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Baxter Announces New Product Developed in Partnership with Water Street

Advancing Baxter’s longstanding commitment to provide hospitals with convenient presentations of medications that drive efficiency during drug preparation and enhance patient safety in administration, Baxter International Inc. (NYSE: BAX) today announced the launch of a ready-to-use VANCOMYCIN injection in 0.9% Sodium Chloride (Normal Saline) in 500 mg, 750 mg and 1 gram presentations.

VANCOMYCIN injection is an antibiotic used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci bacteria.

Baxter is the only manufacturer to offer VANCOMYCIN in a premixed presentation, which uses the company’s proprietary frozen GALAXY container technology. Baxter’s innovative frozen premix technology is specifically designed for unstable molecules that are often administered using standardized doses. Premixed molecules offered in the GALAXY container are illustrative of the leading innovation in medical manufacturing that Baxter has been bringing to the healthcare industry for more than 80 years.

VANCOMYCIN saline injection augments Baxter’s expanding portfolio of generic injectable drugs in the United States available in easy-to-use presentations that hospitals, physicians and patients can rely on because they are manufactured to the Current Good Manufacturing Practice (cGMP) regulations established by the U.S. Food and Drug Administration (FDA). Premixed medications in standardized drug concentrations can help support hospitals’ goals for safe and efficient medication preparation because compounding is not necessary.

“As a company whose mission is focused on saving and sustaining lives, Baxter’s launch of VANCOMYCIN injection in an innovative premixed saline presentation provides new options of an important antibiotic to address patient needs and demonstrates our commitment to making premixed preparations of medications more efficient for healthcare practitioners,” said Brik Eyre, president of Baxter’s Hospital Products business.

The launch is an extension of Baxter’s existing VANCOMYCIN injection in 5% dextrose in 500 mg, 750 mg and 1 gram presentations and provides an alternative to certain patients who may need to avoid receiving additional dextrose. By providing VANCOMYCIN in both saline and dextrose presentations, Baxter makes additional therapy options available of a critical antibiotic that has appeared on and off of the FDA Drug Shortage list.

VANCOMYCIN saline injection is the second of nine clinically important molecules coming out of a collaborative partnership with Celerity Pharmaceuticals, LLC, a company of Water Street Healthcare Partners, to develop new products that use Baxter’s proprietary container technology, enhanced packaging platform, and aseptic filling manufacturing process.

Baxter’s VANCOMYCIN saline injection in 500 mg, 750 mg and 1 gram presentations are available in the United States.

INDICATIONS for Vancomycin Injection, USP:

• For the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.

• Vancomycin is effective in the treatment of staphylococcal endocarditis. Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

IMPORTANT RISK INFORMATION for Vancomycin Injection, USP:

• Vancomycin is contraindicated in patients with known hypersensitivity to this antibiotic and in patients with known allergy to corn or corn products.

• Vancomycin should be administered over a period of not less than 60 minutes to avoid rapid-infusion-related reactions, such as exaggerated hypotension, including shock, and, rarely, cardiac arrest. Stopping the infusion usually results in prompt cessation of these reactions.

• Ototoxicity has occurred in patients receiving vancomycin and may be transient or permanent. It has been reported mostly in patients who have been given excessive doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent, such as an aminoglycoside.

• Patients with renal insufficiency should undergo serial monitoring of renal function and receive appropriate dosing schedules. The risk of toxicity and nephrotoxicity is increased with high, prolonged blood concentrations and concomitant therapy with an aminoglycoside.

• Clostridium difficile associated diarrhea (CDAD) has been reported with Vancomycin Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Prolonged use of vancomycin may result in the overgrowth of nonsusceptible microorganisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

• Risk of High Sodium Load: Avoid use of Vancomycin in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake.

• Reversible neutropenia has been reported in patients receiving vancomycin. Patients who will undergo prolonged therapy with vancomycin or who are receiving concomitant drugs that may cause neutropenia should have periodic monitoring of the leukocyte count.

• Vancomycin is irritating to tissue and must be given by a secure intravenous route of administration. Pain, tenderness, and necrosis occur with inadvertent extravasation.

• The safety and efficacy of vancomycin administered by the intrathecal (intralumbar or intraventricular) route or by the intraperitoneal route have not been established by adequate and well controlled trials.

