Independence Day wasn't the only thing Abbott (Abbott Park, Illinois) celebrated over the July 4th weekend. FDA approval of the company's Xience stent was reason enough to shoot off fireworks.
Abbott received approval of the Xience V everolimus-eluting coronary stent for the treatment of coronary artery disease on July 2, making it the second of the second-generation family of drug-eluting stents to win marketing approval in the U.S.
Medtronic's (Minneapolis) Endeavor DES, which won approval in February, was the first second-generation DES to hit the U.S. market. Both products are expected to elbow aside to a considerable extent the first-generation DES devices, the Cypher from Johnson & Johnson's (J&J; New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit, and the Taxus from Boston Scientific (Natick, Massachusetts).
Abbott says its Xience stent, which went on commercial sale immediately, is the only DES to have demonstrated superiority over Boston Scientific's Taxus paclitaxel-eluting coronary stent system.
Kelly Morrison, an Abbott spokeswoman, told Biomedical Business & Technology that the first implant was performed the morning of July 3rd at New York Presbyterian Hospital-Columbia University Medical Center (New York).
"The strength of the data supporting Xience V is really unprecedented," she said. "It's the first to show superiority over the market leading drug-eluting stent in clinical trials, it demonstrated a 45% reduction in major heart related events compared to Taxus at two years."
Because the device is based on Abbott's market-leading Multi-Link Vision bare-metal stent platform, Morrison said the company expects a healthy physician adoption of Xience.
"I think physicians have been waiting for a next-generation technology that really delivers on the promise of drug-eluting stents," she said. "We've been hearing from physicians that they're very excited [about Xience] based on the clinical data."
Abbott is expecting a 25% to 30% market share in the U.S. within the first year of launch, Morrison said.
"Xience V represents an important treatment advance for the estimated 13 million people in the U.S. suffering from coronary artery disease, and we believe Xience V will quickly become the new standard for drug-eluting stents given its outstanding clinical results," said John Capek, PhD, executive VP of medical devices at Abbott.
The stent will be available on both over-the-wire and rapid exchange (RX) delivery systems.
Xience was launched in Europe and other international markets in October 2006. It is an investigational device in Japan and is currently under review for approval by Japan's Ministry of Health, Labor and Welfare and the Pharmaceuticals and Medical Devices Agency.
Everolimus, developed by Novartis Pharma (Basel, Switzerland), is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott for use on its drug-eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its antiproliferative properties, the company noted.
Approval of Xience also was good news for Boston Scientific, which will share profits from the device. Guidant had been developing the stent and when Boston Scientific acquired that company, it had to divest the stent to Abbott, but it retained the right to sell the same device as the Promus under a private-label arrangement.
Hemopure trial may be Biopure's final hope
Financially embattled Biopure (Cambridge, Massachusetts) could be seeing some small rays of hope in initiating a clinical trial for Hemopure, its blood oxygenating therapy.
Just a few weeks after Biopure reduced its staff by 60% to cut costs the company reported in early July that it has been in discussions with the FDA to initiate a clinical trial of Hemopure for patients suffering from leukemia.
"We haven't gotten the protocol written yet regarding how many patients will be involved in the trial," Tiana Gorham, a spokeswoman for Biopure, told BB&T. "We're very much at the beginning stages of discussion with the FDA."
Hemopure [hemoglobin glutamer 250 (bovine)], or HBOC 201, is approved for sale in South Africa for the treatment of acutely anemic surgical patients.
Biopure has proposed to study use of Hemopure in patients suffering from acute myelogenous leukemia (AML) who refuse transfusion with blood components.
Currently, AML patients who do not accept blood transfusions are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes. Patients would give informed consent before being enrolled in this study.
Hemopure, consists of hemoglobin that has been taken out of the red blood cells of cattle and then purified, chemically cross-linked for stability and formulated in a balanced salt solution similar to Ringer's lactate. The resulting hemoglobin solutions do not contain any cells.
"Hemopure is an attractive application because it doesn't need to be refrigerated and it is universal," Gorham said. "There is no need for a type or cross match."
According to the company, an effective treatment for this patient population represents an unmet medical need because of an expected 100% mortality within six months in the absence of induction chemotherapy. The purpose of the study would be to assess the efficacy of Hemopure in providing an oxygen carrier in lieu of transfusion with red blood cells, as an adjunct to other special procedures, following induction chemotherapy for AML.
Biopure has struggled to get U.S. approval for the human product. The company said that if this proposed trial is successful it could be pivotal to establish an intended use for Hemopure in this clinical setting.
"We are very excited at the possibility of initiating a new clinical trial with Hemopure in the U.S. If this trial provides convincing evidence of benefit in this high mortality population, it has the potential to become a pivotal trial for Hemopure's use as an adjunct to AML induction chemotherapy when transfusion with blood components is refused by the patient," said Zafiris Zafirelis, Biopure president/CEO.
