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bull,
Yes, of course I am holding. Have never sold any of my OPK (one of my largest holdings; has been into 6 figures) or COCP/BZNE (a very small holding).
What gives me pause is how Frost and friends arbitrarily (to someone not on the inside) make these major deals, such as selling all the former BZNE assets in return for a few shares of something else they own to shore that up, leave us hanging in the meantime and then do the reverse merger with CoCrystal to make us whole - even tho we are not quite sure what we have now in COCP. Makes me feel like a pawn on a chessboard or a bystander watching the pea under the walnut shells. As a retail investor, perhaps that's what I am.
Steve
cm,
I am long many of the stocks with which Dr. Frost is involved, including COCP and OPK. I would say a new investor should still do their own Due Diligence, rather than blindly investing in a stock simply because the good doctor has an investment in it.
What COCP suffers from, IMHO, is a lack of transparency, which is the problem with some of the other stocks. Hence the drop in price. I might speculate and buy more shares, but it is purely a speculation and the amount of Due Diligence one can do is extremely limited.
Steve
Thank you. Will do so.
Managed (through luck, not skill) to snag $1.50 this morning to exit ATHX. Might be back, but I need validation of their platform. GLTAL
Takeover speculation on Betaville:
http://betaville123.blogspot.co.uk/2014/04/another-day-another-multibillion-pharma.html
Monday, 28 April 2014
Another day, another multibillion dollar pharma deal....
Wow - today's news about Pfizer formally launching its $100 billion takeover bid for AstraZeneca has sent the pharmacuetical sector rumour mill into overdrive.
One company that is getting a lot of attention in European markets is US-based InterMune, a biotechnology business focused on the research and development of therapies in pulmonology and fibrotic diseases.
Parky over at the The Times picked up on some InterMune speculation in his market report last Friday after Reuters reported in March several mystery parties had been running their "slide rules" over the business. Here is a link to the original Reuters article: http://www.reuters.com/article/2014/03/07/us-intermune-deal-idUSBREA2617G20140307
I understand the InterMune gossip is broadly correct. My sources tell me a few European pharmaceutical companies have been taking a look at InterMune, including Switzerland-based Actelion.
Actelion is said to have expressed an interest in buying InterMune a few weeks ago and lined up between $3 billion and $4 billion in financing from several banks, including the likes of JP Morgan, according to my sources. Actelion declined to comment on the speculation.
Other pharmaceutical companies studying InterMune, which is normally advised by Goldman Sachs, are said to include France's Sanofi, according to sources. Sanofi declined to comment on the speculation.
Novartis and Roche, two Switzerland-based pharmaceutical giants, have also been mentioned in some quarters as a potential bidders for InterMune but I don't have any sources that can corroborate whether these companies have a firm interest.
Don't, though, get too excited. Although InterMune may get bought for a significant premium, Betaville readers should be aware a deal is by no means a certainty and still several weeks, if not months, away, say my sources familiar with the matter.
Elsewhere in the sector, Reuters was reporting this evening that Allergan is set to make a fresh multi-billion pound approach for London-listed Shire in the next few days after holding talks earlier this year.
Allergan is the US-based botox producer that is fending off a $47 billion hostile approach from Valeant Pharmaceuticals and US activist investor Bill Ackman.
Here is a link to the Reuters article: http://www.reuters.com/article/2014/04/28/us-shire-allergan-exclusive-idUSBREA3R16Y20140428
An InterMune spokesperson declined to comment.
UPDATE: Some excellent sources have been in contact this morning to provide an update to the InterMune situation. I don't want observers to get too excited by this potential deal as I understand that it is extremely "early days".
Indeed, I have been told that Actelion and Sanofi have not yet submitted formal indicative offers for InterMune and may decide not to pursue a transaction.
Anyone have a clue why the drop today? At 1.25 now. Saw only good news recently.
Well, my philosophy is "it is what it is," although TEVA sponsoring the other event is a good sign. My french is too old (last studied it 50 years ago) and too non-technical to be of much use.
Disappointed in news this morning on another stock Seel, Wild4ctix and I are in.
Thank you for that as well. Any idea about the drug companies who might be attending, other than the presenters?
Excellent article. Thanks for posting.
Seel, Thank you for the dose of reality. Steve
Best wishes for your wife to stay fully in remission.
Steve
DL1, Thanks for the response. OPK certainly has had enough volatility to do the trading and option-writing you describe and I'm fine with that. GLTU! Steve
Holding. Waiting for that major move up. However long it takes.