• Reports revealed administration of sterile vancomycin by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from a cloudy dialysate alone to a cloudy dialysate accompanied by variable degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.

Please see accompanying full Prescribing Information.

About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

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Water Street Completes Sale of HealthPlan Services

Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that Tampa, Fla.-based HealthPlan Services has been sold to global information technology, consulting and business process services leader, Wipro Limited, for $460 million.

During its seven-year partnership with HealthPlan Services, Water Street helped grow the company into the nation’s leading technology and Business Process as a Services (BPaaS) solution for the individual health insurance industry.

Water Street invested in HealthPlan Services in 2008. Working together, Water Street and the management team developed and executed a strategic growth plan that expanded HealthPlan Services’ outsourcing platform and elevated the company to a leadership role in the insurance exchange market created through the Affordable Care Act (ACA). HealthPlan nearly quadrupled its revenues to $223 million and more than doubled its employees over the course of its partnership with Water Street. Today, more than a quarter of all consumers on the federal health insurance exchange benefit from HealthPlan Services’ solutions.

“HealthPlan and Water Street created a set of solutions, platform and services that previously did not exist. In doing so, we helped many of the nation’s largest health insurance payers acquire, service and retain millions of incremental members under the ACA,” said Jeff Bak, president and chief executive officer, HealthPlan Services. “Water Street enabled us to make a significantly large investment in our platform to execute our vision and strategy. Its industry experience and network of resources were invaluable to our growth and to achieving the next step in our strategic plan through the Wipro transaction.”

“It’s been our privilege to work with Jeff and the entire HealthPlan management team to make a meaningful impact in the health care industry. We are proud of the incredible growth we have experienced over the past seven years, as HealthPlan added more than 1,000 associates and became a critical part of the dynamic individual insurance marketplace. We are pleased that our success has been validated by a global leader committed to continuing the company’s strong growth trajectory,” said Ned Villers, partner, Water Street.

About HealthPlan Services

HealthPlan Services delivers a best-in-class administrative technology platform and consumer engagement services to payers and agents across the public exchange, private exchange and off-exchange individual markets. The company is the largest independent provider of sales, benefits administration, retention, and technology solutions to the health insurance and managed care industries. Headquartered in Tampa, Florida, HealthPlan Services was founded in 1970 and employs over 2,000 associates. HealthPlan Services stands at the forefront of the health insurance industry, providing exchange connectivity, administration, distribution and technology services to insurers of individual, group, voluntary and association plans, as well as valuable solutions to thousands of brokers and agents nationwide. For more information, please visit www.healthplan.com.

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Wipro to Acquire HealthPlan Services from Water Street

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has signed a definitive agreement to acquire HealthPlan Services from Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.

Since partnering with Water Street in 2008, HealthPlan Services has grown to become the leading independent technology and Business Process as a Service (BPaaS) provider in the U.S. Health Insurance market. As part of the agreement, Wipro will acquire 100% of HealthPlan Services’ shares for a purchase consideration of USD 460 million.

Headquartered in Tampa, Florida, HealthPlan Services employs over 2,000 associates. HealthPlan Services offers market-leading technology platforms and a fully integrated Business Process as a Service (BPaaS) solution to Health Insurance companies (Payers) in the individual, group and ancillary markets. HealthPlan Services BPaaS solutions are ideal for payers who want to operate in the private and public exchanges and the off-exchange individual market in the U.S.

HealthPlan Services provides U.S. payers with a diversified portfolio of health insurance products delivered through its proprietary technology platform. In the highly competitive Exchange market, payers rely on HealthPlan Services’ innovative and robust offering to acquire, service and retain members. Payers also leverage the analytical and predictive engines of HealthPlan Services to better serve their members. Today, HealthPlan Services connects its payer clients to over 40 public exchanges and over 150 private exchanges in the U.S. HealthPlan Services has powered many of these payers to achieve desired membership growth, while keeping their administrative costs predictable.

The Patient Protection and Affordable Care Act has dramatically altered the health insurance landscape in the U.S. The post-reform individual market is growing at a fast pace and is expected to continue to grow in coming years. By partnering with HealthPlan Services, Wipro gains the competitive, first-mover advantage in the high growth public and private exchange space for individual, group and ancillary markets. This partnership also strengthens Wipro’s payer portfolio, with access to HealthPlan Services’ payer clientele.

