FDA staff backs J&J’s Xarelto for heart condition

Posted under acute coronary syndrome, atrial fibrillation, Blog, Companies, Diagnostics, FDA, Funding, heart drug, Johnson & Johnson, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos, Xarelto by Ryan McBride

As Johnson & Johnson ($JNJ) builds the blockbuster pedigree of Xarelto, an FDA reviewer has given the thumbs-up to the new clot-busting drug as a treatment for the heart problem known as acute coronary syndrome. The staffers' recommendation of approval comes ahead of Wednesday's advisory committee meeting on the expanded use of J&J and Bayer's Xarelto in ACS patients.

While Xarelto was associated with steep rises in bleeding risks, a 2.5-milligram dose of the drug cut down heart attacks and strokes 15% compared with placebo in patients studied, Bloomberg reported. On Wednesday, the committee of non-agency advisers to the FDA will weigh in on whether those risks and benefits merit the new approval for the drug, which has already gotten the green light to stymie strokes in patients with atrial fibrillation and in patients who undergo knee and hip surgeries.

Yet Reuters chose to bore into how the FDA staff review pointed to a lack of data to support Xarelto's ability to reduce heart attacks and strokes, indicating that this raises questions about the drug in ACS patients.

Bleeding risks are common among blood-thinning drugs, and analysts don't expect this safety issue to thwart approval of Xarelto to combat ACS, which causes clotting that impedes blood flow to the heart. With the ACS indication, Xarelto could eventually bring in an additional $400 million to $700 million annually, according to analysts at Cowen. And the expanded use could give the therapy a new leg up among next-generation blood-thinners such as Boehringer Ingelheim's Praxada and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis.

"Our clinical consultants view Xarelto's reward/risk profile in ACS patients as positive, and predict an approval recommendation," analysts at Cowen wrote in a note to investors on Friday. "They also believe that Xarelto's mortality benefit in ACS is an important differentiation relative to Pradaxa and warfarin, and should bolster Xarelto's adoption across the atrial fibrillation patient population."

- read Bloomberg's story
- see Dow Jones Newswire's report
- and Reuters' take

Related Articles:
Bayer gets positive ruling from NICE on Xarelto
FDA puts Xarelto's ACS indication on fast track
Study flags risk of heart attack, ACS in Pradaxa patients
Bayer predicts blockbuster success for four of its late-stage drugs

Cancer drug experts brace for ASCO abstract dump tonight

Posted under ASCO, Blog, Bristol-Myers Squibb, Companies, dabrafenib, Diagnostics, Funding, GlaxoSmithKline, Johnson & Johnson, Medical Devices, Medical Supply, personalized medicine, Pfizer, Pharmaceuticals, Pipeline, Roche, Startups, trametinib, Universities, Videos, Xalkori, Zytiga by john

Tonight's the big night for cancer drug watchers. ASCO is releasing a mountain of data on cancer studies, and some of the biggest names in the business will be angling for star billing on some closely watched therapies.

Peter Loftus at Dow Jones lists Pfizer ($PFE), GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) among the big names that will be featured tonight. But Bristol-Myers Squibb ($BMY) and Roche (T-DM1) plan to hold back on the headlines until the confab in Chicago gets under way.

For GSK, dabrafenib and trametinib are slated for top billing. Together, the two therapies could earn more than $700 million a year, Cowen reports. Pfizer, meanwhile, will be looking to make a case to expand the approval for Xalkori while J&J will make a case for Zytiga.

As Loftus notes in his report, one of the big themes this year will be the continued focus on personalized medicine, as investigators look for better results from cancer therapies targeted to specific patient populations.

- here's the story from Dow Jones

Special Report: Top 10 Late-Stage Cancer Drugs – 2012

Related Articles:
Cancer drug developers angling for center stage at ASCO
Support seen for U.S. plan to speed nods for 'breakthrough' drugs
J&J's Zytiga's pain relief, ease of use beat Provenge
Oncologists lament growing drug shortages

Big Pharma’s high-risk pursuit of CNS gold faces major market doubts

Posted under Alzheimer's, Big Pharma, Blog, CNS, Companies, Diagnostics, Eli Lilly, Funding, gantenerumab, ISI Group, Johnson & Johnson, Medical Devices, Medical Supply, neuroscience, Pfizer, Pharmaceuticals, Pipeline, Roche, schizophrenia, semagacestat, solanezumab, Startups, Universities, Videos by john

Here's an interesting number for anyone interested in the risks and rewards of drug development: Two of every three analysts and fund managers recently queried by the ISI Group say they expect that new Alzheimer's drugs in late-stage testing at Eli Lilly and Pfizer/J&J will fail. 

