Bayer

Bayer will pay government $97.5M

Christe Bruderlin-Nelson — Wed, 26 Nov 2008 04:00:37 -0500

In an effort to "avoid the time, uncertainty and expense of litigation," among other things, Bayer HealthCare agreed to pay the government $97.5 million to settle a kickback case.

The U.S. Department of Justice alleged that Bayer paid Liberty Medical Supply, a major medical supplier, nearly $2.5 million to convince patients to switch to Bayer diabetic supplies. In addition, the Department of Justice claimed Bayer paid 10 other suppliers about $375,000. As a result, the suppliers submitted false claims to Medicare. The government said that in the "cash-for-patient" scheme, Bayer made payments to Liberty and hid them by saying they were advertising payments.

As part of the settlement, Bayer has also agreed to enter into a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General for its divisions that deal with the government. However, many in the industry question the value of such agreements, claiming that both compliance and enforcement can be low.

The $97.5 million does not include interest.

Arthur Higgins, the chairman of Bayer, said the company is eager to move beyond the litigation.

- here's Bayer's release
- read the Associated Press story
- find out more at MarketWatch

Vermont docs received more secret payments

Christe Bruderlin-Nelson — Wed, 05 Nov 2008 10:17:01 -0500

A March 2007 article in the Journal of the American Medical Association told the story of pharma companies paying physicians in Vermont over $2.7 million between July 2002 and June 2004, but the advocacy group that reported the original findings now says the amount is actually much higher.

According to the organization Public Citizen, the payments total nearly $5 million and "strongly suggest" violations of American Medical Association and PhRMA professional guidelines, which restrict said payments to $100 per doctor, per occassion.

In fact, the group found that more than $3.2 million worth of the payments were greater than $100 each, representing nearly 90 percent of the payments to physicians by drug companies. Twenty-one drugmakers were said to have kept the payments under wraps. The companies involved included Abbott Labs, AstraZeneca, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Merck and Roche.

- see the full story at Pharmalot

Bayer: Nexavar study shows survival boost

Tracy Staton — Fri, 31 Oct 2008 11:25:14 -0400

Bayer and Onyx Pharmaceuticals are anticipating the release of two new studies of their liver cancer treatment Nexavar; the studies include evidence of extended survival in more than 40 percent of patients and identification of biomarkers that might predict success with Nexavar therapy. Release

Bayer gets FDA warning for aspirin marketing

Christe Bruderlin-Nelson — Wed, 29 Oct 2008 08:42:05 -0400

We recently told you about some concerns the FDA had with Bayer regarding its marketing of aspirin products using unsubstantiated claims. The company has been marketing Bayer Women's Low Dose Aspirin Plus Calcium and Bayer Aspirin with Heart Advantage products, both combinations of aspirin and a supplemental product. Bayer Women's contains calcium and Bayer Heart Advantage contains phytosterols.

The company has now received official warning letters from the FDA, since Bayer has not substantiated the claims that the over-the-counter products are effective against either osteoporosis or heart disease, and the FDA now says that Bayer cannot market either product in the U.S. legally.

"Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products," according to a FDA statement, which also said that government scientist must review treatments for heart disease and osteoporosis.

The company says it continues to stand behind the claims it is making on the two products and that it would respond to the FDA letters within 15 business days.

- read the story in the New York Times
- see more at the Wall Street Journal

Rumors of Pfizer bid boost Bayer...again

Tracy Staton — Thu, 23 Oct 2008 11:20:23 -0400

Will rumors of a Pfizer bid for Bayer ever die? The talk boosted Bayer's stock in Frankfurt earlier today, despite the bankers who've persistently pooh-poohed the idea. Where there's smoke there's fire, perhaps--or maybe traders just like to talk. Report

Bayer ignored FDA; Congress asks why

Christe Bruderlin-Nelson — Wed, 15 Oct 2008 06:23:11 -0400

The FDA warned Bayer Healthcare about marketing a product called "Bayer Aspirin with Heart Advantage" as safe and effective, but it appears that Bayer completely ignored the warning and the House Energy & Commerce Committee wants to know why. The product in question contains aspirin in addition to a dietary supplement that purports to lower cholesterol.

