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BioCentury Extra
As published Friday, May 01, 2015 5:50 PM PST


  • Gilead climbs on 1Q15 earnings

    Gilead Sciences Inc. (NASDAQ:GILD) gained $4.52 to $105.03 on Friday, adding $6.7 billion in market cap to $156 billion as investors reacted to the company's 1Q15 earnings, released after market close on Thursday.

    The biotech beat the Street's estimate and raised its 2015 full year net product sales guidance to $28-$29 billion from $26-$27 billion. The company also revealed additional details about the level of access its HCV drugs Harvoni ledipsavir/sofosbuvir and Sovaldi sofosbuvir have on formularies (see BioCentury Extra, April 30).

    EVP of Commercial Operations Paul Carter said on Thursday's conference call that the biotech has negotiated and signed contracts that account for about 90% of the covered lives in the U.S. "Of that 90%, 83% have direct access to Harvoni either through an exclusive arrangement or through a parity arrangement."

    The company also said it expects to end the year at a gross-to-net of 46% for its HCV drugs. Carter clarified on the call that the figure did not represent the size of the rebate or discount it was providing to payers. On the company's 4Q14 earnings call, the biotech had suggested that these figures were the same as the rebates. On Thursday, Gilead didn't reveal the average size of rebates for its HCV drugs (see BioCentury Extra, Feb. 4).

    President and COO John Milligan said that with the Harvoni and Sovaldi launches going well, Gilead was open to M&A opportunities. "I want to stick very closely to the kinds of areas that we're in today," he said, adding that the company tends to look for deals "where we can have an impact on Phase III and where we can accelerate those products either into the approval process or into greater indications after the approval process."

  • Medicines Co. gains on twin approvals

    The Medicines Co. (NASDAQ:MDCO) announced its second approval of a therapy within 24 hours late Thursday, when it said the agency approved Ionsys, a transdermal fentanyl patch, to manage acute post-operative pain in hospitalized adults. Earlier in the day, FDA had approved Raplixa, a dry powder topical fibrin sealant composed of fibrinogen and thrombin previously known as FibroCaps, to treat mild to moderate surgical bleeding.

    The Medicines Co. gained both therapies through acquisitions. In 2013, it acquired ProFibrix B.V., which developed Raplixa. The previous year, it bought Incline Therapeutics Inc., which developed Ionsys (see BioCentury Extra, Aug. 5, 2013 and BioCentury Extra, Dec. 12, 2012).

    Incline shareholders were eligible for $205 million in regulatory and sales milestones under the terms of the acquisition. Incline had acquired rights to Ionsys from Johnson & Johnson (NYSE:JNJ), which had received FDA and EMA approval for Ionsys in 2006. J&J never launched the product in the U.S.; it was recalled in Europe in 2008 due to a manufacturing defect, which The Medicines Co. has said Incline fixed subsequently.

    The Raplixa approval triggers a milestone payment of undisclosed size to ProFibrix shareholders and Vectura Group plc, from which ProFibrix had licensed a dry powder technology used in Raplixa.

    Medicines Co. expects to launch both therapies in 3Q15.

    The stock gained $1.46 to $27.07 on Friday. The Ionsys approval was announced after market close Thursday.

  • Bass challenges second Tecfidera patent

    Hedge fund manager Kyle Bass filed a new patent challenge on Friday against multiple sclerosis (MS) drug Tecfidera dimethyl fumarate from Biogen Inc. (NASDAQ:BIIB), the latest in a string of challenges to marketed drugs and his second challenge of Tecfidera.

    The Coalition for Affordable Drugs V, an entity associated with Bass, filed an inter partes review (IPR) with the U.S. Patent and Trademark Office challenging U.S. Patent No. 8,399,514, which covers Tecfidera and expires in 2028. The '514 patent is the last to expire among seven Orange Book-listed patents covering Tecfidera.

    The IPR argues that various claims in the '514 patent are obvious, and that the specific dosage of 480 mg/day of dimethyl fumarate (DMF) to treat MS protected by the patent is not inventive and therefore unpatentable.

    Biogen reported $2.9 billion in global Tecfidera sales in 2014, including $2.4 billion in U.S. sales.

    Bass already is challenging U.S. Patent No. 8,759,393, which also covers Tecfidera and expires in 2019 (see BioCentury Extra, April 22).

    Last month, the PTO's Patent Trials and Appeals Board declared a patent interference between the '514 patent and patent application 11/576,871 from Forward Pharma A/S (Copenhagen, Denmark), which also covers 480 mg/day of DMF to treat MS. The board declared Forward the senior party, giving Biogen the burden of proof to show that it invented the technology before Forward (see BioCentury Extra, April 14).

