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BioCentury Extra
As published Wednesday, February 10, 2016 5:14 PM PST

  • AbbVie plans NDA for endometriosis therapy

    AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the co-primary endpoints in the Phase III M12-671 trial to treat moderate-to-severe endometriosis-associated pain. The trial was the second of two identically designed Phase III studies. The company plans to submit an NDA for elagolix next year.

    AbbVie said 150 mg once-daily and 200 mg twice-daily elagolix reduced scores of non-menstrual pelvic pain and dysmenorrhea associated with endometriosis after three and six months of treatment as measured by the Daily Assessment of Endometriosis Pain scale vs. placebo. AbbVie plans to present detailed data this year from M12-671, which enrolled 815 premenopausal women.

    The overall discontinuation rates were similar across treatment groups. There was a dose-dependent effect on the mean percent change from baseline in bone mineral density at the lumbar spine at month six. The low and high dose groups had a 0.71% and 2.45% mean reduction in BMD, respectively, vs. a 0.49% mean increase for placebo (p<0.001 for both doses).

    In January 2015, AbbVie said elagolix met the co-primary endpoints in M12-665, the 872-patient first Phase III trial. On Wednesday, AbbVie said the responder rates for the co-primary endpoints were consistent between the two trials (see BioCentury Extra, Jan. 8, 2015).

    Neurocrine Biosciences Inc. (NASDAQ:NBIX) received $75 million up front and is eligible for $500 million in milestones, plus tiered royalties, under a 2010 deal that gave AbbVie exclusive, worldwide rights to elagolix. The non-peptide small molecule GnRH antagonist also is in Phase III testing to treat uterine fibroids.

    Neurocrine gained $1.51 to $33.70 on Wednesday.

  • Priority Review for KemPharm's pain candidate

    KemPharm Inc. (NASDAQ:KMPH) gained $2.16 (21%) to $12.67 on Wednesday after FDA granted Priority Review to an NDA for KP201/APAP for short-term management of acute pain. Its PDUFA date is June 9.

    The NDA is Kempharm's first marketing application. The company submitted the application under the 505(b)(2) pathway, allowing it to reference data from previously approved products.

    KP201/APAP is an abuse-deterrent formulation of benzhydrocodone, a hydrocodone prodrug, and acetaminophen.

    The company raised $56 million in an IPO last year (see BioCentury Extra, April 16, 2015).

  • Grail hires ex-Google exec Huber as CEO

    Cancer diagnostics company Grail Bio (Redwood City, Calif.) named Jeff Huber CEO and said GV invested in its series A round. Huber previously focused on data-driven life sciences projects as an SVP at the Google[X] experimental lab of Google Inc., now part of Alphabet Inc. (NASDAQ:GOOG). GV is that company's venture capital arm.

    Illumina Inc. (NASDAQ:ILMN) formed Grail in January and holds a majority stake in the newco. Earlier this week, Huber resigned from his board seat at Illumina, which he had held since 2014. Grail intends to enable early cancer screening by using Illumina's next-generation ultra-deep sequencing technology to measure circulating tumor DNA (see BioCentury, Jan. 18).

    Huber previously ran Google's Geo division, which includes the Google Maps and Google Earth products.

    Last month, Grail said it raised more than $100 million in the round. On Wednesday, it said GV made an additional investment, but did not disclose its size.

  • Synlogic unveils AbbVie deal in IBD

    Synthetic biology company Synlogic Inc. (Cambridge, Mass.) revealed Wednesday that AbbVie Inc. (NYSE:ABBV) is its partner in a deal to develop engineered bacteria as an oral therapeutic for inflammatory bowel disease (IBD), particularly Crohn's disease and ulcerative colitis (UC). The biotech had told BioCentury in October that it had partnered its IBD program with an undisclosed pharma.

    Synlogic engineers the probiotic gut bacterium Escherichia coli Nissle to express multiple bioconversion enzymes that process a toxic metabolite into a benign or beneficial byproduct. The company calls the engineered bacteria synthetic biotics (see BioCentury, Oct. 26, 2015).

