Good News From Conakry, Guinea: Baby With Ebola Released From Hospital

November 28, 2015 - Leave a Response

Once again, with the aid of Gilead’s experimental GS-5734, and ZMappTM — from Mapp Bio Pharmaceuticals, a likely fatal case was arrested.

We saw much the same in the resurgent (and now vanquished) case of Pauline Cafferkey, last month, in London. Though little Nubia will grow up without her mother — she will, in all likelihood, actually grow up. And in 42 days, Guinea will be declared disease free (again). All from Reuters United Kingdom, just this quiet Saturday afternoon:

. . . .A one-month-old baby girl who was Guinea’s last reported Ebola case left hospital on Saturday, delighting medical staff and putting the country on course to be declared free of the deadly virus.

Guinea will become officially Ebola-free after 42 days if no new cases are reported following the recovery of baby Nubia — thought to be the first baby to survive after being born to an infected mother. . . .

Nubia, who was born Ebola-positive and named after an MSF nurse, was able to survive due to experimental drugs as well as round-the-clock care given by a 20-strong team.

“When she (Nubia) started having convulsions, we thought the virus had entered the brain and that’s when we started the anti-viral,” Sailly said. “Everyone was following hour by hour.”

Sailly said Nubia had received Mapp Biopharmaceutical Inc’s Ebola drug ZMapp as well as an experimental anti-viral drug known as GS-5734 being developed by the U.S. drugmaker Gilead Sciences. . . .

We will keep you posted, here, just as we wish all babies, the world over. . . long lives, and great health!

Gilead’s Counsel Has Answered Merck Counsel’s Claim: No “Crime Or Fraud” Exception Applies — In Sovaldi® Patent Wars

November 25, 2015 - Leave a Response

I am a little late in posting this, with the holiday busy-ness, and airport runs — but it took Gilead’s legal team only one elapsed day to reply to Merck’s lawyers (detailed here, and here — previously).

In sum, Gilead says the disputed emails were in fact privileged communications — from a predecessor-entity officer, to outside counsel, and thus are properly the subject of a claw-back order. Moreover, Gilead’s counsel says Merck never really articulated any plausible crime or fraud theory — let alone offered prima facie evidence of it — so, it all should amount to. . . nothing.

Of course, because both documents are heavily redacted, we have no way of evaluating these arguments, and counter arguments. We are just reporting them. Here is that six-page PDF of the latest Gilead letter — with all of its various redactions — and a bit:

. . . .Simply put, neither Gilead nor its predecessor Pharmasset committed any crime or fraud, nor have Plaintiffs shown that they have. The crime-fraud exception requires that Plaintiffs “make a prima facie showing that (1) the client was committing or intending to commit a fraud or crime, and (2) the attorney-client communications were in furtherance of that alleged crime or fraud.” In re Chevron Corp., 633 F.3d 153, 166 (3d Cir. 2011) (internal citations omitted). Plaintiffs have shown neither. Plaintiffs have not and cannot show: (1) that any fraud was, in fact, committed; and (2) that Pharmasset had any intent to perpetrate a fraud.

The court applies a “reasonable basis” standard to assess the sufficiency of the required prima facie showing, generalized allegations of fraud are not sufficient, rather the proponent of the exception must provide the “requisite factual basis” for the crime-fraud exception to apply. In re ML-Lee Acquisition Fund II, L.P. & ML-Lee Acqueistion Fund (Ret. Accounts) II, L.P. Sec. Litig., 848 F. Supp. 527, 566 (D. Del. 1994); See also Manetar Tech. Corp. v. Six Flags Theme Park, Inc., 886 F.Supp.2d 466, 487 (D. Del. 2012) (noting that to “demonstrate a prima facie case of fraud” sufficient to sustain the crime-fraud exception’s application, “generalized allegations… will not suffice”). That factual basis must include the relevant intent evidence. See, e.g., Finley Assocs., Inc. v. Sea & Pines Consol. Corp., 714 F. Supp. 110, 118 (D. Del. 1989) (noting that the party requesting the crime-fraud exception’s application must “present[] a reasonable basis for believing that the [client’s] objective was fraudulent”) (emphasis added). Plaintiffs fail wholly to meet their burden.

As a threshold matter, Plaintiffs never identify the elements of the fraud or crime they allege. . . .

Now the very able Judge Stark will have to decide: are the emails excluded from evidence, and thus not available for any purpose, in the global perhaps multi-billion dollar litigation? Or, may Merck make hay out of what may have been some intemperate remarks, by a Pharmasset science officer, many, many years ago? We will have to wait and see — our best — to all of good will, and good cheer!

