Is Big Pharma due for another layoff? That’s what the Swiss newspaper Sonntag is reporting, saying that Roche is putting the final touches on a global job-cutting plan. Sources tell the paper that a decision is expected at a scheduled management meeting this week. Roche itself tells Reuters that no layoff news will come that soon.

Sonntag’s sources say that at a recent management meeting, Roche officials discussed “massive” job cuts across the company’s pharma division. The cuts would hit sales and marketing, R&D, manufacturing and management. ”This will not only concern a few hundred people but many more,” one source tells the paper. “And the job cuts will not be made in one single country but on a worldwide scale.”

The company isn’t as willing to talk as Sonntag’s unnamed sources are. “It’s too early to speculate on this,” Roche spokeswoman Claudia Schmitt tells Bloomberg. “There will be no decisions made this week.” Another Roche spokesperson tells Reuters, ”We are always working to improve productivity and will continue to do so. But it is too early to speculate on potential job cuts.”

Source: FiercePharma

Popularity: 1% [?]

An experimental personalized cancer therapy from Roche and Plexxikon registered striking results in a recent clinical study, shrinking the tumors in a majority of metastatic melanoma patients who share a common genetic mutation. And a group of experts in the field are lauding the results, saying that the success of this study could help pave the way to one of the first new skin cancer therapies in some 20 years.

Of the 16 terminal patients who share a mutation of the BRAF gene, 10 taking PLX4032 saw their tumors shrink and one witnessed its disappearance–a 69 percent response rate among the drug group. The other 39 patients in the group did not have the genetic mutation and all saw their cancers progress. In a second group, 81 percent with the mutation experienced a positive response. The drug blocks the BRAF protein and the same mutation is believed to appear in 40 percent to 60 percent of all skin cancer patients.

“I have been treating patients with melanoma for 20 years, and I’ve never seen a drug response like this,” Lynn Schuchter, Penn’s chief of hematology-oncology, told the Philadelphia Inquirer. “Some patients responded in just 72 hours, going off pain meds.” The upbeat study outcome was a triumph for the investigators involved. After the initial doses of PLX4032 failed to generate a response, the researchers reformulated the drug to make it easier for patients to absorb.

“Metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients,” said lead author Keith Flaherty. “Until now, available therapies were few and unreliable, so these findings can really change the outlook for patients whose tumors are fueled by this mutation.”

Source: FierceBiotech

Popularity: 1% [?]

Aileron Therapeutics’ stapled peptide platform has won over Roche, which is paying $25 million upfront and up to $1.1 billion more in milestones to explore the potential to deliver a new generation of drugs right to their target.

For Aileron, a 2009 Fierce 15 company, the billion-dollar deal represents a key endorsement from one of the industry’s most innovative pharma companies. And it’s the kind of high-profile pact that is likely to generate plenty more interest from Roche’s competition, spurring a hard look at the new peptide and protein technologies emerging as one of the hottest fields in drug development.

“This is a significant commitment by a very smart pharmaceutical company betting they’re finally going to unlock the power of peptides as a superclass of drugs,” Aileron CEO Joseph A. Yanchik III told The New York Times.

For now, Aileron is still very much an early-stage developer, with plans to get into the clinic once it gets a green light from the FDA. Roche is taking on five undisclosed targets with Aileron’s help. But with a platform technology like this, Aileron is advancing in a target-rich environment.

“Stapled peptides represent a potentially transformative new technology to create drugs for important disease targets that are intractable to currently available modalities,” Jean-Jacques Garaud, global head of Roche pharma research and early development.

Source: FierceBiotech

Popularity: 1% [?]

While U.S. regulators debate Roche’s Avastin as a breast cancer treatment, U.K. watchdogs aren’t even convinced that the drug works well enough against bowel cancer, one of its key indications. The National Institute for Health and Clinical Excellence once again rejected Avastin for use in patients with advanced bowel cancer–in spite of new-and-better pricing from Roche.

The company previously had offered to supply Avastin at a fixed price of £20,800 ($32,430) per patient for one year; the drug would be free after the first 12 months of treatment, and Roche would also reimburse NICE for the cost of accompanying chemo with oxaliplatin. Under the new pricing offer, Roche stuck to this pricing deal, but added an upfront payment to the National Health Service for each patient who started first-line treatment with Avastin, NICE said.

