Merck Seals Hepatitis C Pact with Roche
May17

Merck Seals Hepatitis C Pact with Roche

Merck is going bare knuckles in the marketing battle for Hepatitis C patients. Just days after receiving FDA approval to market its protease inhibitor boceprevir, now known as Victrelis, it revealed Roche has signed on to co-promote the drug alongside its pegylated interferon drug Pegasys, a cornerstone of HCV treatment. Competition in the HCV arena is expected to be fierce, as Vertex Pharmaceuticals is expected to get the FDA nod to market its own protease inhibitor for HCV telaprevir, to be marketed as Incivek, no later than Monday. Both the Merck and Vertex drugs will need to be taken in combination with the current standard of care, pegylated interferon and ribavirin. Although the two drugs have never gone head to head in the clinic, telaprevir is widely considered to have a better dosing regimen and a slight safety and efficacy edge over Victrelis. As such, analysts have believed that Merck’s main advantage in the HCV market would be its ability to promote Victrelis alongside its own pegylated interferon PegIntron. Now, it will also have Roche’s sales force out there hawking Victrelis with Pegasys, as well. No financials for the deal were announced, so its hard to say at this point how much Merck is giving up in its quest for a bigger piece of the HCV market. It’s also important to note that this is a non-exclusive pact, so time will tell whether Roche and Vertex establish a similar alliance. The deal also allows Merck and Roche to “explore new combinations of investigational and marketed medicines.” As readers will recall, the ultimate goal is to eliminate the need for interferon and ribavirin, which have harsh side effects, and treat HCV using only a cocktail of pills. Roche and Merck each have promising small molecules against HCV in their pipelines: Merck has vaniprevir, an NS3/4a protease inhibitor in Phase II trials, while Roche has the polymerase inhibitor RG7128, the protease inhibitor RG7227, and the earlier-phase polymerase inhibitor RG7432. Read here for past coverage of the race to get new HCV drugs to...

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Haystack 2010 Year-In-Review
Dec17

Haystack 2010 Year-In-Review

This Friday, we're looking back at 2010's big news in pharma and biotech, both the good and the bad. Check out our picks and be sure to weigh in on what you think we missed. 1. Provenge Approved In April, Dendreon's Provenge became the first approved cancer immunotherapy. Dendreon CEO Mitch Gold called it “the dawn of an entirely new era in medicine.” And while prostate cancer patients are excited for a new treatment option, the approval is perhaps most exciting for its potential to reignite interest in cancer immunotherapy research. There’s a lot of room for improving the approach—Provenge is, after all, expensive and highly individualized. Now that immunotherapy have been proven to work, there’s hope that the lessons learned in both its discovery and clinical development will aid scientists in inventing even better cancer vaccines. 2. Obesity Field Slims The obesity drug race played out in dramatic fashion in 2010, with three biotech companies-Vivus, Arena, and Orexigen, each making their case for its weight-loss medication before FDA. As of this writing, Orexigen's drug Contrave seems to be on the surest footing to approval, but longtime obesity-drug watchers know that caution seems to rule the day at FDA, so nothing is a sure bet. Orexigen's Contrave and Vivus's Qnexa are both combinations of already-approved drugs, whereas Arena's Lorqess is a completely new molecule. When C&EN covered the obesity race in 2009, it seemed that Lorqess (then going by the non-brand-name lorcaserin) had the cleanest safety profile, but Qnexa was best at helping patients lose weight. But FDA's panels didn't always play out the way folks expected. There were safety surprises- notably the worries about tumors that cropped up in rats on high doses of Lorqess, and the extensive questioning about birth defect risks from one of the ingredients in Vivus' Qnexa. The fact that FDA's panel voted favorably for Orexigen's Contrave, a drug that's thought to have some cardiovascular risks, generated discussion because FDA pulled Abbott's Meridia, a diet drug with cardiovascular risks, from the market in October. The dust still hasn't fully settled. Arena and Vivus received Complete Response Letters from FDA for Lorqess and Qnexa. Vivus has submitted additional documentation and a followup FDA meeting on Qnexa is happening in January. Also to come in January is the agency's formal decision on Contrave. And if you're interested in learning about the next wave of obesity drugs coming up in clinical trials, read this story in Nature News. 3. Sanofi & Genzyme: The Neverending Story Speaking of drama, Sanofi’s pursuit of Genzyme has been in the headlines for months now, and promises to stretch well into 2011. The...

