Assistant

Catalyst Biosciences Inc. is getting $11 million up front in a discovery and development collaboration with Centocor Inc. aimed at creating engineered protease drugs against two disease targets, and was one of several firms reporting news Monday, as the annual JPMorgan Healthcare Conference got into full swing.

It's the second year in a row that Catalyst has made a splash at the San Francisco meeting. The firm kicked off a 2007 event by signing Wyeth Pharmaceuticals as its first major pharma partner to use its Alterase platform, a discovery platform designed to create engineered protease drug candidates across a range of disease areas. The Alterase platform also is the subject of Catalyst's deal with Malvern, Pa.-based Centocor, a unit of Johnson & Johnson.

"We met with [Centocor] about a year ago, and they expressed an interest" in the Alterase platform, said Catalyst CEO Nassim Usman. Over the past year, Centocor looked further at the program and "decided this was something they wanted in their arsenal."

Under the terms, South San Francisco-based Catalyst will get $11 million up front, made up of cash and an equity investment by Johnson & Johnson Development Corp. (JJDC), plus research funding for two years to handle the design and early preclinical work of Alterase therapeutics against two disease targets - one is inflammatory disease and the other remains undisclosed at the request of Centocor. After that, Centocor will take the lead on further development and commercialization activities in exchange for milestone payments and royalties.

Specific future terms were not disclosed, but Usman told BioWorld Today that "the overall size of the deal is larger than our deal with Wyeth." In that collaboration, Madison, N.J.-based Wyeth agreed to make payments totaling up to $100 million for the successful development of two targets, one in oncology and the other aimed at metabolic disease. (See BioWorld Today, Jan. 9, 2007.)

So the collaboration with Centocor "is a very significant deal for us," Usman said.

Catalyst's platform is based on the idea of taking human proteases, which are known for their ability to cleave certain protein substrates - an example is Indianapolis-based Eli Lilly and Co.'s Xigris (activated drotrecogin alfa), a protease drug for sepsis - and re-engineering them to cleave and inactivate disease-causing proteins. Those drugs, known as Alterase therapeutics, can be designed for treating a range of diseases, Usman said, including disease proteins that "you can antagonize with antibodies or target with small molecules."

On its own, Catalyst is using the Alterase platform to build up an internal pipeline, leading off with a recombinant formulation of Factor VIIa for hemophilia. In an animal model, that compound already has demonstrated efficacy over NovoSeven, a marketed recombinant Factor VIIa product from Bagsvaerd, Denmark-based Novo Nordisk A/S, which is estimated to post sales of $1 billion for 2007, Usman said.

Preclinical development of that program is ongoing, and Catalyst anticipates filing an investigational new drug application in 2009.

A second program, comprised of an anticomplement Alterase, is at the research stage.

Catalyst intends to remain "opportunistic" regarding future partnership discussions, Usman said, though right now the firm has plenty on its plate. "We've got a very full pipeline and two quality partners," he said.

In conjunction with the deal, Asish K. Xavier, of JJDC, will join Catalyst's board.

In other deals news:

• Alkermes Inc., of Cambridge, Mass., entered an exclusive agreement with Cilag GmbH International, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, to commercialize Vivitrol (naltrexone for extended-release injectable suspension) in alcohol and opioid dependence in Russia and other countries in the Commonwealth of Independent States. Under the terms, Cilag will pay up-front fees and milestones up to $39 million, plus ongoing royalties on Vivitrol sales in those regions. Alkermes will retain exclusive development and marketing rights to Vivitrol in all markets outside the U.S., Russia and CIS. In the U.S., Vivitrol is marketed primarily by Frazer, Pa.-based Cephalon Inc.

The ALS Therapy Development Institute, of Cambridge, Mass., signed a research and development agreement with Aptagen LLC, of Jacobus, Pa. Aptagen will use its own technology to develop aptabodies - synthetic "molecular bullets" designed to deliver a therapeutic compound to diseased cells. Aptagen's technology will be used as a research tool to expedite drug development in a mouse model of amyotrophic lateral sclerosis. The hope is that Aptabody drug delivery may reduce the trial and error of developing small molecules to cross the blood-brain barrier to reach targets in the central nervous system.

