Shares in Amicus Therapeutics fell after the company said it ended a partnership with Shire to jointly develop treatments for genetic disorders. On Thursday, Amicus said the companies has reached a mutual termination agreement to end their collaboration on three drug candidates aimed at lysosomal storage disorders.  Shire will pay Amicus $5.2 million as it ends the partnership. The company also said that its Chief Financial Officer Jim Dentzer is leaving the company. Amicus is cutting about 20% of its work force.

TODAY’S NEWS

Takeda buys into Amylin’s weight-loss drug portfolio – Takeda will pay $75 million upfront for medicines including Amylin’s pramlintide/metreleptin and davalintide, in the second phase of testing needed for U.S. regulatory approval, Osaka- based Takeda and San Diego-based Amylin said in a statement…more Plus, quickie update on three other anti-obesity drugs being developed by various companies.

New lupus treatment (HGS/Glaxo) looking promising on pathway to approval – Human Genome Sciences Inc said its experimental lupus drug Benlysta was successful in a second large clinical trial, paving the way for approval of the first new treatment for the disease in 50 years…more

Vertex HepC drug cures 80% – The hepatitis C cure rates of greater than 80% across all four patient groups of the study are also the highest ever recorded in any telaprevir study to date and exceed the cure rates reported in separate studies of boceprevir, a competing hepatitis C drug under development by Schering-Plough…more

Let’s investigate: Amgen and Shire are the latest.

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Not counting on blockbusters – changes, and the future, at Sanofi-Aventis.

JUST FOR FUN

So I decided to have some fun and pick up some of the festival items and work towards the Jig on my warden – she has all the other dances, so figured I’d complete the set.  I didn’t go full out, but enough to get the pumpkin mask and the tavern quest chain.  Thanks to Goldenstar over at the Casual Stroll to Mordor for the excellent walkthroughs of the festival quests and also Tavern rep.  You can find them over here – Fall Festival and Other Festival Quests.  The tavern quest chain probably is one of my more favorite quests as the drunken graphics are pretty impressive.  I captured a video of the last stage of the pub crawl and posted it as well (and yes, that’s Jimmy Buffett as the background music, not planned but fitting).  I did it earlier in the day on my captain and was suffering from the Forochel Fog bug plus the drunken state – talk about hard to see!

I then figured I’d take a couple of snaps from the chairs outside of Bag End to wind down from my afternoon of intoxication.

Finally, I went on a hunt for the Black Rider terrorizing the Shire, but he slipped by me

Shire has announced that it has settled all pending litigation with Sandoz in connection with Sandoz’s Abbreviated New Drug Application and its attempt to market generic versions of Shire’s AdderallXR for the treatment of Attention Deficit Hyperactivity Disorder. The settlement also provides Sandoz with a license to market it own generic versions of AdderallXR in the United States beginning upon approval of its own generic products by the FDA, and Sandoz will pay Shire a royalty from those sales.

De Britten hebben een heel groot openluchtmuseum en dat heet the Lake District. Een Eftelingachtig gebeuren met lieflijk zachte groene grasheuvels, met mos overgroeide bosgronden, stenen muurtjes, stenen huizen, kristalhelder water, hoge bergen en een heleboel fluffy schapen. De afgelopen twee weken hebben Jeroen en ik door dit naïeve-kunstschilderij gewandeld, zoals de illustraties op de verpakkingen van Celestial Seasonings-thee.

Hieronder ben ik bramen aan het plukken waar Jeroen later op de dag jam van heeft gemaakt. Hij raakte zelfs zo geïnfecteerd door het surrealistisch-pittoreske Britse landschap, dat hij voorstelde een weckpot te kopen om de jam in te doen.

Zelfs de mist was mooi:

Onderstaand plaatje doet me telkens denken aan the Shire, het hobbitland uit de Lord of the Rings.

Courtesy of Pharmboy

Good day to all! The corn is ready for harvest, and the fall season is upon our Pharm.  It is time for a quick review to see how we have done, and add a few more goodies to our Plots.

From our 15-Aug-09 list:

Novartis – Buying the $40 Jan10 C @ 6.40 ($1 premium), selling $45 Sept09 for 1.35 (also $1 premium).  The $40s Jan10 are now 9.10, and rolled 2X to the $50 Oct, now at $0.45 (small loss on the roll).  Net ~$2.1 up for the trade.

Bristol-Myers – Buy outright for the dividend, or buying the $20 Jan10 C @ 2.80 ($0.5 premium), selling $22.5 Sept09 C @ $0.55 and $22.5 P@ $0.7.  I think this company has room to run.  Bought outright and the stock closed on OPEX at 22.47…..can’t get better than that……Only stock on this position, but looking to sell the Nov09 24/22 P/C for 0.44/0.75.

