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GlaxoSmithKline terminates Crohn's drug program following a pivotal failure
[Posted on FierceBiotech today]
By John Carroll
When ChemoCentryx ($CCXI) reported last month that its Crohn's disease drug vercirnon (GSK1605786) failed the first of four Phase III trials mounted by GlaxoSmithKline ($GSK), the biotech said it was awaiting word from the pharma giant on its future development plans.
That decision has come down now. Referring to a slate of updates on Sept. 12, Clinicaltrials.gov now lists the other three Phase III trials--SHIELD-2, 3 and 4--as terminated. And a spokesperson for GlaxoSmithKline confirmed to FierceBiotech that the studies were axed.
"Those studies have been terminated," says Glaxo spokesperson Melinda Stubbee in an email to FierceBiotech. "No efficacy was observed with either dose of vercirnon over 12 weeks in SHIELD-1. In addition, dose-dependent increases in rates of adverse events (AEs), gastrointestinal AEs, and cardiac AEs, including two cardiac serious AEs in the 500mg twice daily group, were observed. Those findings have reduced the benefit to risk profile of vercirnon and don't support the continued treatment of the study patients."
Three weeks ago the biotech reported that "new recruitment and dosing in the ongoing clinical program has been suspended pending further review of the SHIELD-1 results," sending its shares down by almost half that day.
Glaxo inked a $1.5 billion deal--$63.5 million upfront--with ChemoCentryx back in 2006 to explore new drugs for inflammatory bowel disease. At that time, vercirnon, or Traficet-EN, was in Phase II/III studies.
GSK had a big program underway. The pharma giant's first trial recruited 608 patients and tested two 500 mg doses--once and twice daily--for moderate to severe Crohn's. The primary endpoint focused on a score of at least 100 points at 12 weeks on the Crohn's Disease Activity Index. Clinical remission (CDAI score less than 150 points) at 12 weeks was evaluated as a key secondary endpoint.
Shares of ChemoCentryx tanked again a few days ago after the biotech released weak interim results for its mid-stage study on a new drug for diabetic nephropathy. The company says the chemokine receptor CCX140 spurred a significant reduction in proteinuria after 12 weeks of therapy, spurring some confident remarks from executives. But some analysts said the drug was not clearly better than a placebo, prompting a 23% plunge in the stock price.
ChemoCentryx did not immediately respond to a query from FierceBiotech.
Thanks, Drill, for your work and time spent on this analysis. I am sure it wasn't easy to pull it all together. Makes one think about averaging down with current SP, considering the upside from this point.
North, I agree with your comments about Mig and questioning his motives. There is something sinister in his remarks and as I said previously, he reminds me of BroStart on SH with his vacillations.
Interesting reading on Big Oil and its development of the Lower Tertiary in the Gulf of Mexico.
http://finance.yahoo.com/news/wildcatter-hunch-unlocks-1-5-113441846.html
Drill, so the question becomes: why hasn't HRT released details of the Amazon plan that has been approved by it, Rosneft and PB? What is in it that HRT wants to keep secret?
One would think that this is a material event and the details should be disclosed to all the shareholders, other than the plan has been approved. I am sure the hedge funds know what is in the plan.
I agree with your follow-up post that this could make HRT an exciting and attractive investment, but now limited as a regional one.
Once again, however, there is no transparency from HRT.
MIG, were you formerly known as "BroStart" on the SH board?
North, thank you for your comments and defense.
I missed crowandthrow's latest deleted message towards me, but I got the gist of it. Not sure what my offense towards him was/is, but so be it. As to his later remark that the board is only positive, I think it has been mostly hopeful with some realistic assessments. He might remember how I expressed that the two positive PR's before the Moosehead PR was probably more indicative of a bad Moosehead result and several posters took issue with me and had some strong criticism.
Van, thanks for policing the board and not letting it become another SH.
So, MIG, what time in Taiwan is it? Have you had your tea, or better yet, some strong coffee?
If you believe that drivel in your post, please sell and get off the board. It is almost as if you don't understand what HRT is doing to survive with the asset sales, besides they still have a lot of cash. The purchase of Polvo is cash neutral with Credit Suisse providing the funding for the payment to BP. After that, they pick up US$2 million weekly after all expenses, on which income taxes are not paid for quite awhile.
Are you trying to scare people into selling so you can buy more at cheaper prices? If so, you are ...
BTW - Has anyone heard what is in the Amazon Plan and what each party is committed to do?
TIA
Sorry that I was not more descriptive in my thoughts on shares issuance.
I am not stating that in its report on raising funds, GS will recommend a share issue for sub-50 cents. In 2-3 months, the SP should stabilize at a better value of cash value plus asset farm-outs plus market values for Polvo as the deal should have closed and the Amazon Plan as some of the commitments might be completed and made known to investors, giving them more confidence.
One possibility in this report is that GS may suggest a reverse share split now and wait for a few months for a share issuance as HRT management proves it can be successful in carrying out some of its plans.