• Bioceros BV, of Utrecht, the Netherlands, and MaimoniDex RA Ltd., of Tel Aviv, Israel, are collaborating to develop a monoclonal antibody specific for CD44vRA, a splice variant of the adhesion molecule CD44 that is involved in the inflammatory process underlying rheumatoid arthritis. Under the terms, Bioceros will receive an option to a worldwide exclusive license on the intellectual property and technology owned by MaimoniDex. Specific financial terms were not disclosed.

• Callisto Pharmaceuticals Inc., of New York, has restructured its license agreement with Genzyme Corp., of Cambridge, Mass., for Atiprimod, Callisto's lead drug to treat advanced carcinoid cancer. The restructured agreement eliminates all milestone payments and reduces royalties owed to Genzyme to single digits. In return, Callisto is paying an up-front fee this year. Callisto said the revisions should make it easier to obtain financing for a Phase III trial. Interim results from a Phase II trial are expected by the end of the first quarter. Financial terms were not disclosed.

• Genomic Health Inc., of Redwood City, Calif., has entered into a collaboration with Pfizer Inc., of New York, for development of a genomic test to estimate the risk of recurrence following surgery for patients with Stage I-III renal carcinoma, clear cell type, that has not spread to other parts of the body. As part of the deal, the companies will apply the same molecular technology and clinical strategy Genomic Health used to develop its Oncotype DX breast cancer test. Financial terms were not disclosed.

• Medistem Laboratories Inc., of Scottsdale, Ariz., has modified its license agreement with the Institute of Cellular Medicine, of the University of Newcastle, UK, revising the royalty rate from 85 percent of ICM's pretax income to 20 percent of ICM's gross revenues. Terms of the agreement also were extended from 2010 to perpetuity, and Medistem was relieved of an obligation to fund ICM. The company said the changes will relieve management from oversight duties, allowing a greater focus on developing the business, improve cash flow and reduce risk.

• Osiris Therapeutics Inc., of Columbia, Md., reclaimed sole worldwide rights to Prochymal for cardiovascular indications and terminated its development and commercialization deal with Natick, Mass.-based Boston Scientific Corp. Under the terms, Osiris regains all rights to its stem cell technology in cardiovascular indications, in exchange for relieving Boston Scientific of a $50 million loan obligation and $45 million in development payments. Osiris agreed to repay a $5 million debt, plus accrued interest in four quarterly installments. Terminating that deal is designed to provide Osiris with greater flexibility to enter more strategically beneficial relationships and, the company said, to accelerate the development of Prochymal in acute myocardial infarction. In separate news, Osiris is receiving a $500,000 milestone payment under its collaboration agreement with JCR Pharmaceuticals Co. Ltd., of Ashiya, Japan, which was triggered when JCR filed notice to start clinical trials with Prochymal in graft-vs.-host disease in Japan. Osiris will be eligible to receive additional milestone payments of up to $6.5 million, plus sales milestones and royalty payments from the JCR deal.

• Oxford BioMedica, of Oxford, UK, signed a license agreement with the Carnegie Institution of Washington and the University of Massachusetts Medical School granting the company rights to RNA interference technology. The rights granted are exclusive for RNAi gene silencing using lentiviral vector technology for human gene therapy applications. Under terms of the license agreement, Oxford BioMedica will make an undisclosed up-front payment, milestone payments and royalties on sales. Those rights will run concurrently with the rights of the existing licensees of the RNAi technology. Further details were not disclosed. In a separate agreement, the Carnegie Institution and the University of Massachusetts agreed to subscribe for a total of 2,369,818 ordinary shares of 1p each at £0.24 per share.

• Rosetta Genomics, of Rohovot, Israel, said its subsidiary Rosetta Genomics Inc. has received a license from Roche Molecular Systems, of Pleasanton, Calif., to use its PCR technology in Rosetta Genomics' microRNA-based diagnostic tests. Rosetta Genomics has developed a microRNA detection platform based on Roche PCR technology. The platform allows Rosetta Genomics to identify microRNA biomarkers in several sample types and body fluids, with very high sensitivity and specificity.

No Comments