Partial Loss For Neutrogena's Helioplex® v. Coppertone's Ultra-Sport®, On False Advertising Claims

Once again, as beach weather approaches around the US, the "Battle Royale" burns just a little crispier. Last month, I mentioned that this one round might go in favor of Coppertone's Ultra-Sport^®. Overnight, it has -- as the very able Judge Robinson has granted partial summary judgment to New Merck's subsidiary (formerly known as Schering-Plough). From the order, then -- there will be a teleconference to discuss settlement, or in the alternative, discovery schedules on June 11, 2010:

. . . .Defendant's message is unambiguous and explicit, insofar as it provided the public with a specific formula for Helioplex®, and its labeling and advertisements for DEHN-free 100+ Product clearly represented that Helioplex was present. Novartis, 290 F.3d at 586-87. In the absence of Helioplex, defendant's labeling and advertisements were literally false. Id. As such, plaintiff need not provide evidence of consumer confusion; stich confusion is presumed. See Castrol, 987 F.2d at 943 (citing Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 227 (3d Cir. 1990); see also Bracco Diagnostics, Inc. v. Amersham Health, Inc., 627 F. Supp. 2d 384, 477 (D.N.J. 2009) (collecting authority).

10. Based on the foregoing, the court grants plaintiffs motion for partial summary judgment to the extent that the labeling and advertising at issue, linking DEHN-free 100+ Product and Helioplex®, is literally false and, therefore, violates section 43{a) of the Lanham Act and the Uniform Deceptive Trade Practices Act. At this juncture, the scope and duration of defendant's violation is unclear. The parties have not yet engaged in discovery. Although it appears as though defendant no longer manufactures DEHN-free 100+ Product, its violation may be ongoing insofar as such product remains on store shelves. Plaintiff indicates that it seeks injunctive relief, an order compelling defendant to publish corrective advertising or a press release, and attorney fees. Defendant understandably requests that the court defer consideration of these issues absent discovery and briefing.

IT IS FURTHER ORDERED that:

11. A telephonic scheduling conference to be initiated by plaintiff's counsel shall be held on Friday, June 11, 2010, at 9:00 a.m. See D. Del. LR 16.1. . . .

Ah, summer's tanning -- and litigating -- season arrives, now in earnest. There are still pending many claims by J&J's Neutrogena unit -- that New Merck's Coppertone itself also engages in false advertising prohibited by the Lanham Act. I'll keep you posted.

Merck's Scientific "Bramble Scramble" -- Exec Sprints To Eisai Subsidiary

New Merck surrendered some more executive talent to the competition today, thus -- from a MarketWatch business wire story:

. . . .Morphotek^® Inc. today announced the appointment of Joye L. Bramble, Ph.D. as Vice President, Pilot Plant Operations. In this role, Dr. Bramble will have full responsibility for the management and operation of Morphotek's new pilot manufacturing plant, which will produce biologics to support the company's early-stage clinical trials. . . .

Dr. Bramble most recently served as Executive Director of Business and Research Integration in Research Planning and Integration at Merck Research Labs (MRL) where she led a staff of 150 people at six sites in three countries that provided business operations support to the President of MRL and his management team. This included the development of therapeutic area and capability strategies, long-range operational and capital plans, and portfolio and pipeline management methodologies.

Over the course of her tenure with Merck, which began in 1990, Dr. Bramble assumed positions of increasing responsibility in Vaccine Technology and Engineering, Project Planning and Management, Bioprocess Research and Development, and Bioprocess Clinical Manufacturing and Technology, before assuming her most recent position in Research Planning and Integration. She also was part of the Merck/Schering Plough Research Integration Team that was charged with developing organizational structures, value capture targets and execution time lines to support the merger as well as the governance structures for the new company's product development activities moving forward. . . .

Morphotek, a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of novel and proprietary technologies. . . .

Fosamax, Singulair, Zetia and Zocor -- 2009 Price Increases: 21 to 36 TIMES Inflation

According to a just-released AARP-sponsored report, of the top 25 Medicare Part D expenditures for drugs (rankings based on 2006 data-sets), New Merck makes four -- and each recorded between 6.3 percent and 10.8 percent manufacturer price increases in 2009 -- before reform took effect. [A sincere H/T Ed Silverman at Pharmalot -- for the report.]

