And Merck Keeps Posting Very Impressive Next Gen Hep C Study “Wins” — This Time, In HIV/HCV Co-Infected Patients

April 24, 2015 - Leave a Response

Once again, overnight, Merck has made headlines in Vienna Austria, at EASL — this time blowing the doors off of its own prior generation successes in treating Hep C patients who also happen to be HIV positive. And that is a not-too-surprisingly common occurrence — that sort of co-infection.

Again — as we said yesterday, AbbVie is steadily grabbing US market share from Gilead, by convincing the payers (and benefit managers like ExpressScripts) to steer patients toward, and effectively choose a less convenient, longer course, at a cheaper all-in price — over the shorter duration, but higher priced offering from Gilead. Both of them will soon likely have to face Kenilworth in the market, too. Prices will head south. That’s a certainty. Here’s a bit:

. . . .Merck today announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1 4 or 6 (GT1 4 or 6).1 Patients in both the HCV infected treatment-naïve (C-EDGE TN) and HIV/HCV co-infected treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218 respectively). In addition HCV infected treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105) respectively and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105) respectively. These data were presented at The International Liver CongressTM 2015 – the 50th annual congress of the European Association for the Study of the Liver (Abstract #G07 E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today. . . .

So have a great Friday — and watch Merck tear it up, here. . . a lil’ late to the party, but posting entirely stellar results.

That Gent, Ed — Over At Pharmalot — On Gilead’s Latest Hep C “Social Experiment Cure” In Former Soviet Nation

April 24, 2015 - Leave a Response

I think it is laudable that Gilead is even thinking of doing this. The immediate commitment is to 5,000 patients, but the goal — in this rugged, rather isolated mountainous region — is to arrest the virus, and perhaps eliminate it — along with the debilitating secondary effects, from an entire country. That’s going to be over 120,000 free courses of treatment.

I’m no epidemiologist, but perhaps Gilead picked Georgia because not many people travel there, and then leave, given the rugged terrain. Thus reinfection rates, from tourists, for example, might be minimized. [Rather sadly, I do have to wonder why a similarly rugged region of Africa was not chosen, for this social experiment. Certainly, the burden of disease is similar, in some Africa nations.]

Gilead I gather thinks governmental forces in Georgia might ultimately reimburse it, or that other Central Europeans might take note — and reimburse, country, by country. As we’ve reported — the company in March of 2014, dropped its price from $1,000 a pill to $10 — in Egypt and up to 91 poorer nations. [Of course, some generic manufacturers are launching “at risk” in many of these countries at prices even below that.] I will keep track of this, as it would be quite a feat to eliminate the scourge of Hep C from an entire geography. Here’s a bite from Ed Silverman — do go read it all:

. . . .Nearly 7% of adults in Georgia are estimated to be infected with hepatitis C, according to the World Health Organization. Alton believes as many as 120,000 people may be infected, which is a sufficiently small population to gauge the effects of the program in a few years.

Alton maintains this is “not just a charitable project. We really see value in the data that can come out of this. . . We want to show if you treat everybody you’ll reduce prevalence of the disease.”

Alton acknowledges, though, that the results may favorably influence reimbursement decisions and guidelines formed by government agencies. The program, by the way, has the backing of the U.S. Centers for Disease Control and Prevention. . . .

I genuinely applaud Gilead management here. Scantly sleeping, of late. Oh well. Onward.

Euro UPDATE: Merck’s All Oral, Ribavirin-Free Combo Pill — For Type 1 Hep C Patients, With Advanced Kidney Disease Hits A Home Run!

April 23, 2015 - Leave a Response

MRK-C-SURFER-2015 Well, I think it is finally time to say that Merck is serving notice — on Gilead’s Sovaldi® run-away lead in the Hep C market. This will, in time lead to solid head to head competition, for all genotypes of Hep C patients, I’ll brashly predict.

Just a few minutes ago, in Vienna, Austria at EASL — in the middle of the night here in the US — Kenilworth announced that 99 per cent of these studied patients achieved SVR (or sustained viral response) at 12 weeks. A few weeks ago, I had guessed it would be over 90 percent — but I didn’t see the cure rate hitting the 99th percentile. [The Abbott spin-off has an solid entrant here, as well — so prices are destined to come down, for certain.]

