The Catalyst Rx Pipeline Report

Transcription

1 The Catalyst Rx Pipeline Report A Brief Summary of New and Generic Drugs Projected to Enter the Market Fourth Quarter 2008 The Catalyst Rx Pipeline Report The purpose of The Catalyst Rx Pipeline Report is to provide a brief summary of new and generic drugs projected to become available in the near future. This information should not be solely relied upon for decision-making purposes. This report only includes select drugs that are expected to signifi cantly impact plan sponsors. Key Generics in the Pipeline, Brand Generic Brand Indication/ Est. Launch Est. Plan Drug Drug Name Drug Name Manufacturer Use Date* Spend Impact* Zerit stavudine Bristol-Myers Squibb HIV infection Dec Low Lamictal lamotrigine GlaxoSmithKline Seizures/ Bipolar disorder Jan Low Imitrex (tablets) sumatriptan GlaxoSmithKline Migraines Feb Low Seizure disorder/ Topamax topiramate Ortho-McNeil Migraine/ March 2009 Moderate prophylaxis Adderall XR amphetamine aspartate; amphetamine sulfate; dextroamphetamine Attention Deficit/ saccharate; Shire US Inc. Hyperactivity dextroamphetamine Disorder April 2009 Moderate sulfate GERD/ Prevacid lansoprazole Takeda Gastrointestinal May 2009 High ulcers Starlix nateglinide Novartis Type 2 Diabetes Sept Low Valtrex valacyclovir GlaxoSmithKline Anti-viral Dec Low Cozaar losartan Merck Hypertension Feb Low Effexor XR extended-release venlafaxine Wyeth Antidepressant July 2010 High *Note Projected launch dates and estimated drug spend impacts are subject to change based on the results of ongoing clinical trials, FDA approvals, timing of approvals, manufacturer decisions and any possible litigation. Sources: FDA Electronic Orange Book. Available at: Drugs@FDA. Available at: Disclaimer: The information contained herein is compiled from various sources and is provided for informational purposes only. Due to factors beyond the control of Catalyst Rx, information related to prospective drug launch dates is subject to change without notice.

2 Key Brand Products in the Pipeline, 2009 Drug Manufacturer Indication/ Use Est. Launch Est. Plan Drug Date* Spend Impact* Multaq (dronedarone) 1 Sanofi-Aventis Zipsor (diclofenac potassium) 2 Xanodyne Pharmaceuticals Ceftobiprole 3 Basilea Pharmaceutica Ltd. Prevention and treatment of atrial fibrillation 2Q2009 Mild to moderate 2Q2009 acute pain Complicated skin and skin structure infections 2009 (CSSSI) including diabetic foot infections Deep Vein Thrombosis Xarelto (rivaroxaban) 4 Johnson & Johnson prophylaxis after knee or 2009 Moderate hip replacement surgery ZolpiMist (zolpidem) 5 NovaDel Pharma Short-term treatment of insomnia Low Low Low 2009 Low *Note Projected launch dates and estimated drug spend impacts are subject to change based on the results of ongoing clinical trials, FDA approvals, timing of approvals, manufacturer decisions and any possible litigation. Comments: 1 New oral Class III antiarrhythmic 2 Immediate-release liquid-filled soft gelatin capsule containing 25mg of diclofenac potassium 3 Anti-MRSA broad spectrum antbiotic. 4 Oral anticoagulant intended to be taken once daily. Will compete directly with enoxaparin. 5 Oral spray preparation of a generically available oral agent. Sources: Drugs.com. New Drug Application Submissions. Available at: FDANews. Available at NovaDel Pharma. Available at Xanodyne Pharmaceuticals. Available at Basilea Pharmaceutica. Available at 2

