Roche has tipped investors on all the key talking points ahead of today’s pipeline review. In a statement released early today, Roche noted that it is positioned to launch six new therapies by the end of 2014 and wants to push beyond cancer therapies and into new arenas, such as metabolism, inflammation and the central nervous system. And it has the potential to add 35 new indications for currently-approved therapies over four years.

Roche’s scientists believe that the pipeline currently includes 10 new molecules with the potential to emerge as a best-in-class therapy. And the company says that it can move 20 programs into late-stage trials by 2015.

Among its top prospects, Bloomberg highlights: Taspoglutide, a new GLP-1 drug for Type 2 diabetes; Aleglitazar, also for diabetes; The ‘good cholesterol’ drug dalcetrapib and PLX4032 for melanoma. All are believed to have solid blockbuster potential.

While Roche’s income from oncology drugs failed to live up to expectations recently, its near-term revenue is pinned on three key blockbusters: Avastin, MabThera and Herceptin. Analysts also credit Roche with being in a far better position than most other Big Pharma outfits, with enough time to develop new products that can boost revenue ahead of any key patent losses. Today’s pipeline show is designed to convince investors that it has that task well in hand.

Source: FierceBiotech

Popularity: 1% [?]

J&J has rattled analysts with a new timeline for the Alzheimer’s drug bapineuzumab, saying that full, late-stage results for the closely-watched therapy may not be available for two years.

“We are conducting some of the largest-scale trials ever in Alzheimer’s disease,” a J&J spokesperson told Bloomberg an e-mailed comment. “When they are complete, we expect to have a very comprehensive understanding of the clinical impact of bapineuzumab.” The delay was attributed to the fact that J&J is still recruiting patients for the late-stage trials, and final results will have to wait until 18 months after the last patient is enrolled. Pfizer, which is partnered on the drug, has its own studies underway.

UBS analyst Gillaume van Renterghem quickly dubbed the delay “bad news,” saying that analysts were eagerly expecting the data on the potential mega-blockbuster “as quickly as possible.” J&J obtained the drug for its portfolio when it bought out Elan’s rights to the Alzheimer’s program last year.

Elan and Wyeth had started Phase III for bapineuzumab back in 2007. They launched a late-stage program even before the Phase II data was in, hoping that an aggressive development timeline would lead to a swifter approval. Van Renterghem estimates top potential worldwide sales at $8 billion, adding that there are a number of pitfalls for this program that would significantly cut that back.

Source: FierceBiotech

Popularity: 1% [?]

Some newly released court documents suggest that Johnson & Johnson was leaning heavily on the geriatric market to boost sales of its atypical antipsychotic Risperdal at a time when federal regulators were warning the company against claiming the drug was safe and effective in elderly patients, Bloomberg reports.

The documents, made public after Bloomberg asked a judge to unseal them, show that J&J was pushing to expand use of the drug beyond its schizophrenia indication. “Schizophrenia represents only 35 percent” of antipsychotic scrips, one executive at J&J subsidiary Janssen wrote in an internal report. “Aggressive expansion of Risperdal use in other indications is therefore mandatory.”

Based on its review of the documents, Bloomberg reports that the company tried to sell Risperdal for a variety of off-label uses, including dementia, an indication for which the drug was never approved. Janssen expanded its geriatric sales force almost threefold during that time. And despite nominal prohibitions against talking about unapproved uses, at least some doctors paid to speak on Risperdal’s behalf didn’t adhere to that policy. “I always plant a shill because if I get asked a question from the audiencee, I can then speak off-label,” one such doctor told the company.

As usual in these cases of big document dumps, there’s a legitimate question of “cherry-picking” the best–or worst–examples from all those pages. A J&J spokesman tells Bloomberg that the Lousiana case that spawned these documents “should be decided on the body of evidence … not on the basis of excerpts from documents.”

Source: FiercePharma

Popularity: 1% [?]

GlaxoSmithKline has cut prices to boost sales in the poorest countries on the globe. Now it’s homing in on middle-income countries as another way to grow its revenues. And the company’s strategy in these nations mirrors its approach in the poorer ones: Make medicines more affordable, improve access to them, and higher sales will come.

“Our strategy is to grow our business in middle-income countries by increasing the volume of products we sell,” CEO Andrew Witty tells Bloomberg.

