AstraZeneca’s new iMed R&D team forges first pact with Axerion

Posted under AstraZeneca, Axerion, Blog, Companies, Diagnostics, Funding, iMed, Medical Devices, Medical Supply, Partnering, Pharmaceuticals, Startups, Targacept, Universities, Videos by john

AstraZeneca's ($AZN) newly hatched iMed unit is in business. Formed just weeks ago as the pharma giant pushed through its latest restructuring effort, the "innovative medicines" team was tasked with taking a virtual approach to developing new neuroscience therapies. And today it's forged its first collaboration: An Alzheimer's program in the hands of Axerion Therapeutics in Connecticut.

The terms of the deal--including an upfront, milestones and R&D support for the preclinical program--were kept under wraps. But it's an important first step for iMed, which has an ambitious mandate to track down new neuroscience therapies and develop them under risk-sharing deals with collaborators.

"This biologic approach is an example of the promising science that fuels our commitment to neuroscience research," noted Mike Poole, who's heading up the unit. His team will be focused on work originally undertaken at Yale. Axerion's program targets the binding of A-beta oligimers to prion proteins, working on a new approach to treating Alzheimer's. 

Neuroscience has been one of the trickiest fields in drug development, as AstraZeneca has learned the hard way. Today AstraZeneca formally dropped its big pact with Targacept ($TRGT) on TC-5214, a once promising depression therapy that flunked four straight late-stage studies.

But rather than just drop the area, as GSK ($GSK) and others have done, AstraZeneca has set out to see if it can do better with a new approach. And while AZ's R&D setbacks ultimately cost CEO David Brennan his job, the company seems determined to plow ahead with new deals aimed at replenishing a badly depleted pipeline. 

- here's the press release
- here's the story on the termination of the TC-5214 deal

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Targacept slashes staff by half in wake of PhIII disaster

Posted under AstraZeneca, Blog, Chutes and Ladders, Clinical Trials, Companies, depression, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Targacept, TC-5214, Universities, Videos by john

The late-stage collapse of Targacept's depression drug--TC-5214--will cost the jobs of close to half of the biotech's staffers, with 65 workers getting pink slips today. The news comes a month after Winston-Salem, NC-based Targacept ($TRGT) and AstraZeneca ($AZN), which had once committed to a $1.24 billion licensing pact on the drug, acknowledged that the treatment had failed the last two of four Phase III studies.

Once considered a bright prospect after upbeat Phase II results, 5214 today looks more like the kind of cautionary tale that has helped drive some of the biggest players out of the neurosciences arena. Depression studies are notoriously unreliable, often scuttled by high placebo responses. But investigators didn't even come close to the goal here: Hitting the primary endpoints in two out of four Phase III trials. The black eye at AstraZeneca, which could ill-afford another pipeline setback, has helped inspire a scramble to in-license other programs.

For Targacept, which had been adding staffers in expectations of a marketing launch, the writing was on the wall once the data hit. But company execs insist that with a cash cache of $220 million, Targacept still has a future.

"This painful step is part of an overall plan to align our resources more closely with nearer-term value creation opportunities," says Targacept CEO J. Donald deBethizy. "We remain well capitalized and focused on operating our business efficiently to ensure we are positioned to exploit our diverse clinical-stage pipeline to bring new medicines to patients." 

Among the departures will be CMO Geoffrey C. Dunbar. The trials chief is retiring at the end of this year.

- here's the press release

Related Articles:
Depression drug research goes off the rails (again)
Final PhIII results wipe out AstraZeneca, Targacept depression drug
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UPDATED: AstraZeneca pays $50M to partner up on Amgen antibodies

Posted under AMG 827, Amgen, AstraZeneca, Blog, brodalumab, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Partnering, Pharmaceuticals, R&D, Startups, Targacept, Universities, Videos by john

AstraZeneca ($AZN) and Amgen ($AMGN) struck a collaboration deal today designed to strengthen each company where it needed help the most. AstraZeneca partnered on a slate of 5 early- to mid-stage anti-inflammation antibody candidates, adding to the potential of a weak pipeline. And Amgen picked up a $50 million upfront payment and a deep-pocket partner able to cover some of the burn on R&D expenses.

