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BioCentury Extra
As published Monday, September 22, 2014 7:09 PM PST


  • Merck buying Sigma-Aldrich for $17B

    Merck KGaA (Xetra:MRK) will acquire Sigma-Aldrich Corp. (NASDAQ:SIAL) for about $17 billion in cash. Merck will pay $140 per share, a 37% premium to Sigma-Aldrich's Friday close of $102.37, before the news was announced Monday. Merck will finance the deal with cash, bank loans and bonds.

    Sigma-Aldrich distributes chemical and biochemical products, provides laboratory kits and services, and manufactures biopharmaceuticals. The company also has an e-commerce platform. It posted revenues of $2.7 billion in 2013.

    Merck said the acquisition would complement its EMD Millipore division, headquartered in Billerica, Mass. Merck said it will maintain a presence in St. Louis, Mo., where Sigma-Aldrich is headquartered, but did not disclose further details.

    The deal is expected to close mid-2015. Sigma-Aldrich's board approved the deal, and Sigma-Aldrich will hold a special meeting of shareholders to approve the deal; a date has not been disclosed. No Merck shareholder vote is required.

    On Monday Merck was up $3.03 to $72.63 and Sigma-Aldrich was up $34.03 (33%) to 136.40.

  • Avalon, GSK launch two newcos

    Avalon Ventures and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) launched Silarus Therapeutics Inc. (San Diego, Calif.) and Thyritope Biosciences Inc. (San Diego, Calif.). Each may receive up to $10 million in series A financing, comprising $3 million in equity investment from Avalon and up to $7 million in R&D support from GSK. The companies will be housed at Avalon's COI Pharmaceuticals incubator, and funded on a quarterly basis.

    Silarus is developing small molecules targeting erythroferrone to treat iron deficiency and iron overload disorders. The hormone, which acts on the hepcidin pathway, regulates iron supply for red blood cell production. Silarus licensed IP from researchers at the University of California, Los Angeles.

    Thyritope is targeting thyroid stimulating auto-antibodies, which cause Graves' hyperthyroidism and Graves' orbitopathy. No approved treatments exist for Graves' orbitopathy, the increase of orbital fat and muscle volume that results in bulging eyes associated with Graves' hyperthyroidism.

    Avalon and GSK partnered in April 2013 to fund 10 new early stage companies, of which Silarus and Thyritope are the second and third. Each expects to identify a clinical candidate within three to four years. The pharma has the option to buy each company prior to IND-enabling studies; if it does not exercise its option, the ownership reverts to Avalon.

    Celiac disease company Sitari Pharmaceuticals Corp. (La Jolla, Calif.) was the partners' first launch, in November 2013 (see BioCentury, Nov. 25, 2013).

  • Pfizer, Circle in macrocycle deals

    Circle Pharma Inc. (San Francisco, Calif.) announced two collaborations with Pfizer Inc. (NYSE:PFE) to design and develop macrocyclic peptides against two undisclosed Pfizer targets. Circle will develop the peptides using computational design algorithms, and Pfizer will test them in undisclosed indications.

    Circle also announced that Pfizer and Mission Bay Capital, the venture affiliate of California Institute for Quantitative Biosciences (QB3), invested in the biotech's June seed round of undisclosed size. Circle is developing its own in-house pipeline of macrocyclic peptides against epigenetic cancer targets.

  • Auxilium board affirms QLT deal

    The board of Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) unanimously reaffirmed its proposed merger agreement with ophthalmic play QLT Inc. (NASDAQ:QLTI; TSX:QLT) after reviewing an unsolicited bid from Endo International plc (NASDAQ:ENDP; TSX:ENL).

    Auxilium said its board determined that Endo's offer was not a superior proposal to the planned QLT merger. Endo bid $2.2 billion for Auxilium alone on Sept. 16 (see BioCentury Extra, Sept. 16).

    The merged company will be incorporated in Canada and led by Auxilium's management. The deal is expected to close in 4Q14.

    Auxilium was up $0.05 to $31.19 on Monday. QLT was off US$0.06 to US$5.14 on NASDAQ and fell C$0.05 to C$5.65 in Toronto.

  • FDA grants expanded access for Tekmira's TKM-Ebola

    Tekmira Pharmaceuticals Corp. (TSX:TKM; NASDAQ:TKMR) jumped US$3.45 (17%) to US$23.61 in New York and C$3.39 (15%) to C$26.01 in Toronto on Monday after FDA granted expanded access use of TKM-Ebola in patients with confirmed or suspected Ebola infections. Tekmira also said Health Canada established a similar framework.

    Last month, FDA converted to a full hold on a Phase I trial of TKM-Ebola to a partial hold, which allowed for the potential use of the product in Ebola-infected individuals (see BioCentury Extra, Aug. 8).

    Separately, the United Nations General Assembly and Security Council established the United Nations Mission for Ebola Emergency Response (UNMEER) to help contain the ongoing outbreak. The World Health Organization said in a statement the mission is the UN's first for a public health emergency. Last month, WHO endorsed the use of investigational Ebola compounds that have not yet been evaluated for safety and efficacy in humans (see BioCentury Extra, Aug 12).

  • Japan approves Eylea for myopic CMV

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said Japan's Ministry of Health approved Eylea aflibercept to treat myopic choroidal neovascularization (myopic CNV), the second leading cause of blindness in Japan. The Bayer Yakuhin Ltd. subsidiary of Bayer AG (Xetra:BAYN) holds ex-U.S. rights to Eylea from Regeneron. The drug is a human fusion protein that binds all forms of VEGF-A and placental growth factor (PGF; PlGF).

