May 22, 2011

Eighty Percent of Surveyed Pharmacy Directors Report that Higher Rebates and Discounts Prompted Their Managed Care Organization to Offer Preferential Reimbursement, According to a New Report from HealthLeaders-InterStudy and Fingertip Formulary

NASHVILLE, Tenn. & GLEN ROCK, N.J.--(EON: Enhanced Online News)--HealthLeaders-InterStudy and Fingertip Formulary find that superior clinical attributes of hepatitis C therapies, such as convenience, improved compliance and improved tolerability, have little influence over reimbursement status compared to rebates and discounts. According to the recent Formulary Forum report entitled Formulary Advantages in Hepatitis C: Despite the Near Certainty of Emerging Oral Protease Inhibitors, Pharmacy Directors Remain Unsure of the Value and Reimbursement Status of Triple Therapy Protocols, most (80 percent) surveyed pharmacy directors report that higher rebates and discounts lead to preferential reimbursement from U.S. health plans.  

The report finds that a greater percentage of managed care organizations receive rebates and discounts for Roche’s Pegasys (peginterferon alpha-2a) than for Merck’s PegIntron (peginterferon alpha-2b). In April 2011, the U.S. Food and Drug Administration recommended the approval of Merck’s boceprevir and Vertex Pharmaceuticals’ telaprevir for use in hepatitis C triple therapy regimens. If Roche continues to maintain Pegasys’ preferred reimbursement status, particularly as a means to encourage greater use of triple therapy protocols that include Pegasys, then telaprevir will be more successful than boceprevir.

“The higher success rates for emerging triple therapy regiments compared with conventional dual therapy regimens will result in higher treatment rates for hepatitis C,” said Leigh Compton, M.D., Ph.D., author of the report. “If Merck wants boceprevir to be considered for preferential reimbursement, they need to increase their efforts to improve the reimbursement status of PegIntron among U.S. health plans by offering more generous rebates and discounts, at least until efficacy data for boceprevir in combination with Pegasys are available.”

The new Formulary Forum report is based on a survey of 50 U.S. pharmacy directors who control formularies at national, regional and state-level managed care organizations, as well as historical formulary data from Fingertip Formulary.

About Fingertip Formulary

Fingertip Formulary (www.FingertipFormulary.com), the leading provider of access to and insight into formulary data in the United States, offers comprehensive formulary data covering commercial, Medicaid, Medicare and PBM plans, among others. Fingertip Formulary is a Decision Resources, Inc. company.

About HealthLeaders-InterStudy

HealthLeaders-InterStudy, a Decision Resources, Inc. company, is the authoritative source for managed care data, analysis and news. For more information, please visit www.HL-ISY.com.

About Decision Resources, Inc.

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Both HealthLeaders-InterStudy and Fingertip Formulary are Decision Resources, Inc. companies. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.
Contacts

Decision Resources, Inc.
Elizabeth Marshall, 781-993-2563
emarshall@dresources.com

Rivals Merck, Roche team up on hepatitis C drugs

The Associated Press May 17, 2011, 4:09PM ET

By LINDA A. JOHNSON

After a decade as rivals, drugmakers Merck & Co. and Roche are teaming up to market their hepatitis C medicines just as drugs from a new class are about to transform treatment of the tough-to-cure virus.

Merck's Victrelis, approved last Friday, and Incivek from Vertex Pharmaceuticals, expected to be approved soon, are the first new treatments for hepatitis C in about 20 years. They significantly boost cure rates when used in combination with the current mainstay drugs, which cause flu-like side effects for months and still don't cure most patients.

Merck, looking to maximize the benefit of being first to market, said Tuesday it's reached a deal under which Roche Holding AG sales representatives will promote Merck's Victrelis pills as part of a new triple combination therapy, with Roche's injected hepatitis C drug Pegasys and ribavirin pills.

"We're maximizing the potential of our new drug" with this deal, Merck spokesman Ian McConnell said in an interview.

Merck salespeople will promote Victrelis along with its similar injected drug, PEG-Intron, and ribavirin. Ribavirin is available as a cheap generic as well as Merck's brand-name drug, Rebetol, and Roche's brand, Copegus.

