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BioCentury Extra
As published Thursday, March 26, 2015 5:50 PM PST

  • Biotech stocks steady after Wednesday's slide

    Biotech stocks traded relatively flat Thursday, recovering from moderate losses in intraday trading. The sector posted sharp declines earlier in the week as some investors feared that biotechs have become overvalued after a multi-year boom (see BioCentury Extra, March 25).

    The BioCentury 100 ended Thursday at 6,952.39, up a fraction of a percent although decliners outnumbered gainers 58 to 42. The index shed 4.6% on Wednesday and had dropped 7.6% over three days since Friday's close.

    The BioCentury 100 index is up 16% year to date, while the NASDAQ is up 3% and DJIA is off 1%.

  • Genomics England partners with industry on 100,000 Genomes Project

    Genomics England Ltd. (London, U.K.) said 10 pharma and biotech companies will form the Genomics Expert Network for Enterprises (GENE) Consortium. The group will collaborate with and analyze data from the U.K.'s 100,000 Genomes Project, which aims to sequence and study the genomes of 100,000 NHS England patients with a focus on rare diseases and cancers including breast, prostate, ovarian, hematological, pancreatic and colorectal.

    Consortium members include AbbVie Inc. (NYSE:ABBV), AstraZeneca plc (LSE:AZN; NYSE:AZN), Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Biogen (NASDAQ:BIIB), Dimension Therapeutics Inc. (Cambridge, Mass.), GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Helomics Corp. (Pittsburgh, Pa.); Roche (SIX:ROG; OTCQX:RHHBY) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). Genomics England said UCB Group (Euronext:UCB) also will be a member, but has not yet signed a contract. Genomics England plans to seek more partners.

    The consortium will begin a one-year collaboration to develop logistics and technology needed to reach the 100,000 genome goal. Consortium members will advise the project on what aspects of its data are most useful for their research, what additional data they seek, and how data should be collected to meet industry's needs.

    Each industry partner will contribute undisclosed funding and resources to the collaboration. Helomics CEO Neil Campbell said his company will contribute its Precision Cellular Analytical Platform (PCAP) tumor profiling technology to identify new biomarkers.

    Campbell said working with the U.K. group gives consortium members access to NHS patient data. Members of the GENE Consortium will have access to up to 5,000 whole genome sequences and corresponding aggregated health information about participants in the project.

    Genomics England has sequenced nearly 3,000 genomes to date, with goals of 5,000 by YE15, 35,000 in 2016 and 60,000 in 2017.

    The U.K. Department of Health established Genomics England in 2013 to lead the 100,000 Genomes Project. Last year, U.K. Prime Minister David Cameron announced a series of new investments in Genomics England totaling more than L300 million ($509.4 million) from Illumina Inc. (NASDAQ:ILMN), the Wellcome Trust, the Medical Research Council and NHS (see BioCentury Extra, Aug. 1, 2014).

  • EC approves Orexigen's Mysimba

    Orexigen Therapeutics Inc. (NASDAQ:OREX) said the European Commission approved an MAA for Mysimba naltrexone/bupropion as an adjunct to reduced-calorie diet and increased physical activity to manage weight in adults who are obese or are overweight with weight-related comorbidities. Orexigen did not disclose a launch timeline and said it will seek commercialization partners outside of North America.

    The company markets the drug as Contrave in the U.S.; sales were $6.5 million in 4Q14.

    Orexigen was up $0.33 to $7.25 on Thursday.

    A cardiovascular (CV) outcomes trial of Mysimba is slated to start this year to meet both European and U.S. approval requirements, with data expected in 2022.

    Partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) launched the fixed-dose combination of naltrexone sustained release (SR) and bupropion SR in the U.S. last October.

    Earlier this week, the EC approved an MAA for obesity drug Saxenda liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, March 23).

  • Celgene, MorphoSys end MOR202 deal

    MorphoSys AG (Xetra:MOR; Pink:MPSYF) plummeted EUR 14.05 (20%) to EUR 54.71 after it regained rights from Celgene Corp. (NASDAQ:CELG) to MOR202, a human mAb against CD38 in Phase I/II testing to treat multiple myeloma (MM). The companies mutually agreed to terminate the partnership but did not give reasons.

    An ongoing Phase I/IIa trial of MOR202 for relapsed or refractory MM will continue as planned; MorphoSys expects data this year. This half, MorphoSys plans to start new trial cohorts of MOR202 in combination with Celgene's Revlimid lenalidomide and Pomalyst pomalidomide.

    Investors likely will compare the MOR202 data with results for daratumumab from Genmab A/S (CSE:GEN; OTCBB:GMXAY) and Johnson & Johnson (NYSE:JNJ). Daratumumab, another human mAb against CD38, is in Phase III testing and has breakthrough therapy designation to treat relapsed or refractory MM (see BioCentury, Jan. 12).