The FDA only regulates the aspirin part of the combination; nevertheless, it sent a letter to the president of Bayer requesting all studies showing the product did indeed have a heart advantage. Bayer claims the supplement can lower cholesterol, but didn't prove it--nor did the company heed the FDA's warning. Instead, Bayer went ahead with direct-to-consumer marketing of its product. Mike Leavitt, U.S. Health & Human Services Secretary, received a letter as well, specifically asking what the FDA has done about the marketing.

- see the Pharmalot blog post

FDA issues warning letter over Yaz DTC ads

Calisha Myers — Wed, 08 Oct 2008 16:30:28 -0400

The FDA has issued a warning letter to Bayer for two commercials, "Not Gonna Take It" and "Balloons," for its birth control pill, Yaz. According to the FDA, the commercials overstate the efficacy of the pill, minimize its risks and broadens the pills indication by falsely suggesting that Yaz has been approved for treating pre-menstrual syndrome.

The Yaz label warns patients that Yaz has not been evaluated to treat premenstrual syndrome, but the FDA notes that this is not mentioned in the "Not Gonna Take It" commercial. Yaz is in fact approved for treating "moderate acne vulgarities," as well as premenstrual dysphoric disorder (PMDD)--a more severe condition that causes disruptive emotional and physical symptoms, including depression, anxiety, persistent anger, headaches and joint pain. But, according to the warning letter, not only does the commercial suggest that Yaz's is able to treat acne of all severities, in touting the benefits of Yaz in treating such common symptoms as "irritability" and "moodiness," the commercial fails to distinguish between PMS and the more serious PMDD, leading viewers to believe that Yaz is effective at treating PMS.

The FDA also warns Bayer about a second commercial, "Balloons (video)," in which the song "Goodbye to You" plays in the background as women release balloons displaying their symptoms into the air. The agency says the ad misleads viewers to believe that Yaz can completely cure patients of their symptoms.

- check out the "Balloons" commercial
- view the FDA warning letter (.pdf)
- view the FDA story board of "Not Gonna Take It" (.pdf)

Bayer on the prowl for weaker prey

Tracy Staton — Thu, 02 Oct 2008 10:56:23 -0400

Bayer appears to be working under Warren Buffett's market-turmoil philosophy: Be fearful when others are greedy and greedy only when others are fearful. The German conglomerate's healthcare unit says it's in an ideal position to capitalize on frightened markets, and it plans to take advantage of the financial stress by snapping up weaker companies.

Bayer Healthcare CEO Arthur Higgins told the Wall Street Journal that his company is mostly interested in businesses that make over-the-counter meds, veterinary drugs and medical devices. That's because Bayer already has a strong prescription drug business, Higgins explained, and would only look at companies that make prescription meds if they carry a significant upside.

"Despite some of the uncertainties that are obviously in the financial markets at the moment, we're in a very strong position to take advantage of the weakness in some other companies," Higgins said. Opportunities should arise in the next "six to 24 months," he said.

- read the WSJ story

Bayer - Top 13 Ad Budgets

Maureen Martino — Tue, 23 Sep 2008 16:11:42 -0400

Company: Bayer
2007 Ad Spending: $861 million
2006 Ad Spending: $683.4 million

Breakdown

Magazines: $102.5 million
Newspaper: $16.1 million
Outdoor: $900,000
TV: $330.6 million
Radio: $18 million
Internet: $5.3 million

Where Bayer is spending money: Almost all of Bayer's top products enjoyed a budget boost, but the largest increases went to Bayer's contraceptives Yaz ($75.8M) and Mirena ($39.5M), which were hiked 253 percent and 209 percent, respectively.

Most of Bayer's consumer products were up as well. Aleve--the company's biggest campaign--was up 42 percent to $87 million, and Bayer's image-advertising came in third behind Yaz with a $74 million budget. One A Day, Ascensia, Alka-Seltzer and Midol rounded out Bayer's ad budgets that saw increases in 2007.

The company upped ad spending for magazines, along with newspaper, TV and local radio. Overall, Bayer's 2007 sales increased a hefty 22 percent to $44 million.

