Takeda Cuts Outlook, While Astellas Get Boost

Takeda Pharmaceutical Co. lowered its earnings outlook as it deals with streamlining costs after last year's $13.7 billion acquisition of Swiss drug maker Nycomed, while rival Astellas Pharma Inc. appears headed toward a new growth phase.Although initial costs will likely weigh heavily on Takeda's earnings, Japan's biggest drug maker by sales is aiming to reap the benefits of the largest acquisition in its history as Japanese drug makers seek overseas growth to compensate for the lackluster home market and a wave of patent expirations.

Takeda to axe 2,800 jobs by 2015

Japanese pharmaceutical manufacturer Takeda Pharmaceutical Company, which recently bought Swiss drugmaker Nycomed, is to trim its workforce by 2,800 over the next four years.

Takeda says it will cut 2,100 jobs in Europe and 700 in the US and combine r&d sites or eliminate some subsidiaries, mostly in Europe by the end of 2015.

The company will align Nycomed’s former operation structures and processes with its global headquarters in Japan and the newly defined organisations of the Chief Commercial Officer, which is headquartered in Zurich, Switzerland, and Chief Medical & Scientific Officer, which is headquartered in Deerfield, Illinois and its expanded affiliate network worldwide.

‘The combination of Takeda and Nycomed, which we acquired on 30 September, brought together Takeda’s strong presence in the Japanese and US markets with the legacy Nycomed business infrastructure in Europe and high-growth emerging markets,’ said Yasuchika Hasegawa, president and chief executive of Takeda Pharmaceutical Company.

‘While our combined operations in more than 70 countries are more complementary than overlapping, there are a number of areas where we will need to make changes to ensure efficient and flexible operations moving forward.’

Takeda will also shift its focus from a product portfolio of mature, high selling products to a more diverse portfolio concentrating on new products.

The combined company has a commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Takeda says this restructuring will cost an estimated JPY70bn (US$912m; €709m) in total during 2011–2015. During this period, Takeda will achieve cost savings of approximately JPY200bn.

apan's Takeda eyes Lupin, Cipla pharma business

Takeda, Japan's largest pharmaceutical firm, has begun talks with two of India's biggest companies for purchasing either of their pharma businesses. The Osaka-headquartered Takeda, which unlike rival Daiichi Sankyo does not have a large presence in the country, has approached Cipla, India's second-largest drug firm by market share, and Lupin, the fifth-biggest by market share for talks, two people with direct knowledge of the development told ET.

Talks with the Mumbai-based DB Gupta-promotedLupin have progressed beyond the initial stage, they added. Takeda is interested in buying the domestic formulations business, along with Lupin's research facility. But the promoters are unwilling to part with the research facility and are insisting on a price that values the company at 17 times its revenue, one of the persons close to the negotiations added. Lupin's FY11 revenue was $1.5 billion. Another person with direct knowledge of the talks said that preliminary negotiations have been held with the YK Hameid-promoted Cipla. He added that Takeda is very keen on a large buyout in the country, but there is no certainty that the talks will lead to a conclusive deal. Takeda did not respond to the email query sent by ET.

Antara Mukherjee, Cipla spokesperson, denied any transaction. "We are not in talks with anyone either to sell our company or any of its brands," she added. "We, as a policy, do not comment on baseless market speculation," Lupin spokesperson said.

India's domestic market is one of the fastest-growing markets in the world and consultant firm McKinsey & Co expects it to grow to $55 billion by 2020 from about $12 billion now. Takeda entered India late and is eager to catch up with rival Sankyo and other global pharma giants, some of whom have done big-ticket acquisitions. Last year, US-based Abbott bought Piramal Healthcare's formulations business for about 17,000 crore to become the country's biggest pharma firm by market share. In 2009, Daiichi Sankyo purchased Ranbaxy for $3.5-4 billion to become India's largest pharma player by revenue. "This is a big market for global pharma giants," said Ranjit Kapadia, Centrum Capital. Last year, Takeda appointed the former Roche executive Shankar Suryanarayanan as its India head and announced a medium range plan from 2010-12, including tie-ups with local companies.