    MorphoSys now expects full year revenues of EUR 101-EUR 106 million ($109-$114.4 million), up from a prior estimate of EUR 58-EUR 63 million ($62.6-$68 million), as a result of deferred revenues from the deal and a one-time payment from Celgene for 2015 development costs.

    MorphoSys and Celgene agreed in 2013 to co-develop MOR202 worldwide and co-commercialize the compound in Europe (see BioCentury Extra, June 26, 2013).

  • Sovaldi among several Japan approvals

    Japan's Ministry of Health, Labor and Welfare (MHLW) approved Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and a basket of other drugs on Thursday.

    In Japan, Gilead said Sovaldi is indicated in combination with ribavirin to treat cirrhotic and non-cirrhotic patients with HCV genotype 2 infection. Gilead said it will launch the drug as soon as possible, but did not respond to inquiries about its price.

    Gilead said the approval was based on results from a Japanese Phase III trial in which Sovaldi plus ribavirin led to an SVR12 rate of 96% in patients with genotype 2 infection, as well as results from international Phase III trials that included genotype 2 patients.

    Gilead submitted an NDA in Japan last September for a single-tablet regimen of ledipasvir and sofosbuvir to treat HCV genotype 1 infection. Gilead markets the combination elsewhere as Harvoni.

    Among MHLW's other approvals on Thursday were Opsumit macitentan, a tissue-targeting endothelin receptor antagonist from Actelion Ltd. (SIX:ATLN) and Nippon Shinyaku Co. Ltd. (Tokyo:4516) to treat pulmonary arterial hypertension (PAH); and Lenvima lenvatinib, an inhibitor of multiple VEGF receptor tyrosine kinases from Eisai Co. Ltd. (Tokyo:4523) to treat unresectable thyroid cancer.

    The ministry also approved Zafatek trelagliptin (SYR-472), a once weekly oral formulation of dipeptidyl peptidase-4 (DPP-4) inhibitor from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat Type II diabetes; and Pomalyst pomalidomide, an analog of thalidomide from Celgene Corp. (NASDAQ:CELG) to treat relapsed or refractory multiple myeloma in patients previously treated with lenalidomide and bortezomib.

    Finally, Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569) said MHLW approved Eklira Genuair, an inhalable long-acting, selective M2 and M3 muscarinic receptor antagonist delivered using the Genuair inhaler, to treat chronic obstructive pulmonary disease (COPD). Kyorin has Japanese rights to the drug from Almirall S.A. (Madrid:ALM) under a 2011 deal (see BioCentury Extra, Feb. 24, 2011).

  • Management tracks

    Jeffrey Yordon retired as chairman and CEO of specialty pharma Sagent Pharmaceuticals Inc. (NASDAQ:SGNT). Also, President James Hussey is departing. Yordon will remain a director. Board member Frank Kung will become chairman, and an executive management committee is leading the company while the board searches for a new CEO. Sagent shed $2.43 to $23.95 on Thursday.

    Genome mapping company BioNano Genomics Inc. (San Diego, Calif.) hired Terry Salyer as CCO. Salyer was VP of worldwide sales at ProteinSimple (Santa Clara, Calif.).

  • Genfit reports Phase II NASH data

    Genfit S.A. (Euronext:GNFT) said GFT505 missed the primary endpoint of the Phase IIb GOLDEN-505 trial to treat non-alcoholic steatohepatitis (NASH) according to the study's initial design. GFT505 met the endpoint after the company reanalyzed its data to account for baseline disease severity and trial site heterogeneity.

    Genfit expects to start a Phase III trial of the dual peroxisome proliferation activated receptor (PPAR) alpha and delta agonist by YE15. Genfit lost EUR 2.25 to EUR 50.85 in Paris on Thursday; it reported the data after market close. Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), which plans to begin a Phase III study this half of OCA obeticholic acid to treat NASH, gained $22.05 to $282.69 on Thursday.

    The primary endpoint of GOLDEN-505 was disease resolution, defined as reaching a NAFLD Activity Score (NAS) of zero on any one of three histological components, without worsening fibrosis. Genfit said there was an unexpectedly high incidence of disease resolution in the trial's placebo arm among patients with mild disease (NAS=3). The study enrolled 274 patients with NASs ranging from 3 to 8.

    Genfit said the treatment met the endpoint in the total (p=0.016) and intent-to-treat (p=0.027) populations after the company applied a statistical analysis that controlled for baseline disease severity, as well as for the high number of trial sites with a small sample size. It did not release uncorrected results.

    Genfit management said on a conference call that the upcoming Phase III trial will exclude patients with a baseline NAS of 3 and will measure fibrosis. The company said the 52-week Phase II trial was too short to assess improvement in fibrosis.

