Thursday, August 25, 2016

Yet Another "Shepherded" Exo-Planet? We Find Proxima b Far More Alluring Than Our Blue Dot...

Ah -- "To burn at a distance, or to freeze nearby. . ." the old poem recites, but in fact, in the hunt for more worlds like ours, the opposite is true.

We are looking for ones that are neither -- neither burning, nor freezing. No, just right. The news of Proxima b is well covered in the video at bottom (and sketched in, to the left of what we Americans call the Southern Cross, in the night sky -- inside the tiny box). Do go watch the video for more. And now permit me a late night tangent:

For my part, this late evening (and countless ones before it) -- I find I prefer the unwasted grace of. . . mystery. Mystery of irises flashing golden flecks at the edges, and dark sienna in the middle -- to the science of blue-eyed Earth-certainty. We are finding that these blue worlds are as common as common might be.

And so in contrast, I will stand with Sweet Will [modified ever so slightly below], and declare that the rarer and darker one -- is most oft' the finer one, thus:

Shakespeare | Sonnet CXXX

My lady's eyes are nothing like the sun

Coral is no more pink than her lips' pink

If snow be white, then her skin cinnamon

If hairs be fine wires, resplendent filamented dark wires grow upon her head

And in no perfume is there more delight

Than in the far-away sighs that from my lady seep

I love to hear her speak, yet well I know

That no music hath a more pleasing sound

I grant I never saw a goddess go, yet

My lady, when she walks, scarcely treads on ground

So, by heaven, I think my love as rare

As any she belied with false compare. . . .

So it is, all in the eye of the beholder, to the edited Sweet Will. . . and to me, as well.

And the science of Proxima b? Right here (as advertised):

Tuesday, August 23, 2016

O/T -- A Wide Smile: 25 Years Ago This Morning, A Preposterously Generous Open Invitation Was Offered...

On this day in 1991, Internaut Day No. 1: August 23, 1991 -- Tim Berners-Lee, later Sir Timothy John Berners-Lee -- first opened what he came to call the world wide web. . . to, well. . . the world. For free.

What an audacious gift of benevolence that was.

He opened it to new users -- all of us, that is. All that appears here, for good or ill, is a result of his original largesse.

So, Happy 25th Anniversary, to you -- oh venerable "www"! It is now hard to imagine (for most of us), how we ever got along without you. Here's to hoping we will never have to.

And as peculiar as it may sound, many -- if not most -- of the people I have come to love dearly, are and remain deeply connected to me through (and at least in part, because of) this astonishing innovation.

Yet it is by voice and by sight and by deed that those bonds remain strong. So, I say thank you, Sir Berners-Lee!

Onward. Ever. . . onward.

Monday, August 22, 2016

Explaining The Price Ian C. Read Just Paid For Medivation...

Eye-watering. That's how much cream -- or premium -- is in this price.

But as I said last night, Mr. Read simply had to play defense here. He could not let any of the other majors get these assets. Even if the Medivation pipeline doesn't pan out -- he had to keep the candidates out of the hands of the rivals Merck, BMS and Roche in particular. Why? On the chance that the Medivation pipeline does perform.

If these were to become next gen oncology blockbusters -- in the others' hands -- Pfizer would be relegated to the back of the bus, for yet another decade -- in oncology. So he is overpaying (in my opinion) -- to play lock-out defense. Here's Tracy Staton on it:

. . . .But at $14 billion, Pfizer is paying a huge premium. At $81.50 per share, the price beats analyst estimates of a "best-case" deal for Medivation. It's a 30% premium to Friday's closing price--and a stunning 180% more than Medivation's stock price when the deal talk first emerged, as Bernstein analyst Tim Anderson pointed out in a Monday investor note. "This is a hefty bid," Anderson said. . . .

The pharma world is a place where history doesn't exactly repeat, but it sure does. . . rhyme. And the rest of the world is a surreal, strange, new and wonderfully familiar place this cloudless morning. . . smile.

Local Planetary Science: Where You'll Want To Be -- Exactly One Year From Yesterday, Starting At 11:15 AM CDT...

For a planetary event that happens only every 250 years or so, it is probably worth taking the day off, and getting on a plane to go see it. At least I think so.

Not since almost a decade before our founders met in Philadelphia, and signed our Declaration, has there been a full solar eclipse centered over North America. It will occur on the morning of August 21, 2017. And the sweetest spot (where the locally-observed solar altitude, relative to the nominal horizon, the full penumbral flaring and high-likelihood of clear skies -- all converge) will be very near Nashville -- just a little north, and east of it, actually.

It is hard to overstate how powerful a sign this sort of a celestial event (last time around) might have been -- in the collective consciousness of the indigenous peoples of North America -- then living on these upper Midwest plains. [But in a bit of reverently-intended historical license, I have at right imaged Tȟatȟáŋka Íyotȟake, whom we refer to as Sitting Bull, the Lakota chief -- circa a century later.] So it is with some considered humility, and at least some reflective silence -- that we probably ought to observe this one, this time around.

