Abbott completes split

by IainBate 2. January 2013 17:18

miles white Abbott (resized) Abbott has completed the separation of its research-based pharmaceutical business as planned to form AbbVie, a new independent biopharmaceutical organisation.

The pharmaceutical company announced back in October 2011 its intention to fragment its research efforts away from its medical products company.

Chairman and Chief Executive Miles D. White (pictured) said Abbott had taken the “most transformative action in its 125-year history” by completing the separation.

AbbVie has taken on a selection of Abbott’s products and now boasts a broad portfolio of treatments in areas such as immunology, virology and breakthrough therapies.

Despite the split, Abbott says it will remain one of the largest science-based healthcare companies with annual global revenues of around $22 billion.

“We wish our colleagues at AbbVie continued success as they become part of a new, independent company that is already making a significant difference, focusing on highly specialised, market-leading therapies for some of the world's most difficult-to-treat diseases,” said Miles White.

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Abbott pays $1.6bn to settle off-label marketing charges

by JoelLane 8. May 2012 11:35

Pf industry news Abbott Laboratories has agreed to pay a total of $1.6bn to settle federal and state charges of off-label marketing regarding its anti-seizure drug Depakote.

The company admitted actively promoting the unlicensed use of Depakote in nursing homes to sedate dementia patients from 1998 to 2006.

The US Government alleges that Abbott exploited a loophole in the legislation protecting elderly patients from inappropriate medication.

Abbott will pay $800m to settle civil allegations, a $700m federal criminal fine and $100m in state level consumer protection fines.

Depakote is licensed by the FDA as a treatment for epilepsy, migraine and manic episodes.

Abbott has pleaded guilty to ‘misbranding’ the drug as a treatment to control agitation and aggression in elderly dementia patients.

From 1998, the company trained a special sales force to promote the off-label use of Depakote to nursing homes.

This promotion continued despite a 1999 clinical trial that showed the drug caused drowsiness, dehydration and anorexia in elderly patients.

Abbott’s marketing highlighted the fact that Depakote was not included in a list of medications banned in nursing homes under by a 1987 law.

Representing one of four ‘whistleblower’ Abbott sales representatives, attorney Reuben Guttman said: “Abbott directed its sales force to get Depakote widely used in nursing homes, principally to neutralise older patients as a substitute for proper staffing.”

Deputy US Attorney General James Cole commented: “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

Humira approved by EC for UC

by IainBate 12. April 2012 11:57

Humira approved by EC for UC - Pharmaceutical Field The European Commission has approved the use of Abbott’s Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

The approval sees Humira become the first and only self-injectable biologic therapy for UC in adults who have failed to respond to conventional therapy.

Marco Greco, Chairman of the European Federation of Crohn’s & Ulcerative Colitis Associations, said the approval “represents an important new therapeutic option”.

Humira is already indicated for the treatment of several other inflammatory diseases. Dr John Leonard, Senior Vice President, Pharmaceuticals R&D, Abbott, says the latest indication highlights the treatment’s usefulness.

He commented: “The approval of Humira for the treatment of moderately to severely active ulcerative colitis further demonstrates Humira’s versatility in treating a wide range of immune-mediated inflammatory diseases”.

UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may eventually lead to life-threatening complications. Around 1.2 million Europeans suffer with UC.

“Having one more option to treat this disease provides new hope that some patients will be able to achieve remission of their disease,” said Marco Greco.

The approval of Humira – which was first approved in the EU in 2003 for the treatment of rheumatoid arthritis – was based on two Phase III global trials including more than 800 patients.

Abbott names its new pharma company

by JoelLane 22. March 2012 14:02

Pf industry news Abbott Laboratories has given the name AbbVie to the research-based pharmaceuticals business it intends to spin out later this year.

The division of Abbott into two separate companies, one for pharmaceuticals and one for diversified medical products, was announced in October.

The Abbott brand name will stay with the medical products company.