Buying out either Cipla or Lupin's formulations business would be extremely productive for Takeda. Cipla is the second-largest generic maker in the country by market share, while Lupin is the fifth-largest player. Both have strong brands and wide distribution network that touches all major cities and towns. Cipla shares fell 2% to 282 on Tuesday. Lupin slipped 0.4% to 438.

M&A deals are very common in India's pharma market, but talks don't always lead to conclusive transactions. Last year, US giant Merck was widely believed to be in talks with Cipla, but the company denied it strongly and there was no transaction. In July this year, Bloomberg reported that Lupin had put its domestic formulations unit for sale, but the company denied the news.

Takeda’s Diabetes Drug Actos Tied to Cancer Risk, U.S. FDA Says

Takeda Pharmaceutical Co.’s diabetes drug Actos may raise bladder cancer risks in patients who take the medicine for more than a year, U.S. regulators said.A five-year interim analysis of data from a decade-long company-sponsored study showed a greater likelihood of bladder cancer in patients who took the drug for the longest periods of time, and at the highest cumulative doses, the Food and Drug Administration said in a safety announcement yesterday. The medicine from Osaka, Japan-based Takeda, Asia’s biggest drugmaker, wasn’t linked to an overall increased cancer risk in all patients who took it.AActos, the world’s biggest-selling diabetes drug, had shown a potential risk of bladder cancer in earlier studies on rats and humans. Takeda won FDA approval of the treatment in 1999 and agreed to conduct the 10-year study to assess that risk. Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from London-based GlaxoSmithKline Plc’s Avandia.Takeda said it is working with the FDA to make “appropriate updates” to the drug’s prescribing information. The company is “confident in the therapeutic benefits of Actos and its importance as a treatment for Type 2 diabetes,” Takeda said in a statement.Takeda shares traded 1.4 percent lower at 3,660 yen as of 9:35 a.m. in Tokyo trading today, while the benchmark Topix Index fell 0.9 percent. |The company’s American depositary receipts, each worth half an ordinary share, dropped 88 cents, or 3.8 percent, to $22.05 in over-the-counter trading yesterday.

Seattle Genetics gets fee in Takeda contract

Seattle Genetics Inc. said Tuesday that it has received an undisclosed payment from Takeda Pharmaceutical's Millennium unit for the licensing of a potential cancer treatment. The Takeda unit is exercising its second option to license a drug target under the companies' existing partnership. Antibody-drug conjugates, or ADCs, are antibodies designed to deliver chemotherapy treatment specifically to tumor cells. This approach is intended to spare healthy cells, thus reducing many of the toxic effects of traditional chemotherapy therapy treatment while boosting the medicine's cancer-destroying ability. Seattle Genetics is entitled to milestone payments and potential future royalties on sales. It will also receive supply and annual maintenance fees as well as research support payments for assistance provided to Millennium.

ITI and Takeda to develop schizophrenia compounds

Takeda Pharmaceutical Company of Japan has entered into an exclusive collaboration with US-based Intra-Cellular Therapies (ITI) to develop and market selective phosphodiesterase type 1 (PDE1) inhibitors for the treatment of schizophrenia.

The agreement is targeted worldwide, but ITI has retained the option to co-promote with Takeda in the US.

ITI's PDE1 inhibitors are orally available, preclinical stage compounds with the potential to become treatments for a variety of psychiatric and neurological diseases, including Alzheimer’s, ADHD and Parkinson’s.

Under the terms of the agreement, ITI will receive an upfront cash sum and will be eligible for payments of around US$500m on certain development milestones and up to $200m in sales-based milestones, along with tiered royalty payments based on net sales by Takeda. Takeda will be solely responsible for development, manufacturing and commercialisation of the PDE1 inhibitors.

‘This programme represents a unique approach to the treatment of cognitive impairment associated with schizophrenia (CIAS) and other disorders,’ said Sharon Mates, chairman and ceo of Intra-Cellular Therapies.

‘We are able to enhance our central nervous system pipeline, one of our core therapeutic areas, through this collaboration,’ said Shigenori Ohkawa, executive vp and chief scientific officer of Takeda Pharmaceutical Company.

