Swiss-based Roche Holding realizes there is little it can do to provoke Genentech into accepting its takeover offer, but that doesn’t mean the pharmaceutical company is going to stop trying to persuade the biotech’s shareholders.

Roche Holding announced Friday that it would raise its hostile takeover bid for the California-based biotech to $93.00 per share, or $47.5 billion, from the lower offer of $86.50 per share, or $42.0 billion, that it pitched the shareholders in January. ) Genentech rebuffed the Swiss stakeholder’s original offer of $89.00 per share, or $43.7 billion, last summer. 

“Based on conversations with Genentech shareholders, we believe that there is a strong sentiment to bring this process to a conclusion,” said Roche Chairman Franz B. Humer. The company added that the conditions of the tender offer that commenced in February remain unchanged and 500,000 shares have already been tendered. 

Shares of Genentech jumped 9.6%, or $6.84, to $89.48, on the announcement. Genentech has told Roche that it would not allow a takeover for anything less than $112.00 per share. Genentech urged shareholders Friday to take no action; it said it would eventually issue a more formal statement with its reasoning.

The hostile offer that was commenced in February was set to expire on March 12 at midnight, which has now been extended to March 20.

The Basel-based company is trying to get its hands on all profits for Genentech’s blockbuster cancer drugs Avastin and Herceptin, as well as an attractive portfolio of new medicines.

Roche is Genentech’s largest shareholder and currently own 55.8% of the biotech. Of Genentech’s seven board members, three are independent directors, one is the Genentech chief executive and the three others are designated by Roche. Genentech Chief Executive Arthur Levinson pointed out at a recent conference in New York that Genentech-developed products accounted for 66.0% of Roche’s top-selling drugs in 2008.

A drug which appears to erase painful memories has been developed by scientists.

The astonishing treatment could help sufferers of post-traumatic stress disorder and those whose lives are plagued by hurtful recurrent memories.

But British experts said the breakthrough raises disturbing ethical questions about what makes us human.

They also warned it could have damaging psychological consequences, preventing those who take it from learning from their mistakes.

Dr Daniel Sokol, a lecturer in medical ethics at St George’s, University of London, said: ‘Removing bad memories is not like removing a wart or a mole. It will change our personal identity since who we are is linked to our memories.

‘It may perhaps be beneficial in some cases, but before eradicating memories, we must reflect on the knock-on effects that this will have on individuals, society and our sense of humanity.’

Dutch researchers claim to have erased bad memories by using ‘beta-blocker’ drugs, which are usually prescribed to patients with heart disease.

The drug could erase frightening memories - such as spider phobia
Experiments on animals had already shown that the drugs - beta-adrenergic receptor blockers - can interfere with how the brain makes and remakes memories of frightening events.

In the latest study, Dr Merel Kindt of Amsterdam University tested the drugs on 60 men and women.

His team created fearful memories in volunteers by showing them pictures of spiders while giving them gentle electric shocks.

The volunteers were urged to ‘actively remember’ the images, creating a strong negative association between spiders and discomfort.

The following day the volunteers were split into two groups. One was given the beta blocker and the other a placebo pill before both were shown the same spider pictures.

The researchers recorded the level of fear in the volunteers by playing sudden noises and measuring how strongly they blinked.

A strong startle response showed they were in a fearful state, while a mild response showed they were calm.

The group given the beta blocker had a much weaker fear response than those given the dummy pill, the researchers report in the journal Nature Neuroscience.

A day later - once the drug was out of their systems - their fear response was tested again.

Once more, those given the beta blocker the previous day showed fewer signs of spider phobia, suggesting the memory was completely erased.

Beta blockers appear to work because each time someone recalls a powerful emotional memory the memory is ‘remade’ by the brain.

The drug interferes with this re-creation of the stressful memory - and prevents the brain renewing it.

In theory, it could eradicate memories of traumatic events that happened years ago. It might also help patients overcome phobias, obsessions, eating disorders and even sexual hang-ups.

Dr Kindt said: ‘Traditionally, therapists seek to teach people with such disorders strategies to build new associations and block bad memories but the problem is the memories remain and people often relapse.’

It could be several years before doctors prescribe the drugs for patients with post-traumatic stress disorder.

