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

Pfizer, BMS face a delay on FDA’s megablockbuster decision on apixaban

Posted under apixaban, Blog, Bristol-Myers Squibb, Companies, Diagnostics, Eliquis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pradaxa, Startups, Universities, Videos, Warfarin, Xarelto by John Carroll

Pfizer ($PFE) and its partner Bristol-Myers Squibb ($BMY) will have to wait an extra few months before hearing whether the FDA will sign off on marketing approval for apixaban, their blockbuster anti-clotting hopeful.

In a brief release, the companies said they had submitted additional information for their NDA, which qualified as a "major amendment" that required added review time for the drug, dubbed Eliquis for commercial purposes. The new PDUFA date is now June 28 and the developers added that there are currently no plans for an advisory panel review.

The FDA had offered a priority review for apixaban in November as the partners hustled to reach the $9 billion market for anti-clotting drugs. If an approval comes through this summer, it will be a year after the EMA formally sanctioned the therapy. The delay also gives Boehringer Ingelheim and Bayer/J&J ($JNJ) more time to penetrate the market with their new therapies.

Analysts have given apixaban a solid shot at an approval, setting up a major showdown on the market with the arrival of a new treatment that is widely viewed as a major advance on warfarin, the old standard. Tim Anderson at Bernstein, who expects a panel review for apixaban, had estimated that the treatment could grab $395 million in sales this year and $3.7 billion by 2020. That initial timeline is likely to change a bit. Leerink Swann's Seamus Fernandez has estimated peak Eliquis sales at $4.2 billion in 2017.

For BMS, an approval would continue a regulatory streak that has included several key approvals. But for Pfizer, which has had a rocky road in the clinic, a megablockbuster OK would help redeem the company's tarnished reputation in R&D.

- here's the press release
- here's the AP report

Special Report: Eliquis - 15 top blockbuster contenders

Related Articles:
Pfizer, BMS drug Eliquis gets FDA priority review
Pfizer, BMS forthcoming data on apixaban has analysts on alert
EU hands Pfizer, BMS an approval for blockbuster apixaban

Bayer CEO Dekkers says price cuts threaten R&D

Posted under Bayer, Blog, Companies, Diagnostics, Funding, Marijn Dekkers, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos, Xarelto by John Carroll

Bayer CEO Marijn Dekkers totted up a $2.7 billion price tag to research and develop the new anticoagulant Xarelto. And he's warning tight-fisted payers that the more they squeeze drug companies on product prices, the harder it will be to come up with important new treatments in the pipeline. "We need innovative pharmaceuticals more than ever, because so many known diseases still cannot be treated adequately, or at all, with medicines," Dekkers asserted as he warned that revenue is likely to stay largely flat in this financial environment. Story

Bayer predicts blockbuster success for four of its late-stage drugs

Posted under Alpharadin, Bayer, Big Pharma, Blog, Companies, Diagnostics, Funding, Marijn Dekkers, Medical Devices, Medical Supply, Pharmaceuticals, regorafenib, Startups, Universities, VEGF Trap-Eye, Videos, Xarelto by John Carroll

You can count Bayer among the Big Pharma companies unwilling to back down from their multibillion-dollar gambles on drug research. The company boldly predicted that four of its late-stage programs are likely blockbusters, and it is committing €2 billion--two thirds of its total R&D budget--for drug research in 2012 as Bayer execs vow to stick to their big research guns.

"We have achieved major progress with our pharma pipeline in 2011 and are therefore lifting our sales forecasts for several products," said Bayer CEO Dr. Marijn Dekkers. "Overall, we believe that four of the drug products currently in advanced development have the potential to become blockbusters, meaning that each of these products can generate peak sales of EUR 1 billion per year and more."

The blockbuster list includes VEGF Trap-Eye along with the cancer treatments Alpharadin and regorafenib. In the case of Xarelto, "Bayer continues to expect peak sales of more than EUR 2 billion per year following the granting of regulatory approval by the European Commission in the new indications this week." Add it all up, and success for these drugs could translate into $6.5 billion in annual revenue.

Bayer now has 40 drug development programs in the clinic, and its CEO predicts that it faces good odds for continued success. "Perseverance is a vital quality in research, and that is particularly true for the pharmaceuticals business. Following our efforts in past years, our pipeline is now beginning to bear fruit," said Dekkers.

- read the press release
- here's the Bloomberg report

Special Report: Xarelto - 15 top blockbuster contenders

Related Articles:
Bayer's blockbuster Alpharadin may roil fast-changing prostate cancer field
Bayer and new partner Onyx crow over PhIII regorafenib success
Regeneron eye drug gets green flag at AdComm