Tag: OsoBio

Albany, NY Jul 1, 2014 – AMRI (NASDAQ: AMRI) today announced that it has completed the acquisition of Oso Biopharmaceuticals Manufacturing, a former portfolio company of Altaris Capital Partners, LLC. The transaction is consistent with AMRI’s strategy to be the preeminent supplier of custom and complex drug product development and manufacturing services to the pharmaceutical industry.
OsoBio is recognized as a premier contract manufacturer of highly complex injectable drug products and their expertise in large-scale commercial production is highly complementary to AMRI’s early stage drug product manufacturing capabilities. Customers will benefit from access to a single source to address their sterile fill/finish needs from Phase 1 development complete to commercial supply.
Total consideration paid was $110 million. AMRI financed the transaction with cash on hand. AMRI anticipates full year run-rate synergies of approximately $3.0 million of EBITDA within 12 months of closing and the acquisition is expected to be accretive to AMRI’s 2014 adjusted diluted EPS. AMRI intends to provide investors with updated 2014 guidance for the combined company when it releases its second quarter 2014 financial results on August 5, 2014.

Significantly Expands Contract Manufacturing Capabilities to Include Commercial Scale Sterile Injectables
Albany, NY Jun 2, 2014 – AMRI (NASDAQ: AMRI) today announced that it has signed a definitive agreement to acquire all of the outstanding membership interests of Oso Biopharmaceuticals Manufacturing, LLC (“OsoBio”) for $110 million in cash. OsoBio is recognized as a premier contract manufacturer of highly complex injectable drug products, including sterile liquid, suspension and lyophilized formulations. The acquisition and associated fees are expected to be financed through cash currently held by AMRI, and, subject to Hart-Scott-Rodino clearance and other conditions to closing, is expected to be completed in the third quarter of 2014.
“The acquisition of OsoBio is highly complementary to our finished dose manufacturing business, and is consistent with our strategy to be the preeminent supplier of custom and complex drug development services and products to the pharmaceutical industry,” said William S. Marth, AMRI’s president and chief executive officer. “OsoBio adds significantly to our sterile manufacturing capabilities, extending our industry-leading position in early stage contract manufacturing to now include OsoBio’s preeminent large-scale commercial production. In addition, we expect to realize savings in capital costs associated with the previously planned facility expansion.”
“We are very excited about the synergies that our Albuquerque operations will bring to AMRI as part of their organization,” said Milton Boyer, OsoBio’s President. “The addition of AMRI’s experience and capabilities in early phase development greatly increases the value proposition for our customers, providing a single source to address all sterile fill/finish needs from phase 1 development complete to commercial supply.”
Located in Albuquerque, New Mexico, OsoBio is a trusted, long-time partner to many of the industry’s leading pharmaceutical companies and is well respected for its expertise in manufacturing complex injectables, its reliability of supply and superior track record of quality. OsoBio’s core capabilities include liquid fill and lyophilized products, highly potent compounds, cytotoxics, proteins and peptides, monoclonal antibodies, vaccines, liposomal suspensions and controlled substances. OsoBio has provided manufacturing support for more than 250 unique products and their attractive development pipeline, which includes multiple late-stage products, is expected to be important contributor for future growth.
On a stand-alone basis, OsoBio’s forecasted full year 2014 revenue is between $58 million and $60 million, with adjusted EBITDA of between $9 million and $10 million, implying a purchase price multiple of 11 times 2014 adjusted EBITDA at the top end of the range. Adjusted EBITDA excludes any deal related costs or purchase accounting impacts.
AMRI anticipates full year run-rate synergies of approximately $3 million of EBITDA within 12 months of closing. Subject to Hart-Scott-Rodino clearance, the Company anticipates the acquisition will be accretive to 2014 earnings and intends to provide investors with updated 2014 guidance for the combined company when it releases its second quarter 2014 financial results. OsoBio is expected to continue to operate independently within AMRI’s Drug Product business unit. Milton Boyer, the current president and chief executive officer, will lead the OsoBio team and report into Steven Hagen, Ph.D., AMRI’s senior vice president of manufacturing and pharmaceuticals.

