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An FDA reviewer recommended approval of 2.5 mg twice-daily Xarelto rivaroxaban from Johnson & Johnson (NYSE:JNJ) to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS), non-ST-elevation myocardial infarction or unstable angina. However, the reviewer recommended against including a mortality claim on Xarelto's label and said the drug should be contraindicated in patients with a history of stroke or transient ischemic attack. The reviewer also said the label should include a boxed warning for bleeding risk in patients 75 years of age or older and in patients weighing less than 60 kg. The recommendations came in briefing documents released ahead of Wednesday's Cardiovascular and Renal Drugs Advisory Committee meeting to discuss an sNDA for Xarelto.
The documents noted that 2.5 mg twice-daily Xarelto plus standard of care reduces the rate of CV death, non-fatal MI or non-fatal stroke compared to placebo plus standard of care. However, the reviewer said the 2.5 mg dose was only "nominally" significant in reducing all-cause mortality, while a 5 mg twice-daily dose was not effective. The application has Priority Review, with a June 29 PDUFA date.
The oral Factor Xa inhibitor is approved in the U.S. to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery, and to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. J&J has U.S. rights to rivaroxaban from Bayer AG (Xetra:BAYN).
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Almirall S.A. (Madrid:ALM) granted Aslan Pharmaceuticals Pte. Ltd. (Singapore) worldwide rights to develop LAS186323, a dihydroorotate dehydrogenase (DHODH) inhibitor in Phase I testing for rheumatoid arthritis. Aslan will conduct and fund development through the end of Phase II trials, after which Aslan will find a partner for Phase III development and commercialization. Details were not disclosed.
Aslan's business model is to pick up molecules to develop through Phase II proof-of-concept (POC) trials and then return a Phase III-ready compound to the originator or find a partner to take it to commercialization. The company was founded in 2010 (see BioCentury, Oct. 3, 2011).
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The U.S. Preventative Services Task Force (USPSTF) issued a final recommendation against using prostate-specific antigen (PSA)-based screening for prostate cancer in all age groups. The task force reiterated last year's draft recommendation and said there is "moderate certainty" that the benefits of PSA-based screening for prostate cancer do not outweigh the harms (see BioCentury, Oct. 7, 2011).
USPSTF received several comments on the draft, including some asking for a separate recommendation for black men, whom the panel said are about twice as likely to die of prostate cancer than other men in the U.S. In response, the panel said black men represented a small minority of participants in the randomized trials and thus no firm recommendations could be made about the benefits and risks of PSA-based screening in the population.
Other comments requested additional information about the consequences of avoiding PSA screening. USPSTF said that choosing not to have a PSA test would result in patients living a similar length of life, with little to no difference in prostate cancer-specific mortality, while avoiding harms associated with PSA screening and subsequent diagnostic procedures and treatments.
The American Urological Association said in a statement it was "outraged" at the recommendations. The association said men in good health with more than a 10-15 year life expectancy should have the choice to be tested and should not be discouraged from doing so.
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Kinex Pharmaceuticals LLC (Buffalo, N.Y.) granted Xiangxue Pharmaceutical Co. Ltd. (Shenzhen:300147) exclusive rights in China, Taiwan and Singapore to develop and commercialize KX02 for cancer. KX02 is a lipophilic dual inhibitor of Src and pretubulin. In the U.S., Kinex said it plans to submit an IND early next quarter. Kinex will receive an upfront payment and is eligible for milestones and royalties. Xiangxue will make an equity investment in Kinex. Details were not disclosed.
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Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) granted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) exclusive rights in the U.S. to co-promote testosterone replacement therapy Testim. Auxilium will book all sales of the topical 1% testosterone gel and pay GSK a percentage of net sales above an undisclosed baseline. GSK is expected to begin promoting Testim early next quarter. Auxilium will remain responsible for all manufacturing, supply and regulatory activities. The deal expires on Sept. 30, 2015.
As a result, Auxilium raised its 2012 global Testim revenue guidance to $225-$235 million from $215-$225 million. Auxilium now expects total revenues for the year of $293-$315 million, up from previous expectations of $283-$305 million. The Street was expecting $299.2 million. Auxilium was up $0.31 to $17.94 on Monday.
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Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) submitted an NDA to FDA for Bronchitol mannitol to treat cystic fibrosis (CF). The formulation of mannitol in a dry powder inhaler system has Orphan Drug and Fast Track designation in the U.S. for the indication. In April, the European Commission approved Bronchitol for use in CF patients aged 18 years and older as an add-on therapy to best standard of care. The product is also approved in Australia. Pharmaxis was down A$0.03 to A$1.08 on Monday.
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General Electric Co. (NYSE:GE) hired Sue Siegel as CEO of healthymagination, GE's $6 billion initiative to improve healthcare. Siegel, formerly a general partner at VC firm Mohr Davidow, replaces Mike Barber, who will become VP and general manager of molecular imaging at GE's GE Healthcare unit. GE launched healthymagination in 2009 with goals to invest $3 billion in R&D for at least 100 low cost healthcare innovations, and provide $2 billion in financing and $1 billion in technology to bring healthcare IT to rural and undeserved areas.
