United Nations Approves Arms Trade Treaty

The United Nations General Assembly voted on Tuesday morning to approve the final text of the world’s first treaty regulating the trade of arms between countries, despite pressure from the National Rifle Association to have the United States kill the measure.

In passing the Arms Trade Treaty (ATT) — with a vote of 154 in favor to 3 with 23 abstentions — the General Assembly has finally completed work that has gone on for years, including two rounds of strenuous negotiations, and two incomplete conferences. The latest attempt to pass the document via consensus was blocked at the last minute through the combined efforts of Iran, North Korea, and Syria. Following that setback, more than one hundred countries — including the United States — co-sponsored the ATT to move forward in the General Assembly, which is made up of all 193 members of the U.N., resulting in today’s vote.

The legal arms trade, comprised of both the import and export weapons, constitutes around $70 billion annually. Attack helicopters, tanks, and other larger arms are covered under the treaty, as well as small arms and ammunition for these weapons. Under the terms of the treaty, states are required to determine whether the shipment of arms to a second country would be used to commit atrocities or violate human rights or if they could diverted for such a purpose, and report back to the U.N. Secretariat on their efforts. Counter to the right-wing fear-mongering in the United States, primacy of national legislation is recognized in the treaty, forgoing any possibility of a government “gun grab.”

It’s not clear, however, that President Obama would sign the newly passed treaty right away or even in the next few months. In a conference call with reporters on Thursday, the principal U.S. negotiator of the ATT Thomas Countryman demurred:

COUNTRYMAN: For any treaty the United States carefully studies it. It’s looked at from all angles by many different agencies, and any statements of clarification about how we interpret the treaty or how we will implement it are prepared before the President is asked to give his signature. That takes, even for a treaty simpler than this one, usually a few months. I’m reluctant to give any specific timeframe. I can only say that as with any other treaty, it will get a careful review by every relevant agency of the U.S. Government before it goes to the President for signature.

That pledge of careful consideration hasn’t done anything to lessen NRA opposition. On Friday the NRA’s action wing referred to the ATT as an “undead” treaty and denigrated the American Bar Association’s conclusion that the ATT will not adversely affect gun-ownership in the United States.

The ATT is already facing heavy opposition in the U.S. Congress, including the efforts of Sen. Jerry Moran (R-KS) to pass a concurrent resolution to keep President Obama from signing the text. But given that Democrats hold the majority in Senate Foreign Relations Committee, however, it is unlikely Moran’s resolution will pass. Unfortunately, Sen. Jim Inhofe (R-OK) did manage toslip an item into the FY 2014 Budget that would create a fund to block implementation of the ATT.

Secretary of State John Kerry has released a statement praising the U.N.’s adoption of the ATT, preemptively countering arguments about its possible infringement on the Second Amendment:

By its own terms, this treaty applies only to international trade, and reaffirms the sovereign right of any State to regulate arms within its territory. As the United States has required from the outset of these negotiations, nothing in this treaty could ever infringe on the rights of American citizens under our domestic law or the Constitution, including the Second Amendment.

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Arkansas House Committee Rejects Tax Break For The Poor, Approves Two For The Rich

States across the country are pushing tax cuts as a way to stimulate economic growth, and an Arkansas House Committee joined them yesterday by approving an income tax cut and raising an exemption on investment taxes. While approving two tax proposals that will largely benefit the wealthy, however, the committee rejected a proposal that would give a tax break to low-income families.

The efforts are aimed at stimulating job and economic growth, according to Republican state legislators, the Associated Press reports:

The income tax proposal, which will cost the state about $57 million a year, is expected to be the largest piece of the tax cut package being negotiated. The proposal would lower the top income tax rate from 7 percent to 6.875 percent and increase the minimum income it applies to from $34,000 to $44,000. The reduction would take effect for the 2014 tax year. The lawmaker behind the idea said it would help Arkansas generate jobs by making its tax rate more competitive with surrounding states. [...]

