Sunday, October 31, 2010

Still More Hep C: Telaprevir® Confirmed -- Again -- As "The Winner"


This is all becoming rather redundant after a spell, but again, Adam Feurstein has it just right here:

. . . .If there's a debate left to have about telaprevir vs. boceprevir in hepatitis C, it's forecasting the market share each drug may garner once both are approved next year. Right now, the Street's consensus is overwhelmingly in favor of telaprevir (roughly 70-80%) to boceprevir's (20-30%). Analysts expect telaprevir sales in the range of $2.5 billion by the end of 2014.

Whether those estimate and market share splits change significantly or not could depend on feedback analysts and investors get from Hep C doctors attending AASLD after they get a chance to see full data presentations from the phase III studies of each drug Monday and Tuesday. . . .

I'd be shocked if Merck were able to pull a rabbit out of Fred Hassan's dingy old top-hat, at this very-late hour. Truly. Shocked.

More Hep C: TMC 435 Shows High Promise -- But Likely Not FDA-Approvable Much Before 2015


Adam Feurstein, writing for TheStreet.com, has done a nice job of summarizing the next-gen Hep C "state of the play" -- as to the most important candidates in Boston, at the big liver conference.

Because there will still be some patients who won't respond to Telaprevir®, or Boceprevir®, J&J (via a The Medicines Company-researched drug candidate, thus the TMC nomenclature) is advancing a powerful alternate candidate, still about four years away from market, to follow in Telaprevir's wake:

. . . .In addition to partnering with Vertex on Telaprevir, Johnson & Johnson is developing its own Hep C drugs, including TMC435. A phase IIb study being presented Monday shows that between 79% and 86% of patients treated with TMC435 and standard of care responded well enough to stop all therapy after 24 weeks.

This interim result for TMC435 looks better than the 58% and 65% of telaprevir-treated patients who were able to stop therapy after 24 weeks, except that J&J used a more liberal definition of response, which inflates its numbers.

Patient treated with higher doses of TMC435 also reported increases in certain liver enzymes levels, raising safety concerns about the drug. . . .

So, the Vertex juggernaut in Hep C may only last for about five years -- but that will certainly be "enough" -- enough to clearly label Ex-Schering-Plough CEO Fred Hassan's Boceprevir as primarily a second-line "me too" candidate. We'll keep you informed.

Saturday, October 30, 2010

3/4ths Of Market To Vertex's Telaprevir®: Leerink Swann & Co.


Well, this is all sort of like reading the opening night notices, on a new musical, in Boston this morning -- but here goes: Winner? Telaprevir®, per BusinessWeek:

. . . .Telaprevir will capture about three-fourths of the demand for the new medicines, said Howard Liang, an analyst at Leerink Swann & Co. in Boston, in a telephone interview. The drug, which Vertex is developing with New Brunswick, New Jersey-based Johnson & Johnson, will generate about $2.6 billion annually by 2013, he said. . . .


Okay -- The Next-Gen Hep C Race To Simply FILE NDA's, At FDA Is Called. . . What?


In what is plainly the work of corporate communications/spin-meister strategists, Merck included a paragraph in its Saturday press release indicating that it has begun filing the new drug application, or NDA with the FDA, "on a rolling basis," for Boceprevir®.

Well.

That's essentially the same as saying. . . we are getting ready to file. FDA won't review partial submissions. It never has. See 21 CFR "somethin' somethin'." [21 CFR Part 314.60(b)(1)-(4).]

This bit of breathy Merck prose is clearly in response to Vertex's Q3 earnings call this past week, in which it announced that it would be filing an NDA on Telaprevir® with FDA "in the coming weeks".

The only real news in the Merck statement is that Whitehouse Station is still committed to having a complete NDA package -- in the FDA's inbox -- by year end 2010.

It looks like Vertex will be at that point, within weeks.