SNY – Not as confident on the SNY story as of yet.  I would sell the $32.5 Sept09 P, being prepared to roll down to the $30 Dec09s.  These expired worthless….nice gain.

JNJ Buying the $55 Jan10 C @ 6.50 ($0.5 premium), selling $60s Sept09 C/P for 2.20.  $55 Jan10s currently $6.10, and the Sept P expired worthless.  Sept09 C rolled to the $60 Oct09 C for a 0.50 credit.  Puts not sold as of yet.

Genzyme – Buying the $50 Oct09C @ 4.2 ($1.5 premium), letting it run for the next few days, and then selling $55 Sept09 for 1.25 or better (all premium).  $50 Oct09 are currently $6.80 and the $55 Sept09s were rolled up to the $57.5s almost even.  These will need cashed out for a $2.5 gain, or to be adjusted to the 50 Apr10 C for 9.8.  To help offset the costs, I would sell the $55 Oct09 P for $1 or better.  For a net $1 out of pocket and this can be collected by selling 0.50 per month over the next few months.  Not too difficult.

Our plays from 14-Sept-09.

I like Shire as a growth story as well as a takeover candidate.  The stock just created a gap from $49-51, and they have been swinging wildly, so being conservative on the jump is the way to go.  Buying $47.5 Apr10s C for $7.5 as well as selling ½ 50 Oct09 C for $3.5 or better.  $47.5 Apr10 calls currently $6.8, and the $50 Oct09s are currently $2.4 (they hit $4 on 9/22).  On target here.

I noted on Wednesday to buy the $41 Feb10 for $6.6 when I mentioned them a few weeks ago (now $7.3), and selling ½ $47s Oct09 for $1.5 or better. $41 Feb10 calls currently $6.8, and the $47 Oct09s are currently $0.8 (they hit $1.25 on 9/21) if they were sold against as they did not hit the target.

I exert a bit more caution on ABT due to Humaria and the drug business being more or less the cash machine, and thus recommend $42 Feb10 @ $6.1, and waiting to see if ABT can make it through the $48 price range, then selling ½ $48 Oct09 for $1 or better, otherwise ½ the $47s can be sold and rolled to $49 Nov09. $42 Feb10 calls currently $5.8, and the $47 Oct09s are currently $1.00 (they hit $.85 on 9/22 and sold against).  Plenty of room here and most likely going to have to roll these, but we will be vigilant.

Now, on to a few more investigations into our fields of Pharma.

Medivation (MDVN) – Medivation, Inc. is a biopharmaceutical company with small molecule drugs in clinical development to treat three large, unmet medical needs—Alzheimer’s disease, Huntington’s disease and castration-resistant prostate cancer. They were bought up in the weekly discussion, and they have several Phase III clinical trials initiated.  That is good for a company with a market cap of $900M, albeit the targets are a bit difficult.  First, on 7/30/09, MDVN and Pfizer (PFE) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine is the proposed generic name for dimebon) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease (the FDA has granted Orphan Drug status for this indication).  Now if that is a winner, then watch out. 

Second, the company announced treatment of the first patient in a Phase 3 clinical trial of the investigational drug MDV3100 in advanced prostate cancer. Known as AFFIRM, the trial will evaluate the novel androgen receptor antagonist MDV3100 in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The randomized, placebo-controlled, double-blind, multi-national AFFIRM trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily versus placebo. There are many companies in the prostate area, so I am not as excited about this indication.

On Sept 11, the CEO and CFO sold some shares (25K) and another round of some 200K were also sold by various officers and directors.  I am not a fan of those high ups selling their shares, but I cannot blame them for taking some money off the table.  I would be aggressive in covering this company if you sold the stock.  The trials have either started or are in progress, so I would assume that they will wander a bit before the stock price starts its ascension upward as the trial dates get closer.  Trading is light, the option pricing is wide, and the current direction is down, so I am a bit hesitant to buy in here (although the overall direction on the 3mo and 1yr daily chart is up).  I would wait until they start a reversal and then go after a Dec 20/25 bull call spread for $3 debit.  Making $5 if they continue their rise.