‘We believe that ITI's PDE1 inhibitors have the potential to be a novel drug with a new mechanism of action which will satisfy unmet medical needs for the millions of patients suffering from schizophrenia.’

UPDATE 1-U.S. FDA clears Takeda blood pressure pill

Takeda Pharmaceutical Co (4502.T) won U.S. approval on Friday to sell a new once-daily pill for adults with high blood pressure.

Takeda's medicine, Edarbi, was more effective in clinical trials than two older drugs - Novartis AG's (NOVN.VX) Diovan and Daiichi Sankyo's (4568.T) Benicar, the Food and Drug Administration said. The company said the studies measured blood pressure at a doctor's office and over a 24-hour period outside a doctor's office.

All three medicines lower blood pressure by blocking the action of angiotensin II, a hormone that constricts blood vessels.

The Takeda drug will carry a boxed warning, the strongest type for prescription drugs, saying use should be avoided by pregnant women. Taking Edarbi during the second or third trimester can cause injury or death to a fetus, the FDA said.

Takeda seeks U.S. approval of hypertension drug

A U.S. subsidiary of Takeda, Japan's largest drugmaker, submitted the application to the U.S. Food and Drug Administration after completing four phase 3 clinical trials with more than 4,000 hypertension patients.

Hypertension, or high blood pressure, affects nearly one in three adults in the United States.

If the application holds up to a preliminary review, the FDA typically decides whether to approve a drug for sale within about 10 months.

The new drug combines azilsartan medoxomil, a medication discovered by Takeda that lowers blood pressure by blocking a certain hormone, with chlorthalidone, a long-acting oral diuretic.

"Millions of patients with hypertension do not have their condition under control," said Darryl Sleep, vice president of clinical science for Takeda Global Research & Development Center, Inc. U.S., a subsidiary of the Japanese pharmaceutical company.

Sleep added that the new compound "could potentially provide an important new treatment option for patients with hypertension and the health care providers who manage them."

The American Heart Association found that hypertension accounted for more than $73 billion in U.S. healthcare expenses in 2009.

Takeda settles diabetes drug patent suits with 11 generic firms

Japan’s Takeda Pharmaceutical Company has settled patent infringement suits out of court with 11 generic drug companies, including Ranbaxy Laboratories, Torrent Pharmaceuticals, Dr Reddy’s Laboratories, Wockhardt and Aurobindo Pharma, over its flagship diabetes drug Actos and its variants.

The settlement will help Ranbaxy, along with Mylan and Watson, launch generic versions of the drug on August 17, 2012 or earlier under certain circumstances. These three companies are the first to challenge the patent of this drug with paragraph IV marketing applications in the US, which will help to gain 180-day marketiTakeda has also granted Israeli drug company Teva a licence to market an authorised generic version of the drug in the US during the same period. Rest of the generic companies, including Dr Reddy’s, Torrent, Wockhardt and Aurobindo Pharma, can launch their versions after the 180-day exclusive period.

According to data of drug sales tracking agency IMS, Actos and its variants had sales of $4 billion last year. Takeda is the inventor and developer of Actos, which was launched commercially in the US in 1999 for the treatment of type 2 diabetes and has been prescribed for more than 10 million patients to date.

Takeda had filed the lawsuits against these companies to enforce several patents that expire in 2016 relating to Actos, Actoplus met, and Duetact. Actos (pioglitazone HCl), Actoplus met (pioglitazone HCl and metformin HCl), Actoplus met XR (pioglitazone HCl and extended-release metformin HCl), and Duetact (pioglitazone HCl and glimepiride) are prescription medications to improve blood sugar (glucose) control in adults with type 2 diabetes.

ng exclusivity during the launch.

Takeda, Envoy Therapeutics In Schizophrenia Research Tie

Takeda Pharmaceutical Co. Ltd. (4502.TO) said Friday it and Envoy Therapeutics Inc. of the U.S. have formed a three-year alliance for discovering new schizophrenia drugs.