. . . .Three Phase 3 studies, ADVANCE, ILLUMINATE and REALIZE will form the basis of the clinical portion of the telaprevir New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which is expected to be complete in the fourth quarter of 2010. . . .

What this all amounts to is very little, as FDA will certainly ultimately approve Telaprevir, as it is a cure for Hep C -- and will likely clear Boceprevir, as well -- despite its more troublesome side effects profile, for use in patients who show no response to Telaprevir. In the longer run, it will be the better efficacy of Telaprevir, coupled to its lower side effects profile, that will lead physicians to prescribe perhaps $4 billion worth of the drug, per year by about 2013, in the US alone -- in my opinion, of course.

Vertex v. Merck | In Black Hep C Patients, Which Drug Is More Efficacious?


It has been known for decades that people of color bear a disproportionate share of the disease burden from the Hepatitis C virus in humans. [I recall first reading of this, in 1991, in the Wall Street Journal.]

As the race to cure Hep C nears the finish line, Merck is making claims about how effective Boceprevir® is in treating the black population subgrouping in its investigational clinical trial (where the law of small numbers clearly applies -- n: 172 total). Within minutes of Merck's breathless presser this morning, Vertex had answered with one of its own, explaining the Telaprevir® subgrouping performance figures.

How is it that so many people are working press lines on the Saturday of Halloween? Well, the 61st Annual Meeting of the American Association for the Study of Liver Diseases is in full swing, in Boston. It is the most important US conference on the subject, and the spin machines (from both companies) are (fittingly) working at near election-day fervor.

Here, though (near as I can tell), is what sorts out from what is actually known -- on the actual data-sets: Vertex's Telaprevir holds a clear lead on overall cure-rates, in patients who've previously failed treatment -- across all ethnic and racial groups. The two are closer, in "new" patients, people who've never been treated for Hep C -- close enough that it wouldn't be fair to call a clear win for Vertex, though on paper it is ahead, statistically.

Similarly, though both drugs clearly blow away the current 25 percent cure rate for African Americans (on standard therapy), Vertex is again ahead, curing about 60 to 62 percent of this subgroup overall (Merck comes in at 58 percent). Either way, this is a momentus day for the advancement of science: it is fair to say that -- between these two candidates -- some time in the coming decade, we will be calling this conference the moment when "the cure" for Hep C was announced. That's heady stuff.

From the Vertex release, then:

. . . .In ILLUMINATE, 72% of people overall achieved SVR with telaprevir-based therapy. New data from this study showed that 60% of African Americans/Blacks and 63% of people with advanced liver fibrosis or cirrhosis achieved SVR with telaprevir-based therapy in the overall study analysis. Of African Americans/Blacks whose virus was undetectable at weeks 4 and 12, 88% of people achieved SVR in both the 24-week and 48-week randomized treatment arms. There was no control arm of pegylated-interferon and ribavirin alone in ILLUMINATE.

The safety and tolerability profile of telaprevir was consistent in both trials, with low discontinuation rates of all drugs during the telaprevir treatment phase due to adverse events.

"Less than half of people with the most common form of hepatitis C - genotype 1- achieve a viral cure with currently approved medicines, and factors such as race and extent of liver fibrosis can further limit cure rates to less than a third," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, at New York-Presbyterian Hospital/Weill Cornell Medical Center, and the Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College. "After treatment with telaprevir-based combination therapy in the ADVANCE study, 75% of people overall achieved a viral cure. Importantly, 62% of African Americans/Blacks and people with extensive liver disease achieved a viral cure -- nearly twice as many as those who received pegylated-interferon and ribavirin alone. . . ."

Merck's comparable rates are lower, overall, and lower for African-Americans -- at 58 percent, on an "apples to apples" basis.

More on the race to file with FDA, in the next post.

Friday, October 29, 2010

Certainly Looks Like $37 Is "Fully Valued": Goldman Sachs; and Jefferies & Co.