inVentiv Health Inc. (VTIV) – VTIV is a provider of value-added services to the pharmaceutical, life sciences and healthcare industries. The Company supports a range of clinical development, communications and commercialization activities that are critical to its customers’ ability to complete the development of drug products and medical devices and commercialize them. In addition, the Company provides medical cost containment services to payors in its patient outcomes business. inVentiv provides services to over 350 client organizations, including all top 20 global pharmaceutical companies, numerous emerging and specialty biotechnology companies, and payors. The Company’s service offerings reflect the changing needs of its clients as their products move through the late-stage development and regulatory approval processes and into product launch, and then throughout the product lifecycle. It operates in four business segments: inVentiv Clinical, inVentiv Communications, inVentiv Commercial and inVentiv Patient Outcomes. In December 2008, the Company completed the acquisition of Promotech Logistics Solutions LLC (PLS). In August 2008, the Company completed the acquisition of Patient Marketing Group, LLC (PMG).  The Company competes with IMS Health, TargetRx, ZS Associates and Trinity Pharma Solutions.

Insiders (directors) were buying some shares recently (August), but mutual funds and institutions were unloading shares (not a good sign for its run to continue).  My biggest concern is that Pharma is merging, and laying off people across the board – so either they are going to outsource their work or increase efficiencies within the merged company.  So, one could look at this in two ways, VTIV is going to make some good money on the outsourcing part, or they are gonna get smacked down.  My vote is for the latter, because if I am a CEO, I want the internal control of my company and increased efficiencies.  That means the opposite will happen, as I am not the CEO, and I am not in control of the company.  I am cautious again with this company, as it as run up over 100% from bottom.  They have some support at $15.5, so easing in is the way to go, selling ½ 15 Nov09C and buying the 12.5 Apr10 for 4.5.

BiogenIdec (BIIB) – BIIB is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen Inc. and San Diego, California-based IDEC Pharmaceuticals (formed in 1986 by biotech pioneers Ivor Royston and Howard Birndorf).  Biogen, one of the oldest biotechnology companies, was founded in 1978 by several biologists, including Phillip Sharp of the Massachusetts Institute of Technology and Walter Gilbert of Harvard (who served as CEO during the start-up phase).

Biogen Idec’s products include multiple sclerosis treatments Avonex (interferon beta-1a) and Tysabri (natalizumab); the latter is also approved for treatment of Crohn’s disease, and is co-marketed with Élan. Biogen Idec also makes Rituxan (rituximab), a treatment for non-Hodgkin’s lymphoma which is also approved for rheumatoid arthritis; Rituxan is co-marketed with Genentech. The company acquired Fumaderm (fumaric acid esters), a psoriasis treatment (licensed in Germany) when it acquired Fumapharm AG in 2006. In December, 2007, Biogen Idec sold the U.S. rights for Zevalin (ibritumomab tiuxetan), another treatment for non-Hodgkin’s lymphoma, to Cell Therapeutics, but continues to produce it for European marketing partner Bayer Schering Pharma. In 2006, the company sold rights for Amevive (alefacept), another psoriasis treatment, to Astellas Pharma, continuing to manufacture the drug under contract. 

Two weeks ago, BIIB moved ahead with a $356 million hostile bid for Facet Biotech (FACT), two weeks after Facet rejected its previous proposal. Biogen Idec’s $14.50 per share all cash offer represents a 64 percent premium over Facet Biotech’s $8.82 share price right before the first proposal. For the time, Facet’s board of directors has recommended that its shareholders do nothing until they can review and consider the offer, which will happen by the end of this week.

BIIB with $14B market cap, and 18.5 trailing P/E, BIIB is right on the heels of big pharma (8-12 range trailing P/E) and better than their competitors (GILD, GENZ).  Growth is steady, and not as great as some competitors (growth and profit margins are narrower).  I am looking at BIIB to cut more deals in the near term with smaller companies that can foster the growth everyone is looking for.  Low is $42, and good support in the $45/6 range, so buying 45 Apr10 for 8.9 and selling ½ 50 Nov09 C and ½ 45 Nov09 P for 0.7c would offer some protection and allow the company to run.

by: Calvin Patimeteeporn (Calvirth)

While I would love to describe th intricacies of the Epic Book 1 and Prologue, I can’t because of my horrible LOTRO skills. My inadequate skills of gaming has severely hindered my advancement to higher levels in the game and I apologize for not being able to reach these quests. However, I have a great substitute topic:

Why is this game SO. CONFUSING?

Today, I realized I have more than one sack to place my items in. I also realized that I can eat a numerous amount of food to regain health (morale? I dont know what to call it). I realized that I can, in fact, change weapons and sell items. All of this happened either today or yesterday. Did I mention I’ve been playing for a month?

Yes. A month.

