Triple Fixed-dose Combination Research Articles

Budget Impact of A New, First-In-Class Triple Fixed Dose Combination Therapy For COPD Patients

Budget Impact of A New, First-In-Class Triple Fixed Dose Combination Therapy For COPD Patients

Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide.

The goals of COPD therapy are to prevent and control symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance. The triple combination therapy of inhaled corticosteroids (ICSs), long-acting beta2 agonists (LABAs), and long-acting muscarinic antagonists (LAMAs) has become an option for maintenance treatment of COPD and as a “step-up” therapy from single or double combination treatments. There is evidence that triple combination ICS/LABA/LAMA with different inhalers improves lung function, symptoms, and health status and reduces exacerbations. A new triple fixed-dose combination of extrafine beclomethasone dipropionate (100 µg/puff)/formoterol fumarate (6 µg/puff)/glycopyrronium bromide (12.5 µg/puff) has been developed as a hydrofluoroalkane pressurized metered dose inhaler. Two large pivotal studies showed that this extrafine fixed ICS/LABA/LAMA triple combination is superior to fixed ICS/LABA combined therapy and also superior to the LAMA tiotropium in terms of lung function and exacerbation prevention in COPD patients at risk of exacerbation. This review considers the new information provided by these clinical trials of extrafine triple therapy and the implications for the clinical management of COPD patients.

On the Use of Group Sequential Study Designs for the Test of Bioequivalence for Complicated Products

A novel modeling approach together with a use of group sequential study design for a complicated triple fixed-dose combination was attempted. Probability of success (POS) was used for determining a weighted average power, where weight was based on available information such as data from previous pilot studies or literature. A simulation study was conducted that resulted in the development of the necessary sample size for the studies in addition to identifying a decision algorithm that was prospectively defined in the protocols. Prospective inclusion of decision algorithms in the respective protocols facilitated a decision analytic approach to continuance or discontinuance of the product concept. Whereas the data suggested going to stage 2 was appropriate, the overall POS of meeting the equivalence requirements upon completion of the study were very low, leading to termination of the selected formulation concepts. The use of such novel designs for bioequivalence assessment can be applied for staged investments, particularly when there is uncertainty in formulation POS or when the pilot-scale pharmacokinetic studies are not likely to predict the final-scale pivotal studies.

An analysis of volumes, prices and pricing trends of the pediatric antiretroviral market in developing countries from 2004 to 2012.

BackgroundThe pediatric antiretroviral (ARV) market is poorly described in the literature, resulting in gaps in understanding treatment access. We analyzed the pediatric ARV market from 2004 to 2012 and assessed pricing trends and associated factors.MethodsData on donor funded procurements of pediatric ARV formulations reported to the Global Price Reporting Mechanism database from 2004 to 2012 were analyzed.Outcomes of interest were the volume and mean price per patient-year ARV formulation based on WHO ARV dosing recommendations for a 10 kg child. Factors associated with the price of formulations were assessed using linear regression; potential predictors included: country income classification, geographical region, market segment (originator versus generic ARVs), and number of manufacturers per formulation. All analyses were adjusted for type of formulations (single, dual or triple fixed-dose combinations (FDCs))ResultsData from 111 countries from 2004 to 2012 were included, with procurement of 33 formulations at a total value of USD 204 million. Use of dual and triple FDC formulations increased substantially over time, but with limited changes in price. Upon multivariate analysis, prices of originator formulations were found to be on average 72 % higher than generics (p < 0.001). A 10 % increase in procurement volume was associated with a 1 % decrease (p < 0.001) in both originator and generic prices. The entry of one additional manufacturer producing a formulation was associated with a decrease in prices of 2 % (p < 0.001) and 8 % (p < 0.001) for originator and generic formulations, respectively. The mean generic ARV price did not differ by country income level. Prices of originator ARVs were 48 % (p < 0.001) and 14 % (p < 0.001) higher in upper-middle income and lower-middle income countries compared to low income countries respectively, with the exception of South Africa, which had lower prices despite being an upper-middle income country.ConclusionsThe donor funded pediatric ARV market as represented by the GPRM database is small, and lacks price competition. It is dominated by generic drugs due to the lower prices offered and the practicality of FDC formulations. This market requires continued donor support and the current initiatives to protect it are important to ensure market viability, especially if new formulations are to be introduced in the future.

Fixní trojkombinace v léčbě hypertenze zlepšuje complianci a kontrolu onemocnění

Fixní trojkombinace v léčbě hypertenze zlepšuje complianci a kontrolu onemocnění

Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial.