Takeda, Japan's largest pharmaceutical company by sales, will make an upfront payment of $3 million and shoulder $2.25 million a year of their joint research cost, they said in a joint statement.

The Japanese drug maker will also pay milestone and royalty fees to the Florida-based company when they successfully develop and commercialize one or more schizophrenia treatments.

Their agreement is aimed at developing a better and safer drug for schizophrenia, a chronic brain disorder affecting more than 20 million people worldwide.

Takeda and Envoy Form Schizophrenia Research Alliance

Takeda Pharmaceutical Company Limited (TSE: 4502), a global pharmaceutical company, and Envoy Therapeutics Inc., a recently formed drug discovery company, today announced that they have formed a three-year research alliance aimed at discovering drugs for schizophrenia that will have greater efficacy and safety compared to current therapies.

Schizophrenia is a chronic, severe and disabling brain disorder that affects more than 20 million people worldwide. Patients with schizophrenia may hear imaginary voices or may believe that others are reading their minds, controlling their thoughts, or plotting to harm them. These experiences can be terrifying and can cause fearfulness, withdrawal, or extreme agitation. Individuals with schizophrenia have difficulty holding a job or caring for themselves, creating a significant inconvenience to their families.

Developed at Rockefeller University, with its roots in the government funded Gene Expression Nervous System ATlas (GENSAT) project, Envoy's "bacTRAP" technology combines innovative genetic engineering with new molecular biology techniques for labeling and extracting the protein-making components of specific types of cells.

To make a protein, a cell first creates a messenger RNA copy of a gene. Next, the cell sends this messenger RNA out of the nucleus to the protein-making parts of the cells, the ribosomes. The ribosomes then read the genetic sequence of the mRNA and put amino acids together into a chain that becomes a protein. Envoy engineers bacterial-artificial-chromosome (BAC) transgenic mice that express a green fluorescent protein-ribosomal protein fusion in a specific cell type, enabling the capture of cell-type-specific ribosomal mRNA through translating-ribosome affinity purification (TRAP). The technology allows scientists to identify new drug targets by measuring the in vivo expression of translated genes in specific, medically relevant cell types among the many intermingled cell types present in the central nervous system without requiring the isolation of cells. Takeda's corporate venture arm, Takeda Research Investment, Inc., invested in Envoy's first financing in October 2009, consistent with the group's goal to nurture external innovation and help Takeda build on its heritage of innovative drug discovery.

Using its proprietary bacTRAP(R) technology, Envoy's scientists will identify proteins that are selectively expressed in specific cell types within the brain that are known to be affected in patients with schizophrenia. Scientists at the two companies will then work together to evaluate and select those proteins that hold the greatest potential for therapeutic modulation. Under the terms of the agreement, Takeda will make a $3 million upfront payment as well as providing $2.25 million per year in research funding and fees. In addition, Envoy will receive potential progress-dependent milestone payments and royalties should one or more compounds advance to clinical development and commercialization.

"We are enthusiastic about collaborating with Takeda on this comprehensive effort to create novel, superior therapies for the millions of patients suffering from schizophrenia", said Paul Greengard, Nobel Laureate and co-founder of Envoy. "The central nervous system expertise of Takeda's research organization is world renowned. We are excited by the opportunity to accelerate our vision of helping people suffering from brain diseases, while clearly demonstrating the utility of our powerful technology."

"Using our research sites in the UK, Singapore and Japan, this collaboration with Envoy offers the potential for Takeda to develop entirely new classes of therapeutics to treat the devastating effects of schizophrenia where there is a high unmet need for patients," said Shigenori Ohkawa, a member of the Board and Executive Vice President, Chief Scientific Officer of Takeda Pharmaceutical Company Limited. "The novel drug targets we will identify and pursue are a key focus of Takeda's stated mission of contributing to the health of patients worldwide."

Takeda's Actos Has Same Heart Risks as Glaxo's Avandia, Researchers Find

Takeda Pharmaceutical Co.’s diabetes drug Actos causes as many heart problems as Avandia, the GlaxoSmithKline Plc pill that had a decline in sales after being linked to higher heart-disease rates, a study found.

