On Fosamax® ONJ Settlement Posture: Remember These Are Merck's "Claims", Not Proven "Facts"

But if these claims are proven, then the plaintiffs' overall reasonable settlement figures must be contracting a bit.

Paul Strain, of the Venable firm -- on behalf of Merck -- claims that a good number of the cases (and perhaps half) are bereft of evidence to support the ONJ injury allegations. Now, it could be that the case files haven't yet been supplemented with all the discovery materials, from these plaintiffs' treating physicians, but it still should be cause for concern. Most of these cases have been pending since 2006 or 2007. The doctors reports and other treatment records should have long since been available, by now.

Here is the full three page letter (as a PDF) -- and a pair of exerpts (as an image, below) (click to enlarge):

We will keep you posted.

Will Tennessee (Or Florida) Now Follow The "Lead" Of Arkansas -- Allow Medicaid Money To "Buy" Private Insurance?

Even though the Tennessee legislature has a bill pending (of supsect constitutionality under the Supremacy Clause, according to the Tennessee AG) to prevent the sale of private insurance products via the exchanges under the ACA of 2010, and Gov. Haslam (R) won't run a state exchange, I've long suspected that the Governor will have to find a politically expedient way to allow a form of Medicaid expansion to enter the state (for Tennessee's neediest citizens) -- while not appearing to have broken campaign promises, to oppose the ACA of 2010.

Enter what I'll dub the "Arkansas Compromise" -- as approved by HHS Secretary Sebelius this afternoon -- per Bloomberg -- do go read it all:

. . . .The Centers for Medicare and Medicaid Services announced the compromise in an e-mail four days before the debut of state insurance exchanges created under the Affordable Care Act. The plan may cost the federal government as much as $1.1 billion in its first year. The health law sought to have states expand existing government-managed Medicaid programs for the poor next year to cover everyone earning about one-third more than the U.S. poverty level.

While the federal government has pledged to pay the entire expense of the expansion until 2017, some Republican-led states balked. The Arkansas program, in which insurance companies will be given the Medicaid money to manage plans for new enrollees, may serve as a template for Iowa, Ohio, Michigan and other states that had been weighing options.

“It represents a way to do a Medicaid expansion without it looking like Medicaid,” said Matt Salo, the executive director of the National Association of Medicaid Directors. “That in and of itself makes it a very, very attractive option for states that are currently in the ‘no’, or ‘unsure’ or ‘leaning no’ columns. . . .”

The Obama administration has said it will approve a limited number of expansions using private plans, without saying exactly how many. Under terms of the arrangement, the expansion can’t cost the federal government any more than it would to expand the traditional state-run Medicaid program. . . .

Note that the Arkansas compromise allows a Democratic governor to mollify the Republican controlled Arkansas State legislature -- granting yet another "back door" Medicaid expansion route. Might this be the bit of wiggle room Governor Haslam (R) needs, to handle his own version of the ACA of 2010 "Catch 22"?

We will -- as ever -- keep you posted.

Q3 2013 Call Scheduled For Morning Of October 28, 2013

Analysis later; busy on other matters -- here is the item:

. . . .[Merck] will hold its third-quarter 2013 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Monday, Oct. 28. During the call, company executives will provide an overview of Merck's performance for the quarter. Investors, journalists and the general public may access a live audio webcast of the call on Merck's website at http://www.merck.com/investors/events-and-presentations/home.html. Software needed to listen to the webcast is available on Merck's website and should be downloaded prior to the beginning of the webcast. A replay of the webcast will be available at approximately 11:00 a.m. EDT on Oct. 28 and will remain on the website for 12 months. The quarter's sales and earnings news release and supplemental financial disclosures also will be available in the Newsroom and Investor sections of the company's website at www.merck.com. . . .

Derek Lowe's Rather Caustic Take On The FDA Bridion® Bounce Letter -- And The Horse It Rode In On

Derek and I used to disagree on this, but over the last four years, he's come to agree: the Merck Schering-Plough buy-out/bust-up didn't really add a ton of value to Merck's long-suffering investor base.

The latest Bridion^® FDA non-approvable letter sent to Whitehouse Station was occasion enough for Derek to restate his case -- one that I will quite immodestly suggest I helped him (ultimately) to accept -- about three years ago, now.

