Gilead’s Q1 2016 Results Show The Stress-Effects Of Merck’s Hep C Pricing Move. . . .

April 28, 2016 - Leave a Response

After market close today, Gilead reported Q1 2016 results — and its flagship Hep C cure franchise showed the corrosive effects (on reported — i.e., post discounted sales revenue) that the entry of a low-priced competitor — like Merck (as of January 2016) engenders. [Backgrounder, here.]

Were I a betting man, I wouldn’t expect that all of Gilead’s loss will become Merck’s gain. That is not how price cutting in the pharmaceuticals markets works out. Merck too is likely discounting off of its list price, and so too palinly is AbbVie. All of them could see some flagging — due to the move. But in truth, a price cut was Kenilworth’s only real play to get some form of toe-hold, in what had been Gilead’s pretty much air-tight space, for at least six quarters running. Here’s The Wall Street Journal reporting tonight, on it all:

. . . .In the first quarter, Gilead said sales of Harvoni, its newer treatment, fell 16% to $3.02 billion. Analysts were looking for $3.15 billion, according to FactSet. Meanwhile, Sovaldi sales jumped 31%, to $1.27 billion, but the increase fell short of expectations amid soft European markets. Analysts had projected a 34% rise in Sovaldi sales to $1.30 billion.

Gilead is facing growing competition in the booming hepatitis space. During the quarter, pharmaceutical giant Merck & Co. launched a new treatment that costs 30% less than rival drugs and comes in the form of a once-daily pill. Meanwhile, AbbVie Inc. markets Viekira Pak, a competing and similarly costly treatment it launched in late 2014. Gilead has managed to protect much of its market share, but analysts have cautioned that pressure is heating up. “People are worried about the hepatitis C market,” said RBC analyst Michael Yoon. “Prices have gone down [and] there’s increased competition,” he said. . . .

As ever, we will let you know whether this Gilead overall revenue miss was “a canary in the coal mine,” as to Merck’s Q1 2016, at least in the in Hep C space — as well. But Merck should show pretty robust growth in the immuno-oncology space — even as it trails BMS, in second, there. That is still a huge pile of reveune, rolling in. As are all of these franchises, in truth. And so. . . Onward.

Smith, et al. v. Merck — We Mention This Solely To Complete The Record. . . .

April 28, 2016 - Leave a Response

Ed Silverman, that fine gent long writing Pharmalot, now over at the Boston Globe’s STAT, first reported early this morning on this item. Nice scoop!

The federal District Court sitting in New Jersey has allowed the Smith FMLA opt-in case to proceed, on a conditional certification of class status basis, in an 18 page opinion, overnight. From Ed’s item, then:

. . . .The lawsuit, which seeks [at least] $250 million in damages, alleges the drug maker systematically discriminated by paying the reps less than their male counterparts, denying them promotions, and subjecting them to sexual harassment. The lawsuit also claims pregnant employees were often pressured to leave. . . .

That is the allegation, anyway. We first mentioned this almost exactly three years ago. So, this will help keep the record here current. We will (once again) return to quietly monitoring this lititgation. Onward, with a son due in town shortly. . . smile. . . .

Merck Union Woes? With No Deal In Sight, First Seven Days Of Pickets Scheduled — USW Local #10-86 West Point, PA Facilities

April 27, 2016 - Leave a Response

Late on Wednesday evening, the USW Local 10-86 web site was down for a bit of updating; when it came back online, the first week’s picket duty rosters (starting Sunday, May 1) were set forth — in a 42 page PDF file. [Last backgrounder here.]

There was a rally again yesterday, but it appears that no overall deal for a new collective bargaining agreement yet exists. So the first seven days of picket-line assignments are now posted.

And that is unfortunate for all concerned parties — but especially for the families that depend on Merck facility wages and benefits.

I’ll keep a good thought, here — and hope that calmer heads prevail, a strike is averted (and talks continue), and that work continues, even without that contract finalized — at the facility.

Now you are right up to date — g’night to all of good will. . . .

Wellcome Trust/Merck Venture Now Enters Phase II With Heat-Stable Rotavirus Vaccine Candidate

April 27, 2016 - Leave a Response

It is hard to overstate the importance of having a vaccine that is heat-stable and lyophilized (in a powdered form, for transport), in the developing world. Getting sterile water to re-constitute the vaccine — on the ground, at point of delivery, is far easier than perserving refrigeration for finished dosing vials — in these mostly remote and often tropical climates.

As the WHO map at right indicates, rotovirus is a vast burden (especially among toddlers) in India, and Africa. One of the chief barriers to safe and effective administration of the current vaccine stock is the need to refrigerate the vaccine — all the way to delivery. As many a prior viral epidemic has taught us, maintaining refrigeration of a liquid vaccine stock, in Sub-Saharan Africa, or in southern India — all the way to point of delivery — is a highly daunting endeavor. This portends a game-changing moment, then.

