Amgen kills anemia drug rebates
Answering critics of its pricing policies, Amgen is discontinuing rebates and discounts designed to boost sales of its anemia drugs. Some said the deals induced doctors to overuse Aranesp--the anemia drug targeted at cancer patients--at a time when questions had arisen about the drugs' safety, especially at higher doses.
Oncologists will still get some up-front discounts, but they won't get rebates for Aranesp use. Nor will doctors get discounts on two other meds, Neulasta and Neupogen, based on their use of Aranesp.
As you know, some studies have suggested that Aranesp and its sister drug Procrit, sold by Johnson & Johnson, could cause cancer to grow, hasten patients' deaths and cause heart problems.
Amgen has said that its discounts and rebates haven't prompted overuse of Aranesp. The company said the pricing changes are a move to "clear up those possible misperceptions."
- read the New York Times story
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Costly Lucentis gets NICE nod
As researchers in the U.S. compare Genentech's macular degeneration drug, Lucentis, with Avastin, another Genentech drug used off-label to treat the eye disease, notoriously tight-fisted regulators in the UK are clearing the much more expensive Lucentis for funding by the National Health Service.
As you know, Genentech has run into controversy over Lucentis, which costs $2,000 per treatment, versus $60 per dose for Avastin when used for the eye malady. The company had moved to restrict distribution of Avastin to compounding pharmacies that repackage the drug for ophthalmic use, but the outcry from doctors and patients led Genentech to soften its stance.
Genentech has come in for criticism from the National Eye Institute, which wanted the company to be part of the head-to-head study. Unsurprisingly, the company wasn't eager to sink money into a trial that pitted two of its drugs against each other--but some have read that refusal as evidence of the company's lack of faith that Lucentis will prevail.
Most importantly, though the study results won't be available for a couple of years, folks are already talking about the prospect that, if the drugs prove comparable at treating macular degeneration, Medicare would refuse to pay any more for Lucentis than it does for Avastin.
In the U.K., however, the National Institute for Clinical Excellence has decided to make Lucentis available to NHS patients. The series of 14 injections will run about $18,000 per eye; under its deal with NICE, Novartis, which markets the drug in Europe, will cover any additional injections needed. Even at the $18,000 cost, NICE figures it will save money compared with the cost of patients' vision impairment.
Why didn't NICE recommend Avastin instead? There's no trial data showing the drug's effectiveness against macular degeneration. And there won't be--until the National Eye Institute trial wraps. We'll see how NICE reacts then.
- see the Boston Globe story
- read the news from the Wall Street Journal
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Genentech rethinks Avastin limits
Eye docs confront Genentech exec
Why should Medicare pay for Lucentis?
Pharma reps meet Star Wars stardom
A long time ago in an imaginary galaxy far, far away, Merck was training an elite squad of Vioxx reps--the V squad--to overcome obstacles to the painkiller's success. Could they beat the futuristic "obstaclizer" and meet their sales goals? See the videos to find out. Report
Bristol-Myers Squibb And Pfizer Provide Update On Apixaban Clinical Development Program
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc (NYSE: PFE) provided an update on the apixaban clinical development program today. The companies announced that new Phase II data in acute coronary syndrome patients (ACS) will be presented at the upcoming meeting of the European Society of Cardiology (ESC).Stanford Med School rejects industry funding for continuing education
By Sarah Arnquist Stanford University's medical school announced this week new restrictions on educational contributions by drug and medical device companies, which turn out to be among the strictest in the nation. The rules are an effort to limit industry...No Fooling Around with New Patent Blog
Gene Quinn, Jr., the force behind the Patent Briefs at the Practicing Law Institute, has struck out in a new venture. Gene has now brought us a new patent blog, PatentFools.com. PatentFools is described thusly:
The point of PatentFools is to try and identify wrongs, articulate positions, influence decision-makers and have some fun saving the world for generations to come. Essentially, we are fighting for truth, justice and the American way, not unlike Superman… well… very much unlike Superman if you are concerning yourself with the faster than a speeding bullet, more powerful than a locomotive and the ability to leap tall buildings with a single bound. We are, however, not affected by kryptonite, so at least we have that going for us, which is nice!
