In 2014 Big Pharma are in a Business ETHICAL Bankruptcy – The Log of Ethical Violations is Updated Daily as Announced
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 6/23/2014
Allergan could be weighing a follow-up bid for Ireland’s Shire ($SHPG), which could neutralize Valeant’s promise of a combined company’s low tax rate. But it will have to move quickly if it wants to get a deal done: Reports say AbbVie ($ABBV) is readying its fourth bid for the company, and Big Pharma peers Bristol-Myers Squibb ($BMY), Merck ($MRK) and Pfizer ($PFE) could be interested, too.
· The Exchange Offer is grossly inadequate and substantially undervalues Allergan’s industry-leading position, financial performance, strong balance sheet, exceptional management and growth prospects.
– Allergan has a longstanding track record of innovation and operational excellence that has created strong and sustainable stockholder value over a substantial period of time.
o Allergan has routinely delivered compelling results, achieving compound annual increases in revenue and non-GAAP diluted earnings per share of approximately 15.7% and 18.4%, respectively, since 1998.
o Allergan has created significant value for its stockholders over the last five years, generating a 256% price return compared to a 113% price return in the S&P 500.
– Its belief that Allergan’s promising outlook should create significant near-term and long-term value for stockholders.
o As previously announced, given the strength in its business, Allergan expects to:
· Increase non-GAAP diluted earnings per share by 20 to 25 percent and continue to generate double-digit revenue growth in 2015.
· Produce double-digit sales growth and produce non-GAAP diluted earnings per share compounded annual growth of 20 percent over the next five years.
· Generate approximately $14 billion in additional free cash flow over the next five years.
o The Company will provide an update to its stockholders on near-term value-driving events on or around the time of Allergan’s second quarter 2014 earnings announcement.
– Allergan’s future prospects are driven by a robust pipeline of new products and services arising from a longstanding and successful dedication to research and development.
o Allergan has a track record of exceeding its guidance every year for the past 15 years, including through numerous business cycles.
o The Board believes Allergan’s ongoing commitment to extensive and efficient investment in research and development will create substantial value for stockholders and customers.
– Allergan has a strong balance sheet and ample leverage capacity.
· Its belief that Valeant’s business model creates significant risks and uncertainties for Allergan’s stockholders.
– Valeant’s acquisition-based revenue growth is unsustainable.
– Valeant’s anemic organic growth is driven by unsustainable price increases.
– Valeant’s projected synergies claims are aggressive, and Valeant’s lack of investment would put Allergan’s core business at risk under Valeant’s ownership.
– Valeant discloses far less in its financial statements than Allergan and its industry peers.
– Valeant’s R&D capabilities pale when compared to Allergan’s track record of innovation and value creation.
SOURCE
Ex-Novartis Pharma Employee Arrested Over Drug Data
TOKYO, June 11 (Kyodo) — Tokyo prosecutors arrested a former employee of Novartis Pharma K.K. on Wednesday on a charge of manipulating clinical study data leading to exaggerated claims in advertising for one of the firm’s drugs.
Nobuo Shirahashi, 63, is alleged to have manipulated cerebral stroke incidence and other data collected by a research team at the Kyoto Prefectural University of Medicine so that the team released a paper in favor of the Diovan blood pressure-lowering drug in 2011.
The arrest came after the prosecutors raided the Japanese sales arm of Swiss pharmaceutical giant Novartis earlier this year over its alleged use of clinical study reports for exaggerated advertising for the drug in violation of the pharmaceutical affairs law.
As a Novartis Pharma employee Shirahashi took charge of analyzing data from clinical tests comparing Diovan and other blood pressure-lowing drugs at five Japanese universities, including the Kyoto school, between 2002 and 2004.
The Kyoto team concluded Diovan was more effective than other blood-pressuring drugs in preventing stroke and angina based on the manipulated data from some 3,000 patients.
The Kyoto medical school’s investigative panel reported the data manipulation last year.
The Jikei University School of Medicine in Tokyo, another of the five universities, also found manipulated data from a clinical study on the drug.
Novartis Pharma contributed a total of 570 million yen to the Kyoto Prefectural University of Medicine and the Jikei University School of Medicine between 2002 and 2012.
Novartis Pharma launched Diovan in Japan in November 2000 and achieved annual Diovan sales in excess of 100 billion yen in and after 2005. Cumulative Diovan sales reached 1.2 trillion yen by 2012.
SOURCE
http://www.pharmpro.com/news/2014/06/ex-novartis-pharma-employee-arrested-over-drug-data
On 4/22/2014 I published
April 2014: Tsunami in the Global Pharmaceutical Industry & Consumer Health Care Sector – New Organizational Structure Emerging
On 6/5/2014 I am compelled to report on
Big Pharma’s Business ETHICAL Bankrupcy – Selected Cases with Periodical Updates
GlaxoSmithKline’s ($GSK) latest penalty for improper marketing practices may seem little more than a slap on the wrist–except that it’s coming at the worst possible time for the embattled British drugmaker. GSK agreed to pay $105 million to settle charges in California, New York, Texas and more than 40 other states that it illegally promoted its asthma drug Advair and antidepressants Wellbutrin and Paxil.