Within that month I’ve discovered the wide variety of objects that can harm or kill me. Bears, wolves, man-eating spiders, and toads. YES. TOADS. How something so small can withstand 20 blows from an ax completely astounds me but I guess Shire toads are extremely resilient. I’ve also been called “n00b” in this game, or even better, completely ignored by other gamers who approach me and then quickly run away when I say, “Hi”. This world confuses me so. A frog can hold up a fight against me but when I fall from a manageable height I am left limping. Or how other gamers interrupt my fight with beasts to land the final blow. Or how it is only when I have very little health left do I fall off a cliff and into a wolf den where I am basically ripped to shreds by “Snarling Wolf” and “Wolf Leader”.

Besides my own frustration with the game, the virtual world of LOTRO that I actually HAVE experienced is amazing. The feeling that I have the entirety of Middle Earth to explore is real and the game designers attention to detail is amazing. It gave me great pleasure to walk around the Farthings and visit famous pubs, or even recognizing characters from the first book.

However, I am fully determined to reach the appropriate levels to enter these quest. Otherwise I would let down my avatar, and Calvirth will not stand for this.

Hear this Toads of The Shire! YOU WILL FALL BEFORE MY AX! I SWEAR TO IT!

My first experiences with Lord of the Rings Online have been rather boring. I have not yet gotten to the Epic Book 1 quests but I did complete the Prologue Quests.  Just like any other game, LOTRO uses the prologue quests to get the player acclimated to the game. For some people this is certainly helpful but for others it is just boring and tedious. I have very little experience with MMO’s, but even I found myself paying very little attention to what I was doing during the Prologue Quests. The quests themselves did not provide all that much action or excitement. I found myself leading my character around to various people and talking to them about things I didn’t care about. I was bored most of the time with the tedious and repetitive tasks I was presented with. Even when I strayed from the quests to go kill some wolves, the game could only keep me entertained for so long. I want instant gratification and excitement from a game and the Prologue Quests did not provide this for me.

                The quests were clearly designed to introduce the story behind the game as well as the controls and various aspects to the game. As a player, I had read the LOTR book and watched the movie. I had a pretty good idea of where I was and what was going on. Also, my experience with gaming made it very easy to figure out how to play the game with very minimal help from the game itself. I found myself being forced to do various activities with my character that I didn’t want to do. I understood the concepts of learning skills, using skills, attacking enemies, talking to characters and so on and so forth. Undoubtedly the prologue serves a role of great importance to new and inexperienced games, but for me it just proved to be tedious. I wanted to complete the prologue quests and get them out of the way. Granted they did not take any more than an hour, but still they left me with a bad first impression of the game.

                As for the quests and their relation to Tolkien’s world, I think there are many similarities. The most obvious of these similarities are the races, the characters, and the landscape in which you play. All these are taken directly from Tolkien because after all the game is based on Tolkien’s work.  A further similarity can be drawn to the Hobbit Prologue Quests.  Here the player begins in the shire just as Tolkien’s story begins with Bilbo Baggins in the shire. The game play itself begins to shift away from Tolkien’s world as the action begins. Tolkien must begin his writing by describing all the various aspects of the new world he is depicting.  In the game however, the character is instantly immersed into the landscape and everything can be seen through the gamers’ eyes. There is no need for words or descriptions as a constant visual is provided. The player is instantly in control and can do as he or she chooses. The player is not being influenced and directed by Tolkien’s words, but now rather the player is in control and making a story for himself.

                Another interesting comparison between Tolkien’s world and LOTRO is the way in which both initially develop. Tolkien describes the world he has created with his words. Any reader would be totally unfamiliar with Middle Earth and its inhabitants, so Tolkien must devote many words to describing these things. In a similar way, the designers of LOTRO assume that a new gamer has no idea what he or she is doing. So the designers put the Prologue Quests in to familiarize a new player with what the game has in store for them.  Both “introductions”, although very different, are also similar in that they both try to create comfort and familiarity with something that may be new or unusual.

                Perhaps it is because I just don’t like MMO’s in general, but I did not enjoy my first experiences with LOTRO. While doing the Prologue Quests I just wanted to be fully immersed in the game. I wanted instant satisfaction and a chance to win but with LOTRO this is not possible. It is a long, winding road to the top and I do not think this is a road I want to travel. I enjoy games that I can become good  at and win at quickly. I do not like having to put extensive time and effort into games to become good at them. I especially do not like this when it comes to games like LOTRO where time and effort are more important than skill. Judging by the Prologue Quests and my prior knowledge of  what MMO’s are I know it will take a lot of time and game play to improve my character.  This is not my type of game and it is not something I can see myself playing much beyond  what is needed for class.