C-SURFER is the name of the late breaker EASL presented study, and since Merck has re-won breakthrough status at FDA (on a subset of genotype 1, and genotype 4), this could lead to an approval, in these subsets, in just a few weeks’ time. No promises, but it could — sporting a nearly-perfect cure rate.

. . . .Merck today announced the first presentation of data from C-SURFER, the company’s Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1. . . .

Of the 122 patients who received grazoprevir plus elbasvir, 83 percent were treatment-naïve, 36 percent had diabetes, 18 percent had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were receiving haemodialysis and 45 percent were African-American. Among those patients who received at least one dose of grazoprevir plus elbasvir, five percent (6/122) were excluded from the pre-specified primary efficacy analysis population, or modified full analysis set, due to missing data caused by death or early discontinuation for reasons unrelated to study drug. In the modified full analysis set, 99 percent (115/116) of patients receiving grazoprevir plus elbasvir achieved SVR12. One GT1b infected, non-cirrhotic, interferon-intolerant patient showed a viral relapse at follow-up week 12. Within the modified full analysis set, efficacy was consistent across the patient sub-populations assessed. In a supportive analysis of all 122 patients who received at least one dose of grazoprevir plus elbasvir in the ITG arms, including patients who did not complete the study for reasons not related to study drug, 94 percent (115/122) of patients achieved SVR12. . . .

Onward — it is truly a new day (well. . . almost). Yeah, this news roused me from a sound sleep. It was entirely worthy of the ungodly early wake-up call!

Fascinating “DIY” DNA Sequencing Battles: Upstart Color Genomics Vs. Upstart 23andMe Edition

April 22, 2015 - Leave a Response

You will recall that I have been paying rather close attention to the winding path the $99 DNA spit test company called 23andMe is now traversing at FDA. I was an early adopter in mid 2013 — prior to the FDA clamp-down on health related DNA data, there.

Fast forward to this week. Color Genomics has launched a more expensive spit test — at $250 per kit — and is focusing on heritable breast cancer risks (and thus targeting women). [Color is backed in part by Steven Jobs’ widow — ironic that 23andMe is led by the separated wife of a Google founder.] In any event, even as 23andMe seeks FDA approval to once again provide that very same data to people who’ve previously bought its spit kits, Color has launched using on-staff doctors to “administer“, and then refer test results to the “patients” who’ve bought their kits.

The claim here is that the staff doctors are using a medical test, inside their own offices, and are thus exempt from the more stringent FDA approvals — for a new so-called 410K diagnostic device (under FDA’s jurisdiction). I truly will enjoy watching this, but it will likely be “game over” for Color, should 23andMe ultimately get an FDA green light — on their DTC (direct to consumers) health data related to these same breast cancer risks. Here is a bit of the blogosphere, on Color’s launch — for background mostly:

. . . .Color Genomics, is backed by well-regarded industry investors, including Khosla Ventures, and Laurene Powell Jobs, Steve Jobs’ widow. The story of a well-connected Silicon Valley personality diving into direct-to-consumer genetics testing is of course a familiar one. Anne Wojcicki, wife of Google co-founder Sergey Brin, launched 23andMe to offer a nearly identical service, only to be shut down by the FDA for presenting consumers with risk profiles that the FDA said had not been exhaustively validated. 23andMe’s regulatory [path is] ongoing, and the company is actively pursuing new monetization strategies that minimize its reliance on consumer-generated revenue. [Ed. Note: Actually 23andMe is relatively close to validating their tests — and clearing FDA, to provide the same service Color claims to provide, at 40 per cent of the price of Color — with a wider array of test results.]

. . .Color Genomics is attempting to circumvent the. . . direct-to-consumer FDA requirements by insisting that only doctors order their genetics tests, putting them in the same class as other private laboratory providers like Quest Diagnostics. What differentiates Color Genomics from Quest Diagnostics is that if a consumer wants a genetic screening from Color Genomics, the startup has doctors on staff that can order the test on behalf of consumers, providing a loophole that will essentially allow them to market their genetic testing direct to consumers via an employed physician that will order the test and then explain the results. . . .

We will stay tuned — and I do generally applaud the idea of democratizing our own genomic data — but I think the pitch Color is using is a little over the top. Color argues that every woman over 35 in the US ought to pay out of pocket to get their spit test. In families with a history of breast cancer, I might agree. But clearly Color simply wants to cut a wider market-swath — with that breathy rhetoric. Anyone care to take the other side of the argument? Anyone? . . . Bueller. . . Bueller. . .