    Under the deal, Synlogic is discovering, characterizing and optimizing candidates that modulate undisclosed effectors involved in the IBD pathway. Synlogic and AbbVie will advance candidates through preclinical development, and AbbVie is responsible for worldwide clinical development and commercialization of any resulting products. Financial terms are undisclosed.

  • Mylan acquiring Meda

    Generics company Mylan N.V. (NASDAQ:MYL) will acquire Meda AB (SSE:MEDAA) for about SEK83.6 billion ($9.9 billion) in cash and stock, or SEK60.3 billion ($7.1 billion) net of debt. Meda makes specialty pharma products, OTC drugs and branded generics.

    The SEK165 per share takeout price is a 92% premium over Meda's Wednesday close. The deal was announced after market hours. Meda gained SEK3 to SEK86.05 on Wednesday. Mylan shed $0.20 to $50.54 during the day, and fell $4.55 to $45.99 in early after-hours trading.

    Mylan said the acquisition would allow it to expand into new emerging markets and would result in a combined business with more than 2,000 products.

    Mylan said Meda's board has recommended that Meda shareholders approve the deal. Meda rejected a takeover bid from Mylan in 2014 (see BioCentury Extra, April 4, 2014).

  • Heptares' selective M1 agonist bound for Phase II

    The Heptares Therapeutics Ltd. subsidiary of Sosei Group Corp. (Tokyo:4565) reported data from a Phase Ib study of HTL9936 and said it plans to start Phase II testing of the candidate in late 2016 to treat dementia and schizophrenia. The muscarinic acetylcholine receptor M1 (CHRM1; HM1) agonist is Heptares' most advanced internal candidate.

    Heptares said HTL9936 led to significant changes in brain activity associated with cognition as measured by electroencephalography (EEG) biomarkers, even at low doses and blood concentrations, and with no gastrointestinal side effects. The study enrolled 28 healthy elderly subjects, and tested different doses of HTL9936 on measures of brain activity.

    In June 2015, Heptares reported data from a Phase Ia trial of HTL9936 that showed no adverse events and increased brain activity associated with cognition as measured by EEG.

    Previous pan-muscarinic antagonists have failed in dementia and schizophrenia as a result of GI side effects due to activity on M2 and M3. Heptares created HTL9936 using its StaR platform for GPCR drug discovery, which the company said designs small molecules with improved pharmacological properties including selectivity (see BioCentury, Aug. 17, 2015).

    Sosei slipped Y300 to Y10,100 on Wednesday.

  • CTI withdraws pacritinib NDA

    CTI BioPharma Corp.(NASDAQ:CTIC; Milan:CTIC) withdrew its NDA for pacritinib (BAX 2201) after FDA placed a full clinical hold on the candidate's IND. On Wednesday, CTI shed $0.20 (40%) to $0.30 on NASDAQ and EUR 0.19 (40%) to EUR 0.27 in Milan.

    CTI said FDA noted a "detrimental effect on survival" in pacritinib-treated patients in the Phase III PERSIST-2 trial to treat myelofibrosis. The company said deaths in the trial were due to intracranial hemorrhage, cardiac failure and cardiac arrest.

    The company said FDA recommended the company conduct dose exploration studies of pacritinib in myelofibrosis patients and submit final study reports and data sets for the Phase III PERSIST-1 and -2 studies, as well as seek a meeting with FDA before responding to the full clinical hold. The company said it would review the PERSIST-2 data to determine next steps.

    On Monday, FDA placed the program on a partial clinical hold, citing "excess mortality and other adverse events" in the PERSIST-1 trial. CTI has lost more than 70% of its value since Friday's close (see BioCentury Extra, Jan. 8).

    CTI had said Monday that mortality risk was most evident in a crossover arm of PERSIST-1, in which control-treated patients could switch to pacritinib. In September 2015, CTI said it would continue the PERSIST trials as originally planned after an independent DMC found "non-statistically significant safety concerns" in the crossover arm of PERSIST-1. The company noted at the time that the crossover design may confound evaluation of survival, but said it informed FDA of its decision to proceed per protocol.