Doglover1,
I am also long and have been since 2011, with a cost (in one lot) of as low as $3.62 (others higher). My investment thesis was to initially follow Dr. Frost's investments and winnow through those which appeared to have reasonable fundamentals. Ended up with about six investments in common with the good doctor.
However, I am really curious about what brought you to OPK? You, being an experienced handicapper - please note I am NOT asking for your assessment of the odds - clearly made your investment on some basis. Care to share?
Steve
Back over $29.
New Forbes article on Moch leaving:
Pharma & Healthcare
|
4/10/2014 @ 9:33AM
Chimerix CEO Out In Wake Of Josh Hardy Compassionate Use Media Frenzy
A month after brokering a new Phase III trial of Chimerix’s investigational antiviral drug, company CEO Kenneth I. Moch has been replaced and will be pursuing other interests. The company announced yesterday that Moch has been replaced by former chief medical officer of Chimerix, M. Michelle Berrey, MD, MPH.
Moch had been in the middle of a traditional and social media firestorm when the company denied compassionate use access of their investigational antiviral drug, brincidofovir (CMX001), to 8-year-old Joshua Hardy. The Virginia boy has been suffering from a potentially-fatal adenovirus infection following a bone marrow transplant for his nearly life-long struggle with rhabdoid carcinoma of the kidney.
John Murawski of the Raleigh News & Observer reported on March 12 that Moch had subsequently received death threats and was placed under armed escort. The 54-person, North Carolina company also required protection, as Murawski then wrote:
The small drug company’s office was put on lockdown this week as employees feared for their safety, a police sentry stationed at the building’s vestibule and another guarding the third-floor entrance to Chimerix’s headquarters in Durham.
Following the death threats, Moch told Murawski, ““I’m concerned by the actions of those who really need to look into their own hearts and souls.”
Compassionate use for one while ignoring the whole
This case came to national attention when reporters picked up on #SaveJosh, an aggressive social media campaign by Hardy’s family to gain compassionate “extended use access” to Chimerix’s CMX001. This FDA designation allows companies to provide pre-approval access to FDA uses to work with companies to provide experimental drugs to patients.
Although Chimerix had a compassionate use program early in the drug’s development, their current focus has been to get CMX001 approved quickly so that it can be made available to as many patients as possible. A small company like Chimerix without any products generating revenue is in a particularly difficult situation, lacking the resources to handle individual compassionate use cases while also trying to get difficult and expensive controlled clinical trials completed on the road to potential FDA approval.
Early in March, Moch expressed that he could appreciate the angst of families, particularly as a father. But the ethical concerns transcended any one patient and they could not give the drug to one without giving it to all who need it. But he and Chimerix were in a no-win situation in the public eye.
CNN led with, “Company denies drug to dying child,” and a Fox News story entitled, “Drug Company Refuses 7-Year-Old Boy Life-Saving Medicine Despite Donation,” discussed an offer by the Max Cure Foundation to pay for the experimental treatment.
Josh's mother: "Praise GOD in Heaven. Two great things today! Josh was moved out of the ICU on to the transplant floor, which is huge!!!! Also the adenovirus blood results came back less than 100 log copies. Pretty much gone!" Credit: Aimee Hardy, from the #SaveJosh Facebook page on March 25, 2014, after Josh received brincidofovir
CMX001 (brincidofovir) is a new drug based on cidofovir (Gilead; Vistide®), the current drug of choice for adenoviral infections. This lipid-modified version of the drug overcomes a major dose-limiting side effect of cidofovir, kidney damage. CMX001 is handled differently, protecting the kidney, while simultaneously having much greater antiviral potency than cidofovir.
Developed in the laboratory of Karl Hostetler, MD, then at the University of California, San Diego, CMX001 may have much broader applications due to it’s ability to target many pathogenic viruses with a double-stranded DNA genome, such as smallpox. For this reason, CMX001 could be a candidate for national stockpiling to protect citizens against bioterrorism attacks with such viruses.
Murawski quoted Moch as having experienced the “dark side” of the social media phenomenon. The #SaveJosh Facebook campaign generated nearly 30,000 likes and a Change.org petition garnered nearly 20,000 signatures. These efforts were then amplified on Twitter when supporters would retweet these campaigns or news stories. For example, Washington Redskins quarterback, Robert Griffin III, urged his 1.13 million followers to #savejosh, referring them to an article in a Fredericksburg, Virginia newspaper, the Hardys’ hometown. A family supporter even pulled together a group of Virginia supporters that were going to travel to Chimerix headquarters to protest on March 13.