This Hilleman Labs venture, with MSD (that’s “our” Merck’s non-North American arm) and the Brits’ Wellcome Trust — is potentially a huge leap ahead, in preventing rotavirus in the developing world. Still a fair stretch to go yet — but here is a bit from the press release, overnight:

“. . . .Since beginning our collaboration with Hilleman Laboratories, we have been closely monitoring the development of both the rotavirus and cholera vaccines. We are now thrilled to get an opportunity to translate research into preventable treatment. . . .”

Lauding the Indian government’s efforts to reduce child mortality by including rotavirus vaccines under the Universal Immunisation Programme, Dr. Gill added, “This is a welcome step taken by the government of India. However, high dependence on cold-chain for vaccine preservation, is a major gap in the delivery system. With our heat-stable rotavirus vaccine, we aim to further support the government’s efforts of expanding coverage and reducing child mortality. . . .”

Rotavirus is the leading cause of severe diarrhea and death among children less than 5 years of age, 90 per cent of these deaths occur in developing countries. According to the ministry of health and family welfare, nearly 80,000 to 100,000 children in India die annually due to rotavirus diarrhea while nearly 900,000 children are admitted to hospitals with severe diarrhea. . . .

And so, as I write this morning, I have upper-most in my mind these children — millions of them — who will live on, if and when this new vaccine becomes available, globally — at an affordable price point. And that is the goal of this venture. Kudos, anew — to Kenilworth. And I am. . . smiling.

Several New (Improved) Features In KaloBios’ Chapter 11 Exit Plan — DiP Financing Auction Tomorrow In NYC

April 26, 2016 - Leave a Response

[This is cross posted (with monir edits) from the KaloBios bankruptcy site.] Overnight, KaloBios filed a major amendment to the Plan and the related Disclosure Statement (that’s a link to the red-lined amended statement, a  1 MB PDF — hefty; not for tight, small bandwidth connections).

I’ll have much more, on other aspects of the re-negotiated exit plan in future posts (over there), but the PIPE group has struck an enhanced preliminary deal, in negotiations with KaloBios and the DiP lender group, likely in order to secure a favorable vote (as to the Chapter 11 exit plan, from the so-called Class 4 claimants — a/k/a the PIPE-ers), thus:

. . . .If Class 4 Accepts the Plan, then the PIPE Claim of each Holder of a PIPE Claim that has Accepted the Plan will be Allowed and, on account of and in full and final satisfaction of such Allowed PIPE Claim, such Holder will: (i) retain the Existing Common Stock purchased by such Holder in the PIPE Transaction; (ii) receive (a) its pro rata share of [277,608] shares of Remaining New Common Stock [and (b) reimbursement of reasonable, documented attorneys’ fees incurred in connection with the PIPE Litigation up to $250,000 in the aggregate among all Holders of PIPE Claims that have accepted the Plan]. The number of shares of Remaining New Common Stock allocated to each Holder of an Allowed PIPE Claim shall be in a 1:1 ratio of the number of shares purchased by the Holder of such Allowed PIPE Claim in the PIPE Transaction. . . .

So, the PIPE group, should they support the plan, will get to keep all the original December 2015 shares bought, plus split up to an additional 277,608 shares (that used to be around 163,000 shares — or, a 70 per cent increase over last offer), upon exit. And tomorrow at Noon EDT is the auction, for DiP Secondary Plan financiers, at Hogan Lovells’ offices in New York City.

Do go see the latest filings at Prime Clerk. More later today — much more (at the KaloBios Chapter 11 site). Onward, into a gray Tuesday — with only the Predators still in the Stanley Cup hunt. . . smiling, just the same.

Updating The Status Of The Keytruda® Vs. Opdivo® Dueling Federal Patent Suits

April 25, 2016 - Leave a Response

It has been over a year since last we mentioned these series of federal suits over whether any of Merck’s pembrolizumb manufacturing and marketing violates patents held by BMS. About ten days ago, Merck filed another suit, this time in the federal District Courts in New Jersey, to have the BMS patents declared invalid, or non-infringed, by Kenilworth’s pembrolizumab. Here is that suit, as a PDF file. So, onward it rolls. . . as ever.

As to the older suits, here is the latest discovery minute entry, in the Delaware federal cases — these are not likely to reach a trial date before early 2017, in my estimation, now:

. . . .Minute Entry for proceedings held before Judge Gregory M. Sleet — Discovery Telephone Conference (#1) held on 4/18/2016.

Discussion on the issues presented in counsels’ joint letter agenda.


(Court Reporter Kevin Maurer.) Associated Cases: 1:14-cv-01131-GMS, 1:15-cv-00560-GMS, 1:15-cv-00572-GMS(mdb). . . .

At the end of last year, in the UK, the BMS patents were held valid — but the wrangling contiues there, and in much of the EU. Now you know — and. . . Go Blackhawks: 2-2! Post scriptum: Hawks are. . . Toast. Congrats to St. Louis. . . .

