Wednesday, October 7, 2015

Diabetes Patent Wars In India: Glenmark's Copycat Enjoined; MSD Prevails

As we have repeatedly noted, MSD India (that's Merck's ex-US naming convention, for its in-country operating subsidiaries) had long ago (circa April 2011) struck a deal with Sun Pharma to eventually make an "authorized generic" of sitagliptin in India.

And so, even as Glenmark completes the sell-off of its existing inventory, Merck is unlikely to benefit much from the India High Court ruling, entered overnight, New York time. Most analysts estimate that Glenmark still has a month's worth of inventory it is allowed to sell -- and then the lower priced Sun authorized generic will take the lead, on low price alternatives to Januvia® and Janumet® in India.

From the Business Standard, in any event then -- the operative bit:

. . . .According to reports, the Delhi High Court today, 7 October 2015, restrained Glenmark Pharmaceuticals from manufacturing and selling its anti-diabetes drugs Zita and Zita-Met, saying it has infringed patent of US-based Merck Sharp and Dohme.

Justice A K Pathak reportedly said that in view of the finding returned on the issues, Glenmark Pharmaceuticals is restrained by decree of permanent injunction from making using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone, or in combination with any other drug, thereby infringing patent of plaintiff (Merck Sharp and Dohme). . . .

I should mention, in passing, that MSD sells its branded products in India for about one-fifth of the US price -- and the generic will be about a third less than that, in country. [See our earlier pharma pricing discussions, in comments.] Onward, then -- with so very much to be grateful about. So much -- Happy Birthday, Tim & Pete!

Monday, October 5, 2015

A Merck Nobel Prize -- For River Blindness Cure; Pacific Trade Pact Reached

Delivered in round-up fashion -- the bigger news first: Dr. William C. Campbell (depicted at right), during a 33 year Merck career as a bio-science researcher (since retired), along with two others, has won a Nobel Prize in Medicine -- for work on Ivermectin, the drug largely responsible for nearly eliminating river blindness in sub-Saharan Africa. Kudos!

In addition, as we mentioned late on Friday, the Trans-Pacific Trade treaty has this morning been agreed by all involved nations. Now begins a 90 day waiting period in the US, while Congress studies the pact. Then (because Congress cannot prevent it), Mr. Obama will sign it.

Here is the bit on Dr. Campbell -- via the Gray Lady:

. . . .William C. Campbell and Satoshi Omura won for developing a new drug, Avermectin. A derivative of that drug, Ivermectin, has nearly eradicated river blindness and radically reduced the incidence of filariasis, which causes the disfiguring swelling of the lymph system in the legs and lower body known as elephantiasis. . . .

So much is new -- and to be hopeful for -- just as though new life. . . is arriving. Onward!

Sunday, October 4, 2015

More On Drug Price Increases -- "The Rule, Not The Exception" -- Unfortunately. [Now IMPROVED With. . . Tech Industry Analogy!]

At the outset, let us recall that Apple is NOT pharma. Apple has tended (for the last five or so years) to hold prices steady, even as it delivers vastly improved capabilities in each iteration of its newest product. Let us also recall that no one will die, if they don't use the Apple specific product. They can "limp along" -- with a Samsung or HTC. [Ironic content fully-intended.]

So, perhaps it is unfair to draw parallels between tech pricing, and pharma pricing. But each industry asserts that a vast R&D expense line is needed to stay competitive. I think we all agree that is true. What happens above that expense line (at the sales revenue/pricing line), is where they differ most significantly -- for the purposes of this post.

That is to say. . . what strikes me most, here is not the randomly obscene Valeant and Turing price increases -- but the idea that pharma wide, prices on mid-stream, older drugs are rising -- in double digit percentages, year after year. In many of these cases, patients will either grow very sick or die, without the now well-vetted drugs. And pharma raises prices. It does so until some generic competitor is able to get to market and undercut them, usually, all at once. But that "frictional" often three to five year price climb, at or very near the end of a drug's patented life -- is more the rule than the exception, as a pharma pricing strategy.

And so (with technology industry examples in mind), it is high time to ask -- why should we as a nation of consumers tolerate that? Apple knows keeping the customer is the best profit inducer. So, keeping the patient "on med" ought to be the number one priority of pharma. To be clear, I don't think government price control (via legislated price mandates) is the answer.

No, I think free market negotiating -- BETWEEN the government, and the drug companies (i.e., repealing the Bush 43-era no-negotiating legislation stance) -- on Medicaid, Tri-Care and the analogous program payers' drug purchasing contracts, is the answer. Clearly private insurers and prescription benefit management companies are negotiating -- and negotiating hard. [Which is why some argue pharma must be free to charge the government payers -- without negotiations. I disagree. The math doesn't bear it out.]

