Teva whacking 11 plants for sure, another 16 being evaluated
Teva whacking 11 plants for sure, another 16 being evaluated
The top dogs at Teva Pharmaceutical Industries have been saying for more than a year that to help cut $2 billion in costs, its manufacturing network needed to be trimmed and its API business cinched up. Now, new CEO Erez Vigodman has put some numbers to the calculation: 11 plants are slated for closure and another 16 are still under evaluation.
Vigodman, in his call with analysts last week, did not say which plants or how many jobs would be lost but did say Teva ($TEVA) has already started in on the reduction, according to a transcript of the call from SeekingAlpha. He also said that the cost-cutting should result in $1 billion in annual savings at the end of this year and another $1 billion cast aside by 2017, with $500 million falling to the bottom line by the end of that year.
“There is a lot of value we can unlock from getting our house in order by delivering on our cost reduction program, by accelerating operational network transformation and integration and by strengthening our global generic leadership, while improving profitability,” Vigodman said.
Read more: Teva whacking 11 plants for sure, another 16 being evaluated – FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/teva-whacking-11-plants-sure-another-16-being-evaluated/2014-05-05#ixzz31XLG0wxj
NCPA Launches Ads, Web Page Advocating for Pharmacy Choice in Medicare Drug Plans
NCPA Launches Ads, Web Page Advocating for Pharmacy Choice in Medicare Drug Plans
Nearly 400 independent community pharmacists have come to Washington, D.C. to advocate for their patients and their communities as part of the National Community Pharmacists Association (NCPA) Conference on National Legislation and Government Affairs. While they will visit several hundred congressional offices, they may not reach 100 percent of Capitol Hill. So To complement their advocacy efforts, NCPA is running advertisements to echo the work of NCPA members.
Most of the ads focus on NCPA’s top priority—ensuring that every community pharmacy has the opportunity to participate as ‘preferred’ pharmacies in Medicare drug plans.
“Pharmacy choice” was the first online ad. Alongside the image, NCPA noted:
Patients prefer independent community pharmacies, surveys show, so give seniors choice. Allow independent community pharmacies to offer “preferred” pharmacy pricing in Medicare Part D drug plans. Right now sweetheart Big Box pharmacy deals are stifling competition. Some Medicare Part D drug plan middlemen have made Big Box pharmacies the “preferred” pharmacy, whether patients like it or not. Independent community pharmacies are often excluded and seek the opportunity to match the “preferred” pharmacy pricing and other contract terms and conditions. This pharmacy choice policy, also known as “any willing pharmacy,” has bipartisan support in Congress, is backed by leading consumer groups and is the best way to increase competition and lower costs in the Part D program.
This ad launched in conjunction with and links to an accompanying Web page—www.ncpanet.org/pharmacychoice—which is a reference point for NCPA’s push for its top priority. The page features key points focused at consumers, government and links to grassroots action alerts that concerned individuals can personalize and send.
That ad was followed by “30 miles.” It features a puzzled consumer holding a prescription and wondering, “Would you ‘prefer’ a pharmacy that’s 30 miles away?” It also links to www.ncpanet.org/pharmacychoice and noted
Independent community pharmacies are the sole pharmacies in many rural areas, but are denied the opportunity to be “preferred” pharmacies in many Medicare Part D drug plans. In about 1,800 rural communities, independent pharmacies are the only pharmacy provider. The next closest pharmacy is many miles away. Independent community pharmacies are excluded from “preferred” pharmacy deals between Big Box pharmacies and Medicare Part D drug plan middlemen. Independent community pharmacies seek only the opportunity to match “preferred” pharmacy pricing and other contract terms and conditions at no added cost to Medicare or seniors. This pharmacy choice policy, also known as “any willing pharmacy,” is supported by the National Rural Health Association and other leading consumer groups.
A third NCPA ad featured a map illustrating the important of independent community pharmacies by state and listed the three top priorities that community pharmacists are advocating:
- Support pharmacy choice in Medicare Part D. Don’t force rural seniors to travel 20+ miles to a “preferred” pharmacy. Allow any willing pharmacy to offer a drug plan’s “preferred” co-pays, which are currently limited to Big Box pharmacies.
- Ensure adequate payments for generic drugs; back H.R. 4437. Pharmacists promote generic drugs to save money. But some generic prices are increasing 1,000% overnight while drug plan middlemen wait months to update reimbursement.
