experimental therapy

Novo Nordisk discontinues Phase III on disappointing results

John Carroll — Wed, 11 Jun 2008 11:14:01 -0400

Concluding that a late-stage trial of its experimental therapy to prevent bleeding in trauma patients was headed to a likely failure, Novo Nordisk discontinued the study of NovoSeven. "Due to an observed lower mortality than anticipated in the overall study group (around 10 percent in the Phase III trial in total compared to more than 25 percent in the Phase II trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint. The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial," the company announced.

"It is regrettable that this trial is coming to an end," said Mads Krogsgaard Thomsen, executive vice president and CSO. "It has, however, already now provided a lot of important data on the treatment of severely injured patients. We will share these findings with the medical community as soon as the full clinical analysis has been completed."

- check out Novo's release

ALSO NOTED: Acorda shares soar; Lexicon wins fast track; NIH grants $533N in research funds; and much more...

Tue, 03 Jun 2008 06:59:50 -0400

> News yesterday that Acorda Therapeutics' experimental MS drug helped patients walk better sent its shares up 27 percent. Report

> The FDA has provided fast-track status to Lexicon Pharmaceuticals' therapy for carcinoid syndrome. Story

> Cougar Biotech says it presented positive Phase I and Phase II data for CB7630, an experimental therapy for castration resistant prostate cancer. Release

> Arana Therapeutics and Greenovation Biotech have forged a pact to develop up to five anti-cancer antibodies. Report

> China's Genesis Pharmaceuticals Enterprises has raised $30 million in a private placement. Release

> Novartis "stole the show" at ASCO, Forbes says. Between the big Zometa news--that the bone drug may actually prevent breast cancer recurrence--and dramatic data on an experimental med, the Swiss pharma came out of ASCO looking pretty sweet. ASCO report

> Guess who's the new up-and-comer in pharma? Brazil. Report

> It's not a new question, but it's one whose urgency is growing: How long can Pfizer pay its big dividend? Report

> Eugene Melnyk (photo) said he'd do it, and now he has. The founder of Canada's Biovail launched a proxy battle for the company, looking to sweep out its board and senior management. Report

And Finally… The Scripps Transitional Research Institute was one of 14 research groups that will gain $533 million from the NIH over five years. The funds are earmarked to speed the development of new technologies. Report

Kennedy's surgery may be followed by experimental therapy

Mon, 02 Jun 2008 06:59:58 -0400

Legendary Duke neurosurgeon Dr. Allan Friedman is scheduled to remove Senator Ted Kennedy's brain tumor this morning, and there's already significant speculation that the lawmaker will undergo experimental therapy in a follow-up treatment. According to a statement, the Duke neurosurgeon will surgically remove the tumor and the senator will undergo radiation and chemotherapy to combat the glioblastoma. About half of all glioblastoma patients die within a year of surgery. Median survival time is 12 to 15 months.

Kennedy, though, is in the hands of the countries best neuro-oncologists. In addition to the chemo drug Temodar, Kennedy may be treated with Avastin. While approved for other cancers, using Avastin to starve the tumor of blood is still only in the experimental stage for brain tumors.

- read the AP report

ALSO NOTED: Dor withdraws app; Researchers advance adenovirus therapy; and much more...

Thu, 22 May 2008 06:59:50 -0400

> Dor BioPharma has voluntarily withdrawn its European Marketing Authorization Application for orBec, a treatment of gastrointestinal Graft-versus-Host disease. Report

> Somnus Therapeutics announced the formation of an executive development team. Release

> Scientists at Saint Louis University School of Medicine say that an experimental therapy being tested by Durham, NC-based Chimerix may become the first candidate for human trials for adenovirus. Report

> In a first, researchers have developed a primate model for Huntington's disease, eliciting harsh criticism from animal rights experts even as it paves the way for future primate models for a host of degenerative brain disorders. Report

> The Federal Trade Commission is none too happy with Big Pharma's dealmaking with generics companies. FTC report

> More evidence that pharma is swinging blue--and that Republicans could have a tough time this election year. Drug and medical device companies, who once contributed to the GOP three-to-one over Democrats, have given $7.4 million to Democratic candidates this cycle. That compares with just $7 million for Republican candidates. Report

> It's been a tough week for outgoing GlaxoSmithKline CEO Jean-Pierre Garnier. Browbeaten during a BBC interview on Tuesday, he was "heckled" by annoyed shareholders at yesterday's annual meeting. GSK report

