Archive for the ‘JAK inhibitors’ Category

May
11

Incyte rides wave after Pfizer’s FDA panel nod

Posted under Blog, Companies, Diagnostics, Eli Lilly, FDA, Funding, Incyte, Incyte Corporation, JAK inhibitors, Jakafi, LY3009104, M&A, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, Regulatory, Rheumatoid Arthritis, Startups, tofacitinib, Universities, Videos by rmcbride

Pfizer ($PFE) scored the endorsement of an FDA panel for its arthritis pill tofacitinib this week, and the win could put some wind in the sails of drug developer Incyte ($INCY). Incyte's shares jumped this week after agency advisers backed approval of Pfizer's potential blockbuster JAK inhibitor for rheumatoid arthritis.

Wilmington, DE-based Incyte has been developing a rival JAK inhibitor in partnership with drug giant Eli Lilly ($LLY). And the interim data from a mid-stage trial data on the drug, known as LY3009104, are due out next month at the European League Against Rheumatism's Annual European Congress of Rheumatology, according to Incyte. Lilly has already wrapped the Phase IIb study of the drug for treating RA and is expected to reveal the results later this year.

This week Goldman Sachs elevated shares of Incyte from "neutral" to "buy," noting that the company has successfully launched the cancer drug Jakafi and has momentum. "[LY3009104's] potential was validated with the positive FDA panel vote on May 9 on Pfizer's tofacitinib," the firm said, as quoted by StreetInsider. With an approved cancer drug and a potential blockbuster RA pill in the pipeline, Incyte fits the profile to be gobbled up by a larger company.

Lilly, which has lost major products such as the cancer drug Gemzar to generic competition, could benefit from buying partner Incyte, Jason Chew, a biotech analyst and co-founder of Chimera Research, told FierceBiotech. "A deal for Incyte would provide a marketed drug and another one that could potentially enter pivotal trials in two indications by 2013--RA and psoriasis," Chew said. "Jakafi could help Lilly regain strength in oncology with the loss of Gemzar."

Both Pfizer's tofacitinib and Incyte's LY3009104 offer new oral remedies to treat RA, an autoimmune disease that attacks the joints and affects more than 1 million patients in the U.S. The treatments could become a new alternative for patients who don't respond to injected meds for the disease. Chew notes that Incyte's drug has dosing advantages over tofacitinib and could present lower risks of side effects to patients.

Incyte's shares were up 2.3% to $23.55 per share as of noon ET today, trading close to the 52-week peak of $24.30 hit earlier this week.

- see the StreetInsider article

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May
09

UPDATED: FDA advisers sign off on Pfizer’s arthritis pill

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

Pfizer took one step closer to an FDA approval of a potential blockbuster. Today an FDA advisory committee endorsed the company's drug, tofacitinib, as a safe and effective treatment for patients with rheumatoid arthritis. Yet there are plenty of doubts about whether the agency will take the recommendation.

The Arthritis Drug Advisory Committee voted 8-2 in favor of approval of the experimental arthritis pill, which could become the first disease-modifying oral drug against the autoimmune disorder in more than a decade and the first JAK inhibitor to hit the U.S. market for this disease, according to Pfizer ($PFE). The company has asked for approval for the drug as a second option for the thousands of RA patients who don't respond to existing injectable meds such as Abbott's ($ABT) Humira and Amgen's ($AMGN) Enbrel. The FDA action date for the application is in August.

Pfizer has a lot riding on the approval of tofacitinib. The U.S. drug giant has lost exclusivity for the mega-blockbuster Lipitor, U.S. sales of which fell by 71% in the first quarter. Tofacitinib is among a handful of prospects in the company's pipeline that could bring more than $1 billion in annual sales and help replace declines in Lipitor revenue. Several analysts estimate sales of the drug to hit $1 billion or more by 2015 if approved this year.

Yet the FDA could spoil Pfizer's blockbuster plans for the drug. The agency's staff reported this week that there were more cases of cancer and infections in patients who took the drug in studies, and they noted that the X-ray method used to measure the impact of the drug on patients' disease wasn't sufficient for the agency to judge the efficacy of the treatment. However, the arthritis panel of non-agency experts voted unanimously that the efficacy of the drug was sufficient for approval.