Behind the scenes, Moch and colleagues worked with FDA to get a 20-patient, open-label Phase III trial in place in a matter of a week. Josh was the first patient to enroll and his doctors at St. Jude Childrens’ Hospital in Memphis administered the first doses within days. Some of Josh’s supporters posted statements thanking God for Chimerix and Ken Moch’s efforts.
Josh’s mother, Aimee, reported on their CaringBridge.org page that Josh’s adenoviral counts dramatically dropped after only two doses. My efforts to reach Mrs. Hardy for further comment have been unsuccessful and their site has not been updated since March 31.
From a bioethics standpoint, Moch’s subsequent statement to Murawski puts the trial in perspective: “It’s not just about Josh, it’s about many Joshes.” Noted NYU ethicist, Art Caplan, and others have publicly expressed concerns about compromising the compassionate use program when the growing use of social media gets the greatest public attention of cases where families and friends are best equipped to mount such efforts.
We subsequently reported on another effort, one by the husband of a 25-year-old former PR specialist trying to obtain an experimental anticancer biopharmaceutical for her metastatic kidney cancer from one of three companies with similar drugs in trials. Keith Knapp and his wife’s PR colleagues have secured nearly 421,000 signatures on their Change.org campaign and attracted international media coverage of their quest to get his wife, Mikaela, one of the anti-PD-1 drugs that might unmask the cancer to the immune system.
Remarkably few pixels have been devoted to the fact that all drugs that are candidates for compassionate use are still being studied for their effectiveness and side effects, most often with highly-defined patient populations to preclude any unrelated factors from compromising the information gained about the drug itself. Moreover, compassionate use also opens the door for drug companies to potentially experiment on human subjects where there might be no chance for their survival.
In a world where drug companies are fined billions of dollars for unanticipated safety issues years after drugs are approved and marketed, it’s difficult to fully reconcile these criticisms with the demand that companies also make available incompletely-tested drugs.
http://www.forbes.com/sites/davidkroll/2014/04/10/chimerix-ceo-out-in-wake-of-josh-hardy-compassionate-use-media-frenzy/?partner=yahootix
zzzzz....
RR, Thanks for posting. Steve
Harmsen,
Thank you for posting. I saw that but it's primarily a pump for Galectin Therapeutics. MNOV just has a peripheral mention as being in the field, with no details. Keep posting what you find! Not enough stuff is out there.
Steve
Not pretty price action today. Broke downward thru $30, after 2pm. We'llsee where it goes.
Thank you Kyle.
Post from the Hardy family:
By Aimee Hardy — Mar 19, 2014 11:52am
..... The measurement they use to measure the adenovirus in Josh's blood is called log copies. When we made our Facebook plea on 3/6, the log copies were 250,000. After 2 doses of the Brincidofovir, the log copies in Josh's blood went down to 1000. ...
http://www.caringbridge.org/visit/joshuahardy/journal/view/id/5329cb65ca16b417335c35eb
From Forbes: Josh responding well to CMRX drug.
David Kroll
David Kroll, Contributor, 4/03/2014 @ 7:39AM |169 views
Virginia Boy Responding To Chimerix Anti-Adenovirus Drug; Celebrates 8th Birthday
Last month, we reported on a request from a Virginia family for compassionate use access to an antiviral drug under development by Chimerix, a small biotech company in Durham, North Carolina. Their son, Josh Hardy, had developed an adenoviral infection following a bone marrow transplant for rhabdoid carcinoma of the kidney at St. Jude Children’s Hospital in Memphis.
The standard drug of choice is an antiviral called cidofovir (Gilead; Vistide®), but its use sometimes causes kidney damage. Josh’s parents report that he had been suffering from this side effect and approached Chimerix for “extended access” to a newer version of cidovofvir called brincidofovir, or CMX001. This version of the antiviral carries a modification to prevent kidney damage while also being more potent as an antiviral drug.
For more specific details, see our March 12th article where we spoke with brincidofovir developer, Dr. Karl Hostetler, former researcher at the University of California at San Diego and now president and CEO of Hera Pharmaceuticals.
