Newron soars on positive PhIII results, $26M pact for Parkinson’s drug

Posted under BioTie Therapies, Blog, Chutes and Ladders, Clinical Trials, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck KgAA, Newron, Newron Pharmaceuticals, Parkinson's disease, Pharmaceuticals, Startups, Universities, Videos by john

Despite being left at the M&A altar last fall after a key partnership deal collapsed, Newron says it has successfully completed two late-stage studies of its experimental Parkinson's drug. And the Italian biotech used the opportunity to announce that it has garnered a 20 million euro licensing deal with Zambon for the drug. At the same time, Newron's founding CEO is exiting after 13 years at the biotech.

Newron didn't release details on the data from the two Phase III studies of safinamide. But investigators assert that the drug achieved positive numbers for maintaining motor functions and improved "on" times for patients who suffer from the disease. And the news fueled a spike in Newron's shares, which soared 60% as news of the results spread.

"The positive results from these global trials provide substantial evidence for the efficacy of safinamide as an add-on treatment to the most commonly prescribed drugs in PD patients," said CMO Ravi Anand. "These results together with the previously reported positive results from Phase II and Phase III studies indicate that safinamide will be a unique addition to the therapeutic armamentarium in the treatment of PD."

Founder Luca Benatti, meanwhile, is out as CEO, replaced by CFO Stefan Weber.

Newron has been scrambling to recover since last fall, when Merck KGaA walked away from its partnership on safinamide, complaining that the commercial potential of the treatment had flagged considerably since it first signed on. That retreat in turn prompted Finland's Biotie Therapies to drop its $63 million offer to buy the company, leaving its share price in tatters. Zambon initially stepped in last April to fund the remaining R&D work and preparations to file for regulatory approval, which is slated for 2013. Meiji Seika Pharma earlier gained rights to the drug in Japan and other Asian markets.

- get the press release on Phase III results
- here's the release on the Zambon deal
- read the press release on the executive switch
- here's the story from Reuters

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Biotie backs out of $63M Newron Pharma buyout
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Serono workers plot strike, lash out over R&D failures

Posted under Blog, Companies, Diagnostics, Europe, Funding, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, Startups, Universities, Videos by john

Whipped into action by the stunning news that Merck KGaA plans to shutter Serono's big Geneva facility, FiercePharma reports that workers are preparing a strike, claiming that the pharma company has been sugarcoating the big layoffs being planned. When it made its initial announcement, the German company said that it planned to transfer 750 workers. But employee groups say that few are willing to take the transfers, as they are being offered "really unattractive" pay packages. And investigators are claiming the company's cumbersome decision-making process has caused poor productivity of recent years. A strike is being threatened for tomorrow. Story

Idera’s troubled TLR program founders in PhII cancer study

Posted under autoimmune diseases, Blog, Clinical Trials, Companies, Diagnostics, Erbitux, Funding, head and neck cancer, Idera Pharmaceuticals, IMO-2055, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, Startups, TLR9, Universities, Videos by john

Cambridge, MA-based Idera Pharmaceuticals lost its big partner on toll-like receptor drugs when Merck KGaA backed out of its $421 million deal last year. This morning the biotech highlighted just how problematic the field is when it announced that the lead drug in that pact--IMO-2055--failed a mid-stage study in advanced head and neck cancer.

Investigators had been hunting signs of progression-free survival for patients in the study, which compared the results for patients taking the drug--a member of the toll-like receptor 9 (TLR9) family--in combination with Erbitux compared to Erbitux alone. Investigator patient assessments concluded the two arms achieved similar results, though an independent radiology review found that patients taking Erbitux alone experienced slightly longer PFS rates: 1.9 months compared to 1.5 months.

Merck KGaA wrote off its investment in the program last year after taking a close look at the depletion of white blood cells in patients as well as low electrolyte levels. But in handing back the rights, the pharma giant also agreed to see through the mid-stage study. Now Idera, which has seen its stock price ($IDRA) dwindle steadily since 2008, says it plans to hunt up new collaborators to pursue other cancer indications while it focuses on autoimmune diseases.

"Idera is focusing its development efforts on the drug candidates in our autoimmune disease program where we recently initiated a Phase II clinical trial of IMO-3100 in patients with psoriasis," says CEO Sudhir Agrawal. "Further, we are planning to submit an IND for IMO-8400 for the treatment of lupus in 2012." 

This isn't Idera's first taste of defeat on the TLR9 front. Novartis ($NVS) pulled out of a TLR9 pact with Idera for respiratory diseases back in 2009, two years after a program at Coley faltered in the clinic.  

- here's the press release

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Merck KGaA nixes development of Idera Pharma cancer drug
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VC group offers to help axed Merck KGaA staffers launch spinoffs

Posted under Blog, Companies, Diagnostics, Europe, Funding, Index Ventures, M&A, Medical Devices, Medical Supply, Merck KgAA, Pharmaceuticals, Startups, Universities, Videos by john

Index Ventures and Eclosion, a biotech incubator, have joined forces to see if they can help shape some of the spinoff companies that could come out of Merck KGaA's decision to close its sprawling complex in Geneva, according to a report in Le Temps.

The pharma giant has already pledged about $40 million in seed cash to help fuel spinoffs. Now the venture group and incubator say they're ready to hear out any ideas coming from the hundreds of workers being let go, ready to offer advice to any that feel they have an idea for a new biopharma business. And Index, a high-profile venture player in Europe, says it will try to match workers with jobs in its network of biotech companies on the Continent.

The original report is in French, providing a few light moments when Google managed to garble some of the language. But the message came through: Merck welcomes the initiative, and more groups are likely to step up with job offers and startup ideas. 

"We will meet to discuss in the coming days and have every intention to evaluate the projects, possible spinoff or startup of interest in the long term," Merck KGaA noted, more or less.

- here's the story from Le Temps (translated)

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Merck KGaA shuttering Swiss complex, dispatching R&D to Boston
Merck KGaA triggers restructuring as it pursues R&D turnaround