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I think the 6.5% price hike Byetta took on April 3rd helped with the Q2 figures more than total scrips.
BMY quiz
1. Zerit (Stavudine)
2. Was the single agent synthetic thymidine nucleoside analogue
of choice for HIV treatment.
Semi OT - Venture funding
Nature 460, 459 (23 July 2009) | doi:10.1038/460459a; Published online 22 July 2009
The incredible shrinking venture capital
http://www.nature.com/nature/journal/v460/n7254/full/460459a.html
John Browning1
1. John Browning is a writer and consultant. He co-founded the First Tuesday networking forums for venture capitalists and innovators.
Abstract
Venture funding is declining quickly and is unlikely to bounce back. But less money means lower expectations — good news for smaller science start-ups, says John Browning.
The incredible shrinking venture capital
The days when stock options put Ferraris into the car parks of start-ups are over, and venture capital is drying up. In the first quarter of 2009, US venture-capital investments in the life sciences fell 40% from the fourth quarter of 2008, in biotechnology they fell 46%, and in software 42%. Even investment in green technologies — such as those designed to improve energy efficiency — was down 84%, more than wiping out the 54% increase from 2007 to 2008.
This isn't necessarily all bad news. The venture-capital boom of the 1990s created expectations that many companies cannot meet. As the amount of venture capital shrinks, both venture capitalists and entrepreneurs are rethinking some of their basic assumptions. Having less money might make companies healthier, given the reduced pressure to be a skyrocketing success and the increased flexibility for business strategy and growth. Although the conventional venture-capital model has best suited fast-growing IT or biotech companies, it could begin to suit science and technology start-ups aimed at smaller markets.
Venture capitalists usually look for companies that will grow quickly — as a rule of thumb, with sales of at least US$50 million within six years — and that can then be sold, either to a larger firm or on to the stock market. Without a sale, venture capitalists can't return profits to those who invested the money in the first place. The microelectronics and Internet booms of the 1990s and early 2000s provided both fast growth and sales; the lure of a Google-like financial cornucopia inspired a fivefold increase in the amount of capital in venture funds between 1996 and 2001. But more and bigger sales were needed to keep investors happy.
Risky business
This style of investing can build great companies. Think of Google, Intel, Apple, Cisco Systems and Genentech. Mercenary though it may be, the focus of creating a sellable company forces managers to make the most of their opportunities. Venture capitalists are also tolerant of risk: a typical fund would expect about a third of its investments to fail outright. But what venture capitalists can't tolerate is the merely average. They have a term for companies that reach, say, $10 million in sales and neither lose so much money that they go out of business, nor grab the markets to continue growing and fetch a high sale price. They call them the 'living dead'. Where many might see a nice little company — including biotech ventures whose names would be familiar to many — a venture capitalist sees mostly frustration. Today, with capital markets crunched and sales slow, more and more investments look as though they fall into this category.
Returns on venture-capital investments have sagged steadily since the Internet boom years. Now both venture capitalists and their investors are losing patience. After a 7% decline in 2007, the collective assets of US venture capitalists shrank by 24% in 2008, to $197 billion. The result was fewer investments, falling from $8 billion across 1,058 deals in the fourth quarter of 2007 to $3 billion for 549 deals in the first quarter of 2009 — the lowest amount of investment since 1997. Paul Kedrosky, a former venture capitalist turned industry commentator, predicts the money isn't coming back. He estimates that the venture-capital industry will settle down to about half the size it was in the early 2000s, or about the same as it was in the late 1990s.
In the face of such declines, some are eschewing outside investment altogether and financing companies with their own resources. In IT, the cost of starting a business has fallen dramatically; one US entrepreneur, Paula Conway, recently financed her travel website by selling cupcakes.
Others have been looking harder at 'angel financing', in which wealthy individuals put their own money into deals. These individuals still want a return on their investment, but they are more willing to take it as a stream of dividends from a company that has found a valuable niche, rather than as profit from the sale of the company. Although the amount of angel financing in the United States shrank by about 26% from 2007 to 2008, it was still about $19 billion for 2008, not far below traditional venture capital, according to a study by the Center for Venture Research, at the University of New Hampshire in Durham. What is more promising is that the money was spread across roughly the same number of deals in 2008 as in 2007: about 55,000.
Given the lacklustre returns of traditional investment strategies, venture capitalists are also looking to do more with less. Marc Andreessen, co-founder of Netscape Communications and a pillar of the Silicon Valley establishment, recently co-launched a venture firm that plans to invest as little as $50,000 per start-up — far less than the $3 million considered to be a minimum by many venture capitalists. Although it is early days, efforts such as this might reshape venture capitalism. Without the weight of Googlesque expectations on their shoulders, companies that might have joined the ranks of the living dead could start to look lively. A start-up focused on a non-blockbuster drug or diagnostic test might now find itself with an attractive niche market, garnering the attention of venture capitalists who would usually have avoided this type of limited-growth company.
Smaller investments will force entrepreneurs to work harder — no more plush offices or fridges stocked with designer fruit juice. But, because the returns demanded by investors are proportional to the amounts put in, smaller investments also reduce the pressure on companies and allow them to become more flexible in their business strategies. And that is what entrepreneurship needs most.
Tidbits from 2Q: Genzyme expects that drugs from the Allston manufacturing facility will be back in the market by November/December. So, if treatment protocols of Shire and Protalix are approved, their drugs could enter the market around September.
Genz-112638 will start phase III studies next month.