After a large social media campaign – and death threats to Chimerix CEO, Kenneth I. Moch – the company made the drug available to Josh’s doctors under a newly-established, open-label CMX-001 trial for 20 patients.
Josh’s mother, Aimee, reported on their CaringBridge.org page that the boy seems to have responded well to the drug. After only two doses of CMX-001, Josh’s adenoviral DNA counts dropped from 250,000 to 1,000 and his kidneys appear to be improving. (Bear in mind that this is a report from the family, not the doctors or Chimerix.)
http://www.forbes.com/sites/davidkroll/2014/04/03/virginia-boy-responding-to-chimerix-anti-adenovirus-drug-celebrates-8th-birthday/?partner=yahootix
A repeat of that amazing growth would be nice.
Thanks for posting the news item.
Schadenfreude.
ok. so it is the biotech black plague! thanks!
Meant to ask "what's up" with the drop.
NR, Any idea what u with the drop, other than the downdraft on biotech? Steve
BZNE is now CoCrystal Pharma, although still trading as BZNE
It appears the "drop" to .26 in SP shown earlier on IHub was simply the bid. No actual transactions today.
No news I can see to explain the current drop in SP.
Chimerix to Present a Summary of Brincidofovir's (CMX001) Hematologic Safety at the Annual Meeting of the European Group for Blood and Marrow Transplantation
Mon March 24, 2014 4:15 PM|GlobeNewswire
DURHAM, N.C., March 24, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced an upcoming presentation on its investigational broad-spectrum antiviral brincidofovir (CMX001) at the 40th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) being held March 30 April 2, 2014 in Milan, Italy.
The presentation will summarize safety data from two placebo-controlled studies and an expanded access trial of brincidofovir. Brincidofovir therapy showed no evidence of negative effects on white blood cell production, an important indication of a successful new bone marrow transplant, which is also known as a hematopoietic cell transplant (HCT). The lack of negative impact on the white blood cells or new bone marrow has allowed brincidofovir to begin dosing at the time of the transplant in the Phase 3 trial, SUPPRESS. SUPPRESS is currently enrolling adult allogeneic HCT recipients to determine the safety and efficacy of brincidofovir for the prevention of cytomegalovirus (CMV) infection in high-risk HCT recipients.
"Pre-engraftment Initiation of Brincidofovir (CMX001) in Hematopoietic Cell Transplant Recipients is Supported by Lack of Myeloid Toxicity" will be presented by Marion Morrison, MD, of Chimerix (CMRX), on Tuesday, April 1, 2014. For more information, please visit EBMT's conference website: www.ebmt2014.org .
The risk of viral infections, especially CMV, is highest in the first three months after bone marrow transplant, while the new immune system is being established. CMV infection remains the most common serious infection following HCT. Available antivirals that have anti-CMV activity are not able to be used as a prevention for CMV infection in at-risk HCT recipients because of the known negative effects on the white blood cells of the immune system. The lack of hematologic toxicity shown in this analysis is an important potential advantage for brincidofovir if the safety profile is confirmed in the ongoing Phase 3 trial.
About the European Group for Blood and Marrow Transplantation (EBMT)
The EBMT is a non-profit organization that was established in 1974 to allow scientists and physicians involved in clinical bone marrow transplantation to share their experience and develop co-operative studies. The EBMT aims to promote all aspects associated with the transplantation of hematopoietic stem cells from all donor sources and donor types including basic and clinical research, education, standardization, quality control and accreditation for transplant procedures. For further information about the EBMT, please visit the website: www.ebmt.org .
About Brincidofovir (CMX001)
Chimerix's lead product candidate, brincidofovir, has the potential to be the first broad-spectrum antiviral for the prevention and treatment of clinically significant infections caused by DNA viruses. Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including cytomegalovirus (CMV), adenovirus (AdV), BK virus and herpes simplex viruses.
In September 2013, data from Chimerix's Phase 2 trial of brincidofovir in the prevention of CMV in recipients of hematopoietic cell transplants (HCT) were published in The New England Journal of Medicine (N Engl J Med 369:1227-36). Building on these positive Phase 2 results in CMV prevention, Chimerix initiated the Phase 3 SUPPRESS trial in the third quarter of 2013 which, if positive, will be used to support Chimerix's initial regulatory submission for the Accelerated Approval of brincidofovir for prevention of CMV infection in adult HCT recipients.
