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BioCentury Extra
As published Thursday, February 26, 2015 6:10 PM PST

  • FDA approves Sanofi's Toujeo

    Sanofi (Euronext:SAN; NYSE:SNY) said FDA approved its Toujeo insulin glargine to improve glycemic control in adults with Type I and Type II diabetes. Sanofi expects to launch the drug and announce its price early next quarter.

    The 300 units/mL formulation of insulin glargine, a synthetic sustained-release subcutaneous insulin analog, is intended to provide prolonged duration of action compared to the pharma's Lantus insulin glargine (100 units/mL) at single subcutaneous doses. Sanofi has said that it expects Toujeo to eventually replace Lantus, which had 2014 sales of EUR 6.3 billion ($7.2 billion).

    However, Toujeo's label does not include data from clinical trials in which it showed a benefit over Lantus in nocturnal hypoglycemia rate. Bernstein analyst Tim Anderson wrote in a note that the Toujeo label is "probably going to be viewed as more undifferentiated than investors have been expecting" without the hypoglycemia data, making it more difficult for Sanofi to promote its benefit to physicians, patients and prescribers. However, at least one payer told BioCentury last year that it didn't think Toujeo or any of the other next-generation insulins would have significant enough benefits on hypoglycemia to warrant premium pricing (see BioCentury, Nov. 17, 2014).

    In October, Sanofi said sales in its diabetes franchise would be flat in 2015 due to competitive pricing in the U.S. (see BioCentury Extra, Oct. 28, 2014).

    There are at least two competitors to Sanofi's insulin products waiting in the wings. Basaglar from Eli Lilly and Co. (NYSE:LLY), has tentative approval from FDA, but cannot receive full approval until 2016, pending the outcome of patent litigation with Sanofi. Basaglar is not a biosimilar, but according to Lilly has the same amino acid sequence as Lantus. Tresiba insulin degludec from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) is under review in the U.S. and also could be available by 2016.

  • Pharmacyclics holds gains after takeout rumors

    Pharmacyclics Inc. (NASDAQ:PCYC) held onto most of Wednesday's gains on rumors that the biotech is considering takeout bids from Johnson & Johnson (NYSE:JNJ) and Novartis AG (NYSE:NVS; SIX:NOVN) in the range of $17-$18 billion.

    Its shares fell $2.50 to $217.72 on Thursday after jumping $31.77 (17%) to $220.22 on Wednesday. At $16.5 billion, its market cap remains below the rumored takeout value.

    Pharmacyclics shares U.S. rights to Imbruvica ibrutinib with the Janssen Biotech Inc. unit of J&J; Janssen holds ex-U.S. rights to the drug. FDA approved Imbruvica for its fourth indication, Waldenstrom's macroglobulinemia (WM), in January. It is also approved to treat chronic lymphocytic leukemia (CLL) in patients with 17p deletion and to treat CLL in patients who have received one prior therapy, and has accelerated approval to treat mantle cell lymphoma (MCL) (see BioCentury Extra, Jan. 29).

    Novartis' blood cancer offerings include Gleevec imatinib and Tasigna nilotinib. FDA approved its Faradyk panobinostat earlier this week to treat multiple myeloma (MM) (see BioCentury Extra, Feb. 23).

    Pharmacyclics and J&J declined to comment on the reports; Novartis did not respond to inquiries.

    Pharmacyclics has gained $3.6 billion in market cap since its Feb. 18 4Q14 earnings announcement, when it guided for $1 billion in 2015 sales of Imbruvica. The company pictured an improved launch trajectory for the drug that includes label expansion of the Bruton's tyrosine kinase (Btk) inhibitor to 1-2 additional indications per year.

  • Otonomy submits NDA for AuriPro

    Otonomy Inc. (NASDAQ:OTIC) submitted an NDA to FDA for AuriPro, a sustained-release gel formulation of ciprofloxacin, to treat middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.

    Otonomy based its submission on results of two Phase III trials, in which a single intratympanic injection of AuriPro met the primary endpoint of reducing the cumulative proportion of study treatment failures (p<0.001) (see BioCentury Extra, July 8, 2014).

    The company plans to develop AuriPro for additional undisclosed indications this half.

    Otonomy gained $2 to $35.92 on Thursday.