Note that all four are mature brands for Merck -- and thus shouldn't rise more than the overall inflation rate, in an otherwise rational economy. Inflation was less than one-half of one percent for 2009 (as measured by CPI).

So -- what's wrong with this picture, then? Plenty [See the full AARP report -- a PDF file]:

Fosamax^® | 70 mg tablet | Osteoporosis Agent | Up 6.7% in 2009 | over 22 times overall inflation rate. . . .

Singulair^® | 10 mg tablet | Respiratory Agent | Up 9.7% in 2009| over 32 times overall inflation rate. . . .

Zetia^® 10 mg tablet | Cholesterol Agent | Up 10.8% in 2009| 36 times overall inflation rate. . . .

Zocor^® 20 mg tablet | Cholesterol Agent | Up 6.3% in 2009| 21 times overall inflation rate. . . .

The takeaway? Just as many of us long suggested they would, pharmaceutical manufacturers increased selling prices whenever possible, in advance of the coming pricing pressure -- driven by health care reform efforts. Perhaps HHS, Medicare and Medicaid ought to suggest that 2011 reimbursement levels will be driven off of 2008 prices, not 2009 or 2010 prices. [Some of my earlier background on the topic.] Just a thought.

New Merck Sues Sandoz -- To Block Generic Version Of Cancidas®, In U.S.

On March 30, 2010, New Merck filed a patent infringement complaint (PDF file), in the federal District Courts of New Jersey, after Sandoz sent it a letter notifying Whitehouse Station that Sandoz would begin selling injectable caspofungin acetate -- a generic form of the 50 mg/vial and 70 mg/vial anti-fungal Cancidas^® as soon as FDA cleared the generic candidate's application. This action will inevitably delay the availability of a lower cost alternative in the United States.

I'll keep an eye on this one (as it is about $600 million a year in worldwide revenues to Merck), but it will be 2012 before a generic form reaches the U.S. market, in all likelihood, now. [Separately, back in December 2009, FDA expressed concerns about liver problems in children given the injectable antifungal. New warning labels were proposed.]

A Rundown, And "Reset" -- Of "The Trials Of Fosamax®"

The bulk of the rest of the boxcars, in the long train of "Fosamax^® bellweather cases" will be tried in the summer and fall of 2010, before Judge Keenan, in Manhattan -- per Merck's recently-filed SEC Form 10-Q (at pages 56 and 57) -- however, there are also cases underway in NewJersey state courts, which I am unable to follow very closely -- due to a lack of fully electonic docketing (and thus unavailability of electronic documents):

. . . .As previously disclosed, Old Merck is a defendant in product liability lawsuits in the United States involving Fosamax^® (the “Fosamax Litigation”). As of March 31, 2010, approximately 1,039 cases, which include approximately 1,417 plaintiff groups, had been filed and were pending against Old Merck in either federal or state court, including one case which seeks class action certification, as well as damages and/or medical monitoring. In these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw, generally subsequent to invasive dental procedures, such as tooth extraction or dental implants and/or delayed healing, in association with the use of Fosamax. In addition, plaintiffs in approximately seven percent of these actions allege that they sustained stress and/or low energy femoral fractures in association with the use of Fosamax. . . .

[A]pproximately 799 of the[se] cases are before Judge Keenan. Judge Keenan issued a Case Management Order (and various amendments thereto) setting forth a schedule governing the proceedings. . . .

The first MDL trial — Boles v. Merck — began on August 11, 2009, and ended on September 2, 2009. On September 11, 2009, the MDL court declared a mistrial in Boles because the eight person jury could not reach a unanimous verdict and, consequently, the Boles case is set to be retried on June 2, 2010. The second MDL case set for trial — Flemings v. Merck — was scheduled to start on January 12, 2010, but Judge Keenan granted Old Merck’s motion for summary judgment and dismissed the case on November 23, 2009. In the next MDL case set for trial — Maley v. Merck — the trial commenced on April 12, 2010 and went to the jury on May 5, 2010. On the same day, the jury returned a unanimous verdict in Merck’s favor. . . .

