heart disease

ALSO NOTED: Researchers testing stem cell therapy for CHF; Boehringer unveils new research center; and much more...

Tue, 27 May 2008 06:59:50 -0400

> Fifty-six of the nation's most creative biomedical scientists are being given the opportunity to tackle their most ambitious, risky research plans, as they become the newest class of Howard Hughes Medical Institute (HHMI) investigators. The Institute is committing more than $600 million over their first term of appointment. Report

> Researchers in Florida are beginning a small, early-stage human trial to test a new stem cell therapy for congestive heart failure. Stem cell report

> Germany's Boehringer Ingelheim has taken the wraps off its new, $36 million research center in Canada. About 40 scientists will be recruited to join the 150 researchers already at work at the center. Report

> Wisconsin is set to save $63 million on prescription drugs because it started buying directly--via a purchasing co-op--rather than paying HMOs to cover pharma costs. Report

> Daniel Vasella is riled. The Novartis CEO says its hometown officials are putting too much pressure on drug prices. Report

> Exploiting a competitor's weakness is a time-honored tradition in business, so it's probably no surprise that GlaxoSmithKline is injecting itself into the Chantix upheaval. GSK report

> It's easy to announce you're opening offices in China. It's not so easy to actually do it--especially when you're wrestling with Chinese red tape. That's what the FDA is discovering as it struggles to establish a presence in Beijing, Shanghai, and Guangzhou. FDA report

And Finally... A strain of bird flu has adapted to create a new version which increases the chances of a human pandemic, according to CDC officials. Report

FDA's delay of Geron ESC trial raises concerns

Thu, 15 May 2008 06:59:57 -0400

Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Geron, which has been racing to become the first biotech with a hESC therapy in clinical trials, says it was given verbal notice that regulators are putting a hold on the planned trial. The company's shares plunged 20 percent on the news.

No details were offered on the reasons for the delay, though Geron's Dr. Thomas Okarma noted that "we are disappointed with this action given the interactions we had with the FDA." Analysts also note that FDA delays can be routine and of short duration.

Advanced Cell Technology has also been in the running to launch an ESC trial, which they hope to get approval for this year.

- check out Geron's release
- read the report from the San Jose Mercury News

BMS inks $227M collaboration deal with KAI

Tue, 13 May 2008 06:59:55 -0400

South San Francisco-based KAI Pharmaceuticals is getting a $25 million boost from Bristol-Myers Squibb---its upfront payment for a collaboration on KAI-9803, an experimental therapy to reduce the severity of a heart attack and improve clinical outcomes. BMS will also buy $10 million in KAI equity and up to $192 million in milestone payments and will pay for all future development efforts, including an upcoming Phase IIb. KAI also retains co-promotion rights in the U.S.

"This is a major milestone for KAI-9803, our most advanced of three clinical programs, and a strategically important collaboration for KAI," says CEO Steven James. "Bristol-Myers Squibb is a great partner for us with its impressive history of developing and commercializing breakthrough medicines in cardiovascular disease. We believe this deal is testimony to the value and potential of KAI-9803 and our broad proprietary technology around protein kinase C modulation." KAI was a 2006 Fierce 15 company.

- check out the press release
- read the Dow Jones report

Cholesterol drug delay signals new FDA standards

Mon, 28 Apr 2008 06:59:58 -0400

In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Researchers for the two companies say they now plan to file for approval in 2010. Shares of both companies were hurt by the announcement, with Isis shares dropping 29 percent Friday.

Genzyme agreed to buy $150 million of Isis shares and provide $175 million in a large upfront fee last January. The two companies planned to file for approval of mipomersen as a therapy targeted against a rare genetic disease. The decision, though, could have a wide ranging impact on drug developers if the FDA will no longer approve a drug based simply on its ability to lower cholesterol. And that could be a direct result of the brouhaha over data showing that Vytorin--while effective in lowering cholesterol--was no better than a generic in preventing thickening of the arteries.

- see this Genzyme/Isis release
- read the story in the Wall Street Journal

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

Trial delay forces Vasogen to hack 85% of staff

Mon, 14 Apr 2008 06:59:58 -0400

Hit by a clinical trial delay triggered by a surprise change-up at the FDA, Canada's Vasogen has hit the brakes on spending and announced plans to lay off 85 percent of its work force. The Canadian Press did the math and concluded that based on the 120 workers on the company's payroll at the end of last year, the layoffs would claim more than 100 workers. And Vasogen has brought in JMP Securities to study the company's strategic alternatives.

