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BioCentury Extra
As published Thursday, April 17, 2014 5:53 PM PST

  • FDA approves Ragwitek

    FDA approved a BLA from Merck & Co. Inc. (NYSE:MRK) for Ragwitek, a ragweed sublingual allergy immunotherapy tablet (AIT), to treat ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, in patients 18 to 65 years of age. Merck said Ragwitek will be available in the U.S. by the end of the month. The U.S. approval triggers an undisclosed milestone payment from Merck to ALK-Abello A/S (CSE:ALK-B) and comes on the heels of FDA's approval on Monday of a BLA from Merck for Grastek, a grass pollen sublingual AIT (see BioCentury Extra, April 14).

    Merck has exclusive North American rights from ALK-Abello to develop and commercialize a portfolio of AITs against grass pollen, ragweed and house dust mite allergy. The Nordic markets were closed on Thursday.

  • FDA approves Arzerra for first-line CLL

    FDA approved an sBLA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanding the label for Arzerra ofatumumab to include first-line treatment of chronic lymphocytic leukemia (CLL). The new indication covers the use of Arzerra in combination with chlorambucil when fludarabine-based therapy is inappropriate. An application to add the first-line indication to Arzerra's European label is still under review. The pharma already markets the human mAb against CD20 in the U.S. and EU to treat CLL refractory to fludarabine and alemtuzumab.

    GSK has worldwide co-development and commercialization rights to Arzerra from partner Genmab A/S (CSE:GEN; OTCBB:GMXAY). The Nordic markets were closed on Thursday.

    In 2012, Sanofi (Euronext:SAN; NYSE:SNY) and its Genzyme Corp. unit withdrew MabCampath/Campath alemtuzumab from the European and U.S. market. Sanofi now markets alemtuzumab as Lemtrada in Europe for relapsing forms of multiple sclerosis (MS).

  • CRUK starting multi-arm lung cancer trial

    Next half, Cancer Research UK (London, U.K.) will start the non-comparative Phase II National Lung Matrix trial to evaluate compounds for non-small cell lung cancer (NSCLC) in small groups of 15-25 patients whose tumors are more likely to benefit based on a genetic mutation. Patients will be screened with a next-generation sequencing panel covering mutations, amplifications and translocations for 28 genes. The trial will evaluate "signs of improvement, such as increased survival, tumour shrinkage or an alleviation of symptoms." The trial will initially evaluate up to 12 compounds from AstraZeneca plc (LSE:AZN; NYSE:AZN) and two from Pfizer Inc. (NYSE:PFE), but CRUK said it hopes more drugs will be added by additional partners and that new trial arms will be able to "plug in and drop out." The not-for-profit and pharmas are funding the trial, with support from NHS.

    CRUK said National Lung Matrix is building on the first phase of its Stratified Medicine Program, which is seeking to find cancer biomarkers and establish a genetic testing service in the U.K. AZ and Pfizer are industry partners for the program (see BioCentury Extra, Nov. 22, 2011).

    National Lung Matrix will be similar to at least two other comparative lung cancer trials that are incorporating upfront genetic screening and are designed to test multiple new investigational drugs simultaneously: the ongoing Phase II BATTLE-2 trial for NSCLC; and the Phase II/III Lung-MAP trial for squamous cell lung cancer, which is slated to start this quarter. The not-for-profit Friends of Cancer Research (FOCR) is developing Lung-MAP (see BioCentury, Nov. 4, 2013).

  • Galapagos reports Phase IIa psoriasis data for GSK2586184

    According to Galapagos N.V. (Euronext:GLPG; Pink:GLPYY), partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said twice-daily 400 mg oral GSK2586184 met the primary endpoint of a greater proportion of patients achieving a PASI 75 response at week 12 vs. placebo in the Phase IIa JAK116679 trial to treat chronic plaque psoriasis. Galapagos and GSK declined to disclose whether the twice-daily 100 and 200 mg doses of GSK2586184 met the endpoint. The double-blind, German and U.K. trial enrolled 66 patients with chronic plaque psoriasis. GSK, which conducted the trial, said it will review the complete data from all trials with GSK2586184 before determining next steps.

    In February, GSK discontinued due to "lack of effect" a Phase II trial evaluating GSK2586184 to treat systemic lupus erythematosus (SLE) after the first planned interim analysis met undisclosed pre-defined stopping criteria. At the same time, the pharma also placed a Phase I/II trial for ulcerative colitis (UC) on hold. Galapagos said the UC trial remains on hold (see BioCentury Extra, Feb. 28).

    In 2012, GSK exercised an option to license exclusive, worldwide rights to develop and commercialize GSK2586184, a Janus kinase-1 (JAK-1) inhibitor, from Galapagos. Galapagos was up EUR 0.18 to EUR 15.71 on Thursday.

  • Heart Metabolics secures $20 million in series A

    Heart Metabolics Ltd. (Dublin, Ireland) raised an undisclosed amount in the first tranche of a planned $20 million series A round from venBio; Seroba Kernal Life Sciences; Brandon Capital Partners; and AshHill. Heart Metabolics is repurposing the generic drug perhexiline for hypertrophic cardiomyopathy (HCM), with plans to start a U.S. Phase III trial early next year. The company said it will receive the second tranche of the A round upon obtaining an SPA from FDA for the trial.

