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BioCentury Extra
As published Tuesday, September 23, 2014 7:05 PM PST

  • Molecular Partners files for IPO

    Ophthalmic and cancer company Molecular Partners AG (Schlieren, Switzerland) said it is planning to raise CHF125 million ($133.1 million) in an IPO on the SIX Swiss Exchange in 4Q14.

    Molecular's lead compound is Abicipar pegol (AGN-150998), a designed ankyrin repeat protein (DARPin) that antagonizes VEGF-A. It is partnered with Allergan Inc. (NYSE:AGN) and is in Phase II testing to treat wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Molecular said Allergan expects to start a Phase III trial in wet AMD in 2Q15.

    The company's most advanced cancer therapy, a DARPin called MP0250, is in Phase I testing to treat solid tumors.

  • Galmed surges on NASH news

    Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) jumped $2.45 (38%) to $8.93 on Tuesday after FDA granted Fast Track designation to Aramchol arachidyl amino cholanoic acid to treat non-alcoholic steatohepatitis (NASH).

    Galmed plans to begin a Phase IIb trial of the fatty acid bile-acid conjugate (FABAC) in 240 obese and insulin resistant patients with NASH by year end. No drugs are currently approved to treat NASH.

    Other companies developing NASH therapies, including Conatus Pharmaceuticals Inc. (NASDAQ:CNAT), Galectin Therapeutics Inc. (NASDAQ:GALT), Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) and Raptor Pharmaceuticals Corp. (NASDAQ:RPTP), were relatively unchanged in Tuesday trading. Conatus was unchanged at $6.12; Galectin was down $0.18 to $5.06; Intercept gained $0.51 to $247.75; and Raptor slipped $0.45 to $9.95.

  • FDA approves Celgene's Otezla for psoriasis

    FDA approved an sNDA from Celgene Corp. (NASDAQ:CELG) for Otezla apremilast to treat moderate to severe plaque psoriasis. Celgene said the oral drug is the only approved phosphodiesterase-4 (PDE-4) inhibitor for the indication. In March, FDA approved Otezla to treat adults with active psoriatic arthritis.

    Otezla is under review in Canada and Europe for psoriatic arthritis and psoriasis.

    Celgene was up $0.93 to $93.12 on Tuesday.

  • T2 gains on approval of fungal tests

    T2 Biosystems Inc. (NASDAQ:TTOO) jumped $1.62 (10%) to $18.55 on Tuesday after FDA approved the company's T2Candida Panel and T2Dx instrument to detect Candida pathogens that lead to sepsis.

    The two products use magnetic biosensor technology to detect Candida species from whole blood samples, enabling detection within about four hours versus two or more days with current blood-culture based diagnostic methods.

  • ZS Pharma jumps on ZS-9 Phase III data

    ZS Pharma Inc. (NASDAQ:ZSPH) gained $3.69 (11%) to $38.05 on Tuesday after announcing positive Phase III data for lead candidate ZS-9 sodium zirconium cyclosilicate for hyperkalemia.

    Preliminary results from the HARMONIZE trial (ZS004) showed all three dose levels of once-daily ZS-9 (5, 10 and 15 g) met the primary endpoint of preventing hyperkalemia recurrence compared with placebo over a 28-day treatment cycle. Last year, ZS-9 met the primary endpoint of reducing serum potassium levels from baseline to 48 hours vs. placebo in the Phase III ZS-003 trial to treat hyperkalemia.

    Data from HARMONIZE will be presented at the American Heart Association scientific meeting in November. In 1H15, ZS Pharma plans to submit an NDA to FDA and an MAA to EMA for ZS-9.

  • DBV jumps on peanut allergy data

    DBV Technologies (Euronext:DBV) jumped EUR 5.82 (23%) to EUR 31.24 on Tuesday after reporting Phase IIb data for Viaskin Peanut (DBV-712) on Monday. At the high dose of 250 ug, Viaskin Peanut met its primary endpoint of desensitizing significantly more patients with peanut allergies after 12 months vs. placebo (p=0.0108).

    DBV evaluated 50, 100 and 250 ug Viaskin Peanut patches applied daily for 24 hours. Among those receiving the high dose, 50% responded to treatment vs. 25% receiving placebo. DBV said full results will be presented at future meetings. The company plans to begin a Phase III trial in 1Q16.