[I've included the ghostly figure of Tȟatȟáŋka Íyotȟake to remind us that dozens of these events occurred -- on the same spot, over many millennia -- while we "Americans" were not yet present. And I also mark it to take USA Today to task (gently) -- for edit copy that appears blissfully unconscious of the history of our lands, prior to the arrival of. . . those white men.] In any event, we shall see -- if USA Today revises its copy, eventually:

. . . .The biggest and best solar eclipse in [my edit: Post-Colonial] American history arrives a year from today, and plans for celebrations, parties and festivities are already well underway.

Organizers of the Oregon SolarFest are calling it "a rare, mind-blowing cosmic experience," while Nashville promises visitors "a once-in-a-lifetime celestial event."

On Aug. 21, 2017, a total solar eclipse will be visible from coast to coast, according to NASA. It will be the first total eclipse visible only in the USA since the country was founded in 1776. . . .

Check back here -- just under one year from now -- for more (that will be a Monday, as well). It ought to be well worth the trip. Ear to ear grins, as I walk in. . . .

Sunday, August 21, 2016

UPDATED: Pfizer Has Offered A Whopping $14 Billion -- For Medivation

In candor, I generally think Mr. Read tends to overpay for his assets. [Full rewrite and update here.]

And this rumored news has all the earmarks of being another one of those kinds of deals. Financial Times is reporting a rumor tonight -- that Pfizer may announce a $14 billion buyout of Medivation -- as early as tomorrow morning.

Last week, I had guessed it would go for between $12 billion and $13 billion, so this is premium pricing again, if the report is accurate.

I suppose one way to think about the high price here is to recognize that Mr. Read cannot afford to spend another decade bringing up the rear, in next gen oncology. That is, he cannot allow any of these other suitors to lock him out of Medivation's pipeline -- and put Pfizer in fourth place (or worse) in oncology for another decade. So, he has to bid over 15 times sales revenue for the asset. Yikes. Here's a bit, from FiercePharma, and the very capable Tracy Staton:

. . . .The Medivation hunt may be all but over. Pfizer is close to striking an agreement to buy the California-based biotech in a deal worth about $14 billion, the Financial Times reports.

If Pfizer and Medivation do finalize a deal, it would wrap up a months-long buyout race that pulled in much of Big Pharma and Big Biotech along the way. With its blockbuster oncology med Xtandi ready to add to a buyer’s sales, plus a much-anticipated late-stage cancer candidate and a pipeline of other prospects, Medivation has been a sought-after prize in an otherwise slow summer for biopharma M&A. . . .

This would mean that Merck has been outbid. And that may turn out to be the very good news. Time will tell. . . now sleep well, all you samba dancers, fondly leaving Rio behind. . . smile. Pssst! A fun one is due up early tomorrow!

O/T: This Is A Great American Story: Flint, Michigan’s Claressa Shields Achieves A Dream

I'll mostly just point you the Detroit Free Press article I've quoted, below. [This concludes our weekend of "girl power" stories.]

But before I so conclude, I will also link you to the excellent long form documentary (on PBS's "Independent Lens") that covers the tough time she's had -- leading up to, and after winning gold last time around -- in London, in 2012. Do watch it -- very well made. And for now, there is this very bright resolution -- to that earlier drama. Hopefully, this time 'round, the folks in Colorado Springs, at the USOC, will get her connected to marketing agents of note. That smile belongs on a Wheaties box.

. . . .Flint’s Claressa Shields made history this afternoon, becoming the first U.S. boxer to win back-to-back Olympic gold medals, defeating the Netherland’s Nouchka Fontijn in the women’s middleweight. . . .

This is gold medal story of survival, escaping from poverty and a difficult childhood, bouncing between 11 homes by the time she was 12, turning all of that pain into a champion boxer.

It is a story of growth and maturity.

After winning the gold at the 2012 Olympic Games in London, Shields did not get the money or fame or endorsements that she expected. She was perceived to be strong, tough and fierce but didn’t have a marketing team behind her. After winning the gold medal, life didn’t get easier. When everybody thought Shields had become rich, there she was, going to a collection agency to pay her mother’s past-due water bill. . . .

With this win, Shields becomes the most successful U.S. Olympic boxer in history – the only one to win two gold medals. . . .

That is quite grin-worthy, indeed. Off now, to the train stations. . . keep it spinnin' in good karma, one and all.

Long-Lingering Effects -- On Young Pregnant Girls -- In Ebola Ravaged Areas

As a reminder of how wise our current First Lady is -- in choosing girls' education, globally, as one of her focused priorities -- and as part of the weekend's theme here, of looking to empower young women, in education -- we must report on some ongoing troubling news, out of Sierra Leone. [And this properly resides here, as Merck (among several others) makes and distributes an array of the contraceptives being only-sporadically deployed, in country, as well as the vaccine -- and we've been covering the race for a reliable acute treatment, as well.] Right to it, then:

The effects of the Ebola crisis there will be felt for decades. Even as the education ministers get back to normal enrollment levels (which sadly are around 50 per cent of all school age eligible children), policies on pregnancies are likely to prevent a whole class of ebola survivors -- young girls -- from using formal education as a means to lift themselves out of poverty, and danger.

Here is the story of the continuing shunning of pregnant ebola girls -- in Sierra Leone. Please do read it all.