Phase IIa results of GSK's next generation integrase inhibitor:
http://www.ias2009.org/pag/Abstracts.aspx?AID=2120
Ok, I see the problem now that complete 90-day data from a 24-patient Phase II study of ALN-RSV01 in adult lung transplant patients infected with RSV are out:
http://finance.yahoo.com/news/INSERTING-and-REPLACING-bw-1471672549.html?x=0&.v=3
The ALN-RSV01 arm had more than double Respiratory Infections After Day 30 (see the table in the link) than placebo!
I think the Questcor huge price hike on Acthar was in 2007 and there was an even bigger one - Ovation, which hiked the price on Cosmegen in 2006 by more than 3,000%.
If you have a couple of hours, watch his talk:
The aggressive ones (prior to the start of generic competition )are of Provigil or Actiq but I don't think they fit in your time frame.
Last patient (the 27th) was treated with BL-1040.
I bet on Avonex - 9% price hike in Nov. and 9.5% in Mar.
And so claim MRK/SGP.
Semi OT - America's Best Hospitals: the 2009–10 Honor Roll
And the winner is - Johns Hopkins:
http://health.usnews.com/articles/health/best-hospitals/2009/07/15/americas-best-hospitals-the-2009-2010-honor-roll.html
Yes, an interim analysis in an imaging trial CIMT, strikes me as uncommon, guess it was meant to save money. If Niaspan didn't show a meaningful effect on IMT, it makes sense to stop the trial and forget about it, if it was more effective, I assume we would have heard about it.
Apparently, I need an editor and a shrink on top ;)
And it's Allen J Taylor, MD, who is the principal investigator of the trial:
http://clinicaltrials.gov/ct2/show/NCT00397657
FDA Sets Conditions for Required Postmarket Studies
http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&id=2240
(MRK ABT) Idit et al: How are you handicapping the halted Niaspan vs Zetia study? T.i.a.
Abbott Profit Slips as Depakote Faces Cheap Copies
http://www.bloomberg.com/apps/news?pid=20601202&sid=aWTXKa.Q1Su8
By Tom Randall
July 15 (Bloomberg) -- Abbott Laboratories’ profit fell 2.6 percent as sales missed estimates, hurt by the rising dollar and growing generic competition to the anti-seizure medicine Depakote. The company’s shares declined.
Second-quarter net income dropped to $1.29 billion, or 83 cents a share, also pulled down by expenses for an acquisition and cost-cutting moves, the Abbott Park, Illinois-based company said today in a statement. Sales increased 2.5 percent to $7.5 billion, less than the $7.57 billion average estimate of 10 analysts.
Abbott Chief Executive Officer Miles White is pushing new heart stents and eye-surgery equipment to reduce reliance on drugs. In addition to growing competition for Depakote, Abbott faces the prospect that sales of Humira -- the company’s biggest product, with $4.5 billion in revenue last year -- may slow as consumers reduce spending, said Rick Wise, an analyst at Leerink Swann & Co. in New York.
“Given bullish sentiment heading into the quarter, investors could focus on the sales miss,” Wise said in a note to clients today. “Humira growth recovered a bit in the quarter. Investors may question whether” the renewed sales growth is sustainable, he said.
Sales of Depakote tumbled 75 percent to $102 million amid competition from generics. The drug had sales of $1.58 billion in 2007 before losing exclusivity in July 2008, and revenue slipped to $1.36 billion last year.
Abbott fell $1.21, or 2.6 percent, to $45.28 at 4 p.m. in New York Stock Exchange composite trading. The stock has declined 22 percent in the past 12 months.
Third Quarter
Abbott forecast third-quarter profit of 83 to 85 cents a share, or 5 cents higher when certain costs are excluded. Analysts had expected 90 cents a share, with the items excluded.
The company recorded charges of $67 million for cost- reducing moves and $33 million for expenses related to the acquisition of Advanced Medical Optics, the world’s top maker of eye-surgery equipment.
With the purchase, valued at $2.8 billion and completed in February, pharmaceuticals make up about half of Abbott’s sales. The deal installed Abbott in the $22 billion-a-year eye-care market and bolstered a medical device business that includes stents, diagnostic tests and insulin pumps for diabetics.
Advanced Medical’s sales for the first full reported quarter at Abbott were $265 million.
Abbott is interested in small- to medium-sized acquisitions to expand its product pipeline, and isn’t interested in mega- mergers, said Thomas Freyman, Abbott’s chief financial officer, repeating comments in a conference call that he has made previously. He didn’t define the size categories.
No Interest in Solvay
The company isn’t looking to buy drugs owned by Solvay SA to expand its presence in fenofibrates, medicines used to lower cholesterol and triglyceride levels, Freyman said.
Solvay, based in Brussels, is considering a sale of its drug division, including the Tricor cholesterol pill that it co- markets with Abbott.
“We have no interest in expanding our participation in the fenofibrate market,” Freyman said. “We already have a presence there and an adequate investment.”
The strengthening dollar pared the value of revenue outside the U.S. for the quarter and lowered total sales by 8 percentage points, Abbott said. The dollar gained 11 percent against six major world currencies during the last 12 months, according to data compiled by Bloomberg.
Earnings Quality
“Aside from the greater-than-expected foreign exchange hit, most segments came in roughly in line with our forecast,” said Michael Weinstein, a JPMorgan Chase & Co. analyst, in a note to clients. “Earnings quality was good, in our view. Humira sales were slightly ahead of our forecast.”
Humira sales rose 20 percent to $1.31 billion, compared with $1.22 billion, the average of two estimates compiled by Bloomberg. Sales of the drug, which costs an average of $19,000 a year for each patient, grew 17 percent in the first quarter, less than analysts expected, as the global recession deepened. Abbott won expanded approval early last year for Humira to treat the skin disease psoriasis and juvenile rheumatoid arthritis.