The panel also endorsed Carter’s proposal to increase the income tax exemption on capital gains of at least $5 million from 30 percent to 70 percent. It would also create a 70 percent exemption for any net capital gains relating to the sale of Arkansas property acquired after Jan. 1, 2014.

Even as it raises the minimum amount needed to qualify for taxation, the income tax proposal would grant more than half of its benefits to Arkansans who make more than $155,000 a year, according to the Institute on Taxation and Economic Policy. The capital gains exemption, which ITEP calls one of the two “most regressive state income tax loopholes,” would only benefit wealthy families. But cutting taxes to stimulate growth isn’t the best strategy: a report from the Center on Budget and Policy Priorities released this week found that states that implemented tax cuts in the 1990s saw slower economic growth afterward than states that did not.

At the same time, the committee rejected a proposed Earned Income Tax Credit that would have given breaks to low-income residents, just as the EITC does on federal taxation. Arkansas’ tax code is already among the most regressive in the country, according to ITEP. It’s poorest residents pay 11.9 percent of their income in taxes, the 10th highest percentage among the 50 states and Washington DC. The richest one percent of its residents pay just 6 percent of their income in taxes. Gov. Mike Beebe (D) has warned the legislature that his budget does not include room for costly tax cuts, which should prevent Arkansas’ House Republicans from making the tax code even more regressive.

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BRIEF-FDA approves Biogen Idec's Tecfidera for Multiple Sclerosis

March 27 (Reuters) - U.S. Food and Drug Administration:

* FDA says approved Biogen idec's tecfidera (dimethyl fumarate)

capsules to treat adults with relapsing forms of Multiple Sclerosis

* Source text for Eikon:

* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))

View the original article here

UPDATE 2-U.S. FDA approves Biogen's oral MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

* Stock rises 3.2 percent to $182.68

(Adds analyst comment, background, stock price)

By Toni Clarke

WASHINGTON, March 27 (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days.

Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some."

Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems.

Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.

"As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience."

Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks "significantly better than Gilenya."

Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and nausea. And its label contains no boxed warnings. The FDA recommended only that physicians monitor patients' infection-fighting white blood cell count once a year.

"That's an excellent label," said Yee. "I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile."

Tecfidera will be used to treat patients with relapsing-remitting MS, a form of the disease in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.

Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent after two years compared to patients taking a placebo. The drug is expected to generate sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis.

Last week European regulators recommended approval for Tecfidera and Aubagio, but they declined to give Aubagio a "new active substance" designation because it is similar to an older drug. Without this designation, generic copies of the drug could be launched in Europe in as little as three years. That could hurt sales of most other MS drugs on the market.

Sanofi said it was disappointed by the decision and plans to request a re-examination of the case.

(Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

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

Keywords: BIOGEN TECFIDERA/

View the original article here

UPDATE 1-U.S. FDA approves Biogen's MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 which helps protect nerve cells from damage and inflammation. It is expected to be launched within days.

Multiple sclerosis is a chronic condition which attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

The U.S. Food and Drug Administration said on Wednesday that the drug may decrease a patient's white blood cell. White blood cells help protect the body from infection, and while no significant increase in infections was seen during clinical trials of the drug, the agency recommended patients have their white blood cell count assessed before treatment and once a year after that.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

View the original article here

U.S. FDA approves Biogen's multiple sclerosis drug, Tecfidera

March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

Combined clinical trial data showed Tecfidera, formerly known as BG-12, cut the average relapse rate by 49 percent after two years compared to patients taking a placebo.

(Reporting By Toni Clarke in Washington; Editing by Tim Dobbyn)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

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

Keywords: BIOGEN TECFIDERA/

View the original article here

UPDATE 1-U.S. FDA approves Biogen's MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

March 27 (Reuters) - U.S. regulators have approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales of more than $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 which helps protect nerve cells from damage and inflammation. It is expected to be launched within days.