It wasn’t enough, NICE chief Andrew Dillon says in a statement: “We are disappointed not to be able to recommend [Avastin]…but we have to be confident that the benefits justify the considerable cost of this drug.”

Predictably, the refusal has NICE critics up in arms–including Roche. According to the company, the U.K. ”is now virtually the only country in the developed world not to provide Avastin for bowel cancer patients through the state healthcare service,” providing “further evidence that the current U.K. reimbursement system is not appropriate for end of life cancer treatments.”

Source: FiercePharma

Popularity: 1% [?]

The latest debate over Roche’s Avastin–whether the FDA should yank its approval for breast cancer use–shows how pulling a drug off the market is a lot more complicated than keeping it off the market to begin with.

Avastin got the breast cancer nod under the fast-track approval program based on just one study showing it staved off tumor growth for about five months. Now, the company has come back with required follow-up studies–two trials that suggest Avastin keeps tumors at bay a month and a half, rather than five. The FDA’s advisory committee reviewed the data and voted 12-1 to revoke the indication; the agency is set to decide by Sept. 17.

That’s how the program is supposed to work. If a drug proves less effective than initially thought, the FDA does an about-face. But in practice, the very suggestion that the FDA would revoke that approval has patient groups and opportunistic politicians up in arms. Not to mention Roche, which is lobbying to keep the indication.

Cost is key. The FDA isn’t supposed to consider cost, and the advisory panel billed its decision as a risk-benefits analysis, with Avastin’s apparently diminished benefit on one side and its not-inconsiderable side effects on the other. But if the indication is lost, insurers likely won’t pay. And everyone knows–even the FDA advisory panel–that Avastin is a pricey treatment. Whether the FDA’s final decision is tainted by the cost question, if it follows the committee’s recommendation, it will be accused of “rationing.”

At least some patient advocates aren’t pulling at those heartstrings. “The FDA should never have approved Avastin for breast cancer to begin with,” Fran Visco of the National Breast Cancer Coalition tells the Washington Post. “We don’t see evidence of benefit, but we do see evidence of harm.”

Source: FiercePharma

Popularity: 2% [?]

The H1N1 pandemic is over and the global outbreak turned out to be much less severe than was feared just over a year ago, the head of the World Health Organization (WHO) said on Tuesday.

WHO director-general Margaret Chan once again rebutted criticism that the United Nations agency had hyped the first pandemic in more than 40 years, whose mildness left some Western governments holding huge stockpiles of unused vaccines.

The Hong Kong public health expert said the world had been lucky the H1N1 virus had not mutated into a more deadly form and that a safe vaccine developed in record time remained effective against it.

“We are now moving into the post-pandemic period. The new H1N1 virus has largely run its course,” Chan said.

“That was the right call,” she said, defending the decision taken in June last year to declare a pandemic.

The swine flu virus will continue to circulate as part of seasonal influenza for years to come, requiring health authorities to remain vigilant, she told a news conference.

It still threatens high-risk groups including pregnant women who would benefit from vaccination, she said.

Stockpiled H1N1 vaccines remain effective against the strain and so far the virus has not developed widespread resistance to the antiviral oseltamivir, the best treatment, she said.

The WHO’s downgrading of the H1N1 outbreak to “post-pandemic” was based on recommendations by external influenza experts who conducted a review earlier in the day.

“I think even if we see severe outbreaks occurring in some countries — which is still definitely possible — that the global threat is really much lower and much different than a year ago,” Keiji Fukuda, WHO’s top flu expert, told reporters.

CONTINUED VIGILANCE

In June 2009, the WHO said a new swine flu virus, H1N1, that emerged in the United States and Mexico and spread around the world in six weeks, was the first pandemic since 1968. A full pandemic corresponds to phase 6 on the WHO’s six-point scale.

“We need to continue to maintain our vigilance and not be complacent,” Chan said, noting that outbreaks continued in countries including India and New Zealand.

The behavior of influenza viruses is notoriously difficult to predict and no two pandemics are alike, flu experts say.