Pfizer Was Paying Lobbyists — On Anti-Trust Issues Specific To The Allergan Redomicile Proposal (Now Abandoned) — In Q1 2016

April 25, 2016 - Leave a Response

As I said before, due largely to the 2016 US Presidential election cycle, lobby spend is up quite a bit in this first quarter reporting, at most large pharma concerns — Pfizer plainly included.

I am highlighting the Pfizer Q1 spend here primarily to mention the company’s focus (through lobby firm Brownstein Hyatt Farber Schreck, LLP) on anti-trust lobbying specifically targeted at the now scuttled “Pfilergan” merger/redomicile transaction. I long suspected (and last-speculated, in December of 2015) that antitrust issues were likely to be pretty daunting in the US, on that proposed deal. That now seems plainly true, with the benefit of actual lobby-spend disclosure hindsight. Of course, the second reason I write on this topic, is simply to mention that as is almost always true, Pfizer outspent Kenilworth on lobbying in DC. Now you know — here is a bit of the detail from Pfizer’s Q1 2016 spending reports, now on file with the US Senate disclosure office:

. . . .Patent Troll Legislation. . . .
21st Century Cures Initiative; Senate Innovation Project; Drug Pricing; Biosimilars Reimbursement Policy. . . .

Medicare Rebates/Medicare Part D; Non-Interference; Medicare Part B Reimbursement; Medicare Part B Demonstration Proposal; Medicare Part B CMMI Demo. . . .

Deferral; Comprehensive Tax Reform; Territorial Systems; Patent Innovation Box; Cadillac Tax; Inversions. . . .

International tax policy, including inversions; Trans Pacific Partnership (TPP) negotiations – Executive Branch action re this issue; Miscellaneous tariff bill; Customs reauthorization conference report – HR 644, Trade Facilitation and Trade Enforcement Act of 2015. . . .

Antitrust issues associated with proposed merger between Pfizer and Allergan. . . .

Omnibus Appropriations Bill. . . .

Out for a bit — to enjoy a perfect Spring midday walk now, will wander by NFL Draft HQ — big fun, there. . . smile.

Update: After Three Days Of Merck/USW #10-86 Local West Point Contract Negotiations

April 22, 2016 - Leave a Response

There is still no agreement on several of the key issues, including 12 hour workdays, outsourcing and part-time workers, among others (just as our earlier anonymous commenters had suggested).

We will keep you posted, but here is the latest from the USW local’s website, late this afternoon:

. . . .Local 10-00086 just completed three more days of negotiations, April the 19th, 20th and 21st. Conversations continue and are at times “passionate.” We did reach two tentative agreements (TAs); one on Safety Committees and another on Inter-Plant Transfers.

However, major proposals, such as Outsourcing/Subcontracting, Premium Pay, 12 Hour Shifts, Part-time Workers and others still remain on the table. Next week we move into the final week of our collective bargaining agreement.

Remember, with the continued support of membership, we will bring home – A FAIR CONTRACT. . . .

Indeed. Sleep well, one and all!

Gilead Has Renewed Its Motion To Invalidate Merck’s Patents On Sofosbuvir

April 22, 2016 - Leave a Response

No surprises here, but as post-trial motion practice, proper, wraps up in the Northern District of California’s federal courthouse, before the very able Judge Labson-Freeman — on the Sovaldi®/Harvoni® patent battles — Gilead has renewed its post bench-trial motion for a ruling that (as a matter of law) Merck’s patents are invalid as (i) merely derivative of other prior art, or (ii) due to prior invention by others.

It will be a bit yet before the briefs are all filed, but as I’ve long said — it is very far from certain that Merck will ever see even a portion of the jury’s earlier award, in this litigation. Here’s the bit, from an overnight electronic filing available in PACER:

. . . .Gilead requests judgment that U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to derivation under 35 U.S.C. § 102(f). Gilead further requests judgment that U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to prior invention under 35 U.S.C. § 102(g). In the alternative, Gilead seeks a new trial on whether U.S. Patents Nos. 7,105,499 and 8,481,712 are invalid due to derivation and prior invention. . . .

As another work-week draws to a close, do go home, and be excellent to one another. Colorado family in town, so much fun ahead. . . smile.

Federal Propecia® MDL Status Conference — In About A Week’s Time

April 21, 2016 - One Response

Not much more additional detail is electronically available, but there will be a status update next week, on Wednesday.

I guess the update will cover (i) discovery progress, and (ii) how the 50 or so bellwether trial selection pool fact sheets are progressing. Those are now due by the first week of May. The initial case pool lists should be complete by May 27, 2016. Here’s the minute entry, in full, from yesterday:

. . . .Set/Reset Scheduling Order Deadlines:

Status Conference set for April 27, 2016 — 02:30 PM in Courtroom 322 North before Magistrate Judge Peggy Kuo. . . .

Onward. Sleep tight all of you — still stunned and saddened, that Viator is traveling out of the Cosmos now (hoping that the salacious Fox News reports are untrue). . . As ever, tomorrow will be a better day.

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