Sigma-Tau OKed to manufacture primary ingredient in Oncaspar
GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.
Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.
“To get a complex biologic medicine, such as this, exactly right takes a great deal of work for both the manufacturer and the FDA,” Sigma-Tau CEO Gregg Lapointe said. “We are pleased to announce that with this approval, there will be no interruption in either the production of the medicine or in the treatment of patients with ALL.”
Getting on board
At the upcoming 2011 Armada Specialty Pharmacy Summit in Las Vegas, Amber Pharmacy president Mike Agostino — recently appointed to the Board of Advisors of Specialty Pharmacy — will give a presentation focused on the specialty pharmacy marketplace and the importance of customers. Specialty Pharmacy had the chance to talk with Agostino about the contents of his presentation and his new role.
Specialty Pharmacy: What will be the topic of your presentation at Armada?
Mike Agostino: The title of my presentation is: “Specialty Pharmacy Services: Where Does the Customer Fit?”
SP: What will be the main focus of your presentation?
Agostino: The presentation focuses on how quickly the specialty pharmacy marketplace is changing and reminds attendees of how critically important our customers are. It includes an analysis of who the customer is — both traditional and nontraditional — and how customers impact our bottom line within a specialized pharmacy care delivery system. Ideas and suggestions on how to provide great customer service will be shared.
SP: If attendees could take one thing from it, what would you like that to be?
Agostino: Making certain your customer comes first and [how] providing great customer service directly impacts your return on investment.
SP: How are you transitioning into your new BOA roles at Amber Pharmacy, Hy-Vee Pharmacy Solutions and DSN Specialty Pharmacy?
Agostino: It is absolutely amazing. Amber Pharmacy’s long-standing presence within the transplant community offered the perfect platform for us to formalize our high standard of care and service within many other specialized conditions. So far, our niche and nimble approach to service has been well-received and is often stated as a ‘breath of fresh air’ within the provider and payer community. Hy-Vee Pharmacy Solutions has allowed us the opportunity to put two great companies together to form a specialized service with over 230 accessible points of care in our model. My transition into our newest company has allowed me to incorporate all of the best practices learned from my retail experience and how it can complement a high touch level of service. I am equally excited about participating in a healthy exchange of dialogue with my peers within our industry as the newest member of the BOA of Specialty Pharmacy.
SP: What are your plans once you start the new position?
Agostino: For my new position within the BOA of Specialty Pharmacy, I look forward to adding to an established dialogue that maintains the importance of our industry’s skill set within our healthcare delivery system. As our model continues to transform and as therapies continue to grow in complexity, I feel that as a stakeholder, I will be able to share challenges and ideas for solutions that will benefit the patient, payer, caregiver and provider.
Healthcare is one of the fastest-growing segments of the American economy right now, and specialty pharmacy is no exception, especially as more baby boomers retire and as drug companies develop more sophisticated therapies.
But by growing, specialty pharmacy can add value to local economies, too. Flint, Mich., has experienced some of the country’s worst economic fortunes since General Motors moved out of town. But now, Diplomat Specialty Pharmacy is helping to fill the economic void, thanks to its new headquarters at the former GM Great Lakes Technology Center, where it plans to invest $12 million and hire new staff. Specialty Pharmacy caught up with Diplomat president and CEO Phil Hagerman to talk about the company’s growth strategies.
Specialty Pharmacy: How have things been at Diplomat since the company moved into its new headquarters?
Phil Hagerman: The move was a tremendous benefit on many levels. The excitement of a new facility is great alone, but the pickup in capabilities the new headquarters offers both for now and in the future has the entire company focused on growth.
SP: How has the transition been?
Hagerman: It has been very smooth. Our information technology team was the key, bringing all systems in our new facility up to speed without a hitch. We then transitioned 300 employees over the next 90 days in three separate groups. Our new distribution system, with a ‘smart technology’ conveyor system, has been more successful than we even anticipated.
SP: What are some significant ways in which Diplomat has grown over the past year?
Hagerman: We have grown in all areas, adding over $200 million in additional revenue in 2010. We had another great year in managed care sales and now have almost 6 million exclusive or semi-exclusive lives under contract. We have expanded our Patient Assistance Program dispensing capabilities. We will also have full-service, VAWD-accredited warehousing and third-party logistics capabilities in our new facility for our biotech partners.
SP: How is the company implementing its new training program?
Hagerman: We launched Diplomat University last year, in September. We now have our new programs and employee educational portals all live. We are currently rolling out programs around all major disease states that affect employees in every department. We are also bringing in outside educational programs for such areas as telephony training and management training.
SP: What is the company doing in terms of new hiring and expansion?
Hagerman: We added 50 new employees in the first quarter of 2011. They were primarily in patient care roles but also included employees in managed care, finance, analytics, [information technology] and human resources. As our retailer partner programs ramp up, we expect to add significant staff in this area over the next two quarters.