This transaction is closely aligned with Wipro’s key levers for growth, which are to dominate the services market through industry utilities that multiple customers can use. This acquisition adds another platform-led Business Process as a Service (BPaaS) offerings, delivered on cloud to Wipro’s services portfolio. Wipro’s clients currently include over 100 U.S. payers, leading healthcare providers, and public health agencies.

“The partnership with HealthPlan Services positions Wipro to participate in the shift of the US health insurance industry towards a consumer-centric business model. HealthPlan Services strengthens Wipro’s position in the health insurance exchange market while offering synergies with Wipro’s presence in the Managed Medicare and Commercial Group Insurance markets. The addition of HealthPlan Services’ capabilities complements Wipro’s strengths in claims processing and back office services. This is a strategic move for us, as it advances Wipro’s vision of leveraging unique insights into customer buying behavior and applying this across the healthcare value chain. This will help us lower the cost of healthcare and transform the quality of the member experience,” said Jeffrey Heenan Jalil, Senior Vice President & Head- Healthcare Life Sciences and Services, Wipro Limited.

“We welcome the HealthPlan Services team to the Wipro family. Over the past eighteen months we have transformed our BPS business into a platform-led BPaaS business with a strong focus on the healthcare services market. This transaction will help us become the leader in administrative service in the U.S. health insurance industry. The partnership with HealthPlan Services also reinforces our commitment to the US market by creating jobs and value within the US economy,” said Nagendra Bandaru, Senior Vice President and Head – Business Process Services, Wipro Limited.

“We are excited about what Wipro and HealthPlan Services can accomplish together for our customers and employees," said Jeff Bak, CEO and President of HealthPlan Services. “The combination creates the first true end-to-end solution in the individual under 65 commercial market and the governmental over 65 and Medicaid markets. Together, Wipro and HealthPlan Services will give payers the power to accelerate growth strategies while providing both Business Platform as a Service (BPaaS) and competitive administrative service solutions. We are delighted that Wipro believes in our talented people, strategic vision, corporate culture and business fit to help insurers succeed in a consumer-centric world.”

This transaction is subject to customary closing conditions and regulatory approvals and is likely to be completed in next 60 to 90 days.

About Wipro Ltd.

Wipro Ltd. (NYSE:WIT) is a leading information technology, consulting and business process services company that delivers solutions to enable its clients do business better. Wipro delivers winning business outcomes through its deep industry experience and a 360 degree view of "Business through Technology.”  By combining digital strategy, customer centric design, advanced analytics and product engineering approach, Wipro helps its clients create successful and adaptive businesses. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, Wipro has a dedicated workforce of over 160,000, serving clients in 175+ cities across 6 continents. For more information, please visit www.wipro.com

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Premise Health Continues Expansion

Premise Health, a leading worksite health and patient engagement company, announced today that it has acquired IMWell Health, LLC.

Headquartered in Fort Smith, Arkansas, IMWell specializes in primary care clinics for mid-size companies and municipalities. The acquisition marks another advancement in Premise Health’s strategic expansion to improve the cost and quality of employer health care.

Premise Health has invested significantly in developing new employee health solutions since it was formed through the merger of CHS Health Services and Take Care Employer Solutions in 2014. The company provides personalized care to more than 200 of the nation’s leading employers, including many of the Fortune 1000, through onsite health clinics. With the addition of IMWell, Premise Health extends its expertise and services to clinics that serve and are located near multiple employers, including mid-size companies, school districts and municipalities.

“The addition of IMWell is a natural next step in our effort to expand our capabilities for serving the mid-sized employer and public employer markets,” said Stu Clark, chief executive officer, Premise Health. “IMWell’s multi-employer, near-site model is an excellent platform from which to leverage our patient engagement and health improvement strategies to a broader market. We are excited to have the IMWell organization join the Premise Health family.”

Founded in 2004, IMWell has grown to operate 17 onsite and multi-site clinics that serve more than 65,000 employees and their family members. The clinics provide acute care, chronic disease evaluation and care management to small and mid-size corporate employers, municipalities and school districts primarily located in the Southwest region of the United States.

