text:
Same-Day Analysis
Genentech's Lucentis Receives Approval and Pricing
Published: 7/3/2006
Global Insight Perspective | |
Significance | Lucentis, an offspring of blockbuster cancer treatment Avastin (bevacizumab), is among the most highly anticipated drug approvals of the year, due to its demonstrated superiority over existing treatments. The drug will immediately be positioned against competitors Macugen (pegaptanib sodium injection; Pfizer (U.S.)) and Visudyne (verteporfin; Novartis (Switzerland)). |
Implications | The pricing of Lucentis was a major issue, as popular media have already criticised Genentech for developing an innovative premium-priced brand product, when many ophthalmologists are injecting small doses of Avastin off-label for AMD for a fraction of the new drug's price. |
Outlook | Lucentis is the first treatment to not only maintain vision but also improve endpoints in AMD patients, and its clear clinical advantage over Macugen and Visudyne will dramatically shift the market in its favour. However, its side-effects profile is still being assessed, amid "theoretical risks". |
Increasing Lucidity in the AMD Market
U.S. biotech Genentech, a subsidiary of Roche (Switzerland), has announced U.S. FDA approval of the company's age-related macular degeneration (AMD) candidate Lucentis (ranibizumab injection) 0.5mg, a derivative of its blockbuster cancer treatment Avastin (bevacizumab). The approval follows a priority review, and the company has indicated that it has already commenced shipping to wholesalers. Roche will not be involved in the marketing of the drug, with Swiss rival Novartis instead holding exclusive international rights.
The approval has long been considered a "shoo-in" for Genentech, on the back of highly impressive Phase III ANCHOR and MARINA data for Lucentis, which showed that 95% of patients maintained their vision, and up to 40% improved their vision by at least three lines. The drug's product label (available via the Genentech website) includes full prescribing and trial information.
The primary risk to the approval of Lucentis was always its side-effects profile, but there has been little practical evidence of problems thus far. The FDA has noted that there is a "theoretical risk" of arterial thrombotic events (ATEs) in anti-VEGF inhibitors - the class of drugs to which Lucentis and its rival Macugen (pegaptanib sodium injection; Pfizer (U.S.) belong. However, the actual risk of ATEs stood at less than 4% in studies so far, with conjunctival haemorrhage presenting the most common adverse event. As expected, Genentech will conduct post-marketing surveillance (PMS) of the drug, primarily to study ATEs, and will include a cohort SAILOR follow-up study in patients for 12 months.
Pricing Innovation
Part of the motivation for the PMS studies will also be to fine-tune the dosing of the drug, which has not yet been fully established. During its press call, Genentech noted that Lucentis dosing will primarily be tailored to the patient, and it is therefore difficult to assess what average annual patient costs will be. Still, recommendations stipulate an intravitreal injection once a month, and if these are not feasible, this can be reduced to one injection every three months, after four initial monthly injections.
Genentech has confirmed that pricing will stand at US$1,950 per dose - equivalent to annual costs of around U$23,400 - and this represents a 96% pricing premium over Macugen, although it falls in-line with (albeit at the higher end of) analyst estimations of US$1,500-2,000 (and well below some of the scenarios of US$4,000 per dose put forward by some media outlets and pressure groups). Genentech expects average annual costs of US$9,750-13,650 per patient, on the basis of an average of 5-7 doses per year. For reference, previous Pfizer-sponsored cost-effectiveness analysis shows that Macugen had an average cost per vision year of US$20,662, compared to US$26,073 for Visudyne; the average cost per quality-adjusted life year (QALY) was US$19,803 for Macugen, and US$20,131 for Visudyne.