Six weeks ago Vasogen announced that the clinical trial for its heart failure therapy Celacade--its lead program--had been questioned by the FDA's Center for Biologics Evaluation and Research, which had taken over from the Center for Devices and Radiological Health as lead reviewer. Celacade has been approved in Europe. Its European marketing partner, Grupo Ferrer, had told Vasogen that the uncertainty in the U.S. could cost it revenue in Europe. Vasogen is now seeking "strategic alternatives" for European marketing with Grupo Ferrer.

"We cannot financially justify maintaining our existing infrastructure in light of the regulatory challenges facing Acclaim II and the revenue forecast received from Ferrer," said Chris Waddick, president and CEO of Vasogen.

- see Vasogen's release
- check out the report in the Canadian Press

Related Articles:
Vasogen shares plunge as Celacade flunks endpoint. Vasogen report
Vasogen shares slide on trial results. Vasogen report
C&L: Waddick takes reins at Vasogen. Waddick report

ALSO NOTED: PDL offers bonuses to top execs; Radius earns $28.3M for milestone;Cytokinetics surges on positive data; and much m

Wed, 02 Apr 2008 07:59:50 -0400

> PDL BioPharma says it will pay four top executives nearly $1 million in bonuses through the end of next year to keep them on board as the company undergoes a transformation into an antibody development outfit. Story

> Radius Health has completed patient enrollment into its Phase II clinical trial of BA058 for osteoporosis. That milestone won the company a second-tranche financing of $28.3 million for a total second institutional investment of $67.5 million. Release

> Sirtris has won orphan drug status for its closely watched therapy resveratrol as a treatment for MELAS syndrome. Release

> Pfizer scooped up 87 percent of Encysive stock in a tender offer that closed on Monday. The $2.35 offer values Encysive at $195 million and a subsequent offering will now run through Friday for all remaining shares. Encysive has been developing new therapies for high blood pressure. Report

> Replidyne plans to pay its CFO and corporate development officer $250,000 bonuses to stay on with the company as it completes an unspecified deal. The biotech has been looking to partner up on its antibiotic drug faropenem medoxomil. Report

> Positive data for Cytokinetics' heart failure drug CK-452 helped spur the company's stock price. Mid-stage results demonstrate improved heart function in patients taking two doses of the drug. Final results from the Phase IIa are expected in the second half of the year. Report

> Shares of Kamada jumped 13 percent on the news that its late-stage trial in the U.S. for its Alpha-1 Antitrypsin treatment of congenital emphysema posted positive interim results. Release

> An experimental drug has demonstrated an ability to improve memory and slow the effects of aging in rats. Researchers believe the same drug--S18986--can interact with AMPA in human brains. Report

> Japanese scientists have found a way to deliver a payload of artificial molecules designed to prevent cells from secreting collagen, possibly pointing to a new approach to treating cirrhosis. Report

> The recent revelation in the New York Times that a tobacco company had quietly--some say secretly--funded a research program on lung cancer prompted the Boston Globe to go out in search of tobacco money behind local research groups. It didn't have to go very far. Report

> Intermune announced that an early-stage study of its experimental hepatitis C drug met safety endpoints and appears effective. The news sent its shares up 18 percent. Release

> A federal court struck down new patent rules that had several drugmakers up in arms, including GlaxoSmithKline. Report

And Finally... Should the feds fund studies to compare drugs' effectiveness? The idea appears to be gaining traction. Report

Clinical trial data disappears in NIH laptop heist

Mon, 24 Mar 2008 07:59:58 -0400

After waiting for nearly a month, officials at the National Institutes of Health alerted some 2,500 people that their names, addresses and detailed personal health information gathered from heart scans in a clinical trial were purloined when an unknown person stole a government laptop with the data on it. NIH officials told the Washington Post that they had hesitated to contact the people, worried that they may be unduly alarmed by the news. But the report notes that the same kind of delay helped raise a hue and cry at the Veterans Administration after one of its laptops loaded with the personal data of U.S. servicemen was stolen. In the case of the NIH laptop, none of the data had been encrypted, as required.

"The shocking part here is we now have personally identifiable information--name and age--linked to clinical data," Leslie Harris, executive director of the Center for Democracy & Technology, told the Post. "If somebody does not want to share the fact that they're in a clinical trial or the fact they've got a heart disease, this is very, very serious. The risk of identity theft and of revealing highly personal information about your health are closely linked here."