Some Blood Pressure Numbers To Contemplate — Over Your Turkey, Stuffing, Gravy And Sweet Potato Pie… Not Really O/T

November 25, 2015 - Leave a Response

I won’t offer a long wind up here — just mostly point you to a terrific post over at MedNewsToday — by Alan Cassels. [Graphic at right is his summarized fine work, as to all the content — ours, as to the derivative styling. Click to enlarge.]

Much was made last month — of the very large SPRINT blood pressure study results, purporting to support the thesis of “even lower” is better — or, “ever lower” if you prefer — for reducing cardiovascular risks. Cassels has admirably offered us the flip side — the numbers needed to harm — when a two-, or three-drug regimen drives those numbers down — very, very low. Kidney problems — up to and including renal failure — emerge as one of those off-target effects, as providers ramp up the dosages. Do read all of his — but these are his takeaways:

. . . .I decided to construct my own table using the individual Secondary Outcomes and Serious Adverse Effects that were found to be ‘statistically significant’ (i.e.: had a P-value lower than 0.05). As you see in the list below, here’s how many people need to be treated to be helped or harmed in the “intensive” blood pressure group compared to “standard” therapy:

125: Number needed to treat to prevent one case of heart failure.

167: Number needed to treat to prevent one death by cardiovascular causes

83: Number needed to treat to prevent death by any cause

100: Number needed to harm to cause one case of hypotension

167: Number needed to harm to cause one case of syncope

125: Number needed to harm to cause one case of electrolyte abnormality

56: Number needed to harm to cause one case of acute kidney injury or renal failure

42: Number needed to harm to cause one serious adverse event. . . .

Those rather low numbers needed to harm, at higher dosages — should give us all pause. So — do take the NEJM Sprint article with this in mind, as you settle into your easy chair, after that second helping of bacon-infused smoky turnip greens and buttery cornbread. I know I will. Safe and Happy Holidays, to all! I’m off. . . .

Seems It’s Gotten Nasty, Between Gilead And Merck: With Allegations Of Crimes — Sovaldi® Patent Wars

November 24, 2015 - Leave a Response

Well, this is not something you run across every darn day. . . But first off — the caveats: I will offer no opinion on the merits of these claims or counter claims. I will simply report on them — from an entirely public court filing, in the federal District courthouse, in Delaware — just this very morning.

Secondly, it is very hard to infer very much, here — since the documents in question are largely blacked out (redacted), at the key passages.

However, it is plain that Merck’s counsel is at least alleging that the e-mails Gilead seeks to “claw back” — ones that Gilead claims were inadvertently produced (in an earlier backgrounder of mine, here, as early as May of 2015) — concern a predecessor to Gilead offering instuctions “made for an improper purpose and in furtherance of a crime or fraud. . . .” In plainer English, then, the claim is that an agent for Gilead’s prior entity was trying to deceive the patent authorities, and apparently trying to do so, about Merck’s allegedly earlier prior art. But that last little bit is really a guess.

I attach here a PDF of the whole four-page letter, with all redactions, so that my readers may judge for themselves — but this fight has suddenly turned especially nasty. [Editorial note: in the syntax of that letter, Idenix is the prior entity in interest, to Merck, here.]

We will, of course, keep you posted as this develops — and will update if/when the court in Delaware rules on the clawback motion, proper. But that is. . . just ugly, IMHO — as the truth sometimes. . . turns out to be. I’ll have a more sunnily-themed post tomorrow, I am sure. Onward.

“Pfilergan” Update: “Execution Risk”? In A Flat Market, BOTH Target And Acquiror Fell Significantly — Announcement Day

November 23, 2015 - Leave a Response

Of course the strong declines could be chalked up to a variety of external events — but a falling overall market today won’t be one of them. We may also safely eliminate a “pre-deal” run-up in either name — for there wasn’t one. Finally, I’ll note that it is highly unusual — for a deal of this size not to see at least one of the two participants’ stocks show at least a modest pop — on announcement day. [Fancy that, Mr. Read. . . .]

Personally, I do see some real “execution risks” to getting this deal done — on anything like the terms announced today (and at the projected correlative synergy values). And so it is at least possible that the 3.44 per cent decline in Allergan’s stock, and the 2.64 per cent decline in Pfizer’s, reflects a discount — which I’ll label an execution risk discount.