Only recently has President Koroma relented -- and started to re-admit pregnant teens from ebola ravaged areas back into school. But perhaps nearly half of them are still not being admitted, for the astonishing reason that they were the victims of sexual violence (and thought to be a bad influence in the classroom). It is not clear how many girls were (and are) affected by that portion of the ban. Official figures suggest at least five thousand, but experts mapping the situation indicate that the true figure may be far higher. Here's a bit, from a slightly dated Amnesty International (PDF here) study, on the topic:

. . . .Visibly pregnant girls in Sierra Leone are banned from attending mainstream school and taking exams. This prohibition was declared as official government policy by the Ministry of Education, Science and Technology in April 2015, just before schools re-opened following the Ebola crisis. The exclusion of pregnant girls from mainstream education and from sitting exams pre-dates the outbreak of Ebola; however, the official declaration of the ban when schools re-opened has sparked renewed debate and concern about this issue in Sierra Leone.

The Human Rights Commission of Sierra Leone described the ban as discriminatory, stigmatizing and likely to worsen the marginalization of pregnant girls and women. . . .

While it seems some 3,000 of those remaining 5,000 have now been re-admitted to schools, an additional approximately 2,000 girls (largely victims of sexual attacks) are still being shunted out of mainstream schooling in Sierra Leone.

From a mid August 2016 report, on this unfolding tragedy, and ongoing crisis:
. . .Teenage pregnancy has long been a problem, but the recent Ebola outbreak saw focus groups comprising of 1,193 children in total report a 47 percent jump in teen pregnancies, according to Save The Children, which trains nurses like Fullah to properly administer contraception and provide vital maternal healthcare services.

The actual reason for the increase in teen pregnancy is a source of contention among the government, NGOs, community leaders, and the girls themselves. But everyone agrees it is a bad thing indeed.

In Freetown, Save the Children health program officer Marget Tucker told Broadly, "During Ebola, schools were closed down, and this put girls at greater risk of teenage pregnancy." Though reliable data in Sierra Leone is difficult to obtain, Tucker estimates that around 20,000 teenage girls became mothers during the Ebola crisis, with poorer girls and those with lower levels of education being more vulnerable to becoming pregnant. . . .

[As many of the girls' mothers and fathers died of ebola, they were left without normal networks of protectors, and stable sources of food and clothing.] "Some of them had to etch out some means of survival and the only means of survival that they resorted to—most of them—was to have sex. Transactional sex, to be specific. . . ."

While there are micro-level financial issues at play here as well (raising the funds to pay school-books fees, etc.), we as members of the UNESCO, and as a nation able to influence WHO policy -- ought to use the power of international aid policies (the purse strings), to more strongly encourage President Koroma to admit all school age pregnant girls to mainstream schooling. Goodnight then, to all here who might "burn at a distance, rather than freeze nearby. . . ." we will smile broadly, just the same -- as it will all be well, in time.

Saturday, August 20, 2016

Science Saturdays Post: Girls'-Power -- In STEM "Chicago Icebox Derby" Challenge 2016 -- Powered By ComEd

As I occasionally do on weekends, this morning I'll highlight an important local science initiative, sponsored by the CEO of a utility here.

But it's not just any CEO, and not just any science competition.

As the collage of images at right makes plain (from 2014 to 2016), this is about finding the science talents in all of us. But especially in those (even today), who are not as regularly encouraged to "play" -- in the field of science and tech. This is a wonderful local STEM for girls event -- and since founding in 2014 -- has been largely under-appreciated by the science scene, nationally. So here's my little boost.

In general, I am rarely a fan of the electrical utilities' overall corporate governance structures -- but in this particular case ComEd is getting it exactly right. So, Kudos to the kids, and to ComEd, and its CEO, as well. From the WSJ reporting overnight, then:

. . . .ComEd’s first female chief executive, Anne R. Pramaggiore, introduced the IceBox Derby in 2014 as a way to get more young women to pursue careers in science, technology, engineering and math, or STEM, fields.

“It’s one thing to sit in a classroom to decide if you like math or not,” Ms. Pramaggiore said. “But we see them not only learn about the technical aspects of building a car, they learn about leadership.”

Career aspirations for this year’s racers range from Therese Jaeger, 17, who wants to be an aerospace engineer, to Morgan Jones, 13, who dreams of being a YouTube personality. . . .

Throwing a helmet on over her orange bandana, Taylor Clark sprinted to her race car, slammed down the accelerator and took off—at 15 miles an hour.

That is top speed at the third annual IceBox Derby, which featured battery-powered cars built by teenage girls using recycled fridges and go-kart parts.

“These refrigerator cars are on the move!” an emcee’s voice rang out, as parents and children cheered in the bleachers.

Earlier this month, 30 girls split on six teams vied for prizes including MacBook Airs and $3,000 college scholarships—seed money provided by race sponsor Commonwealth Edison Co., the local utility, meant to steer them toward studies in math and science. . . .

Many of these bright capable kids (Therese included) will almost certainly one day be sitting on the science panels, at NASA -- offering explanations of the science behind their missions to Mars, and Jupiter, and Pluto, and beyond:

. . .a broad and ample road, whose dust is gold, and pavement stars, as stars to thee appear seen in the Galaxy, that Milky Way. . . .

-- Milton

Onward now, with hot coffee at the ready, fresh icy OJ, a banana and cherry yogurt. Even on a gray morning -- these simple pleasures blast sunshine into my attitude (as do the pings, from old friends, near and far). . . smile.