"Triple combination therapy for hepatitis C marks a major change in the way this disease is treated," Pascal Soriot, chief operating officer of Roche's pharmaceuticals division, said in a statement.

The Roche sales force will start promoting the three-drug combination, likely to cost tens of thousands of dollars for months of treatment, to U.S. physicians, then expand to other countries. The two companies also will educate patients about hepatitis C diagnosis and treatment options.

"This is a win for Roche to safeguard Pegasys' market share," Citigroup Global Markets Inc. analyst John Boris wrote to investors. It's "also a win for Merck to boost promotion of Victrelis."

Meanwhile, researchers at Merck, which is based in Whitehouse Station, N.J., and Switzerland's Roche will collaborate on testing new combinations of existing and experimental hepatitis C medicines from their companies.

The partnership comes after Roche and Merck's Schering-Plough unit spent more than a decade battling for supremacy in the market for hepatitis C drugs. Roche and Schering each produced ribavirin pills and long-acting, genetically engineered versions of the immune system protein interferon: Roche's Pegasys and Schering-Plough's PEG-Intron.

Those injected drugs, together with ribavirin, boost the immune system to fight the hepatitis C virus.

Victrelis and Incivek are part of a new drug class called hepatitis C virus protease inhibitors that block an enzyme needed for the virus to copy itself.

Studies showed the Victrelis three-drug regimen boosted the cure rate to about 66 percent after 48 weeks, from about 40 percent with just ribavirin and interferon.

Hepatitis C can linger silently in the body for years or even decades. By the time it's discovered, liver damage is often so severe a transplant is the only option, and livers are always in short supply.

The new combination treatment carries the same serious side effects as the interferon-ribavirin combination, including nausea, anemia, fatigue and a persistent unpleasant taste in the mouth. With the addition of Victrelis, more patients experienced anemia and unpleasant taste. Because ribavirin can damage or kill a fetus, the new combination cannot be taken by pregnant women or their male partners.

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Pill Burden a Key Concern With New Chronic Hepatitis C Drugs

Only Kadmon Pharmaceuticals' RIBASPHERE® RIBAPAK® Offers a Reduction in Ribavirin Pill Burden Designed to Increase Treatment Adherence
NEW YORK, NY--(Marketwire - May 18, 2011) - This past Friday, the U.S. Food and Drug Administration (FDA) approved the first of a new generation of chronic hepatitis C drugs, known as protease inhibitors. The drug, VICTRELIS® (boceprevir), from Merck & Co., has been shown to increase the rate of sustained viral response and shorten treatment times when used in combination with the current standard of care, ribavirin and pegylated alpha interferon, in the treatment of chronic hepatitis C. Vertex Pharmaceuticals is seeking approval to market a similar drug, INCIVEK® (telaprevir).

The addition of protease inhibitors to the current standard of care puts a new and significantly greater treatment burden on the patient. Under most treatment regimens, pegylated alpha-interferon is injected once a week, and ribavirin is taken twice a day, for a total of five or six pills when prescribed in generic form. VICTRELIS is taken three times a day, for a total of 12 pills. INCIVEK is also taken three times a day, for a total of 6 pills. A treatment cycle lasting 48 weeks could mean that the patient is responsible for taking over 5,700 pills on schedule for the entire regimen. If the patient does not adhere to the prescribed regimen, the risk of treatment failure or relapse is increased (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129). Furthermore, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).

Kadmon Pharmaceuticals' proprietary RIBASPHERE® RIBAPAK® (ribavirin, USP) is the only ribavirin available in a daily, two-pill compliance package designed to enhance therapy adherence. With RIBASPHERE RIBAPAK, the patient takes only two pills each day -- one in the morning and one at night -- reducing the total ribavirin pill burden by up to 66 percent over a 48 week course of treatment. RIBASPHERE RIBAPAK packaging is clearly marked for seven days of AM and PM dosing, and the completion of a compliance pack reminds the patient to administer their accompanying weekly interferon therapy. Kadmon is also offering patients a daily therapy diary to help keep track of their treatment schedule.

