PHARMACY

Generics company based in a small Minnesota town drawing interest from Wall Street

BY Michael Johnsen

 BAUDETTE, Minn. – ANI Pharmaceuticals is carving out a name for itself as a niche generic player here, according to a report published Monday by the MinnPost

The report profiles ANI Pharmaceuticals, which is located in a small town 300 miles north of Minneapolis. 
 
According to the report, ANI grew its per share price from $20.08 at the end of 2013 to more than $67.12 in trading today. The company's revenue is on a similar upward trajectory, having tripled in the past two years to $56 million in 2014. 
 
And the company estimates sales of $80 million to $88 million for 2015, MinnPost reported.
 
In 2014, ANI spent $35.5 million in three separate deals to acquire products – Lithobid, which treats patients with bipolar disorder; Vancocin, an antibiotic used to treat infections; and EEMT, an estrogen drug used to treat symptoms of menopause. The two new drugs have been helping to drive ANI’s growth. But the company’s biggest seller is an estrogen drug known as EEMT, which is used to treat symptoms of menopause. In 2014, EEMT accounted for 42 percent of ANI’s total sales.
 
Growing niche generic products that were languishing in larger pharmaceutical houses is ANI's specialty, the report noted. And with $169 million cash on hand, ANI is looking to acquire more niche generics going forward. 
 

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IMS: Americans filled a record 4.3 billion prescriptions in 2014

BY Michael Johnsen

PARSIPPANY, N.J. – Total spending on U.S. medicines increased 10.3% on a real per capita basis to $373.9 billion in 2014, with a record volume of 4.3 billion prescriptions filled, according to a new report issued Tuesday by the IMS Institute for Healthcare Informatics. 
 
The year also marked the highest number of transformative medicines launched in more than a decade.
 
The study – "Medicine Use and Spending Shifts: A Review of the Use of Medicines in the U.S. in 2014"  – found that total dollars spent on medications in the U.S. rose 13.1% on a nominal basis last year, up from a 3.2% increase in 2013. Primary drivers include higher spending on innovative new treatment options, the lower impact of patent expiries and increases in list prices of branded medicines. The factors that came together to drive the extraordinary spending growth in 2014 are expected to have less impact in future years, resulting in more moderate levels of growth.
 
Much of last year’s innovation-led spending growth was from specialty medicines, which grew 26.5% and accounted for one-third of medicine spending, up from 23% of the total spend five years ago. New drugs contributed $20.3 billion to growth in 2014, including $11.3 billion from four new hepatitis C treatments as nearly ten times as many patients were treated for that disease last year than in 2013.
 
The impact of patent expiries has consistently slowed spending growth over the past five years. In 2014, that impact was $11.9 billion, down significantly from the peak amount of $29.3 billion in 2012. Last year, 42 New Molecular Entities were launched – the largest number in a decade – focused on disease areas that include oncology, autoimmune disorders, hepatitis C, HIV, multiple sclerosis and diabetes. Prices for branded products last year rose at an average rate of 13.5% on an invoice basis, but were reduced to a 5%-7% increase when taking into account off-invoice discounts and rebates.
 
Demand for healthcare services declined in 2014 despite it being the first year of insurance coverage for millions of Americans under the Affordable Care Act. From the end of September 2013 to year-end 2014, the uninsured rate was reduced by 5.1%, with 15.7 million people added to the insured population due to the ACA’s Medicaid expansion, Health Insurance Exchanges and the continued economic recovery.
 
“Last year’s $43 billion growth in spending on medicines was record-setting and the result of simultaneous very high levels of spending on new drugs and an unusually low level of patent expiry impact,” said Murray Aitken, IMS Health SVP and executive director of the IMS Institute for Healthcare Informatics. “It also was a landmark year in the implementation of the Affordable Care Act – and yet, the increase in the number of insured patients under the ACA directly accounted for only $1 billion of the spending growth as patients took some time to ramp up their medicine use."
 
The report’s key findings include the following:
 