Friday, August 19, 2016

Follow Up Friday: Ebola Edition -- Where Are British Public Health Authorities, On The Delayed £4,000 Bonus For Pauline Cafferkey?

Yet another month has rolled by, and still no service bonus for the Ebola hero and nurse named Pauline Cafferkey. We've been covering it, here -- as an offshoot of stories surrounding Merck's Ebola vaccine candidate.

What's new is that the British Health authorities are now saying Ms. Cafferkey concealed her high tempurature, on return to the UK. What's frustrating about that is that eye witnesses have consistently indicated (and PHE is now confirming) that PHE did not follow its own procedures, and encouraged the nurses to take each others' tempurature. After waiting a bit, with an initial high reading, her temprature decreased, and PHE allowed her to fly on. I for one am uncertain how that conduct, even if proven, should merit discipline, of any sort. She was a pure volunteer in Sierra Leone, returning home. From The Guardian (UK), overnight then -- a bit:

. . . .PHE had nurses at the airport to take the temperatures of the travellers, but, the Guardian has been told, not enough were stationed there.

One of the volunteers who returned at the same time as Cafferkey said they were encouraged by PHE staff to take one another’s temperatures and complete the forms.

Cafferkey’s temperature was high, so PHE’s staff were alerted, said the volunteer, who wanted to remain anonymous. Her temperature was taken six more times, but eventually, the volunteer said, Cafferkey was told she could board her flight to Glasgow. . . .

PHE was unprepared and did not follow correct procedure in managing the screening process,” the volunteer told the Guardian. . . .

Now you know -- and, following my theme of yesterday, this too -- volunteering to serve ones' brothers and sisters half a world away, at great personal risk, is another "idea that should live on." I will certainly keep a good thought for her, here. Off now, walking in, on a glorious Friday -- at half past nine, almost on the dot. Grin. . . with fighter jets screaming overhead, in practice runs. . . .

Thursday, August 18, 2016

Just A Short Reminder -- All About "Ideas That Will... Live"

Exactly 39 years ago this afternoon, not far from King William's Town, South Africa, Steve Biko and Peter Jones were stopped by the apartheid era security police, at a road-block.

They were then detained in Port Elizabeth under Section 6 of the then Terrorism Act. What happened after that can only fairly be called murder. Read it all here, from an inside South Africa historical perspective.

But what also happened after that, was a cascading chain of events, that ultimately led to the release from prison of Nelson Mandela, and his eventual presidency.

[That very same day in 1977, I was finishing up a last graveyard shift in the hard rock mines, mailing off all I had earned to the university, and preparing to set off for my first year of college, where a whole new world awaited me -- out of that small mountain town I was then leaving. I had by then received all the benefit of American privilege, no doubt.]

Of course, in August of 1977, I wasn't then even remotely aware of these ongoing struggles in South Africa. But in the ensuing decade, along with most of the rest of planet, I became acutely aware of them, there and here. That was due in no small part to the life -- and death -- of Bantu Steve Biko.

So I'd ask you to stop a moment this afternoon, and ponder which ideas -- here in our nation -- should "live on." Should we remain the most-free nation on Earth? Or should we build walls, conduct religious tests at our borders (and even more ominously, inside them)? The ideas written in our founding charter are too grand, too revolutionary, and hard-won, to sacrifice -- to a thin-skinned petulant man-child.

Please -- we all know so many who have died -- that these ideas might live on: "out of many, one. . ." That is what our currency says (in the original Latin) -- and it is in a very real sense the capital that has distinguished our nation, many times. Don't turn your back on it, America. And do pause to thank Bantu Steve Biko, too. And thank all who came before -- and after -- him, who were willing to die for the ideas of pluralism, and the progress of humankind.

The eyes of the world are watching now... watching now.

Wednesday, August 17, 2016

"Catfished"?! -- Martin Shkreli Was Invited To Speak In Palo Alto On Pharma Deal-Doing -- By A Major Law Firm. No Longer.

All of this (below) transpired in a little over 30 elapsed hours. As it unfolded of course, we had graphics -- so I've put up four three small version images -- click each to enlarge for full effect. [For now, we will call this whole story our Exclusive -- thanks to PathoPhilia.]

It seems a prominent law firm has asked the CEO of Savant HWP, and an affiliate of Savant Neglected Diseases, to speak on a panel -- about the deal he worked on, to secure an FDA approval for his firm's Chagas candidate (and, it is STILL hoped, secure a coveted PRV, worth potentially hundreds of millions of dollars). [The major law firm hosting the conference had represented Savant in the KaloBios bankruptcy -- as it turns out.]

Next, it seems someone (unknown) also asked Martin Shkreli to describe his side of the deal, and observations on the KaloBios bankruptcy -- a bankruptcy that was filed shortly after his arrest, last December. [The odd part of that is Mr. Shkreli (according to at least some public record documents) didn't even have a binding commitment to do the deal, with Savant, by the time of his arrest.] That part of the story unfolded some time on Monday night, with a BusinessWire newswire press release included.

By this afternoon, all references to the appearance of Mr. Shkreli -- at that confab -- had been scrubbed.