We often hear WSJ pundits extoll the free market mechanism. It is time to let it work -- on drug pricing. Here's the snippet of the NYT article that put me in mind of making this point, this morning -- over hot coffee, fresh orange juice, yogurt and a banana:

. . . .[W]hile more conventional [drug] companies do not typically triple or quadruple prices overnight, they do often raise them year after year at a rate far faster than inflation. Big pharmaceutical companies like Pfizer and Merck raised list prices an average of 13 percent in 2014 and 8 percent so far this year, according to Deutsche Bank. . . .

Inflation is barely two per cent, as experienced by consumers overall this year, and less if we fully load the decrease in gasoline prices into current estimates. Compare that to 13 per cent increases on drugs, on average. So -- as I wrote last weekend, over my coffee -- smaller versions of the Shkreli scenario are the rule, not the exception. And as I wrote, both he and Saunders learned these tricks from Fred Hassan. It is the rule -- not the exception. And only a free negotiating market will curb it effectively. Legislation cannot. Here endeth the sermon.

Saturday, October 3, 2015

A Shortfall In US Public Funding Is Not Co-Terminous With "Pharma" Prevention Of Life Saving Drugs. Period.

I don't want to overly belabor the point, but this very well-educated Upshot editorial commenter waits until paragraph 14 of his 16 paragraph essay to acknowledge that perhaps -- just perhaps -- not-for-profit, public-funded, or academic basic science programs should bring unpatentable (i.e., unprofitable) medicines and drug candidates to market -- with yes, public assistance.

[Shareholders of for profit companies, on the other hand, expect. . . (gasp!). . . profits. And pharma profits flow from. . . patents. This is a point not mentioned by the commenter.]

While pharma could always donate more to such efforts, and pharma is very profitable, it is largely nonsensical to suggest that the companies "prevent" unpatentable tech from reaching market. And it is near-lunacy (in my estimation) to suggest that for profit companies be given patent like monopoly periods on such basic, obvious drug candidates, solely to hasten them to market. [Witness Mr. Shkreli's various exploits, here.] So, the entire essay needs rethinking in my view -- but here is the bit where he starts his slide. . . sideways:

. . . .By granting temporary monopolies to innovators, the patent system is widely credited with protecting and promoting innovation. But when it comes to pharmaceuticals, it may be preventing valuable therapies from coming to market. . . .

Now you know: granting pharma ever more profit opportunities by monopolies at law (even shortish ones), isn't the right answer to a shortfall in basic public investment in public science -- even obvious science. [There are, of course, other cases -- where pharma arguably delays or prevents life saving medicines from reaching market -- but these are not those cases.] Onward, on a gray Saturday here. . . but smiling just the same. In short, Prof. Outterson is right.

Friday, October 2, 2015

A Breath Of New Life -- For A Possible Trans-Pacific Trade Accord? Could Be Good For Pharma. . .

Back in July of 2015 -- and earlier, in June -- we offered our perspective here on what such a pact might mean for US drug companies that compete in the Pacific Rim. Do read those. This is a complicated topic, with policy puts and takes, on all sides -- and it covers everything from autos to technology goods. But pharma/biologics have long presented a particularly vexing set of trade issues.

And so, by late July, the talks had ended without an accord -- or even a framework, for reaching one -- in no small part due to the pharma/bio related issues. Chief among the sticking points was the US's insistence on a 12 year biologics IP protection/exclusivity period. Well, tonight we read (courtesy of the New York Times) that there may be an eight year compromise afoot. It is my view that US multi-national drug companies would fare better, in the main, under an eight year compromise on biologics IP data exclusivity, than to leave 2015 without an accord, at all. [With 2016 ushering in a full-on presidential election cycle, with protectionism looming as a key issue (on all sides), I think 2015 is the last best opportunity for several years.] I suspect both BiO and PhRMA see it that way too -- and will end up agreeing -- after some gnashing and wailing. Still, a deal is far from certain, but this is a rather hopeful moment (again quoting The Gray Lady):

. . . .[Mr. Obama's U.S. Trade Representative Michael] Froman was particularly embroiled on Friday in trying to settle the pharmaceutical drug issues. The most vexing question was how long drug companies can have exclusive rights to data related to their development of so-called biologic drugs (products made from living organisms and considered promising for cancer treatments) before they must share the information with generic manufacturers.

The United States, which had insisted on 12 years to ensure drug manufacturers have incentives to innovate, recently proposed an eight-year provision as a compromise. It would give companies five years of exclusive rights followed by a three-year period of limited market sharing. . . .