She has 20+ years experience managing pharma and commercial manufacturing plants
Albuquerque, NM Mar 31, 2014 – OsoBio has appointed Catherine R. Buck director of manufacturing.
In her capacity, Buck is responsible for ensuring that OsoBio’s operations comply with current Good Manufacturing Practices (cGMP) as they apply to the manufacturing of injectable sterile liquid, suspension and lyophilized pharmaceutical products. In addition, she ensures compliance with appropriate U.S. Food and Drug Administration and Drug Enforcement Administration regulations, and directs manufacturing activities to ensure timely, cost-effective and efficient production.
Buck brings to OsoBio more than 20 years of leadership and project management experience within the pharmaceutical, medical device and construction industries. She has managed multiple commercial and clinical pharmaceutical manufacturing plants that generated up to $2.5 billion annually.
“The same continuous improvement expectations that bear on just about every aspect of industrial productivity exist within pharmaceutical manufacturing as well,” said Milton Boyer, president of OsoBio. “We are fortunate to add someone with Catherine’s breadth of experience to lead a manufacturing team that keeps OsoBio competitive without sacrificing our commitment to quality and cGMP compliance.”
Her experience includes the start up, process, equipment and facility validation of a new Amgen manufacturing plant that produced Epogen®, that company’s highest revenue product. Her work included successfully obtaining FDA approval of automated equipment and software, and preparing for inspection and successfully obtaining FDA approval for commercial production. Buck also has managed manufacturing facility operations for Johnson & Johnson and Siemens.
Buck holds a bachelor’s of science degree in electrical engineering from Tufts University, and has completed the Emerging Leader Program at Columbia University.

Dr. Stoker brings to new role nearly 20 years of experience in pharmaceutical quality control
Albuquerque, NM Feb 21, 2014 – OsoBio has appointed Paul W. Stoker, Ph.D., director of its chemistry and microbiology laboratories.
As part of the company’s quality control department, the laboratories are responsible for testing the in-process and finished products – as well as raw materials and components – involved in OsoBio’s cGMP sterile manufacturing operations. The labs also are charged with environmental monitoring and analytical method development.
“While continuous quality compliance is key to OsoBio’s business success, it’s even more important to the patients who rely upon the medications we manufacture – and we try to never lose sight of that fact,” said Milton Boyer, president of OsoBio. “Paul will lead a team of scientists who are knowledgeable, capable and highly committed to integrity – delivering excellence to both our clients and the patients we collectively serve.”
Stoker fills a position vacated when Kathleen Larese, OsoBio’s previous director of laboratories, became the company’s director of technical operations.
Stoker brings to OsoBio nearly 20 years of professional experience managing pharmaceutical laboratories responsible for quality control. Most recently, he served as director of the quality control laboratory at Dendreon, a company that researches, develops, commercializes and manufactures cancer therapeutics. Prior to that, he directed quality control and analytical laboratories for Nektar Therapeutics, a clinical-stage biopharmaceutical company.
Stoker earned his doctorate in biochemistry from the University of Nebraska. He also holds from Brigham Young University a master’s degree in zoology with an emphasis in toxicology and statistics, as well as a bachelor’s degree in chemistry.
OSO BioPharmaceuticals Manufacturing, LLC, is a contract manufacturing organization (CMO) that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of our Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II-V controlled substances.