This might be far-fetched but it is an idea that will receive some consideration. Remember investment banks love share issuances due to the fees they receive.
Of course, everything might be mute if the hedge funds have increased their ownership % into the 40-50% range over the last few days.
A decision needs to be made to determine if HRT will be a regional O&G producer only or if its international ambitions are to go forward.
If the later, then there will probably need to be an increase in the number of authorized shares, so it can issue new shares (read dilution for current s/holders) to accumulate the capital for more drilling in Namibia (and/or ponying up its $$ share of the Amazon project).
For HRT to do this, it needs s/holder approval to increase the number of authorized shares.
Implicit in this may be that no company wants to deal with HRT on Namibia blocks for whatever reason.
You should be on the SH board. You'd fit in with robnhood, Slappy and the others that have ruined that board.
Volume increased and price drop accelerated after Byron King issued a "Sell Alert" a short while ago.
Therefore, there will be no Meerkat drilling. Wasn't that MM's first pick ... not that it matters?
You guys are giving the Brazilians a whole lot of credit for being extremely industrious on a weekend.
Reviewing PR's and Material Facts on the HRT website, there have been only three releases on a weekend. Two PR's were about the spudding in Wingat and Murombe and the third one was the helicopter accident.
Excluding the helicopter one, no negative weekend PR's showing on the website to date.
So, do like the Brazilians, have some fun this weekend and party 'til Monday morning when work begins.
Thanks, Drill, for the info.
Does ships' positioning provide any insight?
Van, the thing is Polvo has not been acquired (it is under contract) as it needs to receive ANP approval and complete other contingency actions before the transaction can be "closed."
Ogo did the same thing on SH giving the impression that it had become a done deal; I wanted to call him on it. The helpfulness from Ogo has gone down hill in the last few months, seemingly around the time MM left HRT.
Ogo (and everyone else, too), please provide the published date when you next post an article written by the media. TIA.
Ogo, what is the date of this news article? April, May or September?
I just hope the Moosehead does not turn out to be Bullwinkle ... that is, nothing between the ears!
GLTA Longs.
Van, my comments were not specific to HRT, but more general based on my experience with several public-traded companies.
I agree how companies can effect timing of completed deals. However. as to manipulating the timing of announcements, there is always the possibility that the other party might walk, deciding the deal isn't worth waiting and waiting and waiting ...
As to HRT, I am not sure it has ever countered any bad news with good as there has been very few good PR's and none of any equivalent value to offset the bad ones.
Timing of PR is determined when a transaction is completed, as there is a specified time period when the news needs to be released; it is not a situation that the company can decide, "We'll hold the bad news for 3 days and release today's good news now."
If the company could control the news, it would be better to release positive news first to build a stronger base before the bad news comes out. If bad news were to be announced first, there is a weak base, with many unanswered questions, to handle the negativity (extreme selling with SP plunging) as the eventual good news is not known and those matters will be in doubt. When released later, the good news will be ignored for all intents and purposes. But ...
... if all the news is good, then who cares about order of PR's.
GLTA Longs!
Might this PR be the precursor of the next PR that states HRT is going to do Meerkat on its own?
Since Meerkat will not be drilled as deeply as the other three, the costs will be less and the funds received (and to be received) from these transactions might be the necessary capital to go it alone.
Nice to see some transactions are being finalized.
Tomas, I know HRT does not have the money for the investment of this approved plan. It is the lack of clarity in the PR with which I have an issue.
What is the status of Rosneft and PB? Is either one taking the lead on the project or is it HRT's to pull it together? What is the approved plan for the Amazon gas?
While it is a nice uptick this morning on the Bovespa, it would have been higher if there had been more clarity and transparency in the PR.
While it is good to see something out on the Amazon, there is a fly in the ointment with this PR. Why is HRT seeking partners? Why aren't those partners Rosneft and PB? Aren't those two the logical ones? If HRT needs additional funds via farm-out for its share, why not state the status of Rosneft and PB? Are they moving forward or not?
Having dealt with Brazilians before and not impressed with their honesty or straightforwardness (their unspoken motto: I win, you lose), this PR is, not surprising, lacking in specifics. I know Brazilians like to hear themselves talk (they'll use 50 words, whereas, American will use 15 and Canadians 10), and if they weren't so nebulous in the action plan, I'd think this is good news.
Unfortunately, it is too vague ... why are Rosneft and PB only mentioned in the committee as each approved a report? That doesn't mean either will do anything about it, i.e., ponying up the necessary funds for a LNG plant.
N.B. I am a Byron King fan, and I believe his research and analysis trumps my Brazilian skepticism. If that has been misplaced, time will tell and shame on me.
Good to see you here, bullionbaby. The air is fresher at iHub than at quality-challenged SH.
Volume is also picking up with over to 700,000 traded in the last 30-45 minutes.
If Star reimbursed JW for this, then it should ask him to resign. If he refuses, fire him. Then, fire the person who approved his expense reports that authorized the reimbursements.
