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Impax Labs acquires Tower Holdings for $700 million

BY Michael Johnsen

 

HAYWARD, Calif. — Impax Labs last week announced the execution of a definitive agreement under which Impax will acquire Tower Holdings, including operating subsidiaries CorePharma and Amedra Pharmaceuticals, and Lineage Therapeutics for $700 million in cash, subject to certain customary purchase price adjustments. 
 
The privately-held companies being acquired specialize in the development, manufacture and commercialization of complex generic and branded pharmaceutical products. The transaction will provide Impax with a profitable and growing commercialized portfolio of products that are expected to generate full year 2014 revenues of approximately $215 million to $225 million. 
 
"This transaction is an important step forward in executing our plan to drive growth and create value through strategic acquisitions that enhance our existing strategies," stated Fred Wilkinson, president and CEO of Impax. "The companies will add a growing, highly profitable, commercial portfolio of generics as well as a lead product in a new brand franchise, which will enhance our brand division and enable us to utilize our brand commercial infrastructure more efficiently. The acquisition also adds a branded and generic pipeline that includes a number of near-term opportunities. In addition, Impax will gain an established campus in New Jersey focused on R&D, manufacturing, packaging and supply chain management. Further, this accretive transaction will move Impax to a more efficient capital structure, while also preserving our ability to pursue additional external strategic growth opportunities."
 
Christopher Worrell, CEO Tower Holdings, Amedra and Lineage, said: "We are pleased with the progress we have made across our companies with an emphasis on the successful implementation of a Quality Improvement Program, which resulted in recent product approvals from the U.S. Food and Drug Administration. Both Impax and the companies have a proven record of developing high value specialty products, and we look forward to being a critical contributor to the future growth strategy and value creation for Impax."
 

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Congress to investigate ‘soaring generic drug prices’

BY Michael Johnsen

BURLINGTON, Vt. — U.S. Sen. Bernie Sanders, I-Vt., and U.S. Rep. Elijah Cummings, D-Md., earlier this month launched an investigation into soaring generic drug prices.
 
“We are conducting an investigation into the recent staggering price increases for generic drugs used to treat everything from common medical conditions to life-threatening illnesses,” Sanders, chairman of a Senate health care subcommittee, and Cummings, ranking member of the House oversight committee, wrote in letters to 14 pharmaceutical companies.
 
They pointed, for example, to the price hike for Albuterol Sulfate used to treat asthma and other lung conditions. The average cost for a bottle of 100 pills was $11 last October. The average charge by this April had shot up to $434. An antibiotic, Doxycycline Hyclate, cost $20 last October for a bottle of 500 tablets. By April, the price was $1,849.
 
The price data on those and other generic drugs came from the private Washington, D.C.-based Healthcare Supply Chain Association. It surveyed average prices paid by organizations that help hospitals, nursing homes and home health agencies negotiate with pharmaceutical companies and other vendors for discounts. The figures are akin to wholesale prices, not the amount patients are charged.
 
Cummings and Sanders cited a survey that found pharmacists across the country “have seen huge upswings in generic drug prices that are hurting patients” and having a “very significant” impact on pharmacists’ ability to continue serving patients. The study for the National Community Pharmacists Association also found some patients refused to fill needed prescriptions because of rising prices.
 
“It is unacceptable that Americans pay, by far, the highest prices in the world for prescription drugs. Generic drugs were meant to help make medications affordable for the millions of Americans who rely on prescriptions to manage their health needs. We’ve got to get to the bottom of these enormous price increases,” Sanders said.
 
“When you see how much the prices of these drugs have increased just over the past year, it’s staggering, and we want to know why,” said Cummings. “I am very pleased that Chairman Sanders has joined me in this bicameral investigation because in some cases these outrageous price hikes are preventing patients from getting the drugs they need.”
 
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Minority groups raise concerns around FDA’s Proposed Rule on Generic Labeling

BY Michael Johnsen

 

WASHINGTON — Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. This is the second such letter sent to the agency by various institutions representing minority constituencies, including healthcare providers, bringing the total number to 34.The letter focuses on the adverse consequences of the proposed rule on patients, on costs and on vulnerable populations.
 
“The questions continue to mount, with more groups speaking out about the negative impact of the FDA Proposed Rule,” stated Ralph Neas, president and CEO of the Generic Pharmaceutical Association. “Now we are hearing from leading minority academic, medical and community organizations that are rightly worried about the impact on patient populations historically and currently underserved by our nation’s health care system. Because they speak for millions of Americans who rely on generic drugs,” Neas continued, “these groups are asking for inclusivity. They are asking to be heard in the FDA decision-making process.”
 
“Healthcare is paramount to the well-being of our communities, and proposed regulations like this one can have unintended consequences. Vulnerable patients — and the doctors, pharmacists and other health professionals who serve them — should be ensured that the rule change does not make decision-making more confusing,” stated Melanie Campbell, president and CEO of the National Coalition on Black Civic Participation.
 
The signatories include the Meharry Medical College, the NAACP, the National Hispanic Medical Association, and the National Medical Association. The letter cites specific challenges the rule presents for providers, noting that a recent survey showing that they favor a policy wherein FDA approval would precede any changes to generic drug labels.
 
“Recently,” the letter reads, “a Farleigh Dickinson University’s Public Mind survey found that health professionals were overwhelmingly in favor of making sure that generic drug safety labels are not changed without FDA approval. The survey results show that the Proposed Rule would cause confusion for both health care providers and patients."
 
According to the survey:
 
  • More than three-quarters (76%) of those surveyed say their patients would be at least somewhat confused by multiple labels for the same medicine;
  • Eight in 10 (88%) say multiple labels would be very confusing (53%) or somewhat confusing (35%) for themselves; and
  • Among prescribers, 60% said the change would have an impact on their willingness to recommend generic drugs in the future.
 
The letter also highlights the reliance of lower-income patients on the savings from generics, stating: “Recent studies have continued to raise serious concerns about the level of generic utilization among lower-income patients. The research suggests that there are cultural barriers to understanding of generic efficacy that can lead patients to miss out on the cost-savings generic medications offer. Even more worrying, this research shows it can lead to dangerous non-compliance. The Food and Drug Administration’s Proposed Rule on Generic Labeling, as drafted, likely will only add to these challenges.”
 
Finally, the letter calls for FDA to “fully explore the potential unintended and harmful consequences that the Proposed Rule may have on patient access and national health care costs before proceeding further with its finalization. 
 
This is the latest in a series of joint letters to the agency raising questions about the Proposed Rule, which were signed by more than 50 groups, including associations that represent more than 100,000 pharmacists and more than 40,000 pharmacies. In addition to virtually every member of the healthcare supply chain and providers, the FDA has received letters on behalf of patient advocacy, disability, veterans and minority organizations.
 
“Generic drug access is a critical part of keeping healthcare affordable and in reach for all Americans,” said Neas. “This letter underscores once more the imperative that during the FDA’s deliberations around its Proposed Rule on Generic Drug Labeling, racial and ethnic minority populations have a seat at the table to be able to discuss and understand the issue. Before finalizing this rule, the FDA must hear from these voices.”
 

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