Johnson & Johnson company Ortho-McNeil Inc. will collaborate
with Isis Pharmaceuticals Inc. to develop two Isis antisense drugs to target type 2 diabetes, the companies said Sept. 13.
The deal could be worth more than $275 million if the two drug candidates, ISIS 325568 and ISIS 377131, meet developmental and regulatory milestones.
Ortho-McNeil will pay Isis $45 million upfront to license the technology. In addition to the licensing fee, Isis could receive more than $230 million in milestone payments on successful development and regulatory approvals, as well as royalties on sales.
Additionally, Ortho-McNeil will help Carlsbad-based Isis fund the joint discovery of novel drugs to treat metabolic diseases, including diabetes and obesity.
After the collaboration phase, Johnson & Johnson Pharmaceutical Research & Development LLC would continue to develop the drugs.
Isis said it also planned to regain ownership of ISIS 301012, its promising cholesterol-lowering drug candidate, from Symphony GenIsis Inc.
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Santarus Claims Patent Infringement:
San Diego-based specialty pharmaceutical company Santarus Inc. said it filed a lawsuit in the U.S. District Court for the District of Delaware against Par Pharmaceutical Cos. Inc. for patent infringement.
The lawsuit is in response to an abbreviated new drug application filed by Par with the FDA regarding the company’s intent to market a generic version of Santarus’ Zegerid capsules prior to the July 2016 expiration of three listed patents.
Santarus commenced the lawsuit within the 45 days required to automatically stay, or bar, the FDA from approving Par’s application for 30 months or until a district court decision against Santarus.
The University of Missouri, licensor of the patents, is named as a co-plaintiff in the litigation.
Par Pharmaceutical is a Woodcliff Lake, N.J.-based maker of generic drugs. In recent years, the company introduced generic versions of several major pharmaceutical products, including Flonase, Paxil, Prozac and Toprol XL.
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Hollis-Eden Plans Clinical Trial For Arthritis Treatment:
Hollis-Eden Pharmaceuticals Inc. said Sept. 17 that it plans to initiate a Phase1/2 clinical trial of HE3286, a drug candidate for the treatment of rheumatoid arthritis, during the fourth quarter.
Rheumatoid arthritis is a condition in which the immune system attacks the joints and sometimes other organs.
The San Diego-based biotechnology company filed an investigational new drug application with the FDA to begin clinical trials of HE3286 for the treatment of diseases of inflammation.
The company said it believes earlier findings of HE3286 in healthy volunteers under a previously cleared IND for its use in treating metabolic disorders could boost its current filing.
Approximately 67 million prescriptions are written each year for corticosteroids for a variety of inflammatory diseases. The market for proprietary corticosteroids is about $7.4 billion in annual sales. The combined market for the anti-inflammatory agents Celebrex and Vioxx was approximately $5 billion in annual sales before Vioxx was pulled from the market in 2004. Novel anti-inflammatory agents with new mechanisms of action and fewer side effects could garner a significant market share, Hollis-Eden said.
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CardioDynamics To Cut Executive Pay, Expenses:
Medical equipment maker CardioDynamics said Sept. 17 that it would reduce executive compensation and expenses as part of its efforts to return to profitability.
An executive management team will take a 10 percent salary reduction and add additional operational duties to their daily responsibilities, the company said. Additionally, CardioDynamics said it does not intend to fill vacancies in several positions resulting from attrition and the consolidation of four middle management positions within its corporate offices.
The initiatives could save the company $2 million a year, it said.
CardioDynamics develops, manufactures and markets noninvasive impedence cardiology products, also known as ICG products, which monitor the heart’s ability to deliver blood to the body and the amount of fluid in the chest.
Earlier this month, the company sold its Vermed unit to Medical Device Partners Inc. for $8 million in cash.