I'd say that, with Merck trading just over $36.20 at midday on the NYSE (on the less than stellar Q3 results -- sales a little light), these bankers called it just right -- Jefferies & Co, and Goldman, Sachs & Co. [But so did I, too -- several months before the calls made by these two.]

. . . .Goldman, Sachs & Co. is. . . suggesting buying puts on Merck as a hedge to long shares through the company's arbitration process.

The analyst believes that the stock is already pricing in a favorable outcome for Merck, noting that options prices are at a three-year low, which makes them a good way to hedge the overdone shares.

The analyst suggested buying the November $35 put for $0.59 on new positions and rolling the previously long Oct. $36 put at this time, which was previously suggested as a long hedge. . . .

Indeed. And we'll have to wait until 2011 for the J&J arbitration answer, most likely.

US Attorneys' Healthcare Fraud Unit/DoJ Vioxx® Settlement To Cost Around $950 Million?


Somewhat immodestly, I would like to point out that I called this one, back in August, as a conceptual problem (inadequate legal expense reserves), in connection with the then-depleted Fosamax® reserves, and then again, last week, specifically about Vioxx®. . . .

From New Merck's Q3 press release this morning, then:

. . . .Other (income) expense was $1.1 billion of expense in the third quarter of 2010, which includes the unfavorable impact of a $950 million legal reserve, compared with $2.8 billion of income in the third quarter of 2009. . . . The company has established the legal reserve in connection with an anticipated resolution of the previously disclosed investigation by the U.S. Attorney's Office for the District of Massachusetts related to Vioxx. Merck's discussions with the government are ongoing. Until they are concluded, there can be no certainty about a definitive resolution. . . .

So, pile another $1 billion, on top of the earlier $4.85 billion in product liability settlement-payments, and even for the No. Two Pharma in the World, with $40 billion plus in annual revenue. . . . nearly $6 billion begins to be a fair chunk of change.

Morgan Stanley Asks My Question Of Peter Kellogg -- Thanks, David!


No real answer given, except that we (as I'd indacted earlier this week) may safely infer that this is a multi-billion problem, should the newly-minted Puerto Rico Law 154 be enfoced, and remain in its present form, on the island. This is courtesy of SeekingAlpha's Q3 2010 earnings call transcript (way, way better -- more accurate -- than my oft-sporatic live-blogging!), this morning:

. . . .David Risinger of Morgan Stanley: The first is with respect to the tax rate outlook, can you just frame how you're thinking about the longer-term tax rate? And the trigger for my question is the tax rate development in Puerto Rico recently. . . .

Answer: Peter Kellogg, CFO: Sure. . . . On the tax rate, obviously we haven't given long-term guidance on our tax rate and articulated obviously there's a lot of different pushes and pulls both ways as you go forward. So that's something that's part of our long-term guidance on the EPS line, but we haven't really broken that out and some of that is because it's not crystal clear. I think on the recent developments that were just announced this week in Puerto Rico, obviously we've made a couple of public statements through PhRMA and so forth and clearly, it's something we need to get understand better. We are clearly disappointed, but on the other hand, we will work with it. . . .

Thanks David!

Thursday, October 28, 2010

The Graves Fosamax® Meta-Narrative Post | Eve Of Trial


It is easy to lose sight of the overall effort Merck undertook to bring Fosamax® to the widest market it possibly could, when looking at the injuries of individual plaintiffs, like Mrs. Graves. But it is critical to keep that larger narrative in mind, when evaluating her claim, as in cases where a drug is aggressively marketed to women who may not need it at all, the emerging common law suggests that there should be some additional responsibility to "first, do no harm." So, I'll let Mrs. Graves' lawyers offer you some of that narrative [click the image at right, to enlarge to reading size], here (from a full 25 page PDF file). [UPDATED: Merck's presser -- in reaction to these stories -- is here. No surprise, here -- Merck predicts the evidence will show that there is no basis for liability.]