> Chantix suffered a one-two punch yesterday, as a watchdog group's report linked the stop-smoking med to a wide variety of health and safety problems, and the Federal Aviation Administration told pilots and air traffic controllers not to use it. Chantix report

And Finally... One of Senator Kennedy's best chances in defeating the malignant brain tumor that afflicts him could be an experimental vaccine, and reports are already circulating that he may be included in a trial. Vaccine report

Aflibercept misses endpoint in mid-stage study

Wed, 21 May 2008 06:59:55 -0400

Regeneron and Sanofi-Aventis announced that their experimental therapy aflibercept missed a mid-stage goal for an ovarian cancer trial. The primary goal was a five percent response for established criteria at two dosages. At the higher dose, researchers tracked a 4.5 percent response and a 0.9 percent response at the lower dose.

Aflibercept is also being tested in late-stage trials for prostate, colorectal, pancreatic and non-small cell lung cancers. Both companies say they're now evaluating how to proceed developing the therapy.

- take a look at the announcement
- read the AP story

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

NicOx shares plunge on Pfizer trial failure

Tue, 06 May 2008 06:59:58 -0400

Shares of France's NicOx tumbled 38 percent after Pfizer announced that it would not advance their experimental therapy for glaucoma into Phase III. Researchers for Pfizer said that Phase II data was "interesting" but failed to meet its primary endpoint. That was all investors had to hear. They drove NicOx shares down to a five-year low.

There was some good news for NicOx. Pfizer says it remains committed to the program and may pursue new research on the compound once a Phase II trial in Asia is wrapped. That data is expected in the third quarter of this year.

NicOx's drug platform involves enhancing therapeutics with nitric oxide. PF-03187207 is a new version of Pfizer's Xalatan, the best-selling glaucoma medicine. The failed mid-stage trial did produce data indicating the new therapy demonstrated "clinically significant reduction in diurnal intraocular pressure" compared to Xalatan.

"We believe this Phase II study for PF-03187207 has provided interesting data," said David Eveleth, Pfizer's vice president, ophthalmology development. "While the study did not meet its primary clinical endpoint and our criteria for launching a global Phase III program for this compound, we remain committed to our joint research program with NicOx, where the follow-up compounds to PF-03187207 have produced encouraging results."

- check out the release

ALSO NOTED: Curis earns $3M milestone; Lethal viral outbreak in China; and much more...

Mon, 05 May 2008 06:59:50 -0400

> Roxro Pharma announced it has received an Excellence and Innovation Award from the Committee on Scientific Papers of the Society for Ambulatory Anesthesia for the Phase III data of the company's novel intranasal pain reliever ROX-888. Release

> Genentech has begun a mid-stage study of an experimental therapy for colon cancer, GDC-0449, triggering a $3 million milestone payment for Curis. Curis release

> Minerva Biotechnology says it has used its nanoparticle technology to elucidate a key molecular mechanism that is involved in cancer cell growth and metastasis. Minerva release

> Pfizer is starting to settle the thousands of lawsuits over painkillers Celebrex and Bextra. Pfizer report

> Outsourcing is still on roll--it's just not rolling quite as fast as it did last year, according to Contract Pharma's 2008 outsourcing survey. Outsourcing report

> Pharma needs to slap some raw steak on its black eye, Dr. Roy Vagelos said during a speech last week. Pharma's elder statesman--and ex-Merck CEO--says the drug industry has lost goodwill and credibility, and needs to get to work to repair its reputation. Report

> Should insurers be allowed to reward docs who switch patients to generics? That debate is going public in Colorado, where legislators have proposed a bill that would prohibit the practice. Report

And Finally… An outbreak of the lethal Enterovirus 71, or EV-71, has stricken more than 6,000 people in China and left 26 children dead. There is no vaccine available to contain EV-71, which triggers a severe form of hand, foot and mouth disease, according to the Wall Street Journal. Article

ALSO NOTED: Analysts predict trouble for second-gen Rituxan; Sucampo earns $50M on FDA approval;and much more...