“This is an ideal partnership for both of our organizations,” said Dan Parker, CEO, IMWell. “Our companies share similar values and are both dedicated to improving the health and wellness of employees and their family members. We are looking forward to gaining access to Premise Health’s extensive clinical, operational and technology resources, as well as sharing our expertise in operating multi-employer clinics.” Clark added that strategic acquisitions, such as that of IMWell, will continue to be a key component of Premise Health’s growth plan.

ABOUT PREMISE HEALTH

Premise Health is a leading worksite health and patient engagement company dedicated to improving the cost and quality of employee health care. With more than 40 years of experience, Premise Health manages more than 500 worksite-based health and wellness centers across the country. The company serves more than 200 of the nation’s leading employers, including a significant number of the Fortune 1000. Premise Health is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. For more information on Premise Health, visit www.premisehealth.com.

ABOUT IMWELL HEALTH

IMWell Health is a leader in developing on-site and multi-employer primary care clinics customized to meet employers’ specific needs. Established in 2004, the company consists of dedicated medical professionals who specialize in improving the health and productivity of the unique workforces they serve. This provides its clients with an enhanced ability to stabilize and lower their overall healthcare costs through IMWell Health’s Patient Centered Medical Home – a commitment to optimal outcomes driven by a compassionate partnership between our medical teams and employers, patients and families. For more information, visit the IMWell Health website at www.imwhealth.com.

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Bioclinica Expands Services with Clinverse Acquisition

Bioclinica®, Inc., a specialty clinical trials services and technology provider, announced today that it has acquired Clinverse, Inc.

The acquisition expands Bioclinica’s offerings into the growing market of automated financial management technology solutions for global clinical trials. Clinverse is the latest investment that Bioclinica has completed to build the company into a leading provider of solutions that bring quality and efficiency to every phase of clinical trial development.

Headquartered in Durham, North Carolina, Clinverse automates and manages the entire financial lifecycle of global clinical trials for contract research organizations (CROs) and pharmaceutical companies. Its suite of products pays clinical trial sites, vendors and their subjects; budgets and forecasts trial expenditures and converts tax and exchange rates in more than 200 countries and 140 currencies globally. Clinverse’s products also can be integrated with other eClinical platforms. The company’s services have saved CROs and pharmaceutical corporations as much as 50 percent of their operational costs.

“We are delighted to add Clinverse’s capabilities to Bioclinica’s portfolio of solutions,” said Dr. John Hubbard, president and chief executive officer, Bioclinica. “Managing clinical investigator payments has been a significant challenge for our industry. For years, sponsors have manually tracked and paid clinical trial sites. Clinverse developed one of the first automated solutions to alleviate companies of this burden. The company is making a significant impact in reducing costly errors, improving satisfaction and increasing operational efficiencies to mitigate this major pain point in drug development.”

Clinverse will become part of Bioclinica’s eHealth Solutions business segment, which offers technology solutions to support pharmaceutical companies and CROs in the efficient management and conduct of clinical trials, as well as Safety and Regulatory Solutions. In addition to eHealth technologies, Bioclinica offers a comprehensive portfolio of services encompassing medical imaging and biomarkers, patient recruitment and retention services, a research site network and a post approval research division. The company has invested in strategic initiatives and acquisitions to expand its capabilities and services since merging with CCBR-SYNARC in 2014 to become a leading clinical trial services provider.

“We are excited to join Bioclinica,” said Jay Trepanier, chief executive officer, Clinverse. “This partnership will accelerate our goal of becoming the best-in-class solution for financial services in the clinical trial industry. Our relationship will allow us to strengthen our operational capabilities out of the gates, while we continue to aggressively invest in enhancing our technology and services. Our customers will benefit from becoming part of an innovative leader in the industry that offers extensive resources and services. We also look forward to bringing our specialized expertise to Bioclinica’s clients.”

Trepanier will continue to lead Clinverse and report to Mukhtar Ahmed, president of Bioclinica’s eHealth Solutions Segment.

About Clinverse, Inc.

Clinverse, Inc. architected the industry’s first automated financial management technology solution for clinical trials. Powered by our secure technology platform, our solution standardizes clinical trial financial management for millions of financial transactions across the globe, including clinical site payments. Used by leading BioPharma companies, our solutions remove antiquated manual process so our clients benefit from reduced workload, time and costs gained through automation and unprecedented transparency and workflow. For more information, please visit www.clinverse.com.