-Matt Almeida

Three weeks later, and I finally got my first paycheck.  $97.07.  Not that great, but it gets the job done.  All I really need is money for gas at the moment.  The rest goes into a savings account.

Lately I’ve been reading a lot more than usual (which is good, I think) and at the moment I’m in the middle of The Fellowship of the Ring AND The Hunchback of Notre Dame.  I also am going to start reading The Case For Christ, but that’s not technically literature, so I won’t count it on my list of required reading, which is already long and extensive.  As I’m reading those two books, I’m constantly looking for parallels between the movies while not looking for mirrors of the movies.  I know that when people make films based on books, they take a lot of artistic license with it (Is that how you say it?  Does one “take artistic license?”) and therefore they’re not quite the same as the books they’re based on.  I’m totally fine with that actually, even though a lot of people aren’t for some reason.  I think it’s fun though to find lines that the movie took directly from the book. To me, it’s sort of like finding little easter eggs.  =]  Here are some similarities between the two, but also some differences.

Lord Of The Rings

1.  My favorite line of the entire series is when Frodo is lamenting about receiving the ring from Bilbo, but Gandalf responds by saying, “So do all who live to see such times.  But that is not for them to decide.  All we have to decide is what to do with the time that is given us.”  It gives me a sense of hope whenever I feel in a rut about anything.  Granted, I don’t have a Dark Lord and his entire orc army after me, so I can’t really compare my feelings with Frodo’s, but I still like the line!  What’s funny though is that in the movie, Gandalf says this in the Mines of Moria, but in the book, he says it when he comes back to Bag End to tell Frodo what the Ring really is.  That’s right at the beginning of the book!  It was a little disappointing, but I thought it best not to worry about it.  The book did come first, after all.

2.  Another glaring difference between the two is the journey from the Shire to Bree.  It’s almost completely omitted in the movie, and the parts that they left in were changed entirely.  In the book, Frodo journeys with Sam and Pippin to Buckland to his new house to meet Merry, but has the intent of leaving them behind to go to Rivendell.  Unfortunately (or fortunately depending on how you look at it), they all already knew about Frodo’s  plan to leave, so they decide to go with him.  This actually all happens on Maggot’s farm, inside his house.  They aren’t chased off like in the movie.  And they hide from the Black Rider on the road before they hit Maggot’s farm, not after.

3.  The third noticeable difference is the sense of time and how it passes.  There’s virtually no sense of passage of time in the movie, in which it seems to take place over the course of a few months.  In the book, however, Frodo spends 17 years in the Shire after he gets the Ring from Bilbo before he leaves.  It then takes him a month to walk to Rivendell.  Each day of the journey is carefully laid out in the book, while it’s just glossed over in the movie.

4.  My favorite similarity has to be the music.  Howard Shore’s score in the movie contains actual lyrics that J.R.R. Tolkien wrote.  The best example would have to be Pippin’s song in The Return of the King that he sings in Lord Denethor’s throne room.  That song was taken from Bilbo’s Walking Song that he sings while leaving the Shire for the final time.  I really do love the music from the movie, and I believe it does the books justice.  The music alone can make me weep.

The Hunchback of Notre Dame

1.  When I talk about the movie, I’m talking about the Disney musical version that came out in 1996.  I don’t care what anybody says about that movie; I thought it was fantastic, and it’s probably my favorite Disney movie.  The music is just phenomenal.  Anyway, the book and the movie bear almost no resemblance to each other at all.  The main storyline in the movie doesn’t even really start until page 200, where it starts to describe Frollo and Quasimodo in depth.  Sure, the first part of the story is about the Feast of Fools, but it looks nothing like it did in the movie.  There was no play in the movie, and there was no Esmeralda dance in the book.  Well, actually there was, but it wasn’t at the Feast of Fools.

2.  The largest omission of the movie was that of the character Pierre Gringoire, the poet philosopher who falls in love and marries Esmeralda.  He isn’t even alluded to in the movie; they simply left him out.  He writes a play that is shown at the Feast of Fools about the relationship between Nobility, Religion, Commerce, and Labor, not that any of that is important.  His show essentially fails because there are too many interruptions, and he tries to escape the crowd for the rest of the day until he finds Esmeralda dancing in the square.  He in entranced, and decides to follow her when she leaves.  Long story short (too late!!), he stumbles into the Court of Miracles and is put on trial by Clopin.  This is te scene that happens at the very end of the movie with Phoebes and Quasimodo.  It happens pretty much the same way, except in more detail, and Esmeralda eventually speaks up and sets him free.  The only downside for her though is that she has to marry the guy.  She does, but then just leaves and locks him in her house.  Great wife.

