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BioCentury Extra
As published Wednesday, January 28, 2015 5:39 PM PST


  • UnitedHealth picks Harvoni

    UnitedHealth Group Inc. (NYSE:UNH) said on Wednesday that it has selected Harvoni ledipasvir/sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) as its preferred regimen to treat HCV genotype 1 over Viekira Pak from AbbVie Inc. (NYSE:ABBV).

    The decision will apply to the payer's 2015 formulary and will affect commercial, fully-insured customers in its Optum Rx pharmacy benefit manager, and self-insured customers, as well as its Medicare and Medicaid customers.

    The payer did not disclose if it would maintain any of the prior restrictions on disease severity it had in place for Harvoni.

    Several payers and PBMs have announced similar deals in the last month since Viekira was launched, with the majority of preferred decisions going to Gilead (see BioCentury, Jan. 19).

    Missouri's state Medicaid agency said earlier this week it had selected AbbVie's regimen as its preferred HCV therapy. A consortium of 24 states including Missouri, plus the District of Columbia, negotiated a rebate on Viekira (see below).

  • State Medicaid group chooses Viekira Pak

    Missouri's Medicaid agency said it will make Viekira Pak from AbbVie Inc. (NYSE:ABBV) its preferred regimen to treat HCV in exchange for undisclosed rebates. Missouri is part of a consortium of 24 states plus the District of Columbia that negotiated a rebate on Viekira.

    The AbbVie regimen will replace Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) as the preferred treatment for HCV genotype 1 patients. Missouri's Department of Social Services (DSS) said Sovaldi will still be available to the estimated 15-20% of patients who cannot tolerate Viekira.

    DSS estimated that the switch from Sovaldi to Viekira would reduce overall HCV treatment costs for the state's Medicaid program by about 30-40% and result in savings of $4.2 million in FY16.

    Jeff Myers, president and CEO of the Medicaid Health Plans of America, told BioCentury that Medicaid agencies can't outright exclude a drug, but they can put in place prior authorization and step therapy requirements that would promote use of one regimen over another.

    DSS spokesperson Rebecca Woelfel would not disclose the size of the rebate, but said that preferred formulary placement decisions are made once each year after soliciting the manufacturers for all drugs within a given class. She said Missouri made its choice "based on the best and final offers for the agents in the class."

    She added that restrictions on disease severity would remain in place. Missouri restricts access to those patients with liver fibrosis scores of F3 or greater. Patients must also test negative for illegal drugs and alcohol for three months prior to treatment.

    Woelfel said Sovaldi and Gilead's Harvoni ledipasvir/sofosbuvir would be listed as non-preferred drugs.

    AbbVie spokesperson Stefanie Prodouz told BioCentury, "The agreement with the state of Missouri is an example of how we will ensure all genotype 1 hepatitis C patients, regardless of symptoms or disease progression, gain access to treatment. We will continue to identify opportunities that will help provide appropriate patients access to Viekira Pak."

    Gilead spokesperson Cara Miller said that while states in the consortium have access to the rebate negotiated with AbbVie, Gilead is still negotiating with the consortium's remaining states "as part of our efforts to increase access to medications for more Medicaid patients."

    According to Matt Salo, executive director of the National Association of Medicaid Directors, under the purchasing consortium model, all parties in the group have access to the rebate but they don't all have to accept the rebate and its terms.

    Mario Molina, president and CEO of Molina Healthcare Inc., said his group manages Medicaid for five of the states in the consortium, including Texas, Florida, South Carolina, Wisconsin and Michigan. "They haven't notified us just yet if they will also prefer the AbbVie regimen, but they probably will," Molina said.

    The other states in the consortium are Alaska, Connecticut, Delaware, Idaho, Kentucky, Louisiana, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New York, North Carolina, Pennsylvania, Rhode Island, Tennessee, Virginia, and West Virginia, plus Washington, D.C.

    This is the first announcement of state Medicaid agencies selecting a preferred regimen for HCV. About 1 million of an estimated 3.2 million Americans with HCV are covered by Medicaid, while another 1 million receive their coverage through the private, commercial market. Another 550,000 are in prison and the remainder, about 700,000, are covered by the U.S. Department of Veterans Affairs. At least seven commercial payers and pharmacy benefit managers have announced exclusive deals for Viekira or Harvoni since December, when FDA approved the AbbVie regimen (see BioCentury, Jan. 19).

  • Applied Molecular Transport, Janssen strike IBD deal

    Applied Molecular Transport LLC (South San Francisco, Calif.) granted the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) exclusive worldwide rights to an undisclosed preclinical oral candidate to treat inflammatory bowel disease (IBD). AMT also joined Janssen's JLABS incubator in South San Francisco.

