UPDATED: New cloud hovers over class of ‘good cholesterol’ drugs

Posted under Blog, cholesterol, Companies, CTEP inhibitors, Diagnostics, Eli Lilly, Funding, HDL, heart disease, heart drug, John LaMattina, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Pipeline, Startups, Universities, Videos by Ryan McBride

Fresh doubts have cropped up for raising "good cholesterol" to combat heart attack risk, after a new study showed that patients genetically programmed to have higher levels of HDL cholesterol didn't appear to be more protected from heart disease than those with low levels. The news comes as Merck ($MRK) and Eli Lilly ($LLY) are spending millions of dollars to develop HDL-raising treatments, aiming to deliver on the blockbuster potential of the CETP drug class.

"I'd say the HDL hypothesis is on the ropes right now," said outside observer Dr. James A. de Lemos, a professor at the University of Texas Southwestern Medical Center, as quoted by The New York Times.

The HDL mechanism took a recent blow last week when Swiss drug giant Roche ($RHHBY) announced that it was nixing development of its contender designed to raise good cholesterol to thwart heart disease because of absent efficacy, following previous failures at Pfizer ($PFE) and Abbott ($ABT). Informed of the new genetic study revealed this week in The Lancet, Merck and Lilly representatives told the Times that the companies were both undeterred and continuing with their massive CETP programs. Yet the findings have dampened expectations for the drugs.

"This will have a sobering effect, it would have to," said John LaMattina, a senior partner at PureTech Ventures and former Pfizer R&D chief, as quoted by Bloomberg. "HDL has always been a controversial area. You have a question that you have to be willing to commit over a billion dollars in order to get the answer, and that is a very daunting commitment."

With billions of dollars in development costs and potential revenues on the line, expect scientists inside and outside of biopharma companies to take heed of the findings and dig deeper into the role of HDL in heart disease. As the Times notes, mouse studies showed that HDL carried cholesterol out of the arteries. But scientists will now look into whether HDL is an indicator or driver of reduced heart-attack risk.

Forbes' Matthew Herper reported that the latest HDL paper might not bring much in the way of new doubt about HDL-raising drugs, which were "already on the ropes" because of conclusions from previous studies. And he noted that The Lancet paper shows a slight 4% reduction in heart attack risk among patients with a mutation to the CETP gene, which might give hope to believers in drugs that target the CETP protein.

- read the NYT's article
- and Bloomberg's report
- see Herper's piece

Related Articles:
Roche abandons potential blockbuster cholesterol drug
Developers spotlight huge potential of new class of cholesterol drugs
Lilly heralds PhII success for mega-blockbuster cholesterol drug contender

Editor's note: Adds analysis of The Lancet paper from Herper's article. 05/20/12.

Cancer drug developers angling for center stage at ASCO

Posted under Ariad Pharmaceuticals, ArQule, Array BioPharma, ASCO, axitinib, Blog, breast cancer, cabozantinib, Cancer, Cancer Drugs, Companies, Diagnostics, Eli Lilly, Exelixis, Funding, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, renal cell carcinoma, Roche, Startups, Universities, Videos by john

Later this week the cancer drug research crowd will examine a tsunami of abstracts filed ahead of the ASCO meeting in early June in the hopes of finding a few new gems in the mountain of data being readied for the confab. ASCO is the place where anyone who's doing anything in cancer tries to make a splash in the spotlight. And with close to a thousand cancer drugs in the pipeline, that's no easy task.

Pfizer ($PFE) and Eli Lilly ($LLY) were both out bright and early this morning touting their work in the cancer arena. Pfizer's best hope at drawing attention lies in updating the data on axitinib, its recently approved treatment for renal cell carcinoma. And Lilly clearly hopes to impress analysts with ramucirumab, which is in 6 late-stage cancer studies.

Digging deeper, Executive Editor Ryan McBride's recent take on the top 10 cancer drugs in late-stage studies includes some of the closest watched therapies likely to elbow their way to center stage. Aveo ($AVEO) will be working hard to distinguish tivozanib--its kidney cancer drug with so-so head-to-head data with Nexavar--as it takes a monumentally important run at an approval later this year. Anything new on Roche's ($RHHBY) T-DM1 for breast cancer, which has racked up positive late-stage data on breast cancer on its way to an odds-on approval at the FDA, will be studied closely. Onyx ($ONXX) has the promising carfilzomib to tout, which is already at the FDA for review, while regorafenib (majority-owned by Bayer) is also in the media mix.

Today in Xconomy, the savvy biotech scribe Luke Timmerman assesses 8 drugs likely to make it into the center ring at ASCO. In addition to the drugs already mentioned, Timmerman includes abiraterone (Zytiga) from J&J ($JNJ) and Exelixis's ($EXEL) cabozantinib, a promising cancer drug that has earned Exelixis CEO Mike Morrissey both acclaim and exceptionally harsh criticism. The development program for cabo has been raked over the coals by a number of analysts. Medivation's enzalutamide (MDV3100), meanwhile, could wind up stealing the thunder for prostate cancer. And there's follow-up data from Ariad ($ARIA) on ponatinib.

Back in mid-March Adam Feuerstein at TheStreet got the first crack at an ASCO preview, listing prospects from Celldex, ArQule, Array BioPharma and Oncothyreon among the more frequently mentioned drug developers. But Celldex's ($CLDX) CDX-011 presentation was scrapped due to a clerical error. Now Celldex is planning a preemptive strike, with plans to hold a press conference of its own on May 23.

If you can't join them at ASCO, you can always try to beat them to the punch.

- here's the story from Xconomy
- read Adam Feuerstein's piece in TheStreet

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

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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

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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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FDA advisers sign off on Pfizer's arthritis pill
Roche arthritis drug beats Humira in clinical study
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