J&J and Bristol-Myers ally on another potential hep C blockbuster

Posted under Blog, Bristol-Myers Squibb, Companies, Diagnostics, Funding, Gilead Sciences, Hepatitis C, Janssen, Johnson & Johnson, Medical Devices, Medical Supply, Medivir, Pharmaceuticals, Pharmasset, Pipeline, R&D, Startups, TMC435, Universities, Videos by john

Just a few months after Johnson & Johnson joined R&D forces with Bristol-Myers Squibb on an interferon-free combo for hepatitis C, the two companies have broadened their development pact to include another one-two interferon-free punch targeted at the virus. And Medivir, a Swedish company partnered with J&J's ($JNJ) Janssen R&D Ireland on one of the key ingredients, saw its stock price pop this morning as it spread the news.

The two research powerhouses will conduct a drug-drug interaction study on J&J's TMC435 with BMS-986094 (formerly INX-189), a hep C treatment Bristol-Myers ($BMY) nabbed with its $2.5 billion buyout of Inhibitex back in February. And as they study the future potential of that combo they say they'll be ready to push immediately into a late-stage study of a TMC435/daclatasvir if their mid-stage study this year goes well.

BMS-986094 is a nucleotide polymerase NS5B inhibitor, like Gilead's ($GILD) closely watched 7977, which inspired the $10.8 billion buyout of Pharmasset. The protease inhibitor TMC435 blocks an enzyme the virus needs to replicate while BMS-986094 takes a different route to quell hep C. The prospects of a blockbuster business awaiting any developer which can market an interferon-free product has triggered a host of collaborations and buyouts as companies scramble to develop the most effective cocktail therapy that can work for a broad cross section of patients.

"We see the expanded clinical collaboration as a strong validation of TMC435, especially as we know of no other competing protease inhibitors running interferon-free combination trials with other direct-acting antivirals externally," which include polymerase inhibitors, noted Hans Jeppsson, an analyst at Danske Bank, according to a report in Bloomberg.

"This represents one of several strategies to explore TMC435 in interferon free regimens; a development we believe will be an important advancement in the HCV field for patients," said Medivir R&D chief Charlotte Edenius in a statement.  

- here's the press release
- get the report from Bloomberg

Related Articles:
Medivir deals generics biz amid HepC drug trials
Analysts pounce on positive Phase II data on hep C combo
Fresh woes for Gilead as two more hep C patients relapse in small 7977 study

Roche headlines autism alliance

Posted under autism, Blog, clinical trial, Companies, Diagnostics, Eli Lilly, Fragile X, Funding, Janssen, Medical Devices, Medical Supply, Pfizer, Pharmaceuticals, Roche, Servier, Startups, Universities, Videos by Mark Hollmer

A European research effort led by Roche ($RHHBY) and others to tackle autism spectrum disorders nailed down $38.7 million in financing for what will be a massive, 5-year project seeking to come up with new diagnostic and treatment options.

According to Genetic Engineering News, Eli Lilly ($LLY), Servier, Janssen Pharmaceutica and Pfizer ($PFE) are among other bio and pharma partners in the substantial collaboration. But Roche is leading the drug-company side of things. King's College London in the U.K. and the non-profit organization Autism Speak are the other head partners. Add in about 14 additional "scientific centers," and you have lots of parties working on autism research.

Roche's involvement is interesting because it has a relatively targeted focus on Alzheimer's. The Swiss drugmaker launched a Phase II study two years ago of a drug to treat Fragile X syndrome, a rare genetic condition thought to be among the most common causes of autism. But the company has more drugs in the pipeline, by comparison, for neurological diseases such as Alzheimer's and schizophrenia, according to its web site.

The collaboration will focus on developing and testing new autism treatments, according to the story. But the consortium also plans to pick and launch multiple autism clinical trial sites throughout Europe, pursue a number of lab and animal tests and identify genetic or proteomic biomarkers to aid in more precise diagnoses and treatments. They face the challenging reality, however, that autism remains hard both to diagnose and to successfully treat.

This massive partnership even has a name: European Autism Interventions--A Multicenter Study for Developing New Medicines, or EU--AIMS, for short. The European Union's Seventh Framework Program, Autism Speaks and the members of the European Federation of Pharmaceutical Industries and Association funded the program, according to the story.

- here's the Genetic Engineering News story
- read the release

Related Articles:
NIH buddies with Afraxis to escort Fragile X program through "valley of death"
Roche begins Ph II Fragile X studies

Forma scores another Big Pharma deal in $700M J&J cancer pact

Posted under Blog, Boehringer Ingelheim, Companies, Diagnostics, Forma Therapeutics, Funding, Janssen, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Just days after inking an $815 million cancer drug discovery pact with Boehringer Ingelheim, Forma Therapeutics agreed to put its fast-growing small molecule ops to work for J&J's Janssen in a $700 million deal. This new pact, which focuses on tumor metabolism, also allows Forma to hang on to the North American commercial rights on one of the programs it develops--adding some long-term upside for the biotech. The announcement did not reveal how much Janssen is paying upfront.

"This collaboration will enable a broad chemical biology approach to understanding the unique biology underlying cancer metabolism," Kenneth Bair, Ph.D., senior vice president and head of research and development at Forma.

The partnership also marks another big step for Forma, a 2011 Fierce 15 company which has been rapidly building up a broad range of deals with biopharma companies as it hones its skills on protein-protein interactions, tumor metabolism and epigenetics. With new facilities in the Boston area and a relatively big discovery outfit in a staff of about 100, Forma CEO Steve Tregay has been laying a foundation for a biotech company which can rely on a steady stream of partnership dollars to pay the bills while offering some early returns to its investors.

"This collaboration with Janssen Biotech further strengthens our drug discovery capabilities and also allows us to look to the future with an opportunity to maintain North American rights, which is a key element of our strategy to create long-term shareholder value within Forma," said Tregay in today's release.  

You can expect more deals from Forma and Tregay, who specialized in pacts for Novartis ($NVS).

- here's the press release

Special Report: Forma Therapeutics - 2011 Fierce 15

Related Articles:
Fast-growing Forma grabs $815M cancer discovery deal with Boehringer
JPM kicks off with fevered focus on the next big biotech deal
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Janssen/Diamyd Medical – Top 10 biotech deal terminations of 2011

Posted under Blog, Companies, Diagnostics, Diamyd, Funding, Janssen, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Partners: Janssen Pharmaceuticals (a subsidiary of J&J)/Diamyd Medical
Based: $JNJ - New Brunswick, NJ; $DMYDY - Stockholm
Termination date: June 2011
Length: 1 year
Deal: $625 million, including $45 million upfront
Program: Diamyd's GAD65-based treatment, a Phase III drug for Type 1 diabetes

What went wrong: J&J jumped on board Diamyd's diabetes bandwagon just as the pivotal European trial was getting under way, a favorite entry spot for the Big Pharma company. In May, when the treatment proved no better than a placebo at preserving beta cell function, Janssen was quick to bail.

Within a few weeks, Diamyd had not only closed the European trial, but it also shuttered a separate Phase III in the U.S. after concluding that the diabetes therapy would do no better on a different continent.

"With all the rights returned to us, we are free to decide on how to extract the most value from GAD65 going forward," said Diamyd CEO Peter Zerhouni at the time. Faced with a total late-stage disaster, though, Diamyd quickly determined that its diabetes-focused Swedish staff would have to go and switched its therapeutic focus to pain--another tough field for developers.