“I am very pleased that European member states prepared for something worse. I’d rather have it go that way than their planning for less or not being prepared at all,” Angus Nicoll, influenza program coordinator at the European Center for Disease Prevention and Control, told Reuters Tuesday.

The WHO has also rejected allegations that it acted under the influence of drug companies in declaring a pandemic.

Chan said that three viruses were now circulating as part of a “mixed virus pattern” in many countries, typically seen during seasonal epidemics. These were H1N1 and H3N2 — both type ‘A’ influenza — as well as type ‘B’.

Either H1N1 vaccine or a trivalent (triple shot) vaccine against the three strains should be used to inoculate those at risk, depending on their availability, she said.

“Pandemic and seasonal vaccine in both hemispheres confer the same protection (against H1N1),” Fukuda said.

An estimated 350 million people worldwide have been vaccinated against H1N1, he said.

Dozens of companies make influenza vaccines, including Sanofi-Aventis, GlaxoSmithKline, Novartis, AstraZeneca and CSL. Roche makes the frontline antiviral oseltamivir, marketed as Tamiflu.

The U.S. Centers for Disease Control and Prevention said the WHO pronouncement will not alter U.S. plans for the upcoming flu season. The CDC recommends that everyone over 6 months of age be vaccinated against seasonal flu this year, the most universal recommendation yet for flu vaccines.

The CDC said vaccine manufacturers are predicting an ample supply of U.S. flu vaccine, which will protect against the 2009 H1N1 swine flu virus, plus the most common strains of the H3N2 and the influenza B virus.

The CDC last month said manufacturers have forecast they will have 170 million doses of flu vaccine for the 2010-2011 U.S. flu season.

Some 18,450 people worldwide are confirmed to have died from H1N1 infections, including many pregnant women and young people. But WHO says that it will take at least a year after the pandemic ends to determine the true death toll, which is likely to be much higher.

Seasonal flu kills an estimated 500,000 people a year, 90 percent of them frail elderly people, according to the WHO. The 1957 and 1968 pandemics killed about 2 million and 1 million people, respectively, it says.

Source: Reuters

Popularity: 4% [?]

Roche’s top-selling Avastin helps patients with the most common form of lung cancer live longer than any other treatment, the Swiss drugmaker said on Friday, giving the drug a boost after a slew of setbacks.

A late-stage trial showed first-line Avastin-based therapy in advanced non-small cell adenocarcinoma of the lung resulted in a median overall survival of 14.2 months — a 3.9-month improvement over chemotherapy alone.

Blockbuster Avastin has had a grim time this year, falling at key hurdles in prostate and gastric cancer, and last month a U.S. panel called on officials to revoke its approval in advanced breast cancer.

Avastin, which is already approved for colon, lung, brain and kidney cancers, is tipped to become the world’s biggest selling drug in 2014.

Source: Reuters

Popularity: 2% [?]

An FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer has drawn rough words from a Republican senator. David Vitter of Louisiana called the decision “essentially government rationing.”

The advisory panel last week voted 12-1 to remove the breast cancer indication from the drug’s label. If the FDA follows the advice of its committee — as it often does — the drug could still be marketed to treat colon, lung and other cancers. New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.

“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.

“I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy,” he wrote.

Vitter’s mother-in-law died of breast cancer. He has slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn’t be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency’s website.

His Avastin statements, says an aide, were partly prompted by an online petition sponsored, according to the petition’s website, by “women with metastatic breast cancer.” The petition was created using a website called Care2, which offers “do-it-yourself tools for creating and promoting a petition” and says “it’s never been easier to support the causes you care about.” The petition overview says, in part, that “despite the study this drug is a miracle drug for some of (sic) metastatic breast cancer patients especially with a type of breast cancer called triple negative.”

The FDA’s spokeswoman said the agency “will respond to Sen. Vitter in a timely fashion.” A final decision on Avastin’s use in breast cancer is expected this fall.

Source: The Wall Street Journal

Popularity: 2% [?]

An FDA advisory committee’s vote to revoke the approval of Roche-Genentech’s Avastin for treating breast cancer has drawn rough words from a Republican senator. David Vitter of Louisiana called the decision “essentially government rationing.”