3.  The funny part is, during the entire Feast of Fools, Quasimodo appears twice; once to win the Pope of Fools for about a page, and once when he’s paraded through the streets in the evening for about a paragraph.  Frollo then only appears once for a brief moment, but in the book he’s the Archdeacon, not the minister, or whatever position he has in the movie.  Quasimodo actually appears later trying to kidnap Esmeralda, because he’s actually quite cruel in the book.

4.  Quasimodo.  What a way to change him.  In the book he’s deaf, mute, almost cripple, ridiculously strong, on the verge of retardation, and completely loyal to Frollo.  In the movie, he’s pretty much the opposite of that (well, except for the strength I suppose).  They sort of had to do that though to make a Disney musical.  It’s no fun having a deaf mute trying to sing.

Shire plc has announcedthat it has entered into a research-based collaboration with Santaris Pharma to develop its proprietary Locked Nucleic Acid technology in a range of rare diseases. According to the company this will enable it to build on its competitive position for its Human Genetic Therapies business.

Did you know you can get Impactiviti Daily (Top Pharma News) direct to your Inbox each morning? Just click here to subscribe!

TODAY’S NEWS

P&G’s drug unit to be snapped up, by… – Warner Chilcott Ltd, a specialty drug maker, is acquiring Procter & Gamble Co’s prescription drug business for about $3 billion, two sources familiar with the matter said on Sunday…more

FDA approves infantile spasm drug (from Lundbeck) – The Food and Drug Administration on Friday approved the first drug for treating infantile spasms, a rare and devastating disease that wracks infants with hundreds of spasms every day, interferes with neurological development and kills as many as 20% of victims…more

J&J’s experimental anti-epilepsy drug – FDA says, no thanks.

From the rumor mill – Teva eyeing Shire?

RECOMMENDED

Training Strategy – One of the areas for which I provide “traditional” consulting is training strategy – working with you to look at the big picture and develop comprehensive blueprints for more effective training. I can also work with your department on RFP development, technology platforms, vendor selection and management strategies, and project management processes. Contact me (stevew at impactiviti dot com, or phone at 973-947-7429) for more information!

PLUS

Some great thoughts on Leading, from Seth Godin’s blog.

JUST FOR FUN

Erupting volcanoes on Earth, as seen from space. Very cool.

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FDA to Zeltia: NO – An FDA advisory committee has handed Spain’s Zeltia a crushing blow, deciding against a combination therapy that includes its lead cancer drug Yondelis (trabectedin) by a vote of 14 to 1. The news cost Zeltia 35 percent of its share price…more

FDA to Shire: Fast-track – Shire plc, the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease…more

Pfizer: We want to be #3! – Pfizer Inc. plans for its worldwide sales of medicines for treating cancer to increase 10-fold by 2018, said Andreas Penk, regional president of the company’s cancer business in Europe. Pfizer, the world’s biggest drugmaker, had about $2.5 billion in cancer-medicine sales in 2008, according to the company. Pfizer plans to become the third-largest maker of cancer treatments, up from about seventh now…more

Daiichi chief talks about Effient.

Med Device firms and Kickbacks – Several large medical device companies have been accused of marketing their products for unapproved uses while charging the federal government, according to documents unsealed in Houston federal court…more

PLUS – What if I was to go back into Pharma Sales?

AND – some recent stats on physicians on-line (globally). Pretty big. And while we’re at pretty big, here is the horrendous tangle that could be the future of healthcare here in the U.S.

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Noven Pharmaceuticals and Hisamitsu Pharmaceutical have jointly announced that they have entered into a definitive merger agreement pursuant to which Hisamitsu has proposed to acquire Noven for total cash consideration of approximately $428 million. The offer price represents a 22% premium to the closing price of Noven’s common stock on July 13, 2009, and a 43% premium to Noven’s average closing price for the preceding 90 days. The tender offer, if successful, would be followed by the merger of a Hisamitsu subsidiary with and into Noven, with Noven surviving as a wholly-owned subsidiary of Hisamitsu. The companies expect that Noven will continue as a standalone business unit, operating at its current locations in Miami and New York with its existing work force.

Noven has a number of joint ventures and alliances including a stake in Novogyne Pharmaceuticals, a joint venture with Novartis. In August 2008, Noven entered into license and supply agreements with Procter & Gamble relating to the development and commercialization of a low-dose testosterone patch for the treatment of Hypoactive Sexual Desire Disorder and other indications.

In the back end of 2008 Noven and Shire plc terminated their agreements for the development of an amphetamine patch for ADHD, and the commercial rights to that product were returned to Noven. In August 2008 Noven received the third and final $25 million sales milestone due to be paid to Noven by Shire under the agreement.