However, Mr. Shkreli's Twitter feed still recites that he is seeking permission from the US District Court, in the Eastern District of New York (Brooklyn) -- essentially for relief from his bail conditions -- to travel to Palo Alto to speak at the Dorsey & Whitney conference.

Problem is, he's no longer speaking. Was he "catfished"? That is, did they (or someone else) prank him? Or, did the equity partners at D&W (after a moment's reflection) vote to "uninvite" him?

Or. . . did his criminal defense lawyer put the brakes on it, when he got wind of the travel request? We will likely never know.

But what a ride it was, over on the KaloBios Reviewed site, during the last two days -- head there for all the blow by blow -- with a sincere hat tip to PathoPhilia, for all the leads -- and the reporting. Now you know.

In other circumstances, I might feel some pity for someone invited to the big Homecoming dance, only to be then left sitting on his doorstep. Tux on; boutonniere already pinned to his lapel. . . .

But not in these circumstances.

To quote an internet meme, of ten years passed, then: "BOOM goes the Dyn-O-Mite"!

Sleep well now, all you science majors, brimming with good will -- this clearly doesn't apply to you. Just the one.

Will Medivation Fetch More Than $12.5 Billion? It Rejected An Earlier Sanofi $10.2 Billion Bid

It is certainly becoming a go-go market for M&A -- in the next gen immuno oncology space, in particular. Medivation's candidates have impressed, as of late -- in trials.

Just look at the pedigree of these names -- orbiting the "nucleus" of Medivation (in 1950s style atomic time, no less!) -- at least according to MSM published rumors.

Here is the Reuters bit on it overnight, but my guess is that something well north of $12 billion will be needed to win the bidding:

. . . .Merck & Co Inc is one of at least five pharmaceutical companies that submitted indications of interest in buying U.S. cancer drug company Medivation Inc earlier this month, according to people familiar with the matter. . . .

Sanofi SA, Pfizer Inc, Celgene Corp and Gilead Sciences Inc also put forward expressions of interest, the sources said. Medivation will have further conversations with potential buyers and ask them to firm up their offers, some of the sources said. . . .

Medivation, best known for its prostate cancer drug Xtandi, said in July it had agreed to share confidential information with potential buyers after France's Sanofi agreed to drop a campaign to oust Medivation's board of directors. . . .

Frothy markets make for big premiums -- but if any sector supports such valuations, it is the oncology wing of the bioscience sector. Onward, for some later-evening cool outdoors symphony listening, then. . . grinning -- as ever, as Mozart, Schubert and Mendelssohn are on tap. . . .

Tuesday, August 16, 2016

The Last Of "Fast" Fred's "Five Stars" Falls: Merck's Zontivity® Is Done, In US

FiercePharma has done a very nice job of covering this long-developing story, while I've been attending to other matters.

I'll just quote some of theirs, and point you to mine -- of May of 2014, when it was approved in the US with a very narrow label. At least two other strong competitors have come on market (and three more are about to) -- in the US -- since May of 2014. [Prior to May of 2014, Merck had already written off some $1.7 billion on the project -- so this brings the total impairment charges to almost exactly $2 billion, over about five years, or $400 million per year. Ouch.]

Of course, our hearts go out to those families whose incomes and careers are ending here. We will keep them in our morning meditiations. But in truth, this one had long been expected. Here's the FiercePharma item, and a bit:

. . . .Merck acquired Zontivity, or vorapaxar, in its 2009 buyout of Schering-Plough. It was a first-in-class PAR-1 drug designed to compete with the old standby clot fighter warfarin in stroke patients, and analysts had pegged its peak sales as high as $5 billion per year.

But as clinical studies progressed, serious bleeding risks emerged, dashing hopes of an approval for stroke patients and limiting its potential market. Its 2014 approval included a “black box” warning about those bleeding risks. . . .

Since then, newer clot-fighters have hit the market, including AstraZeneca’s Brilinta, approved for post-heart attack treatment, and Eli Lilly’s Effient. There’s also a range of next-gen warfarin rivals, including Bristol-Myers Squibb and Pfizer’s Eliquis; Johnson & Johnson and Bayer’s Xarelto; and Boehringer Ingelheim’s Pradaxa. Those drugs have bleeding risks of their own, but reversal agents are nearing the market. . . .

Now you know -- and I do think that is the last of Fred's five favorite candidates -- from the 2008 era. Not one made anything near what Mr. Hassan was literally pounding the table claiming it would. Onward, on a glorious late summer afternoon just the same -- off, to the pop-up farmers' fresh fruit stands, here in the city, on foot. . . . smiling ear to ear.

Monday, August 15, 2016

Federal Propecia® MDL Rescheduled Status Conference In Brookyln: Now October 18, 2016 @ 1 PM EST

A very minor update here -- due to a conflict on the Court's calendar -- the next status hearing on the federal finasteride (branded as Propecia® and/or Proscar®) multi-district litigation has been moved up by a week.

Last week we reported a new slew of dates, this one is one week earlier than originally proposed:

. . . .A Status Conference is scheduled for October 18, 2016 at 1:00 p.m. in Courtroom 322 North before Magistrate Judge Peggy Kuo.

Ordered by Magistrate Judge Peggy Kuo on 8/12/2016. . . .