BackgroundThis study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5).MethodsIn this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period.ResultsA total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were −9.50 (8.46) mmHg in the OM/AML/HCTZ group and −4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated.ConclusionIn Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

Yusuf Hamied: leader in the Indian generic drug industry

Yusuf Hamied: leader in the Indian generic drug industry

Pharmacokinetics of fluticasone furoate, umeclidinium, and vilanterol as a triple therapy in healthy volunteers.

Objective: Two single-center, four-way, single-dose, crossover studies assessed the systemic exposure, systemic pharmacodynamics (PD), and safety profile of the closed triple fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) therapy compared with dual therapies. These are the first studies where pharmacokinetic (PK) profile assessment was possible for this inhaled triple fixed-dose combination product. Methods: Healthy volunteers were randomized to receive 4 consecutive inhalations (each administered as a single dose) via a single ELLIPTA® dry powder inhaler: in study 1 (CTT116415/NCT01691547), FF/UMEC/VI at total doses of 400/500/100 μg, FF/UMEC 400/500 μg, UMEC/VI 500/100 μg, or FF/VI 400/100 μg; in study 2 (200587/NCT01894386), FF/UMEC/VI at total doses of 400/500/100 μg or 400/250/100 μg, FF/VI 400/100 μg, or UMEC/VI 250/100 μg. PK and PD parameters and safety were assessed. Results: Of 88 subjects, 95% completed both studies and received all planned treatments. Total systemic exposure was similar for FF, UMEC, and VI when administered as a triple therapy compared with FF/VI and UMEC/VI. No clinically significant systemic PD findings were detected. The incidence of adverse events was low and similar across treatment arms. Conclusions: Systemic exposure to all three components of the closed triple therapy, following single-dose delivery, was similar to that seen with the dual therapies FF/VI and UMEC/VI. The delivered lung dose and safety profile of all three agents, delivered via a single inhaler, are expected to be similar to those of the dual therapies.

Different strategies from monotherapies to dual or triple fixed dose combination therapies to achieve blood pressure goals: a summary of a satellite symposium from the European Society of Hypertension.

In this special issue of High Blood Pressure and Cardiovascular Prevention we report the proceedings of a satellite symposium at the European Society of Hypertension (ESH) held in Athens, Greece in June 2014. The symposium, entitled ‘‘Effective fixed solutions: one, two, three... goal!’’, addressed a major issue in the contemporary management of hypertension, that is, how to overcome the poor control of hypertension in patients and, more in general, in the population. Professor Josep Redon from Spain provides the introductory remarks in this special issue that outline the current topics in the field of hypertension while another key opinion leader, Professor George Bakris, from Chicago in the United States, provides summary statements about where the field of hypertension is heading. The two keynote papers within this special issue reflect on current clinical data and identify potential areas for improvement for managing BP control in patients with hypertension. The topic on how to achieve BP goal in hypertension by Professor Stephane Laurent from France, is a competent and updated review on the role of combination therapy in the guidelines and in recent studies, and proposes an approach of ‘‘personalized’’ hypertension therapy platform which has also been recently proposed by a panel of international experts. The second paper by Professor Roland Schmieder from Germany focuses on the issue of treatment-resistant hypertension and is a practical, synthetic approach to this topic of growing interest for the medical community. The diagnosis of true resistant hypertension represents an excellent exercise to put in practice clinical guidelines and good clinical practice in the diagnostic process. Finally, two clinical cases entitled ‘‘A patient with apparent compliance’’ and ‘‘A patient with apparent resistant hypertension’’ by Dr. Sarafidis and Dr. Aguiar, respectively, provide practical insights for the readers of this journal who are interested in these subject matters. Single-pill combination therapy based on one, two or three drugs represent a truly new strategy to fight the unmet needs in the control of hypertension, and the title of this symposium, while proposing this new therapeutic solution with a metaphoric soccer representation, reflects the current challenges and the proposed solutions. As the Editor of the Journal, I am honoured and proud to host the presentations of these scientific leaders in the field of hypertension. Massimo Volpe, M.D, FESC, FAHA

Different strategies from monotherapies to dual or triple fixed dose combination therapies to achieve blood pressure goals: a summary of a satellite symposium from the European Society of Hypertension, June 13-16, 2014 Athens, Greece. Introduction.

Different strategies from monotherapies to dual or triple fixed dose combination therapies to achieve blood pressure goals: a summary of a satellite symposium from the European Society of Hypertension, June 13-16, 2014 Athens, Greece. Introduction.