3 Key Brand Products in the Pipeline, 2009 Multaq (dronedarone) Sanofi-Aventis Indication: Prevention and treatment of atrial fi brillation Current Status: On August 8, 2008, Sanofi -Aventis announced that dronedarone had been assigned priority review status for its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA). The NDA was rejected earlier; however, due to benefi cial results from clinical trials, the FDA re-opened the door for the NDA. Description: This agent is a multi-channel blocker that affects calcium, potassium and sodium channels and has anti-adrenergic properties. It does not contain the iodine radical and did not show any evidence of thyroid or pulmonary toxicity in clinical trials. Several studies have been conducted and submitted to the FDA. The ATHENA study indicated dronedarone reduced the incidence of the composite outcome of cardiovascular hospitalization or death, in patients with atrial fi brillation or fl utter, 29 percent of whom had a history of heart failure, compared with placebo. In the ERATO study, dronedarone signifi cantly decreased mean 24-hour ventricular rate. When compared to placebo, the mean treatment effect at day 14 was a reduction of 11.7 beats per minute (beat/min; P <.0001). Similar reductions were sustained throughout the six-month trial. During maximal exercise and compared to placebo, there was a mean reduction of 24.5 beat/min without any reduction in exercise tolerance. Lastly, the effects of dronedarone appeared additive to those of other rate-controlling agents (beta-blockers, calcium antagonists and digoxin). Dronedarone was well-tolerated, with no organ toxicities or proarrhythmia. Comments: If approved, this agent will be the newest Class III antiarrhythmic since amiodarone. Clinical studies indicate its safety and effectiveness with little to no organ toxicities. Outcome data may be key for product placement. Zipsor (diclofenac potassium) - Xanodyne Pharmaceuticals Indication: The number of agents available for mild to moderate acute pain are numerous Current Status: The FDA issued an approvable letter to Xanodyne Pharmaceuticals for Zipsor in July Description: Zipsor is an immediate-release liquid-fi lled soft gelatin capsule containing 25mg of diclofenac potassium. The Zipsor NDA included clinical data from three Phase 3 clinical trials. Although no specifi c mention of study designs was located, press releases state that the product achieved its primary endpoints, and was well-tolerated. Comments: The class of agents available for mild to moderate acute pain is numerous. Additionally, many products are available generically and provide effective and lower-cost alternatives to patients and plan sponsors. Ceftobiprole Basilea Pharmaceutica Ltd. Indication: Complicated skin and skin structure infections (CSSSI) including diabetic foot infections Current Status: The FDA had issued an approvable letter to Basilea Pharmaceutica surrounding the ceftobiprole NDA. In September 2008, the company tendered its complete response to the FDA. Currently, this product is available in Canada and is under review for approval in Europe. Description: This agent is a fi rst-in-class anti-mrsa (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin. The application is based on data from two multinational, double blind pivotal phase 3 trials (STRAUSS 1 and STRAUSS 2) which enrolled more than 1,600 patients with infections caused by Gram-negative and Gram-positive pathogens including MRSA. In a randomized, double-blind, Phase 3 study, ceftobiprole was studied in comparison with ceftriaxone with or without linezolid in patients with community-acquired pneumonia. Results demonstrated that cure rates with ceftobiprole were 87 percent compared with 88 percent in the comparator in patients with moderate to severe pneumonia. Additionally, in patients infected with Strep. pneumoniae, ceftobiprole achieved 93 percent cure rate compared to 89 percent. Results were similar in elderly patients as well. In the Strauss II clinical trial, ceftobiprole achieved 91 percent cure rates compared to 90 percent in the combination of ceftazidime and vancomycin arm. It should be noted that in this trial, nearly one-third of the 882 patients had diabetic foot infections. In MRSA-infected patients, ceftobiprole achieved a clinical success in 91 percent of patients treated compared to 86 percent treated with the combination. Comments: Ceftobiprole appears to be an effective agent against MRSA infections. Additionally, the clinical data indicates that this agent is effective and well-tolerated in CSSSI including diffi cult-to-treat diabetic patients with infections in the feet. 3

4 Key Brand Products in the Pipeline, 2009 (cont.) Xarelto (rivaroxaban) Johnson & Johnson Indication: Deep Vein Thrombosis prophylaxis after knee or hip replacement surgery Current Status: The NDA was submitted to the FDA in July Description: This agent is a novel once-daily oral tablet that will compete directly with current therapies, specifi cally the twice-daily injected enoxaparin. The NDA was submitted based on data from the RECORD clinical program. This program was comprised of four Phase 3 clinical trials involving more than 12,000 patient lives. In these trials, rivaroxaban demonstrated signifi cant superior effi cacy in direct comparison to enoxaparin with no increased evidence of major bleed events. Additionally, clinical trials are continuing to investigate the long-term use in more than 7,000 patients treated for three months of which over 4,000 lives were exposed to rivaroxaban for six to 12 months. Comments: Rivaroxaban has the potential to be a breakthrough agent in this class simply because it is an oral agent which many physicians and patients will most undoubtedly be quick to prefer over twice-daily injections. ZolpiMist (zolpidem tartrate) NovaDel Pharma Indication: Insomnia spray Current Status: The NDA for ZolpiMist was accepted by the FDA in January The manufacturer had expected action from the FDA on the Prescription Drug User Free Act by the end of the year; however, in September 2008, the FDA requested a three-month extension. Description: ZolpiMist is an oral spray preparation of zolpidem tartrate that the company plans to market for the treatment of short-term insomnia. The NDA was submitted via a 505(b)(2) application based on bioequivalence data from two randomized, open-label, dose-ranging studies comparing ZolpiMist with Ambien tablets in young and elderly healthy volunteers. The results demonstrated bioequivalence with Ambien tablets. Comments: There appears nothing spectacular about an oral spray preparation of an agent currently available as a generic oral tablet. There are some references by the manufacturer that the delivery method will provide for a more rapid onset of action. The newer generation of sedative hypnotics, also referred to as non-benzodiazepine sedative-hypnotics, currently has two generically available agents (zaleplon and zolpidem) that can offer lower-cost alternatives to plan sponsors. 4