Why go for yet another patent discussion venue? Well, according to Gene, while he will continue to write for PLI, there are some limitations on what he can write given the need for PLI, as a nonprofit, to keep its tax exempt status.
As an example of what to expect, Gene calls for the USPTO to withdraw its appeal of the permanent injunction enacted by a district court prohibiting the USPTO from putting the new rule changes into effect (Tafas v. Dudas).
The Court of Appeals for the Federal Circuit lowered any expectations the Patent Office and the Department of Justice had about getting the permanent injunction of the proposed claims and continuations rules overturned.
In Cooper v. Dudas, the Federal Circuit was asked to decide whether the the Patent Office had the authority to interpret the term “original application,” a term used in a section of the American Inventors Protection Act with respect to new provisions on filing for an inter partes reexamination of an issued patent.
The Federal Circuit reviewed the authority the Patent Office has to implement substantive changes to the law regarding patent applications:
We have also previously held that 35 U.S.C. § 2(b)(2) does not authorize the Patent Office to issue “substantive” rules. See Merck & Co. v. Kessler, 80 F.3d 1543, 1549-50 (Fed. Cir. 1996). “A rule is ‘substantive’ when it ‘effects a change in existing law or policy’ which ‘affect[s] individual rights and obligations.’” Animal Legal Def. Fund, 932 F.2d at 927 (quoting Cubanski v. Heckler, 781 F.2d 1421, 1426 (9th Cir.1986), vacated as moot sub nom., Bowen v. Kizer, 485 U.S. 386 (1988)). “In contrast, a rule which merely clarifies or explains existing law or regulations is ‘interpretative.’” Id.
Expressing the view that the USPTO stands virtually no chance that the Federal Circuit will overrule the permanent injunction stopping the implementation of the claims and continuations rules, Gene implores the Office to relent:
In fact, the Federal Circuit is not likely to even hear oral arguments in the GSK matter until late Fall 2008, which is after the next election. Even if the Federal Circuit does hear the case late Fall 2008, no decision will be forthcoming until late Winter 2009 at the earliest, which means that by the time the Federal Circuit can agree with Judge Cacheris there will be a new President, a new Director of the Patent Office and a new Attorney General. So why continue with a losing appeal?
Any fool could see the result.
See more here: Tafas v. Dudas: The Continuation Wars
Microsoft HUG–Wish you were here Day 2
If you want to go straight to the really sexy stuff, scroll toward the bottom of this entry and see the photos and video of Microsoft Surface in Health. If you want a more complete view of the day's proceedings, read on.
Yesterday ended with a very nice cocktail reception held at the Microsoft Conference Center; the site for our annual Microsoft Healthcare Users Group meeting in Redmond. I always look forward to the social events around our conference as an opportunity to catch up with good friends and business associates from around the country and the world.
Turning Health Data into Knowledge
Today kicked off with an opening keynote by Steve Shihadeh (left in the photo) VP of Sales and Marketing for our Health Solutions Group. Steve spoke on "The Transformative Power of Technology at the Intersection
of Physicians and Patients". He was joined on stage by Dr. Clyde Wesp, CMIO for St. Joseph Health System in Orange, California. You may recall that St. Joseph Health System was recently featured on my House Calls for Healthcare Professionals audio-cast series when their CIO, Larry Stofko, spoke about the value his organization is experiencing with Microsoft Amalga.
Later in the day, conference attendees received a briefing on Microsoft's Connected Health Framework and Platform in a presentation that was anchored by our senior technical strategist, Teddy Bachour. You can update your knowledge on that topic by visiting a previous HealthBlog posting with links to additional information on the Microsoft Developers Network, MSDN.
Facilitating Caregiver Communication and Collaboration
Both yesterday, and again today, conference attendees were treated to presentations given by my colleagues in our Unified Communications group. HealthBlog readers know that I am a huge proponent for the use of UC in healthcare. Our UC technology brings together messaging, e-mail, telephony, voice, video and conferencing. For developers, our UC platform enables a high degree of customization to better meet the unique requirements of healthcare. I was honored to join my UC colleagues on stage to review the huge opportunities afforded by Unified Communications that will fundamentally change the way care teams communicate and collaborate with each other and their patients. You can learn more by visiting one of my previous posts on this topic. You can also watch a video we produced that will help you envision the possibilities.