On February 1, 2010, Judge Keenan selected a new bellwether case — Judith Graves v. Merck — to replace the Flemings bellwether case, which the MDL court dismissed when it granted summary judgment in favor of Old Merck. The MDL court has set the Graves trial to begin on September 13, 2010 [subsequently postponed to November 1, 2010]. A trial in Alabama was scheduled to begin on May 3, 2010 but the trial court granted the parties’ joint motion to postpone the trial date until the fall of 2010. A trial in Florida was scheduled to begin on June 21, 2010 but on April 7, 2010 the Florida state court postponed the trial date until sometime after January 1, 2011.

In addition, in July 2008, an application was made by the Atlantic County Superior Court of New Jersey requesting that all of the Fosamax cases pending in New Jersey be considered for mass tort designation and centralized management before one judge in New Jersey. On October 6, 2008, the New Jersey Supreme Court ordered that all pending and future actions filed in New Jersey arising out of the use of Fosamax and seeking damages for existing dental and jaw-related injuries, including osteonecrosis of the jaw, but not solely seeking medical monitoring, be designated as a mass tort for centralized management purposes before Judge Higbee in Atlantic County Superior Court. As of March 31, 2010, approximately 219 cases were pending against Old Merck in the New Jersey coordinated proceeding. On July 20, 2009, Judge Higbee entered a Case Management Order (and various amendments thereto) setting forth a schedule that contemplates completing fact discovery in an initial group of 10 cases by March 31, 2010, followed by expert discovery in four of those cases, and a projected trial date of July 12, 2010 for the first case to be tried in the New Jersey coordinated proceeding. On April 15, 2010, however, Judge Higbee advised that the first Fosamax trial in the New Jersey coordinated proceeding will not occur until the fall of 2010 and set a tentative trial date of September 27, 2010. . . .

As of December 31, 2009, the Company had a remaining reserve of approximately $38 million solely for its future legal defense costs for the Fosamax Litigation. During the first quarter of 2010, the Company spent approximately $6 million and added $20 million to its reserve. Consequently, as of March 31, 2010, the Company had a reserve of approximately $52 million solely for its future legal defense costs for the Fosamax Litigation. Some of the significant factors considered in the establishment of the reserve for the Fosamax Litigation legal defense costs were as follows: the actual defense costs incurred thus far; the development of the Company’s legal defense strategy and structure in light of the creation of the Fosamax MDL; the number of cases being brought against the Company; and the anticipated timing, progression, and related costs of pre-trial activities in the Fosamax Litigation. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves. Due to the uncertain nature of litigation, the Company is unable to reasonably estimate its costs beyond the second quarter of 2011. The Company has not established any reserves for any potential liability relating to the Fosamax Litigation. Unfavorable outcomes in the Fosamax Litigation could have a material adverse effect on the Company’s financial position, liquidity and results of operations. . . .

I'll keep you informed, but note that Merck has only set aside money to pay lawyers -- there is no reserve to pay damages to any prevailing plaintiffs or plaintiffs' groups.

Merck-Schering Bust-Up Deal Litigation: $3.5 Million In Plaintiffs' Attorneys Fee Payments Being Appealed

First -- to be clear -- what this appeal does NOT mean: this fee appeal will not affect the settlement of the underlying federal class action lawsuit, which challenged the adequacy of the companies' disclosures contained in the Merck-Schering-Plough tranaction announcements, back in the Spring of 2009. [A PDF file of the original complaint, here -- that complaint alleged the TRA candidate was being undervalued by both companies' boards of dierctors.] That settlement will remain intact -- this is just about how lare the lawyers' bills will be allowed to be -- and still get paid.

Similarly, the appeal will not result in the recovery of any money -- or any additional money -- by the plaintiffs, as no money damages were agreed to in this settled action. The sole remedy was enhanced disclosure. It may, however, reduce the amount Merck is required to pay to the plaintiffs' lawfirm. We shall see.

Finally, to make sure eveyone understands, there are numerous other federal pieces of putative class action litigation still pending -- about the events that led to the transaction.

. . . .TAKE NOTICE, pursuant to F.R.A.P. 3:

A. The Party taking this appeal is:

Allan Marain, class member who objected to the terms of the class action settlement and over whose objection the District Court entered its Order and Final Judgment of approval.

