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Antibiotics company Cempra Inc. (NASDAQ:CEMP) raised $50.4 million through the sale of 8.4 million shares at $6 in an IPO. The price values Cempra at $118.6 million. Last month, the company said it planned to sell 6 million shares at $11-$13. At the $12 mid-point of the original range and 6 million shares, the company would have raised $72 million and been valued at $188 million. Stifel Nicolaus Weisel; Leerink; Cowen; and Needham were underwriters. Cempra gained $0.06 to $6.06 in its first day of trading on Friday.
Cempra plans to begin Phase III testing next half for oral solithromycin (CEM-101), a macrolide antibiotic, to treat community-acquired bacterial pneumonia (CABP). Cempra was founded in 2006 (see BioCentury, May 19, 2008).
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Threshold Pharmaceuticals Inc. (NASDAQ:THLD) gained $1.70 (132%) to $2.99 on Friday after partnering with Merck KGaA (Xetra:MRK) to co-develop and commercialize Threshold's cancer product TH-302. The product, a hypoxia-activated cytotoxic 2-nitroimidazole prodrug of the DNA alkylator bromoisophosphoramide mustard (Br-IPM), is in Phase III testing to treat soft tissue sarcoma (STS) and Phase II testing for advanced pancreatic cancer.
Merck, which will fund 70% of all development costs, will have exclusive commercialization rights worldwide. Threshold will receive $25 million up front and is eligible for $525 million in milestones, plus tiered, double-digit royalties. Threshold has a co-promotion option in the U.S. under the royalty agreement. The biotech also has an option to co-commercialize the product in the U.S. and receive up to 50% of the profits. Threshold will have primary responsibility for developing TH-302 for STS in the U.S., while the partners will jointly develop the product for all other indications.
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Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) said FDA lifted a partial clinical hold on HCV product IDX184 after reviewing interim data from 31 patients in a Phase IIb trial. The biotech now plans to enroll an additional 30 patients in the trial and begin a broad Phase IIb program with IDX184 in the coming months.
The interim data, released last month, showed that 50 and 100 mg IDX184 plus pegylated interferon and ribavirin were well tolerated with no serious adverse events reported. The low- and high-dose arms led to a rapid virologic response (RVR) in 63% and 73% of patients, respectively. IDX184 is a liver targeted prodrug of 2'-methyl guanosine monophosphate (see BioCentury Extra, Jan. 9).
In 2010, FDA instituted the hold after liver function abnormalities were detected in healthy volunteers who received IDX184 and another compound in a Phase I study. FDA later converted the hold to a partial hold to allow Idenix to begin the Phase IIb trial. Idenix fell $1.51 (11%) to $11.68 on Friday despite the news, which coincided with Gilead Sciences Inc. (NASDAQ:GILD) reporting preliminary data for a rival HCV product (see below).
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The U.K.'s NICE issued draft guidance recommending against the use of three breast cancer diagnostics to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer. NICE said it could not consider the tests cost effective because evidence for their clinical efficacy is "limited." The committee noted that most studies were retrospective, which it said is associated with increased bias compared to prospective trials. The tests are MammaPrint from Agendia B.V. (Amsterdam, the Netherlands); Oncotype DX from Genomic Health Inc. (NASDAQ:GHDX); and Mammostrat from the Clarient Inc. subsidiary of General Electric Co. (NYSE:GE). MammaPrint and Oncotype use gene expression profiling, while Mammostrat is based on immunohistochemistry.
NICE said it needed more data on a fourth test -- the IHC4 immunohistochemistry test from the Royal Marsden Hospital and Queen Mary University London -- before it could recommend its widespread use. NICE said the test's incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) was "dominant" compared to current practice, but the lack of data on analytical reliability and clinical utility made a recommendation for widespread use unwarranted at this time. Current practice consists of the Nottingham Prognostic Index or the Adjuvant! Online, a web-based tool to help guide treatment decisions.
NICE estimated the ICERs per QALY for Oncotype DX, MammaPrint and Mammostrat to be L26,940 ($42,223), L12,240-L53,058 ($19,184-$83,158) and L26,598 ($41,687), respectively, compared with current practice. Comments on the draft are due Feb. 24. Genomic Health was up $0.71 to $29.34 on Friday.