I went out on a limb last night, and guessed that the election year US tax howling will — in one way or another, eventually strip most of the tax inversion benefit away from this deal. I think the broader market thinks that, now, too.

In prior widely-reported remarks, Mr. Read had indicated that he would likely “still do” the Allergan deal — even without the inversion tax benefits — but he plainly also said it would be “at a different [i.e., lower] value.”

Some version of that event risk — coupled to at least some antitrust risk, globally, may well explain today’s trading in these two now floating merger arbitrage stocks. Enjoy your pre-holiday cooking nights, one and all. . . Onward!

“Pfilergan 2016”: I’ll Go Out On A Limb, And Bet That The Inversion Aspect Of This Deal Will Be Scuttled

November 22, 2015 - Leave a Response

With unnamed sources reporting tonight that Brent Saunders will secure an integration-related role, and perhaps be in line to take Mr. Read’s seat, one day. . . I imagine the respective boards are in fact meeting tonight.

If that turns out to be true, I’d look for a doozy of an early 2016 tax policy fight here, in the US. No one currently running for President will be happy with Mr. Read’s move. Of course, we may safely except the current shareholders of Pfizer — from those who will howl — but not many more. And, as I will make plain in some later post, when I have more time, Mr. Read grossly overstates his US tax burden, largely for the purpose of forcing the inversion discussion. But as I say, more on that, some other day — if and when a deal is announced formally.

[UPDATED: I’ve just made my whimsical suggestion, at left, for the combined entity’s logo.] Here is the New York Times, on the latest rumors:

. . . .The boards of Pfizer and Allergan are set to approve a merger of the two companies worth more than $150 billion, people briefed on the matter said on Sunday.

A merger would create a huge new pharmaceutical giant and could potentially help Pfizer lower its American tax rate.

Directors of both companies were expected to vote on the transaction Sunday, with an announcement expected as soon as Monday, the people said, noting that final details were still being settled and the timing could change.

Under terms of the proposed deal, Pfizer is expected to pay 11.3 of its shares for each share of Allergan, the maker of Botox, which has its headquarters in Dublin. The transaction would also involve a relatively small cash component.. . .

Wondering if there will be some official word — smoke signals, or other — tomorrow. . .on this, and another topic? Smiling, just the same. . . sleep soundly, like little round river rocks, one and all!

Liberia Reports First New Ebola Cases In Three Months

November 20, 2015 - Leave a Response

Sad and surprising news to report — from Africa: even as Guinea has begun a “disease arrested” countdown to December 18, 2015 (according to W.H.O.), a surprise Ebola infection case — this time, of a ten year old boy — appeared literally overnight, in Liberia. UPDATED: two of his family members are also infected, according to New York Times reporters — in tomorrow’s print edition. That brings the new total to three.

In one other shining bit of good news, though — Sierra Leone remains disease free.

It is — as with all epidemics — two steps ahead; one back — but the trend is clearly encouraging. From this morning’s New York Times, then — a bit:

. . . .Three members of a family in Liberia have contracted Ebola, two months after the country was declared free of the virus, health officials said on Friday.

The first documented case in the family was a 10-year-old boy who started showing symptoms last week, said a Liberian health official, speaking on the condition of anonymity.

After attending school on Monday and Tuesday, the boy was admitted to a hospital and was transported to an Ebola treatment unit on Wednesday, the official said.

The boy’s test came back positive on Thursday, as did subsequent tests for his father and a sibling, the official said, adding that at least seven health care workers may have treated him without the protective equipment essential for Ebola cases.

The World Health Organization declared Liberia free of Ebola on May 9, but a resurgence of the disease the next month sickened four people, two of whom died. The country was declared Ebola-free again on Sept. 3. . . .

My recent Liberia backgrounder here. As with all difficult, but life affirming scientific endeavors, we remain optimistic, and confident: new life — new hope — will. . . inexorably prevail. Onward, toward a holiday-shortened next week. Do treat one another well.

Twin Updates — In Delaware, and Northern California — Regarding Merck Vs. Gilead Sovaldi® Patent Litigation

November 19, 2015 - Leave a Response

First off, in a pair of sealed letters (only the titles of which we may view — from the electronic PACER docket screens), we learn that the parties are now fighting over some emails that were allegedly inadvertently turned over in discovery. It seems that Gilead earlier turned over a cache of emails to Idenix/Merck, and now their lawyers want them back. One letter seeks to “claw back” the would-be errant emails, while the second (predictably) seeks to prevent that claw back order. We may never know what these emails actually said, but we will eventually see whether the claw back is allowed, in a public order entry.

