BioWatch: United BioSource agrees to $730 million sale
Bethesda research company to be acquired by Medco Health
United BioSource, a Bethesda drug and device research business, has agreed to be bought in a $730 million deal by Fortune 100 pharmacy benefits manager Medco Health Solutions, executives said Monday.
Privately held United BioSource, which was co-founded in 2003 by CEO Ethan Leder and President Mark Clein, has grown rapidly through acquisitions and investments to about 1,500 employees with offices in more than 20 countries. Executives expect revenues this year to reach about $280 million, with an annual growth rate of more than 20 percent.
The acquisition by Medco will provide United BioSource with "exciting new resources to accelerate growth, including opportunities to collaborate with clients and contribute to the mission of delivering the right drug to the right patient at the right time," Leder said in a statement.
Upon closing, which is expected in the third quarter, United BioSource will be a wholly owned subsidiary of Medco of Franklin Lakes, N.J., and there are no plans to change management or locations, Jennifer Leone Luddy, a Medco spokeswoman, said Monday. Leder and Clein will remain with United BioSource in the same roles, she said, and report to Robert Epstein, Medco's chief medical officer and president of the Medco Research Institute.
"This acquisition is about growth and opportunity, and we do not anticipate any major changes at this time," Luddy said. "Of course, prudent management requires that you carefully examine the requirements and realities of the business. We are forming a transition team that will take great care and diligence in making decisions that are in the best interest of the business and our employees."
The acquisition will help Medco meet objectives of the new national health care reform, such as improving quality and reducing costs, executives said. In a statement, Epstein praised United BioSource for creating a "powerful, complementary engine for more rapidly advancing clinical insight, discovery and innovation in the areas of safety, economics and outcomes research."
The agreement follows other smaller acquisitions last week involving the Maryland bioscience industry. Emergent BioSolutions of Rockville agreed to buy Trubion Pharmaceuticals of Seattle for up to $135.5 million, and OriGene Technologies of Rockville is acquiring Blue Heron Biotechnology of Bothell, Wash., for an undisclosed amount.
United BioSource studies drugs and products for risk and effectiveness after they are approved by federal regulators. A spokeswoman said the company keeps its client list confidential. United BioSource recently opened a new office in Lˆrrach, Germany, and secured a $150 million line of credit from Capital One, PNC and other financial institutions.
Medco, the largest pharmacy benefit manager in the country as measured by drug spending, ranked 35th this year on Fortune's annual list of the largest companies, up from 45th last year. Revenues last year rose by 16.7 percent from 2008 to $59.8 billion, while net income increased by 16 percent to $1.3 billion. Medco had 22,850 employees worldwide as of Jan. 1, up from 21,800 a year earlier, according to its latest annual reports.
In other Maryland bioscience industry news:
Including its planned acquisition of Trubion, Emergent BioSolutions has been on somewhat of a diversification kick this month.
The company, which sells an anthrax vaccine to the federal government and is developing a next-generation anthrax vaccine, is licensing rights to vaccine and therapeutic candidates for eight infectious diseases, including tuberculosis, from a U.K. biopharmaceutical company, Oxford BioMedica.
The deal comprises an upfront licensing fee of $1 million, potential milestone payments of up to $20.4 million and undisclosed royalties on sales, according to an Oxford statement. One of the milestones is the beginning of a phase 3 trial for the tuberculosis vaccine candidate being developed by the Oxford-Emergent Tuberculosis Consortium, a collaboration of Emergent Product Development UK and the University of Oxford.
"Emergent has a diverse pipeline of vaccine products and is therefore another strong licensee of our heterologous prime-boost technology patents," Oxford CEO John Dawson said in the statement.
For Emergent, the Oxford transaction follows other deals to widen its development efforts. Trubion has two clinical-stage candidates focused on cancer and autoimmunity. Emergent also recently announced the launch, with Temasek Life Science Ventures, of a joint venture called Epic Bio to develop, manufacture and commercialize a vaccine for H5 influenza strains such as avian flu.
Human Genome Sciences of Rockville reported Thursday the U.S. Food and Drug Administration has granted priority review designation for its Benlysta, the lupus treatment it is developing with GlaxoSmithKline.
The designation, which HGS anticipated, is granted to drugs that, if approved, "address serious diseases with significant unmet medical needs," according to FDA information.
The designation expedites the application review from 10 months to six months. HGS submitted its biologics license application on June 9, putting the review completion date at Dec. 9. The application includes the results of two phase 3 clinical trials that treated a total of 1,684 autoantibody-positive patients with lupus.
"We are very pleased that FDA has chosen to grant priority review to belimumab, the first in a new class of drugs called BLyS-specific inhibitors," said H. Thomas Watkins, president and CEO of HGS, in a statement. "We believe that the priority review designation speaks both to the significant medical need of people living with lupus and to the potential belimumab may hold as a new treatment option for these patients."
GlaxoSmithKline submitted a marketing application for the drug to European regulators on June 4. No new lupus drug has been approved in the U.S. in more than 50 years.
