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BioCentury Extra
As published Tuesday, September 30, 2014 8:26 PM PST

  • J&J buying Alios for $1.75B

    Johnson & Johnson (NYSE:JNJ) is acquiring Alios BioPharma Inc. (South San Francisco, Calif.) for $1.75 billion in cash. The pharma receives Alios' antiviral assets, including AL-8176 to treat respiratory syncytial virus (RSV).

    In July, the oral nucleoside analog met the primary endpoint of reducing viral load vs. placebo in a Phase II trial to treat RSV infection. AL-8112 was the only asset that J&J singled out in its brief announcement of the acquisition. According to BioCentury's BCIQ database, AL-8112 is one of two oral RSV treatments in Phase II testing. The other is GS-5806, an RSV fusion inhibitor from Gilead Sciences Inc. (NASDAQ:GILD).

    Alios' pipeline includes a preclinical RSV nucleoside analog, AL-8112.

    Alios also has an HCV pipeline that includes nucleotide NS5B polymerase inhibitor ALS-2200, also known as VX-135, and two unnamed preclinical candidates. In 2011, Alios granted Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) exclusive worldwide rights to ALS-2200. In May, Vertex said it would exit the HCV business and seek to out-license VX-135. J&J and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) have each tested VX-135 in combination with their own HCV therapies.

    Founded in 2007, Alios had raised $73 million in two rounds, primarily from four strategic investors: the Novo Ventures unit of Novo A/S (Hellerup, Denmark); the SR One investment arm of GSK; the Roche Venture Fund unit of Roche (SIX:ROG; OTCQX:RHHBY); and the Novartis Ventures unit of Novartis AG (NYSE:NVS; SIX:NOVN). An unnamed investor led the biotech's $41 million series B round in April.

    The deal is expected to close by year end. Goldman, Sachs was Alios' financial advisor and Latham & Watkins was legal advisor.

    Achillion Pharmaceuticals Inc. (NASDAQ:ACHN), which has been the subject of takeover speculation, lost $0.79 to $9.98 on Tuesday. Its pan-genotypic, second-generation HCV NS5A protein inhibitor ACH-3102 and selective inhibitor of HCV NS3 protease sovaprevir are both in Phase II.

    Gilead shares were down $1.06 to $106.45 on Tuesday.

  • Pfizer, Kyowa partner on cancer combo trial

    Pfizer Inc. (NYSE:PFE) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) will co-fund a Phase Ib trial of Pfizer's PF-05082566 plus Kyowa's Poteligeo mogamulizumab to treat solid tumors. Pfizer will run the U.S. trial, which is expected to start next year.

    PF-05082566 is a mAb agonist of tumor necrosis factor (TNF) receptor superfamily member 9 (TNFRSF9; 4-1BB; CD137) that is in Phase I testing for multiple tumor types. Poteligeo, a humanized mAb against CC chemokine receptor 4 (CCR4; CD194), is approved in Japan to treat the following CCR4-positive cancers: T cell leukemia-lymphoma, relapsed or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL).

    In February, Pfizer and Merck & Co. Inc. (NYSE:MRK) partnered to run a Phase I cancer trial of PF-05082566 plus Merck's Keytruda pembrolizumab, a humanized IgG4 mAb against PD-1 receptor (PDCD1; PD-1; CD279).

  • MacroGenics, Takeda announce second DART deal

    MacroGenics Inc. (NASDAQ:MGNX) granted Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) an option to license exclusive, worldwide rights to four programs against undisclosed jointly selected targets. The products will be developed using MacroGenics' Dual-Affinity Re-Targeting (DART) technology.

    Takeda will fund all R&D activities and reimburse MacroGenics' expenses. The partners declined to disclose specific indications, but Takeda did say the deal includes autoimmune disorders. MacroGenics is eligible for up to $400 million in milestones, plus double-digit royalties for each product. Additionally, MacroGenics has the option to co-promote each product in the U.S. and may elect to fund a portion of Phase III testing of each product in exchange for an undisclosed North American profit share.

    In May, MacroGenics granted Takeda an option to license exclusive, worldwide rights to preclinical autoimmune compound MGD010 following a Phase Ia trial. MGD010 is a bispecific antibody against CD32B and CD79B molecule immunoglobulin-associated beta (CD79B; B29) that was developed using MacroGenics' DART technology.

    MacroGenics was up $0.89 to $20.90 on Tuesday.

  • Ebola plays up after Texas diagnosis

    Post-market traders bid up prices of Ebola plays after the CDC and the Texas Department of State Health Services said a patient in a Texas hospital has been diagnosed with the infection. The agencies said the diagnosis is the first in the U.S.

    The patient was placed into isolation at Texas Health Presbyterian Hospital after admission Sunday. The patient traveled from Liberia to the U.S. on Sept. 20, but did not exhibit symptoms until Sept. 24.

    Several companies investigating Ebola treatments gained in early postmarket trading, many of them in double-digits. Tekmira Pharmaceuticals Corp. (NASDAQ:TKMR) was up $6.51 (31%) to $27.65. NewLink Genetics Corp. (NASDAQ:NLNK) was up $2.94 (14%) to $24.36. BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) gained $1.41 (14%) to $11.19. Sarepta Therapeutics Inc. (NASDAQ:SRPT) was up $1.74 to $22.84.