Here is his piece, as it ran today at Seeking Alpha. Do go read it all:

. . . .At any rate, Merck really doesn't seem to have gotten a lot out of the deal, and this latest rejection doesn't make it look any better. Not all of those problems were (or could have been) evident at the time, but enough of them were to make a person wonder. I'm willing to nominate it as "Most Pointless Big Pharma Merger," and would be glad to hear the case for other contenders. . . .

Pungently put -- but probably right.

Senator Cruz's Own Nominal Party (R) Is Forsaking His "Scorched Earth" Tactics, Now. . .

Well -- he's one goofy little would-be despot. Doesn't he understand he'll never have even 50 votes for this idea? Silly is as silly does. And sad. For it wastes all of our taxpayers' time and money.

From the latest New York Times story, then -- a bit -- do go read it all:

. . . .Mr. Cruz was calling on his colleagues to stonewall a measure they technically supported, reasoning that Senate Democrats would be successful in stripping the health care provision [Editor's Note: one that tries to repeal the ACA of 2010] from the funding bill once the way was cleared to a Senate vote on the measure.

But other Republicans said they saw no reason to oppose opening debate on a measure they actually backed.

“We’d be hard-pressed to explain why we were opposed to a bill we’re in favor of,” said Senator Mitch McConnell of Kentucky, the Republican leader.

Others warned of political repercussions if Senate Republicans, who hope to regain control of the Senate in next year’s elections, were seen as contributing to the government being shutdown. “Getting the majority in the Senate in 2014 is possible, and we don’t want to go down roads that make it harder,” said Senator Lindsey Graham, Republican of South Carolina, who is up for re-election next year.

“Repealing Obamacare is a goal all Republicans share,” he added, “but the tactics of achieving that goal can have a backlash. . . .”

This theatre of the (Republican) absurd is going to cost all of them next election cycle. They have a lunatic running their asylum. He just compared Obama's policies to Nazism. He is a lost soul.

FDA: Legacy Schering-Plough OR Drug Bridion® "Goin' Down -- For The Third Time"

I've been following this "redheaded stepchild of a drug candidate" story since December of 2008 -- and since then, FDA staffers have expressed varying levels of concern about the perceived elevated risks of blood clots and allergic reactions of patients receiving the study medicine. Although approved in the EU, Bridion^® has been a rather weak seller, due to lack of US market approval.

By my count, this is the third complete response letter (formerly called "non-approvables," or rejection letters) from FDA -- related to ex-CEO Fred Hassan's lead "five stars" candidate.

Yep -- Goin' down for the third time, then. It is now possible (probable, perhaps) this drug candidate will never see US FDA approvability, and thus never launch in the US markets. Ni-i-i-i-ice goin', Fast Fred!

Here is a bit of this morning's version of the Yahoo! story -- do go read it all:

. . . .[Merck] has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

The FDA’s letter raised concerns about operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the very near future. . . .

I now think Merck should evaluate whether it should simply write off this US approval effort. Additional studies won't likely lead to blockbuster status. Ever. Perhaps a more-conservative approach would be to conduct some cheap post-hoc meta analysis of the drug's overall emerging experience in the EU, then report to FDA if -- over time -- it looks like the clot and allergic reaction data are more reassuring, when observed over a much larger set of patient on-dosings. Just a thought. But this is a major dis-connect from Fred's endless hype. It seems unapprovable in the US.

Our President To Sen. Cruz (R) And Fellow Obstructionists: "Not Going To Happen"

According to what passes for the intellectuals' (radical right) perspective on these latest ridiculously non-productive matters, the end game for Mr. Cruz, et al., is solely to force all Democrats (even those not in Congress in March 2010, when Obamacare first passed into law) to vote in favor of the ACA of 2010 again. [More background here.]

So -- let me get this straight: these Rethuglicans think it a wise use of the taxpayers' time, money and vastly eroded good will to hold another vote on Obamacare, using a threatened government shutdown -- as the carrot/stick?