The Big News is Surface in Health
Although there is much more that happened at Microsoft HUG, it is beyond the scope of HealthBlog to cover it all. But I wanted to leave you with what I consider to be one of the highlights of the show and that is Surface Computing in health. Until recently, our Surface team has been focusing on other vertical industries. But from the first time I saw surface in Andy Wilson's lab at Microsoft Research, I knew it had healthcare written all over it. It has taken some time to bring together the right developers and partners to apply Surface technology in health, but we are finally there.
I was thrilled to be asked to participate in the closing keynote at Microsoft HUG where we unveiled for the first time some of the healthcare applications being developed for Surface. Randy Fusco, chief technology officer for our US Health and Life Sciences team lead the discussion. He was joined by Erik Rock, CTO of Microsoft partner, Medhost; Tim Huckaby, CEO of Microsoft partner InterKnowlogy; and Dr. Peter Kuhn of the Scripps Research Institute. Erik, Tim and Peter showed examples of how Surface can be used as a collaborative work-flow tool for doctors and nurses in the emergency room, for surgeons mapping out complex new surgical procedures,or for researchers as they work on new drug discoveries. And this is just the beginning! As Surface director of product management, Matt Champagne, said at the opening of the keynote, "Surface is open for business". To help you understand how Surface is being used in health, check out this VIDEO CLIP that I shot just prior to this afternoon's keynote.
So there you have it. If you missed out on Microsoft HUG this summer in Redmond, we hope to see you next time around in Chicago during HIMSS.
Bill Crounse, MD Senior Director, Worldwide Health Microsoft Corporation
Stanford University To Limit Pharmaceutical Industry Financing Of Continuing Medical Education
Stanford University officials on Tuesday plan to announce a new policy under which pharmaceutical and medical device companies no longer will have the ability to select continuing medical education courses that they seek to finance for physicians at the university's School of Medicine, theSun Pharmaceuticals receives favorable ruling
A Tel-Aviv court ruled in favor of Sun Pharmaceuticals, which is headquartered in India, to purchase the ordinary shares of Taro, a United States company.
Taro, which was the plaintiff in the case, said that Sun should have made a special tender offer based on Israeli law, but the court ruled that was unnecessary and that Taro should have paid closer attention to the documents before signing. Therefore, Sun's Alkaloida Chemical Co. Exclusive Group Ltd. unit offer will stand.
The two companies first agreed that Alkaloida would purchase Taro via a merger agreement on May 18, but Taro terminated the agreement just 10 days later. Then, Alkaloida moved forward with an option to acquire Taro shares on June 25. The tender offer will now close on September 3.
- read the story in Forbes
- see more at Nasdaq
- find the Market Watch coverage
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Abbott Has YouTube Channel
Well, the other day I noted that Lilly had opened up a YouTube account called Lilly Diabetes and a few hours later, the site was closed. I discovered yesterday a new Abbott YouTube site called Abbott1888 - not sure what that is supposed to mean - that was launched in June. The site has 7 subscribers, of which I am one and I am aggregating video to the new Eye on FDA YouTube channel where I am assigning vids to playlists along specific health care topics and disease-related vids. The menu is in the sidebar of the Eye on FDA site, where you will find links directly to the playlist of your choice.
The Abbott channel only has a few vids posted to it, specifically 8 - 3 of which are about their stent product, one about baby nutrition, one on diabetes and a few HIV-related PSAs from their I Stand with Magic campaign. It is a pretty soft offering, but perhaps one that will improve with time as they find their voice. There has obviously been no launch, apparently not even an internal one with only 7 subscribers, so I would repeat the advice I outlined in my posting about LillyDiabetes.
