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BioCentury Extra
As published Monday, August 31, 2015 6:31 PM PST

  • Trevena's TRV130 meets in Phase II pain trial

    Trevena Inc. (NASDAQ:TRVN) gained $2.48 (41%) to $8.48 in after-hours trading after TRV130 met its primary endpoint in a Phase IIb trial to treat moderate to severe acute postoperative pain after abdominoplasty surgery.

    The 200 patients in the trial received one of two TRV130 regimens, morphine or placebo. The TRV130 regimens consisted of a 1.5 mg IV loading dose plus 0.1 mg or 0.35 mg on-demand doses. Patients in the morphine and placebo groups also received loading doses followed by on-demand doses.

    The 0.1 mg on-demand group had reduced average pain scores from baseline over 24 hours -- the primary endpoint -- of 2.3 points (p<0.0001 vs. placebo), while the 0.35 mg group's scores were reduced by 2.1 points (p=0.0003 vs. placebo). Morphine reduced average pain scores by 2.1 points (p=0.0001 vs. placebo).

    Both TRV130 regimens demonstrated superiority to morphine on prespecified secondary endpoints, showing a significantly lower prevalence of hypoventilation events, nausea and vomiting compared to morphine (p<0.05).

    Patients who received TRV130 or morphine used rescue analgesics less frequently than those who received placebo. Overall, 64% of placebo-treated patients used rescue analgesics compared to 31% in the TRV130 0.1 mg arm, 21% in the TRV130 0.35 mg arm, and 25% in the morphine arm (p<0.0005 for all three vs. placebo).

    Trevena plans to begin Phase III testing in early 2016 of the G protein-biased mu opioid receptor (MOR; OPRM1) ligand.

    The news was announced postmarket. Trevena lost $0.04 to $6 on Monday.

  • Amicus to acquire Scioderm

    Amicus Therapeutics Inc. (NASDAQ:FOLD) will acquire Scioderm LLC (Raleigh, N.C.), giving it Zorblisa (SD-101), an undisclosed topical cream to treat epidermolysis bullosa (EB). The company expects data in 1H16 from the Phase III SD-005 trial of the compound, and hopes to begin a rolling NDA submission in 4Q15.

    Scioderm shareholders will receive $229 million up front in cash and stock and are eligible for $618 million in milestones.

    Amicus plans to request a Priority Review voucher as part of Zorblisa's NDA submission under FDA's rare pediatric disease Priority Review voucher program. If the company obtains and subsequently sells a Priority Review voucher, Scioderm shareholders will receive the lesser of $100 million or 50% of the voucher's price.

    Zorblisa has breakthrough therapy designation in the U.S. and Orphan Drug designation in the U.S. and EU for EB.

    The acquisition will bolster Amicus' rare disease pipeline, which includes Galafold migalastat for Fabry's disease and preclinical candidate ATB200 for Pompe's disease. Galafold is under accelerated assessment by EMA; Amicus is planning to submit an NDA this half for the small molecule that enhances alpha galactosidase A activity. ATB200 is a recombinant human acid alpha-glucosidase (rhGAA).

    The parties expect the deal to close this quarter. Leerink is advising Amicus and Skadden, Arps, Slate, Meagher & Flom is its counsel. JPMorgan is advising Scioderm and Cooley is its counsel.

    Amicus was off $0.49 to $14.38 on Monday.

  • BMS gets option to buy fibrosis company Promedior

    Bristol-Myers Squibb Co. (NYSE:BMY) obtained an exclusive option to acquire Promedior Inc. (Lexington, Mass.), which would give it rights to idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF) candidate PRM-151. Promedior shareholders are eligible to receive $1.3 billion in the deal, which includes $150 million up front, an exercise fee and clinical and regulatory milestones.

    Promedior intends to begin two Phase II trials of PRM-151 in September to treat IPF and MF, and expects data from both trials in 2017. BMS can exercise its option to acquire Promedior upon the completion of either trial.

    PRM-151 is a recombinant version of pentraxin-2 (PTX-2), a human serum amyloid P component (SAP; APCS) protein. The compound has Orphan Drug designation in the U.S. and EU for MF and IPF, and has Fast Track designation in the U.S. for MF.

    BMS's early stage fibrosis portfolio includes BMS-986020, a lysophosphatidic acid receptor antagonist in Phase II to treat IPF. The company also holds an exclusive option to acquire Galecto Biotech AB (Copenhagen, Denmark), which is developing TD139, an inhaled galectin-3 (LGALS3) inhibitor in Phase I to treat IPF (see BioCentury Extra, Nov. 3, 2014).

    Goodwin Procter represented Promedior.