Multiple sclerosis is a chronic condition which attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

The U.S. Food and Drug Administration said on Wednesday that the drug may decrease a patient's white blood cell. White blood cells help protect the body from infection, and while no significant increase in infections was seen during clinical trials of the drug, the agency recommended patients have their white blood cell count assessed before treatment and once a year after that.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

View the original article here

New Hampshire House Approves Stand Your Ground Repeal

The New Hampshire House of Representatives is on a criminal justice roll. Last week, legislators voted to prohibit private prisons. This week, they passed a bill to repeal the ALEC-sponsored Stand Your Ground law, which authorizes the unfettered use of deadly force in self-defense. The NRA-backed laws, also known as “Kill at Will,” gained notoriety after the tragic killing of Florida teenager Trayvon Martin. Police cited Florida’s Stand Your Ground law as the reason for not initially arresting the suspect in that case. Reuters reports:

The National Rifle Association and gun rights supporters had campaigned to defeat the bill repealing the state’s “Stand Your Ground” law, arguing the change would embolden criminals and lead to greater violence against women.

The bill passed by a roll call vote of 189-184 after a heated debate. The proposed change may face tougher odds in the state Senate, which is narrowly controlled by Republicans.

If repealed, the state would return to the so-called “castle doctrine” under which there is a duty to retreat from a threatening situation unless it occurs inside a person’s home. […]

New Hampshire passed a number of laws loosening control on gun usage in 2011, when Republicans commanded large majorities in both chambers. Since regaining control of the House, Democrats have sought to push back on some of these measures.

In the wake of the Trayvon Martin tragedy, a Florida committee to reform the bill stacked with lawmakers who first proposed the law did not recommend any substantive changes, in spite of empirical research finding these laws were associated with a significant increase in homicides. Some 21 states have laws establishing that there is no duty to retreat, and at least nine include language stating that one may “stand his or her ground,” according to the National Conference of State Legislatures. The NRA has gone so far to offer insurance to cover the costs of a Stand Your Ground defense.

View the original article here

UPDATE 2-U.S. FDA approves Biogen's oral MS drug, Tecfidera

* Tecfidera expected to become dominant oral MS treatment

* Sales of Tecfidera expected to top $3 billion by 2017

* Tecfidera expected to be launched within days

* Stock rises 3.2 percent to $182.68

(Adds analyst comment, background, stock price)

By Toni Clarke

WASHINGTON, March 27 (Reuters) - U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion.

The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days.

Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.

"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some."

Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems.

Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.

"As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience."

Michael Yee, an analyst at RBC Capital Markets, said the overall profile of Tecfidera looks "significantly better than Gilenya."

Tecfidera's side effects appear relatively benign, consisting mainly of flushing, diarrhea and nausea. And its label contains no boxed warnings. The FDA recommended only that physicians monitor patients' infection-fighting white blood cell count once a year.

"That's an excellent label," said Yee. "I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile."

Tecfidera will be used to treat patients with relapsing-remitting MS, a form of the disease in which flare-ups are followed by periods of remission. About 85 percent of people with MS are initially diagnosed with this form of the disease.

Combined clinical trial data showed Tecfidera cut the average relapse rate by 49 percent after two years compared to patients taking a placebo. The drug is expected to generate sales of about $3 billion in 2017, according to data compiled by Thomson Reuters Cortellis.

Last week European regulators recommended approval for Tecfidera and Aubagio, but they declined to give Aubagio a "new active substance" designation because it is similar to an older drug. Without this designation, generic copies of the drug could be launched in Europe in as little as three years. That could hurt sales of most other MS drugs on the market.

Sanofi said it was disappointed by the decision and plans to request a re-examination of the case.

(Reporting By Toni Clarke in Washington; additional reporting by Bill Berkrot in New York; Editing by Tim Dobbyn, Bernard Orr and Leslie Adler)

((toni.clarke@thomsonreuters.com)(202-898-8340)(Reuters

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

Keywords: BIOGEN TECFIDERA/

View the original article here

FDA approves Shionogi's drug for painful sex in women

WASHINGTON, Feb 26 (Reuters) - U.S. health regulators said on Tuesday they have approved a drug made by Japan's Shionogi & Co to treat women experiencing pain during sexual intercourse.