Separately, on the other side of the nation, the date and time for motions to compel witnesses to answer — partly on those vials we discussed last month — have been reset to late in the day, Pacific time (Gilead’s reply was here). They will be heard in an after-hours session, on December 1, 2015 — in San Jose’s federal District Courthouse. I suspect the 4:45 PM PST start time is to allow for the court room to be cleared, as some of this will surely involve trade secrets, and arguments about those secrets. I’d expect that the hearing might last until nearly 8 PM, Pacific Standard Time, that evening. We will report on the outcome of both of these matters, when the electronic docket is updated. Here is the text of the california one:

. . . .CLERK’S NOTICE RESETTING TIME ON DECEMBER 1, 2015 MOTION HEARING, resetting time as to [156] MOTION to Compel regarding Dr. Alexander Clemens and [158] MOTION to Compel Plaintiff and Dr. Seeger to Comply with Discovery Requests and Subpoena: 12/1/2015 10:00 AM Motion Hearing is reset to 4:45 PM (SPECIAL SET) in Courtroom 5, 4th Floor, San Jose before Magistrate Judge Paul Singh Grewal. . . .

Now you are right up to date, on the Sovaldi® patent spats. Onward!

“UN-Shrug-Worthy?” Bloomberg’s Gadfly Blogger Takes Old Line Big Pharma To Task, Too — On Pricing

November 18, 2015 - Leave a Response

This is but one of the stories I missed mentioning, while otherwise occupied earlier this week. It is a meta-narrative line I’ve written about countless times before, over these past seven or so years (that linked one considers the “moral suasion” angle). But here was the latest, along these lines, from last month. It is a timeless, intractable and yet ever-current topic, no doubt. Sort of like I don’t know. . . birth, death and. . . taxes.

The latest voice in this particular meta-narrative arises from a self-styled “gadfly blogger” at Bloomberg, who has added to the din — on pricing — in a pretty rational fashion, to my way of thinking. Do go read it all, but here is a bit:

. . . .[P]rice increases on older drugs are an essential profit driver across the industry. Last year, according to Credit Suisse, 80 percent of net profit growth among 20 of the largest companies came from price increases. Merck has raised prices on 38 brand name drugs this year and Pfizer on 133. Last year, driven in large part by a new generation of Hepatitis C drugs, U.S. drug prices rose 13 percent, the biggest increase in a decade and far, far ahead of inflation. . . .

Most executives seem to assume that nothing in the way of legislation will come of all this fuss in the end. “I think you have to separate a little bit of the rhetoric and the newspaper reports from the fact that I think there’s a lot of rationality in public policy,” Merck’s Frazier said on the earnings call.

Translated? I talked to the folks in Washington, and they’re not really going to do much of anything. . . .

I suspect Mr. Frazier is right — even when Mrs. Clinton is elected as. . . No. 45. But the blogger above does have a point: a price spiral always — always! — breaks at some point; usually violently, often precipitously, but without fail in a capitalist system as ours is — that day is. . . coming. Sleep well, one and all!

UBS Analysis: Merck, AbbVie Next Gen Hep C Candidates (Due in 2016) Not Likely A Big Threat To Gilead’s Franchises

November 18, 2015 - Leave a Response

So sorry. Oh my. I’ve been busy elsewhere in the world, so forgive the delay in postings. . . with a little luck, I’ll be back on track after Friday.

UBS analysts are being quoted in a Forbes blog — from the floor of the AASLD, just wrapping — but do go read it all:

. . . .Based on the C-CREST eight week data, we think Merck has to go to tweleve weeks to get to high SVR’s across genotypes. We see the (Merck) Graz/Elba doublet as less of a threat considering expert questions on persistent ALT elevations, and poor performance in patients with baseline RAVs. AbbVie’s next-gen looks good thus far, albeit in easier patients. In contrast, Gilead’s ASTRAL dataset was a shock-and-awe campaign with very high SVR’s across all six genotypes, including decompensated cirrhotics. This sets a much higher bar for next-gen regimens, which at some point may need to show non-inferiority to gain FDA approvals (as seen in HIV). . . .

Seamus Fernandez at Leerink Swann sees Merck with a shot at being No. 2 in the next gen Hep C space — taking the seat now held (current gen) by AbbVie — for what that is worth. So — now you know! Onward, on a busy working week. Be excellent to one another. . . .


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