AMD Market | ||
Drug | Company | Cost |
Lucentis | Genentech/Novartis | US$1,950 per dose (once a month; may be less) |
Macugen | Pfizer/Eyetech | US$995 per dose (end-price US$1,243 for patient; every six weeks) |
Visudyne | Novartis/OSI | US$1,250 per dose (two-step process of intravenous infusion and light treatment) |
Source: Global Insight research |
Lifetime per Patient Costs (Visudyne vs. Macugen, US$) | ||
Visudyne | Macugen | |
Drug Costs | 13,588 | 5,695 |
AMD-Related Medical Costs | 3,522 | 2,538 |
Other Medical Costs | 58,802 | 60,695 |
Adverse Event Treatment Costs | 40 | 14 |
Average Total Costs | 75,953 | 69,142 |
Source: Pfizer/Global Insight research |
This premium clearly recognises the significant innovation offered by Lucentis - not only over Macugen and Visudyne (verteporfin; Novartis (Switzerland)), but also over the unregulated, off-label practice of injecting Avastin. Naturally, small doses of Avastin are much cheaper, but while most attention has been focused on the "unfairness" of pricing Lucentis this way, it fails to recognise that while Avastin is successful against cancer, it is a drug that can kill, and was not clinically developed for AMD. Lucentis is a "smaller" drug specifically designed to concentrate its impact on the eye, and is cleared from the body in days rather than weeks, as is the case with Avastin.
Outlook and Implications
In an AMD market that is gradually shifting beyond the US$1 billion barrier, Lucentis is the strongest candidate. Its estimated sales reach just under US$100 million in 2006, before moving up to US$500 million by 2008. However, significant concerns remain over reimbursement for the drug on Medicare, given its high cost, and this issue accounted for a substantial portion of the question-and-answer session during the conference call. Genentech maintained that it expects around 85% of insured patients to be covered, and has set up a programme to widen access for the rest.
While there is considerable potential for the AMD market to swell and accommodate the arrival of Lucentis without hitting Visudyne and Macugen too hard, it is clear that Novartis and Pfizer will need to manoeuvre their position in the market, and will probably lose significant share. Re-pricing their products may be an option, and the price of Visudyne has already been reduced from US$1,350, to reflect changes in reimbursement. QLT has forecast 2006 sales of Visudyne at US$370-400 million, compared to US$484 million in 2005, while Macugen is likely to fare better on the back of Pfizer's marketing muscle; sales stood at US$185 million in 2005, and US$51 million in the first quarter of 2006.
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text:
- Frantic Arcade-Style Action The calling card of the Serious Sam series, hold down the trigger and lay waste to a never-ending onslaught of attackers or face being overrun by Mental's savage beasts. No cover systems, no camping it's just you and them. All of them.
- Mental's Fearsome Legions A new battalion of unforgettable minions including the rumbling Scrapjack and towering Khnum join the legendary Headless Kamikaze, Gnaar and Sirian Werebull. Your days of mowing down zombie Nazi space pirates are over.
- Serious Melee Attacks When an enemy slips by your wall of lead and pain, use one of the all-new innovative melee moves to drop an enemy right where they stand in the most violent way possible.
- Pure Multiplayer Mayhem Play through the full campaign mode with up to 16 players or drop the gauntlet and let the heavy ordinance fly in versus modes like Deathmatch and Beast Hunt. This is the next level of Serious Sam multiplayer and all hell is about to break loose.
The screenshot above is just one of many for the game, which will be available for PC and Mac. You can download the whole pack from here: Serious Sam 3 Reveal Assets.
"Holy crap, I am going to make a boatload of cash of this game," Fork Parker, chief financial officer at Devolver Digital, said in a statement. "I mean that's what this is all about, right? If this thing comes out in the summer my wife is totally getting the tit job she's been asking for."
User Comments: 7
Got something to say? Post a comment-
Man countless nights playin these games with friends, so glad to hear some info on it.
venomblade said:
Man countless nights playin these games with friends, so glad to hear some info on it.
+2 on what Venomblade said.
whats with that comment at the end??? lol
If this thing comes out in the summer my wife is totally getting the tit job she's been asking for.
Wow. He actually said that on record?
Fork Parker - that's some pretty funny stuff right there!