Patients taking Avandia or Actos were 4 percent more likely to experience heart attacks, heart failure or die, according to the study published yesterday in the American Heart Association journal, Circulation.

Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from Avandia, which generated $3.3 billion of sales before the findings. The latest study, the first to compare the drugs, suggests the risks are tied to that category of medicine, said Jenny Gunton, a diabetes researcher at the Garvan Institute of Medical Research.

Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination...

DEERFIELD, Ill. and OSAKA, Japan, Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."

"This complete response letter from the FDA is consistent with the June 26 complete response letter for alogliptin, a key component of the alogliptin and ACTOS fixed-dose combination product," said Nancy Joseph-Ridge, M.D., general manager, Pharmaceutical Development Division. "The FDA recently agreed to the study design for a cardiovascular outcomes trial for alogliptin, titled EXAMINE, and patient enrollment is planned to begin this month. We anticipate

that the EXAMINE trial will provide the FDA with the information needed to continue the NDA reviews of both the alogliptin monotherapy and the alogliptin and ACTOS fixed-dose combination."

Takeda, PPD to begin safety study on diabetes drug

Takeda Pharmaceutical Co. Ltd. said Friday it will start a study to assess the cardiovascular risks for its developing diabetes alogliptin, delaying any regulatory application by about two years.

The Japanese drug developer said the Food and Drug Administration agreed to the study design. The study was requested by the agency as part of the drug approval process.

In December, the FDA instituted tougher cardiovascular safety standards for diabetes drugs and in March Takeda said those standards would apply to its application for alogliptin. In June, Takeda confirmed the FDA would not approve the drug, lacking a cardiovascular safety study.

Takeda is developing alogliptin with Wilmington, N.C.-based Pharmaceutical Product Development Inc.

"We are committed to conducting this study to satisfy the cardiovascular safety requirements, leading to the enhancement of the product profile of alogliptin," said Dr. Nancy Joseph-Ridge, general manager of the pharmaceutical development division at Takeda.

The company expects to submit interim results that should meet criteria for approval in about two years.

Alogliptin is part of the DPP-4 class of diabetes drugs, which works by controlling blood sugar. Whitehouse Station, N.J.-based Merck & Co. already markets a drug in that class, called Januvia, while New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca received FDA approval for their drug Onglyza in July.

Other potential competitors in the diabetes drug market include drugs from the GLP-1 class, which also control blood sugar. They include San Diego-based Amylin Pharmaceuticals Inc. and Indianapolis-based Eli Lilly & Co.'s exenatide LAR, which is a long-lasting version of the current drug Byetta. Denmark-based Novo Nordisk meanwhile is seeking approval for its GLP-1 drug, liraglutide.

Shares of Pharmaceutical Product Development lost 13 cents to $20.09 in morning trading.

FDA extends Takeda's alogliptin-Actos drug review

TOKYO, - Takeda Pharmaceutical Co Ltd (4502.T), Japan's largest drugmaker, said U.S. health authorities have extended their review of a diabetes drug combining its top-selling Actos and experimental medicine alogliptin until September.

The combination pill is not expected to be approved after alogliptin last month failed to gain approval, with the U.S. Food and Drug Administration asking for additional safety tests, a process Takeda says could take two years.

Alogliptin, which belongs to a new class of diabetes drugs called DDP-4 inhibitors, has been positioned by Takeda as a successor to Actos, which will lose U.S. patent protection in 2011.

"The approval process for alogliptin by itself is separate from that of the fixed-dose combination," said Takeda spokeswoman Hisako Nagata.

"But it is difficult to think that the combination drug would receive approval prior to alogliptin by itself," she said.

There is currently only one DPP-4 diabetes drug on the U.S. market, Merck & Co's (MRK.N) Januvia.

The FDA said it will respond to Takeda's application for approval on Sept. 4, instead of July 22 as previously planned.

Shares of Takeda were down 0.5 percent at 3,670 yen, while the benchmark Nikkei average .N225 was up 0.4 percent.

