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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Post-BIO News Roundup
May07

Post-BIO News Roundup

Been focusing on Chicago and this year's BIO extravaganza all week? Here's a sampling of news you might have missed. Pirfenidone rejected In a surprisingly twist, FDA refused to approve InterMune’s lung treatment pirfenidone, despite a positive recommendation from its advisory committee. The agency wants another lengthy trial to better demonstrate pirfenidone is effective at treating idiopathic pulmonary fibrosis, a debilitating and ultimately fatal lung disease for which there are no approved treatments in the U.S. or Europe. InterMune’s stock fell over 75% on the news. Check out this piece in Forbes' health care blog on whether FDA is these days less likely to listen to its advisory panels. Birth Control Pill Exalted The mainstream media celebrated as "The Pill" turned 50. Technically, they're celebrating the 50th anniversary of its approval by FDA. C&EN covered the chemistry story of the pill in "The Top Pharmaceuticals That Changed The World" special issue, back in 2005. Don't miss the classy 1950s era photo of Carl Djerassi. Resveratrol Trial Halted A GlaxoSmithKline clinical trial studying a reformulated version of resveratrol was suspended on April 22 due to safety concerns, but company officials say the complications may or may not be related to the drug. The big question remains-what does this all mean for the effort to make drugs out of resveratrol, the trace component of red wine that's been touted as a cancer fighter and a fountain of youth in a bottle? Resveratrol research has been in the spotlight a lot lately, not just for good reasons. GSK got the reformulated resveratrol (also called SRT-501) when it acquired biotech company Sirtris in 2008, to the tune of $720 million. Sirtris based its business around evidence that resveratrol turned on enzymes called sirtuins. The belief was that this activity could underlie some of resveratrol's beneficial effects. Sirtris developed other drug candidates based on this idea that the company says look nothing like resveratrol, and some of those entitites are in clinical trials as well. But the sirtuin connection has been called into question on multiple occasions. And now, with news that some patients in the resveratrol clinical trial developed cast nephropathy, a condition that can lead to kidney failure, the Wall Street Journal Health Blog is wondering aloud whether resveratrol's 15 minutes of pharmaceutical fame are coming to an end. GlaxoSmithKline officials say they are studying the data further, and that they stopped the trial "out of an abundance of caution", according to the Wall Street Journal. The trial was conducted in patients with multiple myeloma, and apparently, cast nephropathy is common in myeloma patients. Commenters at "In the Pipeline" (which, by the...

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