    The company said GFT505 led to improvements in liver, cardio-metabolic and inflammatory biomarkers, and resulted in no adverse cardiac events, cancer signals or deaths.

  • Conatus' emricasan meets Phase II endpoint

    Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) jumped $1 (17%) to $6.76 on Thursday after it said pan-caspase inhibitor emricasan met the primary endpoint of a Phase II trial to treat non-alcoholic fatty liver disease (NAFLD).

    In the 38-patient trial, which included a subset of patients with non-alcoholic steatohepatitis (NASH), emricasan reduced alanine amino transferase (ALT) levels by 39% at day 28 vs. 14% in the placebo arm (p<0.05). Conatus said the compound also significantly reduced the levels of three serum biomarkers that were elevated at baseline: caspase-cleaved cytokeratin 18 (CK18; KRT18), full-length CK18 and caspase 3/7.

    Conatus declined to say when it will start a Phase III trial, but said it will discuss with FDA surrogate endpoints that could be used for accelerated approval to treat patients with NASH-driven cirrhosis.

    Conatus reported no treatment-related serious adverse events, dose-limiting toxicities or adverse effects on lipid levels or insulin sensitivity.

  • Flagship closes $537M Fund V

    Flagship Ventures closed its oversubscribed Flagship Ventures Fund V at $537 million, exceeding its original target of $300 million. Flagship plans to invest the fund in 25-30 companies, with up to 75% going to healthcare companies and the remainder to the sustainability sector. Flagship CEO and senior managing partner Noubar Afeyan did not specify how much of the fund would be allocated to therapeutics, but said the sector "has been and will continue to be the majority of what we do."

    Afeyan declined to name the fund's limited partners, but said they included a mix of existing and new investors.

    Flagship plans to launch 4-5 newcos out of its VentureLabs unit per year, compared to about 2 per year previously. VentureLabs has launched companies including mRNA play Moderna Therapeutics Inc. (Cambridge, Mass.) and microbiome company Seres Health Inc. (Cambridge, Mass.) (see BioCentury, Aug, 18. 2014).

    Flagship portfolio companies that have gone public include Bind Therapeutics Inc. (NASDAQ:BIND), Receptos Inc. (NASDAQ:RCPT), Agios Pharmaceuticals Inc. (NASDAQ:AGIO), Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) and Acceleron Pharma Inc. (NASDAQ:XLRN).

    Flagship also promoted Douglas Cole to managing partner from general partner and David Berry to general partner from partner.

  • Cerenis raises EUR 53.4M in Euronext IPO

    Cardiovascular play Cerenis Therapeutics S.A. (Euronext:CEREN) raised EUR 53.4 million ($57.7 million) through the sale of 4.2 million shares at EUR 12.70 in an IPO on Euronext. The IPO price values Cerenis at EUR 225.9 million ($234.9 million). CM-CIC Securities and Gilbert Dupont were underwriters. Cerenis expects its shares to begin trading March 30.

    Cerenis is developing a portfolio of high-density lipoprotein therapies. It expects data in 1Q17 from a Phase II study of CER-001 to treat post-acute coronary syndrome (ACS), and plans to conduct a Phase III study of the compound to treat familial primary hypoalphalipoproteinemia. The complex of recombinant apolipoprotein A-1 (APOA1) and charged phospholipids received Orphan Drug designation from the European Commission last September to treat APOA1 and ATP-binding cassette transporter 1 (ABCA1) deficiencies.

    Cerenis' investors include Sofinnova Partners, which said it remains Cerenis' "main investor" after the listing; HealthCap; Alta Partners; Fonds Strategique d'Investissement (FSI); TVM Capital; EDF Ventures; OrbiMed Advisors; Daiwa Bank Investment; and iXO Private Equity.

  • OSE Pharma raises EUR 21.1M in IPO

    OSE Pharma S.A. (Euronext:OSE) raised EUR 21.1 million ($22.8 million) in an IPO through the sale of 2 million shares at EUR 10.80. The price, which was the top of its proposed range of EUR 8-EUR 10.80, values the company at EUR 107.8 million ($116.4 million). OSE's shares are slated to begin trading March 30. Invest Securities served as lead manager, bookrunner and financial advisor.

    Next half, OSE plans to start a Phase III trial of lead candidate Tedopi to treat advanced non-small cell lung cancer (NSCLC) in patients who express the HLA-A2 receptor and have failed first-line therapy. Tedopi has Orphan Drug designation in the U.S. to treat NSCLC. The vaccine contains 10 modified epitopes directed against 5 tumor-associated antigens.

  • Market Entry Strategy and Planning with Campbell Alliance

    Find a commercialization partner, or go it alone? This decision involves not only strategic questions regarding a company's identity and core competencies, but also multiple value drivers that are easy to overlook. This article examines how a value-based approach can help companies position themselves to ensure their business plans contribute to a product's success and an improved return on investment. Download your copy now!

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