Legacy Schering-Plough Zenhale® Inhalers Recalled — In Canada Only

February 28, 2015 - Leave a Response

Not material to Merck overall — but noteworthy for its legacy attachment to the Schering-Plough Nasonex® franchise.

Nasonex (a product and brand now owned by Bayer — as part of part of that consumer health transaction) contains the same active ingredient as the Zenhale product in Canada. See graphic at right. Here is the relevant Health Canada notice, in any event — and a bit:

. . . .Merck Canada is initiating a recall of certain lots (see attached list) of Zenhale at the pharmacy/physician level due to the possibility of device malfunction after 24 months shelf-life, resulting in the potential for a patient to receive a lower dose than expected. The company’s investigation has determined that the occurrence of this defect is low.

Merck Canada expects new [inhaler] product to be available in pharmacies by March 23, 2015. Merck Canada will reduce the shelf life of all Zenhale products from 36 months to 24 months. The new product will have a shelf-life of 24 months. . . .

So it goes — all remedied by March 23, 2015. Thus immaterial. Now, here on a snowy Saturday night — going to catch up and see Kingsman. . . .

WHO/SAGE Indicate “No Decision” — On Mass Ebola Vaccinations — Until At Least August 2015

February 27, 2015 - Leave a Response

Clearly, the recent and heartening reduction in the year long outbreak (the world’s worst, thus far) is stretching the time line, but that is net, net, a good thing. And clearly we need to see the immune response is durable in the wild — in the real world. So we will need to be patient here. I am encouraged. And I am sure Merck and New Link are, too. As are GSK and J&J.

Here’s the Reuters bit, overnight:

. . . .WHO spokesman Christian Lindmeier, reporting on a three-day meeting of experts, told a news briefing: “Vaccine introduction is by no means a given and will depend on the results of clinical trials and recommendations from WHO’s Strategy Advisory Group of Experts (SAGE) on vaccines and immunization.

“The earliest that the SAGE is expected to make recommendation on a wide-scale introduction is August. Decisions on whether or not to introduce the vaccine will be made by the respective ministries of health of countries. . . .”

WHO spokeswoman Margaret Harris said: “We know the vaccines are safe, we know they produce a good immunogenic response in humans, but we don’t know if they are effective when you actually have disease in community.”

Guinea, Liberia and Sierra Leone reported 99 new confirmed Ebola cases in the week to Feb. 22, down from 128 the previous week, the WHO said on Wednesday. . . .

So, encouraging declines in new cases continue. . . and Merck will of course “do the right, as it sees. . . the right.” For my part, I’ll keep hoping. . . for “hope is a good thing — perhaps even the best of all things. . . .” Onward.

Jefferies & Co. Continues To See-Saw, On Merck

February 27, 2015 - Leave a Response

The last move from this house was up to $69 — now back to $63 (where, in November 2014, the analysts had it prior to the “breakout” $69 level) — so, the see-saw on near term NYSE price targets for Kenilworth continues.

Always a “Hold” — neither a “Buy” or “Sell”. . .
In the context of other large cap pharma concerns — here is the landscape, at the moment:

. . . .Jefferies Group has also taken action a number of other healthcare stocks recently. The firm raised its price target on shares of Pfizer Inc. from $40.00 to $42.00. They have a buy rating on that stock.

Also, Jefferies Group reiterated its hold rating on shares of Merck & Co., Inc.. They have a $63.00 price target on that stock, down previously from $69.00.

Finally, Jefferies Group reiterated its buy rating on shares of Eli Lilly and Co. They have a $87.00 price target on that stock, up previously from $80.00. . . .

Happy Friday, one and all. Be safe; be warm.

The Company That Acquired Merck’s Boulder Bio Operations — Has Itself Been Acquired — By A Trio Of Investment Companies

February 26, 2015 - Leave a Response

Back in May of 2014, we reported that KBI BioPharma had purchased Merck’s microbial lines API capabilities in Boulder, Colorado. Long before that, we had reported in early-2010 that Merck had itself acquired the facilities from a third party, called Insmed (with additional nuances here).