"Maintaining treatment adherence under the burden of a triple therapy combination will require significantly greater vigilance from the patient," said Bruce R. Bacon, M.D., professor of internal medicine at the Saint Louis University School of Medicine, and a clinical investigator for VICTRELIS. "With only one chance at success with this therapeutic approach, RIBASPHERE RIBAPAK represents an invaluable insurance policy for a treatment combination which could transform the enormous public health risks of hepatitis C."

About Hepatitis C

Hepatitis C is a liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis C virus can be either "acute" or "chronic." Acute hepatitis C virus infection is a short-term illness that occurs within the first 6 months after someone is exposed to the hepatitis C virus. Seventy-five - 85% of acute HCV infections become chronic HCV infections. Chronic hepatitis C virus is a serious disease than can result in long-term health problems, such as serious liver disease, including cirrhosis and liver cancer, or even death. An estimated 3.2 million Americans have a chronic infection of the hepatitis C virus.

About RIBASPHERE® RIBAPAK® (ribavirin, USP)

INDICATION

RIBASPHERE® (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

IMPORTANT SAFETY INFORMATION

RIBASPHERE (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS). The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6 month post treatment follow-up period.

CONTRAINDICATIONS

RIBASPHERE (ribavirin, USP) is contraindicated in:
  • Patients with known hypersensitivity to RIBASPHERE (ribavirin, USP) or to any component of the tablet.
  • Women who are pregnant.
  • Men whose female partners are pregnant, plan to become pregnant, or are not using contraception.
  • Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
  • In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.
RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a combination therapy is contraindicated in patients with:
  • Autoimmune hepatitis.
  • Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.
  • Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.
WARNINGS AND PRECAUTIONS

Treatment with RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy.

RIBASPHERE (ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection.

RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.

There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes. The peginterferon alfa-2a package insert and medication guide should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

Pregnancy: Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.

Anemia: The primary toxicity of ribavirin is hemolytic anemia (hemoglobin < 10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials.

Hepatic Failure: Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alfa-2a. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART.

Hypersensitivity: Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been observed during alpha interferon and ribavirin therapy.

Renal Impairment: RIBASPHERE (ribavirin, USP) should not be used in patients with creatinine clearance < 50 mL/min.

Pulmonary: Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and occasional cases of fatal pneumonia, have been reported during therapy with ribavirin and interferon. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported.

Bone Marrow Suppression: Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine.

Pancreatitis: RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.

Laboratory Tests: Before beginning peginterferon alfa-2a/RIBASPHERE (ribavirin, USP) combination therapy, standard hematological and biochemical laboratory tests are recommended for all patients.

Drug Interactions: Nucleoside Analogues: NRTIs: In clinical trials, cases of hepatic decompensation (some fatal) were observed among the CHC/HIV coinfected cirrhotic patients receiving NRTIs. Patients receiving peginterferon alfa-2a/ribavirin and NRTIs should be closely monitored for treatment associated toxicities.

ADVERSE REACTIONS

Peginterferon alfa-2a in combination with ribavirin causes a broad variety of serious adverse reactions. The most common serious or life-threatening adverse reactions induced or aggravated by peginterferon alfa-2a and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of < 1%. Hepatic decompensation occurred in 2% of CHC/HIV patients. Nearly all patients in clinical trials experienced one or more adverse events.

For more information please see the accompanying RIBASPHERE RIBAPAK (ribavirin, USP) Tablets Full Prescribing Information. The peginterferon alfa-2a Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment.

About Kadmon Pharmaceuticals
Kadmon Pharmaceuticals LLC is a privately held, New York City-based biopharmaceutical company founded on its expertise in novel science. The company explores new understandings in molecular biology to develop therapies that target the metabolomic or signaling pathways associated with disease, including novel anti hepatitis C therapies. Collaborating with academic centers and private enterprise at the forefront of innovation, Kadmon is focused on pioneering medicines in the areas of oncology, infectious diseases and immunology. For more information, visit www.kadmon.com.

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