HGS stock initially jumped 3.6 percent on the news Thursday morning and closed up 2.2 percent for the day.
Technical Resources International of Bethesda won a contract from the National Institute of Allergy and Infectious Diseases to continue providing clinical, regulatory and operational support for domestic and international clinical research programs supported by the agency's Division of Acquired Immunodeficiency Syndrome.
The contract includes an initial award of $9 million and could be worth $75.3 million during the course of seven years, according to information from the privately held, minority- and female-owned contract research organization.
Technical Resources' work will include reviewing protocol documents and preparing and filing new investigational new drug applications and amendments to existing applications.
Nabi Biopharmaceuticals is due to collect $8 million from GlaxoSmithKline Biologicals for reaching a milestone under the sale of its PentaStaph vaccine candidate and related assets.
The Rockville biotech sold PentaStaph, a vaccine to protect against Staphylococcus aureus infection, for total consideration of $46 million. That includes $26 million related to four milestones. Including the most recent $8 million milestone, Nabi has earned $21 million of the $26 million, with the rest due upon completion of a phase 1 trial that began in December. The company expects to achieve that within nine months.
Nabi already received $21.5 million when the deal closed in November.
"We have made tremendous progress in achieving the PentaStaph milestones by completing three of the four milestone tasks in eight short months following the close of this transaction," Nabi CEO Raafat Fahim said in a statement.
The vaccine would be valuable in protecting against multidrug-resistant staph bacteria, according to Nabi information.
Novavax reported results from a preclinical toxicology study of its vaccine candidate to prevent respiratory syncytial virus showed it to be safe and well-tolerated at all doses tested.
"We have now tested our RSV vaccine candidate in well-accepted animal models of toxicity and disease and found sufficient evidence of safety and effectiveness to advance our RSV vaccine candidate toward human clinical trials," CEO Rahul Singhvi said in a statement. "The results of this formal safety study are consistent with our previous findings and provide identification of a safe dose for testing in a Phase I clinical study. We believe that these results, and our overall pre-clinical package, moves us one step closer to filing an Investigational New Drug application with the U.S. Food and Drug Administration."
There is no approved vaccine to prevent the infection, the most commonly identified cause of lower respiratory tract illnesses in infants and young children worldwide, according to the Rockville biotech. More than 8.5 million adults are infected annually. The virus causes about 900,000 hospitalizations annually in the U.S. and major European countries.
Synagis, a drug that helps prevent disease caused by this virus in high-risk children, is a major money-maker for another Montgomery County biotech, MedImmune of Gaithersburg.
A federal review of the national system for producing medical countermeasures such as medications, vaccines, equipment and supplies in a health emergency found room for improvement and made recommendations. All told, the improvements will cost about $2 billion.
Health and Human Services Secretary Kathleen Sebelius released the review Thursday. It was prompted by the U.S. response to the H1N1 pandemic flu last year.
"Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of any attack or threat, whether it's a threat we know about today or a new one," Sebelius said in a statement. "By moving towards a 21st century countermeasures enterprise with a strong base of discovery, a clear regulatory pathway, and agile manufacturing, we will be able to respond faster and more effectively to public health threats."
The FDA needs to improve its science and regulatory capacity, according to the review.
"As a result, HHS will make a significant investment to provide FDA scientists with the resources to develop faster ways to analyze promising new discoveries and give innovators a clear regulatory pathway to bring their products to market," according to the statement.
Furthermore, the nation must be able to faster develop manufacturing processes that can produce multiple medications or vaccines, not just one product. HHS will establish an innovation center to address this concern.
Part of the problem is that "some of the most promising research and development on countermeasures is done by small, emerging biotech companies with little experience in large-scale manufacturing," according to HHS. The new innovation center will be a resource for such companies.
In particular, the U.S. needs to focus on the flu, by improving vaccine production, testing and methods, the review states. HHS plans to invest more in this area.
Also, HHS will try to help small companies that are working on medical countermeasures attract investors.
Among the more prominent Maryland companies that either currently sell or are developing such products are Human Genome Sciences, Emergent BioSolutions, PharmAthene, MedImmune and Novavax.
Late Thursday, Novavax issued a statement endorsing Sebelius' announcement.
"I was pleased to attend today's briefing by Secretary Sebelius and fully support the reforms proposed to improve our nation's ability to respond to disease outbreaks such as pandemic influenza," Singhvi, the CEO, said. "My colleagues at Novavax and I share the government's sense of urgency about accelerating the development and delivery of new vaccines to prevent the spread of infectious diseases as a result of a natural outbreak or a biological attack and have committed our company to the achievement of this goal."
BioMarker Strategies of Baltimore reported raising $1.1 million of a projected $2.4 million equity offering from eight investors, according to a company filing with the Securities and Exchange Commission.
With about $4.3 million in investments raised, plus up to $2.3 million from a recent Small Business Innovation Research grant from the National Cancer Institute, the company is developing its SnapPath biomarker platform to analyze still-living tumor cells removed from cancer patients.
