TheStreet: A roundup of the top drug studies left in 2012

Posted under ArQule, bapineuzumab, Biogen Idec, Blog, Celgene, Clinical Trials, Companies, Diagnostics, Funding, hemophilia, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, solanezumab, Startups, tivantinib, Universities, Videos by John Carroll

Any forward-looking student of the biotech industry will have to check out Adam Feuerstein's review in TheStreet of 22 Phase II and III clinical trials--21 drugs and one diagnostic test--which are expected to read out by the end of this year.

One of the savviest analysts in the business, Feuerstein runs through snaps on studies for Arqule (the closely watched tivantinib cancer study), Biogen Idec (trying to diversify into hemophilia and ALS), Celgene (apremilast for RA and psoriasis) and, of course, the big Alzheimer's studies for solanezumab and bapineuzumab, among others. 

As Feuerstein notes in his report, big studies have a way of either rehabilitating developers' share prices or driving them into the ground. Over the second half of this year we're likely to see plenty of examples of both scenarios as the data hits.

- here's the story from TheStreet

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Genentech drug picked for pioneering $100M Alzheimer’s trial

Posted under Alzheimer's, bapineuzumab, beta amyloid, Blog, Companies, crezenumab, Diagnostics, Funding, Genentech, Medical Devices, Medical Supply, NIH, Pharmaceuticals, Pipeline, semagacestat, solanezumab, Startups, Universities, Videos by john

The NIH has agreed to help bankroll a pioneering $100 million study of Genentech's experimental Alzheimer's therapy crenezumab. Investigators will test the drug in a region of Colombia where a particular genetic mutation is known to trigger the early onset of Alzheimer's, with an eye to determining if they can stop the memory-wasting ailment before it starts.

The NIH has agreed to pay for $16 million of the study, with private donors putting up $15 million more and Genentech adding the rest--about $65 million--to bankroll the effort. The announcement is part of an ambitious effort announced Tuesday to find an effective treatment for the disease by 2025 in the hopes of thwarting a steadily growing epidemic of Alzheimer's as the baby boomer generation turns gray and old.

The news is a coup for Genentech, which had one of 25 therapies considered for the public/private study. Like a number of other therapies in the pipeline, crenezumab targets the toxic protein beta amyloid, which accumulates in the brain of Alzheimer's victims. But while amyloid remains a prime suspect in the disease, investigators have yet to determine whether eliminating or reducing the levels of toxic material is a safe and effective approach to treating the illness.

Earlier attempts to target beta amyloid have met with failure, if not outright disaster, as was the case with Eli Lilly's ($LLY) semagacestat. But in a common strategy, investigators have been testing the treatments in patients with advanced cases. In this instance, the drug will be studied in patients who have yet to see the disease develop to the point where it has already wreaked havoc on the brain. Investigators also believe that crenezumab may be less likely to cause tiny brain hemorrhages which can afflict patients. The drug is currently in mid-stage testing after completing positive early-stage groundwork.

"This will be the first test of an anti-amyloid treatment in a preclinical stage, where it has the best chance to have the most profound benefit," Dr. Eric Reiman, executive director of Banner Alzheimer's Institute, told reporters today. Banner is leading the study.

Two other drugs, bapineuzumab and solanezumab, are in late-stage studies that wrap this summer. Analysts have generally been skeptical of the outcomes, noting the deep uncertainties that surround the disease and past failures.

The news is also a boon to AC Immune, a Swiss company which partnered with Genentech on the program back in 2006.

- get the story from Reuters
- here's the article from The New York Times

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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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Lilly CEO avoids Pfizer-like cuts, focuses on pipeline

Posted under Blog, Companies, Diagnostics, Eli Lilly, Funding, Generic, John Lechleiter, layoffs, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Pipeline, R&D spending, solanezumab, Startups, Universities, Videos by rmcbride

Drugmakers have axed thousands of R&D workers and tightened their belts to weather the patent cliff and other troubles facing their industry, but Eli Lilly ($LLY) CEO John Lechleiter has held firm to his position that cutting expenses alone isn't a solution to the challenges at his company. And he thinks that the way forward for the Indianapolis-based pharma group resides in its pipeline.

Singing a familiar tune in an interview with Bloomberg, Lechleiter said: "I don't think we can save our way out of the enormous challenge we face. The best course is to maintain our focus on advancing our pipeline." He also makes a case for R&D investment in a Forbes commentary posted yesterday afternoon.

Ticktock. The clock is ticking for Lilly, as time is winding down to perhaps the biggest moment of the year for the drugmaker in the second half of 2012 when data from a pivotal study of its Alzheimer's disease drug solanezumab are revealed. Many analysts and industry watchers are giving the program slim chances of success, but a victory would certainly go a long way to replacing revenue from Lilly's drugs that face competition from generic meds.

Sanford C. Bernstein analyst Tim Anderson calls the experimental Alzheimer's drug Lilly's "lottery ticket" that could bring the company $9 billion in revenue if approved, Bloomberg reported. The chilling aspect of that analogy, of course, is that lottery tickets aren't often winners.

In the meantime, Wall Street has been cheering Pfizer ($PFE) CEO Ian Read as he slashes expenses from the drug giant's budget, which he vows will fall by another $1 billion this year.    

- here's the Bloomberg article
- check out Lechleiter's Forbes commentary

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