In late 2013, Chimerix presented data from an exploratory trial of brincidofovir in early AdV infection. A brincidofovir dose of 100 mg twice weekly initiated at the time of detection of AdV in the blood, provided evidence of an antiviral effect, and a numeric decrease in overall mortality. In March 2014, Chimerix initiated an open-label pilot trial of brincidofovir for the treatment of AdV infection in immunocompromised patients.
Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox.
About Chimerix
Chimerix is a biopharmaceutical company dedicated to developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix's proprietary technology has given rise to two clinical-stage nucleotide analog lipid-conjugates, brincidofovir and CMX157, both of which have potential for enhanced activity and safety in convenient, orally administered dosing regimens. In the third quarter of 2013, Chimerix initiated the Phase 3 SUPPRESS trial of brincidofovir for the prevention of CMV infection in adult HCT recipients, also known as bone marrow transplants. Brincidofovir has shown broad-spectrum in vitro activity against all five families of DNA viruses that affect humans, including CMV, AdV, BKV and herpes simplex viruses. Brincidofovir has received Fast Track designation by the FDA, and the Phase 3 data, if positive, would be used to support Chimerix's initial regulatory submission for the Accelerated Approval of brincidofovir for the prevention of CMV infection in adult HCT recipients. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. Chimerix's second product candidate, CMX157, was licensed to Merck in July 2012 for the treatment of HIV infections. For further information, please visit Chimerix's website, www.chimerix.com .
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT: CHIMERIX CONTACT:
Joseph T. Schepers
Executive Director,
Investor Relations and Corporate Communications
jschepers@chimerix.com
919-287-4125
Source: Chimerix, Inc. 2014 GlobeNewswire, Inc.
Washington Post Article:
Crowdsourcing medical decisions: Ethicists worry Josh Hardy case may set bad precedent
By Ariana Eunjung Cha, Published: March 23
Just hours after social-media supporters of a dying 7-year-old boy pressured a reluctant biotech company into giving him an experimental medication, the backlash began.
Is “it rite to save 1 child an[d] not the rest?” wondered one commenter on a news forum. “It’s really not fair to the thousands of others that were turned down just because they didn’t make a big public outcry,” said another.
The Herald-Sun newspaper in Durham, N.C., where the company that makes the drug is based, said it was glad for the boy’s sake that he was able to get the medicine. “But the process leaves us pained,” the editorial board wrote. “This is no way to make health-care decisions.”
The story of how Joshua Hardy — a first-grader from Fredericksburg, Va., who is fighting off an infection after getting a bone-marrow transplant — got access to an unapproved treatment when others with similar requests were turned down highlights the ethical conundrums facing doctors, companies and regulators in the era of Facebook and Twitter.
In the days leading up to the drug company’s change of heart March 11, contrasting photos of Josh — smiling in baseball outfits and then lying in his hospital bed with tubes sticking out of his body — were all over the Internet. He has beaten cancer four times since he was 9 months old. But the disease has left his body without much of an immune system, and in February he was infected with a virus that left him close to death.
Nearly 20,000 people signed a petition supporting “compassionate use” for Josh, which allows a drug to be administered outside of a clinical trial. Hundreds bombarded Chimerix, a small, publicly traded company that makes the drug, with e-mails and calls on the boy’s behalf. Even Washington Redskins quarterback Robert Griffin III took sides, tweeting to his 1.12 million-plus followers to “#savejosh.”
Critics of the strategy say they sympathize with Josh’s parents and admire them for being willing to do anything to save their child, but they decry the crowdsourcing of medical decisions and warn that the case may set a dangerous precedent.
“You couldn’t get a more troubling and impossible-to-resolve moral dilemma than this one,” said Arthur Caplan, director of the division of medical ethics at New York University’s Langone Medical Center.
From the perspective of the public and future patients, it’s best for the company to focus on getting the drug approved as soon as possible so that the largest number of people can be helped, Caplan said. But from a patient’s point of view, getting immediate access to the drug is what’s important.
“It’s a trade-off between the public good versus self-interest,” Caplan said. “They conflict. There is no way of getting around it.”
Richard Plotkin, a 69-year-old retired trial lawyer from New Jersey who started the Max Cure Foundation after his grandson was diagnosed with lymphoma at age 4 and who was at the center of efforts to save Josh, defends the campaign as necessary.
“I knew we had at the latest until the end of the week before the boy would die, and the best way to make a company change its mind — fast — is to get the public involved,” Plotkin said.