And so. . . "Hope is a good thing. In fact, it may be the best of all things." Hope -- of new life. Smile. G'night.

About Seven Months Behind BMS, Merck Likely To Receive A Preliminary Nod, For NSCLC FDA Label Expansion Tonight

UPDATED: The full Commission just granted immediate approval -- so Keytruda® is now authorized for NSCLC. End, update.

Just as we predicted, Merck is now about seven (per our cogent and erstwhile anonymous commenter -- thanks!) nine months behind BMS's Opdivo®, in reaching approval for Keytruda, in the heavy burden of disease lung cancers. If all goes well, this afternoon, Merck will be on market, on Monday is about a month from market.

Assuming that FDA follows its normal course, and the staff recommends the accelerated approval to the full FDA Commission, after the close of trading on the NYSE today, we should see an that an approval (label expansion, actually) is granted to Keytruda, for NSCLC, after non-response to platinum chemotherapy. in about a month. [My math was off, by one -- and the immediate full FDA approval cut a month from the lead, as well.] Should it materialize tonight, it will be good news for Merck, and will allow Kenilworth to beging to directly market the humanized monoclonal antibody to oncologists treating lung cancer patients, rather than relying on those oncologists to be willing to write "off label". I do expect that a fair amount of completely appropriate direct and independent "off label" scrip writing was already underway, by oncologists around the nation. In any event -- welcome news for Merck and its lately sagging NYSE stock price.

[Separately, I highly recommend catching "The Martian" this weekend -- I did, late last night -- and it was a great human interest treat; the sci-fi and amazing effects were. . . just a bonus. Onward!]

Thursday, October 1, 2015

Merck Propecia® (Finasteride) MDL Update: First Bellwether Trial No Earlier Than September 2017

Unfortunately, we are looking at two full years yet, before the first Propecia® MDL test case is opened, before a federal jury, here. That, according to the latest revised PPO No. 10, in this litigation. Yes, the pace of such litigation is decidely. . . glacial.

Now, in addition to setting the aspirational trial schedule, the first few pages of the order set a new certification procedure -- for all files Merck has turned over (essentially requiring Merck to swear that they are complete copies of the actual files). [Even so, no mention as of yet about what the very able judge will do regarding files withheld as privileged -- and no mention of what happened regarding the doctor/PI's clinical trials files.]

I'll attach the entire order, as an 8 page PDF affair, for those who wish to study the time lines (which lead eventually to jury trials), in greater detail. Here are -- to my eye -- the most salient bits, though:

. . . .The Parties will serve upon the other their respective Case Pool selections to fill slots in the initial Case Pool with the Court on May 13, 2016 at 5:00 p.m. Eastern Standard Time. Neither party may select a case for the Case Pool unless the Plaintiffs supplied to Counsel for Merck both: (i) substantially completed medical record authorizations (meaning authorizations for the prescribing physician, the primary care physician, and pharmacy records), and (ii) a Plaintiff’s Profile Form by no later than January 1, 2015. . . .

On September 30, 2016 at 5:00 p.m. Eastern Standard Time, each party shall file with the Court its proposal for three (3) trial cases from its picks among the Case Pool, as the first wave of Bellwether dispositive motions and trials (the "First Bellwether Tranche"). . . .

The Court anticipates that the First Bellwether Tranche shall be trial ready by September, 2017. The Court will issue a scheduling order governing all trial related obligations, including the specific date for commencement of trial, following entry of the Daubert Orders. . . .

So patience will indeed be a virtue here. [It has taken me about a week to get this posted. So sorry.] And as ever, onward we sail -- to see "The Martian" this evening, of course. Of course. Smile. . . .

Tuesday, September 29, 2015

O/T Kentucky Edition: It's All Over -- Except The Shouting, Now. . .

I'll note -- as I depart the office for the day -- that the State of Kentucky's latest salvo of responses to Kim Davis' completely baseless (and tediously repetitious) claims (those having been ginned up by Liberty Law) are now public record in the Eastern District courthouse.

What there appears is a state increasingly (and justifiably) frustrated by a George Wallace like refusal to follow the now-settled law of the land. Here's a bit of what we find (a 17 page PDF file), in the moving papers:

. . . .[A]ny liberty interest Davis might possibly have as a private citizen does not extend to her role as a governmental official. Even if KRS 446.350 were somehow to apply to Davis, it cannot apply in her official capacity as the Rowan County Clerk because accommodating her in the manner she suggests would amount to a violation of the [federal First Amendment] Establishment Clause. . . .