  • Stem cell play ReproCell creates VC fund

    ReproCell Inc. (JASDAQ:4978) and Shinsei Bank, a subsidiary of Shinsei Corporate Investment Ltd., raised Y800 million ($7.28 million) for Cell Innovation Partners LP.

    The venture fund will invest in companies in Japan, the U.S. and Europe that are developing pluripotent cells and regenerative medicine technology. According to ReproCell, the vehicle aims to provide "growth funds" to develop "early practical application" of next-generation technologies in the space. The fund plans to invest Y51.6-Y104 million ($0.5-$1 million) per company.

    ReproCell and Shinsei each are investing Y350 million, and SMBC Strategic Fund No. 2 Investment Limited Partnership is investing Y100 million. The partners had been targeting Y1 billion ($9.7 million) for the fund.

    ReproCell markets induced pluripotent stem cell (iPSC)-derived cardiomyocytes, neurons and hepatocytes for drug discovery. The company also markets primary cells for diabetes research and media and reagents for embryonic stem cells and iPSCs.

  • FDA starts clock on LDT regulation

    On Tuesday, FDA released two draft guidance documents that outline the agency's plans for regulating laboratory-developed tests (LDTs). The draft guidance is largely in line with documents pre-released in July (see BioCentury, August 11).

    Amendments include an updated definition of companion diagnostics to reflect FDA's Aug. 6 final guidance on companion diagnostics, and a technical amendment to the agency's choice of wording regarding traditional LDTs.

    There will be a 120-day comment period after the "Framework for Regulatory Oversight of Laboratory Developed Tests" and "FDA Notification and Medical Device Reporting for Laboratory Developed Tests" are officially issued Oct. 3.

    Stakeholders including the College of American Pathologists (CAP) and Genomic Health Inc. (NASDAQ:GHDX) released neutral statements indicating they would participate in the open comment period.

    Alan Mertz, president of the American Clinical Laboratory Association, reiterated ACLA's issues with imposing FDA oversight for products currently regulated under the Clinical Laboratory Improvement Amendments (CLIA). "There is great concern in the lab community that additional and duplicative regulation will hamper the ability of researchers and sciences to continue their groundbreaking work," he said.

  • CMS says payments database is "first wave"

    CMS released what it called its "first wave" of its Open Payments database, which details consulting fees, research grants, travel reimbursements, and "other" gifts healthcare companies provided to physicians and teaching hospitals during the last five months of 2013.

    Open Payments, mandated by the Physician Payments Sunshine Act -- part of the Affordable Care Act -- contains 4.4 million payments valued at nearly $3.5 billion to 546,000 physicians and about 1,360 teaching hospitals, according to the Medicare agency.

    While CMS said financial transactions between health care companies and providers "do not necessarily signal wrongdoing," PhRMA and BIO both reiterated concerns the database would not provide context for transactions that would enable Open Payment users to evaluate the nature of the industry-healthcare provider relationship. Indeed, according to Tuesday's CMS announcement, "Open Payments does not identify which financial relationships are beneficial and which could cause conflicts of interest. It simply makes the data available to the public."

    The database will include 12 months of payment data beginning in June 2015. CMS also noted it was unable to verify many transactions reported in the system, and said about 40% of the records had been de-identified as a result until the discrepancies can be rectified in 2015.

  • NIAID funds development of new vaccine adjuvants

    NIH's National Institute of Allergy and Infectious Diseases awarded five-year contracts to seven research institutions developing new vaccine adjuvants that boost responses by activating the adaptive immune system. The agency said total funding for all seven contracts could reach $70 million.

    NIAID said the awardees will use computer models to screen molecules for adaptive immune responses, identify and structurally modify promising candidates, and test the optimized candidates in animal models.

    Contracts were awarded to the University of California, San Diego (La Jolla, Calif.); Boston Children's Hospital (Boston, Mass.); Vaxine Pty. Ltd. (Garran, Australia); the Corixa Corp. (Seattle, Wash.) unit of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); Duke University (Durham, N.C.); Oregon Health & Science University (Portland, Ore.); and University of Kansas (Lawrence, Kan.).

    Corixa, UCSD, UK and three other universities also received five-year contracts to discover vaccine adjuvants in 2009 (see BioCentury Extra, Oct. 8, 2009).

  • NIH awards $46M in BRAIN initiative grants

    NIH issued $46 million in grants to support 58 research projects that are part of the Brain Research through Application of Innovative Neurotechnologies (BRAIN) initiative. Most of the grants are for new neuroscience tools and techniques, such as using lasers to guide nerve cell firing and stimulating circuits with radio waves.

    NIH, the National Science Foundation, FDA and the Defense Advanced Research Projects Agency (DARPA) are contributing more than $110 million to the BRAIN initiative for fiscal year 2014. President Obama announced the BRAIN initiative last year as a public-private partnership to give "scientists the tools they need to get a dynamic picture of the brain in action and better understand how we think and how we learn and how we remember."

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