    Eylea is approved in Japan to treat wet age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO). Bayer also is seeking approval in Japan to treat diabetic macular edema (DME) and macular edema following branch retinal vein occlusion (BRVO).

    Eylea is approved in the U.S. and Europe for DME. It is approved in Europe for macular edema following BRVO, and is under FDA review for that indication with an Oct. 23 PDUFA date.

  • Threshold down on Phase III data delay

    Threshold Pharmaceuticals Inc. (NASDAQ:THLD) fell $0.50 (11%) to $3.97 on Monday after saying it expects delayed data from its Phase III trial of TH-302 to treat unresectable or metastatic soft tissue sarcoma (STS).

    The delay is based on the results of a planned interim analysis of the 640-patient trial, which was conducted by an Independent Data Monitoring Committee (IDMC).

    The trial compares TH-302 plus doxorubicin with doxorubicin alone in previously untreated patients, with a primary endpoint of overall survival (OS). The interim analysis projected that the pre-specified number of trial events required to establish clinical efficacy -- 434 patient deaths -- will not occur until 2H15. Threshold had previously expected top-line efficacy data in 1H15.

    TH-302 is a hypoxia-activated cytotoxic 2-nitroimidazole prodrug of the DNA alkylator bromoisophosphoramide mustard (Br-IPM). It has Orphan Drug designation in the U.S. and EU for STS and pancreatic cancer. Top-line data from a Phase III trial evaluating TH-302 plus gemcitabine for pancreatic cancer are expected in 1H16.

    Threshold is partnered with Merck KGaA (Xetra:MRK) to co-develop and commercialize TH-302.

  • Tracon raises $27M in B round

    Tracon Pharmaceuticals Inc. (San Diego, Calif.) raised $27 million in a series B round led by New Enterprise Associates. Additional new investors included BioMed Ventures and an undisclosed institutional investor. Existing investors JAFCO Co. Ltd.; Nextech Invest Ltd.; Brookline Investments; Arcus Ventures; and BHP also participated.

    Tracon is developing TRC105, a human chimeric mAb against endoglin (CD105; ENG). The compound is in multiple oncology trials, including Phase II trials to treat renal cell carcinoma and glioblastoma and Phase I/II trials to treat metastatic breast cancer and soft tissue sarcoma.

    Paul Walker of New Enterprise Associates will join the Tracon board and Bruce Steel of BioMed Ventures will join as a board observer. Tracon also hired Patricia Bitar as CFO. Bitar was VP and Corporate Controller at NuVasive Inc. (NASDAQ:NUVA).

  • Avanir and Vital Therapies propose follow-ons

    Vital Therapies Inc. (NASDAQ:VTL) said in an SEC filing on Monday that it plans to raise $46 million in a follow-on underwritten by BofA Merrill Lynch; William Blair; Canaccord Genuity; and SunTrust Robinson Humphrey. Vital closed down $1.84 to $18.27 on the day.

    Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) proposed after market on Monday to raise $200 million in a follow-on underwritten by J.P. Morgan; Deutsche Bank; and BofA Merrill Lynch. Avanir closed up $0.17 to $11.21 prior to the announcement.

  • Tesaro planning $165M note deal

    Oncology play Tesaro Inc. (NASDAQ:TSRO) proposed late Monday to raise $165 million through the sale of senior unsecured convertible notes through Citigroup; Deutsche Bank Securities; Leerink; Baird; and BMO Capital Markets. The notes mature in October 2021.

    The company plans to use the funds to commercialize oral rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV), to develop intravenous rolapitant and other product candidates, and to finance potential in-licensing or product acquisition deals.

    Tesaro also may use the proceeds to pay the cost of capped call transactions with the underwriters, which it said would reduce potential dilution in the event the company's common stock price exceeds the initial conversion price of the notes.

    The company submitted an NDA to FDA for oral rolapitant on Sept. 8. Tesaro has exclusive, worldwide rights to the neurokinin 1 (NK1) Substance P receptor (TACR1) antagonist from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK).

    Tesaro was up a penny to $28.61 on Monday before the news.

  • FDA meeting on abuse-deterrent opioids

    FDA will hold a public meeting in Silver Spring, Md., on Oct. 30-31 to discuss the development, assessment, and regulation of abuse-deterrent opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of such drugs, and FDA's approach to the benefit-risk assessment of all opioid treatments.

    FDA issued draft guidance regarding development and labeling of new abuse-deterrent opioid formulations in January 2013, and is under pressure from congressional lawmakers to issue the final document.

  • Dems propose increased NIH funding

    Reps. Rosa DeLauro (D-Conn.) and Brian Higgins (D-N.Y.) introduced a bill in the U.S. House of Representatives that would lift the cap on NIH funding due to sequestration.

    The Accelerating Biomedical Research Act, H.R. 5580, would allow annual appropriations to NIH in excess of $29.9 billion to trigger a budget cap increase. If the bill is enacted, the agency's funding could increase incrementally, with 10% hikes in the first two years followed by 5% bumps thereafter.

    According to its sponsors, the bill is designed to restore NIH purchasing power to 2003 levels, adjusted for inflation.

  • Simplify adaptive trial execution with AptivAdvantage

    Integrate project, data and site management in one flexible and seamless platform. AptivAdvantage combines EDC, randomization and drug supply management, making it easy to manage multiple interim analyses and facilitate data driven monitoring while minimizing operational bias and maintaining trial integrity. Watch the video to learn more.


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