Davis asserts that had the Beshear Letter not been issued, the plaintiffs "would have had to sue Gov. Beshear (not Davis)" to obtain their marriage licenses. See Response at 14 (D.E. 123). This incredible statement demonstrates Davis’ stubborn disregard for the rule of law. Obergefell held that the plaintiffs have a fundamental right to marriage. Following Obergefell, they should not have been required to sue anyone in order to exercise that right. Of course, Davis ensured that was not the case in Rowan County. . . .

When an official such as Davis acts in her official capacity to perform an obligation imposed by law, she is acting as the government. Cf. Kentucky v. Graham, 473 U.S. 159 (1985); KRS 62.210 ("[t]he office of county clerk, rather than the individual holder of the office, shall be liable for acts or omissions of deputy clerks"). At issue here are marriage licenses issued by the Office of Rowan County Clerk and not Kim Davis individually, as Kim Davis individually has no authority to issue such licenses. The Office of Rowan County Clerk does not have a right to free exercise of religion. If government officials were permitted to exercise religion in their official capacity, such action would directly violate the Establishment Clause, which prohibits governments from favoring or promoting one set of religious beliefs over another. . . .

[Issuing a marriage license] is a ministerial act statutorily required of the Office of Rowan County Clerk. The issuance of a marriage license simply certifies that the couple satisfies the legal prerequisites for marriage. KRS 402.100. To the extent the issuance of marriage licenses constitutes speech, it is attributable to the government and not Davis. . . . [Even for argument sake, if we assume it was speech] "restricting speech that owes its existence to a public employee’s professional responsibilities does not infringe any liberties the employee might have enjoyed as a private citizen." Garcetti, 547 U.S. at 421-22. . . .

She has no standing. -- so true. Onward. Smile. . . .

"Some Days, This Stuff Just Writes Itself": Reprised From September 2009

Given the propensity of Mr. Shkreli to continue to damage his private company's brand -- and his own meager credibility -- in the last two weeks, I thought it would be useful to rerun my September 2009 piece -- on his "Godpharma" -- one fast Fred Hassan. Mr. Hassan did pretty much the same, by blogging -- in intemperate fashion -- in those days. Morever, the two were thick as thieves not long after this post -- as Hassan was investing in, and guiding the young Shkreli (albeit at his former company), according to numerous MSM published reports. So here it is, in full (I did update the graphic, a bit, though -- at right):

Some days, this blog just writes itself. Today is one of them, per the WSJ Health Blog:
. . . .Ever since Merck announced it was taking over rival Schering-Plough, inquiring minds have wanted to know: What will Schering-Plough CEO Fred Hassan do next?

Perhaps now we have a clue: Hassan is joining us bloggers, at least for some of his time.

In a Huffington Post piece, Hassan weighed in yesterday on the health-care debate, arguing that the discussion has unwisely ignored serious and long-term threats such as Alzheimer’s disease. . . .

The deal for the very-life of his company hangs in the balance. . . and he is off, blogging? Cool. I can FINALLY relate.

Credit for the original work on the fabulous graphic, at right, goes to "The Insider" PharmaGossip.

Overall, though -- sometimes, the truth is far stranger than anything we could make up. . . . This is one of those times, for dead certain (Kudos to The Insider!):

The music in that clip is (given the subject matter, to my ear, at least). . . soul-less, overwrought and sinister. . . perfectly evocative, of the 2015 -- and 2009 -- versions, no? Onward, just the same.

Monday, September 28, 2015

BMS -- And Opdivo® -- Well Ahead In Kidney Cancers @ ECCO 2015

Over the weekend (through to tonight), in Vienna, Austria, the ECCO (or European Cancer Conference) has been underway.

Just as we said it would, back in July 2015, BMS's nivolumab has pretty much turned out to be the belle of the ball. Advanced renal (kidney) cancer is generally a pretty dire prognosis. But on Opdivo®, such patients saw on average, two years of added survival time -- and that led researchers to end the study very early, and give all comers the study drug -- for obvious ethical reasons.

This doesn't mean Merck won't eventually get Keytruda® approved for kidney cancer -- but it does mean BMS is at least a year ahead. And it means that BMS is racking up lots of heavy burden of disease cancers -- as the likely first mover. Here's a bit from the New York Times, of Saturday:

. . . .[A] study of the drug nivolumab (sold as Opdivo), was stopped ahead of schedule because safety monitors found that patients receiving the drug were living longer than those in a comparison group taking the usual treatment, everolimus (sold as Afinitor). The study was halted for ethical reasons, to offer the comparison group nivolumab. . . .

Nivolumab belongs to a class of drugs called immune checkpoint inhibitors, which work by unleashing the patient’s own immune system to fight cancer. The new study included 821 patients with advanced kidney cancer. Half received nivolumab, and half everolimus. Of all who got nivolumab, 25 percent responded, meaning their tumors shrank significantly; only 5 percent responded to everolimus.