Where Bayer isn't spending money: The only big product that experienced a budget cut was the veterinary drug K9 Advantix, down 18 percent from 2006 to $18 million. The company backed off national newspaper spots and radio, as well as Internet advertising, which was down over 50 percent.

Bayer CEO scoffs at takeover talk

Tracy Staton — Tue, 16 Sep 2008 11:12:22 -0400

Market watchers can wag their tongues all they like, says Bayer CEO Werner Wenning (photo). The company isn't vulnerable to a takeover, he told a German newspaper, because its market cap of €42 billion is just too much for a suitor to swallow. Wenning acknowledged that "you can't rule out anything, especially not in the current environment," but allowing for a slim possibility isn't the same thing as admitting a fair chance.

You'll recall that last week, rumors of a Pfizer takeover boosted Bayer shares, in spite of the fact that Pfizer has been pooh-poohing talk of doing any big buyout deals. Wenning's reponse didn't stop traders from bidding up Bayer stock yet again, this time to a seven-month high.

Meanwhile, Bayer has been working on a deal of its own: It has agreed to acquire the German drug developer Direvo Biotech for $298 million. A protein engineering expert, Direvo will help beef up Bayer's capabilities in biologic drugs.

- read the Pharmalot item
- check out the AP story
- here's the release on the Direvo buyout

Bayer up on Pfizer buyout talk

Tracy Staton — Tue, 09 Sep 2008 10:09:17 -0400

Market matchmakers won't leave Pfizer alone. Today, rumors are circulating that the drugmaker is negotiating to buy Bayer, which has a healthy pipeline and a strong consumer drugs business. The euro-conglomerate saw its stock rise about 4 percent on the market chatter.

Would Pfizer do such a thing? Well, we all know that the drugmaker needs to pump up its business, fast. It's losing a major chunk of revenue when Lipitor goes off patent, and so far there's not much waiting to fill that gap. And Bayer's market cap of some $59 billion wouldn't be too big to swallow for the $157 billion-cap Pfizer--especially considering that Bayer would presumably be broken up in such a deal. Bayer's healthcare business accounts for only a third of its revenue, and Pfizer wouldn't be interested in the chemicals businesses.

But Pfizer just recently sold off its non-prescription drug biz to Johnson & Johnson, so why would it want to buy into another one? And as the Wall Street Journal Health Blog points out, Bayer just granted U.S. rights to one of Bayer's most promising drug candidates, rivaroxaban, to J&J. That takes a big asset off the table. For their part, Bayer and Pfizer are refusing comment.

- read the post at the New York Times DealBook
- check out the Health Blog's take

Bid-happy analysts play matchup

Tracy Staton — Mon, 04 Aug 2008 10:20:11 -0400

Analysts just can't get their minds off which drugmakers might make a deal next. The most recent suspects are Bayer and Onyx, which are partnered on the liver and kidney cancer med Nexavar. One industry observer pointed out that both the Roche-Genentech offer and the Bristol-ImClone bid include lucrative cancer meds. And if you're looking at cancer meds, this one naturally comes to mind. Onyx shares leapt accordingly last week.

And then there's Johnson & Johnson and Vertex. They're partners; Vertex is working on a drug for hepatitis C, and J&J doesn't have those U.S. rights. So snapping up the whole company might be attractive. "Not cheap, but look what you get," one analyst wrote to investors.

Meanwhile, Deutsche Bank's Barbara Ryan threw some cold water on speculation that Eli Lilly might buy out Amylin for full access to Byetta, the diabetes med. New scrips for that drug have been flat lately, she said. Plus, Amylin is "a one-product story," whereas Genentech and ImClone have more to offer.