    CTI completed enrollment for PERSIST-2 earlier this month. It reported PERSIST-1's results last year (see BioCentury Extra, June 1, 2015).

    CTI is partnered with Baxalta Inc. (NASDAQ:BXLT) to develop and commercialize pacritinib, an orally available inhibitor of Janus kinase-2 (JAK-2) and FMS-like tyrosine kinase 3 (FLT3; CD135). Shire plc (LSE:SHP; NASDAQ:SHPG) is merging with Baxalta.

  • Yumanity raises $45M series A

    Yumanity Therapeutics LLC (Cambridge, Mass.) raised $45 million in a series A round led by Fidelity. Redmile Group, Alexandria Venture Investments, Biogen Inc. (NASDAQ:BIIB), Sanofi-Genzyme BioVentures and Dolby Family Ventures also participated.

    In 2014, Yumanity was launched by former Onyx Pharmaceuticals Inc. CEO Tony Coles and Massachusetts Institute of Technology Professor Susan Lindquist. The biotech is developing therapeutics for protein misfolding diseases including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis.

    The company has not disclosed a timeline for entering the clinic.

    John Cox and Joel Marcus joined Yumanity's board. Cox is EVP of therapeutic operations at Biogen and Marcus is chairman and CEO of Alexandria Real Estate Equities.

  • Cancer play Armo raises $50M series C

    Armo BioSciences Inc. (Redwood City, Calif.) raised $50 million in a series C round. Existing investors Kleiner Perkins Caufield & Byers, OrbiMed, DAG Ventures and NanoDimension were joined by new investors HBM Healthcare Investments, GV, Celgene Corp. (NASDAQ:CELG), Industrial Investors Group and funds advised by Clough Capital.

    Armo's lead product is AM0010 recombinant pegylated IL-10. By YE16, the company plans to start Phase II/III testing of the product in advanced solid tumors.

  • TransCelerate launches preclinical research subsidiary

    Not-for-profit biopharma consortium TransCelerate BioPharma Inc. (Philadelphia, Pa.) launched BioCelerate, a subsidiary that intends to improve the efficiency of preclinical research.

    BioCelerate's first initiative, Toxicology Data Sharing, aims to "enable access to a broader cross-company set of toxicology data," with the goal of improving translation of non-clinical findings and closing gaps in understanding the relationship between patient response and preclinical toxicology findings.

    BioCelerate expects to release details on additional initiatives this year once they are approved by a governing council comprising member companies. Six TransCelerate members initially committed to launching BioCelerate: Boehringer Ingelheim GmbH (Ingelheim, Germany), Bristol-Myers Squibb Co. (NYSE:BMY), Eli Lilly and Co. (NYSE:LLY), GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Novo Nordisk A/S (CSE:NVO; NYSE:NVO) and Shionogi & Co. Ltd. (Tokyo:4507).

    BioCelerate will be funded separately from TransCelerate, but will be led by TransCelerate CEO Dalvir Gill.

    TransCelerate was founded in 2012 after a group of R&D heads concluded that a precompetitive collaboration was the best way to solve common R&D challenges and clinical trial bottlenecks (see BioCentury, Oct. 21, 2013).

  • Vaccine development proposed to fight bug resistance

    The U.K.'s Review on Antimicrobial Resistance released a report Wednesday that recommends steps to stimulate the development and use of vaccines as tools to prevent infections with drug-resistant pathogens.

    The report recommends steps to create alternative markets for vaccines, including providing advanced market commitments for products that may not generate profits through conventional commercial markets. It says the hospital-acquired infections market needs support because vaccines would be used by a small, targeted population, and because "the poor immune status of many hospital patients will pose a scientific challenge to the success of any vaccines in this category."

    The report is part of a larger effort to create a comprehensive plan for addressing threats posed by antimicrobial resistant pathogens. The review is led by Jim O'Neill, commercial secretary to the U.K. Treasury and former Goldman Sachs chief economist (see BioCentury, Jan. 25).

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