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Centerbrook, CT, United States

Peimer C.A.,Michigan State University | McGoldrick C.A.,Auxilium Pharmaceuticals | Fiore G.J.,SSI Strategy

Background: Collagenase clostridium histolyticum (CCH) is a Food and Drug Administration-approved treatment for adult patients with Dupuytren's contracture with a palpable cord that has been shown efficacious and safe in clinical trials. Methods: This paper summarizes the most common post-marketing clinical adverse event (AE) reports received by the manufacturer of CCH and sponsor of the US Biologics License Application (Auxilium Pharmaceuticals, Malvern, PA, USA) during the first 12 months after drug approval and commercialization in the USA. Results: Of the 115 AE reports describing 270 AEs voluntarily received from patients or health care providers after approximately 5,400 injections of CCH administered, the most common AEs involved local, nonserious reactions to treatment, including skin tears, peripheral edema, and contusion. There were few serious AEs observed (0.6% reporting rate per 1,000 injections), and two flexor tendon ruptures and one flexor pulley injury were reported. Conclusions: Analysis of post-marketing AEs received for CCH in the first year post-approval supports the safety profile reported earlier during clinical development and did not reveal additional clinical risks or concerns about CCH. © 2012 American Association for Hand Surgery. Source

Coyne K.S.,Outcomes Research | Currie B.M.,Outcomes Research | Thompson C.L.,Outcomes Research | Smith T.M.,Auxilium Pharmaceuticals
Journal of Sexual Medicine

Introduction: In order to reliably assess treatment effectiveness, patient-reported outcome instruments must demonstrate adequate psychometric properties. Aim: To assess the responsiveness of the Peyronie's Disease Questionnaire (PDQ) using data from two Phase 3 trials of collagenase clostridium histolyticum for Peyronie's disease (PD). Methods: Both trials recruited adult males with PD who were in a stable relationship with a female partner for at least 3 months. Patients completed the PDQ, International Index of Erectile Function (IIEF), and a global assessment of PD (GAPD) questionnaire at baseline and Weeks 24 and 52. Anchor- and distribution-based methods were used to evaluate the responsiveness of the PDQ. Main Outcome Measure: Peyronie's Disease Questionnaire. Results: The number of men available with baseline and Week 52 data was 267 for Study 1 and 270 for Study 2. The mean age was 58.0 for Study 1 and 57.4 for Study 2; the majority were white (95.2% and 97.3%, respectively). Mean PDQ subscale change scores from baseline to Week 52 for both studies ranged from -1.5 to -4.6 (P<0.0001). In Study 1, effect sizes were moderate to large on the Psychological and Physical Symptoms (-0.56) and Symptom Bother subscales (-0.84). For patients with penile pain at baseline, the effect size was large (-1.05) for the Penile Pain subscale. Similar effect sizes were seen in Study 2. The Psychological and Physical Symptoms and Symptom Bother subscales significantly discriminated patient improvement ratings of GAPD and degree of penile curvature at Weeks 24 and 52. Conclusions: The PDQ is highly responsive to change in men with PD. Coyne KS, Currie BM, Thompson CL, and Smith TM. Responsiveness of the Peyronie's Disease Questionnaire (PDQ). J Sex Med 2015;12:1072-1079. © 2015 International Society for Sexual Medicine. Source

Coyne K.S.,Outcomes Research | Currie B.M.,Outcomes Research | Thompson C.L.,Outcomes Research | Smith T.M.,Auxilium Pharmaceuticals
Journal of Sexual Medicine

Introduction: The Peyronie's Disease Questionnaire (PDQ) is a disease-specific, patient-reported outcome instrument designed to measure the psychosexual consequences and treatment outcomes of Peyronie's disease (PD). Aim: The aim of this study was to evaluate the test-retest reliability of the PDQ. Methods: Adult men with PD were recruited through eight clinical sites across the United States. Participants completed the PDQ during two study visits scheduled 7 (±3) days apart. At Visit 1, participants completed a sociodemographic questionnaire, the PDQ, and the International Index of Erectile Function (IIEF). At Visit 2, participants repeated the PDQ and completed an Overall Treatment Effect (OTE) scale. Test-retest reliability of the PDQ was assessed in a stable subsample (as determined by responses to the OTE). Intraclass correlation coefficients (ICCs) were calculated to evaluate the degree of association between the three PDQ subscale scores at Visits 1 and 2. Internal consistency of the subscales was also evaluated using Cronbach's alpha. Main Outcome Measure: The main outcome measure was the PDQ. Results: Of the 61 PD patients (mean age 59.3) who took part in the study, the majority were not receiving treatment for their PD (n=35, 57.4%). The sample's mean score on the erectile function domain of IIEF was 19.7 (±8.2), indicating mild-moderate dysfunction. Nearly two-thirds reported penile pain at baseline (n=37, 63.8%). Of the participants with baseline PDQ data and who had engaged in vaginal intercourse in the past 3 months, 57 completed both study visits. The PDQ demonstrated excellent test-retest reliability in 53 stable patients. The ICC was 0.85 for the Psychological and Physical Symptom subscale, 0.89 for the Peyronie's Symptom Bother subscale, and 0.88 for the Penile Pain subscale. The Cronbach's alpha estimates for all three subscales were acceptable at the >0.70 level. Conclusions: The PDQ is a highly reproducible measure of PD and can be an effective end point in clinical trials evaluating treatments for PD. Coyne KS, Currie BM, Thompson CL, and Smith TM. The test-retest reliability of the Peyronie's Disease Questionnaire. J Sex Med 2015;12:543-548. © 2014 International Society for Sexual Medicine. Source

Auxilium Pharmaceuticals | Date: 2014-04-17

The present invention is directed to a method of treating or reducing EFP in a patient comprising administering one or multiple low dose injections of collagenase to an area affected by EFP. The invention encompasses methods wherein the dose of collagenase per injection is between about 50 to about 200 ABC units and/or wherein the concentration of collagenase is between about 50 to about 2000 ABC units/milliliter (ml).