The scientists say more tests are needed to confirm the drug’s memory- erasing properties. Dr Kindt said: ‘The next steps are to look at how long the drug’s effects on memory last, and testing the treatment in people who actually are suffering from some kind of disorder or phobia.’

But British experts warned the drug raises some difficult questions.

Professor John Harris, an expert in biological ethics at the University of Manchester, said: ‘It is obviously up to the individual whether or not she wishes to risk the possible effects, including psychological discontinuity, of erasing unpleasant memories.

‘An interesting complexity is the possibility that victims, say of violence, might wish to erase the painful memory and with it their ability to give evidence against assailants.

‘Similarly criminals and witnesses to crime may, under the guise of erasing a painful memory, render themselves unable to give evidence.’

Paul Farmer, chief executive of the mental-health charity Mind, said he was concerned about the ‘fundamentally pharmacological’ approach to problems such as phobias and anxiety.

He told Channel 4 News that the unintended consequences ‘could include the eradication of positive memories’.

Professor Neil Burgess of the Institute of Cognitive Neuroscience told the programme that wide-scale use of the drug was a long way off.

‘All they’ve shown so far is that the increased ability to startle someone if they are feeling a bit anxious is reduced,’ he said.

The ability to remove memories has been the stuff of science fiction for decades.

In the film Eternal Sunshine of the Spotless Mind, which starred Kate Winslet and Jim Carrey, a couple used a technique to erase memories of each other when their relationship turned sour.

GlaxoSmithKline PLC, the world’s second-biggest drug maker by sales, plans to cut prices in the world’s poorest countries and invest 20% of its profit from those markets into building health clinics and other infrastructure.

In a speech at Harvard Medical School on Friday, Glaxo Chief Executive Andrew Witty also proposed that drug companies, nonprofit groups and others donate their patents related to neglected tropical diseases to a common pool, with the hope that such a pool would speed development of new drugs.

“Society expects us to do more in addressing these issues. To be frank, I agree,” Mr. Witty said, according to his prepared remarks. “We have the capacity to do more, and we can do more.”

Mr. Witty said Glaxo will cut prices on its patented medicines in the poorest 50 countries in the world so that they are no higher than 25% of the price in developed countries.

In an interview before his speech, Mr. Witty acknowledged that the concessions won’t cost Glaxo much. The British company’s total sales in the poorest countries are about £30 million, or roughly $43 million, a year; 20% of its profit would probably amount to about £1 million to £2 million annually, he said.

Glaxo’s treatments for hepatitis B, genital herpes, malaria and asthma are among those that will be subject to price cuts, a Glaxo spokeswoman said. Glaxo already sells its HIV drugs in these countries at not-for-profit prices, and if those prices aren’t already lower than 25% of the developed-world price, they will be reduced, as well, she said.

Michelle Childs, director of policy advocacy at Medecins Sans Frontieres, said any price cut is welcome but added that the drop won’t necessarily make the drugs affordable to poor people in countries such as Bangladesh, Uganda and Cambodia. Usually, drugs become affordable only when cheap generics become available, she said.

If a patent pool is created, Glaxo should be able to contribute patents related to malaria and tuberculosis, the Glaxo spokeswoman said. Robert Don, a scientist with Drugs for Neglected Diseases Initiative, a nonprofit drug developer in Geneva, said such a pool would be invaluable.

Many drug companies, including Glaxo, already share their research with Drugs for Neglected Diseases Initiative, but negotiating access to their intellectual property can take as long as a year, he said. And the group sometimes can’t work with more than one company on the same disease area at a time, for fear of leaking one company’s intellectual property to another.

Mr. Witty said Glaxo wouldn’t contribute its HIV patents to the pool, since the company thinks there already is innovation in HIV medicines, spurred by the profits to be made in Western markets.

GlaxoSmithKline Logo

Ellen ‘t Hoen, a senior adviser to the international drug-purchasing consortium Unitaid, said she hopes Glaxo will still contribute its HIV patents to a new pool Unitaid is trying to create. The goal is for big companies to share patents on their latest HIV drugs with generic-drug companies, which would sell the treatments cheaply in the poorest countries and pay the patent holders a royalty.

The generic-drug makers also could tweak the drugs to make them more usable in the poorest countries, such as in pediatric formulations. Ms. ‘t Hoen said Unitaid has had early talks with Glaxo and other companies, and that all have agreed to consider the idea.