The states’ attorneys general alleged that GSK pushed mild asthma sufferers to request Advair even though the FDA did not approve it for mild cases, and that it marketed Wellbutrin and Paxil off-label for use in children.The states also claimed that the company promoted Wellbutrin for other unapproved uses, i.e., weight loss and substance abuse.
A third count charged the company with failing to report safety data on Avandia, its diabetes drug that was later slapped with two black-box warnings about cardiovascular risks. It was the largest healthcare fraud settlement in history, surpassing Pfizer’s ($PFE) $2.3 billion deal in 2009.
Johnson & Johnson ($JNJ), for example, paid $181 million in 2012 to resolve allegations in 36 states that it improperly marketed its antipsychotic Risperdal, but then it got a major reprieve this March: The Arkansas Supreme Court threw out a $1.2 billion judgment in a later case brought by those states against J&J.
Special Reports: Top 10 Drugmakers in Emerging Markets – GSK | The top 10 pharma companies by 2013 revenue – GlaxoSmithKline
Roche-Novartis Probe
Italian finance police searched the offices of the Italian Medicines Agency (Aifa), looking for evidence in a criminal probe of potential fraud and market manipulation by the Swiss drugmakers Novartis ($NVS) and Roche ($RHHBY). Officials have been investigating allegations that the two companies colluded to boost sales of Lucentis, their eye drug, by sidelining off-label use of the drug’s close cousin, Avastin.
Italy has already levied $251 million in fines on the two companies. Now, the country is looking for an additional 1.2 billion euros in damages, or about $1.5 billion. The Aifa raid stems from allegations that the two companies worked together to put Lucentis on the Italian formulary to treat vision-robbing conditions–and to exclude Avastin for the same uses. Aifa itself may also be a target in the probe; according to the Italian news agency ANSA, a consumer association in the country said in March that it would urge state auditors to investigate Aifa’s potential role in the alleged cartel.
The Lucentis vs. Avastin question has a long history. Roche’s Genentech unit allegedly threw up barriers to ophthalmic use of Avastin in the U.S. by cutting off distribution to ophthalmologists. The company says Lucentis is safer than Avastin for eye injections, because Avastin has to be repackaged in syringes for that use, and that repackaging can cause infections. Several clusters of serious eye infections have been traced to repackaged Avastin.
Meanwhile, the National Institutes of Health funded a head-to-head study of the two drugs to see whether Avastin really is an effective substitute, and the study authors concluded that it is more-or-less equally effective, albeit with some differences in side effects. But Lucentis is FDA-approved for eye use and Avastin is not, and Medicare payments tend to encourage eye doctors to use Lucentis for wet AMD and other eye conditions.
Shire – Reports last week listed the company as a potential suitor for NPS Pharmaceuticals, a $3.5 billion company. NPS Pharma boasts meds for short-bowel syndrome and hypoparathyroidism that would fit right in with Shire’s rare-disease focus, Wedbush told the news service. Other potential targets could include Prosensa Holding ($RNA) or Sarepta Therapeutics ($SRPT) because of their muscular dystrophy assets.
“If they want to stay independent, then going on a bit of a shopping spree makes it harder for another entity to go after them,” Piper Jaffray analyst David Amsellem told Bloomberg. “They will be approached. They probably have been approached.”
Allergan ($AGN), which is eager to dodge its own predator, the M&A machine Valeant ($VRX). The Botox maker has reportedly already made one play for Shire, and sources told Reuters back in April that Allergan was preparing another.
Bayer’s pharma division has a new president with a big task ahead of him. A week after the company announced its current leader, Andreas Fibig, would jump ship, Bayer says it’s chosen an Otsuka Pharmaceutical executive to take the post.
Dieter Weinand, 53, is currently president of global commercialization for Japan-based Otsuka. Based in Princeton, NJ, Weinand will join Bayer Aug. 1 as president of Bayer HealthCare Pharmaceuticals and a member of the Bayer HealthCare executive committee.
The company is in the midst of building up or rolling out key new products–such as the pulmonary arterial hypertension treatment Adempas and the radiotherapy Xofigo–that Bayer CEO Marijn Dekkers is counting on to add billions to the company’s top line.
Related Articles:
U.K. fraud police launch GlaxoSmithKline probe in wake of China corruption charges
Polish prosecutors hit GlaxoSmithKline with third round of bribery charges
Arkansas court boots $1.2B J&J verdict on technical grounds
GSK pays $3B to wrap up host of Justice Department claims
SOURCE
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Date: Thu, 5 Jun 2014 16:39:25 +0000 (GMT)
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