As a refresher, then, here is essentially the same information, in a graph (from the Boles I and II trials):



And the below is from Boles II, reciting Merck's own expert's view (Dr. Santora -- as above, now in Graves):

. . . .Dr. Santora’s deposition testimony that there is “no evidence that any drug reduces the risk of fracture in people who don’t have osteoporosis” means that Dr. Santora does not believe that Fosamax provides fracture reduction efficacy in people with a T score above [worse than] -2.5. . . . As the Court has recognized, there “have been several definitions of osteoporosis promulgated over time by different medical organizations,” and some such definitions have included patients with a T-score below -2.0. . . .

[When Dr. Santora] refers to patients who do not have osteoporosis, he is. . . referring to patients. . . with a T-score of [better than] -2.4. . . .

In the [Boles II] case, according to Plaintiff, Dr. Mucci issued a final statistical analysis showing that Fosamax had no fracture reduction benefit for patients with a T score above [better than] -2.5 or for patients who had been on Fosamax for more than three years. . . .



Merck Appeals Boles II To Stop Trial -- On Damages -- In Boles III Fosamax® ONJ Trial


On Tuesday, Merck's Fosamax® ONJ lawyers filed a post-trial memo of law, arguing that Judge Keenan should not proceed to a trial on damages (Boles III) -- but should instead grant an interlocutory appeal (or a "midstream horse change," if you will), while a higher court decides whether there should be any more trials, in Mrs. Boles' case, at all.

These sorts of inter-process appeals are rarely granted. I am providing Merck's memorandum of law, so that you may come to your own conclusions (an 11 page PDF file), but if the goal of these six "bellwether" trials is to assess the damages and begin to evaluate a global settlement posture -- it might be better to know (sooner rather than later) what the Boles III damages might be (including a remote possibility of no damages -- in which case there would be no need for the appeal, at all).

I'll keep you informed.

Jury Selection In Graves' Fosamax® ONJ Bellwether Trial Begins Tomorrow


As both sides get set to pick the next Fosamax® ONJ jury tomorrow in Manhattan, Judge Keenan handed down a new ruling overnight, setting up specific guardrails, called orders in limine -- about what sorts of questions will be allowed on certain contentious matters.

Merck had sought to block lots of the kind of testimony that was admitted in Boles II, and lawyers for Mrs. Graves have asked that any testimony regarding an "appeal to fear" (that Merck might withdraw Fosamax from the market, if Mrs. Graves recovers damages in this case). The fear-mongering thus involves insinuations that if Merck loses, doctors will have fewer choices to treat osteoporosis. Of course, back in June 2010, Amgen's Prolia® was approved by FDA for osetoporosis, so the argument would be. . . demonstrably false, as well. In fact, a whole new generation of osteoporosis drugs are reaching the market, and showing none of the side effects -- decreased bone turnover -- seen in Fosamax (in at least some patients). But of course, none of that is actually at issue -- in this trial. This trial is about whether Fosamax caused Mrs. Graves' injuries -- injuries which required the removal of her lower mandible, or jaw bone, and the replacement of it with a titanium plate structure.

The problem is, Merck has thus far failed to comply with Judge Keenan's orders to provide the lines of questioning it might use. As a consequence, Judge Keenan will have to decide these matters at side bar, in real time, during the trial, disrupting the flow of the testimony. [Merck must believe this will help it -- by creating a less linear, flowing story-line, on why Fosamax is a good drug that ought to remain on the market.] From the early parts of the able judge's order (full eight page PDf file), then:

. . . .Graves moves to exclude "fear mongering" and argument that a verdict for the plaintiff would take a prescription choice away from doctors.

At oral argument, the Court reserved decision in part on this motion because the Court wished to make rulings based on the specific questions that would be posed to [one of the experts]. Thus, the Court ordered Merck to provide the proposed questions. The Court continues to reserve judgment on this motion until it has received and reviewed Merck’s submission. . . .