I can't wait to get a hold of this game.
windmill007 said:
whats with that comment at the end??? lol
That's Fork Parker, he's on the production staff for Devolver Digital who converts the Serious Sam games into cash. He's pretty silly, as seen in a YouTube video of him: http://www.youtube.com/watch?v=Ir5mw3D2L_s
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subset: commoncrawl


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Jefferson and Lafayette
2002 Shaping the World: Conversation on Democracy
A Conversation with Thomas Jefferson and Marquis de Lafayette
presented by:
Thomas Jefferson's Poplar Forest
Blue Ridge Public Television
Virginia Department of Education
Virginia Satellite Education Network
Program Description
Students and teachers can join a conversation between Thomas Jefferson and the Marquis de Lafayette as students from Forest Middle School engage the two men on the topics of the American Revolution, Lafayette's role in that revolution, Jefferson's years in France as the U.S. Minister, the French Revolution, their military and political careers, and their views on the meaning of democracy and advice for the future.
In this interchange between Jefferson and Lafayette, students will have the opportunity to learn more about the men and their opinions on a variety of democratic issues, their work on the American Declaration of Independence and the French Declaration of the Rights of Man and of the Citizen and their views and concerns for their respective countries.
"Shaping the World: Conversations on Democracy" can assist teachers with the following Standards Of Learning
Lesson Plans and Curriculum
Section I: Jefferson and Lafayette
Section II: The Marquis de Lafayette - Fighting for American Independence
Section III: Jefferson - United States Minister to France
Section IV: Guardians and Defenders of Liberty and Democratic Principles
Bibliography & Websites
Primary Sources
Certificate for Revolutionary Medicine
Declaration of Independence (transcription) - National Archives and Records Administration
Declaration of Independence original - National Archives and Records Administration
French Declaration of the Rights of Man and of the Citizen
Intolerable Acts
Jefferson letter to James Madison, Sep. 1, 1785
Jefferson letter to George Washington, Dec. 4, 1788
Jefferson's Notes on the State of Virginia, Queries 14 AND 19, 146--49, 164--65
Noah Webster's essay on education
Poulson's Advetiser
Virginia Statute for Religious Freedom
Poplar Forest
In 1773, Thomas Jefferson and his wife, Martha, inherited approximately 4800 acres from the estate of John Wayles, Martha's father. Jefferson designed an octagonal villa and in 1806 traveled to Bedford County to oversee the laying of the foundation. Poplar Forest was to serve as a retreat for Jefferson and his grandchildren. Poplar Forest was a working farm with more than sixty slaves living on the property. The plantation was sold to William Cobbs after Jefferson's death. The acreage dwindled and the house underwent many structural changes. In 1984, the nonprofit Corporation for Jefferson's Poplar Forest formed to rescue this landmark for the educational and cultural benefit of the public. The exterior restoration of the house was completed in 1998 and earned an Honor award from the National Trust for Historic Preservation. Archaeology and restoration continue. For more information on Poplar Forest, call (434) 525-1806.
Blue Ridge Public Television
Since 1966, Blue Ridge Public Television has provided instructional television for western Virginia, and today broadcasts SOL-correlated programs to 39 school divisions with 197,000 students. BRPTV works on-site with all communities of learners, including teachers, pre-schoolers, and adult learners. BRPTV sponsors Virginia's JASON Project, Homework Helpline, Reading Rainbow Young Authors and Illustrators, Young Heroes, and the McGlothlin Awards for Teaching Excellence.
Virginia Department of Education and the Virginia Satellite Educational Network
The Virginia Satellite Educational Network (VSEN) provides advanced placement and foreign language courses to K-12 students. Programs that support the Virginia Standards of Learning for students, teachers, and administrators are also delivered through VSEN. The Department of Education and VSEN are pleased to make Thomas Jefferson's Poplar Forest's program available via satellite to students across the Commonwealth and nation.