Seriously?! Once again, to this, I say: perfect! Mr. Cruz believes our wounded Iraq war vets shouldn't get treatment at VA hospitals, and kids shouldn't receive their Early Head Start lunches, and federal Marshals should stop chasing bad guys. . . all to hold one more up or down vote on Obamacare (the outcome of which is beyond dispute, and will never ever) stop health care reform's rollout. I say -- let them move forward! As we all know, the Senate will never allow it to reach the President's desk. And, if by dint of some dark magic, it were to do so, the President will simply [line-item?] veto the measure. But this is how the Republicans choose to spend your tax dollars. Re-fighting the last (lost) war, and losing every current battle, in this one -- along the way. Disgusting.

From this morning's New York Times, then, a bit

. . . .Republican state and local officials are trying to thwart the administration’s enrollment efforts by imposing restrictions and requirements on volunteers seeking to inform people about how to enroll in coverage plans under the law. The Heritage Action Fund organized a Defund Obamacare bus tour this summer that helped convince House Republicans that no federal budget deal should be made without stripping the money from the health law.

And in Congress, House Republicans are threatening to shut down the government and risk a default unless Congress eliminates all of the financing for the law, effectively killing it.

“Today, the constitutional conservatives in the House are keeping their word to our constituents and our nation to stand true to our principles, to protect them from the most unpopular law ever passed in the history of the country — Obamacare — that intrudes on their privacy and our most sacred right as Americans to be left alone,” Representative John Culberson, Republican of Texas, said on the House floor on Friday.

Mr. Obama was blunt in a speech to the Congressional Black Caucus on Saturday night, saying he wanted to speak “as clearly as I can” about efforts to derail his health care law: “It’s not going to happen. . . .”

That much is certainly right, Mr. President. I just wish these three stooges would. . . grow up. They lost. Move on, citizens. More than half of Obamacare is already working to save lives -- and money -- system wide.

"Ridiculous-Ness" Alert! One Pseudo-Pharma Asset Merck Is NOT Acquiring; NOT In-Licensing

From the keyboard of the irrepressible Ed Silverman -- comes this great tidbit.

Whitehouse Station yesterday denied rag-paper rumors that it was acquiring some Chinese pseudo- "superdrug". [With air-quotes, for emphasis!] It denied it would ever pay $1 billion for such a homeopathic. A bit from the item, out of Taiwan local news -- do go read it all:

. . . .The paper said a Hong Kong merchant who claimed he represented "Germany's US pharmaceutical giant Merck" tried to buy a patent for a prescription for a liver cancer treatment from the Anhui-based Jinfang Huaixia Traditional Chinese Medicine Research Center.

The report was first published by the website of the People's Daily on Sept. 9 before it made the rounds of several media outlets.

The report has created a headache for international pharmaceutical companies which use the name Merck. . . .

I couldn't make this up -- if I tried. Of course there is no US based Geman Merck. There is Geman Merck and US Merck. Distinct companies for nearly 80 years.

For the record, the German Merck (again, no relation) has also denied that it has interest in the China operation mentioned. So it goes. Nice try, fella!

Merck Honored Again -- As A Top 100 "Mom/Family Friendly" Workplace!

For 26 years running now, Merck has been among the top 100 places to work, for moms who also work outside their homes, as rated by an independent journal.

This is truly praise-worthy! Go get 'em, all you Tiger Moms! Here is Merck's presser on it, from yesterday:

. . . .Honored on the list for the 26th year, Merck is among the 100 companies recognized for their commitment to progressive workplace programs, including female representation, compensation, child care, flexibility, time off and leave, family-friendly programs and company culture. Those chosen also demonstrated their commitment to supporting working moms to be healthy.

“This award recognizes Merck’s commitment to fostering an environment where all employees, including working parents and those who provide care for others, can effectively integrate work and life, take care of themselves and their families and reach their professional goals,” said Dottie Brienza, Chief Diversity Officer and Executive Talent Leader, Merck. . . .

[Specifics on Merck:]

Chairman, President & CEO Kenneth Frazier

Executive VP, HR Mirian Graddick-Weir

Women managers/execs 28%

Women hires in 2012 72%

Average weeks of fully paid maternity leave 10

Average weeks of fully paid paternity leave 1

Average weeks of fully paid leave for adoptive primary caregivers 1

Backup child care Yes

Sick child care No

Employees who use a flextime schedule Not tracked

Employees who telecommute Not tracked. . . .

Kudos, Whitehouse Station!

"Saying The Soft Part... Too Loud" -- Fred Hassan's Mentorships? This Is HILARIOUS!