"The committee ultimately viewed the safety profile of tofacitinib as acceptable; however, several panelists suggested that tofacitinib should be approved for use in patients who have failed other available treatment options, including anti-TNF inhibitors," analysts at Cowen wrote in a note to investors today. "We continue to expect tofacitinib to be approved in aTNF-refractory patients for whom there is still a great unmet medical need."

Pfizer has plenty of opponents in race to develop new oral RA meds. Behind Pfizer, Eli Lilly ($LLY) and Incyte ($INCY) are developing a rival JAK inhibitor for treating RA, and AstraZeneca ($AZN) and Rigel ($RIGL) are in late-stage development of an oral med to combat the disease. Pfizer was predictably upbeat about its own program after today's panel nod.

"We are pleased with the Committee's positive evaluation of the tofacitinib data and its decision to recommend approval," Dr. Yvonne Greenstreet, senior vice president and the head of Medicines Development Group for Pfizer Specialty Care, said in a statement. "The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application."

- here's Pfizer's release
- check out Reuters' report
- see the Wall Street Journal's article

UPDATED: Added additional details about FDA review of tofacitinib, analyst comments and other aspects of the program.

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May
07

FDA harps on risks of Pfizer’s tofacitinib as panel looms

Posted under Blog, Companies, Diagnostics, Drug Safety, Enbrel, FDA, Funding, Humira, JAK inhibitors, Medical Devices, Medical Supply, methotrexate, Pfizer, Pharmaceuticals, Regulatory, Rheumatoid Arthritis, Startups, tofacitinib, Universities, Videos by rmcbride

FDA staffers drew attention to safety risks associated with Pfizer's blockbuster contender tofacitinib in briefing documents. The agency's concerns come days before a panel of non-FDA experts delves into Pfizer's application for approval of the oral med for rheumatoid arthritis.

Tofacitinib--which Pfizer hopes to establish as a rival to a host of multibillion-dollar RA treatments--offers the first oral drug of its kind to combat RA. But FDA staffers raised concerns about increased risks of malignant cancers--particularly lymphomas--and infections tied to the drug. As is common to such reviews, the agency staff questioned whether the benefits of the treatment outweighed the risks to patients, Reuters reported, and they critiqued the X-ray methodology that Pfizer used to measure efficacy.

Pfizer ($PFE) has high hopes for tofacitinib, which the U.S. drug giant has highlighted as one of the hottest prospects to come from its much-maligned R&D organization. Its initial plan is to gain approval of the JAK inhibitor for RA patients who have previously failed on drugs against the autoimmune disease such as methotrexate and blockbuster anti-TNF meds such as Abbott's ($ABT) Humira and Amgen's ($AMGN) Enbrel.

Yet with a slate of effective RA drugs on the market, the FDA appears to be in a position to keep the safety bar quite high in its review of tofacitinib. "Because it's not as much of an unmet medical need as it was a few years ago, the requirements have gone up," said Mark Schoenebaum, an analyst with ISI Group in New York, as quoted in a BusinessWeek article.

Rheumatoid arthritis affects more than 1 million patients in the U.S. and causes the immune system to mount attacks around the joints, causing pain and long-term disability. Pfizer believes there's a significant number of RA patients who aren't served by existing drugs, with 30% to 40% of patients failing to respond to the meds, BusinessWeek reported.

The FDA advisory committee is scheduled to meet on Wednesday to decide whether to back tofacitinib for approval.

- get the FDA briefing docs here
- see BusinessWeek's article
- and Reuters' report

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May
04

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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Archive for the ‘JAK inhibitors’ Category

Incyte rides wave after Pfizer’s FDA panel nod

UPDATED: FDA advisers sign off on Pfizer’s arthritis pill

FDA harps on risks of Pfizer’s tofacitinib as panel looms

Pfizer faces crucial panel vote on blockbuster hopeful tofacitinib