Now you know. Onward, on an easy start to the week -- hunting later afternoon fresh food, on foot. . . smile.

O/T -- Shorter Trump: "Stop Quoting Me." It's Hurting My Chances.

I think the below is a res ipsa moment. That is, the "thing" speaks for himself -- from one of his latest Twitter feed rants:
"...If the disgusting and corrupt media covered me honestly and didn't put false meaning into the words I say, I would be beating Hillary by 20%...."
The media simply quoted the words he uttered, almost without exception.
Mr. Trump, there can be no false meaning put into your actual words, especially when you don't disavow them -- for days on end.
Words mean what they mean. And he is losing precisely because of his own views -- expressed in his own words. That's how this whole free democratic election thing words, Mr. Trump.
Stop being you, and maybe your brand would arrest its plunge, in the polls -- but probably not.
[And a sincere hat tip -- to the sublime Rick Laurent -- for his political cartoon art. Do go see.]

Will Merck India Divest More Of Its Legacy/Matured Meds?

Last year, Merck India sold off a few legacy Organon drug franchises in India (which regular readers will recall was legacy Schering-Plough). Like the rumor reported below, the meds then divested were old, mature brands -- with good cash flow but scant sales revenue growth in their profiles. It would seem a similar set of deals is being bandied about, at least on a preliminary basis, again as to Organon properties, inside India. To be clear, this deal -- should it occur -- would not affect any of Kenilworth's operations outside of the country. So here you go -- what we know, or at least, what we've heard -- after a fine vacation-filled week. . . see below.

As reported overnight, in India then -- from the Delhi bureau of The Economic Times -- an in-country paper (but long ago as many may know, it started life as a British property):

. . . .Merck will probably narrow down on a few therapy areas in the future like its diabetes brands, new generation anti-cancer drugs like Keytruda and vaccines.

"The idea is perhaps to shift gears from a mass market-based revenue generation strategy to improving quality of revenues," another industry executive noted. Last December, MSD had sold five gastrointestinal brands to Piramal Enterprises for Rs 92 crore.

Those products belonged to Organon, a women's healthcare company, which was acquired globally by Schering Plough in 2007. Merck and Schering Plough agreed to merge in 2009 as part of a $41 billion transaction. . . .

An O/T one is up next, on the politics of exclusion -- and losing strategies. Onward then, under a gray but inviting city-scape, for the leisurely walk in. Be excellent to one another. . . .

Thursday, August 11, 2016

No Surprise, Here: Merck Must Pay Gilead's Attorneys' Fees -- But How Much? $14 Million? -- $10 Million?

As our graphic of last week indicated, at right -- this was expected. Now the order has entered.

It would be wise for Merck to offer to pay a substantial portion of the submitted detailed, task based bill -- and avoid more legal spend, on all sides. My guess is it is closer to $13 million, than $10 million, if the able Judge is forced to rule. Here's the end of today's order:

. . . .For the foregoing reasons, IT IS HEREBY ORDERED that Gilead’s motion for attorneys’ fees is GRANTED.

The parties shall meet and confer on a reasonable and appropriate briefing schedule regarding the amount of fees that should be awarded to Gilead. The parties shall submit a proposed stipulated briefing schedule on or before August 18, 2016. . . .

Merck will of course appeal on the underlying issue(s), but offering to pay now, should it lose on appeal -- that just makes economic sense (i.e., stop the legal clocks) -- rather than piling up more spend. But what do I know?

Smile. . . . time to nod off, with two Simones (a gymnast; and a sprint swimmer) showing why each is the envy of the world -- less than 20 minutes, and 20 hours ago -- respectively. Sweet.

Wednesday, August 10, 2016

Additional "Request(s) To Admit" Scheduling Dates -- In Propecia®/Proscar® MDL -- Entered In Federal Court, In Brooklyn Yesterday

Just about 24 hours after we reported that "not much was new," in the SEC Form 10-Q, on the federal Propecia® MDL scheduling front -- it turns out that the able Magistrate Judge Kuo was almost simultaneously entering orders designed to move the whole process forward, closer to trial dates -- in Brooklyn.

In fact, on Tuesday, she ordered that Merck be required to answer up to 60 so-called "requests to admit," all as propounded by the plaintiffs' steering committee lawyers. Essentially, the 60 requests are designed to avoid spending time at trial "proving up" factual matters that Merck does not intend to dispute. For example, Merck isn't likely to dispute that it manufactured finasteride, or that copies of ads with wavy hair in its Propecia® logo were designed or adopted by it. That sort of thing.

So here is my update to the update -- and the full text of the minute order of yesterday, via PACER:

. . . .Minute Order for proceedings held before Magistrate Judge Peggy Kuo.

Status Conference held on 8/9/2016. Attorneys Tim Becker and Trent Miracle for Plaintiffs. Attorneys Chip Morrow and Michael Guerra for the Merck Defendants.

Plaintiffs' Motion [325] is granted with the limitations stated on the record. Plaintiffs may propound 60 Requests for Admissions. The deadline for the requests is October 10, 2016.

The deadline for Defendants' responses is December 9, 2016. Any disputes that cannot be resolved by the parties are to be raised via simultaneous filings by January 17, 2017.

