Sutro raises $26 million in D round
Sutro Biopharma Inc. (South San Francisco, Calif.) raised $26 million in a series D round led by existing investors Alta Partners; Amgen Ventures; Celgene Corp. (NASDAQ:CELG); Lilly Ventures; Skyline Ventures; and SV Life Sciences. Sutro is using its cell-free protein synthesis technology to generate bispecific antibodies and site-specific antibody-drug conjugates (ADCs) with unnatural amino acids. The company's internal pipeline includes undisclosed preclinical ADC programs. Sutro said it plans to advance a bispecific antibody for immunology or cancer indications into the clinic in the next 12-18 months.
CytRx jumps on Phase IIb data for doxorubicin prodrug
CytRx Corp. (NASDAQ:CYTR) jumped $1.63 (68%) to $4.02 on Wednesday after reporting that first-line treatment with IV aldoxorubicin (INNO-206) met the primary endpoint of improving progression-free survival (PFS) vs. doxorubicin in a Phase IIb trial to treat soft tissue sarcoma (STS). Aldoxorubicin improved median PFS as assessed by investigators (8.4 vs. 4.7 months, p=0.0002) and by blinded central laboratory review (5.7 vs. 2.8 months, p=0.018) vs. doxorubicin. The open-label, international trial enrolled 123 patients with metastatic, locally advanced or unresectable STS. Overall survival (OS) data, a secondary endpoint, are expected in 3Q14.
ImmunoCellular plummets in after-hours trading on ICT-107 data
ImmunoCellular Therapeutics Ltd. (NYSE-M:IMUC) tumbled $1.48 (54%) to $1.24 in early after-hours trading after reporting data late Wednesday from a Phase II trial evaluating the company's ICT-107 to treat newly diagnosed glioblastoma multiforme (GBM). In the 124-patient trial, ICT-107 given following resection and chemoradiation missed the primary endpoint of improving overall survival (OS) vs. placebo following resection and chemoradiation in both the intent-to-treat (ITT) population (n=124, p=0.58) and the per protocol (PP) population (n=117, p=0.4).
Prothena, Roche in Parkinson's deal
Prothena Corp. plc (NASDAQ:PRTA) and Roche (SIX:ROG; OTCQX:RHHBY) partnered to co-develop and co-commercialize mAbs targeting alpha synuclein (SNCA) including Prothena's PRX002, which is in preclinical development for Parkinson's disease and other synuclein-related diseases. Prothena will receive $45 million in an undisclosed upfront payment and a near-term milestone payment tied to the start of a Phase I trial for PRX002; the trial is slated to start next half. Roche and Prothena will share U.S. costs and profits 70/30, and Prothena has an option to co-promote PRX002 in the U.S. Roche will be responsible for development and commercialization of PRX002 outside the U.S. Prothena is eligible for up to $555 million in milestones, including $175 million in ex-U.S. commercial milestones, plus double-digit royalties on ex-U.S. sales. Additionally, Prothena and Roche will work to optimize early stage antibodies targeting SNCA, including using Roche's brain shuttle technology.
FDA panel backs metreleptin for generalized lipodystrophy
FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11-1 that the Amylin Pharmaceuticals Inc. subsidiary of Bristol-Myers Squibb Co. (NYSE:BMY) provided substantial evidence that the benefits of Myalept metreleptin exceed the risks in patients with generalized lipodystrophy. However, the panel voted 10-2 that the benefits of metreleptin did not exceed the risks in patients with metabolic disorders associated with partial lipodystrophy. Bristol-Myers has proposed a REMS for metreleptin that would include a physician and pharmacy certification component, as well as a prescriber education program and a metreleptin safety registry. Metreleptin is under Priority Review for the indications, with a Feb. 24 PDUFA date.
Priority Review for Genzyme's Gaucher's disease product
The Genzyme Corp. subsidiary of Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted and granted Priority Review to an NDA for Cerdelga eliglustat to treat Type I Gaucher's disease. The company declined to disclose the PDUFA date. The product -- an oral ceramide analog that inhibits glucosylceramide synthase (GCS) -- is also under review in Europe.
Orexigen resubmits Contrave NDA
Orexigen Therapeutics Inc. (NASDAQ:OREX) resubmitted an NDA to FDA for Contrave naltrexone/bupropion to treat obesity. The resubmission is based on an interim analysis in the Phase III Light Study, which showed that Contrave met FDA's pre-specified criteria for ruling out excess cardiovascular risk. The Light Study is evaluating CV outcomes with Contrave, which FDA requested in a 2011 complete response letter. In October, Orexigen submitted an MAA to EMA for the obesity candidate, which is partnered in North America with Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Nov. 25).