In this same order, Merck was granted the right to exclude the same sorts of testimony we mentioned earlier in the week, from additional sources.

Stay tuned.

Wednesday, October 27, 2010

Additional Color: Merck's Q3 Release Presaged By AP


Some better analysis is appearing in the MSM this afternoon, on what to expect Friday -- out of Whitehouse Station. It largely reiterates what I've written here -- for months now.

In any event, here it is -- per the AP NewsWires:

. . . .[A]nalysts likely will ask what's happening since arbitration hearings ended a couple weeks ago over the rights to revenue from two lucrative drugs for rheumatoid arthritis and other immune disorders. Schering-Plough splits the revenue with Johnson & Johnson, which now argues that under their contract J&J should get all the revenue since control of Schering-Plough has changed. . . .

If Johnson & Johnson wins exclusive rights to revenue from Remicade and successor drug Simponi, which are on pace for a total revenue of well over $7 billion this year, Merck would lose at least $2 billion a year for years. Even for a company bringing in more than $40 billion in sales a year, that's serious money and would reduce profit for years. . . .

My reaction? It is good to see the MSM outlets getting the order of magnitude right -- finally. Check back on Friday, pre-market -- for live blogging.

Hey! What The. . .? | No More Puerto Rico Tax-Haven Manufacturing -- For Merck?


New Merck (in part via legacy Schering-Plough subsidiaries) operates at least SIX multibillion dollar direct or indirect subsidiaries focused on manufacturing (and some research) operations in the former "tax haven" of Puerto Rico, as PR Law 154 has taken effect.

That's right -- former tax haven.

As Ed Silverman, at Pharmalot has mentioned this morning, legislation was passed over the weekend imposing taxes on multinationals operating in Puerto Rico. Multinationals like Merck.

This is bad, bad news for New Merck, and most other pharma manufacturers, like Abbott, Lilly and Baxter -- all with very deep manufacturing footprints on the island. [Coupled to the law is a measure to vastly reduce taxes on truly local businesses, and residents of the island.]

Unlike, say any "ordinary" equipment manufacturer -- one that could simply pick up and move to Costa Rica, for example (and Puerto Rican authorities know this), pharma manufacturers need FDA approval to switch production to new facilities. MSD has other tax haven manufacturing facilities, in Ireland, for example, but it will take time to get FDA approval to "port over" the drugs, biologics and vaccines presently made "on island". This is plainly a multi-billion dollar problem, but I cannot say how many billions, at present, for New Merck. [Hopefully someone (an analyst) will ask after it, on Friday's Q3 2010 earnings call. Hint. Hint.]

In any event, this is what the Puerto Rico Merck operating subsidiaries' website lists as the footprint there:

. . . .Located toward the northwest of Puerto Rico are the plants of Merck Sharp & Dohme Química (MSDQ), contributing for over 30 years to the economic progress of the island. First located in Barceloneta, MSDQ manufactured the active ingredient in one of our earliest medications for the treatment of elevated blood pressure. Success in Barceloneta motivated the Company to enlarge its operations to the towns of Caguas in 1987 and Arecibo in 1991. In the last years, MSDQ has continued to expand its manufacturing facilities, strengthening its commitment to Puerto Rico. Many of the products destined for the North American market are manufactured in Puerto Rico.

MSD Caribbean has Marketing and Sales offices located in the Industrial Park, Carolina, Puerto Rico. This office markets all MSD products in Puerto Rico and the adjoining Caribbean Islands (Antigua & Barbuda, Aruba, Bahamas, Barbados, Bermuda, Cayman Islands, Curacao, Dominican Republic, French Guiana, Guadaloupe, Guyana, Haiti, Jamaica, Martinique, St. Maarten & Bonaire (Netherlands Antilles), Trinidad & Tobago).

