PHARMACY

New PhRMA industry profile reports 7,000 medicines currently in development

BY Michael Johnsen

WASHINGTON  – Pharmaceutical Research and Manufacturers of America’s member companies invested an estimated $51.2 billion last year in the research and development of new innovative treatments and cures, the association announced Monday. The figure represents the majority of all biopharmaceutical R&D spending – both public and private – in the United States. 
 
The new R&D numbers, the result of a recent survey of PhRMA member companies, are highlighted in the newly released PhRMA 2015 Biopharmaceutical Research Industry Profile as well as a new industry chart pack, Biopharmaceuticals in Perspective. 
 
Despite ongoing economic challenges, the biopharmaceutical industry continues to be one of America’s most research-intensive industries. According to a recent analysis from ndp│analytics, the biopharmaceutical industry leads the manufacturing sector in innovation and economic contributions. Biopharmaceutical companies on average invest as much as six times more in R&D, relative to their sales, than the average U.S. manufacturing firm. In 2014, PhRMA member companies invested nearly 24% of domestic sales into R&D.
 
“What the Industry Profile tells us – unequivocally – is that the commitment of America’s biopharmaceutical companies to solving the world’s most vexing medical challenges has never been more resolute,” stated John Castellani, president and CEO, PhRMA. “Our companies are tireless in their efforts to develop new innovative, life-saving medicines for patients – and these numbers are proof of that determination in action.”
 
The industry’s ongoing commitment to R&D was evident in the record number of 51 new medicines brought to U.S. patients last year. Forty-one of those approvals were by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research and 10 medicines were approved by FDA’s Center for Biologics Evaluation and Research. Among the CDER approvals, 41% were identified as first-in-class treatments – meaning they use a completely new approach to fighting a disease – and more than 20% were personalized medicines.  
 
The industry’s pledge to R&D is further evidenced by the robust biopharmaceutical pipeline; more than 7,000 medicines are in development globally. A 2012 analysis of the biopharmaceutical pipeline revealed 70% of medicines are potential first-in-class treatments. 
 
The road to bringing a new FDA-approved medicine to market is a long and formidable one, however, the association noted. Only 12% of drug candidates that enter clinical testing are eventually approved for use by patients. On average, it takes at least 10 years and more than $2.6 billion to bring a new medicine from the research pipeline to patients.
 
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PHARMACY

Fred’s Super Dollar boosts specialty pharmacy presence with closing of EntrustRx deal

BY Michael Johnsen

MEMPHIS, Tenn.  – Fred's Super Dollar on Monday announced that it has completed the previously reported $66 million acquisition of Reeves-Sain Drug Store, a private specialty and retail pharmacy company, including its EntrustRx specialty pharmacy operation.
 
"We continue to be very excited about the prospects for expansion in specialty pharmacy, the largest growth area of the pharmacy industry," stated Fred's CEO Jerry Shore. "And we expect that EntrustRx will increase the momentum of these efforts. Specifically, this acquisition strengthens our specialty pharmacy operations, and the Reeves-Sain Drug Store is a model for a scalable retail experience providing clinical services, immunizations, compounding, and hospice medications. We welcome the skilled and valued EntrustRx and Reeves-Sain Drug Store employees to the Fred's team and know that they will make great contributions to the future of our pharmacy operations."
 
EntrustRx, which is licensed in all 50 states, has a strong regional presence in the Southeast, serviced from facilities in Spring Hill, Tenn. and Columbus, Miss. The single Reeves-Sain retail pharmacy operates in Murfreesboro, Tenn.
 
 
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Teva offers $40 billion for Mylan

BY Michael Johnsen

JERUSALEM — Teva Pharmaceutical Industries on Tuesday announced a proposal to acquire all of the outstanding shares of Mylan in a transaction valued at $82 per Mylan share, or approximately $40 billion, with the consideration to be comprised of approximately 50% cash and 50% stock. 
 