  • Management tracks

    Ophthalmology company Ohr Pharmaceutical Inc. (NASDAQ:OHRP) hired Avner Ingerman as chief clinical officer. Ingerman was formerly VP of ophthalmology at Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).

    Cancer vaccine play Targovax A/S (Lysaker, Norway) hired Oystein Soug as CFO, effective June 1. Soug was CFO of Algeta ASA, which Bayer AG (Xetra:BAYN) acquired last year.

    Diagnostics company Sera Prognostics Inc. (Salt Lake City, Utah) named Douglas Fisher CBO. Fisher resigned from the company's board. He is an executive in residence at InterWest Partners, a Sera investor.

  • Boehringer places clinical hold on BACE inhibitor

    Vitae Pharmaceuticals Inc. (NASDAQ:VTAE) lost $3 to $10.28 in after-hours trading Thursday after it said partner Boehringer Ingelheim GmbH (Ingelheim, Germany) voluntarily placed a temporary clinical hold on a German Phase I multiple ascending-dose trial of BI1181181.

    The partners are developing the beta-site APP-cleaving enzyme 1 (BACE1) inhibitor to treat and prevent Alzheimer's disease. The hold was placed to investigate skin reactions seen in an undisclosed number of patients during the trial.

    Boehringer has exclusive, worldwide rights to Vitae's BACE1 inhibitors under a 2009 deal.

    Vitae fell $0.62 to $13.28 on Thursday. The announcement was made after market close.

  • Lyric debuts with $20.4M series A

    Gastrointestinal newco Lyric Pharmaceuticals Inc. (South San Francisco, Calif.) raised $20.4 million in a series A round led by RiverVest Venture Partners; Sante Ventures; and Third Point Ventures. Aperture Venture Partners also participated.

    Lyric said the round will fund two clinical trials of an in-licensed candidate. President and CEO David Wurtman said Lyric expects data this year from a trial that the company began last week. He said it would then begin a proof-of-concept trial, with data expected in mid-2017.

    Wurtman declined to disclose details of the licensing deal, and said Lyric will not reveal details about the candidate for about a year.

    In 2014, RiverVest led Lyric's $825,000 seed round, which also included angel investors.

  • Illumina raises $40M for accelerator matching fund

    Illumina Inc. (NASDAQ:ILMN) raised $40 million from Viking Global Investors for its Accelerator Boost Capital fund, which will provide dollar-for-dollar matching funds for graduates of its Illumina Accelerator. The Boost fund will match any amount a company raises between $1 million and $5 million during its six-month funding cycle within the accelerator program.

    The accelerator provides start-ups developing next-generation sequencing (NGS) applications with six months of seed funding, business guidance and access to its sequencing systems and San Francisco Bay Area facilities (see BioCentury Extra, Feb. 12, 2014).

    Illumina Accelerator began incubating its first three companies in October 2014: therapeutics company Encoded Genomics Inc. (San Francisco, Calif.), veterinary technology developer EpiBiome Inc. (San Francisco, Calif.) and diagnostics play Xcell Biosciences Inc. (San Francisco, Calif.). Illumina declined to disclose whether the companies have raised any money.

  • Relypsa raises $150M in follow-on

    Metabolic and renal play Relypsa Inc. (NASDAQ:RLYP) raised $150.2 million through the sale of 3.9 million shares at $38.50. BofA Merrill Lynch; Cowen; Oppenheimer; Stifel; and Wedbush PacGrow were underwriters. Relypsa proposed the offering after market close on Tuesday when its shares were valued at $38.27.

    Relypsa's NDA for patiromer to treat hyperkalemia is under FDA review. The PDUFA date for the high-capacity oral potassium binder is Oct. 21.

    Relypsa lost $0.51 to $38.97 on Thursday.

  • Reps. reintroduce bill user fee exemption bill

    Reps. Anna Eshoo (D-Calif.) and Leonard Lance (R-N.J.) reintroduced a bill in the U.S. House of Representatives that would exempt FDA user fees from sequestration. The legislators argued that the fees are paid exclusively by industry and used for the approval of lifesaving drugs and devices.

    Eshoo and Lance were among four members of Congress who first introduced the FDA Safety Over Sequestration Act, or FDA SOS Act, in July 2013 (see BioCentury Extra, July 18, 2013).

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