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In its third acquisition since it received its initial funding last fall, Cardium Therapeutics (San Diego) has bought the assets of the Tissue Repair Co. (TRC; also San Diego), which includes a wound-healing technology and a lead product candidate to treat diabetic ulcers.

Privately held TRC will become a subsidiary of Cardium, which paid $1 million, assumed $120,000 in liabilities and agreed to provide an additional $1 million upon advancing the lead candidate, Excellarate, into a Phase II study. A DNA-activated collagen gel, Excellarate is formulated with an adenovector delivery carrier encoding human platelet-derived growth factor-B and designed for topical administration for non-healing, neuropathic diabetic foot ulcers.

“It fits well with our basic theme to heal, protect or preserve ischemic injury,” said Christopher Reinhard, chairman and CEO of Cardium, adding that the company's goal is to build a regenerative medicine platform comprising a mix of products at various development stages.

“Our strategy is to focus on products of today that are sold and marketed, and products of tomorrow that have the potential to change the practice of medicine,” he told Medical Device Daily's sister publication, BioWorld Today.

Cardium gained its marketed product earlier this year when it acquired InnerCool Therapeutics (also San Diego) in exchange for 2.5 million shares and a one-time $5 million payment if product sales exceed $20 million. InnerCool, which has an FDA-cleared endovascular, catheter-based system for therapeutic hypothermia, also is a subsidiary of Cardium.

Last fall the company brought in its first funding of nearly $30 million and purchased a cardiac angiogenesis drug portfolio from Schering AG (Berlin, Germany). At that time, the firm also merged with a subsidiary of Aires Ventures to gain a public listing.

The latest acquisition supports Cardium's angiogenesis and adenovector work with the addition of TRC's Gene Activated Matrix (GAM) technology, which is a biocompatible matrix made up of a gene or DNA vector encoding a growth factor or other protein. GAM was used to design Excellarate to stimulate a localized and sustained production of PDGF-B over a six- to 12-month period. That would mean only a single administration might be enough to potentially repair the foot ulcer injury.

According to the American Podiatric Medical Association , (APMA) about 15% of diabetic patients suffer from foot ulcers, and the APMA estimates that anywhere from 14% to 24% of foot ulcer patients require an amputation.

While there are several treatment options, including topical dressings, debridement and skin grafts, only one medication has been approved: Regranex gel, a recombinant human platelet-derived growth factor protein marketed by Johnson & Johnson (New Brunswick, New Jersey). For that product, as many as 70 administrations and wound cleanings are needed over a 10-week treatment period.

Excellarate has been tested in a Phase I/II trial, with more than 80% of patients that completed treatment exhibiting complete closure of wounds by 14 weeks.

Based on previous work by TRC, Cardium anticipates beginning a Phase IIb study of Excellarate during the second half of next year.

If Cardium succeeds in commercializing Excellarate, the company would pay a 10% royalty to TRC, minus any third-party royalties such as a payment to the University of Michigan (Ann Arbor), which had a license agreement with TRC.

In addition to foot ulcers, the GAM approach also could be investigated in bone, tissue and cartilage repair, and as an angiogenic therapeutic for ischemic heart disease.

TRC will continue focusing on that technology, and its CEO, Barbara Sosnowski, will serve as chief operating officer of the subsidiary and as vice president of biologics development at Cardium. Mark McCutchen, TRC's chief financial officer, will serve as vice president of business development for Cardium and the new subsidiary.

Also as part of the deal, Cardium is working to transfer from TRC a $1.3 million Small Business Innovation Research grant from the National Heart, Lung and Blood Institute (Bethesda, Maryland) to study cardiovascular angiogenesis, and “maybe bring some of our own technology into the process,” Reinhard said.

Cardium is getting ready to start late-stage work with Generx (myocardial-derived FGF-4), an angiogenic therapy for angina patients. The product is designed to be administered via a cardiac catheter to stimulate the natural growth of collateral circulation that supplies blood to the heart muscle.

Earlier in the pipeline, the company has Corgentin, a candidate that uses myocardial-derived insulin-like growth factor-1 for repairing damaged cardiomyocytes following a heart attack, and Genvascor, a DNA-based endothelial nitric oxide synthase product aimed at enhancing neovascularization in patients with critical limb ischemia due to advanced peripheral arterial occlusive disease.