According to Teva, their proposal provides Mylan stockholders with a more attractive alternative to Mylan’s proposed acquisition of Perrigo Company as announced on April 8, as well as to Mylan on a standalone basis. The Teva and Mylan product offerings are highly complementary, and together, would create the broadest portfolio in the industry, with a combined pipeline of over 400 pending abbreviated new drug applications and over 80 first-to-files in the United States. The combined Teva and Mylan would have pro forma 2014 revenues of approximately $30 billion and pro forma 2014 EBITDA of approximately $9 billion.
 
Teva’s proposal would provide Mylan stockholders with consideration representing a 37.7% premium to the stock price of Mylan on April 7, 2015, which is the last day of trading prior to Mylan’s press release regarding its unsolicited proposal for Perrigo, and a 48.3% premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva and Mylan.
 
The proposed combination of Teva and Mylan would create a leading company in the pharmaceutical industry, well positioned to transform the global generics space, the company stated. “Our proposal is compelling for both Teva and Mylan stockholders and other stakeholders,” said Erez Vigodman, president and CEO of Teva. “Our proposal would provide Teva stockholders with very attractive strategic and financial benefits and Mylan stockholders with a substantial premium and immediate value for their shares, as well as the opportunity to participate in the significant upside potential of the combined company – one that would transform the global generics space and leverage it to hold a unique leadership position in the pharmaceutical industry. We have long respected Mylan’s business, and we are confident that Mylan’s board of directors and stockholders will agree that our proposal represents a significantly more attractive alternative for Mylan and its stockholders than Mylan’s proposed acquisition of Perrigo,” he said. “We are very satisfied with the progress Teva has made over the last year, solidifying the foundation of our company, protecting its main specialty franchises and building our engines for organic growth. We have deep conviction in the future of Teva, building on our people, pipeline and capabilities in generics and specialty. The combination of Teva and Mylan is a truly unique opportunity to build upon both companies' solid foundations. Bringing the two together will create a much stronger, more efficient platform to achieve our goals. As one company, we would have the infrastructure and capabilities to faster pursue a differentiated business model, fully integrating specialty and generics drugs with products, devices, services and technologies to meet the evolving needs of patients and customers.”
 
“The proposal to acquire Mylan was unanimously approved and strongly supported by the Teva board," added Yitzhak Peterburg, Teva chairman. "Teva’s strategy has been to aggressively pursue growth opportunities that advance our goal of being a stronger, more diversified organization with the scale and resources to drive value across our business. Our proposed combination advances these objectives and would result in significant and sustained value creation for Teva stockholders.”
 
This proposal is subject to customary conditions. The transaction would not be subject to a financing condition or require a Teva stockholder vote. Teva’s proposal is contingent on Mylan not completing its proposed acquisition of Perrigo or any alternative transactions.
 
Teva has carefully studied the regulatory aspects of a combination of Teva and Mylan, in conjunction with its advisors. Teva is confident that it would be able to structure a transaction that would not contain material impediments to closing and that it can determine and promptly implement divestitures, as necessary, to gain regulatory clearances.
 
Teva expects that the proposed transaction can be completed by year-end 2015. Teva notes that there can be no assurance that a transaction between Teva and Mylan will be consummated.
 
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J.KRANIS says:
Apr-21-2015 10:14 am

This would benefit Teva more so than Mylan. Mylan is one of the very few in the US that have and continue to be a great generic manufacturing company. When a patient has a Mylan product, they can be secure that is just as good as the brand. I think Mylan should definitely stand on their own.. to me they have always been a huge competitor in the marketplace... While Actavis is buying every generic firm, Teva is trying to as well, as of course these others may not be able to compete due to market share, pricing etc. If Mylan was smart, they would decline any buyout offer and realize they are one of the few (besides Greenstone), that have a huge presence in the US for manufacturing generics and market share. If I were a wholesale distributor, I would want to carry a Mylan product before any other generic manufacturer. The pharmacist and the general public feel very secure with Mylan. While FDA is investigating Indian generic firms, Mylan stands tall.

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