With nivolumab, the median survival was 25 months, compared with 19.6 months for everolimus. Patients taking nivolumab were also more likely to have lasting responses and fewer side effects like fatigue and nausea. . . .

Onward on a lovely fall Monday -- one on which liquid (albeit briny) water has just been found to be presently flowing on. . . Mars. And that makes some form of life. . . at least a slightly closer possibility, there. What a time we are privileged to be living in. . . . Whoosh!

Saturday, September 26, 2015

Even As PhRMA Declares "Shkreli Is NOT One Of Ours" -- It Elects A New Chief; Former Device Lobbyist Ubl

Earlier this week, both BIO and PhRMA -- likely sensing a PR disaster in the making -- openly disavowed Martin Shkreli. PhRMA declared that privately held Turning Pharmaceuticals, and Martin Shkreli, are not, and were not members, and "did not reflect" the trade group's "values or views." This was a wise first step, I think.

But now, PhRMA -- chaired through April 2016 by Merck's Kenneth C. Frazier -- has tapped a legendary medical device lobbyist (understated and pragmatic, is Ubl) to lead PhRMA through these almost certainly more widely-emerging US firestorms -- on pharmaceuticals pricing (even without regard to whether Hilary Clinton is ultimately able to win wider backing for price controls).

From the New York Times, overnight:

. . . .For the last 10 years, Mr. Ubl has been the top lobbyist for medical device makers. He has led efforts to persuade Congress to repeal a tax on medical devices imposed by the Affordable Care Act.

Mr. Ubl, 46, is well known in Washington for his deep knowledge of health policy, shrewd political instincts and low-key manner that sets him apart from many lobbyists.

His selection was announced by Kenneth C. Frazier, the chairman of Merck, who is also chairman of the pharmaceutical trade group.

Some people who have worked with Mr. Ubl said he might be open to pragmatic pro-consumer compromises, but some consumer advocates said he had not been receptive to their appeals for help in recent years.

Marc M. Boutin, the chief executive of the National Health Council, a coalition of advocacy groups for people with chronic diseases, said Mr. Ubl had been a strong ally. As a member of the council’s board from 2008 to 2013, Mr. Ubl helped patients influence the writing of the health care law and the way it has been carried out, Mr. Boutin said. . . .

Almost trivially, I'll note that a NYC punk rock recording label has also cut all ties with Shkreli (he was reputedly an early angel investor). I'm pretty sure he did not expect that following Fred Hassan's playbook would make him such a pariah. But it is 2007 no longer, friends. Health care reform is here to stay. How the world turns. . . Onward, with a grin. . . .

Thursday, September 24, 2015

"Bad Boy Du Jour" Shkreli? Just Fred Hassan's World-View -- Taken To Its Logical Conclusion. . .

You simply must read Matt Herper in Forbes this morning. He is 100 per cent right: sociopath. "Iconoclast"? I think not.

He has written the definitive take-down of the Turing CEO's latest 5,000 per cent price gouging. Go read it -- more in a minute -- but Matt's got this to say about that CEO's mentor/teacher, Fred Hassan:

. . . ."The only person I needed affirmation from was Fred Hassan," Shkreli told me during our first meeting. "So I asked [Hassan and Saunders] do you think I can do this? They said you must do this. We really want you to do this."

Saunders, who is now the chief executive of Allergan, says that the team chipped in to help Shkreli buy the technology [at his former company, Retrophin], but lost interest as Shkreli changed focused more on drug pricing. Saunders and another former Schering executive, Robert Bertolini, say Shkreli listed Saunders as a member of Retrophin’s board of directors on the company’s web site without, in Saunders’ words, "my consent, knowledge, or permission." Bertolini says Saunders was furious at the time, but Shkreli claims that Saunders agreed to be on the board but never finished any paperwork. . . .

That behavior matches Shkreli’s Internet persona. He’ll Tweet vulgar quotes from Wu-Tang Clan and Eminem songs, and he helped ignite the current controversy by calling John Carroll, the editor of industry news site FiercePharma, a “moron.” Shkreli claims he doesn’t care what the media or the public thinks, but he has an almost pathological need to respond to what is said about him, and lacks the good sense, so ingrained in most chief executives, to know when not to talk. . . . Whether Shkreli can keep doing his job with a giant target painted on him is an open question. . . .

And, to be clear, John Carroll is -- in my experienced opinion -- a smart, thoughtful and independent man. Too bad Shkreli cannot see that.