“The beginning of the name connects the new company to Abbott and its heritage of pioneering science,” explained Richard Gonzalez, Chief Executive of AbbVie. “The ‘vie’ calls attention to the vital work the company will continue to advance to improve the lives of people around the world.”

AbbVie’s product portfolio, which includes such major brands as arthritis drug Humira, HIV drug Kaletra and cholesterol-lowering drugs Tricor and Niaspan, brings in almost $18bn per year in revenue.

The new company also has R&D assets in hepatitis C treatment, immunology, chronic kidney disease, women’s health, oncology and neuroscience, including four projects currently in phase III.

This strong pipeline is expected to help it survive the loss of patent protection for Humira, Tricor and Niaspan between now and 2012.

New business development VP at Lundbeck

by IainBate 21. March 2012 12:21

New business development VP at Lundbeck - Pharmaceutical Field Lundbeck has appointed Jacob Tolstrup as Vice President of Business Development.

The 39-year-old joins from the company’s US subsidiary and will spearhead the development and strengthening of its existing and future partnerships and explore new growth opportunities.

Ulf Wiinberg, Lundbeck CEO, said the company was pleased to “recruit such a strong person internally to lead the important work of our on-going business development”.

Mr Tolstrup, who will also join Lundbeck’s Corporate Management Group, has held several management positions since joining the company more than a decade ago.

He began working in the pharmaceutical industry in 1998 at Abbott Laboratories and moved to Lundbeck a year later as Financial Analyst and Financial Planner. He then served in a number of different roles and joins after serving as vice president of finance and administration at Lundbeck US.

“Jacob has delivered strong results in a very professional manner for several years in various positions,” added Ulf Wiinberg.

Abbott leaders take pay cut

by JoelLane 20. March 2012 13:52

miles white Abbott (resized) The executive board of Abbott Laboratories saw their salary and bonus packages reduced by as much as a quarter in 2011.

The leadership of the Chicago-based company’s pharmaceutical division, which is soon to be divested, was among the hardest hit.

Abbott CEO Miles White (pictured) was awarded a $4.2m bonus for leading the company’s split, meaning that his pay cut was limited to 6%.

A proxy statement issued by Abbott revealed a pattern of reduced bonus payments for top executives, who also received no salary increase in a year when other Abbott staff gained 3%.

White saw his income fall from $25.6m in 2010 – the third highest in the industry – to just $24 million.

Richard Gonzalez, Executive VP of Abbott’s pharmaceutical products group, was paid $5.6 million last year – a 27% cut from 2010.

Thomas Freyman, CFO, received $7.9m, a 17% cut. Laura Schumacher, General Counsel and Secretary, was paid $5.6 million – a drop of 22%.

In October 2011, Abbott announced it would spin off its branded drug business in order to allow investors to consider the two businesses separately. This resulted in the company’s share price reaching its highest level in five years.

Hospira boosts compliance team

by IainBate 15. February 2012 12:35

Pharma Industry News Hospira has appointed several new leaders to strengthen its quality and compliance capabilities.

Zena G. Kaufman joins on February 27th, 2012 as Senior Vice President, Quality, and takes on responsibility for global quality systems. She will also serve as a member of the company’s senior leadership team.

Michael Ball, CEO, says he is now confident the company has a team in place to provide the “highest-quality products and best possible service for our customers”.

Ms. Kaufman, who most recently served Divisional Vice President, Global Quality Systems, Global Pharmaceutical Operations at Abbott Laboratories, is joined by a number of appointments in similar roles.

Matt Stober, who joined from Johnson & Johnson last year, has been promoted to Corporate Vice President, US Pharma Operations, and has primary responsibility for Hospira’s Rocky Mount facility in North Carolina, as well as plants in McPherson, Kansa, Austin, Texas, and Clayton, North Carolina.

He is joined at the Rocky Mount plant by Shane Ernst who will take on the role of Vice President, Quality, and by Marty Nealey, Vice President, Operations and Plant Manager.