Competitors include Johnson & Johnson’s Remicade and Amgen Inc.’s Enbrel. In June, J&J won $1.67 billion, the largest patent verdict in U.S. history, from Abbott over an invention used to produce Humira. Abbott pledged to appeal.
Biggest Seller
Humira, the company’s biggest seller, was responsible for about 17 percent of Abbott’s revenue for the second quarter. The company has projected Humira’s global sales growth of 15 percent to 20 percent this year.
Revenue from Abbott’s Xience, a drug-coated mesh sleeve that props open blood vessels, helped drive U.S. vascular sales up 34 percent to $658 million. Xience took the leading share of the $4 billion stent market less than six months after approval in July 2008.
Sales at Abbott Nutritionals, maker of Similac infant formula and Ensure vitamin-fortified drinks to replace meals, rose 4 percent to $1.28 billion for the second quarter. U.S. sales rose 10 percent, while international nutritional products declined 1.9 percent.
Sanofi says experts find Lantus studies flawed
http://www.reuters.com/article/marketsNews/idUSLF73372620090715
* 14 experts say cancer studies inconclusive and conflicting
* More analysis of existing data, new research recommended
* Sanofi says "moving forward confidently" to resolve issue
* Sanofi shares gain 1.2 percent
By Helen Massy-Beresford and Ben Hirschler
PARIS/LONDON, July 15 (Reuters) - Sanofi-Aventis (SASY.PA: Quote, Profile, Research, Stock Buzz) said on Wednesday a group of independent experts had concluded that studies highlighting a possible link between its Lantus diabetes drug and an increased risk of cancer were flawed.
A multidisciplinary board of experts from the United States, France, Germany, Italy and Canada reached the conclusion after being asked by the French drugmaker to assess four studies published last month in the medical journal Diabetologia.
They found "significant methodological limitations and shortcomings" and said the results were "inconsistent and inconclusive".
But they added the important scientific questions raised called for further analysis of existing data on Lantus, as well as more basic and clinical investigations.
Sanofi shares were up 1.2 percent at 42.70 euros by 0910 GMT, outperforming a 0.4 percent advance in the DJ Stoxx European drugs sector index .
Sanofi is relying on its long-acting insulin Lantus to offset a fall in sales of other products, such as Plavix and Lovenox, which could soon face generic competition.
Its stock dived last month when worries about a possible but uncertain link with cancer first surfaced.
The drugmaker said at the time that the data was of "poor quality" and no firm conclusions could be drawn -- though that did not stop analysts slashing sales forecast for the drug.
Wednesday's statement, signed by 14 medical experts, may go some way to restore confidence, but analyst Jeffrey Holford at stockbroker Jefferies said it did not shed any significant new light on the controversy.
"What the market is really waiting for is not statements from experts on data we've already seen but new information, new studies and new data," he said.
SPECTRE OF AVANDIA
Matthew Riddle, professor of medicine at Oregon Health Sciences University in the United States and one of the 14 experts, said the problems with the studies in Diabetologia meant there was no reason to change clinical practice.
"The nature of these limitations and their potential magnitude are such that, individually or in aggregate, these studies provide inconsistent and inconclusive results which do not justify new clinical recommendations to patients," he said.
Jean-Pierre Lehner, Sanofi's chief medical officer, said: "We are moving forward confidently with the external scientific and medical experts and health authorities toward next steps to resolve this controversy."
Lantus had sales of 2.45 billion euros ($3.43 billion) in 2008 and had been expected to continue to grow strongly, reflecting the growing incidence of diabetes worldwide.
The last big safety scare over a diabetes drug involved GlaxoSmithKline's (GSK.L: Quote, Profile, Research, Stock Buzz) pill Avandia, which was linked to heart attack risk in a U.S. study in 2007. Glaxo contested those findings, but sales of the drug still halved.
That precedent has spooked many investors, although it may not offer a direct parallel to the case of Lantus.
In the case of Avandia, safety concerns were championed by a high-profile medical expert -- U.S. cardiologist Steve Nissen -- and received massive U.S. media coverage. But with Lantus there is no big name campaigner involved and media coverage has been much more low key.
"We're seeing daily and weekly prescription data pointing to a slight deterioration in Lantus," said Holford. "It looks nothing like Avandia in terms of the rundown in prescriptions but you just don't know if it is going to be a slow death."
Investors are watching closely to see how the affair plays out for Sanofi's rivals.
Beneficiaries could include Denmark's Novo Nordisk (NOVOb.CO: Quote, Profile, Research, Stock Buzz) -- provided its rival long-acting insulin Levemir remains free of similar safety scares -- as well as makers of other types of diabetes medicines. ($1=.7149 euros)
Aha a geneticist! :)
(good for genomic&proteomic researchers, i should think)
the reason for the precipitous fall in JNJ’s Cypher revenues is the colossal success of ABT’s Xience
How Injured Racehorses Might Save Your Knees
http://www.technologyreview.com/biomedicine/22998/
Orthopedic stem-cell therapies are moving into human trials.
By Emily Singer
A runner with a torn tendon has reason to envy a racehorse with the same affliction: horses have treatment options not available to human patients--most notably, injections of adult stem cells that appear to spur healing in these animals with shorter recovery time than surgical treatments. Now the same stem-cell therapies used routinely in competitive horses and increasingly in dogs are beginning to make their way into human testing.
Human stem-cell treatments are advancing quickly in many areas: therapies using adult stem cells derived from both fat and bone marrow are currently being tested for a variety of ailments, including Crohn's disease, heart disease, and diabetes. (Bone-marrow-derived stem-cell transplants have been used for decades to treat blood diseases and some cancers.) But when it comes to orthopedic injuries, such as torn tendons, fractures, and degenerating cartilage, veterinary medicine has outpaced human care.