    Biogen gained $12.29 to $386.22 on Friday.

  • Nektar bounces after reporting earnings

    Nektar Therapeutics (NASDAQ:NKTR) gained $1.96 (21%) to $11.48 on Friday after delivering some unanticipated news with its 1Q15 earnings.

    On Thursday's call, CEO Howard Robin highlighted that partner AstraZeneca plc (LSE:AZN; NYSE:AZN) has successfully obtained preferred formulary access for Movantik naloxegol, its newly launched therapy for opioid-induced constipation (OIC). AZ launched the pegylated form of the peripheral mu opioid receptor (OPRM1; MOR) antagonist naloxol in the U.S. on March 31, triggering a $100 million milestone payment that helped Nektar beat Street expectations (see BioCentury Extra, March 31).

    Nektar posted EPS of $0.25, beating consensus estimates of a loss of $0.40. Most analysts had not anticipated it would recognize the Movantik milestone during the quarter.

    The company also said it expects to begin a clinical study by YE15 of cancer immunotherapy NKTR-214, an immunostimulatory cytokine engineered to selectively activate IL-2 receptors on cytotoxic cells.

    Friday's gains still leave Nektar well below its 52-week high of $17.05 set last Dec. 1. The shares are off 26% YTD.

  • Merck, PeptiDream to develop macrocycles

    Merck & Co. Inc. (NYSE:MRK) and PeptiDream Inc. (Tokyo:4587) have partnered to use the biotech's Peptide Discovery Platform System (PDPS) to generate macrocycles against multiple undisclosed targets selected by Merck.

    Merck will have the right to develop and commercialize the macrocycles, and has an option to non-exclusively license the PDPS technology. PeptiDream will receive an upfront payment and research funding, and is eligible for preclinical and clinical development milestones, plus royalties. Merck spokesperson Ian McConnell declined to disclose financial details or disease areas included in the deal.

    Merck has previously funded at least two macrocycle projects. In December 2014, Merck awarded macrocycle company Encycle Therapeutics Inc. (Toronto, Ontario) the first grant under its Canadian translational initiative. Before that, Merck and three other pharmas helped fund the creation of Encycle's target-agnostic library of 1,500 nacellin macrocycles. Each pharma has the right to screen the library against two targets of its choice (see BioCentury Innovations, Dec. 4, 2014 and BioCentury, Aug. 4, 2014).

    PeptiDream said it has at least nine ongoing partnerships to develop macrocycles and has licensed its PDPS to Novartis AG (NYSE:NVS; SIX:NOVN) and Bristol-Myers Squibb Co. (NYSE:BMY).

    The news came after market close in Tokyo; PeptiDream fell Y510 to Y11,440 on Friday.

  • FDA approves Vernalis' Tuzistra XR

    Vernalis plc (LSE:VER) said FDA approved Tuzistra XR to treat cough and common cold symptoms in adults. The product is an extended-release formulation of codeine polistirex and chlorpheniramine polistirex using the OralXR+ extended release formulation technology from Tris Pharma Inc. (Monmouth Junction, N.J.).

    In a presentation discussing the approval, Vernalis said it will be ready to launch the product by the start of cold season in September.

    Vernalis obtained exclusive North American commercial rights to Tuzistra XR from Tris in 2012. Tris SVP of Strategy and Corporate Development Peter Ciano said the approval triggers a milestone payment of undisclosed size to Tris.

    Vernalis gained 8.25p (16%) to 59.50p on Friday.

  • Management tracks

    Autoimmune company Horizon Pharma plc (NASDAQ:HZNP) named John Thomas EVP of strategy and investor relations. Thomas was VP of investor relations and public affairs for Abbott Laboratories (NYSE:ABT).

    Cancer company Sorrento Therapeutics Inc. (NASDAQ:SRNE) hired Mark Durand as CFO. Durand was CFO and SVP of finance and business development at Watson Pharmaceuticals Inc., now known as Actavis plc (NYSE:ACT).

    Drug delivery play Zosano Pharma Corp. (NASDAQ:ZSAN) rehired Thorsten von Stein as CMO. von Stein was CMO at Zosano from 2009-14.

  • Financial tracks

    Lazard named Alexander Stern CEO of financial advisory and Matthieu Pigasse global head of M&A and sovereign advisory. Stern was COO at Lazard, and Pigasse was CEO of Lazard France.

  • Personalized oncology: A roadmap

    Personalized oncology promises to transform cancer treatment but significant obstacles remain. L.E.K. Consulting outlines major barriers to realizing the vision of personalized oncology and highlights the importance of integrated data, as well as some organizations poised to succeed. Click here to download your copy.


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