New Cell Removal Technique Could Make Drugs Cheaper
A new method to remove dead cells from the cell cultures that are routinely used to manufacture protein-based drugs has been developed by researchers at the University of Edinburgh. Protein-based drugs are ever more being prescribed to treat various diseases. To produce these drugs, it is usually most efficient to harness the efforts of cells in mass culture which have been given the ability to produce the protein.Manhattan Research Announces Top 10 Product Sites Visited By Physicians
Diabetes treatment brand sites from Januvia, Actos, Byetta, and Avandia are among the top pharmaceutical product websites in terms of primary care physician visitation, according to a new from pharmaceutical and healthcare market research company Manhattan Research (www.manhattanresearch.com). Breaking into this year's top product site list are Actos, Actonel, Amitiza, and Aciphex, proving to be successful in increasing physician awareness online.Finalists Nominated For The 2008 European Biotechnica Award
The three finalists of the 2008 EUROPEAN BIOTECHNICA AWARD have been determined. The biotechnology companies nominated are Cambridge-based Astex Therapeutics Limited (UK), GENEART AG from Regensburg (Germany) and immatics biotechnologies GmbH based in Tübingen (Germany). The prize, worth EUR 100,000, is awarded to innovative European biotechnology and life sciences companies.FDA sends Sandoz warning letter
On August 12, FDA issued a warning letter to Novartis's Sandoz generic unit. The letter focused on manufacturing processes for a blood pressure medication. According to the letter, the manufacturing process did not undergo proper validation and FDA therefore questioned whether further distributing the product was prudent given the lack of solid process controls. The manufacturing process in question was for a generic version of Toprol XL, made by AstraZeneca.
The FDA said in its letter that it also had concerns about how the problems it found in process validation might affect other products the company has.
A spokesperson for Novartis said the company is working with FDA to address the concerns in the warning letter, which the spokesperson says were mainly about "documentation and validation."
- read the Pharmalot post
- see the FDA Warning Letter here
Novartis decision hurts NexMed shares
Novartis will not submit a new drug application for NexMed's topical experimental treatment for nail fungus, and that decision is hurting NexMed's share prices. The drug developer saw shares drop several times throughout the day yesterday. According to Novartis, late stage clinical trials on the treatment, called NM100060, were the cause of the decision. The topical treatment is aimed at mild to moderate toenail fungus.
In 2005, Novartis took on all regulatory, manufacturing, commercialization and clinical development responsibilities for the treatment in an exclusive, worldwide $4 million licensing deal, which had potential to net NexMed up to $47 million.
NexMed is hoping to recover following a mid-2009 release of the results of a comparator study in Europe, according to the company's president and chief executive officer, Vivian Lu.
- see NexMed's release
- read the story at CNN Money
- find out more at Market Watch
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Allopurinol may lower blood pressure in teens
A medication used to reduce uric acid levels might help lower blood pressure in adolescents if lifestyle modifications don't work or aren't attempted. That's according to a new study published in the Journal of the American Medical Association. In fact, elevated uric acid levels may be the cause of high blood pressure in certain individuals, according to some studies, but since there are several possible causes of higher-than-normal uric acid levels in patients with hypertension, there is no proof of a causal relationship.
The researchers evaluated adolescents, ages 11 to 17 years, who have elevated uric acid levels as well as a new diagnosis of high blood pressure to see if the drug allopurinol would reduce blood pressure.
Although the sample size was very small--just 30 teens in the study--two-thirds of the teens taking allopurinol during the trial showed a reduction in blood pressure to normal levels, whereas only one in 30 did so when taking the placebo medication.
Allopurinol's side effect profile, however, includes Stevens-Johnson syndrome a rare, but serious allergic reaction, as well as gastrointestinal problems, precluding the researchers from recommending its use as a hypertension treatment. Still, the study seems to justify further research into the biochemical causes of high blood pressure.
- read the Washington Post story
- see the study abstract for more
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FDA holds back on J&J schizophrenia drug
Johnson & Johnson will have to provide the FDA with more information about its candidate schizophrenia drug paliperidone palmitate before it gets approval, the company announced yesterday. J&J's Janssen will market the drug. While J&J did not disclose the specifics of the FDA request, the company did say it will not have to perform any additional studies on the drug and that it intends to comply with FDA and provide the requested information. Release
Lilly, Amylin suffer on Byetta deaths
The death toll for Byetta, the diabetes drug that Eli Lilly and Amylin Pharmaceuticals together market, is rising. According to only a week's worth of reports, the drug has lead to six deaths.
