Actavis acquires Forest for $25bn

Actavis acquires Forest for $25bn
Ramps up its shift into specialty pharmaceuticals

Actavis has announced its largest acquisition to date, confirming a $25bn takeover of Forest Laboratories.

Once finalized the generic drug company will gain blockbuster franchises in CNS, gastroenterology, women’s health, urology and cardiovascular, and combined annual revenues expected to top $15bn next year.

Paul Bisaro, chairman and CEO of Actavis, said: “With this strategic combination, we create an innovative new model in specialist pharmaceuticals leadership, with size and scale, a balanced offering of strong brands and generics, a focus on strategic, lower-risk drug development, and – most important – the ability to drive sustainable organic growth.

“Bolstered by one of the deepest and most diversified product portfolios in the industry with an exceptionally strong pipeline, this transaction creates a powerful engine for generating long-term, double-digit revenue and earnings growth.”

Bisaro will lead the combined company, while Forest CEO and president Brent Saunders, along with two other members of the Forest board, will join Actavis’ board of directors.

The deal continues Actavis’ shift into specialty medicines, an area that will now be responsible for around 50 per cent of its revenues, complementing its generic drug operations, where it is ranked fourth in the market behind Teva, Sandoz and Mylan.

The combined company will have an annual R&D budget of more than $1bn and Actavis gains a number of new product candidates, with those nearing regulatory submission including treatments for Alzheimer’s disease, cardiovascular disease and COPD.

The deal would also provide economies of scale in the region of $1bn and give Actavis the size needed to negotiate competitive positions for its medicines among US hospitals, insurers and doctors.

Expected to be completed midway through this year the Forest deal will be the Actavis’ biggest-ever purchase, eclipsing last year’s $8.5bn acquisition of Ireland’s Warner-Chilcott as well as the $5.6bn reverse takeover by Watson in 2012.

Read Full Article Here: http://www.pmlive.com/pharma_news/actavis_acquires_forest_for_$25bn_544832

US to expedite imports for some drugmakers under new supply chain plan

US to expedite imports for some drugmakers under new supply chain plan
By Zachary Brennan, 19-Feb-2014

The US FDA announced on Monday that it would initiate a Secure Supply Chain Pilot Program to enhance the security of imported drugs.

Full Article: http://www.in-pharmatechnologist.com/Regulatory-Safety/US-to-expedite-imports-for-some-drugmakers-under-new-supply-chain-plan

NCPA: U.S. Reps. contact Medicare in support of proposed changes for 2015 drug plans

NCPA: U.S. Reps. contact Medicare in support of proposed changes for 2015 drug plans
February 12, 2014 | By Michael Johnsen

ALEXANDRIA, Va. — Members of Congress are contacting the U.S. Centers for Medicare and Medicaid Services in support of pro-patient improvements the agency proposed for Medicare Part D prescription drug plans in 2015, a development applauded today by the National Community Pharmacists Association.

In response to problems with “preferred pharmacy” networks, CMS has proposed allowing any willing pharmacy to offer a plan’s lowest, or preferred, cost-sharing to give seniors more choice and to foster greater competition among pharmacies.

U.S. Representatives Mike Rogers, R-Ala., and Lynn Westmoreland, R-Ga., have written to CMS to back the change.

“I was encouraged to hear that the proposed rule for Part D dealt with many of the concerns that [community pharmacists] shared with me,” Rep. Rogers wrote. “Not only were these community pharmacies not allowed to even try and compete with lower co-pays that larger stores can offer, but many seniors signed up for these plans not realizing they would no longer be able to continue using their community pharmacy after signing up.”

Rep. Westmoreland wrote to CMS that, “Your agency’s recent release of its proposed rule on Part D has some very encouraging language that addresses” concerns raised by community pharmacists and patients, adding that “I believe the work is not yet complete and that it is crucial that Congress and the Executive Branch make sure small business pharmacies have the ability to compete on a level playing field with all the entities involved.”

Both lawmakers represent rural communities and noted that independent community pharmacies often serve such areas where national chain pharmacies may not exist.

“We commend these lawmakers for voicing their support on behalf of their constituents for the common-sense enhancements that Medicare has proposed for drug plans next year,” said NCPA CEO Douglas Hoey. “Patients will benefit from more choice and competition among pharmacies if CMS’ proposal is made final. Independent community pharmacies deserve the opportunity to match the contract terms and conditions, including pricing, of ‘preferred’ pharmacies. As Medicare officials have noted, this is ‘the best way to encourage price competition and lower costs in the Part D program.’”

In March 2013, 31 U.S. representatives sent a letter to CMS to express concerns over exclusionary preferred networks in Medicare Part D. In particular, the lawmakers said, “We fear these networks could lead to a decrease in access to quality care and threaten the survival of community pharmacies” and further demanded a response from CMS. Shortly thereafter, the agency received a similar letter from 16 U.S. senators. CMS subsequently issued the proposed rule open until March 7, 2014 for public comment.

While preferred pharmacy networks have been championed by pharmacy benefit managers as producing astronomical cost savings, a series of analyses of Medicare data have found repeated instances where preferred pharmacy plans and PBM-owned mail order are more expensive for Medicare.

Read Full Article Here: http://drugstorenews.com/article/ncpa-us-reps-contact-medicare-support-proposed-changes-2015-drug-plans

GAO: Federal upper limits 1.4% lower than National Average Drug Acquisition Cost

GAO: Federal upper limits 1.4% lower than National Average Drug Acquisition Cost
February 7, 2014 | By Michael Johnsen

WASHINGTON — In a report publicly released Thursday by the U.S. Government Accountability Office, the GAO found that the total draft federal upper limits amount based on the new formula under the Patient Protection and Affordable Care Act was about 1.4% lower than the total National Average Drug Acquisition Cost amount in aggregate for 1,035 outpatient drugs subject to the FUL in first quarter 2013. GAO found large differences between the total PPACA-based FUL amount and the total NADAC amount for generic and for branded generic versions — brand-name drugs with other versions that can be substituted for one another — of the drugs subject to the FUL in first quarter 2013.

GAO found that the total PPACA-based FUL amount for the generic versions was 19% higher than the total NADAC amount, but for the branded generic versions was 26% lower. GAO’s work indicates that CMS is close to having a formula under which FULs would better reflect pharmacy acquisition costs, but continues to apply FULs that were calculated more than 4 years ago. Additionally, the relationship between PPACA-based FULs and NADACs may be affected by several factors, including rebates and discounts that are not reflected on pharmacy invoices. To determine whether GAO’s early results of the relationship between the PPACA-based FULs and the NADACs holds over time will require continued monitoring by CMS, GAO reported.

To develop a national benchmark for retail pharmacy acquisition costs of Medicaid covered outpatient prescription drugs — known as the National Average Drug Acquisition Cost — the Centers for Medicare & Medicaid Services within the Department of Health and Human Services surveys each month randomly selected retail community pharmacies for invoice data on their actual drug acquisition costs. CMS then calculates an average acquisition cost for each drug based on invoice data received from about 500 to 600 pharmacies. CMS officials expressed confidence in their current process, but noted that some limitations may exist, GAO noted. For example, CMS officials stated the extent to which NADACs reflect rebates and discounts is limited because most occur off-invoice or are not tied to a specific drug purchase. CMS has developed and published more than 5,000 NADACs, which CMS has estimated apply to more than 90% of the drug claims reimbursed by Medicaid.

Read Full Story Here: http://drugstorenews.com/article/gao-federal-upper-limits-14-lower-national-average-drug-acquisition-cost