B. The Order(s) and Final Judgment appealed from are:

1. Order of March 25th, 2010, granting an award of attorneys fees to (Plaintiffs’) Class Counsel;

2. Order and Final Judgment of April 16th, 2010, at ¶6 and 13, insofar as it awards and orders payment of counsel fees and costs to Class Counsel in the amount of $3,500,000, (inclusive of $131,777.16 in costs).

C. The Court to which appeal is taken is:

United States Court Of Appeals For The Third Circuit. . . .

I'll keep an eye on this. Here is what Mr. Hassan kept an eye on, primarily, during that dark time last summer:

Merck To Rehash Tuesday's Presentation -- For Banc of America -- This Afternoon

I'd expect a condensed version -- at 1 p.m. EDT today -- of what was said Tuesday. Tuesday was a whole lot of nuthin' new.

I'll be off the grid, but you may listen in live, here:

. . . .Peter Kellogg, CFO

Luciano Rossetti, SVP, Global Scientific Strategy. . . .

Be excellent to one another.

Who Will Win The Lead Banker Role On These Deals?

Reuters' DealTalk is running a rather breathless piece this morning. If I didn't know better, I'd suspect that the Reuters staff writers are being played as patsies for the two pharma giants' buyer-stalking efforts. The purported "news report" seems more designed to help the investment bankers scare up buyers, or drive up prices, for the to-be-divested New Merial animal health businesses. Do go read it all, nonetheless:

. . . .As part of that process, the two drugmakers are now looking to shed assets worth several hundreds of millions of dollars, as they await regulatory approval for creating a group that would hold 29 percent of the global animal health market.

People familiar with the matter say Sanofi and Merck met investment banks recently and are likely to name advisers around the end of May. . . .

[T]he U.S.-French duo may have to divest businesses accounting for about 9 to 12 percent of annual sales, or some $450 to $650 million, to cut overlaps and placate competition watchdogs. . . .

Watch closely to see if Banc of America is named an adviser to Merck (and Goldman Sachs & Co. is not -- given that B of A defended Merck stock on the very afternoon that Goldman downgraded it). We shall, as ever, see -- but I don't think Goldman has had much success wooing Sanofi, in recent years, either. BNP Parabas seems to be Sanofi's recent local big-deal favorite.

[Postings will be scarce over the next few days, as I hit South Florida for some R&R with the fam.]

USW Local No. 10-86 Approves Three Year Merck West Point, PA Contract

This just in, from the union local's website:

. . . .Wednesday, 12 May 2010 @ 9:33 pm EDT

The contract was approved by membership by a vote of 871 to 580. . . .

I'll trust this is the best thing for the families. UPDATED | May 13, 2010 @ 7 a.m.: Meanwhile, overnight Merck has announced a plan to add 150 financial shared services jobs, across the pond, in Dublin, Ireland.

UPDATE: Merck | West Point, PA | USW Local No. 10-86 Contract Ratification Vote Tonight

Again, our sincere thanks go to our anonymous "on-the-scene" reporter:

. . . .I just wish I had better news to report. Unfortunately, I have additional details regarding the contract. Along with the out-sourcing of the Security Dept. -- it will include the Grounds & Maintenance Dept., as well. Possibly to JL Maintenance(?). . .

After talking with the others, it would appear morale is very low. Some feel they should've [gone out on] strike earlier; that it's too late to do so now. They feel the vote tomorrow night will have majority in favor of the new contract. Thereby, giving the company authority to lay off Union workers by end of 3 year contract.

Perhaps even sooner.

This may be the end for USW at West Point. That's all I have for now.

Anonymous | May 11, 2010 @ 12:41 p.m. . . .

We'll all know more tonight, after about 9 p.m. EDT., but in this bruising job market, this may have been about the best that could be expected of the union leadership -- to preserve at least some job, if not any specific position, for each union member. Certainly, some 17,000 to 25,000 other (non-Union) New Merck/Legacy Schering-Plough employees weren't offered any position, at all, post bust-up. Either way, I feel for the families. Sad times.

New Merck R And D Day 2010 -- One Troubling Slide

This is as of May 11, 2010 -- and it is a $3.8 billion per year hole. New Merck is now admitting, in graphics, no less, that it has no follow-on candidate in the Hypertension space, and Cozaar/Hyzaar is falling like a rock, now that it is available in generic form from Teva [click to enlarge]:

Some LiveBlogging, Tomorrow -- Of New Merck's "Roadshow": Expectations Decidely Modest

Most analysts polled have some version of this to say, about the live R&D Day webcast Merck will conduct tomorrow morning, starting at 8:30 a.m. EDT:

. . . .expectations are fairly low, here -- not much real news is expected from the conference. . . .