In an article that purports to be about how Mr. "Fast Fred" Hassan, former CEO of Schering-Plough, mentors new young would-be public company CEOs -- we learn that at least one protégé of Fast Fred seems a little short, on the ethical dimension. This, from his own board of directors. The article was, I take it, supposed to highlight Hassan's able grooming of emerging leaders, not corporate jet flight-attendant romancers. The article nicely does so, as to the other executive profiled, the former CEO of Campbells' Soups. Seriously, even if I was trying -- I could not make this stuff up. Do go read it all.

From The Wall Street Journal, overnight, then:

. . . .Mr. Hassan brought Mr. MacMillan to Pharmacia in 2000 to oversee consumer products and four smaller divisions. He says he soon alerted fellow directors that the executive "could be a potential CEO."

Ahead of board presentations, he coached Mr. MacMillan to keep things simple, leave time for frank discussion and "show your humility," Mr. Hassan remembers. "Really value what (directors) say," he told his protégé. "It can't be fake."

Pharmacia board member William U. Parfet was so impressed that in 2003, he recruited Mr. MacMillan to be president of Stryker Corp., where Mr. Parfet also was a director. Promoted to CEO of the medical-device maker at age 41 in January 2005, Mr. MacMillan won analysts' accolades for its steady performance as the orthopedics market stalled.

Yet Stryker forced out Mr. MacMillan early last year, partly because some directors were bothered by his relationship with an ex-flight attendant for its corporate jets while his wife pursued a divorce, people familiar with the situation have said. In hindsight, Mr. MacMillan realizes he joined Stryker when he had just begun to grasp the nuances of board management from Mr. Hassan.

"Managing a board was not my strength at Stryker," Mr. MacMillan concedes. "It hurt me." He now leads sBioMed LLC, a private manufacturer of infection-control products. . . .

R-e-e-e-e-e-ally?! You think so? Nah. . . I don't. Priceless.

Like The Mylan Labs Action, Aurobindo Sued By BMS; Merck: Claims Sustiva® Patents Infringed

Just about three years ago, back in August of 2010, BMS (relying on licenses from legacy Merck patents) sued Mylan Labs, alleging that Mylan's intention to sell a version of the efavirenz AIDS therapy infringed various patents jointly being exploited by the companies, under the brand name Sustiva^®. Here is that story, from our blog archives. [UPDATED | 09.17.13 @ 10 PM EDT: Thanks to the commenter below who pointed out an obvious error on my part. I had it as Mylam, not Mylan. My earlier story and graphic remain correct; I was just thinking about a client of mine when I was typing. The misspelling is the client's actual name. So it goes.]

Last week, in the New Jersey federal district courthouse, BMS and Merck again filed suit, this time detailing a July 2013 Hatch-Waxman letter received from Aurobindo Pharma. That letter advised Merck and BMS that an abbreviated new drug application in the HIV space has been filed by it, with the FDA. Merck and BMS contend that the July letter makes it clear that Aurobindo intends to violate at least three patents as it prepares to get FDA approval to sell a "generic" version of efavirenz -- as soon as this fall. [The drug has already gone generic in the U.K. and the EU, if memory serves.] So, Merck and BMS have now sued in the US, seeking to prevent Aurobindo's efavirenz beach head incursion here. Here is the patent infringement complaint at law (an 11 page PDF file).

We will, of course, keep the readership informed.

. . . .By letter dated July 30, 2013, purporting to be a notice pursuant to 21 U.S.C. § 355(j)(2)(B)(ii) (“Notice Letter"), Defendants notified BMS and Merck (collectively, “Plaintiffs”) that Defendants had submitted ANDA No. 205322 to the FDA under section 505(j) of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 355(j)) seeking approval to engage in the commercial manufacture, importation, use, and sale of 600 mg efavirenz tablets (“Defendants’ ANDA product”) as a generic version of BMS’s Sustiva® drug product. . . .

Defendants’ ANDA was submitted to obtain FDA approval to engage in the commercial manufacture, importation, use, sale, and/or importation of Defendants’ ANDA product prior to the expiration of the ‘071, ‘964, and ‘372 Patents. The ‘071 and ‘964 Patents are listed in the FDA Orange Book as being applicable to BMS’s Sustiva® drug product. . . .