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Site: www.bloombergview.com

Whichever party is in the majority in the House and Senate after the November elections, the next Congress should make repairing our broken tax code a bipartisan priority. That fix must be comprehensive; more tinkering won't work. Last month, Treasury Secretary Jack Lew unveiled proposed regulations intended to bring an end to so-called inversions -- which allow a U.S.-based company to change its address to a foreign country to avoid our high tax rates and escape our uncompetitive tax code. Rather than addressing the flaws in our tax system that drive our companies overseas, the new regulations try to hem businesses into an outdated system that includes, at 39 percent for combined federal and state taxes, the highest statutory corporate rate among the developed countries. Worldwide, only the United Arab Emirates and Chad have higher rates. When companies leave the U.S., they take along jobs and investment, so inversions must end. But Treasury's proposed regulations won't achieve that goal because they offer no remedy for our broken code. Only this week, my home state of Ohio received confirmation of their ineffectiveness. Steris Corp., a health-care products company, based in Mentor, announced that it would merge with U.K.-based Synergy Health and move its corporate home to England. Analysts say the move will lower Steris's effective tax rate to 25 percent and save the company millions of dollars. Burger King and Medtronic also have decided to go through with their inversion deals despite Treasury's announced inversions. Worse yet, companies that the regulations would keep at home are becoming foreign takeover targets. One of those, Pennsylvania drugmaker Auxilium Pharmaceuticals, has agreed to be acquired by Endo, which itself Steris Corp. its headquarters to Ireland from Pennsylvania last year. Casting blame or questioning the patriotism of these companies will achieve nothing. Instead, we should use this opportunity to make the U.S. the best place to do business again. The defects in the tax code that make inversion Steris are the same as those that make those companies attractive as foreign takeover targets. They are well-documented and fixable: Not only does the U.S. have the highest corporate tax rate in the developed world, but in contrast to most of its foreign competitors, which use a so-called territorial system, this rate is imposed not only on income companies make at home, but also on income earned around the world. Making matters worse, the U.S. only taxes foreign sales when companies repatriate earnings, providing a strong disincentive for companies to bring money home. As a result, $2 trillion that could be reinvested in the U.S. economy sits in foreign bank accounts or is spent in other countries, creating jobs overseas that should be here. The good news is that, unlike many problems in Washington, there is bipartisan consensus on a solution: Tax reform. There's also general agreement on how it should be done. We must rid the code of ineffective deductions and loopholes that go only to favored interest groups. The money raised by eliminating those loopholes should be used to get our corporate rate down to at least the global average of 25 percent. We also have to move to a competitive territorial system of international taxation that taxes only income made in the U.S. There's an example of a country that has successfully applied this approach. In 2010, after the U.K. had endured its own spate of inversions, the government lowered the corporate rate to 21 percent from 28 percent, adopted a territorial system and declared the country "open for business." These reforms stopped inversions, and some companies that had left even came home. It shouldn't be surprising that that many U.S. companies now are ending up in the U.K. Given this broad agreement among U.S. policy makers that changing our tax code is urgent and necessary, it was disappointing to hear the Treasury secretary attempt to redefine a central ingredient of any change -- revenue-neutral tax reform -- saying that the traditional, 10-year budget window shouldn't apply. This has important consequences for businesses and workers. Put simply, the administration believes revenue-neutral tax reform outside of the 10-year budget window will require billions in tax increases in the first 10 years after reform legislation is enacted. Instead of sticking to a bipartisan approach, Secretary Lew suggested a return to the policies of using tax reform as a piggy bank to pay for new spending. But even more distressing, the secretary and President Barack Obama must know that such a proposal would be dead on arrival, no matter which party controls Congress. If we allow politics to stop us from fixing our broken code, the American worker will suffer. A 2007 Congressional Budget Office study showed that as much as 70 percent of the burden of corporate taxation is passed on to labor in the form of lower wages and benefits. Our labor force is struggling already: Unemployment is still high, and for every net job created under President Obama, almost three people have dropped out of the labor force completely, leaving us with the lowest labor participation rate since the Carter administration. Tax reform can only happen as a bipartisan effort, not a partisan squabble about tax cuts versus tax increases. We have accomplished that kind of bipartisanship in the past. Leading up to the last large-scale tax reform in 1986, President Ronald Reagan directed the Treasury to provide recommendations for a comprehensive overhaul. President Reagan then submitted 489 pages of specific policy proposals to a Democratic House and a Republican Senate, which hammered out the new code. We need this kind of engagement from the executive branch again if we're going to get tax reform across the finish line. This column does not necessarily reflect the opinion of Bloomberg View's editorial board or Bloomberg LP, its owners and investors.

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