Curriculum researched and developed by Octavia Starbuck and Jackie Almond


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Website | anaqua.com |
@AnaquaIP | |
Category | Software |
Phone | 1 617 375 5808 |
Employees | |
Founded | 2004 |
Description | Asset management (IAM) software solution |
Private Equity, 7/2013 Insight Venture Partners | $100M |
Private Equity, 10/2013 Bessemer Venture Partners | $25M |
Anaqua, Inc. provides intellectual asset management (IAM) software solutions and services worldwide. It offers Anaqua Business Impact, an intellectual property (IP) management system to support IP strategies; ANAQUA Enterprise, an IAM software for organizations with large IP portfolios and complex IAM requirements; and ANAQUA Express, a hosted life-cycle solution for managing inventions, patents, trademarks, and other intellectual assets. The company also provides ANAQUA Element, a cloud-based solution for IP professionals managing small portfolios; and ANAQUA Essential, a solution for law firms to manage intellectual assets on behalf of their clients. In addition, it offers IAM training, enterprise implementation methodology, and hosting services; and IP, patent annuity, trademark renewal, and registry assignment services. The company serves large and mid-sized consumer goods, technology, and industrial companies. Anaqua, Inc. was founded in 2004 and is based in Boston, Massachusetts. The company has additional offices in London, United Kingdom; and Pau, France.


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Everybody knows Long Island is an expensive place to live, but more expensive than San Francisco? According to the latest Most Overpriced Cities list from Forbes, it is.
Long Island ranked seventh on the list, which examined cost of living, housing opportunities, unemployment and average salaries in the country's 50 largest metropolitan areas, putting us past expensive cities like Philadelphia, San Diego and Orlando, Fla.
Our neighbor to the west, New York City, was fourth.
Breaking it down, for cost of living, LI was 40 out of 50 (50 being the worst). For housing opportunities, LI was closer to the top at 48 out of 50. Unemployment, however, put LI at 17 out of 50, and 24 out of 50 for average salaries.
Los Angeles topped the list, due to its combination of high unemployment, high cost of living and high real estate costs.
From the Forbes story:
Indeed, though the median home price in the Los Angeles metro area has dipped from $525,000 to $319,000 over the last two years, Angelinos still face one of the least affordable housing markets in the country. According to the NAHB/Wells Fargo's Housing Opportunity Index, only New York, Long Island, N.Y., and San Francisco are more expensive.


text:
Perner Manuela
Perner Manuela is a recipient of farm subsidies in Austria.
Since 2007 Perner Manuela has received €10,285 in payments from the European Union .
Details of payments
Year | Scheme | Total |
2008 | Direct payments under European Agricultural Guarantee Fund | €4,028 |
2008 | Alpine farmers - disadvantaged areas | €3,475 |
2008 | Environmental activities | €2,782 |
Total: | €10,285 |
We have no additional information about this recipient
Currently all we know about Perner Manuela are the few bits of information released by the Austria government.
We need your help to find out more about this recipient. Is it a multi-national company or a small farm? What does it produce? Is it a subsidiary of a larger company? How large is it? Is it owned by anyone noteworthy?
Create an account or sign in to tell us something about Perner Manuela.


text:
Realize the irony of asking us to use an "eco-friendly font" for our papers to turn in tomorrow?
She wants us to print out 10-30 pages of PDF for each class, which doesn't give a rat's ass what kind of font it's on, and she asks us to use eco-friendly font?
Why not just EMAIL the paper to her? If we're gonna be eco friendly, why not just go all the way, eh?


text:
Freakcity — This is a local website for local people. There's nothing for you here. Well, unless you're a) a bit gay, b) a bit of a freak or c) don't mind hanging out with them.
The internet is lost to the advertisers. Everyone wants your money, we just want your love. And your soul. (but hey, we're cheap...)
Do you dread waking up after the night before to find your mother has liked whatever the hell it was you thought sensible to post at 2am? Are you fed up with ancient schoolfriends demanding you grow them vegetables on the internet? What the hell is BranchOut anyway? Do you have an urge to do something online without everyone noticing? Do you have a soul?
Join us.