Veterinarians and private companies have aggressively tested new treatments for the most common injuries in racehorses, in large part because these animals are so valuable and can be so severely incapacitated by these wounds. "Soft-tissue injury is the number-one injury competitive horses will suffer and can end a thoroughbred horse's career," says Sean Owens, a veterinarian and director of the Regenerative Medicine Laboratory, at the University of California, Davis. Veterinary medicine also has much more lax regulations when it comes to treating animals with experimental therapies, allowing these treatments to move rapidly into routine clinical use without clinical trials. "Regulatory oversight of veterinary medicine is minimal," says Owens. "For the most part, the USDA [U.S. Department of Agriculture] and the FDA [Food and Drug Administration] have not waded into the regulatory arena for us."
Owens's newly created research center aims to move both animal and human stem-cell medicine forward by conducting well-controlled trials not often performed elsewhere. "Part of our mission is to do basic science and clinical trials and also improve ways of processing cells," says Owens. The center has a number of ongoing clinical trials in horses--one for tendon tears and one for fractured bone chips in the knee--that are run in a similar way to human clinical trials. The goal is to develop better treatments for horses, as well as to leverage the results to support human studies of the same treatments. Owens is partnering with Jan Nolta,director of the Stem Cell Program, at UC Davis, who will ultimately oversee human testing.
A handful of studies in animals have shown that these stem-cell therapies are effective, allowing more animals to return to racing, reducing reinjury rates, and cutting healing times. VetCell, a company based in the United Kingdom that derives stem cells from bone marrow, has used its therapy on approximately 1,700 horses to date. In a study of 170 jumping horses tracked through both treatment and rehabilitation, researchers found that nearly 80 percent of them could return to racing, compared with previously published data showing that about 30 percent of horses given traditional therapies could return to racing. After three years, the reinjury rate was much lower in stem-cell-treated animals--about 23 percent compared with the published average of 56 percent, says David Mountford, a veterinary surgeon and chief operating officer at VetCell.
While scientists still don't know exactly how the cells aid repair of the different types of injuries, for tendon tears, initial studies show that stem cells appear to help the tissue regenerate without forming scar tissue.
Mountford says that the company chose to focus on tendon injuries in horses in part because they so closely resemble injuries in humans, such as damage to the Achilles tendon and rotator cuff. For both people and horses, tendon tears trigger the formation of scar tissue, which has much less tensile strength and elasticity than a healthy tendon. "It becomes a weak spot and prone to injury," says Owens.
Next year, VetCell plans to start a human clinical trial of its stem-cell treatment for patients with degeneration or damage of the fibers of the Achilles tendon. As in the horse therapy, stem cells will be isolated from a sample of the patient's bone marrow, then cultured and resuspended in a growth medium also derived from the patient. Surgeons will then inject the solution into the area of damage, using ultrasound imaging to guide the needle to the correct location. "Our long-term goal is to use it to treat a number of tendon injuries," says Mountford.
Stem-cell therapies also show promise for arthritis. Vet-Stem, a California-based company that uses stem cells isolated from fat rather than bone marrow, has shown in a placebo-controlled trial that the treatment can help arthritic dogs. "About 200,000 hip replacements are done every year in humans," says Robert Harman, a veterinarian and founder of the company. "That's a very good target for someone to look at cell therapy."
For osteoarthritis, the stem cells seem to work not by regenerating the joint, but by reducing inflammation. "But in the last couple of years, evidence has come out that the cells we use reduce inflammation and pain, and help lubricate the joint," says Harman.
While Vet-Stem does not plan to move into human testing, Cytori, a company based in San Diego, has developed a device for isolating stem cells from fat in the operating room. (Vet-Stem does the procedure manually: veterinarians collect a fat sample from the animal and then send it to the company for processing.) Cytori's device is currently approved for use for reconstructive surgeries in Japan but not yet in the United States.
Even if Tarceva gets approved for maintenance (and it probably will), I don't think docs will use it, they will probably stick to the old way of taking the patient off the drug and use 2nd line after progression.
Roche/OSIP Tarceva extends lung cancer survival
http://www.reuters.com/article/marketsNews/idINLD51812720090713?rpc=44
* Study shows patients treated with Tarceva live longer
* Lung cancer most common cancer worldwide
* Positions drug well versus competitor
(Adds details, stock reaction, comment)
ZURICH, July 13 (Reuters) - Roche Holding AG's (ROG.VX: Quote, Profile, Research, Stock Buzz) Tarceva cancer drug improved the survival of patients with advanced lung cancer when used immediately after initial chemotherapy, the Swiss group said on Monday.
The Phase III SATURN study showed Tarceva improves overall survival when used immediately after initial chemotherapy in patients with advanced lung cancer, the group said.
The news helps the position of Tarceva, which is co-marketed by U.S. biotech company OSI Pharmaceuticals(OSIP.O: Quote, Profile, Research, Stock Buzz), against Eli Lilly's (LLY.N: Quote, Profile, Research, Stock Buzz) Alimta and supports filing for approval in the United States and European Union, Sal Oppenheim analysts said.
"We have made no changes to our estimates, but this new data reinforces our view of Tarceva's approval and commercial potential," they said in a note.
Roche stock rose 0.1 percent to 145.60 Swiss francs by 1146 GMT, versus a 0.1 percent drop in the DJ Stoxx European health care index.
Treating patients immediately following first-line chemotherapy versus waiting for the cancer to grow or spread before giving additional treatment represents a new approach in advanced non-small cell lung cancer (NSCLC), Roche said.