GSK is part of the Big Pharma parade into Asia and other emerging markets. Faced with the prospect of more generic competition and tougher pricing policies, drugmakers have been looking past the slow-growth U.S. and Europe. GSK’s revenue from emerging markets grew by 20 percent in 2009 to about $4.5 billion, and the company is looking for more growth this year.

So, GSK is using flexible pricing models to make drugs more affordable; because middle-income countries have a wide range of socioeconomic groups, the pricing models will allow for different prices in different settings. “[E]conomic status, demography and healthcare infrastructure … can vary significantly,” Witty says. “Taking a single pricing approach would be difficult, inappropriate and inequitable.”

Source: FiercePharma

Popularity: 1% [?]

Ever wonder how the cancer drug Sutent made it to market? Barely, according to a behind-the-scenes piece from Bloomberg. The drug almost hit the R&D discard pile back in 2003, said Dr. George Demetri, an oncologist who was involved in testing it. It was a meeting with FDA officials encouraged by the data that got the drug back on track, Demetri said.

Sutent has gone on to prove effective for both kidney cancer and gastrointestinal stromal tumors–and to become one of the more expensive cancer drugs on the market at around $50,000. But even at that price, it’s become key to a treatment approach known as daisy-chaining, in which patients use one drug until it stops working, then move on to another. Some patients have survived as long as seven years this way.

“Improving cancer survival rates are a real success story that sometime get lost in the noise over our healthcare system,” Douglas Blayney, president of the American Society of Clinical Oncology, tells Bloomberg. “Targeted drugs are driving that survival in a major way.”

Is paying for that survival sustainable? In Sutent’s case at least, even the U.K.’s cost watchdog thinks so; the National Institute for Health and Clinical Excellence finally OK’d the drug after Pfizer agreed to pay for the first cycle of treatment, which should weed out the patients who just won’t respond to the drug at all.

But taken together with other expensive therapies, some experts doubt that society can keep paying for such costly treatment. “All the recent health policy talk is that in the U.S. we don’t ration, but that isn’t a true statement,” said UnitedHealth Group’s SVP Lee Newcomer. “We just keep pricing more and more people out of the ability to afford health insurance.”

Source: FiercePharma

Popularity: 1% [?]

Growth in Asia, growth via acquistion, growth via acquisition in Asia: Drugmakers promised investors all these strategies over the weekend. Here’s who plans to use which approach:

• Eli Lilly said it expects its Japanese revenues to grow in the “mid teens” percentage-wise in 2010, the chief of its Japanese unit said today. That’s on top of 19 percent growth in 2009, Bloomberg reports, which put Lilly’s Japanese sales at 109 billion yen for the year, or $1.2 billion.

• Traveling in India, GlaxoSmithKline CEO Andrew Witty pledged to continue expansion in that country via acquistions and organic growth. Speaking on the sidelines of a company event in Nashik, Witty told reporters that India is a crucial market for the company. “[Acquisition] opportunities will be evaluated based on a variety of factors, including the strategic nature of the fit,” he said (as quoted by the Wall Street Journal).

• Fresh off his deal to buy the biotech-equipment company Millipore, Merck KGaA CEO Karl-Ludwig Kley tells a German newspaper that more acquisitions are on the way. “We have indeed a few ideas,” he says. “Acquisitions are part of our strategy … And so it should continue.”

Obviously, these companies aren’t unique; almost everybody in pharma is either looking to buy or be bought these days, and the list of companies targeting Japan for growth gets longer by the day.

Source: FiercePharma

Popularity: 1% [?]

Canada’s Resverlogix is in mid-stage trials for its experimental drug RVX-208. The company, which has no marketed products, is hoping it can achieve the Holy Grail of heart disease drug development: Finding a product that can raise “good” HDL cholesterol.

It’s a tree that Pfizer has been barking up for years, but without success. In 2004, the pharma giant spent $1.3 billion purchasing Esperion Therapeutics, and with it the rights to ApoA-1 Milano. The drug, heralded as “Drano for the heart,” looked promising. But Pfizer abandoned development after it determined producing the therapy would be too expensive. It eventually sold the ApoA-1 Milano rights to the Medicines Company.