NEW DELHI: Four years after the drug for erectile dysfunction, Viagra, was launched in India, the Haryana Police claimed to have seized on Sunday more than 200 kg of fake drugs from a unit in Udyog Vihar in Haryana. The drug was being manufactured for the past six months at the Udyog Vihar unit and being sent to countries like UK, US and Canada, said the police.

The raid was conducted after a watchdog organization called Enforcers of Intellectual Property Rights (EIPR) alerted cops about possible manufacturing and supply of fake medicines like Viagra. A spokesperson of this body, Dhirendra Singh, said, “We zeroed in on this manufacturing unit after we got to know that Viagra variants were being circulated in Indian and overseas markets.”

Viagra

“The samples of drugs were collected and sent for examination and after months of painstaking efforts, the Udyog Vihar unit was identified. We informed the Haryana Police and joint raids were conducted. There were around 1 lakh fake Viagra tablets manufactured by Chem Pharma Company at Udyog Vihar,” Singh added.

Haryana State crime DIG Shatrujeet Kapur told TOI “The raids were conducted on Sunday evening and we are still in the process of weighing the medicines. They are all fake, and so far 122kgs of Viagra have been found. Chem Pharma Company was also manufacturing other drugs and we are in the process of verifying them. The drugs seized are in finished, semi-finished or in raw material form.”

Kapur also added that eight employees of the firm have been detained and their statements are being recorded. We will also register a case against the company and its owner S C Bhardwaj has also been detained. He is likely to be arrested,” DIG Kapur added.

Police said that they have seized some papers pertaining to supply and shipment of the fake drugs and are being examined. “Details about the supplier of raw materials have also been sought. We are now focusing on those who used to purchase the medicine in India. We will be conducting more raids in connection with the case,” said a senior police officer of Haryana crime branch.

This is one of the biggest seizures of fake drugs by the state police in recent past. Sources said that the pharma company was also raided by central drug controller and reports are being sought about those raids. In 2007, the Mumbai police had also seized a huge quantity of fake Viagra reportedly shipped from China.

IT LOOKS AS IF ABBOTT LABORATORIES HAS discovered the secret of healthy living. While most of its rivals are flat on their backs, the pharmaceutical giant has been cranking out promising new products, dodging competition from makers of generic drugs and posting double-digit gains in profits.

The company’s shares managed to climb 32% over the past three years, while health-care stocks as a group fell 15%. And with Abbott ’s main products poised for strong growth, the stock could do even better over the next few years.

The stock isn’t cheap. At a recent 56, it’s trading at 15.3 times expected earnings for this year, versus the sector’s multiple of 12. But bulls argue convincingly that the premium is deserved because of the company’s earnings power. Abbott has a broader product base than many drug companies, including a sizeable medical-devices business, and it has relatively little exposure to patent expirations, the bane of Big Pharma. Looming patent expirations on key drugs helped convince Pfizer (PFE) that it should strike a $68 billion deal for Wyeth (WYE).

The Illinois-based Abbott, with a market value of $87 billion, posted a 17% earnings jump last year, to $3.32 a share, on nearly $30 billion of sales. In contrast, the sector’s earnings were flat.

Abbott’s gains have been fueled in part by its fast-growing business in heart stents, which are used to prop open damaged arteries. Stent sales surged 78% last year, to $1.2 billion, and Abbott’s Xience drug-coated stent, which hit the U.S. market last summer, has leapfrogged to a leading position in the U.S. market, mainly at the expense of competitor Johnson & Johnson (JNJ). Coming next: versions of Xience for Europe and Japan.

But Abbott’s biggest growth engine is Humira, an injectable drug used to treat rheumatoid arthritis, Crohn’s disease, psoriasis and other ailments. Humira sales jumped 48% last year, to $4.5 billion, or 15% of total revenue. Abbott also does a brisk business in cholesterol drugs such as Niaspin, and nutritional products like Similac baby formula.

Though it’s clearly getting harder for drug companies to increase earnings — think pricing pressures from possible health-care reform — Abbott executives exude confidence. “We are committed to double-digit earnings growth over the next several years,” says CEO Miles White, who has been at the helm for 10 years.

Two years ago, Barron’s cast a skeptical eye on Abbott, concerned about the safety and effectiveness of the company’s drug Tricor (”A Troubling Lab Report,” June 4, 2007). One of Abbott’s top sellers, Tricor helps patients lower triglycerides, a type of noncholesterol fat. Since our earlier story, laboratory studies have failed to support the concerns, and a company spokesman cites data showing the drug to be safe.