I've said it so many times before -- Saunders is (in my experienced opinion) just a milder version of Shkreli -- both taught their particular version of deal-craft skull-duggery, by Ex Schering-Plough CEO "Fast" Fred Hassan. His world-view leads to these abberant next-gen pharma CEOs. But at least the Turing CEO has now been definitively unmasked, thanks in no small part to Matt. [And to that CEO's own over the top idiocy.] How long until Brent is? That's a quesiton for the ages. . . [Fred pretty much has been -- and is. . . a has been.] Onward, in any event, on a lovely fall noon-time. . . .

Monday, September 21, 2015

Even With Good R&D News, JP Morgan Crimps Merck Price Target A Bit

JP Morgan is keeping Merck at an "Overweight" rating, but has trimmed its 12 month price goal, to $65 -- crimped from $68. You'll recall that Piper Jaffray made a similar move -- dropping Merck to a $60 target -- last week.

And yet, this comes amid good pivotal C. difficile clinical results, from Sunday. Add to this that this morning, Merck announced a wide array of new "hard tp treat" cancer programs data sets will be appear shortly -- for Kenilworth's pembrolizumab onslaught of programs.

Of course, the counter-argument -- on C. difficile treatment -- is that a capsule of purified stool sample is doing pretty much the same thing, in trials, at a potentially much lower price point. On pembrolizumab, BMS is a very strong first mover, with Opdivo®. And perhaps of the greatest near term importance, the Merck sitiglipin franchise is likely to be pressured by the Jardiance® home run data sets, into 2016. So it goes -- here's the bit:

. . . .Merck had its target price lowered by JPMorgan Chase & Co. from $68.00 to $65.00 in a research note issued to investors on Monday, reports. The brokerage currently has an "overweight" rating on the stock. JPMorgan Chase & Co.’s price objective would suggest a potential upside of 24.69% from the stock’s previous close.. . .

We will watch the horizon, here -- as ever. Have a great evening, one and all.

Sunday, September 20, 2015

Passengers Arriving In US From Liberia Will No Longer Be Screened For Ebola: CDC

I offer this as some additional encouraging positive proof that the current threat has passed -- at least as to the 2014 epicenter of Liberia -- which has been completely disease free, since September 3, 2015. U.S. Customs and other border authority agencies will no longer routinely screen arriving passengers from Liberia for the virus. Screenings will continue (at least for now), for passengers arriving from Sierra Leone and Guinea, however.

Here is the bit -- as reprinted by Time magazine's Monday edition:

. . . .Federal agencies have decided to end the mandatory screening for air travelers arriving in the U.S. via Liberia, effective Monday.

The Centers for Disease Control and Prevention (CDC) and Customs and Borders Protection decided to remove Liberia from its list of countries requiring additional screening, USA Today reports. The screening, in which travelers fill out questionnaires and have their temperatures checked, is currently conducted at five airports in the U.S. that service connecting flights from West Africa.

The World Health Organization declared Liberia, once at the epicenter of the Ebola outbreak, free of the disease earlier this month on Sept. 3. . . .

Onward, with a smile. . .on yet another perfect early fall Sunday -- here, in the City of Big Shoulders. . . .

Saturday, September 19, 2015

O/T -- Kentucky Marriage Equality Matter, Back In Judge Bunning's US District Court, Come Tuesday. . .

More in a minute, but it seems the intrepid County Clerk, Mrs. Davis, feels the certificates should now read "issued only pursuant federal court order" -- rather than the way they always did.

The state officials see this as a compromise, apparently -- as they suggest this allows Davis to clear her conscience. So, the state says they are still valid certificates. The ACLU suggests these changes may make the certificates of questionable validity -- after all, Kentucky law requires that county-level clerks issue them -- under local authority. And, the ACLU says, these changes are in arguable violation of Judge Bunning's order -- telling the Clerk not to interfere with the orderly certificate issuance process. Here's the full filing -- for the very able Judge Bunning's consideration come Tuesday, and a bit:

. . . .In fact, Davis has modified the marriage licenses currently provided by her office to state that they are issued only "Pursuant to Federal Court Order #15-CY-44 DLB". . . .

Additional material alterations made by Davis to the licenses issued by her office include requiring her clerk to issue licenses in his capacity as a "notary public" rather than a deputy clerk of the Rowan County Clerk’s Office. Id. See also Notice of Filing by Bryan Mason. [RE #114.] These alterations call into question the validity of the marriage licenses issued, create an unconstitutional two tier system of marriage licenses issued in Kentucky and do not comply with the September 3 Order prohibiting Davis from interfering with the issuance of marriage licenses. . . .

So -- we shall see. The notary public nonsense is of no moment -- in my opinion.