- read the post at the Wall Street Journal Health Blog
- check out the item at Pharmalot

AZ raises forecast; Sanofi reports 'bloodbath'

Tracy Staton — Thu, 31 Jul 2008 10:36:34 -0400

More big earnings news today, with the undisputed winner being AstraZeneca, which raised its 2008 forecast and trounced analyst expectations for the quarter. Not so lucky: Sanofi-Aventis, whose earnings suffered on the weak dollar. Here's more:

Bayer posted a 13 percent drop in profits, but still beat the Street's forecast. Sales rose 3.6 percent to €8.51 billion. The healthcare unit reported a 6.6 percent increase in revenue, helped by a 90 percent leap in sales of the cancer treatment Nexavar, and big growth for contraceptives Mirena and Yasmin, and the multiple-sclerosis med Betaferon.
Allergan didn't suffer much from lower-than-expected sales of Botox and other meds; its sales rose 20 percent to $1.16 billion, and profits climbed to $147.3 million from $138 million a year ago.
AstraZeneca posted a 9 percent boost to sales to $7.96 billion, as the cholesterol med Crestor, asthma treatment Symbicort, and antipsychotic med Seroquel grew by more than 10 percent each. Nexium, the heartburn treatment, and heart med Toprol XL continued to lose sales, however, to generic competition. In emerging markets, overall revenues grew by 20 percent to $1.15 billion.
Sanofi-Aventis saw profits drop by 4 percent to €1.61 billion, as sales dropped almost the same amount to €6.69 billion. Currency losses outweighed increasing sales of big drugs such as the Lantus insulin injection and breast cancer med Taxotere. The company also discontinued development on four drugs. One analyst called the report a "bloodbath."
Japan's Takeda Pharmaceutical saw its first-ever operating loss this quarter on costs from its $8.8 billion acquisition of Millennium Pharmaceuticals. The drugmaker saw a loss of $251.7 million (¥27.18 billion) on an 8.3 percent rise in revenues to 396.88 billion.
Daiichi Sankyo saw sales drop for the quarter, to ¥203.73 billion from ¥235.54 billion a year ago. Net income dropped, too, to ¥25.08 billion from 41.41 billion. The company also announced a procedural delay in its buyout of India's Ranbaxy Laboratories, as the companies await regulatory approval there.

- see the Bayer numbers in the Wall Street Journal
- check out Allergan's report in the Los Angeles Times
- read the Financial Times news on AstraZeneca
- find Sanofi's earnings at MarketWatch
- get Takeda's figures in Forbes
- see the RTT News piece on Daiichi

Bayer eyes 20% annual growth in China

Tracy Staton — Tue, 08 Jul 2008 10:09:10 -0400

Like its Big Pharma brethren, Bayer is casting a gimlet eye on the drug market in China. The company says it's aiming for 20 percent-plus annual growth in China for each of the next five years. Most forecasts show Chinese healthcare growing at a 20 percent clip yearly, and the German company means to expand there faster than the market does to keep its market-share lead there.

Bayer currently operates four manufacturing plans in China and has plans to finish a $39 million expansion of one facility in Beijing that makes aspirin, diabetes meds, and other drugs. Last week, the company wrapped up its $156 million buyout of over-the-counter cough and cold meds from China's Topsun Science and Technology Quidon Gaitianli Pharmaceutical. And yesterday after its Chinese growth pledge--but not only because of it--ING reiterated its "add" rating for Bayer stock.

- check out the post at Pharmalot
- see the story at Trading Markets

Barr, Bayer clinch generic Yasmin deal

Tracy Staton — Tue, 24 Jun 2008 09:24:06 -0400

Another generic deal that antitrust watchdogs love to hate: Barr Pharmaceuticals inked a deal to sell an "authorized generic" version of Bayer's birth control pill Yasmin by July 1, several years before the product's last patent expires. Barr also will launch an authorized copycat of Bayer's Yaz product on July 1, 2011. In both instances, Barr gets exclusive rights to sell the meds in the U.S., and Bayer will supply the pills. In return, Bayer will get a share of the sales.

You'll recall that in March, a federal court deemed one of Yasmin's key patents invalid. Bayer is appealing that decision. Even if Bayer wins, though, Barr will still get to sell generic Yasmin. It will just have to pay a larger share of sales to Bayer for the privilege.

