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BioCentury Extra
As published Thursday, May 28, 2015 7:41 PM PST

  • Merck, NanoString seek Keytruda biomarkers

    Merck and Co. Inc. (NYSE:MRK) and NanoString Technologies Inc. (NASDAQ:NSTG) will collaborate to develop a biomarker assay that may predict patient responses to melanoma drug Keytruda pembrolizumab. NanoString CEO Brad Gray said the collaboration could lead to development of a companion diagnostic for the PD-1 inhibitor, which the pharma is developing for multiple cancers.

    Merck will identify gene expression signatures and use NanoString's nCounter Analysis System to evaluate them as part of Keytruda's development program. NanoString will receive $4 million, mostly during 2015; the parties will negotiate a separate development agreement if a companion diagnostic assay results from the collaboration.

    The companies said four presentations at the American Society for Clinical Oncology (ASCO) meeting will include data from studies of Keytruda based on gene expression signatures analyzed using nCounter. The studies evaluated Keytruda's effect on patients with multiple cancers who had the interferon gamma response gene signature.

    In September, FDA approved the humanized IgG4 mAb against PD-1 to treat advanced melanoma.

    NanoString gained $0.20 to $13.78 in trading on Thursday.

  • Padlock secures GSK assets

    Padlock Therapeutics Inc. (Cambridge, Mass.) licensed an asset package from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) related to peptidyl arginine deiminases (PADs). The assets include IP, undisclosed compounds, data sets and assays. Padlock CEO Michael Gilman declined to disclose specific financial details, but said GSK received a "meaningful amount" of equity; GSK's Rab Prinjha will join Padlock's board as an observer.

    Padlock is developing a pipeline of PAD inhibitors to treat autoimmune disorders. PADs convert the amino acid arginine to citrulline and generate autoantigens that play a role in autoimmune diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and multiple sclerosis (MS) (see BioCentury, Jan. 19).

    GSK did not receive options or rights to any compounds, and Padlock will not pay milestones or royalties. Gilman told BioCentury GSK had de-prioritized its own PAD project, allowing Padlock to license the asset package.

    Padlock hopes to submit an IND for at least one program by YE16, but Gilman said it has not yet decided which one.

    In December, Padlock raised $23 million in a series A round led by Atlas Ventures. Gilman is a venture partner at Atlas.

  • DNDi, pharmas form tropical disease consortium

    The Drugs for Neglected Diseases initiative (DNDi) and four pharmas launched the Neglected Tropical Diseases Drug Discovery Booster consortium to accelerate the discovery of new treatments for leishmaniasis and Chagas disease. The consortium includes Eisai Co. Ltd. (Tokyo:4523), Shionogi & Co. Ltd. (Tokyo:4507), Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and AstraZeneca plc (LSE:AZN; NYSE:AZN).

    The DNDi will provide its four partners with an initial "seed" compound against Leishmania or Trypanosoma cruzi, the parasites that cause leishmaniasis and Chagas disease, respectively. The companies will search their own compound libraries for similar molecules and send the most promising candidates to the DNDi, which then will screen them for efficacy. It will choose new seed compounds and repeat the process, seeking better molecules.

    Charles Mowbray, DNDi's head of drug discovery, said the initiative has identified several undisclosed compounds from prior screening campaigns. The consortium aims to identify at least four seed candidates for each disease and move at least two compounds to the next stage of development. The DNDi said this approach could cut up to two years from the early drug discovery process.

    The Global Health Innovative Technology (GHIT) Fund will provide EUR 640,000 ($702,336) to support the work of Eisai, Shionogi and Takeda. The GHIT Fund supports global R&D partnerships between Japanese and non-Japanese entities to treat diseases including HIV/AIDS, malaria, tuberculosis and neglected tropical diseases (see BioCentury Extra, April 8, 2013).

    DNDi's own funds will support the rest of the consortium's work, including AZ's.

  • Teva agrees to $1.2B pay-for-delay settlement

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) will pay $1.2 billion to settle a Federal Trade Commission antitrust suit alleging that Cephalon Inc., which Teva later acquired, paid generic drug manufacturers more than $200 million to drop challenges against patents covering sleep disorder drug Provigil modafinil and delay the entry of generics into the market.

    The FTC's suit, filed in 2008, alleged that Cephalon paid Ranbaxy Laboratories Ltd., Mylan N.V. (NASDAQ:MYL) and Barr Pharmaceuticals Inc., as well as Teva itself, to wait until 2012 to begin generic competition for Provigil, a film-coated modafinil that promotes alertness. Teva acquired Barr for about $7.5 billion in 2008 and paid $6.8 billion to acquire Cephalon in 2011 (see BioCentury, May 9, 2011).

    Teva will make the $1.2 billion available to compensate drug wholesalers, pharmacies and insurers who the FTC said overpaid due to Cephalon's illegal conduct. It also agreed to a prohibition on similar reverse-payment, or "pay-to-delay," settlements. In a separate 2013 case, the U.S. Supreme Court ruled that such settlements are subject to antitrust litigation (see BioCentury Extra, June 17, 2013).