It is a closer question as to whether a federal court will order another change to the certificates, once the state officials have declared them valid (even if I hate that the Clerk once again has meddled, to manufacture this latest "showdown" -- between state and federal authorities). It is the duty of the clerk to simply comply with the law. Not clear her conscience. But I suspect this will be the end of it -- Judge Bunning may well just say "she's received too much attention, already. Her 15 minutes are. . . over". Onward -- Have a wonderful Saturday, one and all!

Friday, September 18, 2015

Propecia® MDL -- Slight Delay Until September 25, 2015 -- On Procedural Orders

Well -- we still have no hint about any outcome -- from the show cause hearing held September 10, 2015.

But this afternoon, we do see that the parties have been working to resolve their disagreements -- about the plan for amended discovery procedures, in view of the Court's order on, and observations about, the state of the privilege logs, previously submitted by Merck. So much so, that they need a short continuance to submit an agreed order. That order was due today; now it is due in a week (assuming the Court enters the continuance, as proposed).

While it seems unlikely, I suppose it is at least possible that this amended order will address whatever the issues were that radiated from the appearance of Dr. Imperato-McGinley, in court, last week. In fairness, I would expect that to be the subject of some separate order -- but we shall see. Here is the bit, from the afternoon's proposal for an order:

. . . .The parties are continuing to discuss certain terms of the amended Discovery Plan And Trial Plan Order (PPO No. 10) and requesting that the Court allow them to submit the Order on or before September 25, 2015. . . .

Thus we see that all things worth knowing take a bit in federal court. That will likely apply to the Imperato-McGinley documents (to the extent that there are any more) as well. Have a stellar weekend, one and all of good will -- big triathalon to take in, here!.

Thursday, September 17, 2015

As We Previously Predicted, Lilly's SGLT-2 Will Get A Boost, Even As Merck Hits Headwinds -- In Diabetes

Even as Merck was outlining its pipeline, and plans, at the Morgan Stanley confab -- in the diabetes management franchise -- it was actually Lilly's new SGLT-2 drug making the real waves today in that space.

Just as we had directly suggested in August, the cardio-protective side benefit of Lilly's Jardiance® may well cause a sea-change, among prescribers -- away from Kenilworth's Januvia®. Here is a bit of the Reuters item, of earlier today:

. . . .Sanford Bernstein analyst Tim Anderson more than tripled his annual sales forecast for Jardiance and combination drugs containing it to $2.7 billion by 2020. He cut his 2020 sales forecast for Merck & Co Inc's Januvia, the leading member of a competing class of oral diabetes drugs called DPP-4 inhibitors, to $6 billion from $7.8 billion.

Anderson estimates Jardiance could boost Lilly's earnings per share by 8 percent on average across 2016 to 2020.

In the study, patients taking Jardiance had a 38 percent reduction in cardiovascular death, including from heart attacks and strokes. There was no significant difference in non-fatal heart attacks or non-fatal strokes. . . .

To be sure, Merck will be fine -- with Keytruda® (in cancers) off and running, and more than filling the Januvia revenue gap, in years beyond 2016. But in the short term, it may prove to be a bit of a pinch -- at the revenue line, globally. Hooray -- it is almost Friday!

Wednesday, September 16, 2015

President Obama Makes An Excellent Choice -- To Lead FDA

We have long admired Dr. Califf (as the 2009-vintage graphic at right will attest). Overnight, our 44th President tapped him to lead the FDA -- where he's been serving as Deputy Commissioner, since Spring.

He is smart, fair, balanced and open minded. In short, a great pick. From the White House presser then:

. . . .President Obama announced his intent to nominate the following individuals to key Administration posts:

Dr. Rob Califf, Nominee for Commissioner of Food and Drugs, Department of Health and Human Services

Dr. Rob Califf is Deputy Commissioner for Medical Products and Tobacco at the Food and Drug Administration (FDA), a position he has held since March 2015. Dr. Califf has served in various capacities at Duke University School of Medicine and the Duke University Medical Center between 1982 and 2015. At Duke University School of Medicine, he served as Vice Chancellor, Director of the Duke Translational Medicine Institute, which he founded in 2006, and as Professor of Medicine. He also served as the Director of the Cardiac Care Unit at the Duke University Medical Center. He founded the Duke University Clinical Research Institute in 2006 and served as its Director. Dr. Califf also served on the Executive Committee of the Duke Health System. He has served in a number professional organizations, including committees of the Institute of Medicine of the National Academies (IOM), the IOM Clinical Research Roundtable, the IOM Committee on Medication Errors, and the IOM Board on Health Sciences Policy. He served on the FDA’s Cardio renal Advisory Committee from 1996 to 2000 and on the FDA’s Science Board Working Group from 2007 to 2008. Dr. Califf received a B.S. and an M.D. from Duke University. . . .