For the reasons stated on the record, Defendants' Motion [324] regarding the use of internal Merck documents is granted in part and denied in part.

The parties are to submit by August 12, 2016 a letter proposing 2-3 dates and times for the next status conference. . . .

Now you know. And. . . isn't summer-time just a grand season? With fresh, juicy, and darkly-ripened Michigan cherries to be devoured from the pop-up farmstands throughout the Loop? I certainly think so. . . grinning ear-to-ear. We need not live high, to live. . . well.

That Longish Keytruda® Vs. Opdivo® Global Patent Wars Update I Promised...

It has taken me a full day to get back to this, but as I promised yesterday -- before all that silly Mattersight mayhem unfolded -- here finally is the update, on all the various patent spats around the globe, between Merck and BMS, in immuno oncology. [Our backgrounder, from 18 months ago, here.]

As I've indicated below, by bolding parts -- this cornucopia of global litigation is still in the early stages, but is hotly contested -- as billions are once again potentially at stake. Of particular note is that the formal EU litigation has not yet been filed, but could potentially eventually result in an injunction against sales by one of the parties, there -- though I think that is not especially likely. In any event, here's the whole section, in context, from Monday's SEC Form 10-Q filing, at pages 22 to 23:

. . . .As previously disclosed, Ono Pharmaceutical Co. (Ono) has a European patent (EP 1 537 878) (’878) that broadly claims the use of an anti-PD-1 antibody, such as the Company’s immunotherapy, Keytruda, for the treatment of cancer. Ono has previously licensed its commercial rights to an anti-PD-1 antibody to Bristol-Myers Squibb (BMS) in certain markets. The Company believes that the ’878 patent is invalid and filed an opposition in the European Patent Office (EPO) seeking its revocation. In June 2014, the Opposition Division of the EPO found the claims in the ’878 patent are valid. The Company received the Opposition Division’s written opinion in September 2014 and the Company submitted its substantive appeal in February 2015. In April 2014, the Company, and three other companies, opposed another European patent (EP 2 161 336) (’336) owned by BMS and Ono that it believes is invalid. The ’336 patent, as granted, broadly claimed anti-PD-1 antibodies that could include Keytruda. In February 2015 and May 2016, BMS and Ono submitted requests to amend the claims of the ’336 patent. During a hearing in July 2016, the EPO allowed the May 2016 amendment and, as a result, the claims of the ’336 patent no longer broadly claim anti-PD-1 antibodies such as Keytruda.

In May 2014, the Company filed a lawsuit in the UK seeking revocation of the UK national versions of both the ’878 and ’336 patents. In July 2014, Ono and BMS sued the Company seeking a declaration that the ’878 patent would be infringed in the UK by the marketing of Keytruda. The Company has sought a declaration from the UK court that Keytruda will not infringe the ’336 patent in the UK. BMS and Ono notified the Company of their request to amend the claims of the EPO ’336 patent and of their intention to seek permission from the court to similarly amend the UK national version so that the claims of the ’336 patent would no longer broadly claim anti-PD-1 antibodies such as Keytruda. A trial was held in the UK in July 2015. At that trial, the issues of validity and infringement of the ’878 patent were heard at the same time by the court. In October 2015, the court issued its judgment, finding the ’878 patent valid and infringed. Merck appealed this judgment. The appeal is scheduled to be heard in March 2017. BMS and Ono have concurrently started a proceeding to determine the amount of damages and royalties the Company would pay should the appeal be denied. A hearing in that proceeding is scheduled for October 2017.

In February 2015, the Company filed lawsuits in the Netherlands seeking revocation of the Dutch national versions of both the ’878 and ’336 patents. BMS and Ono amended the claims of the ’336 patent so that the claims of the ’336 patent no longer broadly claim anti-PD-1 antibodies such as Keytruda. Trial regarding the validity and infringement of the ’878 patent was held in January 2016. In June 2016, the District Court in The Hague issued its judgment finding the Dutch ‘878 patent valid and infringed. Merck will appeal this judgment. In December 2015, BMS and Ono filed lawsuits against the Company in France, Ireland, Switzerland and Germany alleging infringement of the ’878 patent. In January 2016, BMS and Ono filed a lawsuit against the Company in Spain alleging infringement of the ’878 patent. In France, BMS and Ono filed for preliminary relief seeking payment of damages while the case is pending. A hearing on this preliminary relief was held in February 2016 and BMS’s and Ono’s request for preliminary relief was denied. Dates for trials regarding the validity and infringement of the Irish, French, Swiss and Spanish national versions of the ’878 patent have not yet been scheduled. A trial concerning the infringement of the German version of the ’878 patent is currently scheduled to begin in March 2017. The Company continues to believe the ’878 patent is invalid.

The Company can file lawsuits seeking revocation of the ’878 patents in other national courts in Europe at any time, and Ono and BMS can file patent infringement actions against the Company in other national courts in Europe at or around the time the Company launches Keytruda. If a national court determines that the Company infringed a valid claim in the ’878 patent, Ono and BMS may be entitled to monetary damages, including royalties on future sales of Keytruda, and potentially could seek an injunction to prevent the Company from marketing Keytruda in that country.