If the expense reports were not approved, then fire PP and CFO for lack of internal controls and fiscal oversight.
Then, hire executives that can make Anatabloc sales move faster than the piddly percentages it is achieving now!
But, for now, we want HRT to find oil in the Orange Basin ... Walvis can wait.
There weren't any rallies in SP before Wingat or Murombe PR's.
Wingat announcement on Monday, May 20th.
Price at close on May 10th in São Paulo: R$4.60. It did not trade as high the following week and ended at R$3.28 on May 20th before the results were released that evening.
For Murombe, the closing price on July 11th was R$2.55. It hit R$2.65 on the 12th, but not again during the following week and closed at R$2.02 on Friday, the 19th, ahead of that day's PR.
I would not call those rallies ... unless you are a shorty.
[Information taken from Yahoo! Finance.]
I don't believe the article states that HRT can do this without PB; it only states that HRT is going to Goldman to find funding for its capital needs.
Like my Jack Russell terriers chasing vermin, HRT was hot and exciting out of the gate this AM. But once the chase was over, the dogs retired to a shady tree to watch the world go by and HRT did pretty much the same.
My guess is, early on, shorts wanted to cover to avoid weekend exposure, by bidding up prices to hit pre-set price targets of sellers. When no one jumped on the band wagon to take SP higher with added volume, they decided no good news is coming this weekend and retired to the sidelines.
GLTA and enjoy your weekend ... next week, let's get dirty (dogs) and gooey (HRT).
This is problematic for HRT and Rosneft. They need PB's participation in a NG pipeline or other infrastructure-like project in the Amazon. Rosneft is not willing to commit $1 billion plus to this project, considering its other options. PB needs to put a significant amount of money into the project but, if ANP limits its funding, this decision will not be helpful to HRT in the long run ...
It appears there is strong volume today with over 1.7 million traded in Brazil in the first hour or so. SP up some (~5%), too.
Investors buying so they don't miss any Moosehead success, either oil or gas.
Thanks, NJ.
Also, has anyone read where Patrick Cox has ended up, i.e., does he have a blog, posting on MB's, etc.? Let us know if someone does know.
NJ, please place this post (#13522) at the top of the page in the yellow box.
It will be an inspiration to all Anatabloc fans in o' so many ways.
The default notice is for R$ 62 million, not US dollars.
Disclose on the Balance Sheet is probably in the line "Advances to parners" (sic!), which shows ~ BR57 million. Since the dates the default covered isn't mentioned, the amount is probably the June 30 total.
I accept Franke's statement that it is an administrative matter due to the purchase of TNK by Rosneft and will be resolved soon.
Drilling at HRT's third test well is now underway, with results expected in mid-October, he added.
Is this another translation into English error or has something changed?
P.S. My apologies for the failed formatting in prior post.
Firm confident of major Namibia oil find [color=red][Posted by creditcrunch on Chariot's board.
][/I][color=red][/color][/color]
Published August 15, 2013
AFP
WINDHOEK (AFP) – Finding large quantities of oil in Namibia is only "a matter of time" the head of Brazilian oil firm HRT said on Thursday, playing down lacklustre initial drilling results.
The chief executive of HRT, Milton Franke, told AFP he was confident Namibia would become the latest in a string of major Africa crude producers, despite around a dozen exploratory wells largely coming up dry.
HRT discovered some oil in a Walvis Basin well off Namibia's Skeleton Coast earlier this year but not in commercial volumes.
"HRT believes that finding oil in Namibia is a matter of time. Both basins, Walvis and Orange, have good source rocks, in the oil generation window," he said.
Drilling at HRT's third test well is now underway, with results expected in mid-October, he added.
Franke said they had learned from experience in Brazil that patience is needed.
"We see that in Campos Basin the first commercial oil discovery came with the drilling of the ninth well. Today it is the largest producer of the country."
Similarly, in Brazil's Santos Basin around 50 wells were drilled before major energy discoveries, he said.
In Namibia offshore exploration began in the late 1960's and resulted in major gas finds, but so far no oil.
But there are high hopes that Namibia could replicate crude discoveries in neighbouring Angola to the north, Africa's second-biggest producer of crude, after Nigeria.
"There is much work to do in Namibian basins exploration. If it is not HRT that will come up with the first oil discovery, it will be another major or independent oil company."
The company operates 10 offshore blocks in Namibia and its exploratory drilling programme is worth around $200 million.
Franke became CEO in May, after serving as the firm's production director and working with Brazilian state-backed oil major Petrobras.
Other companies with exploration licenses in Namibia include Spain's Repsol and Petrobras.
Read more: hxxp://www.foxnews.com/world/2013/08/15/firm-confident-major-namibia-oil-find/#ixzz2c43ifZFQ
Van, that has been there for a few hours. It was done to prepare the site for the link when the PR is released.
Could be the gas deal is being finalized with last minute details ... or one could hope that is the reason for the delay.