Efficacy and Safety of Triple Drug Fixed-Dose Combination of Telmisartan, Amlodipine and Hydrochlorthiazide in the Management of Hypertension

Effective BP control is far away from reality in many patients in spite of advancements in many classes of antihypertensive drug therapy. Use of triple drug combination in the management of hypertension have already been established, however this study was conducted to evaluate the efficacy and safety of triple drug fixed dose combination of Telmisartan 40 mg, Amlodipine 5 mg and Hydrochlorothiazide 12.5mg. 69 hypertensive patients with seating cuff systolic blood pressure e” 160 mmHg and diastolic blood pressure e”100 mmHg were enrolled in the study. Patients were prescribed to take triple drug fixed dose combination for 120 days. Patients were evaluated on 30th, 60th and 120th days of treatment. There was statistically significant (p&lt;0.0001) decrease in systolic blood pressure from baseline to 30th, 60th and 120th day of treatment mean±SD (166±18.6 mmHg vs.147±16.1, 137±14.7 and 130±13.9 mmHg) respectively. Similar to SBP, decrease in DBP was highly significant (p&lt;0.0001) from the baseline to the 30th, 60th and 120th day of treatment (104±11.5 mmHg vs. 93.7±12.3, 89±10.2 and 84.5±8.98 mmHg respectively). Moreover at the end of the study period of 120 days 85.7% and 87.8% patients of age group &gt;60 years and &lt;60 years respectively achieved the JNC VIII recommended goal. This triple drug fixed dose combination of Telmisartan, Amlodipine and hydrochlorothiazide was found to be effective and safe option for the optimal management of hypertension.DOI: http://dx.doi.org/10.3329/jom.v16i1.22383 J MEDICINE 2015; 16 : 18-22

Pharmacoeconomic evaluation of fixed-dose triple combination for antihypertensive therapy in Ukraine

In Ukraine, the efficacy of treatment of arterial hypertension is only 19% in urban areas and 8 % in rural populations. The most important reasons of low efficiency of antihypertensive therapy (AHT) are a wrong choice of tactics of the patient management and low adherence of patients to treatment. The latter decreases with increasing amounts of prescribed drugs. One possible way to increase patients’ compliance to treatment and the effectiveness of therapy is to use fixed-dose combinations (FDCs) of antihypertensive drugs (AHDs). The share of FDCs consumption (in terms of DDDs/1000/day) in Ukraine in the total structure of AHDs consumption is 25%, which is significantly less than the proportion of patients (60%), requiring combined AHDs. This is an indirect evidence of low compliance of Ukrainian patients to HD treatment and the need of pharmacoeconomic study of benefits of antihypertensive therapy using FDCs. As a result of pharmacoeconomic cost-effectiveness analysis it has been found that antihypertensive therapy in patients with moderate and severe AH using triple FDC Val+Aml+HCTZ compared with three dual FDC: Val+HCTZ, Val+Aml, Aml+HCTZ provides greater clinical efficacy (the number of patients with the achieved target level of blood pressure). This triple FDC Val+Aml+HCTZ has pharmacoeconomic benefits (greater cost efficiency), compared with only one dual FDC Val+HCTZ. This gives the opportunity to save money, presents additional advantages in efficiency and justifies benefits from its use by hypertensive patients in need of appointing the third AHD CCB amlodipine in addition to the existing dual one using valsartan and hydrochlorothiazide.

Effect of food on the oral bioavailability of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide fixed dose combination tablets in healthy subjects.

A double fixed dose combination of amlodipine/valsartan and triple fixed dose combination of amlodipine/valsartan/HCTZ tablets have been developed to treat patients with moderate-to-severe hypertension. Here, we present the effect of food on the oral bioavailability of these two fixed dose combination tablets from two separate clinical studies in healthy subjects. Single oral doses of amlodipine/valsartan (10/160 mg) and amlodipine/valsartan/HCTZ (10/320/25 mg were administered under fasted or fed conditions. Blood samples were collected in both studies to determine the pharmacokinetic parameters of amlodipine, valsartan, and/or HCTZ using non-compartmental analysis. Following amlodipine/valsartan administration, the geometric mean ratios (GMRs, 90% CI) of AUC0-∞ and Cmax were 1.09 (1.05-1.13) and 1.03 (0.97-1.09) for amlodipine, and 0.94 (0.81-1.10) and 0.86 (0.73-1.02) for valsartan, respectively. Following amlodipine/valsartan/HCTZ administration, the GMRs (90%CI) of AUC0-∞ and Cmax were 1.09 (1.04-1.15) and 1.11 (1.05-1.08) for amlodipine, 1.14 (0.99-1.31) and 1.12 (0.98-1.29) for valsartan, and 1.09 (1.02-1.16) and 0.86 (0.79-0.93) for HCTZ, respectively. Considering the sample size and pharmacokinetic variability associated with analytes, these study results indicate that food effect is minimal or none when fixed dose combination tablets are administered with food. In conclusion, both fixed dose combination tablets can be administered without regards to meals.