Investigations on behalf of current investors of Noven over potential breaches of fiduciary duty and other violations of state law in connection with an alleged unfair takeover price were announced following the merger announcement. Noven reported sales of $108 million in 2008 with a net income of $33 million in 2008. Earnings from the Novogyne joint venture were $46 million. Net assets were $160 million at year end.

Hisamitsu Pharmaceutical has collaborations with Banyu Pharmaceutical, SIGMA-TAU and Kyowa Hakko Kogyo.

Sunday 12 July 2009
Sustainable Building Workshop
The Murrindindi Climate Network in partnership with the Moreland Energy Foundation is hosting the second in a series of sustainable building workshops to provide information on the different options available for rebuilding after the fires.
- View Flyer
12noon – 5.00pm 
Kinglake West Hall
1055 Kinglake-Whittlesea Rd
Kinglake West    

10, 11 & 12 July 2009
Bush to Beach Retreat for Woman
We are excited to announce a weekend retreat for women affected by the 7 February bushfires to the Cumberland 5 Star Resort in Lorne, Victoria.
This weekend is run by local women for local women and supported by VBRRA.
It will be entertaining, inspirational, educational and FUN.
To register and for all enquires phone: 0414 255 384  
Lorne, Victoria    

Saturday 18 July 2009
Rebuilding Expo
The Shire of Yarra Ranges is hosting an expo to provide residents (bushfire affected and others considering reno-vation) with the opportunity to speak to building experts, local contractors and suppliers to assist them through the rebuilding process.
Murrindindi Residents Welcome
- View Flyer
10.00am – 4.00pm 
Lilydale Showgrounds
27 – 29 Market St
Lilydale
Mel Ref 38 E4    

Sunday 19 July 2009
Community Recovery Plan Workshop
Flowerale Recovery Committee invites the community to discuss a long-term community recovery plan. 
11.00am 
Flowerdale Community Hall    

Sunday 19 July 2009
Remake Kinglake
Your chance to shape the design of our townships, economy and environment. 
10.00am – 4.00pm 
Kinglake Ranges Basketball Stadium
and Community Centre
Exton’s Rd
Kinglake    

Sunday 23 August – Wednesday 26 August 2009
Camp Phoenix
Camp Phoenix is a retreat for Australian burn survivors and their families, that provides opportunities to share experiences in a safe, fun and friendly environment.
- View Flyer
Camp Wilkin, Anglesea, Victoria   

Who is responsible for the removal of roadside trees?

Vicroads are responsible for highways and main roads.

Murrindindi Shire Council is responsible for local roads.

What trees are being removed?

All trees are being assessed by qualified arborists.

Trees are removed from roadside reserves and crown land if they are identified as unsafe, are unlikely to regenerate, or they pose a threat to houses or other buildings.

If you believe a tree has been incorrectly marked you can register this with engineering services and it will be reassessed. Contact the Alexandra Council office on 5772 0333.

Why are some white crosses being “blacked out”?

The initial white cross markings may have been placed on trees by various people or agencies. As part of the roadside safety restoration works, Council contractors have reassessed each roadside tree using qualified arborists, and in some cases, previously marked trees are considered to be safe and therefore the previous markings have been “blacked out”.

If residents are concerned about the safety of a roadside tree they can contact the Alexandra council office on 5772 0333 and an inspection will be arranged.

What about habitat or culturally significant trees?

Every effort is made to leave habitat (hollow) trees even if lopping is undertaken to make these safe.

Identified “scar” trees are reported immediately to the Department of Sustainability and Environment for inspection.

Can the local communities access mulch?

Yes, designated collection points have been set up to allow local residents to take mulch for personal use at the following sites:

• Whittlesea Yea Road at Stony Creek, Kinglake West

• Whittlesea Yea Road, approximately 3kms north of Stony Creek

• Whittlesea Yea Road, approximately 3kms south of Stony Creek

Can the local communities access firewood?

Yes, again a number of designated collection points are being set up to allow local residents to take firewood for personal use.

Stockpile sites:

• Buxton – Meeting of the Waters*

• Marysville – Gallipoli Park*

• Flowerdale – Moores Road*

• Toolangi – Healesville Kinglake Road (logs only)

• Kinglake – Global Care, located adjacent to the Kinglake Services Centre* – please contact 5786 1452 for enquiries regarding firewood at this location

* Split wood may be available at these sites

Vicroads sites (logs only):

• Whittlesea Yea Road at Stony Creek, Kinglake West

• Whittlesea Yea Road, approximately 3kms north of Stony Creek

• Whittlesea Yea Road, approximately 3kms south of Stony Creek

Can I collect firewood from the roadside?