And then, of course, was the now-legendary failure of the CETP inhibitor torcetrapib, which was once projected to bring in $13 billion in annual sales. The day after Pfizer announced the late-stage failure of the drug, its stock dropped 11 percent, taking with it $21 billion in market value. The company would go on to cut almost all its early-stage heart disease work–as well as 10,000 jobs.

Bloomberg notes that after pouring $2 billion into developing a “good” cholesterol drug, Pfizer is still facing the loss of Lipitor patent protection and doesn’t have a new heart drug to take its place.

Cleveland Clinic cardiologist Steve Nissen was the lead investigator for both Pfizer drugs, and he’s also the lead for RVX-208. He points out that the drug works differently than other drugs by activating a protein that causes the production of HDL. The drug is currently in Phase II testing. Not surprisingly, there’s been a lot of interest from Big Pharma; if the drug works, it could be as big as Lipitor. But there are hurdles left yet to overcome. Nissen isn’t giving up, though. “Hope springs eternal,” he tells Bloomberg. “We need to keep trying to find an HDL-raising strategy that works.”

Source: FierceBiotech

Popularity: 1% [?]

One of OSI Pharmaceuticals’ major shareholders is balking at Astellas Pharma’s $52-a-share tender offer for the company, saying that the Japanese drugmaker needs to raise its bid by 15 percent. And given the way OSI stock has been trading–yesterday it closed at $56.39, 8.4 percent higher than the bid–other investors appear to agree.

OrbiMed Advisors, which is OSI’s fifth-largest shareholder, is targeting a new bid of $60, managing partner Samuel Isaly told Bloomberg. “The market price is higher than the bid because investors expect a higher bid,” Isaly told the news service. “We think $60 is a fair price.”

As you know, the Astellas effort to buy out OSI went public earlier this week, and it quickly turned nasty. Saying that OSI managers had already rejected a $52 bid, Astellas took the same figure directly to shareholders with a hostile bid. Plus, Astellas sued OSI for rejecting the offer. But hopeful investors traded the stock upward, and, perhaps because it could afford to be magnanimous under those circumstances, the OSI board promised to consider the bid. If shareholders like OrbiMed continue to agitate for more, the board won’t have to be the only voice opposing Astellas’ price.

Source: FiercePharma

Popularity: 1% [?]

Sanofi-Aventis has pulled the curtain back on a slate of promising, late-stage data for its prostate cancer drug cabazitaxel, demonstrating that the therapy prolongs the life of men with advanced tumors.

Reviewing the data scored on 755 men who participated in the study, researchers concluded that patients with treatment resistant tumors lived an average of 15.1 months, 2.4 months longer than the average for men who were treated with chemotherapy.

“This is only the third agent in history to show a survival benefit, so this is huge news for patients,” lead author Oliver Sartor, told Bloomberg. “Not only was overall survival better, progression-free survival was better, response rate was better, and virtually every subgroup of patients did better.”

Currently, advanced prostate cancer is treated with a therapy to cut off testosterone, which fuels cancer, and is followed by Taxotere. Now cabazitaxel appears poised to become the next drug in that series for hard-to-treat cases. Sanofi says that it plans to wrap its marketing application for the therapy in the first half, which might make it available to patients before the end of the year.

Source: FierceBiotech

Popularity: 1% [?]

Incoming Bristol-Myers Squibb CEO Lamberto Andreotti certainly has his work cut out for him. As several news outlets have pointed out, job No. 1 will be overcoming the loss of $11 billion in revenue to generic competition by 2016. He’s said that he’s confident BMS can do so, in part by stepping up the pace of its “string of pearls” acquisition strategy.

But investors aren’t so sure, so Andreotti is meeting with them today in an attempt to persuade, Bloomberg reports. And in advance of that meeting, Bristol released forecasts for 2013 sales that neatly beat analyst estimates, at $1.95 per share versus the expected $1.88. Beginning in 2014, the company says, it will embark on a period of “sustained growth.”

“We have important strategic, operational and financial levers which will allow us to fully realize our potential as a biopharma leader, and to deliver on our near-term and long-term growth opportunities,” Andreotti said in the statement. We’re not sure which levers he’s talking about, so we’ll have to wait and see what specifics he shares with investors in that meeting.

Source: FiercePharma

Popularity: 1% [?]