Wed, 30 Apr 2008 06:59:50 -0400

> Jim Reddoch, a biotech analyst with Friedman, Billings & Ramsey, is raising some interesting questions about Genentech's second-generation anti-CD20 antibody that is in development as a more benign version of Rituxan. Given the recent trial failure in lupus, Reddoch tells Pharmalot that he's more skeptical about its chances when the more potent Rituxan fails to hit endpoints in a trial. And that could eliminate a potential "growth area" for the biotech giant. Report

> Sucampo has won a $50 million milestone payment on the FDA's approval of a new indication for Amitiza. Report

> A JDRF collaboration between Johns Hopkins researchers and Genentech has shown that a drug for the treatment of diabetic eye disease--ranibizumab--has performed better in clinical trials than the current standard treatment using laser surgery. Release

> Metabasis Therapeutics announced Monday that its experimental therapy for type 2 diabetes hit its endpoints in a Phase IIa trial. Release

> What's bad for Merck is good for Abbott Labs. When the FDA said "no" to Merck's niacin-based cholesterol treatment Cordaptive, it raised the prospects for Abbott's extended-release form of niacin, Niaspan, and its regular niacin drug Simcor. Abbott report

> The FDA finally put its mouth where the money is. During congressional hearings yesterday, CDER chief Janet Woodcock said the agency would need $225 million to $250 million in additional funding to inspect foreign plants as frequently as it does in the U.S. FDA report

> Consider this scenario from Fred Hassan's nightmares: The $800 million Clarinex, ostensibly under patent till 2020, falls early victim to generic competition. Clarinex report

> Last fall AstraZeneca EVP David Smith said the company was looking to outsource most of it manufacturing, but then backpedaled after the ensuing outcry. Now the company has affirmed a big chunk of those outsourcing plans. Outsourcing report

> Management consultant Dr. David A. Shaywitz has joined with Dr. Dennis A. Ausiello, the physician-in-chief of Massachusetts General Hospital and a director at Pfizer, to deliver a rebuttal to a small group of research scientists who have sworn off any industry-financed drug research work. Report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

And Finally...
Two new human trials of a gene therapy for inherited blindness have demonstrated that injecting replacement genes under the retinas of the blind can spur at least partial sight in some volunteers. Report

Merck shares hammered after FDA rejects Cordaptive

Tue, 29 Apr 2008 06:59:58 -0400

Shares of Merck were sliding again this morning on the news that the FDA has turned thumbs down on MK-0524A, its new cholesterol therapy. The stock dropped eight percent after regulators announced that the experimental therapy, a combination of niacin and laropiprant that had been high up on the drug giant's list of potential blockbusters, failed to make the grade. Getting an approval on Cordaptive, as the therapy was dubbed, would have gone a long way to easing the sting from the massive fallout that has hit Merck since new Vytorin data cast doubt on its efficacy.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, executive vice president of the company and president of Merck Research Laboratories, in a prepared statement.

- see Merck's release
- check out the report in TheStreet.com

Dyax forges $231M development deal for DX-88

Thu, 24 Apr 2008 06:59:57 -0400

Cubist Pharmaceuticals has agreed to pay Dyax $15 million upfront and up to $216.5 million more in potential milestone payments for collaboration rights to Dyax's experimental therapy for the prevention of blood loss during surgery in North America and Europe. Cubist will fund development costs for an ongoing Phase II trial of DX-88. And Dyax has co-promotion rights in the U.S. and retains development rights for other indications. The first $2.5 million milestone payment will be paid this year.

"As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing blood loss and inflammation in multiple surgical indications," says Cubist CEO Mike Bonney. "There is a serious unmet medical need and a large market opportunity for a successful therapy here."

- see Cubist's release
- read the story in StreetInsider

ALSO NOTED: Arqule hires new CEO; Kosan launches mid-stage study; and much more...

Tue, 15 Apr 2008 06:59:50 -0400

> Is the U.S. drug industry bargain-basement land right now? Analysts say that the low, low dollar means low, low prices for pharma companies. Rivals in Asia and the Eurozone could snap up drug companies just like they've bought up Manhattan condos. Report

> Chutes & Ladders: Arqule has hired Paolo Pucci, currently president of the Bayer-Schering Pharmaceuticals Global Oncology/Specialized Therapeutics divisions, as its new CEO. Pucci is taking over in June, following Stephen Hill, who was named the new CEO of Solvay. Report

> Kosan Biosciences has launched a mid-stage study of an experimental therapy for non-small cell lung cancer. Release

> Innogenetics has completed a $9.5 million settlement and licensing agreement with U.S. group Abbott Laboratories, ending a lawsuit. Story

> Medivir has entered into a co-promotions deal with GlaxoSmithKline for the Swedish market. Release

> AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. Report

> Remember that drug-safety database Congress required the FDA to set up? Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth. Report

> A few prominent research doctors are saying "No, thanks," to any payments from drug and device companies. Report

> The FDA's China office is slated to open next month. Report

And Finally... Contrary to what most of us would like to believe, decision-making may be a process handled to a large extent by unconscious mental activity. Release

Amgen's D-mab posts positive in late-stage trial

Thu, 03 Apr 2008 07:59:58 -0400

Amgen got a badly needed boost with its announcement that its most promising experimental therapy, denosumab, significantly increased bone mineral density in a Phase III trial. The drug, delivered as a twice yearly injection, outperformed Fosamax in a study that was wrapped in January. This new study focused on the outcomes of 332 patients with post-menopausal osteoporosis.