Model-Supported Development of CS-8635: A Fixed-Dose Combination of Olmesartan, Amlodipine, and Hydrochlorothiazide.

CS-8635, a fixed-dose triple combination of olmesartan, amlodipine, and hydrochlorothiazide, was developed to address the growing need for additional blood pressure (BP) reduction in patients not controlled with dual-combination therapies. Prior to Phase III, modeling and simulation (M&S) was conducted to estimate the additional BP lowering effect of CS-8635 compared to the respective dual combinations. The Phase III study evaluated CS-8635 BP lowering effects only at the highest dose strength among the five dose strengths to be developed. Post-trial M&S was performed using an integrated dataset from three Phase III programs; CS-8635 plus two prior dual combinations. M&S robustly estimated and described the BP lowering effects of CS-8635 evaluated in a clinical setting. Furthermore, M&S evaluated BP lowering effects of the additional four dose strengths not studied. In summary, M&S aided the development of the clinical study and full characterization of the BP lowering effects of CS-8635 across intermediate doses.

How do Compliance, Convenience, and Tolerability Affect Blood Pressure Goal Rates?

Uncontrolled hypertension imposes a substantial global health burden, and poor patient compliance with prescribed antihypertensive medication makes a major contribution to the development of suboptimal blood pressure (BP) control. The asymptomatic nature of hypertension, side effects of medication, treatment complexity, and high pill burdens all have a negative impact on patient compliance. It is important to address the issue of poor patient compliance as studies have shown that good compliance is associated with improvement of BP control and positive health outcomes. As the majority of hypertensive patients require treatment with two or more agents to achieve goal BP, treatment guidelines have acknowledged the value of simplifying treatment through the use of fixed-dose combination (FDC) therapy. Triple FDC therapy comprising an angiotensin II type 1 receptor antagonist (angiotensin receptor blocker), calcium channel blocker, and thiazide diuretic is a novel treatment strategy for the improvement of BP control in hard-to-treat patients.

Single-session intense pulsed light combined with stable fixed-dose triple combination topical therapy for the treatment of refractory melasma

The effectiveness of intense pulsed light (IPL) has been reported in adults with melasma, but there is little information about IPL with triple combination topical therapy (TC) and refractory melasma. Sixty-two patients with totally or partially refractory melasma were enrolled in this randomized open-label study. Thirty-one patients were treated with IPL in a single session, bleaching agents and broad-spectrum sunscreens. Thirty-one patients were in the control group, receiving only bleaching agents and broad-spectrum sunscreens. The Melasma Area and Severity Index (MASI) and the investigator's global assessment using a seven-point scale were used to determine the impact and effectiveness of the treatment. The IPL group results based on MASI showed a 49.4% reduction (from 17.6 to 8.9; p < 0.001) after six months and a 44.9% reduction after 12 months (from 17.6 to 9.7; p < 0.001). The investigator's global assessment showed that the difference in the improvement rate between the IPL group and control group was significant (p = 0.002), with a better response in the IPL group. Single session IPL combined with stable fixed-dose triple combination treatment is a safe and effective treatment for refractory mixed and dermal melasma.

Three in one: safety, efficacy, and patient acceptability of triple fixed-dose combination medicine in the management of hypertension

Hypertensive patients whose blood pressures are more than 20 mmHg above their goal will often require three or more medications. Careful selection of medications whose actions are complementary or have an improved adverse effect profile when combined can affect not only the blood pressure but also patient acceptance, thus improving persistence in taking the medications as prescribed. This review will highlight the three single-pill three-drug combinations currently available in the US and will address their efficacy, safety, and tolerability. All three include the dihydropyridine calcium-channel blocker, amlodipine, and the thiazide diuretic, hydrochlorothiazide. They each contain a different renin–angiotensin system blocker. One includes the angiotensin-receptor blocker, olmesartan, while another contains valsartan. The third combination includes the direct renin inhibitor, aliskiren. All three fixed-dose combinations (FDC) at maximum doses of each component lowers the blood pressure of patients with stage II hypertension by 37 to 40 mmHg systolic and 21 to 25 mmHg diastolic, which is superior to any two of the components that comprise the three-drug FDC. These drugs are effective in males and females, the elderly, diabetics, minority populations, and patients with metabolic syndrome. Triple-drug FDCs are well tolerated with a low incidence of adverse effects, the most common being peripheral edema related to amlodipine. Extrapolation of data from two-drug FDC suggests that medication compliance (adherence and persistence) should be better with these FDCs than with the individual components taken as separate medications, although additional studies are necessary to confirm this.