Andrew Knudten will take on the role of Vice President, Operations and Plant Manager at the McPherson site, where he will be responsible for operations from March 5th.

Dr Thomas Templeman completes the appointments in the newly created position of Vice President, Pharma Operations Excellence.

“In their previous roles, our new team members have successfully delivered the highest standards of quality and regulatory compliance,” said Mr. Ball. “These seasoned industry veterans will work with Hospira’s current leadership to remediate the Rocky Mount facility and extend improvements there across all Hospira sites. I’m confident that their extensive backgrounds in operations and quality, expert knowledge of FDA regulations and strong leadership abilities will help take Hospira to the next level of operational excellence.”

Abbott expands Irish plant

by IainBate 13. February 2012 11:57

Pharma Industry News Abbott Laboratories has committed €85 million to expand its manufacturing plant in Sligo, Ireland, which it expects will create up to 175 “highly skilled” jobs.

The expansion will provide additional space for manufacturing with positions created in engineering, quality, pharmaceutical science and other science-based areas.

Azita Saleki-Gerhardt, President of Global Pharmaceutical Operations at Abbott, said that the Sligo site is an important part of the company’s manufacturing network.

Abbott, which employs nearly 4,000 people across Ireland, expects the expansion to be completed by 2014 and to create 150 temporary construction jobs to complete the project.

It says the expansion is required to support the company’s “pipeline in the key therapeutic areas of virology, oncology and nephrology”.

The investment is supported by the IDA Ireland, the country’s investment promotion agency. Barry O’Leary, the IDA’s Chief Executive, said the pharmaceutical company is “of key importance to Ireland’s life sciences sector” and is “hugely important to the local economy”.

New MD at Napp

by IainBate 31. January 2012 00:01

New MD at Napp Napp Pharmaceuticals has appointed Dietmar Leitner as its new Managing Director.

Mr Leitner has more than 16 years experience within the pharmaceutical industry having worked at Abbott Laboratories before joining Mundipharma Gesellschaft m.b.H. in Austria.

The new Managing Director says he is “delighted” to be joining the Cambridge-based company and hopes to continue and build on its success.

He succeeds Antony Mattessich who left Napp in May 2011 to become Regional Director Europe at Mundipharma International Limited.

Napp specialises in the field of pain control. It has been committed to furthering the understanding and treatment of pain relief for the last three decades. It also has a growing expertise in oncology and respiratory medicines.

“Napp has significant expertise in analgesics, an expanding oncology portfolio and a very promising respiratory franchise,” commented Mr Leitner. This, alongside our very collaborative approach to business, will, I believe, be a significant strength in the emerging healthcare environment.”

Humira drives Abbott Q4 results

by IainBate 27. January 2012 13:02

Humira drives Abbott Q4 results Sales of anti-inflammatory drug Humira (adalimumab) helped Abbott Laboratories post strong sales and earnings growth in Q4 of 2011.

Revenues from Humira increased 15.89% to $2.18 billion and helped overall pharmaceutical sales climb 6.7% to $4.78bn in the quarter.

Miles D. White, Chairman and CEO, Abbott, said that despite “another challenging year” the company “again delivered leading performance”.

An increase in sales of Humira helped Abbott record net income of $1.62bn (+12.3%) with group sales also up 4.1% to $10.38bn.

But sales of ‘established pharmaceuticals’, which includes branded generics outside the US, dropped 4.6% to $1.39 billion. Sales of HIV drug Kaletra (lopinavir/ritonavir) were also down 15.6% to $288 million. TriCor (fenofibrate) and TriLipix (fenofibric acid) also saw revenue fall 4.3% to $409 million.

However, the news was better for prostate cancer therapy Lupron (leuprolide) which rose 4.0% to record sales of $208 million and for Synthroid (levothyroxine) which saw revenue increase by 2% to $163 million.

Abbott, which recently revealed plans to split into two separate companies, says it is now “on track” to complete the switch by the end of 2012.

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