoundationOne Heme, an LDT for profiling genomic alterations for hematologic malignancies, sarcomas and pediatric cancers. Roche gained ex-U.S. rights to FoundationOne and FoundationOne Heme under a 2015 deal (see BioCentury Extra, Jan. 12).

    The financial results were released after market close. During Wednesday's regular trading session, Foundation fell $0.72 to $29.30, and is off 46% from the stock's 52-week high of $54.28 in January.

  • NICE issues draft guidances on HCV treatments

    The U.K.'s NICE published three draft guidances recommending Daklinza daclatasvir from Bristol-Myers Squibb Co. (NYSE:BMY), Viekirax ombitasvir/paritaprevir and Exviera dasabuvir from AbbVie Inc. (NYSE:ABBV), and Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) for certain populations of HCV patients.

    NICE recommended a 12-week course of Daklinza plus Gilead's Sovaldi sofosbuvir for non-cirrhotic HCV genotype 1 and 4 patients with significant fibrosis who have been previously treated or who are ineligible or intolerant of interferon. The draft guidance did not recommend Daklinza plus Sovaldi for untreated genotype 1 or 4 patients, nor for those with genotype 3.

    The average list price of a 12-week course of Daklinza is L59,501 ($92,280).

    The committee recommended 12-week courses of Viekirax plus Exviera with or without ribavirin to treat HCV genotype 1b patients regardless of prior treatment status or cirrhosis; Viekirax plus Exviera and ribavirin for non-cirrhotic genotype 1a regardless of prior treatment status; and Viekirax plus ribavirin in previously-treated non-cirrhotic genotype 4 patients.

    A 12-week course of Viekirax costs L32,200 ($49,939) and a 12-week course of Exviera costs L3,100 ($4,808).

    NICE's updated draft guidance for Harvoni is largely in line with a previous guidance issued in March. It now recommends the drug for previously-treated cirrhotic HCV genotype 4 patients who meet certain criteria. The guidance did not recommend Harvoni to treat genotype 3 (see BioCentury Extra, March 3).

    A 12-week course of Harvoni is L38,980 ($60,455).

    Comments for all three guidances are due Aug. 19.

  • FDA accepts NDA for ZS Pharma hyperkalemia candidate

    ZS Pharma Inc. (NASDAQ:ZSPH) said FDA accepted for review an NDA for sodium zirconium cyclosilicate (ZS-9) to treat hyperkalemia. The PDUFA date is May 26, 2016.

    The inorganic crystal form of zirconium silicate designed to trap potassium ions over other ions throughout the GI tract met the primary endpoint of the Phase III HARMONIZE trial last year and the Phase III ZS-003 study in 2013 (see BioCentury Extra, Sept. 23, 2014).

    ZS Pharma gained $1.60 to $57.64 on Wednesday. It announced the news after market close.

  • Sanofi's LixiLan meets in Phase III

    Sanofi (Euronext:SAN; NYSE:SNY) said LixiLan, its fixed-ratio combination of lixisenatide and Lantus insulin glargine, met the primary endpoint of significantly reducing HbA1c over Lantus or lixisenatide alone in the Phase III LixiLan-O study to treat Type II diabetes.

    The 1,170-patient, 30-week trial evaluated a single daily injection of LixiLan in diabetes patients taking metformin. Sanofi said LixiLan's safety profile was similar to that of lixisenatide and Lantus. Spokesperson Susan Brooks told BioCentury the company is likely to release full results from the study next year.

    Sanofi plans to submit an NDA to FDA in 4Q15 and an MAA to EMA in 1Q16. The NDA will be based on the results of Lixilan-O and the ongoing Phase III LixiLan-L trial, which is evaluating LixiLan in patients with uncontrolled Type 2 diabetes on insulin therapy.

    Sanofi markets lixisenatide, a glucagon-like peptide-1 receptor (GLP-1R) agonist, in Europe as Lyxumia. In March, the company said it planned to re-submit an NDA to FDA for lixisenatide in 3Q15. The company had withdrawn the application in 2013 (see BioCentury Extra, March 19).

    Lantus is a synthetic sustained-release subcutaneous insulin analog approved to treat Type I and Type II diabetes.

  • Foresite closes $450M fund

    Foresite Capital Management closed Foresite Capital Fund III with $450 million. Managing director Christine Aylward said the firm will make investments of up to $100 million in public and private late-stage U.S. companies in the therapeutic, diagnostic, device and healthcare services sectors.

    Foresite's recent investments include Adaptimmune Ltd. (Abingdon, U.K.), Aduro Biotech Inc. (Berkeley, Calif.) and Jounce Therapeutics Inc. (Cambridge, Mass.). The firm closed its second fund at $300 million in April 2014 (see BioCentury, April 7, 2014).

  • Ariad, PDL in Iclusig royalty deal

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) will receive $100 million from PDL BioPharma Inc. (NASDAQ:PDLI) in exchange for royalties on future sales of Iclusig ponatinib. The drug is approved in the U.S. and EU to treat acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML).

    PDL paid the first $50 million tranche Tuesday; Ariad is to receive the balance in one year. PDL will receive 2.5% of global Iclusig sales during the first year; 5.0% after the first year through 2018; and 6.5% from 2019 until PDL reaches a 10% rate of return (IRR), at which time royalty payments are to cease.

    Ariad is also entitled to draw up to an additional $100 million from PDL, in one or two installments, within six and 12 months. If PDL pays Ariad more than $150 million, the 6.5% royalty rate in 2019 will increase to 7.5%.

    Ariad is permitted to buy out the royalty for prespecified terms. PDL is also guaranteed a minimum return equal to its payments to Ariad.

    Sales of Iclusig, a pan-BCR-ABL tyrosine kinase inhibitor (TKI), were $55.7 million in 2014. Ariad expects 2015 sales to be $130-$140 million. PDL had $418.9 million in cash at March 31.

    Ariad plans to use the funds for the pivotal Phase II ALTA trial of brigatinib (AP26113) to treat non-small cell lung cancer (NSCLC). It expects to complete enrollment this quarter and intends to submit an NDA next year. The dual inhibitor of anaplastic lymphoma kinase (ALK) and EGFR has breakthrough therapy designation from FDA.

    Ariad dipped $0.44 to $7.78 on Wednesday; PDL shed $0.03 to $5.86. Houlihan Lokey was placement agent and financial advisor for the deal.

  • China FDA says sponsors must verify data in drug applications

    China FDA released a circular last week that imposes an Aug. 25 deadline for sponsors to inspect and validate clinical data in regulatory applications, or withdraw them without penalty.

    According to Sidley Austin LLP, a backlog of 1,622 applications will be affected by the requirements, including both domestic and imported drugs.

    The firm, which specializes in Asia-Pacific life sciences law, said sponsors are to provide CFDA with self-inspection reports verifying that locked clinical data have not been altered and provide records on handling procedures for biological samples. Sponsors are also to provide details about compliance with trial protocols, screening and inclusion criteria.

    CFDA intends to inspect clinical sites without notice. Sponsors found to have provided false, inauthentic or incomplete data risk being barred from submitting any NDAs to CFDA for three years, the firm said.

    The 1,622 applications include NDAs for drugs and biologics, as well as ANDAs for which a bioequivalence study was required. Sidley Austin had not immediately determined how many applications on CFDA's list might involve multinational pharmas.

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