About Bioclinica, Inc.

Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized into three business segments to deliver focused service and multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technologies and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The company serves more than 400 pharmaceutical, biotechnology, and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. For more information, please visit www.bioclinica.com.

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Zenith American Solutions Acquires Benserco

Zenith American Solutions, Inc.® (Zenith), a leading third-party benefits administrator, announced today that it has acquired Benserco, Inc., a company specializing in Taft-Hartley benefit plan administration.

The acquisition expands Zenith’s national presence and strong base of clients. The company is continuing to pursue targeted acquisitions that support its goal of building Zenith into a premier national service provider.

Zenith currently administers benefits to nearly 2 million employees, retirees and dependents on behalf of multi-employer Taft-Hartley trust funds, trade associations, government entities and corporate employers. Since its founding in 1944, the company has steadily grown to serve an increasing number of clients. In 2008, Zenith partnered with Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry, to accelerate its growth. By joining forces with Benserco, Zenith bolsters its presence in the Northeast and offers complementary solutions to a larger group of clients.

“Bringing together Benserco and Zenith was a great opportunity. Our companies are closely aligned with our offerings and our commitment to providing clients with outstanding service,” said Art Schultz, chief executive officer, Zenith American Solutions. “We are excited to work with Benserco to identify new ways to provide greater value to our clients in today’s increasingly complex regulatory environment.”

Effective immediately, all three of Benserco’s companies, including Benserco, Benefit Services of PA, Inc. and Dentsco, Inc., become part of Zenith American Solutions. Lucille Hart, who has served as president of Benserco, will continue to lead the organization and report to Mr. Schultz.

“We are very pleased to partner with Zenith. It has an outstanding reputation for offering high-quality services and shares our values of going above and beyond to serve its clients,” said Ms. Hart. “I look forward to leveraging our combined expertise and capabilities to support employees participating in the Taft-Hartley plans we serve.”

About Benserco, Inc.

Headquartered in Englewood Cliffs, New Jersey, Benserco, Inc. has been providing third- party administration services since 1966. The company specializes in administering Taft-Hartley benefit plans, including pension, health, dental, vision, legal services, training and apprentice and vacation plans. Benserco also houses Benefit Services of PA, Inc., which specializes in third-party claims administration, and Dentsco, Inc., which designs and administers dental programs. For more information, visit benserconj.com.

About Zenith American Solutions, Inc.

Zenith American Solutions, Inc. (Zenith) has been providing high-quality administrative services since 1944. With 33 offices across the country, Zenith manages benefit plans as a third-party benefits administrator (TPA) serving over 700,000 health plan members and dependents, and over 800,000 retirement plan participants for Taft-Hartley trust funds, trade associations, government entities and corporate employers. Zenith American Solutions is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry. For more information, visit www.zenith-american.com.

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MarketLab Expands Product Portfolio

MarketLab, a leading national provider of unique and hard-to-find healthcare products, announced today that it has acquired Hopkins Medical Products to expand into home healthcare.

Founded in 1945, Hopkins specializes in catalog and web-based sales of products and supplies to home healthcare practitioners.

MarketLab currently offers a comprehensive portfolio of healthcare products to the anesthesia, clinical laboratory, hospital nursing and imaging markets. With the addition of Hopkins, MarketLab expands its product offering into medical supplies for nurses and clinicians in home health, hospice and assisted living settings. Hopkins is the fifth brand MarketLab has acquired since it began collaborating with Water Street Healthcare Partners, a strategic investor focused exclusively on healthcare.

“Hopkins is a highly complementary acquisition that enables us to enter a new, growing market and broaden our product offering. It is a well-established 50-year brand known for providing outstanding products, including its market-leading line of Hopkins-branded nurse bags and totes,” said Gene Babcock, chief executive officer, MarketLab. “We look forward to continuing to work with Water Street to expand our unique portfolio of products into new markets.”

Since partnering with Water Street, MarketLab has grown to become a leading specialty distributor of products to niche medical markets through six well-established brands. Together with Water Street, the company is actively seeking additional acquisition opportunities to expand its products and services into adjacent healthcare markets.