For decades, Merck Sharp & Dohme has been an active part of the Puerto Rico community. Today, more than 2,000 employees proudly belong to one of the top pharmaceutical companies in Puerto Rico. Along with the more than 60,000 employees of Merck & Co., Inc. worldwide, we are dedicated to bringing the important discoveries of the Merck research pipeline to the people of Puerto Rico. . . .

[In addition as of 2006, MSD conducted the following research activities there:] 14 pharmaceutical products in 18 clinical studies protocols at 32 different sites, in 17 research centers spread across four countries (in addition to the possession of Puerto Rico), employing six clinical monitors with 996 randomized patients. . . .

We'll keep you posted, but here is PhRMA's statement on the weekend passage of PR Law 154. It would seem that this measure would also blunt any incentive -- as a further stimulus measure -- the Obama administration might have, at present, to allow tax-free repatriation (at least from the former haven of Puerto Rico). I suspect there will be amendments to the measure, as the longer-term incentive to "de-invest" on the island becomes clearer.

Tuesday, October 26, 2010

The First Few Of The Femur Fracture Fosamax® Lawsuits Start To Appear


This is not surprising, given that we've been following this emerging story for over a year, now. However, the severity of the ongoing injuries sustained -- if a causual link between long-term Fosmax® use, and these low energy, or "spontaneous" spiral fracturs of the thigh bone is established -- will be every bit as (if not more) debilating as the ONJ injury profiles now being seen, in the current set of "bellwether" trials.

In my estimation, full hip replacements, it will turn out, will not be an uncommon outcome. And in many cases, otherwise relatively healthy seniors may never really be able to walk again -- may be largely relegated to a wheelchair, for locomotion. This looks to be as big as the jaw cases. From an early one of these complaints-at-law, filed in New Jersey, but ultimately likely to be transferred to the federal District Courthouse in Manhattan (the full 11 page PDF file) -- click to enlarge, below:



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

Merck's Q3 2010 Earnings Call: Also This Friday, Pre-Market Open


As we mentioned two weeks ago, New Merck reports results Friday. Here is what that might look like:

. . . .[Merck] is seen reporting earnings of 82 cents and $11.24 billion in revenue. A year earlier, the company earned $1.61 a share, or 90 cents minus items like a gain from the sale of its stake in an animal-health joint venture, as revenue was $6.05 billion.

Key Issues: Merck's results will once again be boosted by last fall's acquisition of Schering-Plough. Sales of its key drugs, which had been a strong point in recent quarters, tailed off slightly in the spring, so investors will be looking at whether they rebounded during the summer. The company has also seen pricing pressure in Europe, where national health programs have been cutting prices to help close budget gaps. . . .

All not mentioned, in the Fox Biz(!) pull quote above: (i) whether a settlement will be announced on the J&J arbitration; or (ii) a settlement in these latest ONJ cases (Boles II/III, and/or Graves); or (iii) an update on when the US Hart-Scott-Rodino (Antitrust) and ECC filings might be made on the New Merial venture transactions, with Sanofi -- leading to a more precise estimate of the timing for those divestitures (likely to aggregate north of $1 billion), and any possible final approval of the deal. In any event, I'll live-blog it all.

What Will Graves v. Merck Bring, This Friday? As The Next Fosamax® ONJ "Bellwether" Trial Begins. . .


In Manhattan over the weekend, US District Court Judge John F. Keenan ruled on Merck's motions to exclude various pieces of testimony purportedly to be offered by various of the Plaintiff's experts -- granting Merck the right to exclude a few, but preserving, in my opinion, the heart of her case. These cases are usually "battles of the experts", and it often comes down to whose expert sounds more convincing, in offering his or her opinion testimony. Yes, in these cases, doctors (if qualified as experts on a given matter, by the court) may offer their opinions as to what caused Mrs. Graves' injuries -- and whether Fosamax® use made those injuries worse. Mrs. Graves has had portions of her lower mandible, or jaw bone, replaced with titanium protheses structures -- the anchoring of which, to her natural jawbone, has subsequently failed (at least once), requiring that more of her jawbone be cut out, and new titanium replacements be inserted.