Just the same, I'll listen in, and live-blog at least some of it -- on the off chance that some important development is disclosed. [Merck will essentially re-do the presentation, in an abridged fashion, on Thursday, at a Banc of America health care investors' conference.] Hey -- wait! -- wasn't it B of A that came out to defend Merck's stock on the day that Goldman Sachs downgraded it? Right. It was.

In any event, see below, tomorrow UPDATED -- 05.11.10 LIVE, now:

▲ Bridion (suggamadex) won't be resubmitted to FDA for approval in 2010 -- now it will be in 2011. Another delay for suggamadex; not a huge surprise -- after the non-approval in the summer of 2008.

▲ The MK 2578 (peglyated erythropoietin) candidate program has been discontinued due to regulatory feedback that cardiovascular risk studies would be required.

▲ Tredaptive is back -- planning US FDA filing in 2012 (this is the one Carrie Cox, in Spring 2008, predicted was only 60 days away from approval -- but the FDA rejected it!), because the required 25,000 patients have been enrolled in the FDA re-submission study. Yawn.

Like I said, not much terribly new and exciting (on the upside), here. UPDATE -- this will be a problem [Click to enlarge]:

Details Of Proposed Merck-West Point, PA Union Contract Emerge

A huge thank you, to my readership, here. In a thread earlier tonight, I was graced with this status update, from an anonymous commenter:

. . . .Okay, Condor. So be it. Here's the 411. One of the things I'm informed of is in regards to [Merck's West Point, PA] Security Dept. The contract states the Security Dept. "will be out-sourced" according to an anonymous source. More than likely to be out-sourced to Allied Barton considering they are the security company around the other "non-union" facilities. The contract does state [the outsourced Security employees] "will be absorbed into other fields" within the company.

The other issue that my co-worker was told [about] was in regards to a lack of a "lay-off clause". Which, in their words, "would protect us in the future from losing our jobs."

The contract, I was told, would be good for 3 years. As you know, they still have to vote on it. They are working under "indefinite extension" of their old contract, as I type this. I did ask someone what would happen should the majority of the vote be negative? Reply: "Then I guess we might strike." Some are for the new contract, some feel otherwise.

Hope this helps. Will get back if I hear more. Take care.

May 10, 2010 9:03 p.m. . . .

Fabulous -- I think this is a world-wide exclusive, thanks to the readership!

Just To Complete The Record, Here Tonight. . . .

This had been earlier widely-reported -- concerning Zetia^®. From DowJones Newswires, then:

. . . .Merck said Monday it has agreed to settle patent litigation surrounding its cholesterol drug Zetia, which will allow a generic manufacturer to begin selling copycat versions of the drug in December 2016, about four months before the scheduled U.S. patent expiration.


Merck's settlement agreement with Glenmark Pharmaceuticals comes more than two weeks after a U.S. judge ruled that some patent claims covering Zetia were invalid, but other claims were valid. . . .

Settled on the eve of trial -- but no Glenmark launch until 2016? Odd. That raises more questions than it answers -- given that Glenmark looked to have the upper-hand, at trial. Maybe someone (hey stock analysts and press people -- hint, here) will ask after this, at Merck's R&D Day, tomorrow morning -- during Q&A.

Merck Apparently Settled With Perrigo, Today -- Generic MiraLAX® Trade Dress Litigation

MiraLAX^® will likely only generate about $200 million in annual sales revenue in 2010 -- so it is not a franchise offering. Even so, it is encouraging to see this settle, as it likely means lower-priced alternatives will now be more widely-available throughout the United States, from Perrigo Pharmaceuticals, the generic's manufacturer. Here's that notice -- of a confidential settlement agreement, pending. And, from the original complaint at law, filed in the federal District Court, of Delaware:

. . . .This is an action for infringement of the trade dress of S-P’s [now New Merck's] highly successful MiraLAX® oral laxative, as well as related false designation of origin, unfair competition, copyright infringement, unjust enrichment and state law dilution. [Merck's] MiraLAX® trade dress is highly distinctive and strongly associated in the minds of consumers with S-P’s high quality laxative product. Perrigo has wrongfully copied [Merck's] MiraLAX® trade dress and related copyrighted designs to make private label/generic "knock off" versions of [Merck's] famous product, which Perrigo is now distributing in numerous retail outlets across the country. . . .