- check out the article from the Washington Post

Related Articles:
VA pledges better data security. Report
VA loses records on 1.8 million vets, doctors. Report

SPOTLIGHT: Stem cell trial approved

Wed, 27 Feb 2008 06:59:53 -0500

Osiris Therapeutics has been given a green light by the FDA to start a Phase II trial of Prochymal--a formulation of adult stem cells--for heart attack victims. Release

ALSO NOTED: ZymoGenetics to chop jobs; Evotec extends collaboration; Iomai touts results for vaccine patch; and much more...

Thu, 14 Feb 2008 06:59:50 -0500

> ZymoGenetics is chopping 80 jobs--mostly in R&D--after facing some tough reviews for the potential of its newly released drug Recothrom--a genetically engineered form of thrombin to prevent surgical bleeding. Several analysts have cast doubt on the future of the drug, which was independently released, as well as ZymoGenetics other lines of research. Those prognostications have weighed heavily on the company's stock at a time the stock market has been roiled by speculation of a looming recession. The Seattle Times also notes that the cutbacks reflect the difficulty biotech companies face when moving from pure research to a combination of R&D and marketing. Release | Report

> Evotec stands to gain up to $37 million through the extension of its collaboration with the CHDA Foundation for new therapies to fight Huntington's disease. Release

> Officials in West Virginia are highlighting a new report that calls for an investment in new drug research, noting that the state is near the bottom of the 50 states in research funding and venture capital. Report

> Iomai is touting the results of a mid-stage study of its vaccine patch for traveler's diarrhea. Report

> Sanofi Pasteur has struck a licensing deal with the Statens Serum Institut of Denmark covering the use of its technology for a new tuberculosis vaccine. Report

> A Chinese plant never inspected by the FDA turned out an active ingredient in the heparin vials recalled last month. The Baxter-made blood thinner has been implicated in hundreds of adverse reactions and four deaths. Now, the FDA is investigating, planning an expedited examination of that plant and its records. Report

> The feds are accusing Cephalon of bribing drug makers to keep copycat Provigil off the market. Report

> Biogen Idec and Cardiokine have launched a late-stage trial of Lixivaptan for congestive heart failure patients suffering from hyponatremia. Release

> Alex Gorsky has left the building. As Novartis' U.S. pharma CEO, Gorsky (photo) had been with the company four years; he's now "pursuing opportunities outside of the company." Report

> It's not personal, it's political. When the Republicans were in charge on Capitol Hill, drugmakers were in favor--or so it appeared to the minority party. Now that the Dems run Congress, they're turning the tables. Report

And Finally… Generic drug makers are enthusiastic about the Bush administration's decision to back a regulatory pathway for follow-on biologics. Article

GSK, Adolor face another Entereg delay

Mon, 11 Feb 2008 06:59:58 -0500

The FDA has told Adolor and GSK that it will take three more months to review Entereg, a anti-constipation drug candidate. The agency is now expected to announce its decision on May 10. Recently, an FDA advisory committee narrowly endorsed the drug, saying that the benefits of the drug outweigh the potential risk of heart attacks that has been associated with Entereg. Adolor also submitted an updated risk management plan for the drug today.

GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data.

- see this release for more

Related Articles:
Entereg wins key FDA advisory committee vote. Report
Adolor shares rise on NDA news. Report
Investors cheer FDA's acceptance of Entereg response. Report
FDA wants more safety data on Entereg. Report
Adolor shelves Entereg studies; shares plunge. Report
FDA needs more data on Adolor drug. Report
Adolor hit by FDA's approvable letter for Entereg. Report

PDL sells off drugs as it counters harsh criticism

Tue, 05 Feb 2008 06:59:54 -0500

PDL BioPharma has auctioned off two marketed drugs and two experimental therapies as it restructures in the face of some severe criticism over how it's been managed. PDL was hammered last year for losing $130 million and moving into a swanky new headquarters building in Redwood City, CA. As a result, it started auctioning off assets. In this new deal, EKR Therapeutics will buy the hypertension drug Cardene and the heart therapy retavase along with an experimental therapy for heart failure and a new formulation of Cardene.