"The effect of denosumab on wrist BMD [bone mineral density], reinforced by the BMD increases at the total body and hip regions, suggests denosumab has a positive effect on highly cortical sites," said Javier San Martin, global development lead for the denosumab osteoporosis program.

Data on another late-stage study evaluating denosumab's impact on fracture risk reduction in women with postmenopausal osteoporosis is due later this year.

- see Amgen's release on the trial
- check out the report in the Wall Street Journal

ALSO NOTED: ImClone hires Zuerblis for CFO post; Tekmira plans merger; Argos touts HIV data; and much more...

Mon, 31 Mar 2008 07:59:50 -0400

> ImClone Systems has hired Kenneth Zuerblis as its new chief financial officer. Zuerblis has been CFO at Enzon before his resignation in 2005 for personal reasons. Report

> After posting a $2.6 million loss for last year, Tekmira Pharmaceuticals announced that it will merge with Protiva Biotherapeutics. Release

> Argos Therapeutics says its Phase I trial of AGS-004 for HIV demonstrated positive safety and feasibility data. "Initial data revealed no serious adverse events," said Jean-Pierre Routy, M.D. "Mild adverse events observed were consistent with immune response induction and typical of similar therapies." Release

> Japanese regulators have approved Naglazyme for as Maroteaux-Lamy syndrome. The drug is being developed by AnGes MG and Biomarin Pharmaceuticals. Report

> Business leaders in Arizona are touting a $1.4 billion bond package that would provide funds to expand biomedical research in the state. Story

> Crucell has pushed its rabies monoclonal antibody combination into Phase II, hitting a milestone in its development deal. Report

> Genta announced that the Data Safety Monitoring Board for its Phase III trial of Genasense Injection, its lead oncology product, has recommended that the trial be continued as originally planned after initial review of blinded safety data from the study. Release

> Encorium Group has inked a $1.6 million contract with Protherics for a Phase II trial of its novel immunotherapeutic vaccine, Angiotensin Therapeutic Vaccine for hypertension. Release

> Neurosearch has begun an early-stage trial of NSD-788, an experimental therapy for anxiety and depression. Report

> If Merck and Schering-Plough really expected their Enhance presentation to turn the tide on Vytorin and Zetia, then they were sorely disappointed this weekend. Report

> Some cholesterol med-makers do have reason to rejoice today. AstraZeneca stopped a study of its blockbuster Crestor, saying the pill had already demonstrated clear benefits over placebo. Report

>What's the long-term impact of the heparin scare? It's shattered U.S. claims of "it can't happen here," for one thing. Report

And Finally… A new study links pesticides with Parkinson's disease. Release

SPOTLIGHT: Sepracor touts data

Mon, 17 Mar 2008 07:59:53 -0400

Sepracor says its experimental therapy for seasonal allergic rhinitis hit its primary and secondary endpoints in a mid-stage trial. Omnaris "demonstrated a statistically significant reduction in 24-hour total nasal symptom scores versus placebo." Release | Report

ALSO NOTED: Neurochem pursues new Kiacta trial; Teva drug fails ALS trial; Columbus tapped as promising new life sciences hub;

Thu, 13 Mar 2008 07:59:50 -0400

> Neurochem is forging ahead with plans to launch a new late-stage trial for Kiacta in a renewed bid for regulatory approval. Regulators had declined to approve the amyloidosis therapy, saying they needed to see more data. Release

> Teva says that a mid-stage trial of glatiramer acetate (GA) 40 mg for ALS failed primary and secondary endpoints. Release

> In a review of up-and-coming tech hubs, Forbes picked Columbus, OH as the most promising new hub on the U.S. map, in part because of the life sciences work being done at the Battelle Memorial Institute. Palm Beach County also lands high up on the list, as new R&D institutes spring up for discovery work. Report

> CyDex has filed for an IPO that could be valued at up to $50 million. The Lenexa, KS-based developer has patented technology used to improve solubility, stability, bioavailability, safety and dosing. Release