Genstar Capital (San Francisco), a middle market private equity firm that focuses on investments in selected segments of the healthcare services, life sciences, business services and industrial technology sectors, reported the acquisition of OnCURE Medical (Newport Beach, Calif-ornia), which it termed “one of the nation's leading operators in the $7 billion radiation therapy industry.”

Terms of the transaction were not disclosed.

OnCURE Medical owns and operates treatment centers exclusively focused on providing the most technologically advanced radiation treatment alternatives. The company and its physician partners provide radiation therapy services in 33 freestanding treatment centers in California, where it is the largest provider of such services, and in Florida.

OnCURE was founded in 1998 by industry veterans Jeffrey Goffman, president, and Dr. Shyam Paryani, chairman and medical director. It is led by CEO Richard Zehner, who prior to joining OnCURE founded and built Alliance Imaging into a leading publicly traded company with $430 million in annual revenues.

Jean-Pierre Conte, chairman and managing director of Genstar, said the investment in OnCURE “is consistent with our strategy of partnering with high-quality management teams in industries we know well. It solidifies our investment focus in the healthcare sector.”

He added that OnCURE is “well-positioned as a platform investment and there are a number of strategic and organic expansion opportunities that we will pursue to further grow the business while, at the same time, identify new ways to provide the highest quality patient care.”

Genstar described the radiation therapy market in the U.S. as “highly fragmented” with no single competitor currently operating more than 10% of the nation's radiation therapy centers. More than 2,000 radiation therapy centers operate in the U.S., with the top three companies owning less than a combined 20% of those centers.

“OnCURE has a successful track record of partnering with physician groups and acquiring and integrating new facilities into its network, and because of the fragmented nature of the industry we will be able to tap into a rich pipeline of opportunities as we execute strategic acquisitions into new geographic regions and existing markets,” said Robert Weltman, managing director of Genstar.

Zehner said, “There is a growing trend toward outpatient care where high-quality services are provided in patient-friendly environments and we look forward to partnering with Genstar to capitalize on that trend.”

GE Healthcare (Giles St. Chalfont, UK), which after the completion of its public offer to the shareholders of Biacore (Stockholm, Sweden) owns more than 98% of the shares in that company, has asked the Biacore board of directors to convene an extraordinary shareholders' meeting as soon as possible for the election of a new board of directors for the company.

The Biacore board said it would convene such a meeting, but did not set a date. The board also has resolved to apply for delisting of Biacore from the Stockholm Stock Exchange's O-list since Biacore no longer fulfills the exchange's requirements regarding the number of shares which must be publicly owned.

Biacore is a global supplier of systems for protein interaction analysis, an area of increasing importance for scientists in the academic, pharmaceutical, biotechnology and diagnostic markets. The company's systems generate data on the interactions between proteins and other molecules.

GE Healthcarein June (Medical Device Daily, June 21, 2006) reported that it has made an offer to acquire Biacore for about SEK 3,220 million (about $390 million), through an offer of SEK 330 a share.

The companies said that GE Healthcare's offer represented a premium of 35% relative to Biacore's volume weighted average share price of SEK 245 on the SSE during the month ending June 19 and a premium of 17% relative to the closing share price of SEK 282 on the SSE on June 19, the last trading day before the announcement of the offer.

In a conference call at the time the purchase plan was announced, Peter Ehrenheim, CEO of GE Healthcare Lifesciences (Uppsala, Sweden), cited a variety of commonalities between the two companies in terms of complementary products and vision.

Biacore employs about 300 people worldwide, and operates R&D and manufacturing facilities in Uppsala, Sweden, where GE Healthcare Life Sciences is headquartered. Upon completion of the tender offer, GE Healthcare said it would combine the expertise of Biacore with GE Healthcare Life Sciences to create a center of excellence in protein science.

BiaCore was founded in 1984 under the name of Pharmacia Biosensor AB after the merger of Linköping Institute of Technology and the Swedish National Defense Research Institute. In 1996 the company changed its name to Biacore AB.