About MarketLab

MarketLab is a leading distributor of unique and hard-to-find products to the anesthesia, clinical laboratory, home healthcare, hospital nursing, and magnetic resonance imaging (MRI) markets under the MarketLab, Sharn Anesthesia, Cone Instruments, MNC, Newmatic Medical and Ceil Blue brand names. It is committed to providing customers with customized solutions that contribute to a better healthcare experience for their patients. The company is headquartered in Caledonia, Michigan. MarketLab is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on healthcare. For more information, visit marketlabinc.com.

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BioClinica Acquires Synowledge

BioClinica®, Inc., a specialty clinical trials services and technology provider, today announced that it has acquired Synowledge to expand its offering into the growing drug safety and regulatory business process outsourcing market.

Headquartered in Miami, Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events.

“This acquisition extends BioClinica’s solutions into an important new area for our customers,” said BioClinica President and Chief Executive Officer John Hubbard.  “Synowledge is a highly regarded provider that biopharmaceutical corporations trust to manage the critical process of monitoring and reporting adverse drug events.  Its capabilities complement our deep scientific expertise and technology-enabled services that support our customers in developing and bringing new drugs to market as safely and efficiently as possible.”

Since its founding in 2006, Synowledge has grown rapidly to serve many of the world’s leading pharmaceutical and biotechnology organizations.  The company offers pharmacovigilance services across all therapeutic areas and stages of drug development, including case processing, aggregate reporting, medical literature review, call center support and signal detection.  Synowledge employs a highly skilled global workforce of more than 500 people who provide customers with around-the-clock expertise and support remotely or onsite.  The company also offers information technology services for drug safety applications.

Sankesh Abbhi, who founded Synowledge, said, “We are very pleased to become part of BioClinica.  Our companies share a deep commitment to serving our customers and supporting their goals through highly specialized expertise and tailored solutions. Together, we offer customers a broader set of services and increased access to resources that support their overall drug development process.”

Effective immediately, Mr. Abbhi will serve as senior vice president and head of global safety and regulatory solutions.  He will report to Mukhtar Ahmed, president of BioClinica’s eClinical Solutions Division.

“Synowledge is a proven industry leader in the adoption of pharmacovigilance and regulatory technologies,” said Mr. Ahmed. “With its depth of expertise in business process execution, data analysis and application-managed services, we will further extend our eClinical product and services portfolio so that we can provide our customers with a comprehensive offering that spans across the life sciences landscape.”

About BioClinica, Inc.

BioClinica is a specialty clinical trials services provider that improves the development of new medical therapies by delivering expertise and technologies that enhance clinical research data and analytics, worldwide. The company offers industry-leading medical imaging services, enterprise eClinical technologies, clinical research centers and cardiovascular safety solutions that bring quality and efficiency to every phase of clinical development. BioClinica’s experience spans three decades and includes thousands of studies in all therapeutic areas.  The company serves more than 400 pharmaceutical, biotechnology, and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia.

About Synowledge

Synowledge is a specialized Pharmacovigilance, Regulatory Affairs and IT services provider that assists and enables small, medium and large life sciences organizations to satisfy their global regulatory requirements. The Synowledge team consists of highly qualified and skilled experts who are committed to helping companies meet and exceed the challenging demands of the R&D lifecycle. Our comprehensive outsourcing solutions cover all therapeutic areas and combine the unique strengths and knowledge of industry leading experts. Our commitment to quality allows us to deliver accurate, consistent, and robust solutions to the life sciences industry. Synowledge was founded in 2006 and is headquartered in Miami, Florida.  Synowledge has global offices in North America, Europe, India, and Japan.

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Baxter and Water Street Announce FDA Approval

Baxter International Inc. (NYSE: BAX) and Water Street Healthcare Partners announced the United States Food and Drug Administration (FDA) has approved CEFAZOLIN Injection in GALAXY Container (2 g/100 mL), which is Baxter’s flexible container that uses the company’s proprietary aseptic filling manufacturing processes.

CEFAZOLIN injection is a cephalosporin antibacterial indicated for preoperative prophylaxis treatment. When used for preoperative prevention, it may reduce the incidence of certain postoperative infections for high-risk patients undergoing surgical procedures. See below for full Indication and Important Risk Information.

