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BioCentury Extra
As published Wednesday, August 26, 2015 5:36 PM PST

  • CMS panel backs current Cologuard reimbursement rate

    Exact Sciences Corp. (NASDAQ:EXAS) said CMS's Advisory Panel on Clinical Diagnostic Laboratory Tests voted 11-0, with one abstention, to maintain Medicare's reimbursement rate for Cologuard in 2016 at $492.72 per test.

    During a CMS meeting last month to discuss 2016 payment levels for clinical tests, Exact Sciences Chairman and CEO Kevin Conroy proposed that Cologuard reimbursement be continued at $492.72 based on a current procedural terminology (CPT) code created by the American Medical Association (AMA). Jacob Ma-Weaver, portfolio manager of hedge fund Cable Car Capital, had proposed a reduced reimbursement rate for the non-invasive DNA screening test for colorectal cancer. Cable Car holds a short position in Exact Sciences (see BioCentury Extra, July 16).

    Today's vote was the first by the CMS advisory panel, which was established in 2014 under the Protecting Access to Medicare Act.

    CMS is expected to publish preliminary payment levels in September and issue final reimbursement decisions around November.

    Cologuard was the first product to undergo a pilot parallel assessment by CMS and FDA. The product uses a multiplexed quantitative Invader assay for the simultaneous detection of methylated and unmethylated sequences in the promoter region of the vimentin (VIM) gene (see BioCentury Extra, Oct. 9, 2014).

    Exact rose $1.34 to $21.06 on Wednesday.

  • PTAB institutes IPRs against Teva's thrice-weekly Copaxone

    The Patent Trials and Appeals Board of the U.S. Patent and Trademark Office instituted inter partes review (IPR) proceedings challenging two patents that cover the thrice-weekly formulation of multiple sclerosis drug Copaxone glatiramer acetate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA).

    Mylan N.V. (NASDAQ:MYL) filed the IPR petitions against U.S. Patents Nos. 8,232,250 and 8,399,413 in February. Both patents expire in 2030 and claim methods of treating MS with a 40 mg dose of Copaxone three times per week. The patents are owned by Yeda Research & Development Co. Ltd. and are licensed to Teva.

    PTAB said Mylan had established a "reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim." PTAB is expected to issue a final determination in 12 months, but could extend its review for an additional six months.

    There are three Orange Book-listed patents covering the thrice-weekly formulation of Copaxone. Mylan has another IPR petition pending against the third patent, U.S. Patent No. 8,969,302, which also expires in 2030.

    In June, the U.S. Court of Appeals for the Federal Circuit invalidated the last U.S. patent for once-daily Copaxone, allowing the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to launch Glatopa, a generic version of the once-daily formulation. By the end of June, 68% of U.S. Copaxone users had been converted to the thrice-weekly dosage form (see BioCentury Extra, June 18).

    Teva gained $0.61 to $64.82 on Wednesday.

  • Sucampo launches tender offer to acquire R-Tech Ueno

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP) launched a tender offer to acquire R-Tech Ueno Ltd. (JASDAQ:4573) for Y33 billion ($273.9 million).

    R-Tech manufactures constipation drug Amitiza lubiprostone for Sucampo and its commercialization partners including Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Mylan N.V. (NASDAQ:MYL) and Harbin Gloria Pharmaceuticals Co. Ltd. (SZSE:002437). Its pipeline includes candidates in opthalmology, gastroenterology, autoimmune/inflammatory disease and oncology.

    Sucampo offered to purchase 56% of R-Tech for Y1,900 per share. Sucampo also entered an agreement with R-Tech's founders and an undisclosed entity to acquire the remaining 44% of R-Tech for Y1,400 per share. Sucampo and R-Tech were both founded by Ryuji Ueno and Sachiko Kuno.

    Both companies' boards approved the deal, which is expected to close in 4Q15.

    Moelis & Co. advised Sucampo. Cooley and Mori, Hamada & Matsumoto were its counsel.

    Sucampo gained $0.61 to $24.55 on Wednesday. R-Tech gained Y108 to Y1,278.