Sucampo, Takeda bowel-drug study shows mixed data

* Drug fails in one trial, succeeds in another

* To continue another follow-on trial

* Sucampo shares up 8 pct

Sucampo Pharmaceuticals Inc (SCMP.O) and a unit of Japan's Takeda Pharmaceutical (4502.T) said two identical late-stage trials of their experimental drug for opioid-induced bowel dysfunction (OBD) showed mixed results, with one study meeting the main goal and the other failing.

The study named OBD0631 met the main goal of showing a statistically significant change in the frequency of spontaneous bowel movements at the eighth week of treatment when the drug, lubiprostone, was compared to a dummy drug.

However, another trial, named OBD0632, failed to achieve the same goal.

Sucampo will continue another follow-on safety study in 445 patients who would receive one 24-mcg gel capsule of lubiprostone twice a day for nine months. It expects data from this study in late 2009.

If the follow-on study is successful, Sucampo expects to submit the data to U.S. health regulators in 2010.

Sucampo shares were up 8 percent at $7.00 in trading after the bell. They closed at $6.50 Tuesday on Nasdaq.

New Insomnia Medication Receives FDA Approval

Rozerem (ramelteon) by Takeda Pharmaceuticals North America in July received FDA approval for the treatment of insomnia characterized by difficulty with sleep onset, according to a company news release. Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. It will be available to patients by late September.

Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence. It has not been designated as a controlled substance. All other prescription medications indicated for insomnia are classified as schedule IV controlled substances, according to the release.

Rozerem should be taken within 30 minutes before going to bed, and activities should be confined to those necessary to prepare for bed, according to the release. Patients should not take Rozerem with or immediately after a high-fat meal. Patients should not engage in hazardous activities that require concentration after taking Rozerem.

The most common adverse events associated with Rozerem were somnolence, dizziness and fatigue.

FDA wants additional data for Takeda’s diabetes drug

Osaka, The Food and Drug Administration (FDA) in the United States rejected Takeda Pharmaceutical Co’s (TYO: 4502) application to market its new diabetes drug, citing insufficient data.

The largest pharmaceutical company in Japan will now have to provide more data on cardiovascular risks associated with the drug named Alogliptin.

Takeda spokesman Hisashi Tokinoya said, “We expect to resubmit the application in about two years. We’re still negotiating the design of the test with the FDA and hope to reach agreement in the near future.”

Big blow to Takeda

The rejection is sure to spoil Takeda President Yasuchika Hasegawa’s applecart. Hasegawa wanted Alogliptin to become a cash cow for the pharmaceutical giant.

Takeda’s present diabetes treatment, Actos, a top seller, will lose patent protection in 2011. Alogliptin was expected to be its successor.

“We expect to lose patent protection on Actos, and with the decision by the FDA it’s difficult to have the drug in time for the patent expiration," Tokinoya added.

No surprise

The FDA had, way back in March, requested for an additional study and more safety data from Takeda on the drug.

The Osaka, Japan based Takeda had applied to the FDA to sell Alogliptin, or SYR-322, in December 2007. The drug is meant to be a once-daily treatment for Type-2 diabetes.

Last week, the FDA reiterated its stance that the clinical data on Alogliptin was not enough based on new guiding principles on diabetes management and cardiovascular risks.

Therefore, the company and the stock markets expected a delay in the approval of the drug.

Kumi Miyauchi, an analyst at Daiwa Institute of Research, said, “The delay itself was not a surprise. But we now expect a further one year delay from the previously expected deadline of March 2012 in the drug's approval, as the company has not yet begun the needed additional study, which will take two years."

The new guidelines released December apply to all experimental diabetes drugs, whether studies are in progress or the medicine has been submitted for an FDA approval.

ADA trials boost Januvia, question costly meds

Avandia wasn't the only headline-maker at the American Diabetes Association's confab over the weekend. Docs at the meeting were virtually rolling in new diabetes-drug data. Some of the news was sure to cheer certain drugmakers; other studies weren't so sales-boosting. Here's a roundup.