    Perhexiline was originally approved in the 1960s in the U.K. and EU to treat angina, but had limited use due to idiosyncratic nerve and liver toxicities and was subsequently withdrawn. The small molecule inhibitor of carnitine palmitoyl transferase 1 (CPT1) and CPT2 has been available in Australia and New Zealand since 1990 for angina with a requirement to monitor drug plasma levels.

    venBio's Robert Adelman, Seroba's Alan O'Connell and Brandon Capital's Stephen Thompson joined Heart Metabolics' board.

  • Fertility play Nora raises $18 million in series B

    Nora Therapeutics Inc. (Palo Alto, Calif.) raised $18 million in a series B round led by new investor Novo A/S. Existing investors Burrill; Prospect Venture Partners; Rho Ventures; and Vivo Capital also participated. Nora's NT100 is in the Phase II THRIVE-IVF trial to improve pregnancy outcomes for women with a history of failed in vitro fertilization (IVF). This quarter, the company also plans to start the Phase II RESPONSE trial in women with unexplained recurrent pregnancy loss. NT100 is a recombinant human G-CSF (CSF3). Novo's Heath Lukatch will join Nora's board.

  • Ampio subsidiary Vyrix files for IPO

    The Vyrix Pharmaceutical Inc. subsidiary of Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) filed to raise up to $28.8 million in an IPO on NYSE MKT. Aegis Capital and Fordham are underwriters. Ampio carved off its sexual dysfunction business into Vyrix in December. Vyrix's lead product is Zertane tramadol, an oral fast-dissolving tablet formulation of tramadol hydrochloride in development for premature ejaculation (PE). Next half, Vyrix plans to submit an IND for a pair of U.S. Phase III trials, with the goal of starting the trials "soon after the IND becomes effective."

    Ampio was off $0.08 to $5.44 on Thursday.

  • Actelion reports first full quarter of Opsumit sales

    Actelion Ltd. (SIX:ATLN) reported CHF15 million ($16.9 million) in the first full quarter of sale of the pulmonary arterial hypertension (PAH) drug. The company launched the tissue-targeting endothelin receptor antagonist in the U.S. in November and in Canada and Europe earlier this year. In February, Actelion said it expects peak sales of Opsumit to exceed those of its PAH drug Tracleer bosentan, which had 1Q14 sales of CHF383 million ($432.1 million), up from CHF375 million ($394.7 million) in 1Q13.

    Actelion reported 1Q14 core EPS of CHF1.46, up from CHF1.23 in 1Q13. Sales for the quarter rose 13% to CHF469 million ($529.2 million) from CHF433 million ($455.7 million) in 1Q13. The company reiterated that it expects low single-digit core earnings growth in 2014. All percent changes are in constant currencies. The company was up CHF0.15 to CHF85.85 on Thursday.

  • HCV therapies cost UnitedHealth $100M in 1Q14

    On a conference call to discuss the company's 1Q14 earnings, UnitedHealth Group Inc. (NYSE:UNH) CFO Dan Schumacher said the insurer recorded a little more than $100 million in costs in the quarter for HCV treatments, which President and CEO Stephen Hemsley said was a result of "the rapid launch of an effective and very expensive" new HCV therapy. Hemsley declined to provide specifics, but said the "aggressive U.S. pricing practices on this have been well-publicized, and continues to be quite controversial." Hemsley added that UnitedHealth is "working diligently to ensure this medication is applied under clinically appropriate standards." Schumacher attributed the costs to pent-up demand and said UnitedHealth's costs are "not inconsistent with what folks are seeing across the industry."

    Gilead Sciences Inc. (NASDAQ:GILD) has been under pressure from insurers and pharmacy benefit managers as well as patient groups and legislators to reduce the price of its newly launched HCV drug Sovaldi sofosbuvir, which has a wholesale acquisition cost (WAC) of $84,000 for a 12-week course. Earlier this month, pharmacy benefit manager Express Scripts Holding Co. (NASDAQ:ESRX) said it expects U.S. specialty drug spending to grow 63% by 2016 compared to 2013, driven primarily by a predicted 1,800% increase in spending on HCV drugs like Sovaldi.

  • White House provides update on ACA figures

    Eight million people have enrolled in health plans offered on state and federal health insurance exchanges, according to figures released by the White House on Thursday. The number exceeds the 6 million the Congressional Budget office (CBO) estimates would be enrolled through the marketplaces by the end of 2014. Of the enrollees through federally run marketplaces, 35% are under 35 years of age and 28% are aged 18-34.

  • NHS England creates Sovaldi fund

    NHS England approved L18.7 million ($31.3 million) in funding to treat advanced HCV patients with Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD). Treatment will be limited to patients at significant risk of death or who require liver transplantation, a population NHS estimates at about 500 patients. The U.K.'s NICE is reviewing Sovaldi for chronic HCV, with a first appraisal committee meeting scheduled for May 15.

    Gilead was up $0.72 to $70 on Thursday.


    Most North American and European markets are closed on Friday, April 18, in observance of Good Friday. BioCentury Extra will publish as needed on Friday, and will resume regular postings on Monday, April 21.

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