- Expand pharmacists’ role in patient care to provide more health services to those in medically underserved areas. Co-sponsor H.R. 4190.
Read Full Article Here: http://ncpanet.wordpress.com/2014/05/07/ncpa-launches-ads-web-page-advocating-for-pharmacy-choice-in-medicare-drug-plans/
Multiple Stakeholders Send Letter to Secretary Sebelius Urging One-Year Transition Period for AMP- Based FULs (Including a primer on the history and acronyms)
Multiple Stakeholders Send Letter to Secretary Sebelius Urging One-Year Transition Period for AMP- Based FULs (Including a primer on the history and acronyms)
By: Chris Cobourn | On: April 15, 2014 | In: CIS Compliance Blog | General | Government Programs
In an April 9th letter to CMS, multiple stakeholders sent a joint letter to Kathleen Sebelius, Secretary of the Department of Health and Human Services. In this letter, the stakeholders express their concerns about CMS’ plans to implement AMP-based FULs in July 2014 and ask for a one-year transition period.
The key argument in the letter is a concern that the states are not ready to make such a quick transition and need time to be able to implement that change. Part of the reason given for why the states cannot be prepared by July is that they require legislative or regulatory changes and would need more time for cost of dispensing fee studies and filing State Plan Amendments (SPAs).
From another perspective, I would also agree with delaying AMP-based FULs as CMS has not yet published the Final AMP Rule which will define how manufacturers must calculate AMP. Manufacturers have been operating without regulatory direction since the implementation of the Patient Protection and Affordable Care Act (PPACA) which redefined AMP in October 2010. The legislative language defining AMP in PPACA was minimal, and manufacturers have had to make assumptions in what was considered an “interim period” while waiting for the Final Rule. However, this “interim period” has now lasted more than two years. CMS published proposed rules in February 2012 which would make significant changes to the calculation of AMP (http://cis-partners.com/cis-compliance-blog/pharma-compliance/the-proposed-amp-rule-some-initial-thoughts/), but manufacturers don’t know which items will ultimately be included in the Final Rule. If the Final Rule is released in May, as is posted on the Office of Information and Regulatory Affairs website (http://cis-partners.com/cis-compliance-blog/amp-rule-delayed-again/), there would be a defined date for when the rule becomes effective and hwen manufacturers need to start calculating AMP under the new rules.
Quick History and Acronyms Primer
For the reader who may not be a savvy in all of this terminology, AMP, or Average Manufacturer Price, is calculated by pharmaceutical manufacturers and reported to CMS. AMP has been used since the beginning of the Medicaid Drug Rebate Program to determine the Unit Rebate Amount (URA) paid by manufacturers to the States for Medicaid utilization. Under the 2007 Final AMP Rule, CMS proposed to also use AMP to determine the Federal Upper Limit, or FUL, which is the most that a State can reimburse a pharmacy for its Medicaid dispensed units. The National Association of Chain Drug Stores (NACDS) successfully sought and was granted a court injunction on implementation of the rule which pushed out the implementation of AMP-based FULs. The concept of AMP-based FULs was later integrated into PPACA, with a new definition of AMP, and the injunction was withdrawn. Although the February 2012 Proposed Rule provided language around how manufacturers would calculate AMP, there was a broad consensus across industry stakeholders disagreeing with some of the proposed key elements. In particular, the rule proposed the use of a “build up methodology” when calculating AMP (http://cis-partners.com/cis-compliance-blog/pharma-compliance/the-amp-comments-keep-coming-in-and-what-about-the-build-up-amp-methodology/), and many stakeholders commented that this methodology would not accurately reflect the average price paid to manufacturers for drugs sold to the retail class of trade (this recent April letter gave me flashbacks to the last industry stakeholders’ letter making that case to CMS – http://www.regulations.gov/#!documentDetail;D=CMS-2012-0012-0265).
AMP-Based FULs Calculated with an Interim AMP?
That is a lot of information in a few sentences, but the point I want to make from my perspective, is that if CMS was to start publishing AMP-based FULs for use by the States in July, those FULs would be based upon the “interim AMP methodologies” that are subject to shift significantly after the Final AMP Rule is published. Although the April 9th letter is making the case for delay based upon the States’ ability to meet the deadline, I think it is also a concern that CMS would be basing FULs on AMPs that they have yet to define.