The parents of 11-year-old Sarah Murnaghan also have faced intense criticism. The girl received two lung transplants (the first one failed) last June after her parents launched a Change.org petition that got more than 370,000 signatories and sued in an effort to get their daughter an organ more quickly.
Janet Murnaghan said she knows that not everyone agrees with the way her daughter’s case was resolved — a judge ordered the transplant network to put her on the adult list, and she jumped to the top because of the severity of her condition — but she believes it did the public good by demanding that patients and their families have a larger voice in how organs are allocated.
Since the early days of the AIDS epidemic, patients with life-threatening conditions have become increasingly vocal about demanding access to drugs still in development. The Food and Drug Administration in 1987 created new rules, amended in 2009, for expanded access or compassionate use to allow what it says is “broad and equitable access” to those treatments. But the program remains limited. Since 2009, the agency has approved an average of 1,030 applications each year; each request may be for multiple patients.
Most patients’ requests never make it to that stage.
Before the FDA gets involved, companies must agree to allow their drug to be used. But many companies are reluctant to do so for a host of reasons — legal, financial and logistical — and, in most cases, they hold firm despite intense public pressure.
Andrea Sloan, 45, a lawyer whose case drew the support of several Texas legislators as well as Newt Gingrich, died Jan. 1 while fighting for access to a drug to treat ovarian cancer made by BioMarin Pharmaceutical. Nick Auden, a Denver father of three with melanoma who was able to gather 500,000 signatures for a petition for compassionate use of a Merck drug, died in November without getting the treatment. He was 41.
The companies argue that if something goes wrong with a patient who gets a drug outside the clinical-trial process, it could slow down their larger development program while the FDA investigates. Moreover, insurance companies typically won’t pay for unapproved treatments, so either the drug companies have to bear the costs or give the treatment only to those who can afford it. The companies also often create only a small supply of a drug for clinical trials; making more or diverting it could be time-
consuming and costly.
Even if those challenges can be overcome, companies say, there are ethical issues.
Kenneth Moch, chief executive of Chimerix, which makes the drug that the Hardys were seeking, said that until 2012 the company had a large compassionate-use program but had to discontinue it to focus its limited resources — it has only 60 employees and is not profitable — on getting the drug approved.
During the past two years, Chimerix has nonetheless received 200 applications for compassionate use, and 80 were for adenovirus infections like the one Josh has. All of the requests were turned down. “Every one of those is heart-wrenching. But making it available for one child, whatever the reason, as an exception is not equitable distribution,” he said.
Chimerix turned down the Hardys’ requests, too. But after several days of intense phone calls with officials at the FDA’s Division of Anti-Viral Products — who heard about Josh’s plight through the media — they worked out a solution.
Instead of getting the drug through the compassionate-use program, Josh got it through the clinical-trial process. Although he wasn’t eligible for the trial in progress — it is for adults with a different condition — the FDA offered to immediately green-light a new clinical trial that would be designed for pediatric patients with Josh’s condition.
In this way, medical experts say, the FDA created a wall that would allow Chimerix to give Josh and up to 19 other children the drug for free without opening the floodgates to others.
The deal was also a big win for Chimerix: No only did it solve its public relations crisis, it allowed the company to cut through the red tape that is typically required to get another clinical trial approved. The company’s stock has soared nearly 29 percent since the news was announced Tuesday.
“There is no doubt that the social media campaign by the Hardys helped accelerate the dialogue,” Moch said.
Josh, who on Wednesday received his second dose of the treatment — an antiviral drug called brincidofovir — remains in intensive care at St. Jude Children’s Research Hospital in Memphis.
His mother, Aimee Hardy, wrote hopefully on Facebook that the virus in Josh’s blood is replicating more slowly, and he is in less pain than before. “Glory to God,” she said, “the medicine is working.”
http://www.washingtonpost.com/national/health-science/crowdsourcing-medical-decisions-ethicists-worry-josh-hardy-case-may-set-bad-precedent/2014/03/23/f8591446-ab81-11e3-adbc-888c8010c799_story.html
Motley Fool article on ITMN:
http://www.fool.com/investing/general/2014/03/21/why-intermune-inc-shares-jumped.aspx
which cites
https://cms.psav.com/cPaper2012/myitinerary/session-9738.html?congress=ats2014#.UywyQnIMFGg.twitter
Why InterMune Inc. Shares Jumped
By Sean Williams March 21, 2014
Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of InterMune (NASDAQ: ITMN), a biopharmaceutical company focused on developing therapies to treat orphan fibrotic diseases, jumped as much as 17% after privately held rival Boehringer Ingelheim unveiled results from its two late-stage studies involving nintedanib as a treatment for idiopathic pulmonary fibrosis, or IPF.