  • Spending on medicines. Spending reached $373.9 billion in 2014, up 13.1%, the highest level since 2001 when growth was 17%. In addition to the lower impact from patent expiries and the record spending on new brands, price increases for protected brands also increased spending in 2014 by $26.3 billion, contributing 8.2% to total market growth on an invoice price basis. Estimated net price growth was substantially lower, as rising off-invoice discounts and rebates offset incremental price growth and reduced the net price growth contribution to 3.1%. Spending on specialty medicines increased $54 billion over the past five years, contributing 73% of overall medicine spending growth in that period. The biggest driver of specialty spending growth was the more than 161,000 patients who started treatment for hepatitis C in 2014, more than four times the previous peak as spending on widely adopted new treatments totaled $12.3 billion;
  • Changes in the demand and payment for medicines. In the first full year of enrollment for expanded Medicaid and exchanges under the ACA, patients with Medicaid in states that expanded eligibility filled 25.4% more prescriptions than in the prior year, compared with 2.8% more in non-expansion states. Newly covered patients in Health Insurance Exchanges had slightly lower levels of increase in medicine use, and 70% of them were commercially insured in the prior year. Patients with employer-based insurance filled fewer prescriptions in 2014 due in part to the impact of rising co-pays and deductibles. High out-of-pocket costs can be mitigated with various forms of co-pay assistance, including coupons and vouchers. For example, as many as half of all branded prescriptions in newer diabetes treatments are now being supported in this way, compared with 8% of brands in all therapy areas. Overall, healthcare services demand shifted last year as patients had 3% fewer office visits and 1.7% fewer hospital admissions – but filled 2.1% more prescriptions; and
  • Transformations in disease treatment. The drug R&D pipeline has shifted to specialty medicines over the past decade, with 42% of the late-stage pipeline now specialty – up from 33% 10 years ago. As many as 10 therapies were launched in 2014 with “Breakthrough Therapy” status as designated by the FDA under the 2012 FDA Safety and Innovation Act. Last year saw the largest number of orphan drugs launched in a single year, bringing the total number of treatments with orphan designation to 230. Cancer remains the most common orphan drug category, and nine “ultra-orphan” drugs – for populations fewer than 10,000 – became available last year. Among the most anticipated innovations are biosimilars – generic versions of biologic drugs – which began being filed for FDA review in 2014 with approvals already underway this year.
 
Analyses conducted for the report are based on IMS Health information resources and focus on prescription-bound products, including Insulins that are available without a prescription. OTC products are excluded from the report. Spending figures are derived from IMS National Sales Perspectives and reported at wholesaler invoice prices that do not reflect off-invoice discounts and rebates. Prescription data are derived from IMS National Prescription Audit, which tracks national prescription trends and activity for all pharmaceutical products. Other IMS Health information resources used in this report include NPA Market Dynamics, IMS National Disease and Therapeutic Index, National Prescription Audit, Xponent PlanTrak Copay and IMS MIDAS. 
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McKesson will be headed to San Diego for its annual ideaShare in June

BY Michael Johnsen

SAN FRANCISCO – Only two months away, McKesson ideaShare 2015 is set to take place June 24–28, 2015, at the San Diego Convention Center this year, McKesson announced Tuesday. 
 
“For more than 30 years, our annual conference has provided independent pharmacy owners and their staff with a comprehensive experience that puts innovative ideas, expert-led education sessions, networking face-to-face with peers and access to new products and services at the forefront for building a stronger business and delivering the best patient care possible,” stated Mark Walchirk, president, McKesson U.S. Pharmaceutical.
 
The annual event kicks off with the opening general session, where McKesson executives and a special guest will discuss investments, initiatives and opportunities for pharmacies to gain access to preferred networks, bring new customers into their stores, expand services, increase revenue and improve their bottom line. The presenters will announce the winners of the Pharmacy of the Year award and showcase their stand-out activities.
 
McKesson's Health Mart division will also hold its annual meeting during the ideaShare. More than 3,800 Health Mart members and prospective franchisees are invited to the Annual Meeting where Health Mart president Steve Courtman, chief pharmacist Tony Willoughby, and guest speaker — former pro baseball player Mike Robins — will share strategies and new solutions to level the playing field so that independent pharmacies can grow their business. The meeting will also celebrate the winners of the new Health Mart Independent Spirit award and showcase how they exemplify the qualities that set independent pharmacies apart, as well as the innovative things they are doing in their communities every day.
 
Complementing the general session and Health Mart annual meeting are several seminars and continuing education courses. Attendees will learn from and engage with industry experts and peers through more than 30 interactive courses, including topics such as medicine synchronization, marketing best practices, legislative and regulatory issues, Medicare Part D, financial management, buying or selling a pharmacy and specialty pharmacy strategies.
 
This year’s Ownership Transfer Luncheon will feature a moderated panel discussion that explores solutions to key issues around starting, buying or selling a pharmacy and highlights how RxOwnership expertise and tools facilitate pharmacists’ ownership goals. Pharmacy students are invited to participate in the “Future Pharmacists” track to learn more about independent pharmacy, find a mentor, build relationships and explore career options.
 
McKesson ideaShare's exhibition floor features more than 200 exhibitors. Participants will discover the newest, most innovative products and services from new and returning suppliers. They can schedule one-on-one demonstrations of the latest in pharmacy technology and services and explore the latest Rx and OTC products. And, attendees can visit the Health Mart model store to learn more about McKesson’s portfolio of marketing programs, design and décor ideas and revenue-generating clinical services.  
 
And this year for the final night party conference participants will celebrate together aboard the USS Midway on the San Diego Bay in a setting featuring historic exhibits, tours, live entertainment and signature California cuisine.
 
The McKesson ideaShare conference and exhibition provides an interactive forum for independent pharmacies across the U.S. to gain practical ideas for driving profits, patient satisfaction, and awareness of the quality care and outcomes they deliver. 
 
 
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