The company has four ongoing Phase II trials of Hemopure for these indications: during percutaneous coronary intervention; for patients undergoing coronary artery bypass graft surgery; for use in lower limb amputation resulting from critical limb ischemia; and in-hospital use in trauma patients.
Biopure also is developing Hemopure, with support from the U.S. Navy, for a potential out-of-hospital trauma indication.
Synthetic Blood now Oxygen Biotherapeutics
Elsewhere in the synthetic blood sector, the company known as Synthetic Blood International (Costa Mesa, California) has changed its name to Oxygen Biotherapeutics. The company's new trading symbol on the Over-the-Counter Bulletin Board is OXBO.
"Our new name better reflects the broader scope of our development activities," said CEO Chris Stern. "We have several exciting bio-therapeutic applications for Oxycyte, yet none of them is synthetic blood. What we're doing is developing advanced oxygen-based therapies using Oxycyte including traumatic brain injury, sickle cell pain crisis, wound treatment, organ transport, heart attack, stroke, and, as a long shot, spinal cord injury."
The company is the developer of Oxycyte, a perfluorocarbon therapeutic oxygen carrier.
Northstar Neuroscience under pressure
After turning down an unsolicited takeover offer from Tang Capital Partners (San Francisco) in early July, Northstar Neuroscience (Seattle) is under pressure from a major stockholder to sell itself off or split its sizable cash hoard among shareholders.
Tang had offered to buy Northstar for $2.25 a share in cash, but the company's board said the proposal, representing a 50% premium to the closing sale price of Northstar's common stock on July 1, was "not in the best interests of all shareholders. That offer valued the company at $58 million.
In a letter, RA Capital Biotech Fund (Boston) said it was "surprised" by the company's rejection of te offer from Tang, another major shareholder. RA Capital asked Northstar to maximize shareholder value by "reducing expenses and either finding a buyer or making a cash distribution." Northstar's value plummeted after its lead therapy which sought to stimulate the brain to improve motion in stroke survivors failed in a clinical trial in January.
Tang's offer was about a 47% premium to Northstar's average trading price since Jan. 22, when the company reported its disappointing EVEREST clinical trial results. The company had $73 million cash as of March 31, considerably larger than its market capitalization of $49 million. RA Capital owns about 2.5 million Northstar shares, about 9.6% of its outstanding stock.
Angiotech creates new biz
Angiotech Pharmaceuticals (Vancouver, British Columbia), a specialty pharmaceutical and medical device company, reported in early July that it is creating a new subsidiary, Angiotech Pharmaceuticals Interventions (API), with an investment of up to $300 million from Ares Management and New Leaf Venture Partners.
Angiotech said the new subsidiary would hold most of its assets outside of its Taxus coronary stent business, a product sold by Boston Scientific (Natick, Massachusetts) for which Angiotech provides the paclitaxel drug coating.
The company also reported that the British House of Lords has confirmed the validity of one of its patents for its DES coating. The company said that Britain's highest court had overturned the rulings of the lower courts that claimed the patent issued to Angiotech by the European Patent Office for its paclitaxel stent coating was invalid.
Rival stent maker Conor Medsystems (Menlo Park, California) and four other companies had launched various challenges to the validity of Angiotech's patent.
The House of Lords ruled against the decisions of the lower courts, noting that it "did not agree with the reasoning that the lower courts had used in justifying revocation." Instead it based its argument on an earlier Dutch decision.
Registry gathering data on Sonablate
It's common to hear a med-tech company mention a "global" solution, but to pin down what is meant by a global solution is sometimes a tad difficult.
There is no question however, about what the g-word means when it comes to a new registry aimed at tracking the progress of USHIFU's (Charlotte, North Carolina) Sonablate 500, a prostate cancer therapy that uses ultrasound.
The Sonablate International High-Intensity Focused Ultrasound (HIFU) Registry is expected to contain information on nearly 6,000 patients across the U.S. and around the globe who have been treated with the device a feat the company touts as a first.
It doesn't get any clearer than that, according to representatives from USHIFU.
"To my knowledge this registry is the first of its kind in a global sense," Amanda Willis, a spokeswoman for USHIFU told BB&T last month. "From (USHIFU's) perspective, this registry will give participating physicians all across the world larger sets of data to draw from."
While there have been other device registries, this marks the first to incorporate data from outside as well as inside the U.S., Willis said.
The database was established by USHIFU along with Misonix (Farmingdale, New York) and Takai Hospital Supply (Tokyo) to offer what all parties are calling a single, secure, standardized repository of treatment information for those users.
"The Sonablate International HIFU Registry was created to capture the 'real life' practice of prostate cancer treatment, which for the most part fell outside the responsibility of clinical trials," said Rowland Illing of the clinical effectiveness unit at the Royal College of Surgeons of England. "Sponsorship of this registry by the worldwide distribution partners of the Sonablate demonstrates their high level of confidence in the technology."
