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BioCentury Extra
As published Tuesday, April 15, 2014 4:30 PM PST


  • PanOptica secures $45 million in series B

    Ophthalmology play PanOptica Inc. (Mount Arlington, N.J.) secured $45 million in a tranched series B round co-led by new investor Novo Ventures and existing investor Third Rock Ventures. Existing investor SV Life Sciences also participated. PanOptica said the tranches are tied to milestones related to PAN-90806, but declined to disclose details, including how much the company raised in the first tranche. Novo's Thomas Dyrberg will join PanOptica's board.

    PAN-90806 is in Phase I testing as a topical treatment for wet age-related macular degeneration (AMD), with data expected by year end. PanOptica has exclusive, worldwide rights to the small molecule selective inhibitor of VEGF for ophthalmic indications from OSI Pharmaceuticals Inc., which Astellas Pharma Inc. (Tokyo:4503) acquired (see BioCentury, Jan. 10, 2011).

  • Court temporarily halts Massachusetts Zohydro ban

    A judge in the U.S. District Court for the District of Massachusetts granted a preliminary injunction stopping Massachusetts' statewide ban on pain drug Zohydro ER hydrocodone bitartrate from Zogenix Inc. (NASDAQ:ZGNX). Last month, Massachusetts authorities prohibited the prescription or sale of Zohydro ER until FDA approves an abuse deterrent formulation after Gov. Deval Patrick declared opiate addiction a public health emergency. Zogenix filed suit challenging Patrick's executive order (see BioCentury Extra, April 7).

    Zogenix said the preliminary injunction becomes effective on April 22, after which Zohydro ER will be available in Massachusetts while the suit is ongoing. The product is an oral, non-abuse deterrent extended-release (ER) formulation of hydrocodone. There are no scheduled upcoming hearings listed on the docket for the suit.

    Zogenix was off $0.11 to $2.34 on Tuesday.

  • FDA approves GSK's albiglutide

    FDA approved Tanzeum albiglutide from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat Type II diabetes as monotherapy or as add-on therapy. GSK plans to launch Tanzeum in the U.S. next quarter, but declined to comment on pricing. The drug is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist comprised of two copies of modified human GLP-1 fused in series to human albumin. Tanzeum has a black box warning on the risk of thyroid C cell tumors and was approved with a REMS comprising a communication plan. GSK is required to conduct a postapproval cardiovascular outcomes trial; the pharma declined to comment on a timeline for starting the trial.

    The European Commission approved albiglutide as Eperzan last month (see BioCentury Extra, March 26).

  • Prosonix, Mylan in generic respiratory deal

    Prosonix Ltd. (Oxford, U.K.) granted Mylan Inc. (NASDAQ:MYL) rights to market generic versions of asthma product Flixotide/Flovent from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in several regions, including the U.S., EU, Canada and Japan. Prosonix's generics -- PSX1001 and PSX1050 -- are formulations of fluticasone monotherapy in pressurized metered dose inhalers. Prosonix plans to submit an MAA to EMA for PSX1001 this year based on in vitro equivalence data. PSX1050 is the same formulation of fluticasone as PSX1001 but the inhaler includes a dose counter. Prosonix and Mylan aren't disclosing further details. GSK reported L796 million ($1.3 billion) in 2013 worldwide sales of Flixotide/Flovent.

    Mylan was up $0.20 to $46.23 on Tuesday.

  • IQWiG rebuffs Novo's NovoEight

    Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that NovoEight turoctocog alfa from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) has "no additional benefit" vs. other Factor VIIIs (FVIIIs) to treat and prevent bleeding in hemophilia A patients. IQWiG said the company did not submit relevant studies or "valid data" from other sources. Comments are due May 6, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in early July. Novo also markets the third-generation recombinant FVIII (rFVIII) in the U.S. and Japan.

  • Germany again rebuffs Trobalt

    Germany's Federal Joint Committee (G-BA) again concluded that epilepsy drug Trobalt retigabine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) has "no additional benefit" vs. individualized antiepileptic therapy. According to G-BA, GSK did not submit complete, necessary data. The pharma, which does not market Trobalt in Germany, did not provide next steps in time for publication. Comments on the assessment are due May 6, with a final assessment from G-BA expected in early July.

    This is the second assessment for Trobalt in Germany. In 2012, G-BA said Trobalt had no additional benefit, and GSK requested a new benefit assessment. Last year, EMA updated Trobalt's label to restrict its use to last-line therapy in patients with partial epilepsy (see BioCentury Extra, Aug. 15, 2013).