The normal process of obtaining a wood collection permit applies and residents need to contact our Local Laws officers on 5772 0331 for details.

Residents are strongly advised to access the community wood stockpiles as collection from roadsides could be dangerous due to the presence of dangerous trees.

Who is responsible for trees on private property?

The owner is responsible. If you are registered with the government funded program for site clean up, trees that have been assessed as dangerous immediately adjacent to destroyed buildings will be removed as part of the site cleanup.

For the free Federal and State Government funded bushfire affected property clean-up and demolition operation please contact – 1800 240 667 or visit www.wewillrebuild.vic.gov.au

Licensed contractors who are interested in taking part in the government funded clean-up and demolition program can contact: firecleanup@grocon.com.au.

A Frequently Asked Questions sheet about the clean-up program is available by contacting Grocon or at the following link:

www.wewillrebuild.vic.gov.au/clean-up-a-rebuilding/frequently-asked-questions.html

What do I do about dangerous trees on Crown land?

If trees are on crown land and are in danger of falling on private buildings, the Department of Sustainability and Environment (DSE) will arrange an arborist inspection and if necessary the removal of the tree at no cost to the owner. Residents should contact DSE – Alexandra office on telephone 5772 0200.

For further information or to report a dangerous tree please contact engineering services on 5772 0322.

Issue 59 for the 8th of June has been published.

Click the link below for access

http://www.murrindindi.vic.gov.au/page/page.asp?page_id=835

]]> http://slyofthekinglakeranges.wordpress.com/2009/06/30/lets-go-to-the-shed-what-shed/ Tue, 30 Jun 2009 12:40:41 +0000 slyofkinglake http://slyofthekinglakeranges.wordpress.com/2009/06/30/lets-go-to-the-shed-what-shed/

The Community wants it!

The Men need it!

The State supports it!

So where is it?

Ask the Council.  The Council as usual are hopeless, stalling, delaying…why?  Who the hell knows, Sly doesn’t even think they know.  Block after Block is being placed in front of the Shed.  And Block after Block gets removed by the Shed.

It’s Time for the Men of the Ranges to Stand Up and TELL the Shire to get their act together an approve The Shed!

Annabelle’s foal surprised us my making her entrance into the world a little sooner than expected!  She is the most beautiful, perfect, spotted draft filly with lanky legs, beautiful, long eyelashes, and a skip in her step . . . all in her first day!

Annabelle is the MOST PERFECT mother, catering to her young daughter’s every wish . . .

Of course, timing is everything and when I got the call early Thursday morning that our new baby had arrived, I didn’t believe it at first.  I was also heartbroken because I was hours away, giving an educational workshop.  Even though school was out for students, it wasn’t for me and I was dying to bond with our new baby.  I dashed out just as soon as I could and spent the next 2 hours in the barn, just admiring this work of perfection!  She is so perfect, it is almost surreal!

We’re still searching for JUST the right name for her.  Under consideration at the moment are:  Isabelle, Belle, Beauty, Rosabelle, Belle of the Ball, Cinderella, probably all preceeded by Rose Farms’ ___________.  It’s a difficult decision to agree on!  Any thoughts?

To see more pix, skip on over to our Rose Orchards site.  Abbie and I have taken hundreds of photos of our new treasure in the first couple of days and will post more soon, as soon as I return from barn to admire her some more . . .

Hey Guys! Lettucejr posting. Woah! The site is completely goin under construction for sure! I just made a new header and i hope all of yuh guys like it. Its really cool! Now. There is a new beta item today. So yuh better hurry up and get it. Casue in Shire’s last post. Me said dat Henry got ALOT of e-mail’s saying dat they want da beta t-shirt back. Henry did so. He brought back a BLUE “I’m A Beta” T-Shirt. Its really AWESOME!! And im just warning yuh guys. Henry is not gonna bring out more beta t-shirts dat say “I’m A Beta”. Becuase he already brought out 2 of them in different colors. Da first one was white if yuh guys didnt know. So, dont blame Pandanda or Henry if yuh guys didnt get da beta t-shirt. Its not there fault. Its yours cause yuh didnt get it. And he told yuh about it in da PLA Today and da Blog.

Here is da new Shirt: Hurry up and get it NOW!! Or else yuh lose yuh luck. Ok. I think dat covers wat needs to be said for today. Cya next time. Bye Panda’s!

~Lettucejr

Walking to Bear Hollow…

Murrindindi_Recovery_Newsletter_Edition_55