    Viaskin Peanut, which delivers peanut proteins epicutaneously by Viaskin patch technology, has Fast Track designation in the U.S. to treat peanut allergy. In June, the Consortium of Food Allergy Research (CoFAR) completed enrollment in the U.S. Phase II CoFAR6 trial of Viaskin Peanut once daily for 30 months.

    Also on Monday, DBV filed to raise up to $96 million through the sale of 3 million ADSs on NASDAQ in a deal underwritten by Citigroup; Leerink; Bryan, Garnier; and Trout Capital. Each ADS will represent one ordinary share.

  • More mixed data for Egalet's analgesic

    Egalet Corp. (NASDAQ:EGLT) said 15 mg Egalet-001 missed one endpoint for bioequivalence to 15 mg MS Contin morphine sulfate controlled-release oral tablets from Purdue Pharma L.P. (Stamford, Conn.). In Study 067-EG-006, Egalet-001 met bioequivalence criteria based on area under the curve (AUC) concentration but did not meet bioequivalence criteria based on maximum plasma concentration (Cmax). A 100 mg dose of the compound missed similar criteria in two previous bioequivalence trials (see BioCentury, August 6).

    Egalet said it will need to run more trials and hopes to meet with FDA next quarter to discuss a registration path. A Phase III trial of Egalet-001 in individuals with chronic low back pain is slated to begin enrollment in 1Q15, and an NDA is planned for mid-2016. Prior to the results from the trio of bioequivalence studies, Egalet had hoped to submit an NDA to FDA in 4Q14 under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products.

    Egalet, which announced the news post-market, was down $0.37 to $9.31 on Tuesday.

  • Eureka raises $21M in C round

    Cancer company Eureka Therapeutics Inc. (Emeryville, Calif.) raised $21 million in an untranched series C round led by new investor Yuan Capital. Additional new investor Majuven and existing investors Acorn Campus Ventures, Suma Venture and Harbinger Venture Capital also participated.

    Eureka's lead product is ESK1, a preclinical mAb against Wilm's Tumor 1 (WT1). In January, Eureka and Memorial Sloan Kettering Cancer Center granted Novartis AG (NYSE:NVS; SIX:NOVN) exclusive, worldwide rights to develop and commercialize the mAb (see BioCentury Extra, Jan. 28).

  • OIG calls for federal healthcare coupon safeguards

    HHS's Office of the Inspector General said current safeguards are insufficient to prevent consumers from using coupons to fund drug copayments to federal healthcare programs such as Medicare Part D.

    In a report, OIG found that although manufacturers took precautions to prevent the improper use, coupons could still be used to pay for Medicare Part D drugs. The report said manufacturers are at risk of violating anti-kickback laws and may be subject to sanctions if they do not take appropriate steps to prevent unpermitted use.

    Copayment coupons are offered by drug manufacturers to incentivize use of drugs. The report said coupon use may drive up Medicare Part D costs because it encourages beneficiaries to choose more expensive branded drugs over cheaper alternatives. The report does not estimate the cost increase, but noted that other surveys have suggested 6-7% of the 36 million people using Medicare Part D, potentially more than 2 million people, could be using coupons for copayments.

    OIG recommended that CMS work with stakeholders to improve transparency in the system, including facilitating verification of Medicare Part D enrollment and making manufacturer coupons more clearly identifiable. In a statement included in the report, CMS agreed with OIG's recommendation.

    Late last year, CMS and HHS gave mixed messages about ACA-related drug coupons and payment assistance (see BioCentury, Nov. 11, 2013).

  • FDA plans REMS studies

    FDA published a draft report, "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which outlines four projects aimed at "reducing the burden of implementing" REMS for patients and healthcare practitioners.

    The planned projects follow a July 2013 public meeting on REMS that was held as part of the agency's PDUFA V commitments. According to the draft report, FDA plans to conduct research into REMS patient counseling tools to improve communications about the benefits and risks of drugs that have REMS; to evaluate the feasibility of providing continuing education certification specific to a REMS; to identify an approach for using Structured Product Labeling to standardize and integrate REMS into pharmacy systems and other health IT systems, including electronic prescribing; and to develop a webpage as a "central source of REMS information."

    Details of the proposed projects and documents from the 2013 meeting are posted on FDA's website.

  • Simplify adaptive trial execution with AptivAdvantage

    Integrate project, data and site management in one flexible and seamless platform. AptivAdvantage combines EDC, randomization and drug supply management, making it easy to manage multiple interim analyses and facilitate data driven monitoring while minimizing operational bias and maintaining trial integrity. Watch the video to learn more.

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