These are pretty horrific facts, and the demonstrative schematics of how the surgeries had to be performed, and the records of her necrosis, are likely to make for very tough-sledding for defense counsel (Merck's lawyers).

Here is the able judge's full Memorandum Opinion, and order (a 24 page PDF file). Several of Mrs. Graves' doctors, or experts, will be permitted to testify, as opinion experts, to the matters indicated below. Although her original prescription was not written to treat "regular" osteoporosis, I do think the fact that Graves was not a smoker (Maley was -- and many believe that confounding variable led to her dismissla) will help convince the jury that she shouldn't be prevented from recovering against Merck solely because she had another concurrnet disease -- RA:

. . . .In June of 1999, Fosamax was approved for the treatment of glucocorticoid-induced osteoporosis (“GiOP”) in men and women. Glucocorticoids are a class of drugs that includes prednisone and other steroids used to treat rheumatoid arthritis [a disease that afflicts Mrs. Graves, the Plaintiff]. . . .

On August 4, 2005, while treating [Mrs. Graves], Dr. James Cherry, a maxillofacial and oral surgeon, formed a “working diagnosis” that Fosamax was contributing to Graves’ condition.

Graves has also been treated by Dr. Douglas Villaret, a specialist in head and neck reconstructive surgery, who performed a radical resection of Graves’ mandible in June of 2006 and a revision surgery in June of 2007. Dr. Villaret diagnosed Graves as having bisphosphonate-associated ONJ using a differential diagnosis. Dr. Villaret reasoned that the only three possible causes for Graves’ injuries, as reflected in her medical records, were radiation therapy, severe trauma, and bisphosphonate use.

Given that there was no record of Graves having suffered from severe trauma or radiation therapy, he concluded that bisphosphonate use was the cause of Graves’ injuries. On August 8, 2007, Dr. Robert Marx began to treat Plaintiff after the fracture of a titanium plate placed in her jaw during Dr. Villaret’s second resection surgery. At the time that Dr. Marx treated Graves, she was no longer suffering from ONJ, but Plaintiff characterizes Dr. Marx as having treated her for the “sequelae,” or resulting injuries, of ONJ. Dr. Marx has testified that he concluded that Graves had suffered from ONJ related to her Fosamax use and based this conclusion on his review of prior doctors’ treatment records. . . .

Unlike many Fosamax patients that were prescribed Fosamax because they suffered from osteoporosis, or osteopenia, Dr. Adams prescribed Fosamax in order to prevent Graves from developing GiOP. . . .

As Drs. Villaret and Akers have provided admissible expert opinion that Graves’ injury was proximately caused by her Fosamax use, Plaintiffs have put forth sufficient evidence to create a genuine issue of material fact on the issue of specific causation. Merck’s motion for summary judgment on this ground is denied. . . .

Keep an eye out, on Friday, to see whether the jury is seated by end of day. If not Friday, then it will likely be Monday, November 1, 2010. Honestly, from where I sit, this one bears many of the earmarks of another large verdict against Merck.

Monday, October 25, 2010

Vertex Update: The Street.com Is Busily "Spinning" A Small Phase IIb Study Anomaly


Adam Feurestein, writing for TheStreet.com, is working himself into a lather tonight -- over a very small Phase IIb study's Hep C viral rebound in one very low dose arm of a Vertex Telaprevir® study.

"Methinks the lady doth protest too greatly. . . ." In any event, here is a snippet from his report -- do go read it all:

. . . .A phase IIb study combining two of the company's experimental hepatitis C drugs -- VX-222 and telaprevir -- had to be modified after viral loads in some patients rebounded during the first four weeks of treatment. The adversely affected patients were being treated with a low-dose of VX-222 plus telaprevir. . . .

