After long fight, Roche to release all Tamiflu drug data

LONDON, April 4 (Reuters) - After a lengthy fight, Swiss drugmaker Roche Holding AG said it had agreed to hand over data from all clinical trials of its best-selling flu drug Tamiflu to a group of outside researchers.

Tamiflu has been approved by regulators worldwide and stockpiled by many governments in case of a pandemic, but some scientists claim there is little evidence it works and have lobbied since 2009 for Roche to release all its trial data.

Sales of the drug hit close to $3 billion in 2009 due to the H1N1 swine flu pandemic, although they have since declined.

In an email to the Cochrane Collaboration, a non-profit group that reviews trial data to assess the value of drugs, Roche said it would provide clinical study reports on all the 74 studies into its medicine, over the next few months.

A copy of the April 2 email was supplied to Reuters on Thursday.

Roche said it would edit the study reports to ensure patient confidentiality and protect legitimate commercial interests, adding that handing over the information would take time since some of the reports ran to thousands of pages.

Campaigners who have been pushing pharmaceutical companies to be more open said they were pleased Roche had finally done the right thing, although they argued it should not have delayed access to the data in the first place.

"It shouldn't have taken the researchers years of persistence and publicity to get these Tamiflu results," said Sile Lane, director of campaigns at Sense about Science.

The Cochrane group gave Roche's move a cautious welcome but its researchers said they were still concerned that editing of the data and other problems might make analysis and interpretation difficult.

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CORRECTED-UPDATE 3-FDA approves Roche drug for late-stage breast cancer

(Corrects paragraph 5 to show control arm included Xeloda, not Herceptin)

* Drug is first of its kind for solid tumors

* To carry warnings on liver, heart damage

* ImmunoGen shares up 1.9 pct; Roche up 1.5 pct

WASHINGTON, Feb 22 (Reuters) - U.S. health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the Kadcyla's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.

Still, fewer patients in a clinical trial experienced severe side effects than those who received standard therapy.

The approval was based on a study of about 1,000 women who had already been treated with Roche's drug Herceptin and a taxane chemotherapy. Patients who were given Kadcyla survived an average of 30.9 months, compared with 25.1 months for those in the control arm who took Xeloda and GlaxoSmithKline Plc's Tykerb.

The drug will be priced at $9,800 a month, higher than Wall Street analysts had expected but likely acceptable to insurers.

"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeonidis, an analyst at Cowen and Company, in a research note on Friday.

Kadcyla works by attaching Herceptin, also known as trastuzumab, to a drug called DM1, developed by ImmunoGen Inc , which interferes with cancer cell growth.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr. Richard Pazdur, director of the FDA's office of hematology and oncology products.

Other drugs approved for HER2-positive breast cancer include Herceptin, Tykerb, and Perjeta, or pertuzumab, which is also made by Roche and was approved in 2012.

Kadcyla is a member of a class of drugs known as antibody-drug conjugates, or "armed antibodies." They combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case DM1, and a link that binds them together to deliver a highly potent bomb within the diseased cells.

The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.

The first conjugate to be approved was Mylotarg which was pulled from the market in 2010 by Pfizer Inc's after a study showed it did not extend survival for patients with myeloid leukemia, a bone marrow cancer.

In 2011, Seattle Genetics won U.S. approval for Adcentris, a conjugate targeting Hodgkin's lymphoma, several types of T-cell lymphoma and other hematologic malignancies.

Kadcyla is the first armed antibody to be approved to treat a solid tumor.

The approval triggers a $10.5 million payment to ImmunoGen and sets the stage for the company to receive royalties of between 3 and 5 percent, depending on sales. The 5 percent level is triggered when sales top $700 million in the United States. The company also receives 5 percent when sales top $700 million elsewhere in the world.

Analysts estimate the drug could generate annual peak sales of $2 billion to $5 billion, assuming it is used earlier in the disease's progression and for longer periods of time.

John Sonnier, an analyst at William Blair & Co, said he believes the Kadcyla approval validates ImmunoGen's technology and will translate into other partnerships and the development of new wholly-owned compounds.

ImmunoGen's chief executive officer, Daniel Junius, said ImmunoGen has nine other compounds using some version of its TAP technology, which stands for targeted antibody payload. Some are being developed with partners and some are wholly owned by ImmunoGen.

The most advanced is a drug for non-Hodgkin's lymphoma being developed with Sanofi. The company also is conducting mid-stage trials of a proprietary drug for small-cell lung cancer.

"We believe this can be a very important tool for oncologists across a wide variety of indications," Junius said.

An analyst at J.P. Morgan, Cory Kasimov, said the approval of Kadcyla by itself is not enough to warrant owning ImmunoGen's shares.

"To justify a premium valuation, ImmunoGen needs to generate meaningful data with one of its other antibody assets, preferably one that is fully owned," he said in a research note.

Breast cancer is the second-leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013, and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

Shares of ImmunoGen closed up 1.9 percent at $14.57 on Nasdaq. Roche's shares closed up 1.5 percent.