No longer -- the matter is settled.

West Point Union Contract Voting Procedures, For Wednesday Night

This just in from the West Point, Pennsylvania union leaders:

Monday, 10 May 2010 @ 14:39

United Steel Workers Local Number 10-00086

Brothers and Sisters,

The contract ratification meeting is scheduled for Wednesday, May 12, 2010, at 6:00 PM in the North Penn High School Auditorium. As we prepare for the meeting, we need to communicate the rules. Please remember that there is no smoking permitted on the High School grounds. The High School parking lot only holds 1200 cars, therefore please make every effort to carpool, especially members leaving site for the vote. Parking will not be permitted on the grass areas surrounding the High School. If you park outside of the designated areas, you will be responsible for the outcome, towing, fines; etc. There will be no children permitted to enter the meeting. No member will be permitted to cast ballots until the vote is called by the President. The judges and tellers will not take ballots early; members are expected to stay for the duration of the meeting to vote. There will be members assigned to assist the Sergeant at Arms and those members will ensure that the rules regarding voting are strictly enforced.

These rules are to ensure that the information that membership receives is accurate and all questions are answered. Each member attending the meeting will receive one (1) ballot and will only be permitted to cast one (1) vote.

In solidarity,

/s/ Michael I. Parente, Sr.
President


/s/ Phil Hughes
Vice President

We will let you know what we hear, as we hear it.

Merck's Emerging "Second To Market" Hep C Reimbursement Campaign?

On Thursday there was news of a study which suggested that one or both of New Merck/legacy Schering-Plough's Boceprevir^TM, and Vertex's Telaprevir^®, would ultimately be needed in so-called next generation "cocktails". Either one of these -- in combinaiton with pegylated interferon (one version of which is made by Roche, and another version of which is made be Merck -- as successor to Schering-Plough), might be used to combat rapidly mutating strains of Hepatits C. That would suggest -- in pursuit of a humane treatment of patients who have previously failed treatment -- that payors ought to ultimately provide Tier I coverage for both of these new drugs, when they reach the US market. [UPDATED: Additional sentence, and edits above, courtesy of Salmon's helpful suggestions in comments, below.]

This morning, two health industry study groups have put out a white paper (of sorts). The two, HealthLeaders-InterStudy and Fingertip Formulary, suggest that while the first to market will enjoy a clear formulary advantage, as many suggest they will only cover one of the two drugs. This paper goes on, however, to subtly argue that both ought to be covered, from a humanitarian standpoint, citing the $138,000 projected drug cost, over the Hep C patinets' lifetime, for failed Hep C drug treatments:

. . . ."While there is a need for emerging therapies for those hepatitis C virus patients who have failed therapy with existing drugs, the second-to-market status will hamper uptake of whichever brand reaches the market second, because some health plans will only include either boceprevir or telaprevir on formulary," said Michael Malecki, Ph.D., product director, Formulary Forum. "However, there's a high percentage of pharmacy directors who do not know the costs associated with drug failure. Surveyed national health plans that do have an estimate for the cost of treatment failure report spending an average of $138,000 over the lifetime of a hepatitis C virus patient who fails drug therapy. For marketers of emerging therapies, pharmacoeconomic analyses of these costs may be persuasive tools to gain formulary inclusion. . . ."

We'll keep an eye on this one, but as I've long surmised, Merck is likely to finish second in this race to market.

"Why Teva Works So Well" -- A Balanced And Well-Written New York Times Article, Tonight

The Times' Natasha Singer has done a nice job of capturing the inner-ethos of Teva -- from flying CEOs commercial, only (take note, Whitehouse Station!), to second-hand office furniture for lead executives, and take-out pizza in conference rooms, for reporters -- instead of novelle cuisine in some Tiffany's-appointed executive dining room. And she's done it all without pandering -- the recent scrapes with FDA are ladeled right in, just as they ought to be.