Tarceva is already approved to treat pancreatic cancer in the United States and EU.
Lung cancer is the most common cancer worldwide with 1.5 million new cases annually and NSCLC accounts for almost 85 percent of all lung cancers, it said.
Hisamitsu has proposed to acquire Noven for total cash consideration of approximately $428 million, or $16.50 per share, in an all-cash tender offer for 100% of the outstanding shares of Noven. The offer price represents a 22% premium to the closing price of Noven’s common stock on July 13, 2009
http://www.thestreet.com/_yahoo/story/10542447/1/hisamitsu-to-buy-noven-for-428m-noven-soars.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Teva aims to relieve
http://www.haaretz.com/hasen/spages/1100055.html
By Yoram Gabison
Teva Pharmaceutical Industries has set its sights on chronic pain and cancer treatments as the company's next target markets. The first drug under consideration for purchase is Zenvia, which is being developed by Avanir Pharmaceuticals. Avanir is trading at a market cap of $145 million, after its share price skyrocketed 353% since the beginning of the year. This company's shareholders include venture capital funds such as Clarus Ventures (12.5%), ProQuest Investments (19.9%) and Vivo Ventures (11.2%).
Zenvia, which is in the third and decisive stage of clinical trials, is being developed to treat two medical conditions: pseudobulbar affect (involuntary outbursts of crying or laughing in patients suffering from Alzheimer's, ALS, multiple sclerosis, Parkinson's, stroke or head trauma) and diabetic peripheral neuropathy (DPN). DPN, one of the most common complications of diabetes, is a neurological disorder of the limbs, causing both a strong burning sensation and a pins-and-needles sensation in the soles of the feet. About 50% of diabetes patients develop neuropathic pain.
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Teva is likely to consider buying other companies, too, such as Durect, which is developing technologies for administering very strong painkillers such as oxycodone, therefore preventing this drug from being abused as a heroin substitute. Durect is trading at a market cap of $200 million. Another buyout candidate is Pain Therapeutics, which is trading at a value of $183 million and owns the development rights to Remoxy, Durect's leading product. Pain Therapeutics is also developing Oxytrex, an innovative chronic pain treatment that does not cause dependency.
Analysts such as Ken Cacciatore of Cowen and Company have posited that Teva could buy competing pain treatment companies such as Endo Pharmaceuticals, trading at a value of $2 billion and King Pharmaceuticals, whose current market cap is $2.2 billion. King has also formed cooperative ventures with companies that specialize in developing pain treatments, such as Pain Therapeutics. A Teva source responded by saying that the company does not comment on conjectures regarding its business dealings.
CaFite is simultaneously recruiting patients for a Phase I/II clinical trial for CF102 for treating HCV and liver cancer.
http://www.globes.co.il/serveen/globes/DocView.asp?did=1000480599&fid=1725
The pramlintide/leptin phase IIa trial enrolled overweight and obese patients with a BMI of 27-35 kg/m2. Think this subgroup might be too 'light' to tolerate 2xday injections.
Note that this is an evaluable study population analysis, not the ITT. Also, this study randomized 608 obese or overweight patients with a BMI ranging from 27-45 kg/m2 but they only give results of those with BMI less than 35 kg/m2.
Making big drugs during troubled times
http://money.cnn.com/2009/07/08/news/companies/amgen_kevin_sharer_biotech_pharmaceuticals.fortune/index.htm
Amgen CEO Kevin Sharer's job is to produce blockbuster drugs. Will health-care reform make that harder?
By Geoff Colvin, senior editor at large, July 9, 2009
(Fortune Magazine) -- These are momentous times for Amgen, the world's largest biotech company. The health-care revolution brewing in Washington could be dramatically good news or bad for a business whose drugs tend to be life-changing -- and highly expensive. Also on deck this year is a critical FDA decision on Amgen's denosumab, a possible blockbuster treatment for osteoporosis and bone cancer on which Amgen is betting heavily. If it's approved, analysts expect annual sales of at least $1 billion -- maybe double or triple that. Overseeing it all is CEO Kevin Sharer, 61, who joined the company 17 years ago as a newcomer to biotech after a career with the U.S. Navy, McKinsey, General Electric, among others. Amgen (AMGN, Fortune 500) stock has been up and down during his nine years as chief, but right now Wall Street likes its prospects: 19 analysts rate it a buy or a strong buy, based on denosumab's prospects and further operating efficiencies, while five say it's a hold in light of the recession and strengthening competition. Fortune's Geoff Colvin talked with Sharer recently about health-care reform, cancer treatments, advice for new CEOs and aspiring CEOs, and much else. Edited excerpts:
Health care looks like the big issue of the summer, and President Obama's major theme is cost reduction. Many Amgen drugs are very expensive. Does that make them especially vulnerable?
To give a little context, the biopharmaceutical industry, including pharmaceuticals and biotechnology, is about 8% of the total health-care bill, and it's projected that, due to generic drugs and a few other things, that expenditure line is going to be flat for a few years. So the biopharmaceutical part of the system is sort of self-correcting.
As for individual biotechnology drugs, I think we have to look to value. For example, one of our drugs, Enbrel, is profoundly important to people with rheumatoid arthritis. It lets people who in many cases couldn't even get out of bed have a full life. It's an expensive drug [costing typically $20,000 to $24,000 a year], but the value it delivers is there. Sixty percent of the potential medicines for cancer are in the biotechnology pipeline, and if we can have a cancer drug that has profound benefit, generally that's seen as really good value. But we do have to be able to defend the value of the drug.
What about value in enabling the system to avoid costs that would be greater without the drug?