The poll comes up in a broad look at Big Pharma's relentless pursuit of CNS gold by Bloomberg. The story starts off with a look at Roche's ($RHHBY) central nervous system picks, which include a mid-stage Alzheimer's drug as well as a shot at schizophrenia. Analysts have been pushing Roche to show that it can succeed in developing new drugs outside of the cancer arena. And the stakes spiked considerably last week when Roche tanked its high profile cholesterol drug after it failed to register efficacy in Phase III.

Drawn by the prospect that even a modest success against a disease like Alzheimer's will deliver Lipitor-sized rewards for years to come, pharma companies have been diving ever deeper. In Lilly's ($LLY) case, the push to complete a late-stage program for solanezumab follows the failure of semagacestat. But this time around Lilly says it has a better understanding of the disease. And Roche has ventured into the same arena, with four of its 10 brain drugs focused on treating the memory-wasting disease. Its Alzheimer's program--gantenerumab, which reduced amyloid in a small study--is now in mid-stage testing.

Not all pharma outfits are as bullish. Big setbacks in depression prompted AstraZeneca ($AZN) to restructure its CNS division, downsizing its staff and looking for outside partners to share the risk. GlaxoSmithKline ($GSK) famously decided to stay away from high-risk CNS drugs several years ago. And fresh reversals later this year could prove an even more painful setback for the field, where the high failure rate may force other companies to change tactics as well. 

"The central nervous system will remain the highest of the high-hanging fruit," Citigroup's Andrew Baum tells Bloomberg. And fewer hands will be reaching for it if the market turns even more skeptical about the odds of this game. Lilly, for one, is already in a weak position with one of the industry's weakest late-stage pipelines. Another blow could force major changes.

- here's the article from Bloomberg

Related Articles:
Pfizer faces crucial panel vote on blockbuster hopeful tofacitinib
Elan chases a holy grail of Alzheimer's treatment: Prevention
Lilly gains FDA approval for its controversial brain plaque test
Analysis: Grim stats on CNS drugs demand fresh approach to development

J&J and Bristol-Myers ally on another potential hep C blockbuster

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Janssen, Johnson & Johnson, Medical Devices, Medical Supply, Medivir, Pharmaceuticals, Pharmasset, Pipeline, R&D, Startups, TMC435, Universities, Videos by john

Just a few months after Johnson & Johnson joined R&D forces with Bristol-Myers Squibb on an interferon-free combo for hepatitis C, the two companies have broadened their development pact to include another one-two interferon-free punch targeted at the virus. And Medivir, a Swedish company partnered with J&J's ($JNJ) Janssen R&D Ireland on one of the key ingredients, saw its stock price pop this morning as it spread the news.

The two research powerhouses will conduct a drug-drug interaction study on J&J's TMC435 with BMS-986094 (formerly INX-189), a hep C treatment Bristol-Myers ($BMY) nabbed with its $2.5 billion buyout of Inhibitex back in February. And as they study the future potential of that combo they say they'll be ready to push immediately into a late-stage study of a TMC435/daclatasvir if their mid-stage study this year goes well.

BMS-986094 is a nucleotide polymerase NS5B inhibitor, like Gilead's ($GILD) closely watched 7977, which inspired the $10.8 billion buyout of Pharmasset. The protease inhibitor TMC435 blocks an enzyme the virus needs to replicate while BMS-986094 takes a different route to quell hep C. The prospects of a blockbuster business awaiting any developer which can market an interferon-free product has triggered a host of collaborations and buyouts as companies scramble to develop the most effective cocktail therapy that can work for a broad cross section of patients.

"We see the expanded clinical collaboration as a strong validation of TMC435, especially as we know of no other competing protease inhibitors running interferon-free combination trials with other direct-acting antivirals externally," which include polymerase inhibitors, noted Hans Jeppsson, an analyst at Danske Bank, according to a report in Bloomberg.

"This represents one of several strategies to explore TMC435 in interferon free regimens; a development we believe will be an important advancement in the HCV field for patients," said Medivir R&D chief Charlotte Edenius in a statement.  

- here's the press release
- get the report from Bloomberg

Related Articles:
Medivir deals generics biz amid HepC drug trials
Analysts pounce on positive Phase II data on hep C combo
Fresh woes for Gilead as two more hep C patients relapse in small 7977 study