BREAKING — Whitehouse Station (Former HQ) Is Now Under Contract: NJ.com

April 22, 2015 - Leave a Response

This is good news — we all should hope it proceeds to a closing. Let us also hope that the buyer(s) will not remove it from the local taxable census of properties. In 2014, taxes on Merck’s portion were about $5.8 million — the single largest taxable property in that New Jersey township.

Here is a NJ.com piece on it:

. . . .The company placed the hexagonal-shaped main building and less than half of its 1,000-acre corporate campus on the market in October 2013, listing it with real estate company Cushman & Wakefield. Merck retained a smaller office building and about 550 acres at routes 22 and 523 near Route 78.

Since then, Merck also listed its Summit facility, consolidating operations at its Kenilworth site. . . .

In late 2012 Merck announced that it would move its global headquarters from Readington.

The main building is a five-story granite and glass structure with a five-acre courtyard. It includes a 900-seat dining area overlooking the courtyard, a 250-seat auditorium, a full fitness center and 35,000-square-foot data center.

The corporate campus includes a 17,000-square-foot childcare center, a solar “farm,” basketball and tennis courts, a ball field and a helipad. . . .

As my recent (2015) bylines repeatedly suggest, Merck now uses the legacy Schering-Plough HQ in Kenilworth as its home. The Kenilworth property was, about five years ago, now — also on the market. But that selloff plan was abandoned. Overall. . . most encouraging! Onward.

Sharp Overall Two Year Decline, In Lobby Spend Continues, At Kenilworth, In Q1 2015

April 22, 2015 - Leave a Response

While the first quarter of 2015 is up, just marginally, from the first quarter of 2014, the four year trend is unmistakable: Merck is decreasing its lobby spend, to about half of the all time highs seen in 2012 and 2013 (six full years’ data background here). The first quarter data clearly backs this general thesis. [Even so, Merck this quarter spent well over double what Apple spent, in Q1 2015 — a trend I’ve also noted before.]

Here is what the bulk of the Q1 2015 spend went toward:

. . . .Issues relating to the further development of antibiotics and antimicrobials for serious and unmet medical needs; H.R. 512, DISARM Act of 2015 (Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015). . . .

Medicare Coverage and Reimbursement issues; Medicare access to DXA services; Medicare reimbursement for antimicrobial drugs, including related provisions in HR 4187. . . .

Diabetes Prevention & Treatment, including related provisions of HR 3322, The Eliminating Disparities in Diabetes Prevention, Access and Care Act of 2013 and HR 074, The National Diabetes Clinical Care Commission Act. . . .

Potential legislation or legislative provisions relating to Medicare Part D and the establishment of a Medicaid style mandatory rebate on prescription drugs); H. Con. Res. 27, Establishing the budget for the United States Government for fiscal year 2016 and setting forth appropriate budgetary levels for fiscal years 2017 through 2025 (potential provisions relating to Medicare Part D and the establishment of a Medicaid style rebate, NIH funding provisions drawing funds from BIO/PhRMA industry government settlements, or other Medicare revenue raising provisions); S. Con. Res. 11, An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2016 and setting forth the appropriate budgetary levels for fiscal years 2017 through 2025 (potential provisions relating to Medicare Part D and the establishment of a Medicaid style rebate, NIH funding provisions drawing funds from BIO/PhRMA industry government settlements, or other Medicare revenue raising provisions). . . .

H.R. 2 – Medicare Access and CHIP Reauthorization Act of 2015; H.R. 1470/S. 810 – SGR Repeal and Medicare Provider Payment Modernization Act of 2015; no specific bills, access to contraception, biosimilars guidance, immunization access; general budget resolution, reconciliation, deficit reduction, debt ceiling; H.R. 83 – Consolidated and Future Continuing Appropriations Act, 2015; H. Con. Res. 27 – House budget resolution; S. Con. Res. 11 – Senate budget resolution. . . .

Trade Promotion Authority; Trans-Pacific Partnership; Issues relating to vaccines; Orphan drugs. . . . .

