Pfizer faces crucial panel vote on blockbuster hopeful tofacitinib

Posted under Blog, Companies, Diagnostics, Eliquis, FDA, Funding, JAK inhibitors, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, Rheumatoid Arthritis, Startups, tofacitinib, Universities, Videos by rmcbride

Wounded by plummeting Lipitor sales, Pfizer ($PFE) has high hopes for one of the gems of the pharma giant's pipeline, tofacitinib, and next week FDA advisers will take their turn dissecting the upsides and downsides of the first-in-class drug for rheumatoid arthritis. Odds are in favor of a positive panel vote, Reuters reported.

The FDA advisory panel for tofacitinib comes as Pfizer refashions its research and development efforts to become more productive and cost-efficient. And since the blockbuster hopeful emerged from Pfizer's own labs, the success of the drug could provide a major victory for the company's maligned R&D operations, according to the article. Pfizer, the world's largest drugmaker, is counting on tofacitinib and other major products in the firm's pipeline such as anti-clotting drug Eliquis and the Alzheimer's therapeutic bapineuzumab to replace skidding sales of Lipitor, which dropped 71% in the U.S. during the first quarter.

Tofacitinib, the first in a string JAK inhibitors in development for RA, comes packaged with all the promise and problems of a first-in-class experimental drug. Tablets of tofacitinib offer the advantages of oral dosing, unlike the injected anti-TNF treatments such as Abbott's ($ABT) Humira and Amgen's ($AMGN) Enbrel. As the article notes, however, Pfizer's RA drug hasn't proven to be more efficacious than the anti-TNF drugs and the long-term safety of the drug remain a mystery. For instance, it's unknown whether the risks associated with tofacitinib such as increased cholesterol and liver-enzyme levels are easily remedied or indicators that patients on the drug face future heart problems and serious organ damage.

"When we already have good treatments available, and there's no evidence that this drug really is better than others, I tend to encourage patients to go with what I know, which is things like Humira or Enbrel," Dr. Scott Zashin, clinical professor of medicine at the University of Texas-Southwestern Medical School, said, as quoted by Reuters.

Still, analysts expect an overall positive review of tofacitinib and an approval of the drug, which could gain early traction in the market for patients who fail to respond to anti-TNF drugs and methotrexate, Reuters reported. The news service cited analysts projecting $2 billion to $3 billion in eventual annual sales of the drug. Those are the types of numbers that Pfizer will need to put up to start easing the company's Lipitor aches.

The FDA staff documents on tofacitinib are expected to be available on Monday, with the advisory panel slated for Wednesday next week.

- read the Reuters report

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Pfizer turns to late-stage pipeline to make up for Lipitor crash

Posted under Alzheimer's, Alzheimer's disease, bapineuzumab, Blog, Companies, Diagnostics, Eliquis, Funding, Lipitor, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Startups, tofacitinib, Universities, Videos by john

As expected, Lipitor sales are being blasted by generic competition in the U.S. And with Pfizer's ($PFE) sales numbers plunging, the pharma giant is staying focused on the fate of a trio of late-stage therapies that are desperately needed to fill a growing gap.

For the record, Lipitor sales in the U.S. dropped 71% in the first quarter. But Pfizer is betting that after years of pipeline snafus and bad deal-making strategies, it can demonstrate once and for all that it has turned the corner on a smarter, more focused development approach.

The three main characters in that story line are tofacitinib, a potential blockbuster for rheumatoid arthritis with an August PDUFA date, the anti-clotting drug Eliquis, up for a decision in June, and the high-risk Alzheimer's Phase III studies for bapineuzumab.

Some analysts have been fretting over safety issues for tofacitinib, as Dow Jones' Peter Loftus reports. But many still expect it to fare well at the FDA, which is an experienced hand at considering the risk/benefits of new RA treatments. Eliquis, meanwhile, is widely considered an odds-on favorite for an approval. The wild card is bapineuzumab, partnered with Johnson & Johnson. According to Dow Jones, Pfizer expects late-stage data in the summer. But TheStreet's Adam Feuerstein tweeted this morning that the first Phase III trial is finished but Pfizer wants to wait until the second study is completed later in the year before releasing data. 

For Feuerstein, one of many Alzheimer's skeptics who have seen a series of R&D fiascos in the space, that's an ominous sign. A number of analysts note that an approval would be worth billions, but the odds of success are slim. A pair of regulatory wins ahead of the data release, though, would soften any blow from a bapi failure.

- here's the story from Dow Jones

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Bristol turns to blockbuster pipeline as Plavix goes generic

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Eliquis, Funding, Generic, Hepatitis C, M&A, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Plavix, Startups, Universities, Videos, Yervoy by rmcbride

Bristol-Myers Squibb ($BMY) has enticed other drugmakers to mimic its strategy of buying up mid-sized biotechs, and the New York-based pharma has seen some of those bets pay off with approvals of drugs such as Yervoy, acquired from Medarex ($MEDX). With clot-buster Plavix facing generic competition, the company is banking on some more wins in its pipeline to replace revenue from declining sales of its top seller.

Plavix sales slipped 4% in the first quarter to $1.69 billion, while sales of newer meds such as melanoma treatment Yervoy and hepatitis B drug Baraclude made solid gains, Bloomberg reported. And the news service provided some analysis on the role of the company's top pipeline prospects, which promise to enable Bristol to weather the loss of Plavix to generics if approved.

For starters, the FDA is expected to make a decision on approval of Eliquis, Bristol and Pfizer's ($PFE) potential blockbuster blood thinner, by June 28. In the meantime, analysts are keeping an eye on Bristol's progress in the development of oral treatments for hepatitis C that don't require injections of interferon. Bristol upped its stake in the oral hepatitis C race in January with the $2.5 billion buyout of Inhibitex ($IHNX), and recently the company hitched up with Johnson & Johnson and Medivir on an interferon-free combo therapy. 

"We want to understand how [HepC is] going to fit into things," Les Funtleyder, an analyst and portfolio manager at Miller Tabak & Co., told Bloomberg. "There's going to be some combination therapy, and it almost certainly requires some partnering, because not everybody's going to have all that's required."

- check out Bloomberg's article

Special Report: Eliquis - 15 top blockbuster contenders

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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

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