> Dani Bolognesi, the co-founder of Trimeris, is back at the helm of a start-up biotech company, hoping that B3Bio can score advances for inflammation, cancer and infection. The start-up is relying on technology developed at Duke and the University of Texas. Story

> Sciele Pharma has paid $29 million to buy Verus's Twinject epinephrine auto-injector along with other products. Release

> Juvaris BioTherapeutics has tapped Grant Pickering to replace founder Martin Cleary at the helm. Pickering had earlier founded Pharmada, a developer of cancer therapies. Cleary remains as chairman of the board. Release

> Avexa announced "excellent" data from a Phase IIb trial of its HIV therapy, with 90 percent of patients achieving undetectable viral loads after 48 weeks of therapy. Report

> Urigen announced positive mid-stage results for its experimental therapy for a painful bladder syndrome. Release

> The investment firm Warburg Pincus has taken a 13.7 percent stake in ZymoGenetics. Report

> Researchers figured out how two different cancer drugs--Avastin and Erbitux--might lead to side effects. Report

> Yesterday, the embattled Endo Pharmaceuticals named a pharma veteran David Holveck (photo), who some call "Mr. Fix-It," to replace its departed executive officer. Report

And Finally… Hong Kong closed its schools after three children died from influenza. Officials say there's no sign of SARS or bird flu in the outbreak. Article

ALSO NOTED: Memory refocuses on lead programs; GRL, Sirnaomics extend RNAi deal;and much more...

Wed, 12 Mar 2008 07:59:50 -0400

> Memory Pharmaceuticals is retooling its operations to focus less on drug discovery research a near-term and mid-term efforts. Report

> General Research Laboratory (GRL) and Sirnaomics are advancing their partnership initiated in July 2007 for development of two RNAi therapeutic products. Release

> Japan-based TPG Biotech and JCR Pharmaceuticals jointly announced that they have entered into an investment agreement to fund the late-stage clinical development of two drug candidates for JCR, JR-013 and Growject. Release

> Northwestern University scientist Richard Silverman's work led to the blockbuster Lyrica, which translated into more than $700 million in royalties from Pfizer. And his story--told by the Chicago Tribune--illustrates the crucial role that a technology transfer office can play in moving an experimental therapy into the hands of a biopharma company with deep pockets. Report

> The FDA is taking a look at a fresh set of standards that demand new tests to determine if diabetes drugs elevate heart risks. Report

> A group of some of the most prestigious research groups in the country says that five years of flat budgets for the National Institutes of Health is threatening to deter an entire generation of young researchers. Report

> Connecticut is joining the queue of states suing Eli Lilly over Zyprexa marketing. Report

> Scientists at the Virginia Bioinformatics Institute used a new computer modeling program supported by the NIH to simulate how a lethal pandemic flu outbreak could hit a modern American city. Report

> Since the Democrats took over Congress, drug makers have been scrambling to make nice with their former foes. Report

And Finally... According to a news CDC study, one in four teenage girls has an STD. Release

ALSO NOTED: ImClone kicks off liver cancer trial; PhRMA boosts lobbying efforts; and much more...

Fri, 22 Feb 2008 06:59:50 -0500

> Did a big boost in drug industry lobbying pay off last year? The industry's top trade group, PhRMA, spent more than $22 million lobbying in 2007--a 25 percent increase from the year before. Report

> ImClone has kicked off a Phase II trial of IMC-1121B, an experimental therapy for liver cancer. Release

> Chutes & Ladders: Neurochem announced that Dr. Andreas Orfanos, Executive VP of Strategic Planning and Scientific Affairs, and Ms. Christine Lennon, VP of Business Development, are leaving the company. The company says the changes come "in light of Neurochem new strategic direction." Release

> A jury hit AstraZeneca with $215 million in damages as payback for overcharging the state of Alabama for drugs for 15 years. And AstraZeneca is just the first of 70 drug makers to go to trial. Report

> Pharma's favorite dynamic duo, Reps. John Dingell and Bart Stupak, are threatening to force the FDA to inspect foreign plants before drugs or ingredients are exported to the U.S. Report

And Finally... Humans aren't the only ones struggling with obesity. According to a recent study, the prevalence of obesity in dogs is between 22 and 40 percent; cats are also suffering from excess weight. Release

SPOTLIGHT: S&P likes GTx's Acapodene

Tue, 12 Feb 2008 06:59:53 -0500

Standard & Poor's Equity Research says that GTx is in an enviable position. Late-stage data is due this quarter for Acapodene, an experimental therapy for prostate cancer. "We believe both target markets represent population opportunities of more than 1 million patients." Report