Merck's Januvia boosted the effectiveness of diabetes-drug therapy when added to a regimen of insulin or Actos, the Takeda Pharmaceutical drug. Blood-sugar control was better for patients on combo therapy, the study found. Merck has asked the FDA to approve Januvia as an add-on treatment for patients already using insulin. Merck's diabetes franchise has been one of the bright spots in the company's quarterly reports.

Both Avandia (GlaxoSmithKline) and Actos (Takeda), which carry a known risk of heart failure, also appear to increase patients' risk of bone fractures by 43 percent. Avandia was already linked to the fracture risk, but this new trial showed an equal risk for Actos. And women on the drugs are twice as likely to suffer fractures as men are, the Wall Street Journal reports.

Aggressive use of expensive diabetes drugs and cardiovascular stents did no better than cheaper treatments at preventing deaths, heart attacks or strokes in a large study of diabetics with heart disease. The NIH-funded research (several drugmakers chipped in, too) is sure to fuel more debate over a.) costly diabetes meds and b.) the use--or overuse, depending upon your point of view--of stents. And it's an illustration of the sort of "comparative effectiveness" research newly funded by Congress.

Novo Nordisk's experimental diabetes shot liraglutide worked better than a competing generic at lowering blood sugar and triggering weight loss after two years of treatment, a company-sponsored study showed. Hypoglycemia was also less likely on the new drug, with weight loss more likely.

The once-weekly version of Eli Lilly and Amylin Pharmaceuticals drug Byetta (exanatide) worked better than Takeda's Actos and Merck's Januvia in one study, which used various ADA goals as benchmarks. As you know, the long-acting drug is a make-or-break for Amylin and a potential revenue boost for Lilly.

Drug stocks slide; Lundbeck sinks on drug woes

The Amex Pharmaceutical Index (DRG 253.84, -1.12, -0.44%) edged down 1% to 252.19 and the Amex Biotechnology Index (BTK 674.22, -4.58, -0.67%) eased 0.7% to 673.94. The Dow Jones Industrial Average (XX:DJII 11,229, -279.97, -2.43%) fell about 90 points to 8,675.

Shares of Lundbeck (HLUK.Y 18.85, -3.50, -15.66%) sank 17% to $18.60.

The Danish drugmaker said that two Phase III clinical trials for LuAA21004 had failed to show the drug was effective against a placebo in treating major depressive disorder. A third study indicated a higher dose might be needed.

As a result, Lundbeck said it will delay filing for U.S. approval for up to 24 months as it works out appropriate dosing for the product.

Lundbeck is developing the drug with Japanese drugmaker Takeda Pharmaceutical Co. Ltd. (TKPH.Y 18.80, +0.05, +0.27%) The product is also in Phase III testing for the treatment of generalized anxiety disorder.

Lundbeck already markets one of the world's most popular antidepressants, Lexapro.

Shares of Takeda dipped about 1% to $18.66.

On the upside, biotech group Micromet Inc. (MITI 5.00, +0.05, +1.01%) saw its U.S.-traded shares soar almost 17% to $5.37. The company reported positive Phase II data for its antibody-based treatment blinatumomab in the treatment of acute lymphoblastic leukemia.

Also on a roll were shares of tiny Keryx Biopharmaceuticals (KERX 1.35, +0.27, +25.00%) , up 22% at $1.31.

The biotech company reported favorable Phase II clinical results for its compound Zerenex in the treatment of dialysis patients. Keryx plans to move the product into Phase III testing.

Arena Pharmaceuticals (ARNA 5.20, +0.26, +5.26%) shares shot up 23% to $4.84. On Friday, Arena unveiled positive Phase III data for its weight-loss drug lorcaserin.

Dyax Corp. (DYAX 2.23, +0.10, +4.70%) shares leapt 12% to $2.09. The Cambridge, Mass.-based biotech firm released a favorable analysis of Phase III data for its drug DX-88, a treatment for the inflammatory disorder hereditary angioedema.

Shares of Xoma Ltd. (XOMA 1.20, +0.02, +1.70%) were also stoked, rocketing 20% to $1.27. Late Friday, Xoma released positive early-stage clinical data for its antibody-based therapy for diabetes, XOMA 052.