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FDA's Oncologic Drugs Advisory Committee will meet on March 21 to discuss an NDA from Talon Therapeutics Inc. (OTCBB:TLON) for Marqibo vincristine to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in patients with two or more relapses or in patients whose cancer has progressed following two or more leukemia therapies. The PDUFA date is May 13. The biotech is seeking accelerated approval based on data from the open-label Phase II rALLy study in 65 patients that showed an overall response rate of 35%, with 20% of patients achieving the primary endpoint of a complete remission (CR) or CR with incomplete hematologic recovery. Marqibo is a nanoparticle liposomal formulation of vincristine. Talon (formerly Hana BioSciences Inc.) was up $0.04 to $0.89 on Friday.
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Genfit S.A. (Euronext:ALGFT) gained EUR 1.57 (84%) to EUR 3.45 on Friday after GFT505 met the co-primary endpoints of improving insulin sensitivity in the liver and peripheral tissues in the Phase II GFT505-210-6 trial to treat non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The product significantly reduced insulin-induced hepatic glucose production by 0.86 mg/kg/min from baseline to week 8 vs. 0.63 mg/kg/min for placebo (p=0.006). GFT505 also significantly increased glucose infusion rate by 3.8 mg/kg/min vs. 3.2 mg/kg/min for placebo (p=0.019). The single-blind, crossover, French trial enrolled 22 insulin-resistant patients with abdominal obesity. GFT505 is also in Phase II testing to treat diabetes and atherogenic dyslipidemia in patients with abdominal obesity. The product is a dual peroxisome proliferation activated receptor (PPAR) alpha and delta modulator.
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Gilead Sciences Inc. (NASDAQ:GILD) gained $5.38 (11%) to $54.69 on Friday after releasing preliminary rapid virologic response data from the Phase IIb ELECTRON trial of HCV product GS-7977 in its financial results conference call late Thursday. All evaluable patients with HCV genotype 1 infection who received GS-7977 plus ribavirin achieved an RVR at week four. The data were collected from the trial's null responder and treatment-naive cohorts. The number of evaluable patients was not disclosed. The stock move translates to an increase in market cap of about $4 billion. Gilead's cap is now $41 billion.
Gilead added that sustained virologic response (SVR) data at four weeks after the end of treatment for the null responder cohort will be presented at the Retroviruses and Opportunistic Infections meeting in Seattle in March. Gilead gained GS-7977, a single isomer form of a nucleotide analog polymerase inhibitor PSI-7851, through its acquisition of Pharmasset Inc. last month (see BioCentury, Dec. 5, 2011).
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MannKind Corp. (NASDAQ:MNKD) raised $75 million through the sale of 31.3 million units at $2.40 in a bumped-up follow-on underwritten by Jefferies; Piper Jaffray; Cowen; and JMP Securities. Each unit comprises a share and a four-year warrant to purchase 0.6 shares, with each whole warrant exercisable at $2.40. Mannkind proposed to raise $50 million in a follow-on on Tuesday. MannKind had also proposed to raise up to $161 million through the sale of senior secured convertible notes, but said on Friday it opted not to pursue the debt financing at this time. MannKind also said it elected not to pursue a September 2011 proposal to sell $370 million in senior secured notes due 2017.
MannKind is conducting two Phase III trials of Afrezza in Type I and Type II diabetes. The trials were requested by FDA in a January 2010 complete response letter. The company expects to complete the trials by year end, and to submit the results to FDA in 1H13. Afrezza is a dry powder formulation of insulin plus an inhaler. MannKind was off $0.30 (13%) to $2.17 on Friday.
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Research tool and services supplier Transgenomic Inc. (OTCBB:TBIO) raised $19 million through a private placement of 19 million shares at $1. The price is a 16% discount to Transgenomic's close of $1.19 on Thursday, before the offering was announced. Investors also received five-year warrants to purchase 9.5 million shares at $1.25. Craig-Hallum Capital was placement agent. The company was off $0.02 to $1.17 on Friday.
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The Internal Revenue Service proposed a rule on Friday that would implement a 2.3% excise tax on the sales price of certain medical devices sold after Dec. 31, 2012. The excise tax was mandated by the Patient Protection and Affordable Care Act. Comments on the proposed rule are due 90 days after publication in the Federal Register. IRS will hold a public hearing on the rule on May 16.
The Advanced Medical Technology Association said in a statement that the "unique characteristics" of the device industry make it "ill-suited" for a blanket excise tax. The industry group added that the tax could cost as many as 43,000 jobs and that some companies have already reduced R&D.