Bioheart adds in-home monitor for HF
The list of companies hoping to offer heart failure patients peace of mind through at-home monitoring of their disease just got a bit longer. Bioheart (Sunrise, Florida) said it has secured worldwide non-exclusive distribution rights to the Bioheart 3370 heart failure monitor, an interactive device designed to improve available healthcare to patients outside hospitals who are suffering from heart failure.
The device, made by RTX Healthcare (Noerresundby, Denmark), is FDA-cleared for marketing in the U.S. and has CE-mark approval in Europe. Bioheart said it planned to begin commercial distribution immediately.
"What you have is a patient population that really is ill and they do go home and they live their lives and things happen to the patient and oftentimes they go to the emergency room because it's an onset of something," Marty Schildhouse, a spokesman for Bioheart, told BB&T. "Daily monitoring allows for that constant awareness of any potential changes."
The compact Bioheart 3370 heart failure monitor engages patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. It is available in both a wireless configuration and through hook-up to regular telephone lines, the company said. A remotely located medical professional regularly monitors the data for any abnormal readings that may signal a change in the patient's health status. These changes are reported back to the treating physician.
Promising results with ovarian cancer assay
Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said last month that its new product, OvaSure, will be able to assess the presence of early stage ovarian cancer in high-risk women. The company reported that the device a blood test that uses six biomarkers to determine the presence of cancer in the body is available for commercial use.
"LabCorp is offering the OvaSure test as a laboratory-developed test, which is regulated by CLIA and CMS," Eric Lindbolm, a spokesman for LabCorp told BB&T via e-mail "LabCorp does plan, however, to continue to seek guidance on the regulatory status of our offering from the FDA."
The test identifies six biomarkers in its detection of ovarian cancer; MIF, Prolactin, CA-125, Osteopontin, Leptin and IGF-II.
The report says that the potential implication of early detection of ovarian cancer on patient outcome is shown by the differential survival rates of women diagnosed at different stages of disease progression. The 10-year survival rate is nearly 90% when the disease is localized to the ovaries at the time of diagnosis and drops to 20% when the disease has spread to distant sites at the time of diagnosis.
According to a Phase II clinical trial, the test was shown to discriminate between disease-free women and ovarian cancer patients (stage I-IV) with high specificity (99.4%) and sensitivity (95.3%).
Invitrogen's Herceptin test approved
Oncologist now have another weapon to add to their breast cancer armamentarium with the addition of a test that can help to determine if a patient is likely to respond well to Herceptin, a drug developed by Genentech (South San Francisco, California) and FDA-approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative breast cancer.
Invitrogen (Carlsbad, California) has received PMA approval from the FDA for its Spot-Light HER2 CISH Kit to help in the assessment of breast cancer patients for whom Herceptin treatment is being considered.
The approval is a significant marker for the company, since it is the first PMA won by Invitrogen, thus giving it a first step in a different direction. Invitrogen previously has specialized in products for the research community in the U.S. rather than those for clinical use.
"The PMA approval is a milestone for us. We plan to launch in the U.S. during the second half of August," Brett Williams, senior director of cellular analysis and Invitrogen's molecular probes unit, told BB&T. "We already sell this kit outside of the U.S. There are reimbursement codes those used for other in situ tests — already in place, and it will be priced at $1,400 for 20 assays, or $70 per test."
Longitude closes $325M VC fund
Longitude Capital (Menlo Park, California) reported the closing of its first investment vehicle, Longitude Venture Partners, a $325 million venture capital fund dedicated to life sciences investments. The fund exceeded its target of $250 million, the company said.
The team at Longitude Capital includes managing directors Juliet Tammenoms Bakker, Patrick Enright and Marc-Henri Galletti, venture partner Jeffrey Gold, principals Douglas Foster and David Hirsch, and CFO Elaine Erickson. The firm was formed following the team's spin-out from Pequot Capital, where they were responsible for venture capital investments in life sciences companies since 1997.
"We have a strong team and a unique style of investing that has produced excellent returns over multiple fund vintages," said Bakker, Longitude co-founder and managing director. "As has been the case in the past, we are active investors across all sectors and stages but tend to favor earlier-stage medical device companies and later-stage opportunities in biotech."
Prior to forming Longitude, the team was collectively responsible for more than 100 venture capital investments in the life sciences. Representative investments include Ablation Frontiers, Acufocus, Align Technology, Cephalon, Codexis, CryoVascular Systems, Embolic Protection, eyeonics, Eyetech Pharmaceuticals, Horizon Therapeutics, Insulet, MAP Pharmaceuticals, Oratec, Prestwick Pharmaceuticals, Sequenom and SUGEN.
The team's experience spans all stages of companies in most therapeutic areas within the medical device and biotechnology sectors.