Onward, on a truly flawless morning.

Tuesday, September 15, 2015

Interesting Statements -- Back When FDA Approved Propecia® (Finasteride) For Hair Loss -- By Dr. Imperato-McGinley

Back when Merck originally sought FDA approval of finasteride for the indication of male pattern baldness, the doctor appeared at the Advisory Committee hearing and spoke for the company. [Merck by then already had obtained FDA approval for prostate enlargement, under the brand name Proscar® -- but baldness was a much wider market.] She generally noted the safety of the drug candidate for that purpose, and apparently made reference to her earlier work in the Dominican Republic. I mention this because that is what our erstwhile anonymous commenter was pointing to, in the cogent comment to my last post on this topic. Her statements to FDA, on behalf of Merck do make her a likely witness to these matters, in my estimation. So she is likely to be asked quite a few more questions, as discovery rolls forward. She ought to get used to it.

To be fair, though, the FDA still feels that sexual dysfunction is a relatively rare side effect. To wit, recently, the FDA has cleared an update to the finasteride label, and weighed in on these topics. From FDA then, a bit:

. . . .Q5. Do all men experience sexual adverse events when using Propecia or Proscar?

A5. No. Only a small percentage of men using these drugs have experienced a sexual adverse event. The frequency of sexual adverse events is best obtained from controlled clinical trials. Analysis of these controlled clinical trials showed that during treatment with Propecia, 36 (3.8%) of 945 men had reported one or more adverse sexual experiences as compared to 20 (2.1%) of 934 men who did not receive Propecia (received placebo).

Sexual adverse events associated with Proscar use were identified in two clinical trials. This information is included in the Proscar label. In one trial, these events were reported more frequently during the first year of treatment with Proscar as compared to men who received placebo. In years 2-4 of the trial, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder. . . .

It should be noted that the Proscar studies mentioned above generally involved much older men -- in short, men more likely to be on other medications which might mask the alleged off-target effects -- as those men might well already be experiencing sexual decreases -- even from the passage of time. The same was generally not true of Propecia candidates -- they tended to be younger and healthier, and so (the plaintiffs' argument runs) were more likely to notice and report any sexual side effects. We shall -- as ever -- see.

UPDATED: 1 PM EDT | 09.15.2015 -- To make the record complete, here is the full five page PDF of the November 19, 1997 Merck letter to FDA that our erstwhile anomymous commenter points us to -- and an image of the part I personally found most interesting, though the opinions of Dr. Imperato-McGinley are quoted a few other times, in that letter:

And still we have no idea what transpired on Thursday, September 10, 2015 -- in Brooklyn. There has been no update to the electronic record, through noon Eastern, here on Tuesday. So. . . onward, with a big smile.

Monday, September 14, 2015

More News: Solvaldi® Patent Spats Scheduling -- In Merck-Gilead Litigation

As Monday draws to a close, with no word on the finasteride hearing of last week, I'll update the status of the potentially material Gilead - Merck patent litigation.

Here is the latest from the very able Judge Burke -- as he tries to have the parties work out a reasonable schedule, given the competing and conflicting criss-cross patchwork field of lawsuits (in which each alleges infringement of one or more of the others' patents). See below -- this is the full text of his oral order entered today at lunchtime:

. . . .IT IS HEREBY ORDERED that the parties shall meet and confer and discuss, in person and/or by telephone, each of the matters listed on Chief Judge Stark's Case Management Checklist ("Checklist"). Within thirty (30) days from the date of this Order, the parties shall jointly file the following:

(i) a copy of the "Checklist" indicating the names of Lead Counsel and Delaware Counsel for each party;

(ii) a proposed Scheduling Order (consistent with the Chief Judge Stark's Revised Patent Form Scheduling Order); and

(iii) a letter, not to exceed three pages, that contains the following:

(a) a description of what this case is about;

(b) the parties' positions regarding the disputes in the proposed Scheduling Order, and

(c) a list of the three most significant topics (other than Scheduling Order disputes) discussed during the parties' review of the Checklist items, along with a brief description as to what was discussed as to those topics.

Thereafter, the Court will schedule an in-person Case Management Conference/Rule 16 Scheduling Conference to be held with Judge Stark and/or Judge Burke.

The Checklist and Revised Patent Form Scheduling Order can be found on this Court's website (

Ordered by Judge Christopher J. Burke on September 14, 2015. . . .

Sovaldi® does represent -- potentially, at least -- a several billion dollar patent fight -- just so you know. So much has happened in the year that is marked by today's date, one year ago. . . so much indeed. Smile.