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Vertex Unveils Positive Telaprevir Data
May25

Vertex Unveils Positive Telaprevir Data

Ending months of anticipation, Vertex Pharmaceuticals unveiled the first set of data from a Phase III trial of telaprevir, a protease inhibitor for the treatment of hepatitis C. The company is expected to submit for regulatory approval later this year, and launch the drug in 2011. Vertex said that 75% of genotype-1 patients—viewed as the toughest to treat--who received 12 weeks of telaprevir treatment on top of the current standard of care (48 weeks of pegylated interferon and ribavirin) were cured of the infection. Only 44% of patients in the control arm, which received only the standard of care, were cured after 48 weeks. Leerink Swann analyst Seamus Fernandez told investors the results set an "impressively high bar" for treatment in HCV. Importantly, adding the drug to the standard of care will lessen the total treatment time for many HCV patients. In addition to not being very effective, many people can’t tolerate the harsh side effects associated with interferon and ribavirin. Physicians liken the 48-week regimen to living with a nasty flu for a year. In hopes of halving the number of weeks on interferon and ribavirin, Vertex conducted what is called a “response-guided trial.” If the virus was sufficiently quelled after four weeks with the telaprevir addition, patients went on to receive just 24 weeks total of therapy. The company said “the majority” of patients received just 24 weeks of treatment. That 24-week figure is a critical one. Merck is hot on Vertex’s heels with its own protease inhibitor, boceprevir. Both companies are expected to launch their drugs next year, and with similarly mild safety issues, analysts say the drug that can shut down the disease the quickest will win. Merck is also conducting a response-guided study and at its R&D day said a retrospective look at its Phase II data suggests patients can be successfully treated in 24 weeks with boceprevir. BMO Capital Markets analyst Jason Zhang was dead on with his estimates for the drug. As we wrote earlier this month: Zhang expected the Phase III data to show a sustained viral response (the equivalent of a cure) of 75% of patients receiving telaprevir. His guess for telaprevir’s biggest competitor, Merck’s boceprevir? 74% sustained viral response. We’ll have to wait and see how close he comes on that figure, as Merck has been vague about when its Phase III results will be released. The big pharma firm has only said that it expects to present the data at an upcoming conference. My guess? We will likely be waiting for the American Association of Liver Disease’s annual shindig, also known as “The Liver Meeting,” in October. For...

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Merck Unveils Overhauled Pipeline
May11

Merck Unveils Overhauled Pipeline

I’m in Whitehouse Station, N.J., today to get a birds-eye view of Merck’s overhauled pipeline following last year's merger with Schering-Plough. The company is unveiling its pipeline as part of an overall business briefing for investors. Here are a few highlights after the R&D segment of today’s meeting: --The company has jettisoned what had been expected to be its first biosimilars product, MK-2578, a pegylated form of erythropoietin that would have gone up against Amgen's Aranesp. The product has been developed using technology acquired for $400 million in 2006 from GlycoFi, which figured out how to coax yeast into make homogeneous glycoforms. Peter Kim, president of Merck Research Laboratories, said that regulatory authorities indicated that given the safety concerns over erythopoeitin stimulating agents, the company would have to conduct a cardiovascular assessment for MK-2578. The delay—and one can assume the cost—caused the company to ditch the project. Merck BioVentures, its biologics business, still has two biosimilars in the clinic, and plans to have five in Phase III trials by 2012. --Merck devoted a lot of time to its cardiovascular business, which seems to be almost an even distribution of legacy Schering-Plough and Merck products. Vorapaxar (Schering-Plough), in Phase III; betrixaban (Merck), expected to enter Phase III trials next year; Brinavess (Merck), a novel multi-ion channel blocker under regulatory review in Europe; Acadesine (Schering-Plough), an adenosine-regulating molecule in Phase III trials; Tredaptive (Merck), extended-release niacin combined with laropiprant, a compound that prevents flushing, expected to be submitted for regulatory approval in 2012; and anacetrapib (Merck), a reversible inhibitor of CETP in Phase III studies. --Kim came out swinging in a discussion of boceprevir, a protease inhibitor for Hepatitis C compound that he called “potentially the most impactful near-term product” for Merck. Without ever mentioning boceprevir’s biggest potential competitor, Vertex Pharmaceutical’s telaprevir, by name, Kim went through a point-by-point discussion of areas where boceprevir might have an advantage over telaprevir. Neither Vertex nor Merck have unveiled Phase III data on their drugs, but as discussed in last week's magazine, analysts have given telaprevir an edge over boceprevir on several fronts: its side effect profile appears milder (telaprevir causes a rash, boceprevir exacerbates anemia already caused by ribavirin, one of the two drugs given as the current standard of care) and, importantly, it appears to decrease treatment time to 24 weeks from 48 weeks. Kim described a “post-hoc” analysis of Phase II data for boceprevir that suggests it could also be effective after just 24 weeks. A Phase III study for boceprevir plus standard of care includes a “response-guided therapy” arm, which means that patients who have undetectable levels of the virus...

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