    AMT founder and CBO Tahir Mahmood said the companies are not disclosing specific financial terms. AMT is eligible for upfront fees, research support and milestones, plus royalties.

    Four-year-old AMT is developing technology to engineer molecules that can overcome gastrointestinal epithelial barriers, so that injectable products can be converted to oral forms.

  • Ascendis raises $108M in upsized IPO

    Ascendis Pharma A/S (NASDAQ:ASND) gained $0.83 to $18.83 in its first day of trading after raising $108 million in an upsized IPO on NASDAQ through the sale of 6 million American Depositary Shares (ADSs) at $18. The IPO price values Ascendis at $412.8 million. BofA Merrill Lynch; Leerink Partners; and Wells Fargo are underwriters.

    Ascendis filed to raise up to $86.3 million in December, and on Monday amended the offering to sell 5 million ADSs at $16-$18. At the midpoint it would have raised $85 million.

    The company expects top-line data in mid-2015 from a Phase II study of its TransCon PEG Growth Hormone to treat growth hormone deficiency.

  • Flex bumps up IPO, raises $86.4M

    Flex Pharma Inc. (NASDAQ:FLKS) raised $86.4 million in an upsized IPO on NASDAQ through the sale of 5.4 million shares at $16. The IPO price values Flex at $284.9 million. Last week, the neurology company proposed to sell 4.6 million shares at $12-$14.

    Flex filed in December to raise up to $60 million in the offering. Jefferies; Piper Jaffray; JMP Securities; Cantor Fitzgerald; and Roth Capital Partners are underwriters.

    The company's lead program, previously known as FLEX 767, is a transient receptor potential vanilloid 1 (TRPV1; VR1) agonist comprising naturally occurring capsaicin, capsicum, gingerol and cinnamaldehyde. Flex plans to start at least one proof-of-concept study in 2Q15 evaluating the program to treat nocturnal leg cramps (see BioCentury Extra, Dec. 29, 2014).

  • Spark upsizes proposed IPO

    Spark Therapeutics Inc. (Philadelphia, Pa.) amended its IPO on NASDAQ and now plans to sell 6.5 million shares at $19-$21. At $20, Spark would raise $130 million and be valued at $459.8 million. Last week, the gene therapy company proposed to sell 5.5 million shares at $15-$17.

    The company filed in December to raise up to $86.3 million. JPMorgan; Credit Suisse; Cowen; and Sanford C. Bernstein are underwriters.

    Spark expects data next half from a Phase III trial of lead program SPK-RPE65 (AAV2-hRPE65v2) to treat inherited retinal dystrophies, including Leber's congenital amaurosis (LCA). The adeno-associated viral (AAV) serotype 2 vector encoding the retinal pigment epithelium-specific protein 65kDa (RPE65) gene has Orphan Drug designation in the U.S. and EU for LCA, and breakthrough therapy designation to treat nyctalopia, or night blinding, in patients with LCA.

    The Children's Hospital of Philadelphia owns 53.4% of Spark pre-IPO (see BioCentury Extra, Dec. 31, 2014).

  • Kolltan withdraws IPO

    Cancer play Kolltan Pharmaceuticals Inc. (New Haven, Conn.) withdrew its proposed IPO on NASDAQ. The company did not provide a reason in its SEC filing and did not respond to inquiries. In September, Kolltan filed to raise up to $86.3 million in an offering underwritten by Leerink Partners; Stifel; Guggenheim Securities; and Janney Montgomery Scott.

    Last month, Kolltan said it expected to report data this half from its Phase Ib trial of KTN3379, a human mAb against epidermal growth factor receptor 3 (EGFR3; HER3; ErbB3), to treat advanced solid tumors.

  • PCORI to create communications panel, test PCORnet

    The Patient-Centered Outcomes Research Institute is seeking members for a new advisory panel on communication and dissemination research, which will provide guidance to PCORI and help identify topics for possible funding. PCORI is targeting 12-21 members, with at least one-quarter being patients, caregivers, or representatives of patient advocacy organizations. At least two members will have experience in health literacy, numeracy or risk communication, and at least two in dissemination and implementation research, PCORI said.

    PCORI also said it will provide $9 million to fund two observational obesity studies that will test the technical resources of PCORnet, the National Patient-Centered Clinical Research Network, which brings together data from multiple networks. The studies will include a comparative effectiveness study of multiple bariatric surgical procedures and a study comparing the risks of childhood weight gain associated with different antibiotics given before age two.

    The Affordable Care Act (ACA) established PCORI to conduct comparative effectiveness research. In December, PCORI pledged up to $50 million to fund comparative effectiveness studies on the best methods to diagnose and treat HCV (see BioCentury Extra, Dec. 9, 2014).

  • 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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