The way I think about value is avoided cost and quality of life or extension of life. Extension of life is very, very hard to achieve, but quality of life is important. We haven't yet developed a language in society to have that conversation. We need to develop a language of value in health care.
A central part of the debate right now is whether the program, whatever it turns out to be, should include a public plan. What's your view?
The devil's in the details. I would generally favor a private-sector solution, but if a public plan is deemed necessary, I would hope that it's on a level playing field. I fear statements like "What the industry needs is a not-for-profit plan to keep it honest." I'm not sure how that works. We do need to get access for people who don't have insurance. But I'd favor private sector over public.
If you could write the bill and have the President sign it, how would it read?
There are three big principles I'd want to keep in mind. First, access -- are we giving access to people in a reasonable and affordable way? Second is hope. The real thing I think America looks for my industry to do is come up with cures for the toughest diseases society faces, and I wouldn't want to do anything to diminish innovation. And the last thing I'd hope for is equity -- each member on the game board is going to have to contribute money to pay for this new environment, and we're probably going to have to tighten our belts. I hope those decisions are made on an equitable basis and everybody feels like they're paying their fair share.
When biotech was getting started back in the 1970s, part of the excitement was its potential for someday defeating cancer. It's 30 years later -- how are we doing?
It's still an important goal. There's definitely been progress made. There are many cancers that would've been a complete death sentence 30 years ago and that now we manage in a chronic way. We still have a lot of work to do. We understand the biology a lot better, but cancer is hundreds of different things, at least seven to 10 different biological mechanisms. And the body is amazingly redundant -- you block one thing, something else happens. I think we're going to be fighting cancer as a disease for the next 50 to 100 years, which seems very, very long, and it is long, but in a medical products development time frame, that's probably four or five product development cycles. We are making progress, there's no doubt about it.
They say every problem is an opportunity. Have you found any opportunities in this recession?
The opportunities are for a company that has a strong financial position and a good reputation. In our industry there are many biotechnology companies that are having a hard time raising cash. Those are opportunities for us to help them develop products. Our biggest opportunity in this situation is to reach out to some of the earlier-stage companies and see if we can find some products we can help develop. Just the other day we announced a $50 million investment in a small company called Cytokinetics (CYTK), which has a novel mechanism of action for congestive heart failure. It's a difficult disease. This is an early stage, but we think the biology is exciting, and we were delighted to have the chance to invest.
In April you cut Amgen's full-year sales outlook. How come?
For the first time in anybody's memory we're starting to see the biopharmaceutical industry and the medical industry at large affected by a recession. I think there are a couple of reasons. One is very high unemployment, and every time the unemployment rate goes up, people lose health insurance. Second, I think people are more aware of what they have to pay -- some of the cost has been shifted to them. While people don't have a full understanding of their cost of health care, they now bear more cost. That combination, I think, is unique.
And so what we did, out of caution, is we said it looks like a 1% effect on sales. We cut some costs, and our earnings should still be fine.
Everybody has made cost cuts in this recession, but choosing what to cut is a major management decision. How did you make that decision?
We made it as a team. I have eight or nine people I work with, and we try to make decisions based on collective judgment. The most important thing is to develop the products we have in the pipeline, so we protected that. Equally important is to make sure of the quality of the products we deliver to the market -- no compromise. But you'd be surprised when you look at things as mundane as travel, temporary workers, and vendors. You can get more money out than you might think. It's no one big thing. It's tightening the belt across the board but keeping the critical activities well funded.
One area where companies typically cut in a recession is training and development. What have you done?
We have not cut anything in development. When I became CEO about nine years ago, we decided that executive development was profoundly important, and we run weeklong classes with case studies from Amgen's experience, mostly things we didn't do well, because that's what you learn the most from. We haven't cut back on that at all. Developing people is the future of the company.
Earlier in your career you worked in three of the highest-performing organizations I know of: the U.S. Navy, McKinsey, and General Electric. What lessons did you take away about what creates a high-performing organization?
I was in the submarine force in the Navy, Adm. Rickover's child, and the basic thing that came out of the Navy was that the level of excellence you should hold yourself to should be extraordinarily high. At McKinsey what I learned was to make complexity simple in an analytic way and to communicate it so people can quickly understand it, and be right. At General Electric (GE, Fortune 500) I learned how to be a general manager. It was probably the best factory I ever saw for that. I spent time on the chairman's [Jack Welch's] staff, and watching him up close showed the power of embracing reality, being nimble, being adaptive, aggressive, competitive -- but still, as he used to say, we can be hardheaded in business yet softhearted when it comes to taking care of people.
All those organizations are intensely people-focused.
My life experience has taught me that there is no substitute for the best team. If I were going to give advice to a new CEO, I'd just say there is no substitute for the best team, and do what it takes to get one.
What have you learned about evaluating people when you're trying to distinguish the future stars from the rest?
Early in my career I thought I was able within a minute or two to evaluate anyone. I'm not that cocky anymore. So I've learned it's good to have multiple views of someone before you make a decision. The second thing I've learned is that personal characteristics are fundamental. If you don't have the right personal characteristics, I don't care what experience you have. The third thing is that, particularly at the senior levels, looking at where someone has been and what they've done is profoundly important in deciding what they can do. Then there's some intangible that's hard to describe, but you know it when you see it -- and if you're right three out of four times, you're in the hall of fame.
You mentioned Enbrel, the arthritis treatment. It accounted for almost a quarter of revenues in the first quarter, and sales of it were down markedly. How is Amgen going to make up for that?
One of the things that has affected that drug is these high co-pays that I talked about, and we've taken steps to relieve consumers of that burden. We're making sure that consumers don't pay any more than a nominal amount in co-pay, and we basically will handle the co-pays for them.