On information and belief, Defendants intend to engage in the commercial manufacture, importation, use, and sale of Defendants’ ANDA product promptly upon receiving FDA approval to do so. . . .

In the Notice Letter, Defendants notified Plaintiffs that their ANDA contained a "paragraph IV" certification that, in Defendants’ opinion, the ‘071and ‘964 Patents will not be infringed by the commercial manufacture, use, sale, offer to sale or importation of Defendants’ ANDA product. The Notice Letter did not provide any statement regarding the ‘372 Patent. . . .

On information and belief, the commercial manufacture, use, sale, and/or importation of Defendants’ ANDA product by Defendants will infringe, induce infringement, and/or contributorily infringe one or more claims of the ‘071 Patent literally or under the doctrine of equivalents. . . .

I'll drop stuff in here sporatically, it seems -- if it helps me make sense, of the senselessness.

Outage Alert -- One Week, At Least

My non-blog-worthy (private) life has gone slightly haywire. Use the comments section to keep yourselves informed and amused. I'll even kill the spam filter -- post as you wish.

Not enitrely sure when or whether I'll be back (unless it feels therapeutic to be here). In the mean time, listen up -- Tonic had it down right -- with one edit: slip gold in, for blue. . . .

Brent Saunders To Run Forest Labs: Twist On The Legacy Schering-Plough Rumor

A few weeks back an anonymous commenter offered a rumor mill tip, from CaféPharma, that Fast Fred Hassan would become the new CEO of embattled Forest Labs.

That's almost right, apparently. But only almost. It is Fred's shadow guy -- yep. The new CEO, according to Ed Silverman at Pharmalot is. . . Brent Saunders. Here is some of Ed's fine reporting:

. . . .Brent Saunders, a former Schering-Plough exec who has been a Forest director for the past two years and was CEO at Bausch + Lomb, but became available after the eye-care company was purchased by Valeant Pharmaceuticals for $8.7 billion a few months ago.

“We have long thought Brent would be an ideal CEO to succeed Howard when the time came. Over the course of our announced search and rigorous board process, during which we seriously evaluated a number of excellent candidates, this belief became crystal clear. We are delighted that, following the recent sale of Bausch + Lomb, Brent became available at just the right time," says Ken Goodman, an independent Forest director who on the succession committee, in a statement.

The move comes after Solomon, who is 86 and has been CEO since 1977, has had a decidedly mixed tenure. On one hand, he helped build the drugmaker into a large purveyor of medicines, but more recently, he presided over setbacks that prompted corporate raider Carl Icahn to attack his leadership and successfully place a representative on the Forest board after accumulating 9 percent of the stock. . . .

It's a small pharma world -- with rapidly rotating revolving doors -- it seems. Here's my older background on Brent's post Schering-Plough career.

Expansion Analysis: As Goes South Carolina, So Goes Kentucky, Tennessee, Ohio and Others

Just a short note to encourage interested readers -- and those tracking the varying state-by-state effects -- of ACA of 2010 implementation dogfights, to read this morning's New York Times article discussing Gov. Nikki Haley (R). Gov. Haley's inability to carry out her threat -- to keep federal funds out of South Carolina, even for the neediest medical cases -- is clearer, day by day. The Refusnik stance is being dismantled, state by state, and day by day, through backdoor expansions in definitions -- by rule -- of who will be eligible for Medicaid. And those are increasingly federal rules -- passed down to the states, for implementation -- along with earmarked federal funds to implement the changes. Sweet.

The analogs for this -- in other Republican led states -- will not be one for one, but the general theme will very likely play out: eventually, all of these states will end up covering more and more people of limited means, using allocated federal money. That will happen through the October 1 start date for the federal exchanges, or through increases in eligibilty definitions, as a backdoor to outright in-state comprehensive Medicaid expansion. Maybe I should call those, um. . . metaphors -- for what is happening in South Carolina -- but the theme is likely to hold true in broad strokes. And that is a good thing for the nation.