5 Key Specialty Products in the Pipeline, 2009 Drug Manufacturer Indication/ Use Est. Launch Est. Plan Drug Date* Spend Impact* interferon beta-1b (Extavia) 1 Novartis Multiple Sclerosis 2Q2009 Low treprostinil (Viveta) United Therapeutics/ Pulmonary Arterial 2 2Q2009 Low Lung Rx Hypertension paliperidone 3 Johnson & Johnson/ Elan Schizophrenia 2009 Low vernakalant (Kynapid) 4 Cardiome Pharma Atrial Fibrillation 2009 Low *Note Projected launch dates and estimated drug spend impacts are subject to change based on the results of ongoing clinical trials, FDA approvals, timing of approvals, manufacturer decisions and any possible litigation. Comments: 1 This is the same drug as Betaferon/ Betaseron. 2 Inhaled version of treprostinil currently available as SC or infusion preparation found in Remodulin. 3 First long-acting injectable agent using new formulation technology. It is the ester formulation of paliperidone found in Invega. 4 Vernakalant selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation. Sources: Novartis International AG. Novartis Media Release May 26, Drugs.com. Available at United Therapeutics. Available at 5

6 New Specialty Products in the Pipeline, 2009 interferon beta-1b (Extavia) - Novartis Indication: Multiple Sclerosis Route of Administration: Subcutaneous Injection Current Status: This agent was recently approved by European Union. Novartis expects to receive U.S. approval and to launch interferon beta-1b by the fi rst half of Comments: Novartis brand of interferon beta-1b is not a new agent. It is the same agent currently marketed as Betaseron, a drug used for many years in patients treated for multiple sclerosis. Novartis has also submitted for approval a fi rst-of-its-kind oral agent, fi ngolimod, for the treatment of multiple sclerosis. While interferon beta-1b is considered fi rst-line treatment, if fi ngolimod is approved, it will be unclear how committed Novartis will be in promoting this agent. treprostinil (Viveta) United Therapeutics/ Lung Rx Indication: Pulmonary Arterial Hypertension Route of Administration: Inhalation Current Status: The NDA for this agent was fi led in June 2008 and a response is expected early in Description: This is not a new agent. Treprostinil is currently marketed in its intravenous and subcutaneous preparation known as Remodulin. Treprostinil was studied in combination with sildenafi l or bosentan and compared with sildenafi l or bosentan monotherapy. The studies researched the primary endpoint of change in six-minute walk distance at 12 weeks in a double-blind, placebo-controlled environment. Results indicated a signifi cant improvement with the combination of treprostinil with either product in the median walk-distance of 20 meters. Comments: Treprostinil provides a unique inhalation delivery with signifi cant study results. Disadvantages seem to arise surrounding the dosing frequency, which in the comparison studies, required four daily dosing sessions lasting one to two minutes. Additionally, this agent was studied only in combination and not as monotherapy which may set this agent up for step therapy edits for plan sponsors. paliperidone Johnson & Johnson/ Elan Indication: Schizophrenia Route of Administration: Intramuscular injection Current Status: The NDA for paliperidone for Intramuscular injection was submitted in October In August 2008, the FDA requested additional information but did not require additional studies. Description: Paliperidone is currently available as an oral agent marketed as Invega (Janssen). The Intramuscular preparation is formulated utilizing NanoCrystal Technology an Elan Pharma registered trademark. This technology is intended to increase the bioavailability of a drug and is used for those agents that are poorly water-soluble. Comments: If approved, this preparation of paliperidone will be the fi rst long-acting agent using Elan s NanCrystal Technology. This preparation may have its advantages in patients diagnosed with schizophrenia who have trouble with compliance with oral agents. However, like other agents used with schizophrenia where there are long-acting injectable agents and oral agents, therapeutic duplication may be troublesome for some health plans. vernakalant (Kynapid) Cardiome Pharma Indication: Atrial Fibrillation Route of Administration: Intravenous injection Current Status: The NDA was submitted in February 2007 and an FDA Advisory Committee recommended the approval of Kynapid in December Most recently, the FDA issued an approvable letter in August Description: Kynapid s mechanism of action is by the selective blockage of ion channels which become active during atrial fi brillation. Cardiome has conducted numerous Phase 3 studies to support the NDA for Kynapid. The ACT 1 study involved more than 400 patients. In short, the results of this study indicated that 52 percent of patients who suffered from recent onset of atrial fi brillation, defi ned as three hours to seven days, converted to normal rhythm after receiving Kynapid, as compared to four percent of those receiving placebo. The ACT 3 study was structured much like the ACT 1 study but involved 276 patients. Similar results were reported in this study as the ACT 1 study. ACT 3 results indicated that 51 percent of patients with recent onset atrial fi brillation converted to normal heart rhythm after Kynapid administration compared to four percent of those receiving placebo. The results of both studies demonstrated this agent was safe and well-tolerated. Comments: This agent has been in the NDA process now for some time; however, it does appear that it will fi nally be approved by the FDA early in This agent will mostly be used in the hospital/critical care environment and should have a low impact to plan sponsors as it relates to their pharmacy benefi t. What makes this agent relevant for this document is that Cardiome has already put the wheels in motion for an oral version of this drug and should begin the NDA process for it within the near future. NL