  • Cellectis spikes on takeout rumor

    Cellectis S.A. (Euronext:ALCLS; NASDAQ:CLLS) gained $6.67 (16%) to $47.66 on NASDAQ Thursday on media reports that the company is discussing a potential sale to Pfizer Inc. (NYSE:PFE). Cellectis and Pfizer declined to comment.

    Cellectis received $80 million up front in a June 2014 deal giving Pfizer a license to develop cancer immunotherapies using the biotech's CAR T cell technology (see BioCentury, July 14, 2014).

    Cellectis shed EUR 1.24 to EUR 36.75 on Euronext. The reports circulated after European markets closed.

  • Roche grants Galenica U.S. rights to Mircera

    Galenica Ltd. (SIX:GALN) gained exclusive U.S. commercialization rights to Mircera methoxy polyethylene glycol-epoetin beta from Roche (SIX:ROG; OTCQX:RHHBY). Roche will manufacture and supply the drug to Galenica. Financial terms were undisclosed.

    Mircera was approved in the U.S. and EU in 2007 to treat anemia associated with chronic kidney disease (CKD), though its U.S. launch has been delayed by litigation. In December 2009, the U.S. District Court for the District of Massachusetts entered final judgment and a permanent injunction preventing Roche from selling Mircera in the U.S., concluding a five-year patent dispute between Roche and Amgen Inc. (NASDAQ:AMGN). The decision came after the companies said in a joint filing to the court that Mircera infringed five of Amgen's erythropoietin patents (see BioCentury Extra, Dec. 22, 2009).

    Amgen and Roche settled, and Roche was allowed to begin marketing Mircera in the U.S. in July 2014. In November, Roche entered a deal with Fresenius Medical Care North America (FMCNA) to supply Mircera to its dialysis facilities.

    Under a separate deal, Galenica will supply Mircera to FMCNA's dialysis centers.

    Roche markets Mircera in the EU and the rest of world excluding Japan, where Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) holds rights. Amgen markets Epogen epoetin alfa and Aranesp darbepoetin alfa.

  • Management tracks

    Juno Therapeutics Inc. (NASDAQ:JUNO) named Hyam Levitsky CSO and EVP of research. Levitsky was head of cancer immunology experimental medicine at Roche (SIX:ROG; OTCQX:RHHBY).

    Cell therapy play Cellular Biomedicine Group Inc. (NASDAQ:CBMG) named Richard Wang COO. Wang was senior site leader and head of R&D operations in China at GlaxoSmithKline plc (LSE:GSK; MYSE:GSK)

    The EMD Serono division of Merck KGaA (Xetra:MRK) named David Trexler SVP of oncology commercial. Trexler was SVP of the Americas oncology business unit at Eisai Co. Ltd. (Tokyo:4523).

    Cancer play Cerulean Pharma Inc. (NASDAQ:CERU) said Karen Roberts will resign as SVP of finance, effective Aug. 31. Cerulean named Gregg Beloff, a managing director of Danforth Advisors, as interim CFO.

    Autoimmune play CytomX Therapeutics Inc. (South San Franciso, Calif.) named Bob Goeltz CFO and Cynthia Ladd SVP and general counsel. Goeltz was CFO of the Onyx Pharmaceuticals Inc. subsidiary of Amgen Inc. (NASDAQ:AMGN). Ladd was an independent consultant.

  • Pronutria raises $39M series C

    Pronutria Biosciences Inc. (Cambridge, Mass.) raised $39 million in a series C round led by new investor Fidelity Management & Research Co. Existing investor Flagship Ventures and other undisclosed investors also participated, including individuals and family offices.

    Pronutria is developing amino acid-based therapeutics to treat muscle, metabolic, neurological and liver disorders. President and CEO Robert Connelly said the company expects to begin a proof-of-concept study of PN107 to treat myopenia (muscle wasting) and hopes to start a pivotal study of at least one candidate by 2H16. PN107 is an orally ingested protein with an amino acid combination and physicochemical profile optimized for myopenia conditions.

    In addition to therapeutics, the company is developing medical foods and supplements.

  • Seres proposes $100M IPO

    Microbiome company Seres Health Inc. (Cambridge, Mass.) filed to raise up to $100 million in an IPO on NASDAQ underwritten by Goldman Sachs; BofA Merrill Lynch; Leerink; and Canaccord Genuity.

    In mid-2016 Seres expects data from a Phase II study of lead candidate SER-109 to treat recurrent Clostridium difficile infections. Seres discovered the orally available mixture of undisclosed bacteria using its Ecobiotic platform, which identifies the physiological condition of the microbiome in a healthy person, compares it to the condition in a sick person and determines what organisms could be added to convert the diseased microbiome back to a healthy state (see BioCentury, June 16, 2014).

    Affiliates of Flagship Ventures hold a 55% stake in Seres; the company emerged from the firm's Flagship VentureLabs incubator in 2013. The Nestle Health Science subsidiary of Nestle S.A. (SIX:NEXN) holds 18%, affiliates of Fidelity hold 8% and Enso Ventures 2 Ltd. holds 6%. Seres raised a total of $113 million in its December 2014 series C and January 2015 series D rounds (see BioCentury Extra, Jan. 6).

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