FDA to again review QRxPharma's MoxDuo IR
FDA accepted for review a resubmitted NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The PDUFA date is May 25. The company said FDA will schedule an advisory committee meeting to discuss the NDA, which contains an audit of data from the company's Phase III Study 022 trial. In August, FDA issued a complete response letter for the product after QRxPharma submitted a revised analysis following discovery of an error in the time points at which some respiratory data in Study 022 were collected. MoxDuo IR is an immediate-release combination of oxycodone and morphine (see BioCentury Extra, Aug. 28).
GSK investing additional L200M in U.K. manufacturing
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it will invest about L200 million ($327.4 million) for manufacturing in the U.K. The pharma said it will build new manufacturing facilities at its Ware site as well as a new bulk sterile building and filing line at its Worthing site for the pharma's antibiotic Augmentin, a combination of amoxicillin and clavulanate, a beta lactamase (LACTB) inhibitor. GSK said it also will build a new center to develop practical manufacturing applications from emerging science and technologies. The pharma said it expects the investment to create 250 new jobs.
Crealta to acquire Savient assets
Crealta Pharmaceuticals LLC (Lake Forest, Ill.) will acquire the pharmaceutical portfolio of Savient Pharmaceuticals Inc. (OTCQB:SVNTQ), including gout drug Krystexxa pegloticase, for about $120.4 million. The deal is the first for Crealta, which debuted in August to acquire specialty pharmaceutical companies and products that are already approved or marketed, as well as late-stage development assets. Crealta is a partnership between Chairman and CEO Ed Fiorentino and private equity firm GTCR. Savient filed for Chapter 11 bankruptcy in the U.S. Bankruptcy Court for the District of Delaware in October. Krystexxa is approved in the U.S. and EU for chronic gout.
Sprout appealing FDA complete response for flibanserin
Sprout Pharmaceuticals Inc. (Raleigh, N.C.) is appealing a complete response letter from FDA for flibanserin to treat hypoactive sexual desire disorder (HSDD). Rhe company received the complete response letter for the resubmitted NDA in September. Sprout said it expects a decision on the appeal in 1Q14.
CymaBay raises $35.2 million
CymaBay Therapeutics Inc. (Hayward, Calif.) has raised $35.2 million since September, which the company said should provide enough runway to get to a Phase IIb readout in gout for lead compound arhalofenate (MBX-102). The company raised $30.2 million through the sale of 6 million shares at $5 in private placements that closed on Sept. 30 and Oct. 31. Investors also received warrants. National Securities Corp. was placement agent for both offerings. Also in September, CymaBay drew down $5 million of a $10 million loan from Oxford Finance and Silicon Valley.
POLITICS & POLICY
Congress advancing FY14 top-line budget, appropriations to come
The Senate and House subcommittees responsible for appropriating FDA and NIH funding are not yet scheduled to discuss appropriations for the agencies for the remainder of FY14. However, the House and Senate Conference Committee on the Budget reached an agreement, H.J. Res. 59, on top-line spending levels for the remainder of FY14 as well as FY15 that bumped FY14 discretionary spending by about $45 billion from post-sequester levels and will "turn off" the next round of planned sequestration cuts.
Reps. to introduce bill for antibiotic pathway, breakpoints
On Thursday, Reps. Phil Gingrey (D-Ga.) and Gene Green (D-Texas) are expected to introduce legislation in the U.S. House of Representatives that is anticipated to include provisions to create a limited population approval pathway for antibiotics and to recommend HHS update breakpoints for antibiotics based on pharmacokinetic and pharmacodynamic data. The sponsors declined to disclose details of the bill prior to its introduction.
Life Tech, NIH release siRNA data
Life Technologies Corp. (NASDAQ:LIFE) and NIH's National Center for Advancing Translational Sciences (NCATS) made data from the company's Silencer Select small interfering RNA library available to researchers for free via NIH's PubChem database. The library contains 65,000 siRNA sequences targeting more than 20,000 human genes. NCATS is also releasing data on the effects of siRNA molecules on biological functions. Life Tech is being acquired by Thermo Fisher Scientific Inc. (NYSE:TMO).
HHS releases November exchange enrollment figures
According to an HHS report, 258,497 people selected a qualified health plan in the healthcare exchanges in November, bringing the total number to 364,682 since the exchanges opened on Oct. 1. The total number enrolled includes both people who have and have not paid a premium. Among those who have selected a plan through the end of November, 227,478 (62%) have enrolled through a state-run exchange and 137,204 (38%) through the federal exchange. Additionally, HHS said 1.9 million people who have filled out applications have been determined to be eligible for exchange plans but have not yet selected a plan.
CPRIT releases request for proposals
The Cancer Prevention and Research Institute of Texas released a request for applications for grant awards, the first request since Texas Gov. Rick Perry and state officials lifted a moratorium on the agency. CPRIT agreed to the moratorium in December 2012 at the request of state officials after the institute came under fire following public complaints by former CSO Alfred Gilman that CPRIT's management was interfering in the scientific review process (see BioCentury Extra, Oct. 31).