Here’s the bit from Genetic Engineering & Biotechnology News:

. . . .KBI says its capabilities include delivering expert and integrated process development and cGMP manufacturing of recombinant protein active pharmaceutical ingredients (API). Among clients offering testimonials on KBI’s website are Auxillium Pharmaceuticals (acquired by Endo International for $2.6 billion in a deal completed January 29), DynPort Vaccine (a CSC company), Elusys Therapeutics, Trans Tech Pharma, and UCB Celltech.

KBI expanded to Boulder last year, when it bought the microbial process development and manufacturing operations of Merck & Co. for an undisclosed price. As part of that acquisition, KBI agreed to provide ongoing development and manufacturing services to Merck, as well as to third-party customers. . . .

So it goes — this Boulder bunch has a great pedigree and does excellent science. But it sure has been passed around a bit — and on very short round-trips, too. I’m just sayin’. . .

An Update — On Gilead’s Tax Haven Utilization — For Its Sovaldi® Juggernaut

February 26, 2015 - Leave a Response

Since we have long followed the way Gilead’s Sovaldi® has all but crushed the life out of both Vertex’s and Merck’s last gen Hep C drugs (which were revolutionary in their day), I thought the readership might enjoy an update on how the Sovaldi train is running, ex-US.

Tonight, the Chicago Tribune has a nicely nuanced story — about how effective Gilead has become, in sheltering its Sovaldi income from US taxation. [It shouldn’t entirely escape notice, however, that Gilead’s chief competitor here, Abbott Labs, calls the Chicagoland area home — and so this is a bit of home town boosterism, in a back-handed way. Boosterism, by casting an unflattering light on Gilead’s Irish haven operations.] here is a bit of the Trib story — do read it all:

. . . .The company reported foreign income before taxes of $8.2 billion for 2014, earning more in non-U.S. profits than it recorded in non-U.S. sales. The data released in a securities filing Wednesday suggest that Gilead is taking advantage of U.S. rules that let companies shift valuable intellectual property to low-tax countries, said Robert Willens, an independent tax consultant based in New York.

“Whenever you have huge, very high profit margins and a lot of income as well, it almost always results from the exploitation of intangibles,” Willens said in a telephone interview. “It’s quite a dramatic increase from one year to the other. That’s something you don’t see very often. . . .”

When a multi-national company (with dozens of subsidiaries) records more net income — than sales — in a given non-US geography, it must mean that the US entities in the chain are paying a hefty patent royalty on each dollar of their own sales, in the US — to the patent holding company (usually a parent or subsidiary in Ireland, or a Benelux jurisdiction).

This is plainly defensible for truly ground breakingly revolutionary drugs — the heart of which rely upon extremely valuable inventions, or intellectual property — usually patented.

So it would seem, as to Gilead. Fascinating, and good tax planning — sez me. Land smoothly. . .

NICE To Routinely Reimburse For Merck’s Remicade®: United Kingdom Good News

February 26, 2015 - Leave a Response

While this expansion of coverage probably won’t counter the erosion from bio-similars, it is good news for Merck’s non-US operations. We will keep an eye out for Pound Sterling revenue trend lines, in the first and second quarters of 2015.

Here’s a it, from PharmaTimes:

. . .Merck Sharpe & Dohme’s Remicade (infliximab) and Simponi (golimumab) and AbbVie’s Humira (adalimumab) will be routinely funded on the NHS to treat the chronic bowel condition in patients with moderate to severe disease, significantly expanding access to these biologics.

Around 146,000 people in the UK live with UC, and the new recommendation means that more options are available to patients giving them a greater chance of controlling symptoms “so they can have a much better quality of life,” said Carole Longson, NICE Health Technology Evaluation Centre Director. . . .

Onward — out, into the snow!

Launch Day! — Euro Biosimilar to Merck’s Remicade®

February 25, 2015 - Leave a Response

The estimate is that over the next decade, over $100 billion of value will be transferred away from branded makers, to the bio-similar producers, in the class of biologics overall.

It begins in earnest, for Merck, today. Here is Reuters on it:

. . . .Paul Greenland, head of biologics at Hospira, said that biosimilars are likely to be priced about 20-30 percent cheaper than originals.

Because biotech drugs are made from living cells it is impossible to manufacture exact copies, as happens with simple chemical medicines, so regulators have come up with the notion of approving products that are similar enough to do the job.