Rationale for triple fixed-dose combination therapy with an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic

Hypertension is a growing global health problem, and is predicted to affect 1.56 billion people by 2025. Treatment remains suboptimal, with control of blood pressure achieved in only 20%–35% of patients, and the majority requiring two or more antihypertensive drugs to achieve recommended blood pressure goals. To improve blood pressure control, the European hypertension guidelines recommend that angiotensin II receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) are combined with calcium channel blockers (CCBs) and/or thiazide diuretics. The rationale for this strategy is based, in part, on their different effects on the renin-angiotensin system, which improves antihypertensive efficacy. Data from a large number of trials support the efficacy of ACEIs or ARBs in combination with CCBs and/or hydrochlorothiazide (HCTZ). Combining two different classes of antihypertensive drugs has an additive effect on lowering of blood pressure, and does not increase adverse events, with the ARBs showing a tolerability advantage over the ACEIs. Among the different ARBs, olmesartan medoxomil is available as a dual fixed-dose combination with either amlodipine or HCTZ, and the increased blood pressure-lowering efficacy of these two combinations is proven. Triple therapy is required in 15%–20% of treated uncontrolled hypertensive patients, with a renin-angiotensin system blocker, CCB, and thiazide diuretic considered to be a rational combination according to the European guidelines. Olmesartan, amlodipine, and HCTZ are available as a triple fixed-dose combination, and significant blood pressure reductions have been observed with this regimen compared with the possible dual combinations. The availability of these fixed-dose combinations should lead to improvement in blood pressure control and aid compliance with long-term therapy, optimizing the management of this chronic condition.

Blood Pressure Variability

A series of articles1–4⇓⇓⇓ published recently in The Lancet and Lancet Neurology raise an interesting issue that has implications for both the clinical management of hypertension and future research in hypertension, particularly in the development and use of different classes of blood pressure (BP)–lowering drugs. These studies, which were led by Peter Rothwell at the John Radcliffe Hospital in Oxford, United Kingdom, suggest that, whereas there is undoubted and well-proven benefit in the current practice of reducing mean BP to prevent cardiovascular events, there may be additional benefit in also reducing BP variability (BPV), especially to prevent stroke. The studies suggest, moreover, that different classes of drugs are superior to others in reducing BPV (calcium channel blockers being best and the β-blocker atenolol being worst). However, these articles, by virtue of their sheer volume (≈50 pages of printed text and many pages of supplementary web appendix data), could overwhelm all but the most stoic readers, and misinterpretation of the data could lead to confusion and have an adverse effect on clinical practice. It is important, therefore, to assess the scientific reality and determine how attention to BPV might benefit patients with hypertension. In the first analysis, systolic BPV between visits and maximum BP reached in 4 cohorts of patients with previous transient ischemic attacks were strong predictors for subsequent stroke.1 In treated hypertensive patients in the Anglo-Scandinavian Cardiac Outcome Trial-Blood Pressure Lowering Arm systolic BPV between visits was also a strong predictor of stroke and coronary events independent of mean clinic or ambulatory BP measurement (ABPM). BPV on ABPM was a weaker predictor overall but was related to visit-to-visit variability. Traditional measures of variability, such as SD and coefficient of variation (CV), were used in these analyses, but one of the problems encountered in the …

The UNITAID Patent Pool Initiative: Bringing Patents Together for the Common Good

Developing and delivering appropriate, affordable, well-adapted medicines for HIV/AIDS remains an urgent challenge: as first-line therapies fail, increasing numbers of people require costly second-line therapy; one-third of ARVs are not available in pediatric formulations; and certain key first- and second-line triple fixed-dose combinations do not exist or sufficient suppliers are lacking. UNITAID aims to help solve these problems through an innovative initiative for the collective management of intellectual property (IP) rights – a patent pool for HIV medicines. The idea behind a patent pool is that patent holders - companies, governments, researchers or universities - voluntarily offer, under certain conditions, the IP related to their inventions to the patent pool. Any company that wants to use the IP to produce or develop medicines can seek a license from the pool against the payment of royalties, and may then produce the medicines for use in developing countries (conditional upon meeting agreed quality standards). The patent pool will be a voluntary mechanism, meaning its success will largely depend on the willingness of pharmaceutical companies to participate and commit their IP to the pool. Generic producers must also be willing to cooperate. The pool has the potential to provide benefits to all.