In fact, Abbott is working with British drug maker AstraZeneca (AZN) to develop a drug that combines TriLipix — a next-generation fenofibrate, the generic name for Tricor — with AstraZeneca’s blockbuster cholesterol drug Crestor, a statin. Abbott plans to submit a new-drug application for this combination in the second half of this year.

That’s just one of several important product-initiatives under way. Just a few weeks ago, Abbott moved to expand its niche in ophthalmology, announcing it would purchase vision-care company Advanced Medical Optics (EYE) for $2.8 billion in a deal that positions it to benefit from the growing need for cataract treatment as baby boomers age.

Meanwhile, Abbott is developing an asthma treatment called Flutiform and expects to file for approval this year. A drug called ABT-847 is being tested for treatment of psoriasis and Crohn’s disease, and the company is exploring further applications for Humira.

Abbott Laboratories

“We continue to advance a number of compounds with breakthrough potential,” says White. “We are focusing on discovering new treatments across a spectrum of therapeutic areas,” including oncology, neuroscience and immunology.

AS IT PROCEEDS, ABBOTT is facing far fewer problems than rivals in maintaining product exclusivity. The company has lost protection for only one of its major products, Depakote, used to treat bipolar disorders, which went off patent last year. And it faces no patent losses over the next few years. Humira remains on patent through December 2016.

Patents expired last year for J&J’s Risperdal antipsychotic and Merck ’s (MRK) Fosamax bone-building drug, leading to cheaper copycat versions. Pfizer loses the patent for its blockbuster Lipitor cholesterol drug in 2011, and Eli Lilly (LLY) that year will lose protection on its big antipsychotic drug Zyprexa. Swiss drug maker Novartis (NVS) loses patent protection for its top-selling blood-pressure drug Diovan in 2012.

For Abbott, the combination of strong products and solid patent protection adds up to potentially stellar profits. Morgan Stanley analyst David R. Lewis believes Abbott will beat consensus earnings estimates in 2010 and 2011 with per-share net of $4.23 and $4.72, respectively. When he adds up the value of Abbott’s various businesses, he arrives at $102.4 billion, or about $66.44 a share, which is in line with his 12-month target price of $67.

Portfolio manager Rick Helm of the Cohen & Steers Dividend Value fund (DVFAX) likes the company’s consistent dividend growth. Indeed, Abbott has raised its dividend for 36 years and shows no signs of slowing the increases. The dividend now stands at $1.44, for a yield of 2.6%. Pfizer, on the other had, recently ended a 41-year run of dividend boosts.

“We expect Abbott’s dividend to grow nearly 10% this year and roughly 9% a year for the next few years,” says Helm, whose $146 million fund focuses on companies with rising dividends. But he also sees ample room for stock appreciation: “We believe there’s 40% upside in the stock based on the growth of the company’s core businesses, lack of any significant generic competition in its key products and a pipeline that’s not sexy but has a number of promising products.”

ABBOTT, FOUNDED IN 1888 by Chicago physician Wallace Abbott, has undergone a revolution in recent years, improving both its products and profitability through diversification and acquisitions. Once regarded as slow-moving, dull and problem-plagued, the company now participates in some of the largest and fastest growing markets in medical technology.

Credit for the change mostly goes to White, 53, a Stanford University MBA who joined the company in 1984. He has made a number of key acquisitions that have propelled revenue and earnings gains and brought major new products under the Abbott roof. Abbott got Humira through the 2001 acquisition of Knoll Pharmaceuticals, while the 2006 purchases of the vascular and endovascular businesses of the former Guidant Corp. brought Xience into the fold.

Abbott is less acquisition-minded these days, focusing more on internal research-and-development and organic growth than pursuing more acquisitions. “The good news is that we don’t need to do any more M&A to deliver on our commitments,” White says.

That doesn’t mean that double-digit growth is in the bag. The key will be to keep Humira hot. After all, that mainstay product been growing an average of 30% annually in recent years, nearly triple the growth of the rest of Abbott.

There’s some concern on Wall Street that the sales growth is unsustainable, that it will have to level off and then decline. It would certainly be hard to replicate Humira’s recent growth with another product.