OsoBio President Milton Boyer to serve as vice president of DCAT’s executive committee
Albuquerque, NM Dec 17, 2013 – OsoBio has reaffirmed its long-standing partnership with the Drug, Chemical and Associated Technologies Association (DCAT) by accepting new volunteer leadership positions within the organization.
OsoBio President Milton Boyer will serve as vice president of DCAT’s executive committee in 2014. And Bob Cashman, vice president of business development at OsoBio, will serve as chairman of DCAT’s scholarship funding committee.
“Members direct DCAT’s efforts and events, which not only differentiates DCAT within the drug and chemical industries, but also increases its value proposition for individual participating companies like OsoBio,” Boyer said. “I am honored that my industry peers chose me to serve in this capacity for DCAT and am excited about what the year holds in store for all member companies.”
Founded in 1890, DCAT is a premier business development association whose membership consists of companies that manufacture, distribute or provide services to pharmaceutical, chemical, and related industries. Attended by thousands each March, the organization’s DCAT Week® is one of the pharmaceutical industry’s largest and most important educational and networking meetings. This year, Hillary Rodham Clinton, former U.S. Secretary of State, will be the keynote speaker at DCAT Week’s annual dinner.
OSO BioPharmaceuticals Manufacturing, LLC, is a contract manufacturing organization (CMO) that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. Our company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of our Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II-V controlled substances.
OsoBio surpasses quality-assurance expectations within our industry. Our employees are industry veterans who provide innovative solutions to our clients’ most difficult projects. To learn more about our company and the value we offer clients, visit www.OsoBio.com.

Albuquerque, NM Jul 22, 2013 – OsoBio has named Lindsey Pruitt manager of new business development for its East Coast market.
Working in her new capacity in OsoBio’s Philadelphia location, Pruitt will identify and foster new business opportunities throughout the Northeast.
Pruitt has worked nearly a decade in sales and marketing within the pharmaceutical and specialty chemical manufacturing industries.
Most recently, she served as manager of commercial operations and sales for Siegfried USA, a manufacturer of active pharmaceutical ingredients (APIs). There, she was responsible for managing key accounts and serving as the primary customer contact from research and development to commercial product launch.
“Lindsey shows a real passion for working in partnership with OsoBio’s clients to deliver life-saving pharmaceuticals to the patients who need them,” said Milton Boyer, president of OsoBio. “She will demonstrate for clients the value OsoBio can bring as the contract manufacturer of choice for their sterile injectable needs.”
Pruitt graduated cum laude from Lee University with a bachelor’s degree in psychology and advanced studies in microbiology and chemistry.
OSO BioPharmaceuticals Manufacturing, LLC, is a contract manufacturing organization (CMO) that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. Our company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.
In the history of our Albuquerque, N.M., facility, OsoBio has manufactured more than 250 distinct commercial presentations in every major therapeutic category. The U.S. Drug Enforcement Administration (DEA) has granted OsoBio registrations for Schedule II through V controlled substances.

Albuquerque, NM June 24, 2013 – OsoBio has named Kathleen Larese director of laboratories.
As part of OsoBio’s quality control department, the microbiology and chemistry laboratories that Larese now directs are responsible for environmental monitoring, analytical method development, and testing all incoming raw materials, components, and in-process and finished products involved in the company’s cGMP sterile manufacturing operations.
“Kathleen provides direction and organization to functions that help ensure the continuous quality of the sterile injectable drugs we manufacture – as well as the safety of the patients who rely upon them,” said Milton Boyer, president of OsoBio. “Managing a team of highly capable scientists fiercely committed to data integrity, Kathleen will drive operational excellence and deliver distinct value to our clients.”
Larese brings to OsoBio more than 10 years of management experience in laboratory operations responsible for regulatory compliance, project documentation, quality assurance, inventory management and waste disposal. Most recently, she was senior technical staff member at Sandia National Laboratories, where she used her black belt certification in Lean and Six Sigma to reduce waste and optimize operations.
Larese holds a master’s degree in business administration from the University of New Mexico Anderson School of Business, and is finishing her master’s degree in biomedical science from the university’s School of Medicine. She completed a graduate fellowship in nuclear and radiochemistry at San Jose State University, and holds an American Chemical Society-certified bachelor’s degree in chemistry from Western Washington University.
A member of the Parenteral Drug Association, Larese is a member of the American Chemical Society and past president of the Albuquerque chapter of Executive Women International.