Why are investors and the industry so interested in denosumab?
Denosumab is a drug for osteoporosis. It has a new mechanism of action. It works on the bone biology to slow down the molecule that chews up the bone. You only have to take a shot twice a year, and you're protected from osteoporosis. We've very, very excited about it. We're also developing it for a kind of bone cancer, and we look forward to the final results of those trials this year. This has been a drug we've worked on for 15 years. We did the fundamental biology and invested over $1 billion. I bet my job on it. So I was happy that it turned out okay.
What happens next?
We're working with the FDA now, and it's not over till it's over, and you never predict exactly what agencies in the government are going to do, but I'm very, very enthusiastic, and more important, the doctors who've looked at it have been very positive in their response. I think it'll really be important for patients.
How dependent will Amgen be in its near-term future on this drug?
As is often the case in our industry, one drug is important, and this is clearly important in the intermediate term to us. Some analysts have predicted that it could have quite large potential. The unmet need for osteoporosis is huge. So it's very, very important to us.
You're an engineer, not trained or educated as a biologist or scientist, but you're managing a company that's built entirely on science and biology. How can you make the big decisions you have to make?
I leave the early discovery decisions to the scientific leadership. It's not something I have expertise in. It doesn't cost that much money. When I get involved is when we start spending a lot of money, which is when we start registration trials. For example, denosumab was over 10,000 patients, 25 countries, hundreds and hundreds of millions of dollars. We put the firm's reputation on the line. It gets publicity. So as the product moves through the pipeline, I get more and more involved. Again, I don't independently make the decision. I just convene the right people, listen to the conversation, and ask the right 10 questions.
Would I be correct in saying research is the core of Amgen?
Yes.
So much depends on the passion and dedication of your scientists and researchers. How can the CEO manage that?
The board asked me that question, and sitting on our board is a Nobel Prize winner in biology [David Baltimore, now president emeritus and a professor at Caltech] and a distinguished physician-scientist who's run big systems [Gilbert S. Omenn, former CEO of the University of Michigan Health System, now a professor at Michigan]. So it was a serious question. When I knew I was going to be CEO, I took a little sabbatical at their direction to learn about R&D, and I thought maybe there was a system, an answer. What I found out is, there's about 16 things you've got to do right, but the single most important thing, I decided, was hire the best person in the world to run research and development, and support that person. That's what I tried to do, and I think I got close to succeeding. [Amgen's R&D chief since 2001 has been Dr. Roger M. Perlmutter, a former Merck executive and professor at the Howard Hughes Medical Institute at the University of Washington.] It's having that person, then giving them the money and telling them to swing for the fences.
Presumably that person has tremendous power to attract other scientists.
Another easy concept I have is that A's don't work for B's very long, so you'd better start with A's at the top.
Earlier you told us your advice to a new CEO. What's your advice to somebody who wants to be a CEO but isn't one yet?
First is broad responsibility -- don't get channeled into just one functional area. Second is to focus on the job at hand, not your career. Third, be willing to embrace risk and know that you only grow outside your comfort zone.
Abbott Study of Niaspan Against Merck’s Zetia Halted
http://www.bloomberg.com/apps/news?pid=20601202&sid=atu8hw5KcjXM#
By Shannon Pettypiece
July 9 (Bloomberg) -- A study comparing Abbott Laboratories’ cholesterol drug Niaspan with Merck & Co. and Schering-Plough Corp.’s Zetia was ended early, for reasons unrelated to patients’ safety.
The study, called ARBITER 6 HALTS, ended after a decision “based on results of a prespecified, blinded interim analysis,” according to a posting in the National Institutes of Health’s clinical trials database. “It was not stopped due to safety concerns.” The research was funded by Abbott and conducted at Walter Reed Army Medical Center, in Washington.
Researchers looked at whether using Niaspan to raise HDL cholesterol was more effective than lowering LDL cholesterol with Zetia, judging by the thickness of patients’ neck arteries. Positive results for Niaspan may boost Abbott’s earnings by 2 percent in 2012 and add as much as $400 million in sales, Larry Biegelsen, an analyst with Wells Fargo Securities LLC in New York, said in a note to clients today.
“We think Niaspan likely performed better than Zetia in the HALTS study,” Biegelsen said. “A positive result for Niaspan and Simcor in HALTS could represent upside potential to our Abbott estimates.”
The Simcor drug combines Niaspan and the older cholesterol pill simvastatin. Niaspan had $786 million in sales last year. Sales of Zetia fell 22 percent in the U.S. to $310 million in the first quarter, after a study last year showed the drug wasn’t any better at unclogging arteries than simvastatin.
Abbott, based in Abbott Park, Illinois, said it wasn’t told by the researchers why the study was ended early and wasn’t involved in the decision.
Amgen's Uphill Marketing Battle
http://www.businessweek.com/technology/content/jul2009/tc2009078_741612.htm
Shares of the biotech giant surged on signs its bone-loss treatment is effective, but getting doctors to prescribe the drug will be tough
By Arlene Weintraub
When biotechnology giant Amgen (AMGN) announced study results for its experimental bone-loss treatment denosumab, Wall Street cheered.
In a head-to-head trial against the popular Novartis (NOVN) drug Zometa, denosumab was clearly superior in treating breast cancer patients who suffered bone loss when their cancer spread, according to research results released July 7. Deutsche Bank (DB) added $550 million to its forecast of the drug's peak annual sales, suggesting it could someday bring in $3 billion a year. Other analysts were even more bullish, predicting the drug could generate $1 billion to $2 billion in the breast-cancer market alone—that's on top of what Amgen might haul in by selling the drug to women with post-menopausal osteoporosis. Early in the day's trading session, Amgen's stock soared 15%, to 60 a share, before closing at 59.50.
