PHARMACY

Mylan boosts EPS guidance

BY Allison Cerra

PITTSBURGH — Mylan has increased its 2012 earnings per share guidance range, the generic drug maker said.

The company boosts its EPS guidance range to $2.45 to $2.55 in adjusted diluted earnings per share, up from $2.30 to $2.50 per share. All of Mylan’s other 2012 guidance metrics remain unchanged.

In related news, Mylan also announced that its board of directors has approved the repurchase of up to $500 million of the company’s common stock in the open market.

"As we have said previously, we expect 2012 to be the best year to date in Mylan’s history. The increase in our guidance is a result of our continued strong operational performance," Mylan CEO Heather Bresch said.

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NCPA ends Legislative Conference with congressional rally

BY Michael Johnsen

ALEXANDRIA, Va. — The National Community Pharmacists Association wrapped up its three-day NCPA Legislative Conference Wednesday with a rally, the association announced.

Speakers at the rally included Sen. Mark Pryor, D-Ark., the original sponsor of the Pharmacy Competition and Consumer Choice Act (S. 1058); Rep. Tom Marino, R-Pa., the original sponsor of the Preserving Our Hometown Independent Pharmacies Act (H.R. 1946); Rep. Peter Welch, D-Vt., the original sponsor of the Medicare Access to Diabetes Supplies Act (H.R. 1936); as well as Sen. Roger Wicker, R-Miss.; and Reps. Judy Chu, D-Calif., and Ruben Hinojosa, D-Texas.

“Independent community pharmacists offer vital health care services to millions of patients across America that could be compromised without passage of S. 1058, H.R. 1946, and H.R. 1936,” NCPA CEO Douglas Hoey said. “These common-sense, bipartisan bills will rein in some of the most egregious behavior of pharmacy benefit managers help level contract negotiations between [pharmacy benefit managers] and pharmacies and ensure seniors can continue receiving essential diabetes testing supplies and face-to-face counseling from their local pharmacies," he said. “After our rally we will flood the halls of Congress to deliver our message, spurred on by the support we are receiving from Sen. Pryor, and Reps. Marino and Welch. They know independent community pharmacies are often in underserved rural and urban communities, and the bills they are championing will ensure the continuum of health care is preserved in those and other communities.”
 
During the previous two days Legislative Conference attendees also heard from Reps. Dave Camp, R-Mich.; Frank Pallone, D-N.J.; and Aaron Schock, R-Ill.; and Sens. Jerry Moran, R-Kansas; Al Franken, D-Minn.; and Sherrod Brown, D-Ohio. Jonathan Blum, deputy administrator and director for the Center for Medicare, Centers for Medicare and Medicaid Services and Colonel George Jones Jr., deputy chief pharmaceutical operations directorate for Tricare Management Activity, also spoke.

In addition there were panels on the Federal Trade Commission’s PBM-related decisions, efforts to combat pharmacy crimes and the challenges facing long-term care providers. Another highlight was a comprehensive media briefing with NCPA’s leadership team and Rep. Cathy McMorris Rodgers, R-Wash., who is co-chair of the Community Pharmacy Caucus.
 
“The Legislative Conference certainly achieved its goal of providing our members an opportunity to both hear from and advocate with members of Congress,” Hoey said. “They know the best way to address the questionable business practices of the PBM industry is through grassroots activism in support of pro-patient reforms.”


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Sandoz to testify at FDA biosimilars hearing

BY Alaric DeArment

HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

Sandoz, the generics arm of Swiss drug maker Novartis, and a major supplier of biosimilars, said its head of global biopharmaceutical development, Mark McCamish, will testify on what it called the need for a single, science-based regulatory standard that the FDA should apply across all biologics. The FDA released draft guidances in February.

"Sandoz is pleased that the FDA has taken another step toward increasing patient access to affordable, high-quality biologics," McCamish said. "We support the flexibility of the draft guidances and hope that [the] FDA will provide similar science-based, pragmatic approaches in its final guidelines."

In advocating for a single standard, McCamish will note that several originator biologics have undergone manufacturing changes since their commercialization, saying that it creates "highly similar" biologics that overlap with the originator products’ attributes, saying that such a highly similar product should justify abbreviated clinical trial programs, as outlined in the draft guidances.

McCamish also plans to say that biosimilar clinical studies are only confirmatory because advances in biotechnology allow a biosimilar manufacturer to use various means to more efficiently pick up differences between a biosimilar and its reference product than any clinical trial, thus allowing full characterization between the two products. Third, he will address interchangeability between biosimilars and their reference products.

Sandoz currently makes biosimilars mostly for the European market, alongside Teva Pharmaceutical Industries and Hospira. While the healthcare-reform law included a regulatory approval pathway for biosimilars in the United States, so far the only biosimilar available here is Sandoz’s Omnitrope (somatropin [rDNA origin]), a treatment for children with growth hormone deficiencies and a biosimilar of Pfizer’s Genotropin.

 


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