The companies reported four deaths this week, in addition to the two deaths that made headlines last week. Interestingly, both the FDA and the two companies were well aware of the four patients who have now also died of acute pancreatitis, but elected to withhold the information, since they had less severe cases of pancreatitis. The deaths reported last week involved patients with necrotizing pancreatitis, but the latest four had a less severe form of the condition.
Both companies are seeing stock prices plummet as a result, although the drop is more painful for Amylin, since Byetta is the company's number one product. Amylin shares are down to about $25, while shares of Eli Lilly are just over $46. Some analysts say the reaction is overblown and that it is still safe to hold on to shares of both companies.
Although the companies maintain that there is no proven causal relationship thus far, they are working with the FDA to up the warnings on the drug labels. A spokesperson for Lilly said that he believed that the cause of death likely related to something besides the acute pancreatitis in the four patients. No surprise here: a spokesperson for Amylin agreed.
- read the story in the New York Times
- see more at CNN Money
- hear what Pharmalot has to say
- find the Wall Street Journal blog post
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Microsoft HUG–Wish you were here
Today was the launch of the annual Microsoft Healthcare Users Group conference in Redmond. If you are not among the several hundred attendees, we wish you were here.
The Redmond Microsoft HUG meeting is US-focused by design. We kicked off the event with an opening keynote by Microsoft Health and Life Sciences General Manager, Steve Aylward. Steve did a nice job summing up our US health industry business and our focus and strategy across the various health groups at Microsoft.
There were many memorable presentations during the day, but perhaps one of the best was that delivered by Dr. Edward Barthell of the Wisconsin Health Information Exchange. The Exchange is one of our early adopter customers of Microsoft's Unified Health Intelligence System known as Amalga. Dr. Barthell provided the audience of
developers, IT pros, clinicians and industry executives with ample evidence on the value to be gained from regional clinical information exchange and real-time analysis; a capability enabled by Microsoft Amalga. Time and time again he illustrated how the system is helping to coordinate care, improve patient safety and contribute to higher care quality among the connected emergency facilities in Wisconsin. Whether it is being able to appropriately respond to and triage patients to area hospitals based on real-time bed capacity, reassuring public health officials regarding the prevalence of diarrheal illness in the community secondary to local flooding, or helping ER physicians avoid a potential life-threatening reaction due to a drug allergy; Amalga is proving to be the clinicians' and the patient's best friend.
My colleague Sean Nolan, chief software architect for Microsoft HealthVault, also gave a standing room only presentation. Sean provided developers with a progress report on Microsoft HealthVault and supplied information on how to work with the platform to drive new consumer-focused health applications and services.
As Dr. Barthell's final slide suggested (with a bit of Wisconsin humor) the future for Health IT is very bright indeed.
Amalga and HealthVault; two solutions that are helping bring order to the chaos of disconnected data in healthcare.
Bill Crounse, MD Senior Director, Worldwide Health Microsoft Corporation
FDA Issues New Complete Response Letter
Pursuant to my posting earlier today, by coincidence, Johnson & Johnson announced the receipt of a Complete Response Letter. It is worth noting that they provided no details about the contents of the letter, except to say that there were "questions" and that no further clinical studies were needed.
This is the second Complete Response Letter that J&J has received this month, the first being for Doribax. By comparison, the information in the press release issued today for the NDA for paliperidone palmitate was far less forthcoming than that of the earlier CRL received by the company for Doribax.
Text of today's press release:
FDA ISSUES COMPLETE RESPONSE LETTER FOR PALIPERIDONE PALMITATE FOR THE TREATMENT OF SCHIZOPHRENIA - Titusville, NJ (Aug 26, 2008) - Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that the Food and Drug Administration (FDA) has asked for additional data before it will approve the company's New Drug Application (NDA) for paliperidone palmitate, an investigational once-monthly atypical antipsychotic intramuscular injection for treating schizophrenia and preventing recurrence of its symptoms.
The letter outlined remaining questions that need to be addressed prior to granting approval for paliperidone palmitate. The agency does not require any additional studies.
J&JPRD is currently evaluating the FDA complete response and intends to work with the agency to resolve any outstanding questions. The NDA for paliperidone palmitate was submitted in October 2007.
Paliperidone palmitate utilizes the NanoCrystal® Technology patented by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.
Upon approval, paliperidone palmitate will be marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the U.S. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.