The U.S. Food and Drug Administration approved the drug, Osphena, for a type of pain known as dyspareunia, which is a symptom of vulvar and vaginal atrophy due to menopause.

Dyspareunia is associated with declining levels of estrogen hormones during menopause. Osphena, known chemically as ospemifene, is a pill that acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in pain associated with intercourse.

The drug's label includes a boxed warning, the most severe available, alerting patients to an increased risk of strokes and deep vein thrombosis. Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating.

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

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

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

Keywords: SHIONOGI DRUGAPPROVAL/

View the original article here

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)

View the original article here

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)

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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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FDA approves Celgene drug for blood cancer

WASHINGTON -- The Food and Drug Administration said Friday it approved a new drug from Celgene for patients with hard-to-treat multiple myeloma, a cancer of the blood.

The agency approved the pill Pomalyst for cases of the disease that have spread even after treatment with two other cancer drugs.

Multiple myeloma mainly affects older adults and kills about 10,700 people annually, according to the National Cancer Institute.

FDA noted that Pomalyst is the second drug approved for multiple myeloma in the past year. The agency approved Kyprolis from Onyx Pharmaceuticals Inc. in July 2012.

"Treatment for multiple myeloma is tailored to meet individual patient's needs, and today's approval provides an additional treatment option for patients who have not responded to other drugs," said Dr. Richard Pazdur, FDA's office director for cancer drugs, in a statement.

Pomalyst carries a boxed warning, the most serious type, alerting patients and doctors that the drug can cause severe birth defects in pregnant women and can cause blood clots.

Shares of Celgene Corp., based in Summit, N.J., rose $2.29, or 2.4 percent, to $100.13. The stock added 17 cents to $100.30 in after-hours trading.

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BREAKING: Colorado Senate Approves Civil Unions Legislation

Civil unions sponsor Sen. Pat Steadman (D) speaking before supporters in May 2012.

Just now, the Colorado Senate voted 21-14 to approve Senate Bill 11, which would create civil unions for same-sex couples. This was the second of two readings, with a final vote expected on Monday. During the debate, several Republicans attempted to add various amendments that would create special religious protections for adoption agencies to discriminate against same-sex couples, but none of them passed. Denver area political reporter Eli Stokols pointed out that last year’s civil unions bill had such protections, but House Republicans went out of their way to block that bill from passing.

The bill is expected to advance quickly through the House this year. Not only did Democrats win control over the House, but they also elected openly gay Representative Mark Ferrandino (D), the bill’s sponsor, as Speaker of the House. A November poll found that 70 percent of Coloradans support legal recognition for same-sex couples.

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Senate Approves John Kerry As Secretary of State

The Senate this afternoon overwhelmingly voted in favor of approving John Kerry’s nomination to become Secretary of State, with only three Senators — Ted Cruz (R-TX), John Cornyn (R-TX), and James Inhofe (R-OK) — voting against their colleague. Earlier today, the Senate Foreign Relations Committee moved forward Kerry to the full Senate unanimously, reflecting the relative ease that Kerry has had in ascending to Obama’s second term cabinet.

Kerry has spent the last twenty-eight years in the Senate representing Massachusetts, all of them serving on the Foreign Relations committee, the last four as Chairman. The closeness in foreign policy vision that he shares with the Obama administration made Kerry one of the most likely choices to take the reins of State for the next four years. The ties between the two during Kerry’s chairman ship was close enough that former Sen. Gary Hart once called Kerry effectively “the congressional secretary of state.”

Kerry is the first of the President’s nominees to be confirmed following his inaugural. Kerry and current Secretary of State Hillary Clinton have been speaking “almost daily” to prepare him to move into the 7th floor office in Foggy Bottom. Secretary Clinton will be stepping down following her last day on the job, Friday, Feb. 1.