The Maryland Industrial Partnerships Program of the Maryland Technology Enterprise Institute at the University of Maryland, College Park, has awarded $3.3 million to 16 teams of Maryland companies and university researchers to support their development of products with commercial prospects.
The total comprises $1.9 million from the participating companies and $1.4 million from MIPS.
Of the awards, 11 went to bioscience endeavors:
-Bio-Quick of Silver Spring, $195,570 to support a clinical study of its ultrasound-facilitated system designed to reduce tissue-preservation time from two days to one hour.
-BlueWing Environmental Solutions & Technologies of Ellicott City, $139,000 to help develop its BioHaven Floating Islands, designed to remove harmful nutrients such as nitrogen and phosphorus from polluted water.
-Cellex of Rockville, $172,600 to support a second phase clinical evaluation of its QFLU test, which simultaneously diagnoses influenza and detects flu virus drug resistance in point-of-care settings.
-Corridor Pharmaceuticals of Lutherville, $223,031 to help test an anthrax treatment.
-EcoEmergence of Olney, $440,745 to help develop a test to evaluate bioremediation products for sewer-clogging fats, oils and grease.
-Fyodor Biotechnologies of Baltimore, $180,330 for developing a yeast-based platform to produce artemisinin, a therapeutic effective against malaria and other diseases.
-Integrated BioTherapeutics of Germantown, $137,277 to develop a toxin-based vaccine against Staphylococcus aureus.
-KYDES Pharmaceuticals of Halethorpe, $300,399 to develop compounds that deactivate drugs such as opiates, amphetamines and benzodiazepines when they are tampered with to prevent their abuse.
-Opticul Diagnostics of Rockville, $325,849 for pre-clinical and clinical tests of its rapid, point-of-care test system for antibiotic-sensitive and -resistant Staphylococcus aureus.
-Pregmama of Gaithersburg, $143,278 to develop Fertamax, a therapy to prevent egg aneuploidy, infertility, miscarriages and trisomic pregnancies for women older than 35.
-StarEnergyCo of Bethesda, $225,848 to develop an economical, turn-key process to produce astaxanthin, which can be used as an antioxidant and a pigment in aquaculture, from algae and using carbon dioxide emitted from ethanol plants.
The Cellex and Integrated BioTherapeutics projects also received funding from the Maryland Biotechnology Center. The BlueWing project received funding from the Maryland Department of Natural Resources.
VSL#3, a high-potency probiotic medical food, can help children with irritable bowel syndrome, according to new data published in the July issue of the Journal of Pediatric Gastroenterology and Nutrition.
"There is evidence that some probiotics, such as VSL#3, have a beneficial role in the dietary management of children and teenagers suffering with [irritable bowel syndrome]," said Stefano Guandalini, professor and chief of the Section of Pediatric Gastroenterology, Hepatology and Nutrition at the University of Chicago, in a statement. "This has the potential to make a real difference for kids who suffer from pain, bloating and discomfort of IBS."
VSL#3 is licensed from VSL Pharmaceuticals by Sigma-Tau Pharmaceuticals of Gaithersburg.
Maryland biotech veteran John Holaday of Bethesda has racked up an award with his newest venture, QRxPharma of North Sydney, Australia.
QRxPharma won the 2010 North American Frost & Sullivan Award for New Product Innovation of the Year for its MoxDuo immediate-release dual opioid for pain management.
The product contains morphine and oxycodone in a fixed-ratio dosage that has a complementary effect on pain, so patients can take lower doses with fewer side effects, such as nausea, vomiting, respiratory depression, somnolence and constipation, according to a statement from Frost & Sullivan, a research and growth consulting firm.
In a phase 3 clinical trial, patients taking MoxDuo reported better results and fewer side effects than those taking morphine, oxycodone or Percocet, according to the statement.
Holaday is CEO and managing director of publicly held QRxPharma, and heads its U.S. operations. Previously, he founded and led EntreMed of Rockville until retiring in 2003, founded MaxCyte of Gaithersburg and co-founded HarVest Bank of Maryland, also in Gaithersburg.
Neuralstem of Rockville reported that the U.S. Patent and Trademark Office has upheld the patentability of all claims in its patented methods culturing and expanding neural stem cells.
A re-examination request had been filed by a third party in September.
Neuralstem is developing stem cell treatments for amyotrophic lateral sclerosis, traumatic spinal cord injury, ischemic spastic paraplegia and Huntington's disease.
Innovative Therapies of Gaithersburg signed a deal with the Mid-Atlantic Group Network of Shared Services to rent and sell its negative pressure wound therapy product.
Under the contract, the network will be able to distribute the product to about 9,500 providers, such as hospitals, physician practices and clinics, in the Northeast, mid-Atlantic region and Midwest.
The product uses foam dressings and an irrigation technology to promote wound healing and patient comfort, according to a company statement.
BioElectronics of Frederick is expanding its television advertising campaign in the U.K. and Canada, according to a company statement.
BioElectronics brand managers are assuming direct control of those efforts. The company manufactures and markets electronic skin patches for healing wounds and menstrual pain.