The Bottom Line

Abbott’s stock could rise 40% over the next 18 months, as a result of a well-executed diversification strategy. And the dividend should keep climbing.But even if Humira’s sales growth does decline, it should still be robust. The drug is nowhere near saturating its current markets: Its penetration of rheumatoid-arthritis treatments alone could climb from 25% now to 33% in 2016, says Morgan Stanley’s Lewis, with more patients switching from products like J&J’s Remicade. And Abbott is exploring new applications such as treating ulcerative colitis — potentially a $500 million market. Use of the drug for that ailment is in Phase III clinical trials, as is its use for pediatric Crohn’s.

In all, Lewis sees Humira sales increasing by an average of 23% a year through 2011. Though not even half of last year’s blistering pace, it should be enough to keep Abbott’s profits, and stock price, moving ever higher. In these times of global economic turmoil, settling for 23% growth doesn’t sound too bad at all.

]]> http://www.natafod.com/2009/02/14/abbott-labs-a-prescription-for-success/%/feed http://www.natafod.com/2009/01/26/creative-capitalism-vs-malaria-the-back-story/% http://www.natafod.com/2009/01/26/creative-capitalism-vs-malaria-the-back-story/%#comments Tue, 27 Jan 2009 04:00:32 +0000 15P8 http://www.natafod.com/?p=8315 Very interesting stuff.. Hopefully this is a sign of things to come. Businessweek

My colleague Steve Hamm has a piece in the Jan. 26 issue of BusinessWeek on one of the most forward-thinking collaborations out there today. It’s called the Artemisinin Project, an unconventional effort by Big Pharma’s sanofi-aventis, biotech upstart Amyris Biotechnologies, a University of California researcher, and the first nonprofit drug developer in the U.S., the Institute for OneWorld Health, to take on malaria.

The goal is to get cheap drugs into the hands of poor people around the world who do not have access to health care, and the partners are on track to have a new semi-synthetic version of artemisinin—the only truly effective treatment for the disease—into Africa and Asia in 2012. They wouldn’t be this close without Nina E. Grove, a OneWorld Health vice-president.

Photo of Nina Grove by Timothy Archibald

Grove hired on with the San Francisco-based organization in early 2006. Grove, who has master’s degrees in public health and medical microbiology from the University of California in Berkeley, had just stepped away from biotech giant Genentech, where she had spent 20 in product development, including work on an AIDS vaccine. In 2007, she was promoted to head OneWorld Health’s malaria program.

One of the tricks in any partnership is keeping everyone on the same course. Often this requires a commander. Grove set up a steering committee of representatives from Amyris and sanofi-aventis. Together they came up with a strategy for developing the chemical, scaling up production, and getting it into the marketplace. “Our challenge was to get everyone on board with our process,” Grove told Hamm.

“I believe in collaborative leadership,” she continued. But she clarified there is a chain of command: “I’m the boss.”

Nina Grove

While pharmaceutical companies and nonprofits have worked together before, particularly on AIDS treatments, this project is more ambitious. “This is part of a grand effort to link biotechnology, industry, and academia on product development,” says Regina Rabinovich, head of the infectious diseases group at the Bill & Melinda Gates Foundation, which has written a $42.6 million, five-year grant to OneWorld Health to fight malaria. “Without these kinds of partnerships, the pharmaceutical industry can’t afford to make the investments in developing products for poor people.”

“We’re the engine that pulls it together,” Grove said. “We bring people together. We hope we’re shaving years off the normal time line.” By thinking creatively, she and her corporate partners seem to be winning one battle at least.

The injection is being sold in two dosages, 50mg and 100mg, and is used mostly in hospitals and clinics as an intravenous neuromuscular blocking agent.

“In addition to safety measures such as barcoding and latex-free stoppers, APP has incorporated a peel-off syringe label on all of its rocuronium vials,” said Thomas Silberg, president and chief executive at the firm.

The drug is one of the most extensively used muscle relaxants in the US, Canada and many European nations, according to IMS figures from 2007, generating $127 million (£92 million) worth of sales in the US.

Last month, APP launched a safety initiative on its website designed to educate patients about heparin, a drug used to reduce blood clotting during open-heart surgery which is given to patients suffering from conditions such as acute coronary syndrome, atrial fibrillation, deep-vein thrombosis and pulmonary embolisms.

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