Separately, for the first time (if memory serves) Merck disclosed that it had hired the Barbour Griffith & Rogers, LLC lobbyist firm (yes that Barbour!). That firm will provide “guidance and strategic counsel with regard to regulations and legislation that could impact the pharmaceutical industry generally, and Merck, specifically.” So they are sort of a quarterback for the others, I gather. Or maybe, that engagement comes as a package as Mr. Frazier accepted the Chairmanship of PhRMA for 2015-2016. Now you know — or, at least, my best guesses. Busy day — in the real life gig, here — will likely be silent for the balance of the day.

Orion Has Captured Half The Norwegian Market For BioSimilar Remicade® — In Two Months!

April 22, 2015 - Leave a Response

This very morning, Bloomberg claims Kenilworth is being bullied, in Norway. Me? I’m not so sure (i.e., how big is Norway, to the full EU, anyway?). First off, we do know that both Hospira and Celltrion had long ago entered, with their biosimilar (or “bio-better”!) versions of infliximab (which Merck and J&J brand as Remicade®), in the EU more broadly. So, one other perspective would be that Orion is simply doing in Norway what a generic would normally do, there — as the third party in. Orion is grabbing share by slashing price. And even so, this is likely immaterial to Merck — since the decline was previously well-baked into Merck’s NYSE price, two months ago (per our coverage in real time, then).

As additional evidence of this, here is Ed Silverman’s nuanced and experienced analysis:

. . . .A price war is under way in Norway where Orion Oyj slashed the price for a copycat version of the Remicade arthritis medicine that is also sold by Merck and the 69% reduction paid off swiftly: by last month, Orion grabbed half the market, Bloomberg News reports. The discount has irked rivals. Hospira, which sells the same copycat version of Remicade under a different name, says the markdown will prove too massive to sustain. Hospira and Orion both license the drug from South Korea’s Celltrion.

Merck is urging doctors to be cautious about switching patients. . . .

Even if Orion can’t stay at a nearly 70 per cent discount to Merck forever, it is certain that sales of Remicade will never recover, for Kenilworth. This is a melting ice cream cone, at the revenue line. Even so, Merck will be fine without the full muscle of Remicade on the oars. . . the sculling will continue, no matter what. Onward. Life is indeed. . . just. . . too short — to spend any more time worrying — about the things outside our grasp.

After A Rather Checkered Past Five Years, Merck Makes Important New Vaccine Investment — In Ireland: Carlow

April 21, 2015 - Leave a Response

We have covered the fallout from Fred Hassan’s overpromise/underdeliver antics, on the Emerald Isle, lo’ these past seven years, at least.

So it is wonderful to see Kenilworth putting even a modest amount of new capital to work, inside Carlow — a world-class biologics facility — and now, a fine vaccines facility. [A few years ago Merck put almost $335 million in to modernize the facility, as legacy Schering-Plough withdrew from Rathdrum, in County Wicklow.] It would make sense to manufacture the Ebola vaccine there, inasmuch as that is a low cost jurisdiction, and Merck will need to get the very lowest cost structure for that candidate to make a profit, in the still-developing world — where the bulk of it will be sold. No published report indicates that this is behind Merck’s thinking — it is purely my (experienced) conjecture. Here’s a bit, from FiercePharma Manufacturing — do go read it all:

. . . .Merck, known as MSD outside of the U.S., said last week that it would invest €11.5 million ($12.4 million) in the Carlow facility. In an announcement, the company didn’t specifically line out how it would invest the money at the site where it has a 200,000-square-foot manufacturing facility but in an email, a Merck spokesperson said the “infrastructure” investment” will include a training facility. There are no new jobs coming at this time from the “phased project,” the spokesperson said but about 440 people currently work there.

MSD pointed out Carlow is its first standalone human vaccine facility. . . .

Carlow is also supporting the Kenilworth effort to ramp up Keytruda®, a very promising oncolology monoclonal antibody — and that tech will lever nicely, in manufacturing an engineered Ebola vaccine inserted into a cold livestock virus container/casing. Onward, one and all!

Will Roche/Genetech Pivot Hard, Drive The Lane — And Snag “First Mover” Anti-PD1L Rights In Certain Breast Cancer(s), This Fall?

April 20, 2015 - Leave a Response

To be sure, Merck’s three pieces of monoclonal antibody Anti-PD1L good news created quite the buzz at AACR, yesterday afternoon. I do still believe that BMS’s Opdivo® has the lead in all cancers, for at least the next 12 months. I’ll explain why, at the bottom of this post.