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, John Wallace, Matthew Lewis and Carol Bishopric)

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UPDATE 3-FDA approves Roche drug for late-stage breast cancer

* Drug is first of its kind for solid tumors

* To carry warnings on liver, heart damage

* ImmunoGen shares up 1.9 pct; Roche up 1.5 pct

(Adds additional analyst comment, background)

By Toni Clarke

WASHINGTON, Feb 22 (Reuters) - U.S. health regulators approved a new drug made by Swiss drugmaker Roche Holding AG

for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the Kadcyla's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.

Still, fewer patients in a clinical trial experienced severe side effects than those who received standard therapy.

The approval was based on a study of about 1,000 women who had already been treated with Roche's drug Herceptin and a taxane chemotherapy. Patients who were given Kadcyla survived an average of 30.9 months, compared with 25.1 months for those in the control arm who took Herceptin and GlaxoSmithKline Plc's Tykerb.

The drug will be priced at $9,800 a month, higher than Wall Street analysts had expected but likely acceptable to insurers.

"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeonidis, an analyst at Cowen and Company, in a research note on Friday.

Kadcyla works by attaching Herceptin, also known as trastuzumab, to a drug called DM1, developed by ImmunoGen Inc , which interferes with cancer cell growth.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr. Richard Pazdur, director of the FDA's office of hematology and oncology products.

Other drugs approved for HER2-positive breast cancer include Herceptin, Tykerb, and Perjeta, or pertuzumab, which is also made by Roche and was approved in 2012.

Kadcyla is a member of a class of drugs known as antibody-drug conjugates, or "armed antibodies." They combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case DM1, and a link that binds them together to deliver a highly potent bomb within the diseased cells.

The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.

The first conjugate to be approved was Mylotarg which was pulled from the market in 2010 by Pfizer Inc's after a study showed it did not extend survival for patients with myeloid leukemia, a bone marrow cancer.

In 2011, Seattle Genetics won U.S. approval for Adcentris, a conjugate targeting Hodgkin's lymphoma, several types of T-cell lymphoma and other hematologic malignancies.

Kadcyla is the first armed antibody to be approved to treat a solid tumor.

The approval triggers a $10.5 million payment to ImmunoGen and sets the stage for the company to receive royalties of between 3 and 5 percent, depending on sales. The 5 percent level is triggered when sales top $700 million in the United States. The company also receives 5 percent when sales top $700 million elsewhere in the world.

Analysts estimate the drug could generate annual peak sales of $2 billion to $5 billion, assuming it is used earlier in the disease's progression and for longer periods of time.

John Sonnier, an analyst at William Blair & Co, said he believes the Kadcyla approval validates ImmunoGen's technology and will translate into other partnerships and the development of new wholly-owned compounds.

ImmunoGen's chief executive officer, Daniel Junius, said ImmunoGen has nine other compounds using some version of its TAP

technology, which stands for targeted antibody payload. Some are being developed with partners and some are wholly owned by ImmunoGen.

The most advanced is a drug for non-Hodgkin's lymphoma being developed with Sanofi. The company also is conducting mid-stage trials of a proprietary drug for small-cell lung cancer.

"We believe this can be a very important tool for oncologists across a wide variety of indications," Junius said.

An analyst at J.P. Morgan, Cory Kasimov, said the approval of Kadcyla by itself is not enough to warrant owning ImmunoGen's shares.

"To justify a premium valuation, ImmunoGen needs to generate meaningful data with one of its other antibody assets, preferably one that is fully owned," he said in a research note.

Breast cancer is the second-leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013, and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

Shares of ImmunoGen closed up 1.9 percent at $14.57 on Nasdaq. Roche's shares closed up 1.5 percent.

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, John Wallace, Matthew Lewis and Carol Bishopric)

((toni.clarke@thomsonreuters.com)(+ 1 202 898-8340)(Reuters Messaging: toni.clarke.thomsonreuters.com@reuters.net))

Keywords: ROCHE APPROVAL/

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UPDATE 2-FDA approves Roche drug for late-stage breast cancer

* Drug is first of its kind for solid tumors

* Drug to carry warnings on liver, heart damage

* ImmunoGen shares up 2.6 pct; Roche up 1.5 pct

(Adds details on ImmunoGen, share prices)

Feb 22 (Reuters) - U.S. health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.

The U.S. Food and Drug Administration said on Friday it had approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the drug's potential to cause liver and heart damage or even death. The drug can also cause life-threatening birth defects.

In clinical trials, patients who took the drug, known during its development process as T-DM1, survived an average of 30.9 months, compared with 25.1 months in a control group.

Analysts at Jefferies have estimated the drug could generate annual peak sales of $1.9 billion as usage in different settings increases. The drug will be priced at $9,800 a month.

"We don't expect to see significant payer pushback on pricing at launch, given the drug's efficacy and safety," said Simos Simeonidis, an analyst at Cowen and Company, in a research note.