- check out the release
- read the Associated Press story
- see the coverage in Forbes

Bayer fined $16.2M in price-fixing probe

Tracy Staton — Thu, 29 May 2008 10:50:12 -0400

Bayer was fined $16.2 million for fixing the prices of aspirin and other over-the-counter meds in Germany; the government alleged that a local Bayer subsidiary made illegal rebate deals with more than 21,000 pharmacies. Bayer denied the allegations, saying it agreed to the fine to avoid a long legal fight. Report

Swiss pricing pressure angers Vasella

Tracy Staton — Tue, 27 May 2008 10:09:32 -0400

Daniel Vasella (photo) is riled. The Novartis CEO says its hometown officials are putting too much pressure on drug prices. Swiss Interior Minister Pascal Couchepin should keep in mind that reduced prices could interfere with innovation--and would lower Novartis' tax revenues, too. (The company pays $488 million or so to the Swiss government each year.) "The pressure from (Couchepin) is too strong,” he told the Berner Zeitung. “Drugs in Switzerland are now cheaper than in Germany.”

Meanwhile, Novartis may be celebrating the EU's OK to sell its new Extavia MS drug. Rightfully so. But even after launching the drug--first in a new portfolio of Novartis treatments for MS--the company has, shall we say, a long row to hoe. Extavia will face stiff competition from existing drugs such as Bayer's Betaseron. It could take a couple of years for Novartis to penetrate the MS market in any significant way, analysts say. "It is difficult to know what market percentage Novartis is going to achieve with this new drug," Tom Muller, an analyst with Theodoor Gilissen, told Forbes.com. "They have to start from scratch."

- see the Forbes article on Extavia
- check out the Pharmalot item on Vasella

Italians arrested in pay-for-approval scandal

Tracy Staton — Fri, 23 May 2008 10:47:48 -0400

There's another corruption scandal brewing in Italy--this time involving a pay-to-play scheme at AIFA, the pharma regulatory agency. Authorities arrested Pasqualino Rossi, Aifa's vice president and a senior rep at the E.U. regulatory body, the European Medicines Agency, after a two-year investigation. At issue: licenses for about 30 meds (as yet unidentified by authorities, but many of them are believed to be generics). Allegedly, drugmakers or their representatives bribed regulators to accept falsified clinical data and approve their products.

According to PharmaTimes, five drug-company lobbyists were also arrested. Among them were people "linked" to Bayer and GlaxoSmithKline, Italy's La Repubblica newspaper is reporting. Both companies vehemently deny direct involvement, however. Bayer says that the investigation had looped in some "collaborators" whose behavior Bayer had no knowledge of. "We will cooperate...with the investigating authorities," the company's Italian spokesman said. A GSK spokesman said neither the company nor any of its associates were involved. "The claims are completely untrue," he said.

- read the story at PharmaTimes

Bayer's Werner Wenning - CEO Pay

Tracy Staton — Mon, 19 May 2008 15:03:13 -0400

Werner Wenning - Bayer

Total Compensation: $4.77M

2007 Revenue: $50.84B
2006 Revenue: $45.46B
Change: 11.8%

Details: Wenning earned just over half a million dollars in base salary, $2.3 million in bonus pay and $1.1 million in stock grants.

Bayer News:
Bayer lower 2008 expectations
Bayer plans to beef up biotech pipeline

Is this the end of the Trasylol story?

Thu, 15 May 2008 06:59:57 -0400

A new study could be the last nail in Trasylol's coffin. In a head-to-head comparison of Trasylol (aprotinin) and two other anti-bleeding meds, patients getting Trasylol during heart surgery were much more likely to die than patients on the other meds. "In all likelihood, this is the end of the aprotinin story," two researchers wrote in a New England Journal of Medicine editorial accompanying the study's publication.

Bayer, you'll recall, temporarily suspended Trasylol sales last fall when this government-funded Canadian study was stopped early because of the death rates among patients using that drug. An analysis of the data showed Trasylol boosted the chance of death by 54 percent, with 6 percent of patients using that drug dying within 30 days of surgery, compared with 4 percent on the other two drugs.

Bayer faces some 80 lawsuits over the drug, claiming that Trasylol caused unnecessary deaths and that the company hid evidence of its potential risks. Responding to the NEJM article, the company said it is still deciding what to do about the med.

- see the Los Angeles Times article
- check out the Toronto Star's piece