Starting then, Kerry will have a full diplomatic plate, including pending negotiations with Iran over its nuclear program, managing a rising China, limiting fallout from the Arab Spring in the Middle East, and advancing international action on climate change. In meeting these challenges, Kerry will find himself working closely with his replacement as Chairman on the Foreign Relations Committee, Sen. Robert Menendez (D-NJ).

Kerry’s pending resignation of his Senate seat will prompt a decision among the people of Massachusetts regarding his successor. Retired Congressman Barney Frank (D-MA) has made no secret of his desire to be named as interim Senator by Gov. Deval Patrick (D). No matter who temporarily fills the seat, a special election will be held in June, following an April primary. Former Sen. Scott Brown is thought to be the most likely Republican candidate, while Rep. Ed Markey (D-MA) has received the support of the Democratic Senatorial Campaign Committee and other key Massachusetts Democrats.

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FDA approves 3 new diabetes drugs from Takeda

WASHINGTON -- The Food and Drug Administration on Friday approved three new formulations of a Takeda Pharmaceuticals Co. Ltd. diabetes drug designed to help patients control their blood sugar.

The common ingredient in all three drugs is a new compound called alogliptin, which stimulates the release of insulin, a hormone that controls blood-sugar levels. The FDA approved the drug in stand-alone form under the brand-name Nesina. The drug will also be sold in combination with metformin, under the name Kazano, and with pioglitazone, as Oseni. Metformin is a diabetes drug that has been used for decades. Pioglitazone is a newer diabetes drug sold by Takeda as Actos.

All three new drugs were approved for patients with type 2 diabetes, the most common form of the disease that affects about 24 million Americans. People with the disease have excessive levels of sugar in their blood, which can lead to heart attacks, kidney problems, blindness and other serious complications.

The FDA created tougher cardiovascular-safety standards for diabetes drugs in December 2008 after concerns were raised about certain treatments such Avandia, which was found to increase the risk of heart attacks.

Last year the patent on Takeda's best-selling diabetes drug Actos expired, allowing generic drugmakers to market cheaper versions. Nesina gives the company a new exclusive medicine in the diabetes market.

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FDA approves new use for Roche's Avastin in colon cancer treatment

Jan 23 (Reuters) - The U.S. Food and Drug Administration on Wednesday approved the use of Roche's Avastin for patients whose colorectal cancer has worsened despite previous treatment with the drug.

The new use will allow patients first treated with Avastin plus chemotherapy to be treated again with the biotechnology drug in combination with a different chemotherapy regimen.

A pivotal clinical trial showed that such a treatment strategy improved survival.

"The majority of people diagnosed with metastatic colorectal cancer receive Avastin plus chemotherapy as their initial treatment," Hal Barron, chief medical officer at Roche's Genentech unit, said in a statement. "These people now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone."

Avastin, also known as bevacizumab, is an antibody that blocks vascular endothelial growth factor, or VEGF, a protein tumors need to grow nutrient-providing blood vessels.

The drug is approved in the United States for treating glioblastoma, a brain tumor, and colorectal, lung and kidney cancers.

Worldwide Avastin sales totaled $5.3 billion Swiss francs ($5.5 billion) in 2011.

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FDA approves Novartis drug for rare iron disorder

WASHINGTON -- The Food and Drug Administration has approved a Novartis drug to treat a rare genetic disorder that causes an overload of iron in the blood.

The FDA cleared Novartis' drug Exjade to treat patients 10 and older with a form of thalassemia, which affects about 1,000 people in the U.S. The disorder can lead to internal organ damage.

Patients with traditional thalassemia often require red blood cell transfusions to replace the protein that carries oxygen throughout the bloodstream.

Novartis' drug is for patients with a milder form of the condition known as non-transfusion-dependent thalassemia. These patients do not require frequent blood transfusions.

The FDA approved the drug in combination with a diagnostic test that measures iron concentration in the liver.

Novartis is headquartered in Basel, Switzerland with U.S. offices in East Hanover, N.J.

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