Kadcyla works by attaching trastuzumab, sold under the brand name Herceptin, to a drug called DM1, developed by ImmunoGen Inc , which interferes with cancer cell growth.

"Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival," said Dr Richard Pazdur, director of the FDA's office of hematology and oncology products. "It is the fourth approved drug that targets the HER2 protein."

Other drugs approved for the disease include Herceptin in 1998, lapatinib, made by GlaxoSmithKline Plc and sold under the brand name Tykerb in 2007, and pertuzumab, marketed as Perjeta and also made by Roche, in 2012.

The approval triggers a $10.5 million payment to ImmunoGen and sets the stage for the company to receive royalties of between 3 and 5 percent, depending on sales. The 5 percent level is triggered when sales top $700 million in the United States. The company also receives 5 percent when sales top $700 million elsewhere in the world.

Kadcyla is the first drug in its class, known as antibody-drug conjugates, or "armed antibodies" to be approved to treat a solid tumor. These drugs combine an antibody, Herceptin in the case of Kadcyla, with a killer toxin, in this case ImmunoGen's DM1, and links them together to deliver a highly potent bomb to the diseased cells.

The drugs seek out specific cells that express proteins associated with the cancer, while leaving other cells alone.

Breast cancer is the second-leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with the disease in 2013, and 39,620 will die from it, according to the National Cancer Institute. About 20 percent of breast cancer patients have increased amounts of the HER2 protein.

The most common side effects in patients treated with Kadcyla were nausea, fatigue, muscle and joint pain, increased liver enzymes, headache and constipation.

Shares of ImmunoGen were up 2.6 percent at $14.67 in midday trading on the Nasdaq. Roche's shares were up 1.5 percent at 212 Swiss francs.

(Reporting by Toni Clarke in Washington; editing by Gerald E. McCormick, John Wallace and Matthew Lewis)

View the original article here

FDA approves Roche drug for late-stage metastatic breast cancer

Feb 22 (Reuters) - U.S. health regulators said on Friday they have approved a new drug made by Roche Holding AG for some patients with late-stage metastatic breast cancer who have failed other therapies.

The U.S. Food and Drug Administration said it approved Kadcyla, also known as ado-trastuzumab emtansine, for patients whose cancer cells contain increased amounts of a protein known as HER2.

The drug's label will carry a boxed warning, the most serious possible, of the drug's potential to cause liver and heart toxicity and death. The drug can also cause life-threatening birth defects.

In clinical trials, patients who took the drug, known during its development process as T-DM1, survived an average of 30.9 months, compared with 25.1 months in the control group.

(Reporting By Toni Clarke in Washington; Editing by Gerald E. McCormick)

((toni.clarke@thomsonreuters.com)(617-856-4340)(Reuters

Messaging: toni.clarke.reuters.com@reuters.net))

Keywords: ROCHE APPROVAL/

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Roche CEO: Emerging Markets Key to Momentum

"We see strong double digit growth in emerging markets, astable business in the U.S. and price pressure in Europe, we clearly seedifferent dynamics from a regional perspective," CEO Severin Schwan told CNBCWednesday.

He said while the pharmaceutical industry has been facingprice pressures, Roche was bearing up better than most.

"We are less exposed to price pressure then our competitorsdue to the value and differentiation of our products. Specifically, there havebeen 6 percent price decreases in the industry but Roche prices decreasedaround 3 percent – half the industry pressure and reflects the innovation thatwe offer," he said.

Global pharmaceutical and biotech companies are facingincreasing competition from generic drugs as insurance companies and statemedical systems look to reduce costs. But Roche, the world's biggest maker ofcancer drugs, has been spared some of that pain as it doesn't face imminentpatent expiration for some of its key drugs.

Schwan conceded that generics were an accepted part of theindustry and rejuvenating Roche's existing pipeline would be the core strategyfor the drug giant in offsetting generic competition.

"We have a contract with society that we have patents forsome limited time and it's absolutely ok that generics come into the market.Our strategy is all about rejuvenating our pipeline continuously and I'm gladin 2012 we've made major progress in this respect," he said.

The Swiss drug maker post an 11 percent rise in full-yearearnings on the back of strong sales in cancer medicines and improvements inproductivity. Core earnings for 2012 rose to 13.62 Swiss francs per share,compared to 12.30 Swiss francs a year ago. Analysts in a Reuters poll hadforecast earnings of 13.60 Swiss francs.

The Basel-based drugmaker said it hoped sales this year willgrow in line with 2012, when group sales rose 7 percent to 45.5 billion Swissfrancs ($49.35 billion). It is also aiming for core earnings per share to growahead of sales.

This positive assessment contrasts with cross-town rivalNovartis which guided for a fall in profits in 2013 as it grapples withcompetition from cheaper copies of its top-selling product.

Schwan added that he expected to keep Roche's headcountstable but indicated a possible rise in emerging markets as it meets growingdemand.

He indicated no change to the company's strategy on mergersand acquisitions in the coming months.

Last year, the company pulled its hostile takeover attemptfor U.S. genetics company Illumina.

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