The United States Patent and Trademark Office (USPTO) granted US Patent Nos. 8,728,474 to Ono and 8,779,105 to Ono and BMS in May 2014. These patents are equivalent to the ’878 and ’336 patents, respectively. In September 2014, BMS and Ono filed a lawsuit in the United States alleging that, by marketing Keytruda, the Company will infringe US Patent No. 8,728,474. BMS and Ono are not seeking to prevent or stop the marketing of Keytruda in the United States. The trial in this matter is currently scheduled to begin in April 2017. The Company believes that the 8,728,474 patent and the 8,779,105 patent are both invalid. In June 2015 and July 2015, Ono filed lawsuits in the United States alleging that, by marketing Keytruda, the Company will infringe US Patent Nos. 9,067,999 and 9,073,994, which are patents related to the 8,728,474 patent. The Company believes the 9,067,999 and 9,073,994 patents are also invalid. In June 2016, the Company filed petitions for Inter Partes Review (IPR) in the USPTO alleging that the 9,067,999 and 9,073,994 patents are invalid.

In April 2016, the Company filed a declaratory judgment action in the United States against BMS and Ono seeking a ruling that US Patent Nos. 8,779,105 and 9,084,776 are invalid and/or not infringed by the sale of Keytruda. These patents are equivalents of the ’336 patent, as originally granted. In June 2016, Ono and BMS filed a counterclaim that the Company’s marketing, making, using, selling, offering for sale, and/or importing Keytruda in the United States for the treatment of certain cancers, including melanoma and non-small-cell lung cancer, infringes these patents.

In September 2014, the Company filed a lawsuit in Australia seeking revocation of Australian Patent No. 2011203119, which is equivalent to the ’336 patent as originally granted. In March 2015, BMS and Ono counterclaimed in this matter alleging that the Company’s manufacture and supply of Keytruda to the Australian market will infringe Australian Patent No. 2011203119. A trial on this patent is scheduled for September 2017.

Ono and BMS have similar and other patents and applications, which the Company is closely monitoring, pending in the United States, Japan and other countries.

The Company is confident that it will be able to market Keytruda in any country in which it is approved and that it will not be prevented from doing so by the Ono or BMS patents or any pending applications.

In October 2015, PDL Biopharma (PDL) filed a lawsuit in the United States against the Company alleging that the manufacture of Keytruda infringed US Patent No. 5,693,761 (’761 patent), which expired in December 2014. This patent claims platform technology used in the creation and manufacture of recombinant antibodies and PDL is seeking damages for pre-expiry infringement of the ’761 patent.

In July 2016, the Company filed a declaratory judgment action in the United States against Genentech and City of Hope seeking a ruling that US Patent No. 7,923,221 (the Cabilly III patent), which claims platform technology used in the creation and manufacture of recombinant antibodies, is invalid and that Keytruda and bezlotoxumab do not infringe the Cabilly III patent. In July 2016, the Company also filed a petition in the USPTO for IPR of certain claims of US Patent No. 6,331,415 (the Cabilly II patent), which claims platform technology used in the creation and manufacture of recombinant antibodies and is also owned by Genentech and City of Hope, as being invalid. The USPTO has six months to decide this petition. . . .

We will of course keep an eye on all of this, so you don't. have. too. Smile. Onward, on a lovely morning -- to the symphony tonight, in all likelihood. . . . and an earlier recording of the signature work.

Tuesday, August 9, 2016

Strictly O/T: Largely Hapless Little Chicago "Software As A Service" Public Company Reports Q2 Results Tonight

Strictly speaking, this has nothing to do with the life sciences. So feel free to scroll on by.

But for the last five years or so, on and off -- mostly as an MBA-level business school style case study -- (along with an anonymous commenting co-hort) I've curated a chronicle of the reversals of fortune, and manifold mis-steps -- of a hapless Chicago company called Mattersight.

I don't think there's ever been a public software/consulting/tech company that retained (and repeatedly bonused) the same CEO over a 16 year period (and essentially the same board majority, over the same time period) -- all while switching cash draining business models at least three times, and never once making a penny of GAAP EPS from continuing operations. Not once in over 16 years. That goes back to the Y2K bug, and internet bubble no. 1. . . . And the stock has fallen from over $305.00 per share, to as low as $2.80 a share (bottom of the melt-down of 2008-2011), and sits at $3.80 per share today.

The reason I choose to mention it today, is that the company will report its Q2 2016 losses this evening after NASDAQ close. Last week, on what appears to be an emergency basis, it took out its old bank lender (likely due to a covenant default), and replaced it with a venture debt lender -- on terms that approach vulture lending.

So, tonight's call portends to be a watershed moment. I expect continuing and perhaps widening losses -- as the company spends about $1.50 for every dollar of sales it generates, at present. Last quarter, they parted ways with their CFO of nine months -- the third in four years, after only nine months on the job.

The company also admitted it could not reliably track how many copies of its flagship product/software are installed at customers, so it could not be sure it was being paid fairly, on a seat license basis. And still the same team awards itself equity and bonuses, for non-performance -- year after year.

So, like the mini-site on KaloBios, in the coming weeks -- I'll add an icon at left, so you may easily follow along -- if the above holds any interest. But I expect that MATR stock will keep falling into tomorrow, at a minimum. Now you know. Onward, for a relaxing walk in. . .