  • Sanofi, Google in diabetes deal

    Sanofi (Euronext:SAN; NYSE:SNY) and the life sciences unit of Google Inc. (NASDAQ:GOOG) partnered to develop data management tools to improve care in Type I and II diabetes. Joslin Diabetes Center of Harvard Medical School will serve as an advisor to the partners.

    Google said the companies aim to improve diabetes management by developing technology that provides real-time tracking of parameters that affect glucose control. Neither Google spokesperson Jacquelyn Miller nor Sanofi spokesperson Mary Kathryn Steel would disclose any financial details or specific collaboration projects.

    Google is in the process of creating a stand-alone company under its new Alphabet Inc. corporate umbrella to house the life sciences team from its Google X special projects division.

    Earlier this month, DexCom Inc. (NASDAQ:DXCM) partnered with Google to develop body-worn continuous glucose-monitoring products, including one with a bandage-sized sensor. Last year, Google partnered with the Alcon Inc. unit of Novartis AG (NYSE:NVS; SIX:NOVN) to develop glucose-monitoring contact lenses (see BioCentury Extra, July 15, 2014).

  • Priority Review for Intercept's OCA in PBC

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) said FDA accepted and granted Priority Review to an NDA for obeticholic acid (OCA; DSP-1747) to treat primary biliary cirrhosis. The PDUFA date is Feb. 29, 2016.

    The oral farnesoid X receptor (FXR; NR1H4) agonist has Orphan Drug designation in the U.S. and EU to treat PBC and primary sclerosing cholangitis (PSC). FDA has also granted OCA Fast Track designation to treat PBC and breakthrough therapy designation to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. The compound is under EMA review.

    This quarter, Intercept expects to start a Phase III study of OCA to treat NASH (see BioCentury Extra, May 19).

    Intercept gained $0.81 to $189.76 on Monday.

  • Alnylam's ALN-PCSsc shows durable LDL-C lowering

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said patients receiving ALN-PCSsc had a lowering of LDL-C that persisted for up to 140 days in an ongoing Phase I study. The therapy is a subcutaneous formulation of small interfering RNA (siRNA) against PCSK9.

    The primary objective of the randomized, single-blind placebo-controlled study was to evaluate safety and tolerability of ALN-PCSsc in subjects with elevated baseline LDL-C. Secondary objectives included pharmacokinetics and activity assessment by PCSK9 and LDL-C levels. Alnylam presented the data at the European Society of Cardiology meeting.

    From baseline to 12 weeks, three subjects receiving a single 300 mg dose had a least squares mean reduction in LDL-C of 50.1%; six subjects in a cohort receiving 300 mg once monthly had a mean reduction of 59.4%. Phase III studies of approved anti-PCSK9 mAbs Praluent alirocumab from Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Repatha from Amgen Inc. (NASDAQ:AMGN) have reported mean lowering of LDL from baseline ranging from 46-67%.

    Alnylam reported no serious adverse events or "clinically significant drug-related adverse events."

    CEO John Maraganore told BioCentury the data support once quarterly, and possibly bi-annual, subcutaneous dosing. Praluent and Repatha are given every other week; Repatha can be dosed monthly in some cases.

    Alnylam was off $6.16 to $102.91 on Monday. Alnylam's partner under a 2013 deal, The Medicines Co. (NASDAQ:MDCO), gained $7.36 (22%) to $41 on the day. Medicines Co. will now assume responsibility for developing and commercializing ALN-PCSsc, including the Phase II and III ORION program. A Phase II trial is expected to start by YE15, and Phase III trials are to begin in 2017. ORION is expected to include a study comparing ALN-PCSsc with anti-PCSK9 mAbs.

  • Ascletis to start Phase II HCV trial in Taiwan

    Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said Taiwan FDA approved the start of the Phase II EVEREST trial of danoprevir (ASC08) plus ASC16 (PPI-668) to treat HCV. Ascletis intends to enroll treatment-naive, non-cirrhotic patients with HCV genotype 1 infection in EVEREST, beginning in September.

    A clinical trial application (CTA) for the HCV regimen is under China Food and Drug Administration (CFDA) review. In June, Ascletis said it was the first Chinese company to submit CTAs in China for an interferon-free HCV regimen (see BioCentury Extra, June 24).

    The company licensed Chinese rights to danoprevir, a second-generation HCV NS3/4A protease inhibitor, from Roche (SIX:ROG; OTCQX:RHHBY) in 2013 after Roche discontinued development. In November 2014, Ascletis obtained Chinese rights to ASC16, a second-generation HCV NS5A inhibitor, from Presidio Pharmaceuticals Inc. (San Francisco, Calif.).