So what: According to an abstract posted to the website of the American Thoracic Society (the 3:25 p.m. time slot for those interested), Boehringer Ingelheim's nintedanib hit its primary endpoint of significantly reducing the annual rate of decline in forced vital capacity in both its INPULSIS-1 and INPULSIS-2 studies. It also delivered a similar safety profile relative to the control arm. But the INPULSIS-1 study failed to meet a key secondary endpoint of improving overall health and reducing flare-ups of the disease. Investors have taken this minor shortfall as a reason to believe that InterMune's Esbriet (known also as pirfenidone) might therefore be the first-in-line and/or superior therapy of the two.
Now what: This could ultimately wind up being exciting news for InterMune, but this is merely an abstract and we don't have the full data set to even try and attempt to compare the two IPF therapies as of yet. Until we have that data it's probably best to hold off on declaring InterMune's Esbriet the king of the jungle. In addition, based on a wide range of peak sales estimates, with InterMune currently valued at anywhere from three to 10 times global peak sales estimates of Esbriet, I would suggest shareholders remain cautious as there could be more downside potential built into its shares than upside at this point.
Chevelle, Thanks for posting that Instablog. Steve
ITMN up on bad news for competitor
http://www.reuters.com/article/2014/03/21/us-intermune-stocks-idUSBREA2K14Y20140321
InterMune shares jump as Boehringer's rival drug shows mixed results
BANGALORE Fri Mar 21, 2014 10:27am EDT
(Reuters) - Shares of InterMune Inc rose as much as 17 percent on Friday after data showed German drugmaker Boehringer Ingleheim's rival drug had mixed results in late-stage trials.
Data from two late-stage trials of Boehringer's nintedanib showed the drug improved patients' lung function, but one trial fell short of meeting its key secondary goals of improving overall health and delaying a disease flare up.
Nintedanib and InterMune's pirfenidone are aimed at treating idiopathic pulmonary fibrosis (IPF) — an irreversible condition that leads to progressive loss of lung function due to scarring, which hinders a lung's ability to absorb oxygen.
InterMune recently completed a late-stage trial of pirfenidone, which showed that after a year of treatment 16.5 percent of patients taking the drug experienced disease progression, around half the level of those using a placebo.
Pirfenidone is already in use in Europe, Canada and Asia and is marketed as Esbriet.
"We believe based on both studies hitting their primary endpoints that nintedanib could very well be approved... we believe most patients will likely cycle through both drugs sequentially such that there could be a $1 billion opportunity for Esbriet even splitting the market," Wells Fargo Securities analyst Brian Abrahams wrote in a note.
Data from the two Boehringer trials was published on Friday, as part of an industry conference. (link.reuters.com/kew77v)
InterMune shares were up 11 percent at $36.42 in morning trade on the Nasdaq on Friday. They touched a high of $38.29 earlier in the session.
(Reporting by Esha Dey in Bangalore; Editing by Simon Jennings)
Let's hope!
ITMN completes sale of shares. I expect the price will drift upward for now. BWTFDIK
Form 8-K for INTERMUNE INC
19-Mar-2014
Other Events
Item 8.01 Other Events.
On March 19, 2014, InterMune, Inc. (the "Company") completed the sale and issuance of 8,625,000 shares (the "Shares") of its common stock, par value $0.001 ("Common Stock"), which includes the exercise in full of the underwriters' option to purchase 1,125,000 additional shares of the Company's Common Stock granted under the Company's Underwriting Agreement, dated March 13, 2014, entered into with Goldman, Sachs & Co. and J.P. Morgan Securities LLC, as representatives of the several underwriters named therein. The net proceeds to the Company from the sale of the Shares was approximately $268.0 million, after deducting underwriting discounts and estimated offering expenses.
The Shares have been registered pursuant to the Company's automatic registration statement on Form S-3 (Registration Statement No. 333-176787) (the "Registration Statement") filed with the Securities and Exchange Commission (the "Commission"), including the prospectus supplement filed by the Company with the Commission, dated March 13, 2014 (the "Prospectus Supplement"), to the prospectus contained in the Registration Statement dated September 12, 2011.