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BioCentury Extra
As published Wednesday, July 01, 2015 5:47 PM PST

  • Baxalta makes its debut

    Baxter International Inc. (NYSE:BAX) spun out its innovative biopharmaceuticals unit, Baxalta Inc. (NYSE:BXLT), as a separate public company. In its first day of trading on Wednesday, Baxalta shares lost $0.44 to $31.50.

    Baxalta has 14 marketed drugs in core areas of hematology, immunology and oncology. Its worldwide net sales were $6 billion in 2014.

    John Orloff, Baxalta's head of R&D and CSO, told BioCentury the company's pipeline is focused on indications where "there are key unmet needs and we can play in our own sandbox." Baxalta's pipeline includes at least 12 clinical programs, plus two biosimilars: BAX 2200, a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN) in Phase III; and BAX 923, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV) in Phase I.

    Based on the 676.4 million shares outstanding cited in Baxalta's prospectus, the company ended Wednesday with a market cap of $21.3 billion. Baxter holds a 19.5% stake in Baxalta.

  • Gilead uses Priority Review voucher for HIV regimen

    Gilead Sciences Inc. (NASDAQ:GILD) submitted a Priority Review voucher along with an NDA to FDA for a single-tablet regimen combining its Emtriva emtricitabine and tenofovir alafenamide plus Edurant rilpivirine from Johnson & Johnson (NYSE:JNJ) to treat HIV-1 infection in patients aged 12 and older.

    In November 2014, Gilead paid Knight Therapeutics Inc. (TSX:GUD) $125 million for the voucher, which was issued under FDA's tropical disease program (see BioCentury Extra, Nov. 19, 2014).

    Gilead plans to submit an MAA to EMA for the combination this quarter.

    Tenofovir alafenamide is a prodrug of tenofovir, the active agent in Gilead's Viread tenofovir disoproxil fumarate for HIV and HBV infection. Viread is a nucleotide analog prodrug reverse transcriptase inhibitor. Emtriva is a nucleotide analog reverse transcriptase inhibitor (NRTI). Edurant is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor (NNRTI).

  • Novo pulling Tresiba in Germany

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said Wednesday it will no longer market Tresiba insulin degludec in Germany after failing to agree on a price with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband).

    Novo EVP of China, Pacific & Marketing Jakob Riis told BioCentury the company markets Tresiba at a price of about EUR 2.50 per day and that GKV-Spitzenverband offered less than EUR 1 per day.

    In December, Germany's Federal Joint Committee (G-BA) said the long-acting insulin analog has "no additional benefit" compared to other long-acting insulins in combination with short-acting insulin to treat Type I and II diabetes

    Novo markets Tresiba in Europe and Japan; the drug is under review in the U.S. to treat Type I and II diabetes. Novo received a complete response letter in 2013 from FDA for Tresiba; it resubmitted an NDA with data from a CV outcomes trial (see BioCentury Extra, April 7).

    Novo will continue supplying Tresiba in Germany through the end of September.

  • Exelixis falls on delayed cobimetinib NDA review

    Exelixis Inc. (NASDAQ:EXEL) was off $0.27 to $3.49 on Wednesday after FDA pushed back the PDUFA date for melanoma therapeutic cobimetinib to Nov. 11 from Aug. 11.

    Exelixis said FDA changed the date after Exelixis' partner, the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), submitted additional analyses requested by the agency of previously submitted data from the Phase III coBRIM trial.

    In February, FDA granted Priority Review to the MEK inhibitor in combination with Roche's marketed BRAF inhibitor Zelboraf vemurafenib to treat metastatic melanoma in patients with BRAF V600 mutations. An MAA for the combination is under EMA review.

    In May, data from coBRIM showed the combination increased progression free survival (PFS) to 12.3 months vs. 7.2 months for Zelboraf alone (HR=0.58, 95% CI: 0.46, 0.72).

    Genentech has worldwide rights to cobimetinib from Exelixis, which in 2013 exercised its option to co-promote the compound in the U.S.

  • AZ completes antibiotics spin-out

    AstraZeneca plc (LSE:AZN; NYSE:AZN) completed its previously announced spin-out of its early stage antibiotics programs into stand-alone company Entasis Therapeutics Inc. (Waltham, Mass.). AZ was the sole investor in the biotech's $40 million series A round in March.

    Entasis' lead candidate is ETX0914 (AZD0914), a benzisoxazole DNA gyrase inhibitor against Neisseria gonorrhoeae in Phase II testing to treat uncomplicated gonorrhea. ETX0914 has Qualified Infectious Disease Product (QIDP) and Fast Track designations from FDA. Entasis' preclinical portfolio includes candidates targeting Gram-negative pathogens such as Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae.