Here's a bit -- do go read it all:

. . . .In her State of the State speech in January, Gov. Nikki R. Haley, a Republican, said, “South Carolina will not implement the public policy disaster that is Obamacare’s Medicaid expansion.” And she boasted of her stance at a recent rally announcing her bid for re-election. “When it came to Obamacare,” she said, “we didn’t just say ‘no,’ we said ‘never.’ ”

The reality, however, is more complex. South Carolina officials say they welcome the prospect that more than a half-million state residents — out of a population of 4.7 million — could soon gain access to affordable coverage, even without the expansion of Medicaid eligibility. And they are working to remake Medicaid so that it does not just pay claims but produces measurable improvements in the health of poor people. . . .

Have a great weekend, one and all!

Durham Vaccine Facility Lines Now FDA-Approved And Open For Production; West Point, PA Implications?

Well, the union shop stewards -- at the United Steel Workers Local 10-086 -- knew this day would come.

It has arrived. Vaccine production in the non-union Durham, NC facility has been cleared by FDA -- could begin as soon as tomorrow. And that will inexorably lead to additional shifting of capacity -- from higher cost West Point, to lower cost Durham. It is the way of things I am afraid. But no one can say they are surprised, in Pennsylvania -- here's my latest 2010 backgrounder on it.

And here's a bit of the Street Insider report on it -- do go read it all:

. . . .“The licensure of the Durham varicella bulk facility marks a significant milestone for Merck and adds additional manufacturing capabilities to an already strong Merck vaccine network,” said Willie Deese, president, Merck Manufacturing Division. “The Durham facility will help us meet the increasing global demand for our quality vaccines that enhance health care for millions around the world.”

“Producing more of our chickenpox and shingles vaccines means we can help protect more children and adults against these diseases,” said Julie Gerberding, M.D., president, Merck Vaccines. . . . Prior to this licensure, all global bulk supplies for Merck’s varicella-containing vaccines were produced at the company’s facility in West Point,PA. . . .

We will, of course, keep you posted.

Thanks Go Out To Marilyn Mann: Gilead Counters Merck's Demand For 10% Patent Royalty On New Hep C Drug

I'll have a chemical structure graphic, and more here -- late night, tonight. My 2013 backrounder, on the chances of Merck being leapfrogged by Gilead's sofosbuvir candidate. [On the road -- then grilling -- most of the rest of the day today.]

And so, Marilyn Mann, longtime friend of this blog, has alerted us that Gilead is now defending itself in federal court in San Francisco, against Merck's demand for a 10 per cent running alleged patent infringement royalty on sales of Gilead's next gen Hep C drug.

That drug is likely to drop the curtain on Merck's boceprevir -- a legacy Schering-Plough Hep C drug.

UPDATED @ 10:30 PM EDT: Of course, Merck's current Hep C franchise is at best holding even, or perhaps, slighly declining. Whitehouse Station's next gen candidates are clearly threatened by the success of sofobuvir in late stage clinical trials. So Merck is looking to collect some of Gilead's coming revenue, with very little additional downside risk. It is fairly inexpensive -- trivial, almost -- to write a demand letter, seeking to impose a license deal, by threatening patent litigation. That's what Merck did. Gilead answered, directly in the federal courts, though -- by seeking a declaration from the courts that its next gen drug candidate doesn't read on any of Merck's patents.

That approach costs Gilead a bit more, up front, in legal fees -- but will effectively prevent Merck from prematurely strong-arming a license deal, unless a judge starts hinting that Gilead does, in fact, infringe. And I think that outcome is unlikely -- at this point. So my guess is that Gilead likely is cleared of infringement, and Merck doesn't get a free 10 per cent of pure margin, on its already deployed capital. It is simply a continuing erosion of Merck's Hep C franchise. But you absolutely should do your own diligence here. [END UPDATE.]

Now, here's a bit, from Bloomberg:

. . . .Merck. . . asked Gilead to pay a 10 percent royalty on the net sales of the medicine until the patents expire, a request “meant to threaten Gilead” on the eve of U.S. regulatory approval of sofosbuvir, according to the complaint. Gilead seeks a judge’s declarations that the patents aren’t enforceable or infringed so it won’t have to license them to sell the medicine.

Gilead, based in Foster City California, said June 7 that sofosbuvir will receive a priority marketing review by U.S. regulators with a target review date of Dec. 8. . . .

Back tonight with more. Merck is fishing for a revenue enhancer here -- and while it won't be damaged terribly if it loses -- Merck is not likely to win on this one. Just my $0.02.