- see the release for more

Related Articles:
PDL BioPharma puts out 'for sale' sign. Report
In last act, PDL chief takes out the axe. Report
PDL chief resigns in wake of investor wrangle. Report
Biotech CEOs face rising fury of angry investors. Report
PDL BioPharma rises on shareholder complaint. Report

Teva snaps up CoGenesys in $400M buyout

Tue, 22 Jan 2008 06:59:56 -0500

Teva has whetted at least part of its appetite for fresh acquisitions with the announcement this morning that it is buying CoGenesys for $400 million in cash. The Israeli generic drug company says the buyout will give it a better position to compete in the fledgling biogeneric field. CoGenesys has drug candidates in the pipeline for cardiovascular disease, multiple sclerosis, diabetes and autoimmune diseases. It uses technology that retains therapies in the body for a longer period of time, reducing dosage requirements.

"CoGenesys' acquisition reflects our commitment to capture the significant long-term prospects we believe the biogenerics market will offer," said Teva CEO Shlomo Yanai in a statement. CoGenesys was a 2007 Fierce 15 company.

- see this release
- read the AP report

ALSO: It took a much sweeter offer, but Roche has prevailed in its bid to buy Ventana Medical Systems. Report

Related Articles:
Teva earmarks $1B for India. Report
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report

ALSO NOTED: Agennix OK'd to launch late-stage lung cancer trial; QLT reorganizes; Ventana still resisting Roche bid; and much m

Thu, 17 Jan 2008 06:59:50 -0500

> Houston-based Agennix has been given a green light to launch a late-stage trial of a new therapy for lung cancer that includes an ingredient found in mother's milk. Talactoferrin closely resembles human lactoferrin, which establishes a baby's immune system. Report

> QLT is laying off more than a hundred workers and selling its QLT USA division and its Vancouver HQ is it undertakes a restructuring that will leave it focused on marketing Visudyne. Report

> Roche has extended its offer for Ventana Medical Systems, but Ventana is still urging shareholders not to tender their shares. Report

> Targacept has priced an offering of 3.8 million shares at $7.07 apiece. Report

> Eisai's takeover of MGI Pharma has been approved by federal regulators. Report

> RNCOS estimates that the global vaccines market should hit $21 billion by 2010. Report

> Doctors overprescribe brand-name meds, and it's pharma's fault. Or so says a new report from the UK's Committee of Public Accounts. Report

> Did Schering-Plough execs peek at the Vytorin trial data and, spooked, bail out of millions worth of stock? Report

And Finally… In what may become the most far-reaching effects of the failed Vytorin trial, experts are questioning the sacred link between cholesterol and heart disease. Report

VC: Genizon rounds up $31M

Thu, 10 Jan 2008 06:59:52 -0500

Genizon rounds up $31M

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
Genizon BioSciences Canada	$31M Fifth	BTF	Genizon's has DNA resources and a platform that is applicable to many stages of drug development.
Corthera San Mateo, CA	$23M Third	Caxton Advantage Life Sciences Fund	Corthera lead therapy is Relaxin, which is being developed to treat heart failure.
Primera Biosystems Providence, RI	$21M Second	Abingworth	Primera has been developing new technology related to gene expression, DNA/RNA analysis, micro RNA analysis, mutation analysis and methylated DNA analysis.
Arcion Therapeutics Baltimore	$8.8M First	CMEA Ventures and InterWest Partners	Arcion has been developing ARC-4558, a topical gel to treat moderate and severe pain caused by diabetic neuropathy.
Follica Boston	$5.5M First	Interwest Partners	Follica is developing a therapy for androgenetic alopecia and other hair follicle disorders.

deCODE touts heart attack prevention study

Wed, 09 Jan 2008 06:59:56 -0500

Iceland's deCODE genetics says that its heart attack prevention drug--DG051--produced convincingly positive data in a Phase IIa study, paving the way to a Phase IIb. This recent study produced data showing that DG051 reduced leukotriene B4 (LTB4), an inflammatory molecule linked to a higher risk of heart attacks. No safety issues were raised in the study. Now deCODE plans to recruit 400 patients for its next study, slated to begin this spring.

"Our gene discovery work pointed us to the branch of the leukotriene pathway producing LTB4 as a major mechanism involved in promoting inflammation in atherosclerotic plaque and thereby increasing risk of heart attack, said Kari Stefansson, CEO of deCODE. "DG051 has been shown to bring this pathway under control and with a very satisfactory safety and tolerability profile."