    AZ previously said it will retain its marketed anti-infectives, late-stage small molecule infection programs and the biologic anti-infectives portfolio in its MedImmune LLC unit (see BioCentury Extra, Feb. 27).

    Entasis' President and CEO is Manos Perros. He was head of infection and site lead for Boston R&D at AZ. Its CSO, Ruben Tommasi, was AZ's EVP of infection chemistry.

    Entasis also named Michael Fitzgerald as CFO and Chris White as CBO. Fitzgerald was SVP and CFO at Link Medicine Corp. (Cambridge, Mass.). White was CBO at AMAG Pharmaceuticals Inc. (NASDAQ:AMAG).

  • Management tracks

    Cancer play NuCana BioMed Ltd. (Edinburgh, U.K.) named Chris McGuigan CSO. McGuigan is professor of medicinal chemistry at the Cardiff School of Pharmacy and Pharmaceutical Sciences and chair of Life Sciences Hub Wales Ltd. (Cardiff, Wales).

    Cardiovascular play Bellerophon Therapeutics Inc. (NASDAQ:BLPH) named Amit Agrawal COO. Agrawal was director of strategy and corporate development at Amgen Inc. (NASDAQ:AMGN).

    Celldex Therapeutics Inc. (NASDAQ:CLDX) promoted Richard Wright to SVP and chief commercial officer from VP of commercial operations.

    Gene editing company Editas Medicine (Cambridge, Mass.) named Andrew Hack CFO. Hack was a portfolio manager at Millennium Management.

    Hematology play Merganser Biotech Inc. (Newtown Square, Pa.) named Remy Sukhija COO. Sukhija was VP and leader of the hemophilia business unit at Biogen Inc. (NASDAQ:BIIB).

  • Xenon tumbles after Phase IIb OA miss

    Xenon Pharmaceuticals Inc. (NASDAQ:XENE) fell $2 (17%) to $9.53 after its topical TV-45070 failed in a Phase IIb trial to treat chronic pain in patients with osteoarthritis of the knee. The company said 4% and 8% topical formulations of the sodium channel sub-type Nav.1.7 (SCN9A) blocker were no more effective than placebo at reducing walking pain from baseline.

    "Our best hypothesis may be insufficient drug exposure in the knee joint," Xenon President and CEO Simon Pimstone told a conference call.

    Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA) holds exclusive, worldwide rights to the compound under a 2012 deal. Pimstone said the partners do not plan to continue developing TV-45070 in OA. Topical TV-45070 is also in a Phase IIb trial to treat postherpetic neuralgia (PHN), with results due in 2H16.

  • Kiadis raises EUR 32.7M in IPO

    Kiadis Pharma B.V. (Euronext:KDS) raised EUR 32.7 million ($36.2 million) through the sale of 2.6 million shares at EUR 12.50 in an IPO underwritten by Kempen; KBC Securities; and Peel Hunt. The IPO price values the company at EUR 166.4 million ($184.2 million). Kiadis expects its shares to begin trading on Thursday.

    Last month, Kiadis said it hoped to sell 2.3 million shares at EUR 11-13.75. A sale of that many shares at the midpoint of EUR 12.38 would have raised EUR 28.1 million ($31.1 million) and valued the company at EUR 160.5 million ($177.6 million).

    Kiadis is conducting a Phase II trial of ATIR101, a cell-based therapy containing mismatched donor lymphocytes depleted of alloreactive T cells, to reduce transplant-related mortality following hematopoietic stem cell transplant (HSCT). The therapy has Orphan Drug designation in the U.S. and EU.

    Kiadis also said it intends to run an exploratory clinical trial of ATIR201 for inherited blood disorders.

  • Corvus reveals $33.5M series A round

    Immuno-oncology play Corvus Pharmaceuticals Inc. (Burlingame, Calif.) disclosed that it raised $33.5 million in a series A round in December 2014. OrbiMed Advisors led the round, and Novo Ventures and Adams Street Partners also participated.

    Corvus' management team includes several executives from Pharmacyclics Inc. Its CEO, Richard Miller, and CFO, Leiv Lea, held the same titles at Pharmacyclics. AbbVie Inc. (NYSE:ABBV) completed its $21 billion acquisition of Pharmacyclics in May.

    Corvus' lead compound is an oral immune checkpoint inhibitor. Miller told BioCentury Corvus in-licensed the candidate, but would not say from where; he said it has been studied in Phase I and II trials to treat indications other than cancer. He declined to disclose its target. Corvus expects to begin Phase Ib testing of the candidate in early 2016 to treat solid tumors.

    OrbiMed's Peter Thompson, Novo's Peter Moldt and Adams Street Partners' Terry Gould joined Corvus' board.

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