  • Verastem sinks after release of defactinib data

    Verastem Inc. (NASDAQ:VSTM) fell $1.70 (26%) to $4.91 on Wednesday after an abstract was released in advance of the World Conference on Lung Cancer describing a Phase II trial of defactinib (VS-6063) to treat non-small cell lung cancer (NSCLC) in patients with K-Ras (KRAS) mutations.

    The abstract said two patients in the study died due to respiratory failure. According to Verastem, both patients had advanced disease, received multiple concomitant medications and had multiple co-morbidities. Adverse events that the abstract said were "at least possibly related" to treatment occurred in 35 patients, including 11 with grade 3-5 adverse events.

    The abstract said 15 (28%) of 53 patients across the trial's four cohorts achieved progression-free survival (PFS) at 12 weeks; there was one partial response.

    Verastem Director of Corporate Development Brian Sullivan told BioCentury the study has already met its primary endpoint of PFS at 12 weeks in two of the four cohorts; data are incomplete in the other two cohorts. Verastem will present data at next month's WCLC meeting in Denver.

    Defactinib, an inhibitor of focal adhesion kinase (FAK) targeting cancer stem cells, has Orphan Drug designation in the U.S. and Europe to treat mesothelioma. Verastem expects results from an interim analysis of a Phase II trial in that indication this quarter. The company acquired exclusive, worldwide rights to defactinib from Pfizer in 2012 (see BioCentury Extra, July 11, 2012).

  • Novo plans oral semaglutide trials, invests $2B in facilities

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) plans to start seven Phase IIIa trials of oral semaglutide (NN9924) to treat Type II diabetes. The global PIONEER program will include six safety and efficacy trials and one cardiovascular trial of the long-acting glucagon-like peptide-1 (GLP-1) analog. Novo expects the first study to begin in 1Q16.

    Novo also intends to invest $2 billion over five years to construct new production facilities in Clayton, N.C., and Malov, Denmark. The company expects the new facilities to be operational in 2020. The Clayton facility will produce APIs for diabetes drugs including oral semaglutide, while the Malov production facility will create and package tablet forms of oral products.

  • Biotech, broader markets post gains

    Biotech stock indices rose sharply Wednesday after several days of instability. The BioCentury 100 surged 294.40 (4%) to 6,885.18, with gainers outnumbering decliners 96-4. The index remains 16% below its July 20 peak of 8161.20.

    The NYSE Arca Biotechnology Index (BTK), the NASDAQ Biotechnology Index (NBI) and the iShares NASDAQ Biotechnology Index (IBB) all rose 5% on Wednesday. Among broader indices, the Dow Jones Industrial Average (DJIA) and the NASDAQ both gained 4%.

  • Merus raising EUR 72.8M series C

    Merus B.V. (Utrecht, the Netherlands), which develops bispecific antibodies for cancer, raised an undisclosed amount of money in the first tranche of a EUR 72.8 million ($83.6 million) series C round led by new investors Sofinnova Ventures and Novo A/S. Other new investors included RA Capital; Rock Springs Capital; Tekla Capital Management; and an undisclosed investor. They joined existing investors Novartis Venture Fund; Johnson & Johnson Innovation-JJDC Inc.; Pfizer Venture Investments; Bay City Capital; LSP Life Sciences Partners; and Aglaia Oncology Fund.

    Merus' lead product, MCLA-128, is in Phase I/II testing for solid tumors expressing epidermal growth factor receptor 2 (HER2; EGFR2; ErbB2; neu). The antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced human common light chain bispecific IgG1 antibody targets HER2 and HER3.

    Sofinnova Ventures' Anand Mehra and Novo's Jack Nielsen joined Merus' board.

  • OMB reviews FDA's proposed rule for biological drug names

    The White House Office of Management and Budget completed its review Tuesday of a proposed rule entitled "Designation of Official Names and Proper Names for Certain Biological Products." FDA had submitted the proposed rule to OMB on Friday. FDA declined to discuss with BioCentury the content of the rule or its relation to earlier biosimilar guidance.

    In April, FDA said it planned to publish a draft guidance this year titled "Nonproprietary naming for biological products," intended to clarify the agency's thinking on biosimilar naming (see BioCentury Extra, April 29).

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