“The availability of CEFAZOLIN 2 gram in an efficient, ready-to-use, flexible premix container that can improve pharmacy efficiency will provide additional supply options of an important antibiotic,” said Brik Eyre, president of Baxter’s Hospital Products business.

CEFAZOLIN injection has been on the FDA’s drug shortage list for more than one year due to high demand. Baxter anticipates launching CEFAZOLIN injection 2 gram frozen premix in its GALAXY container in the United States in the fourth quarter of 2015.

CEFAZOLIN injection 2 gram represents the first of nine molecules actively under development to provide healthcare providers needed injectable formulations of essential drugs frequently used in critical care settings through Baxter’s development partnership with Celerity Pharmaceuticals, LLC, a company of Water Street, a strategic investor focused exclusively on the healthcare industry.

“Baxter’s innovative development partnership with Water Street allows us to accelerate product development and offers healthcare providers additional options for critical care medications produced with our proprietary manufacturing capabilities and in our container technology,” Eyre said.

Indication Cefazolin injection is a cephalosporin antibacterial indicated for preoperative prophylaxis.

Use an alternative cefazolin product when lengthy surgical procedures require supplemental doses and when postoperative dosing is required.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin injection and other antibacterial drugs, Cefazolin injection should be used only to prevent infections that are proven or strongly suspected to be caused by bacteria.

Important Risk Information • Cefazolin injection is contraindicated in patients who have a history of immediate hypersensitivity reactions to cefazolin or the cephalosporin antibacterial drugs, penicillins, or other beta-lactams. • Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Cefazolin injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems. Maintain clinical supervision if this product is to be given to penicillin-sensitive patients. If an allergic reaction to Cefazolin injection occurs, discontinue the drug. • Clostridium difficile associated diarrhea (CDAD) has been reported with Cefazolin Injection and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, appropriate management should be instituted as clinically indicated. • Hypersensitivity reactions have been reported with administration of dextrose-containing products and corn-derived dextrose solutions. • Altered Laboratory Tests: Positive direct Coombs’ test and false-positive test for urinary glucose. • As with other dextrose-containing solutions, maintain clinical supervision when prescribing Cefazolin injection to patients with overt or known subclinical diabetes mellitus or carbohydrate intolerance for any reason. • The most commonly reported adverse reactions were nausea, vomiting, diarrhea, and allergic reactions (anaphylaxis, urticaria, skin rash). Please click accompanying full Prescribing Information.

About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

This release includes forward-looking statements concerning CEFAZOLIN, including expectations with regard to its availability in the U.S. and risks associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

BAXTER and GALAXY are trademarks of Baxter International Inc.

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Water Street Expands Team to Support Companies

Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that it has appointed Paul T. Cottey as chief information officer.

A former executive partner with Accenture, Mr. Cottey brings nearly 30 years of information technology experience to Water Street.  He will collaborate with the firm’s group of health care companies to engage and align their IT strategy and infrastructure to support their growth objectives.

During a nearly 20-year career with Accenture, Mr. Cottey consulted with numerous corporations on their IT strategy.  He also oversaw IT initiatives for a variety of companies as vice president of IT and Systems at The Gores Group.  Mr. Cottey has significant health care experience, having served as CIO of Accretive Health, Inc.  During his tenure with the company, he was recognized as one of ComputerWorld’s Premier 100 IT Leaders.  Prior to Water Street, Mr. Cottey was CIO and a member of the executive leadership team of Patient Matters, LLC.

“We are excited to expand our team of health care executives and investment professionals with another leader of Paul’s caliber,” said Kevin Swan, partner, Water Street.  “His expertise in information technology strategy and operations brings another important component of support to growing and creating long-term value in our family of health care companies.”

Mr. Cottey augments Water Street’s Corporate Resources Group, which is comprised of specialists who work with the firm’s companies to execute strategies that support their growth objectives.  The group offers expertise in corporate communications, corporate development, information technology and talent management.

Water Street has completed more than 50 strategic acquisitions and mergers to build 22 market-leading companies in key segments of health care since its founding in 2005. The firm is pursuing proprietary investment opportunities in four segments of health care:  medical and diagnostic products and devices, specialty distribution, outsourced health care services, and specialty pharmaceutical products and services.  Target investments range in size from $50 million to $500 million in value.

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