    Ascletis is attempting to reach the China market with an HCV treatment before Gilead Sciences Inc. (NASDAQ:GILD) does (see BioCentury, April 13).

  • MicuRx's MRX-1 comparable to linezolid

    MicuRx Pharmaceuticals Inc. (Hayward, Calif.) said lead candidate MRX-1 was comparable to linezolid in a Chinese Phase II trial to treat complicated skin and soft tissue infections (cSSTI).

    In a top-line analysis of 178 evaluable patients with Gram-positive bacterial infections, MicuRx said 96.5% of patients treated with 800 mg MRX-1 were clinically cured after 14 days, compared to 95.5% of those treated with 600 mg linezolid.

    MicuRx said its oral oxazolidinone, a bacterial protein biosynthesis inhibitor, was well tolerated with no serious treatment-related adverse events.

    The trial was funded by Shanghai MengKe Pharmaceuticals Inc., MicuRx's joint venture with Zhangjiang Biomedical Industry Venture Capital. The partners formed the JV in 2012 to develop MRX-1 for the Chinese market.

    Next quarter, the company expects results from a U.S. Phase II trial of MRX-1 to treat acute bacterial skin and skin structure infections (ABSSSIs). MicuRx did not respond to inquiries.

    Pfizer Inc. (NYSE:PFE) markets linezolid as Zyvox.

  • Shanghai Pharma forming healthcare fund

    Shanghai Pharmaceuticals Holding Co. Ltd. (HKSE:02607; Shanghai:601607) partnered with Shanghai Real Power Capital Co. Ltd. to form a fund that will invest in medical e-commerce, therapeutics, medical equipment and other healthcare companies. Shanghai Pharma said it and Shanghai Real Power each will invest RMB250 million ($39.2 million) as part of a RMB1 billion ($156.7 million) first close for the fund.

    The fund has a target size of RMB3 billion ($470.1 million). Both Shanghai Pharma and Shanghai Real Power are partially owned by the Shanghai government.

  • ASCO updates NSCLC treatment guidelines

    The American Society of Clinical Oncology published new guidelines for treating advanced non-small cell lung cancer (NSCLC). The recommendations incorporate greater use of targeted therapies than prior guidelines from 2011.

    The new guidelines, published in the Journal of Clinical Oncology, differentiate recommended treatments by mutation status. ASCO's recommended first-line therapies in patients with EGFR-sensitizing mutations are Gilotrif afatinib from Boehringer Ingelheim GmbH (Ingelheim, Germany); Tarceva erlotinib from the Genentech unit of Roche (SIX:ROG; OTCQX:RHHBY) and Astellas Pharma Inc. (Tokyo:4503); and Iressa gefitinib from AstraZeneca plc (LSE:AZN; NYSE:AZN).

    The organization recommended Xalkori crizotinib from Pfizer Inc. (NYSE:PFE) as first-line therapy in patients with anaplastic lymphoma kinase (ALK) or c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1) rearrangements.

    Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) was not included in the guidelines, although the manuscript noted that data showing its superiority to docetaxel as second-line treatment of squamous NSCLC were published after the guideline went to press. The manuscript said ASCO's Update Committee "awaits fuller data on adverse events before full incorporation into this guideline."

    Gilotrif is a dual inhibitor of EGFR1 and HER2; Tarceva is a small molecule inhibitor of EGFR tyrosine kinase activity; Iressa is an EGFR kinase inhibitor; Xalkori is a dual inhibitor of c-Met receptor tyrosine kinase and ALK and their oncogenic variants; and Opdivo is a human IgG4 mAb against PD-1.

  • Amarin, FDA may settle free speech case

    According to a court filing, Amarin Corp. plc (NASDAQ:AMRN) and FDA have "agreed to explore the possibility of settlement" of Amarin's suit against FDA and requested a stay of further proceedings until Oct. 30, when the parties will advise the court of their views on next steps.

    Amarin had filed suit in May, claiming that limitations on off-label promotion of its cardiovascular drug Vascepa icosapent ethyl constitute unconstitutional infringement of its First Amendment rights. Earlier this month, the U.S. District Court for the Southern District of New York granted Amarin preliminary relief, allowing the company to engage in "truthful and non-misleading speech" under the First Amendment to promote off-label use of Vascepa (see BioCentury Extra, Aug. 7).

    In June, FDA sent a letter to Amarin saying the agency would not object if the company distributed peer-reviewed articles or truthful, non-misleading summaries of a Phase III study of Vascepa (see BioCentury Extra, June 10).

    Amarin slipped $0.02 to $2.21 on Monday.

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