- here's the release for more info

Related Articles:
Promising results for DeCode's blood clot drug. Report
DeCode touts early heart data. Report
DeCode launches genetic trial. Report

Lilly submits prasugrel NDA

Fri, 04 Jan 2008 06:59:58 -0500

Eli Lilly and Daiichi Sankyo have submitted the much-watched drug prasugrel to the FDA. The drug--an oral antiplatelet agent--is poised to take on the blockbuster Plavix. In a recent study prasugrel was more efficient than Plavix at reducing the number of heart attacks and other significant events. However, an increased number of bleeding incidents among the prasugrel group cast a shadow over the results. 1.7 percent of patients taking Plavix experienced serious bleeding incidents, compared to 2.2 percent of prasugrel patients.

FDA approval is crucial for Lilly; analysts say the company has no other blockbuster hopefuls in its pipeline, and patent expirations could eat away at 60 percent of its revenue in the coming years. The hope is that the FDA thinks prasugrel's benefits outweigh the increased bleeding risk. "We feel confident in the strength and completion of this submission package, and plan to complete our submission in Europe in the first quarter of 2008," said one Lilly VP. If approved, the drug will be marketed under the name Effient.

- check out this release for more
- read this article from Forbes

ALSO: TAP Pharmaceutical has submitted an NDA for TAK-390MR for the treatment of acid related diseases. Release

PLUS: Takeda has submitted an NDA for its type 2 diabetes drug alogliptin. Release

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Doubters see big obstacles for Lilly's prasugrel. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report

Corthera pockets $23M in VC, names CEO

Thu, 20 Dec 2007 06:59:54 -0500

San Mateo, CA-based Corthera has closed a $23 million third round of venture capital. Caxton Advantage Life Sciences Fund joined A-list life science investors Domain Associates and Kleiner, Perkins, Caufield & Byers in providing the money. And Stan E. Abel, the co-founder of Cerexa, was named president and CEO. Its lead therapy is Relaxin, which is being developed to treat heart failure.

"Given Relaxin's beneficial hemodynamic properties, it is very well-suited for patients suffering from acute heart failure," said Rachel Leheny, Ph.D., managing director of Caxton Advantage Life Sciences Fund. "We are looking forward to working with the Corthera team as they develop Relaxin for this largely unmet medical need."

- read the release on the venture round

ALSO: Agile Therapeutics has raised an additional 5.6 million in its fifth round, bringing its Series E total to $17.6 million. Release

GSK shakes up R&D

Wed, 12 Dec 2007 06:59:56 -0500

Like so many other big drug developers, GlaxoSmithKline has announced that it will be shaking up its R&D operations. The goal? To create new drugs faster and cheaper. Speaking to the Financial Times, Moncef Slaoui--GSK's R&D chief--also said that within a few years time, about half of the company's new drugs will come from outside partners rather than from internal development efforts.

Previously, GSK reorganized its R&D activities into Centres of Excellence for Drug Discovery, which were designed to be more entrepreneurial and nimble than Big Pharma. Many other developers have since copied the move. So what's next for GSK? "Mr. Slaoui...stressed that the company would increasingly focus on four therapeutic areas: oncology, vaccines, biological medicines and neuroscience."

- see this Financial Times article

ALSO: Take a look at GSK's pipeline. Report

PLUS: An independent study of 159,000 older people with diabetes found that patients treated with GlaxoSmithKline's Avandia and Takeda Pharmaceuticals' Actos had a higher risk of heart attack and death. Report

Related Articles:
GSK plant closure begins 5,000 job cuts. Report
Behind the scenes of GSK's overhaul. Report
Musical chairs at GSK leaves Stout out. Report

Doubters see big obstacles for Lilly's Prasrugel

Mon, 19 Nov 2007 06:59:56 -0500

The news that Eli Lilly's experimental anti-clotting drug Prasrugel was linked with a higher risk of fatal bleeding has converted a large group of analysts into disbelievers in the company's stock price. Specifically, Barron's is quoting a slate of analysts skeptical that the drug can be approved as is and worried by the absence of any other potential blockbuster in the Lilly pipeline. Lilly has maintained a much more optimistic attitude, noting that its recent crop of data indicates that the drug demonstrated efficacy in reducing heart attacks and strokes with fewer major incidents than Plavix. The analysts are betting that the FDA will want more studies--and that will take considerably more time than planned.

- read the report from Barron's

Related Articles:
Lilly drug outperforms Plavix, but there's a catch. Report
Lilly suspends dosing in crucial drug trial. Report
Lilly pits drug against Plavix in trial. Report