The future of hepatitis C treatment is in the combination of new drugs that act powerfully and directly against the virus, eliminating the need for. . . older, established drugs like [legacy Schering-Plough's, now New Merck's] long-acting interferons and ribavirin which work in less than half of patients. . . .

Vertex said on a conference call that viral breakthrough in the low-dose VX-222/telaprevir arm of the study was not accompanied by any safety issues. Patients continue to be treated with a high-dose VX-222-telaprevir combination, also without safety issues. None of the patients in the remaining three arms of the 100-patient study have experienced viral breakthrough, the company said. . . .

As I say, I suspect this will amount to. . . a whole lot of nuthin'. The now-replicated results of multiple Vertex clincial trials point to a better than 75 percent Hep C cure rate in people on these higher doses of Telaprevir.

But I will keep you informed -- either way.

Vertex To File Telaprevir® FDA Application "Within Weeks"


I am surprised -- and happily so -- that the filing of the FDA New Drug Application is only weeks away, now. I was a little concerned that it would slip into 2011. Merck should be very chastened by this Telaprevir® news, by the way. Here is a salient bit of the Reuters reporting:

. . . .Vertex. . . said it plans to seek U.S. approval for the medicine [Telaprevir] in coming weeks. . . .

Telaprevir, from a new class of hepatitis C treatments, is an antiviral drug that is expected to compete with a similar medicine being developed by Merck, called boceprevir. But analysts have been virtually unanimous in their belief that telaprevir is the superior medicine.

Merck has completed phase III trials. . . .

No doubt. It is good to see the unanimity set in stone, by the MSM (as we've long foretold). And importantly, more than one analyst is now calling Telaprevir a $4 billion a year drug -- when it really gets rolling. It is, effectively, a cure for Hep C.

Small Cancer Drug Candidate -- But Mildly Good Mid-Stage Study News: Ariad And Merck


Okay -- the limitations: it's a small study (114 patients); and on a fairly early stage (Phase II) candidate; and it has been stopped early. So we'll not know for quite a while whether there are other reasons to be concerned about any interactions from Ridaforolimus. Still, it is mildly good news, per Reuters reporting:

. . . .Patients taking stand-alone treatment with ridaforolimus, which Ariad is developing in partnership with Merck, went significantly longer without a worsening of symptoms than did patients receiving standard medicines, Ariad said. Half the 114 patients in the study received oral ridaforolimus, while others received either oral progestin or chemotherapy.

Cowen and Co. has estimated the medicine, which blocks a protein called mTor, could generate sales of $250 million in 2015 if it is approved. . . .

So, this simply will. not. move. the needle. at Merck, near term. It is clearly a longer-horizon, non-blockbuster potential drug candidate (at only $250 million per year, and not until 2015) -- but it is good news -- something that's been in short supply lately, at Whitehouse Station.

Merck's 2007 EPA Settlement At West Point: Two Steps Closer To Complete


The Lansdale borough council could vote approval today, it seems.

Recall that, back in 2007, Merck's West Point facility was caught befouling the local waterways with an unpermitted bolus of potassium thiocyanate. To settle with the US EPA, and the New Jersey environmental agencies, Whitehouse Station agreed to pay for, and have built, a "tiny bubbles" scrubber system (cost: $850,000) in Upper Gwynedd township.

Per The Reporter, a local paper, online:

. . . .The project is meant to connect the Merck facility with the borough treatment plant, so Merck could send the borough roughly 300,000 gallons per day of its roughly 1.1 million gallons per day of wastewater.

Upper Gwynedd Township's board of commissioners could vote to approve the plan as soon as Monday, according to borough Manager Timi Kirchner, who thanked the borough staff and Merck and Upper Gwynedd officials who have worked with the borough on the project.

The votes to approve the Act 537 plan and to grant the easement were both passed by unanimous votes of [Lansdale's] borough council. . . .

We'll keep you posted. [H/T: Pharmalot's "Morning Roundup" column.]