Albuquerque, NM May 1, 2013 – OsoBio has named David M. Lee vice president of quality.
Lee is responsible for overseeing all quality-related functions to ensure the company’s continued compliance with Current Good Manufacturing Practices (cGMP), including quality systems, quality control and manufacturing quality assurance.
Lee brings to his role more than 20 years of professional experience managing quality operations and API and sterile manufacturing.
Prior to joining OsoBio in June 2012, Lee served as director of validation and quality at Amgen Inc., where, among other responsibilities, he managed all validation activities for a $1.2-billion site expansion. During his time at Amgen, he also managed production operations for two of the company’s signature chemotherapy drugs, NEUPOGEN® and Neulasta.®
“David’s knowledge and expertise in quality operations will support OsoBio’s ongoing ability to deliver exceptional sterile pharmaceutical manufacturing products and service,” said Milton Boyer, president of OsoBio. “David has already proven to be a great asset to the OsoBio team and the clients we serve.”
Lee holds a master’s degree in biology from California State University, Northridge, and a bachelor’s degree in biology from the University of California, Riverside. He is a member of the Parenteral Drug Association.

Albuquerque, NM Feb 20, 2013 – OsoBio President Milton Boyer will serve on a panel of experts examining shortages of injectable pharmaceuticals during DCAT Week.
Boyer and other industry leaders will review the unique challenges facing the sterile injectable supply chain during a panel discussion 9 a.m. Wednesday, March 13. The panel, “Key Trends for Sterile Injectable Manufacturing and Outsourcing,” will meet in the Vanderbilt Room at the Waldorf-Astoria Hotel in New York City.
DCAT Week – sponsored annually by the Drug, Chemical and Associated Technologies Association (DCAT) – is one of the pharmaceutical industry’s largest and most important annual educational and networking meetings. Last year, nearly 2,000 people attended the DCAT Week keynote address.
Companies developing sterile products are being challenged by significant regulatory pressures and uncertainty in the supply base, which can affect quality, compliance and cost competitiveness. As a result, shortages of sterile injectable pharmaceuticals are on the rise, according to the U.S. Food and Drug Administration.
The DCAT Week panel will lead a discussion examining trends and steps underway at contract manufacturing organizations (CMOs), as well as pharmaceutical companies, to improve operational security while remaining competitive. Boyer will focus on the changing regulatory climate and its influence on traditional drug sponsor and CMO relationships.
“The industry is seeing simultaneous increases in both outsourcing and regulatory actions, which are changing how drug sponsors and CMOs collaborate,” Boyer said. “DCAT Week brings together a broad coalition of strategic thinkers willing to look at the big picture, which should make this a timely and informative conversation.”
During DCAT Week, OsoBio will serve as the registration partner and reception host for a session called “Facilities of the Future: Single-Use Technologies” taking place March 13 from 2:30 to 4:30 p.m., with the reception following immediately afterward.
OSO BioPharmaceuticals Manufacturing, LLC, is a CMO that specializes in delivering injectable sterile liquid, suspension and lyophilized biologic and pharmaceutical products to the pharmaceutical industry. The company offers significant knowledge and experience in late-phase clinical products and successfully taking them to commercialization.

Albuquerque, NM Feb 15, 2013 – OsoBio is proud to receive two CMO Leadership Awards that recognize our strength in regulatory affairs and productivity.
The awards – which will be given out during DCAT Week – are based on industry research compiled by Life Science Leader magazine and Nice Insight. Nice Insight surveys thousands of industry executives about outsourcing companies, and combines those findings with other key analyses to identify collaboration models.
Milton Boyer, president of OsoBio, said receiving two CMO Leadership Awards was an honor.
“We are very pleased at OsoBio to have been recognized as a leading CMO in the categories for productivity and regulatory,” he said. “We believe a strong commitment to regulatory compliance is the cornerstone of productivity. Our site history reveals a track record of regulatory success, having been inspected by almost every worldwide regulatory agency during the commercialization of more than 250 distinct products. We are honored to be recognized by our industry peers.”