Do go read it all, but here is a bit of it:

. . . .As recently as a decade ago, the pharmaceutical industry disparaged generics as "copycat" drugs that profit off the innovations and research of brand-name makers. But lately, some of the biggest name-brand makers have been buying stakes in or doing distribution deals with generic makers, particularly in Brazil, India and other emerging markets.

But name-brand makers accustomed to wide margins may not be able to keep up with Teva, says Mr. Khanna.

"If you are used to the fat margins of big pharma, it’s hard to compete in the rough and tumble of price-cutting generics," he says.

Generic drugs saved the American health care system $734 billion between 1999 and 2008, according to a study by IMS, the research firm. That may be no consolation to name-brand drug makers whose profits Teva has helped erode, or to rival generic makers that lack Teva’s resources.

But for patients, its ascent means that medicine has ultimately become much more affordable.

"We are aggressive and not everybody likes us," Mr. Marth says. "But we are doing something every day that lowers health care costs and helps consumers. . . ."

Indeed -- and making a veritable killing at it, too. Teva'a widely-announced goal is $31 billion of recurring worldwide annual revenue -- by the middle of this decade. I wouldn't bet against them. It's an Irish-American/"kibbutznik" thing.

BREAKING -- West Point, PA -- USW Local No. 10-86, To Hold Contract Vote Wednesday

STRIKE LIKELY AVERTED.

Well, this is decidedly good news:

. . . .Tentative Agreement

Saturday, 08 May 2010 @ 09:11

A tentative contract has been reached between the Union and the Company as of late Friday night, May 7th. The Ratification Meeting will most likely be Wednesday evening, May 12th. A lot of information is flowing as we speak. Once we have all relevant details set firmly in place we will update this posting. Stay tuned. . . .

UPDATED @ 10:26 a.m. EDT

CAT Team Message

Late Friday night, and after months of intense negotiations, USW Local 10-00086 and Merck reached a tentative settlement on a new 3-year agreement that would run through April 30, 2013.

As we have recently reported, our negotiations grew increasingly difficult as the process dragged on. As much as we argued, as hard as we fought to save West Point jobs, the Company simply refused to listen to our message that Merck’s USW employees –- many of whom have dedicated their working lives to the success of the West Point site -- are better suited to secure and maintain the West Point facility than $10/hour day laborers. At the end of the day, however, the Committee was able to conclude our negotiations at a point where we could protect all of our people if not their current jobs.

There are a number of provisions in the new, tentative agreement. Many are significant improvements. Some are not. But considered as a whole, we believe that the tentative settlement is worthy of consideration by our full membership.

The tentative agreement will be placed before the membership for approval or rejection at a special membership meeting that will take place in the North Penn High School auditorium this coming Wednesday evening, May 12th at 6:00 p.m. Because of Wednesday’s vote, the regular membership meeting previously scheduled for Monday, May 10th is cancelled.

Before then, and as promised, the full tentative agreement will be available for review and inspection by all members at various locations throughout the facility beginning Monday morning. Every word.

All members are encouraged to attend. We look forward to seeing you Wednesday. . . .

Great news, for the families involved. Now, let's see what the terms are. Calling all USW Local No. 10-86 members! -- feel free to share what the proposed contract says, in the comment box attached to this post.

LIVE Video Webcast Of FDA Advisory Committee Meeting -- On Rotavirus Vaccines

Click this link to launch a WindowsMedia live video stream of the FDA Advisory Committee meeting, provided by fda.gov. It is clear from listening in -- that the Advisory Committee is going to vote (probably unanimously) to reintroduce the GSK product, and keep the Merck product on the market.

Here is a chunk of what this is all about, from my post of last night:

. . . .FDA recently received information from Merck & Co, Inc. that its preliminary studies have identified fragments of DNA from PCV1 and from a related porcine circovirus type 2 (PCV2) in its RotaTeq vaccine. Merck’s findings suggest that the number of PCV DNA fragments in its vaccine may be smaller than what has been found in Rotarix. These preliminary findings will be included in discussions with the Committee.

FDA has been working closely with manufacturers of the two licensed rotavirus vaccines, has consulted with experts inside and outside of the federal government, and has considered issues related to the novel testing that led to the identification of PCV. . . .

I may yet get a chance to live-blog some of it, during lunch this afternoon, on the West Coast. If so, that will appear below.