For more information about the April 9th letter, see the NACDS article “Transition Period Necessary to Ensure Patient Access to Pharmacy Services, Stakeholders Tell HHS.”
TRxADE.com Releases Rx Guru Acquisition Pricing & Comparison Tool
TRxADE.com announces the release of the RxGuru. RxGuru is a downloadable desktop application that simplifies the complex process of comparing pharmaceutical pricing and source availability for Independent Pharmacy. RxGuru is a must-have tool for today’s community pharmacist. This revolutionary no-cost tool provides, at a glance, all of the following data features:
* Pricing and availability of pharmaceutical products from top industry suppliers
* PAC – Pharmaceutical acquisition price benchmark for generic pharmaceuticals
* Shortage and price increase indicators
* Reimbursement data and retail selling price recommendations
And much more…. To learn more, go to: www.TRxADE.com
Sun Pharma hopes to turn fortunes of Ranbaxy around with $3.2B buyout
Sun Pharma hopes to turn fortunes of Ranbaxy around with $3.2B buyout
Sun Pharmaceutical Industries has been shopping for deals that would give it more exposure to the U.S. market, and now it has pulled off a stunner. The Indian drugmaker will pay $3.2 million to buy competitor Ranbaxy Laboratories, a company with serious issues but one with big potential in the world’s largest market.
Read more: Sun Pharma hopes to turn fortunes of Ranbaxy around with $3.2B buyout – FiercePharma http://www.fiercepharma.com/story/sun-pharma-hopes-turn-fortunes-ranbaxy-around-32b-buyout/2014-04-07#ixzz2yJQ54E4C
Pfizer stock trades halted over drug patent ruling
Pfizer stock trades halted over drug patent ruling
Original Post: bigstory.ap.org – By LINDA A. JOHNSON — Mar. 12, 2014 5:36 PM EDT
TRENTON, N.J. (AP) — A federal court on Wednesday invalidated the key patent for one of Pfizer’s most lucrative medicines, potentially opening the door for cheaper generic versions 18 months sooner than expected and cutting into the drugmaker’s profit.
Pfizer Inc., still trying to make up for the loss of about $7 billion in annual sales since generic competition hit its cholesterol fighter Lipitor in December 2011 , could lose a couple billion more if the court decision on the Celebrex patent stands. The world’s second-biggest drugmaker said it disagrees with the ruling and will “pursue all available remedies,” including immediately appealing Wednesday’s ruling by U.S. District Judge Arenda Allen of Virginia’s Eastern District in Norfolk.
Celebrex, Pfizer’s fourth-bestselling product, brought in $2.9 billion in worldwide sales last year. The anti-inflammatory pill is widely used for arthritis and acute pain. Celebrex has been on the market for more than a decade, so Pfizer’s gross profit margin on the drug may exceed 90 percent.
Trading of Pfizer shares on the New York Stock Exchange was briefly halted before the announcement. Shares closed at $31.98, down 44 cents, or 1.4 percent, but still near Pfizer’s 52-week high. In after-hours trading, shares fell another 7 cents.
The case involves a “reissue patent” that prevented U.S. sales of generic versions until Dec. 2, 2015. Last March, the U.S. Patent & Trademark Office granted Pfizer the “reissue patent,” which corrected what Pfizer called technical deficiencies in the original patent covering the diseases treated by the drug’s active ingredient, celecoxib. Those include acute and menstrual pain, rheumatoid and osteoarthritis, and a painful spinal joint disorder called ankylosing spondylitis.
Five makers of generic drugs have been seeking Food and Drug Administration permission to sell generic Celebrex starting on May 30, when the drug’s original patent expires.
New York-based Pfizer sued, alleging patent infringement by the companies: Teva Pharmaceuticals USA Inc., Mylan Pharmaceuticals Inc., Lupin Pharmaceuticals USA Inc., Apotex Inc. and Watson Laboratories Inc., which became Actavis Inc. early last year after a merger.
The lawsuit had been scheduled for a trial beginning on March 19, but last week Judge Allen notified the parties that she would rule on motions they had filed in the case, instead of holding a trial.
“Odds are in favor of generics launching early,” BernsteinResearch analyst Dr. Timothy Anderson wrote to investors. He estimates Pfizer’s earnings per share would then be reduced by 4 percent this year and 8 percent in 2015.
Full Story: http://bigstory.ap.org/article/pfizer-stock-trades-halted-over-drug-patent-ruling