  • NICE recommends ESAs for cancer treatment anemia

    The U.K.'s NICE issued draft guidance that now recommends erythropoietin-stimulating agents (ESAs) epoetin and darbepoetin to treat cancer treatment-associated anemia. NICE said the most plausible incremental cost-effectiveness ratio (ICER) for the six recommended ESAs was below L20,000 ($33,460) per quality-adjusted life year (QALY) after taking into account the benefits of avoiding blood transfusions and the use of ESAs only for starting hemoglobin concentrations in line with marketing authorizations. NICE recommends six ESAs, including Eprex epoetin alfa from Johnson & Johnson (NYSE:JNJ), NeoRecormon epoetin beta from Roche (SIX:ROG; OTCQX:RHHBY) and Aranesp darbepoetin alfa from Amgen (NASDAQ:AMGN). Comments are due May 9.

    The draft guidance will replace 2008 final guidance from NICE that recommended against routine use of erythropoietin analogs -- including Eprex, NeoRecormon and Aranesp -- for cancer treatment-associated anemia, except in women receiving platinum-based chemotherapy for ovarian cancer and in patients with very severe anemia who couldn't receive blood transfusions (see BioCentury Extra, May 28, 2008).

    Amgen was up $1.68 to $115 on Tuesday.

  • WuXi snags AZ's Yang as COO

    WuXi PharmaTech Inc. (NYSE:WX) hired Steve Yang as EVP and COO. Yang was VP and head of the Asia and emerging markets innovative medicines unit (iMED) at AstraZeneca plc (LSE:AZN; NYSE:AZN). He succeeds Edward Hu, who will remain CFO and become chief investment officer.

    WuXi was up $0.47 to $35.13 on Tuesday.

  • J&J reports first simeprevir sales

    Johnson & Johnson (NYSE:JNJ) reported 1Q14 earnings on Tuesday, including $354 million in worldwide sales of Olysio simeprevir in the HCV drug's first full quarter of sales. U.S. sales of the drug were $291 million for the quarter. The pharma launched the HCV NS3/4A protease inhibitor in the U.S., Canada and Japan in December. J&J's Janssen Research & Development LLC unit has ex-Nordic rights to develop and commercialize simeprevir from Medivir AB (SSE:MVIR B), which was up SEK1.25 to SEK108.25 on Tuesday.

    J&J's worldwide pharmaceuticals sales were $7.5 billion in the quarter, up 11% from $6.8 billion in 1Q13.

  • The Column Group targeting $250 million for second fund

    Biotech VC firm The Column Group has raised $175.9 million of a planned $250 million for its second fund, according to an SEC filing. The firm could not be reached for details in time for publication. According to its website, The Column Group invests $15-$30 million in 10-12 companies per fund; the firm closed its first fund with about $250 million in 2008, according to an SEC filing. The Column Group's portfolio includes cancer company Igenica Inc. (Burlingame, Calif.) and cancer vaccine play Immune Design Corp. (Seattle, Wash.).

  • Gene therapy play AAVLife secures $12 million

    AAVLife (Paris, France) secured $12 million in a series A round led by new investor Versant Ventures. New investor French National Institute of Health and Medical Research (Inserm) Transfert Initiative also participated. AAVLife is developing an adeno-associated virus (AAV) vector encoding the frataxin gene to treat Friedreich's ataxia. Next year, the company plans to start a Phase I/II trial to evaluate the gene therapy to treat cardiac dysfunction associated with Friedreich's ataxia.

  • Quotient lowers IPO range

    Transfusion diagnostics company Quotient Ltd. (Penicuik, U.K.) amended its planned IPO on NASDAQ to lower the proposed price range. The company now plans to sell 5 million shares at $9-$11. At the $10 midpoint, Quotient would raise $50 million and be valued at $143.8 million. Earlier this month, the company said it planned to sell the shares at $14-$16. UBS; Baird; and Cowen are underwriters.

    Quotient markets reagents for characterizing blood and serological disease screening for the transfusion diagnostics market. The company is also developing MosaiQ, a fully automated high throughput instrument for blood grouping and serological disease screening. Quotient reported $14.4 million in revenues for the fiscal year ended March 31, 2013.

  • Angion files for IPO

    Angion Biomedica Corp. (Uniondale, N.Y.) filed to raise up to $34.5 million in an IPO on NASDAQ underwritten by Aegis Capital. Angion's BB3 is in Phase II testing to treat delayed graft function in renal transplant recipients. The company also plans to resume a Phase II trial of BB3 for acute myocardial infarction (MI) upon completion of the IPO and to start a Phase II trial for acute kidney injury (AKI) in the next six to nine months. BB3 is a hepatocyte growth factor/scatter factor (HGF/SF) mimetic.

  • FDA reschedules risk-benefit assessment meeting

    FDA rescheduled for May 12 a public meeting to be held with Institute of Medicine (IOM) to discuss sources of uncertainty in assessing the benefits and risks of drugs and the implications on regulatory decision-making. The meeting was originally scheduled for Feb. 13, but was postponed due to weather (see BioCentury Extra, Nov. 8, 2013).

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