The advisory panel last week voted 12-1 to remove the breast cancer indication from the drug’s label. If the FDA follows the advice of its committee — as it often does — the drug could still be marketed to treat colon, lung and other cancers. New studies presented to the panel showed more side effects among women being treated with Avastin and no overall survival benefit, though they did show women taking the drug had an extra month to 2.9 months of progression-free survival. Advisory panels do not discuss monetary costs of the drugs they consider.

“I shudder at the thought of a government panel assigning a value to a day of a person’s life,” Vitter said in a statement. “It is sickening to think that care would be withheld from a patient simply because their life is not deemed valuable enough.” In a letter to the FDA cancer division leader, Richard Pazdur, Vitter said the committee’s vote appeared to be based on cost effectiveness, not safety issues.

“I am not suggesting that Avastin is a perfect drug, but it has a proven record of effective treatment for some patients when used along with chemotherapy,” he wrote.

Vitter’s mother-in-law died of breast cancer. He has slammed the new U.S. Preventive Services Task Force mammogram guidelines that said yearly tests shouldn’t be automatic for most women under 50. In May he asked the HHS to take the recommendations off the agency’s website.

His Avastin statements, says an aide, were partly prompted by an online petition sponsored, according to the petition’s website, by “women with metastatic breast cancer.” The petition was created using a website called Care2, which offers “do-it-yourself tools for creating and promoting a petition” and says “it’s never been easier to support the causes you care about.” The petition overview says, in part, that “despite the study this drug is a miracle drug for some of (sic) metastatic breast cancer patients especially with a type of breast cancer called triple negative.”

The FDA’s spokeswoman said the agency “will respond to Sen. Vitter in a timely fashion.” A final decision on Avastin’s use in breast cancer is expected this fall.

Source: The Wall Street Journal

Popularity: 2% [?]

Roche shares hit 52-week low, and final decision is expected by mid-September.

Roche’s Genentech confirmed that FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12–1 in favor of retracting Avastin’s existing provisional endorsement as first-line therapy combined with paclitaxel against advanced Her2-negative breast cancer. FDA is expected to make a final decision on whether to rubber stamp the committee’s recommendation by September 17.

Genentech admits that it is “disappointed by the ODAC conclusion” and says that it will continue to discuss data from the three relevant Phase III Avastin studies. “We believe Avastin should be an option for women with this incurable disease,” stresses Sandra Horning, M.D., Genentech’s svp and global head of clinical development hematology/oncology. The firm also points out that whatever the outcome, the U.S. ruling will not impact Avastin’s sanctioned uses for other cancer types or affect any approvals in other countries.

News of the ODAC’s recommendation caused Roche’s shares to slide 4.2% on the previous day’s close, effectively hitting a 52-week low and hovering at about the CHF 135–137 mark as the day’s announcement took its toll.

Avastin’s use in the U.S. as first-line combination therapy for Her2-negative breast cancer was sanctioned in February 2008 under FDA’s accelerated approval program. The decision was based on data from the Phase III E2100 study demonstrating an improvement in progression-free survival (PFS), Genentech explains. In November last year the firm submitted two sBLAs to FDA based on the Phase III Avado and Ribbon 1 trials, as part of its push to convert the accelerated approval to full approval. The two studies evaluated Avastin in combination with either docetaxel chemotherapy or with a taxane, anthracycline-based or capecitabine chemotherapy in women with advanced, previously untreated Her2-negative breast cancer.

Avastin was first approved for the treatment of breast cancer by the EMEA in combination with paclitaxel for first-line therapy of advanced Her2-negative disease in 2007. In July 2009, the approval was expanded to include Avastin in combination with docetaxel.

Avastin is currently approved in major markets including the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small-cell lung cancer, and kidney cancer. The drug is also available in the U.S. for the treatment of patients with advanced brain cancer.

As Roche’s top-selling drug in 2009, Avastin made sales of CHF 6.2 billion (some $5.9 billion), up 21% on 2008 in local currencies, and representing 16% of overall sales.

Source: GEN

Popularity: 3% [?]