FC Dick Words of the Day
Random word plucked from the ärse of the dïck every day for your amusement
- London bound FreakCitySunday February 23rd, 2014 at 8:31am scott
- Happy 10th Birthday! FreakCityMonday July 1st, 2013 at 11:30am flux
- The Oatmeal Comics/Anime/MangaFriday February 8th, 2013 at 6:17am scott
- Once Upon A Time... ArtFriday February 8th, 2013 at 5:55am scott
- Top gay marriage quotes! PoliticsTuesday February 5th, 2013 at 18:14pm scott
- Upgraded FreakCitySunday January 20th, 2013 at 14:26pm scott
- Guess who got funded! Elite: Dangerous GamingFriday January 4th, 2013 at 10:41am scott
- Merry Christmas, wherever you are FreakCityTuesday December 25th, 2012 at 11:07am scott
- Bugs FreakCityMonday December 24th, 2012 at 7:54am scott
- New t-shirts... FreakCityWednesday October 24th, 2012 at 7:39am scott


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MOUNT VERNON — An evening away from the business of regular meetings and a chance to meet up with friends and enjoy a good meal was the agenda Monday evening at the Knox County Granges Farm-City Dinner. Conducted at the Mount Vernon High School cafeteria, the 56th annual dinner brought in members from Union, Wayne, Morgan, Liberty, Middlebury, Harrison and Monroe-Dan Emmett granges.
The Farm-City Dinner takes place each year during National Grange Week. The National Grange, an agricultural fraternity, is the oldest family fraternity in the country, organized in 1867. Welcoming the 66 people in attendance was Lonnie Totten, Knox County Grange Deputy. A flag presentation was given by the Knox County Career Center Junior ROTC. All sang the "Star-Spangled Banner," led by accompanist Charlien Beightol, and the invocation was given by Mary Jewell, Knox County Junior Deputy.
After a covered-dish dinner was enjoyed by all, numerous door prizes were drawn, provided by area businesses and a Farm-City committee. Knox County Pomona Master Marie Walker recognized the visitors in attendance, and musical selections were then enjoyed, sung by Sarah Howard of Wayne Grange.
Attending the Farm-City Dinner for the 15th year was Dorothy Seitz, along with her husband, George, who is a member of Monroe-Dan Emmett Grange. "I like it because I know a lot of people all over the county, and I have met other new friends as well," said Seitz about coming out the Farm-City Dinner each year.


text:
$ 9.99
Chicken Soup for the Soul: Living Catholic Faith : 101 Stories to Offer Hope, Deepen Faith, and Spread Love
These 101 poignant and spirit-filled stories written by Catholics of all ages and religious experiences cover the gamut, from fun stories of growing up Catholic to serious stories of sacraments and miracles. Affirming God's unconditional love, these stories share the role the Church plays in personal and professional lives, expressed in religious rituals and everyday activities. Catholics will be blessed to see how the secular is often saturated with the sacred.
Whether the reader is a cradle Catholic or a convert; lay, clergy or religious; simply curious or struggling, these stories describe what it means to be a Catholic. They bring happiness, hope and healing to everyone, from the teenager celebrating confirmation to the elderly looking back on a long life.
The first Chicken Soup for the Soul book was published in 1993, and became a publishing industry sensation, ultimately selling eight million copies. Since then, more than 150 Chicken Soup titles have been published, selling more than 100 million copies.
Chicken Soup for the Soul has won dozens of awards over the past 15 years, and its founders, Jack Canfield and Mark Victor Hansen have become celebrity motivational speakers and authors.
Author Information
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Product Details
Published by
Chicken Soup for the Soul
Publish Date
December 01, 2008
eBook ISBN
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text:
We found
4 lodge parks
within 27 miles Weymouth
2 bookable
Chard, Somerset Show on map |
Two-bedroom lodge | 5 x | No availability |
Bridport, Dorset Show on map |
Camping pod | 4 x | From £43 per night |
Want to see more? We're only showing the sites that are bookable on Pitchup.com.
Show campsites and holiday parks that aren't bookable through Pitchup.com...
Oathill Farm Holiday and Touring Park Lyme Regis, Dorset Show on map |
Poole, Dorset Show on map |