Mohr Davidow is one of four VC firms that together with GE launched a healthymagination grant program last September for research on breast cancer diagnostics (see BioCentury, Sept. 26, 2011).
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Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) jumped $0.71 (11%) to $7.21 on Monday after reporting Phase Ib data for ACH-2684 in 30 patients with HCV genotype 1 infection. Once-daily 100 mg oral ACH-2684 led to a mean maximum reduction in HCV RNA levels from baseline to day three of 3.36 log10 IU/mL vs. 0.68 log10 IU/mL for placebo. Additionally, once-daily 400 mg ACH-2684 led to a mean maximum reduction in HCV RNA from baseline to day three of 3.73 log10 IU/mL, while twice-daily 400 mg led to a mean maximum reduction of 4.16 log10 IU/mL. The data are from one portion of a three-part, double-blind, U.S. Phase Ia/Ib trial. Full data from the trial are expected in 4Q12. ACH-2684 is an HCV NS3 protease inhibitor.
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A widely used combination treatment for idiopathic pulmonary fibrosis led to significantly greater rates of death, hospitalization, acute exacerbations and serious adverse events compared to placebo in the Phase III PANTHER-IPF trial, according to an interim analysis published by University of Michigan researchers. The researchers subsequently stopped the trial, which was evaluating the combination of prednisone, azathioprine and N-acetylcysteine compared to placebo.
There was no significant difference between the three-drug combination and placebo in the change from baseline in serial forced vital capacity at a mean follow-up of 32 weeks. The researchers said data from patients receiving N-acetylcysteine alone are still being gathered and analyzed. There are no FDA-approved drugs for IPF.
The trial, which was sponsored by NIH's National Heart, Lung and Blood Institute (NHLBI), enrolled IPF patients aged 35-85 with mild to moderate lung function defined as an FVC of at least 50% and a carbon monoxide diffusing capacity of at least 30% of the predicted value. Data were published in the New England Journal of Medicine.
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Johnson & Johnson (NYSE:JNJ) said induction therapy with low- and high-dose Simponi golimumab each met the primary endpoint of a greater proportion of patients achieving a clinical response at week six vs. placebo in the Phase III PURSUIT trial to treat ulcerative colitis (51.8% and 55%, respectively, vs. 29.7%, p<0.0001 for both). Both doses of Simponi also met the secondary endpoints of a greater proportion of patients achieving clinical remission and mucosal healing vs. placebo. The double-blind, international trial enrolled 774 patients with moderately to severely active UC who had failed to respond to or tolerate treatment with 6-mercaptopurine, azathioprine, corticosteroids and/or 5-aminosalicylate, or were corticosteroid dependent.
Data were presented at the Digestive Disease Week meeting in San Diego. J&J plans to submit regulatory applications in the U.S. and EU for the mAb against tumor necrosis factor (TNF) alpha to treat UC this year. Simponi is approved in 52 countries for rheumatologic indications, including the U.S. where the drug is approved for moderate to severe rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis.
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Peregrine Pharmaceuticals Inc. (NASDAQ:PPHM) gained $0.09 (21%) to $0.53 on Monday after reporting top-line data from a Phase IIb trial of bavituximab as a second-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The primary endpoint of overall response rate was higher in patients receiving once-weekly 1 mg/kg bavituximab plus docetaxel (15%) and 3 mg/kg bavituximab plus docetaxel (17.9%) vs. placebo plus docetaxel (7.9%). Peregrine said the trial was not powered to detect statistical significance.
Median progression-free survival (PFS), a secondary endpoint, was 4.2 months in the low-dose bavituximab group and 4.5 months in the high-dose bavituximab vs. 3 months for placebo. Median overall survival, also a secondary endpoint, was less than six months in patients receiving placebo and has not yet been reached in either bavituximab arm. The data were from 117 evaluable patients in the double-blind, international trial. Bavituximab is a chimeric mAb against phosphatidylserine.
This year, Peregrine expects to report OS data from the trial, as well as OS data from a pair of separate Phase II trials of bavituximab as first-line treatment of NSCLC and as first-line treatment of pancreatic cancer, respectively. Peregrine also said the Phase IIb results support Phase III development of bavituximab to treat NSCLC, but details were not disclosed.
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Vaccines company Novavax Inc. (NASDAQ:NVAX) raised $12.2 million through the sale of 10 million shares at $1.22 in a private placement to RA Capital Healthcare Fund. The price is a 5% premium to Novavax's close of $1.16 on May 18, the day before the offering was announced.
Novavax is evaluating its trivalent and quadrivalent seasonal influenza virus-like particle (VLP) vaccines in Phase II testing. Novavax was up $0.05 to $1.21 on Monday.