In the mean time, though — there is some very exciting news for Roche. It seems that Roche’s early results with its MPDL3280A, also a PD1L monoclonal antibody (like Merck’s) — in breast cancer — will allow Roche to take its breakthrough designation straight to an approval filing at FDA as early as this summer. So, will Roche be able to crash the lane, and lay one in (or even throw down a dunk?!) in some of the most aggresive breast cancers, effectively “posterizing” both Merck and BMS — for at least this $5 billion segment? We shall have to watch and see. Here is the latest Bloomberg note on it all — do go read it:

. . . .In an early-stage trial of people with an aggressive form of breast cancer who took the experimental Roche drug called MPDL3280A, tumors shrank in four of 21 patients, with cancer disappearing in two cases, according to findings announced Monday at an oncology meeting in Philadelphia. . . . While Merck and Bristol have already won regulatory approval for immunotherapies — Keytruda for melanoma in Merck’s case and Opdivo for melanoma and lung cancer in Bristol’s — Roche has a strong track record in cancer research and development that “may translate into commercial differentiation,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. . . .

About 15 percent of breast-cancer patients have the triple-negative type studied in the trial. In that form of the disease, tumor cells don’t have estrogen and progesterone receptors, and lack extra HER2 proteins. MPDL3280A would be used along with chemotherapy, which is now the primary treatment option. . . .

Even so, as I said at the top, BMS is the one to beat. I am increasingly hearing from oncologists at teaching hospitals that a few government programs are agreeing to cover so called “off-label” use of nivolumab.

It is that good — and it is being used, right now, to fight a wide array of cancers, in clinics all over the nation. While the government payers (Medicare/Medicaid) aren’t reimbursing at full retail rates, for the off-label cancers, the trend is in the right direction. I wonder how long it will be before private insurers will no longer be able to resist coverage for these revolutionary agents — even prior to full FDA approval of them for — say end stage kidney, liver or breast cancer.

I think the field is wide open, but BMS’s Opdivo has the clearest lane to the hoop, and victory now. Merck had better get its specialist detailers in gear, and offer the oncologists the recent evidence that reimbursement is happening, even off-label. That would be very good for Kenilworth’s Keytruda® ramp up, here in the latter parts of 2015. [Ed. note: fair use, and transformative/derivative use claimed (under applicable US common law) for Jill Laufer’s fine CGI (a video, from which that single antibody still was derived, in my image), all on the Roche candidate called MPDL3280A, above.]

As ever, we shall watch and see.

As Predicted, Merck Has Filed Its sBLA With FDA — For Breakthrough NSCLC PD-L1 Indication, On Keytruda®

April 19, 2015 - Leave a Response

On the heels of the disclosure of its strong NSCLC data — in patients whose tumors predominantly express PD-L1, at AACR in Philadelphia this morning (and in the prestigious New England Journal of Medicine) — Kenilworth just said it had recently filed a supplemental biologics license application with FDA, for those sorts of patients, with that variant of lung cancer.

This is exactly as I suggested Merck would, the day after St. Patrick’s, this year. And yes, this is good news. Here’s a bit:

. . . .”In this study, NSCLC patients whose tumors express PD-L1 in the majority of their cells experienced the highest response rates to KEYTRUDA treatment,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “The results from this study formed the basis for our Breakthrough Therapy designation and our recent FDA submission for advanced NSCLC, and indicate that tumor PD-L1 expression may be a relevant biomarker to identify patients more likely to have higher rates of response to KEYTRUDA in this tumor type. . . .”

Merck recently announced that the company submitted a supplemental Biologics License Application (sBLA) for KEYTRUDA in advanced NSCLC with the U.S. Food and Drug Administration (FDA). Under PDUFA, the FDA has 60 days from submission of the sBLA to determine if the application will be accepted for review. KEYTRUDA was granted Breakthrough Therapy designation in advanced NSCLC by the U.S Food and Drug Administration (FDA) in October 2014. . . .

In addition, Merck expects to file by June 30 with FDA to list Keytruda® as a first line melanoma therapy. [Merck does hold third line FDA approval already, in melanoma, for Keytruda.] All good — and still, BMS holds a clear timing lead here. And so. . . Onward! Do have a blast, one and all.

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