The rally was fueled by some mighty big expectations that won't be easy for Thousand Oaks (Calif.)-based Amgen to meet. For starters, the Food & Drug Administration won't decide whether to approve the drug until October. More important, in getting doctors to prescribe the drug and patients to clamor for it, Amgen may be facing its biggest marketing challenge yet. The osteoporosis market is dominated by some of the most famous names in pharmaceuticals: Roche's Boniva, Novartis' once-yearly version of Zometa called Reclast, and Merck's (MRK) Fosamax, which went generic last year. About 38 million prescriptions are written for bone-loss treatments every year, and the market reached $4.6 billion in sales in 2007, according to IMS Health (RX). Total sales dropped 22% last year when cheap versions of Fosamax became available.
Breaking Down Barriers
Denosumab will offer some distinct advantages over its rivals. In post-menopausal osteoporosis, patients will be able to get denosumab as a twice-yearly injection from primary-care doctors. That will make it more convenient than Fosamax, which is a daily or weekly pill, and Boniva, which patients take monthly. And unlike some of the older drugs, denosumab does not seem to touch off a frightening side effect called osteonecrosis of the jaw (ONJ), which can cause pain and bone protrusions in the mouth. (In the most recent trial, ONJ was rare in the Zometa group, too.)
But Amgen will have to achieve what none of its peers has ever attempted before: getting primary-care physicians comfortable with the idea of injecting a biotech drug into their patients. Denosumab, which will likely carry the brand name Prolia, will be the first nonvaccine biologic product to be marketed to general practitioners. It's a gigantic market where the 29-year-old company has until now been a complete nonplayer. Amgen's biggest products, such as Araesp and Enbrel, are sold to rheumatologists, oncologists, and other specialists. What's more, denosumab is not the type of product patients can inject themselves, so doctors will have to prod them to come into the office twice a year. That could be a hard sell, especially when physicians have the option of prescribing inexpensive pills. Roger Perlmutter, Amgen's vice-president of research and development, isn't worried. "Most elderly people are seeing a doctor every six months anyway," Perlmutter said in a June interview.
Even though Amgen has not yet detailed its marketing plans, it's a safe bet the company will have to hit the airwaves with direct-to-consumer (DTC) ads. Its competitors have been spending heavily on ads for their products: In 2008, Roche spent $92 million on Boniva ads featuring actress Sally Field, according to TNS Media Intelligence. About $60 million of that was spent on TV spots. And Novartis spent $53 million pitching Reclast as the most convenient osteoporosis drug on the market, due to its once-yearly dosing. Perlmutter is quick to point out that Reclast has to be given by IV infusion, making it not quite as convenient as it may appear to be on TV. "General practitioners would have to set up infusion centers," he says. "They won't want to do that. The hassle factor is significant."
Itching for a Blockbuster
Amgen does have some experience with DTC ads, though it hasn't always been positive. In 2005, the FDA asked the company to withdraw ads for Enbrel, a rheumatoid arthritis drug that was also approved to treat psoriasis. The agency felt the psoriasis ads overstated the drug's efficacy and understated its risks. It took eight months for the company to revamp the campaign. And last year, Congressmen John Dingell and Bart Stupak, both Michigan Democrats, looked into whether aggressive advertising of anemia drugs developed by Amgen and marketed both by it and Johnson & Johnson (JNJ) encouraged oncologists to prescribe them in excessive doses. The FDA added "black boxes" to the drugs' labels, warning that they were associated with increased tumor growth.
Such troubles have investors itching for Amgen to prove that denosumab can be its long-awaited next blockbuster. The company's net income grew just 2% last year, to $4.8 billion, on sales that also increased 2%, to $15 billion. But the latest trial results had even the most conservative analysts sitting up and taking notice. Christopher Raymond of Robert W. Baird raised his price target on the stock from 60 to 65. "Dmab," he wrote, invoking the drug's nickname, "hit one out of the park." Soon it may be up to Amgen's marketing staff to follow up with a home run of its own.
Even if ONJ rates on D-mab are a bit higher than those on Zometa, D-mab's reversible activity might provide a better ability for bone healing.
Agree on the potential of their plant cell platform. That's partly why I bought back (Biocell) after the huge peak, here at TASE, late 07 and still holding.
PTIE/KG Remoxy NDA resubmission - they have 6-month stability data, they are repeating them and a PK trial in healthy volunteers and also adding likeability study to the package.
http://finance.yahoo.com/news/King-Provides-Additional-prnews-3836489675.html?x=0&.v=1
PTIE/KG Remoxy NDA resubmission only in mid-2010
http://www.reuters.com/article/marketsNews/idINN0730472220090707?rpc=44
DOJ Shifts Policy on Generic Drug Patent Settlements:
http://online.wsj.com/article/SB124691728092502381.html
You did look attractive in that hospital gown
On the other hand, the BL-1040 trial is going to cease recruting any day now, so be a good lad and take it easy.
Marathon Venture Capital Fund (TASE: MARA) has sold a large part of its holding in Protalix Biotherapeutics Inc. (AMEX:PLX). Marathon sold 600,000 shares for $2.8 million, reducing its holding to 7.8%. It expects to report a pretax capital gain of NIS 10 million on the sale.
http://www.globes.co.il/serveen/globes/docview.asp?did=1000478303&fid=942
The FDA is trying to avoid supply shortage of Cerezyme and it means that both drugs from Shire and PLX could be available to US patients, for free before approval. So, no money and I doubt many patients will switch, but it's a nice PR for the new drugs.