In the deal, the two big developers agreed to set up joint governance groups for AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827). AstraZeneca, though, will finance about two thirds of the R&D expenses for 2012 to 2014 with an even split envisioned from 2015 on. AstraZeneca takes the lead on 139, 157 and 181, while Amgen is primarily responsible for calling the shots on 557 and 827. They also agreed to a split of the profits for any treatments that move on to an approval.

The deal is driven by some stark realities at each big company. AstraZeneca has been faced with growing pressure to bolster a weak pipeline, especially after a partnered depression drug program with Targacept ($TRGT) failed a slate of late-stage trials. And Amgen was forced to restructure its R&D effort last fall after research expenses climbed past the 20% mark as late-stage programs ate a growing chunk of capital.

"For AstraZeneca investors, the deal is a non-dilutive way to replenish its pipeline and is clearly preferable to large-scale M&A," noted Savvas Neophytou at Panmure Gordon. "To boot, the assets under license are biologicals, which plugs a gap and provides a better balance to the pipeline. More deals of this nature are expected."

Analysts also noted that the deal gives AstraZeneca a chance to finally demonstrate some added value from its acquisition of MedImmune. But not everyone was cheering the news. "It's hard to see what AstraZeneca brings to the table other than cash and the ability for Amgen to maintain their share buybacks and dividends," Sanford Bernstein biotech analyst Geoffrey Porges told Reuters. "The fact that Amgen has to partner yet another one of their strategic initiatives isn't really going to fill investors with very much confidence."

The most advanced program in the lot is 827, brodalumab, which is on the threshold of Phase III for psoriasis and in mid-stage studies on psoriatic arthritis and asthma. The rest of the antibodies in the deal are in Phase Ia or Ib studies.

"We are delighted to join forces with Amgen in developing and commercializing these novel clinical-stage assets that add value to our pipeline and build on our expertise in biologics. This creative collaboration will make the most of both companies' respective capabilities, including AstraZeneca's extensive global reach, to help bring these potentially innovative treatment options for a variety of respiratory and inflammatory diseases to patients around the world," said AstraZeneca chief David Brennan.

- here's the press release
- get the Reuters story
- here's analysis from The Guardian

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Targacept scuttles diabetes drug program in fresh setback

Posted under asthma, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Phase II, Startups, Targacept, TC-6987, Type 2 Diabetes, Universities, Videos by John Carroll

A beleaguered Targacept ($TRGT) took one step forward and two steps back today, killing a development program for TC-6987 as a treatment for type 2 diabetes while signaling that a separate study for the same drug hit its primary endpoints in a mid-stage study for asthma.

Investigators for the Winston-Salem, NC-based Targacept had been hoping to track a significant improvement in fasting plasma glucose among the patients taking the treatment in the Phase II diabetes trial. But when that didn't pan out, Targacept decided to dump the diabetes work and push ahead on asthma.

"The exploratory asthma trial of TC-6987 as an adjunct to a low-dose inhaled corticosteroid showed a drug effect that was seen at the first assessment point, 30 minutes after initial dosing, and was sustained throughout the duration of the study, suggesting that TC-6987 has promise and may also have benefit in a monotherapy setting," said James F. Donohue, a professor at the University of North Carolina School of Medicine.

News of the diabetes setback cost Targacept another bite out of its share price this morning. Its shares have been battered in recent days after its depression drug TC-5214--partnered with AstraZeneca ($AZN)--failed the last two of four late-stage studies. With an 0-and-4 record in Phase III, Targacept was forced to write off a program that AstraZeneca had offered to pay more than a billion dollars for in milestones.

- get the release
- here's the story from Dow Jones

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Final PhIII results wipe out AstraZeneca, Targacept depression drug
Analysis: Big Pharma is backing out of more biotech deals