Remicade, which has annual European sales of about 2 billion euros ($2.3 billion), and the two biosimilar copies all contain an antibody known as infliximab. . . .

Probably at least a 15 per cent down bubble in sales of Remicade®, over the next three years, in the EU then — for Kenilworth. But it is priced into today’s NYSE quote.

Once Again, Doing Well — And Doing The Good. . . Isentress® Access For Limited Means HIV+ Children Globally

February 24, 2015 - Leave a Response

The Medicines Patent Pool announced this morning that Merck, via MSD, has granted non-exclusive licenses in up to 92 limited means countries, for pediatric raltegravir dosings.

This is both moral, and smart, business. Merck follows on the heels of its iDesign HIV Awareness and patient assistance programs with this humanitarian effort. My hat is off to the team that made it happen. From ABC News, then:

. . . .Drugmaker Merck & Co. has granted a free license allowing one of its HIV medicines to be made and sold inexpensively for use in young children in poor countries hard hit by the AIDS virus. . . .

The deal, announced Tuesday, lets any generic or brand name drug manufacturer make low-cost pediatric versions of Merck’s raltegravir for sale in 92 low- and middle-income countries, according to the Medicines Patent Pool. The group, backed by the United Nations, works with brand-name drugmakers to find ways to make their HIV medicines still covered by patents available in developing countries for a fraction of the price charged in Europe or the United States. . . .

Of course, MPP officials have renewed their call for Merck to make the life-saving drug available to adults, under a similar license. I don’t expect that Kenilworth will agree to that. There is just too great a risk of it being pirated, and resold in the post industrial world — undercutting Merck’s perhaps $1 billion invested in bringing Isentress® to market, globally.

Ed Silverman: New Merck’s “Old School” Biotech Collaboration — With NGM Biopharmaceuticals

February 23, 2015 - Leave a Response

More later — but this is fascinating. Up to $450 million over five years — and a “go wherever your head & gut lead you” mandate. Amazing.

LATER UPDATE: Here is a rather breathless account of the deal’s back and forth — from Bloomberg. I’ll not need to add. . . anything to that link. I guess Roger has known the NGM folks since at least 2004, at Amgen.

In any event — from that gent, Ed, who had it first — at Pharmalot, then:

. . . .Merck will provide a $94 million upfront payment and a $106 million equity investment for a 15% stake, and also fund $250 million of NGM R&D projects over the next five years, although NGM has full authority to control R&D. Merck R&D chief Roger Perlmutter and NGM chief scientific officer, Jin-Long Chen, by the way, once worked together at Amgen. . . .

Off to court, and other sundry duties!

How The Mighty Have Fallen. . . Part Two: Fred Hassan Founder & Chairman Of (Wait For It. . .) A “Peppermint Oil” Company

February 22, 2015 - Leave a Response

As ever, picture is worth 1,000 words — so I offer one, at right. And, still no clinical trial proving his delivery system provides any real world benefit over a drop or two on the tongue. [I just checked again this morning.] So, the $25 for about two weeks of supply. . . is in my opinion — outrageous. From my earlier piece — in June of 2014, then:

Of course. . . not all homeopathic remedies are without merit. Far from it. Some are as effective as FDA approved drugs, at a fraction of the cost. And there is some research suggesting that peppermint oils (properly delivered) might calm upset stomachs. [But I’ll flat out guarantee you there is no peer reviewed research of any kind — showing that Fred Hassan’s delivery system here — micro-beaded capsules — actually achieves any positive clinical outcomes, beyond that of a few pennies a dose, in the form of a drop or two of ordinary peppermint oil, on the tongue. If he had it — he’d tout it, to the high heavens! Trust that.]

So, what is truly beyond the pale, here — in my opinion — is the price ($25 for 48 capsules!?!), and the pseudo-science in which “Fast Fred” drapes his latest “medical food” — actually something more akin to a nutri-ceutical, if the truth be told. But FDA is taking a hard look at nutri-ceuticals. Fast Fred is likely trying to “fly under the radar,” here — by calling it a medical food.

I might ask Fred “How many foods require that they be consumed ONLY under a doctor’s close supervision?” Doesn’t that contradict the idea of GRAS? How is that “generally recognized as safe“? An overdose of purified, concentrated menthol in the gut can lead to several serious side effects. No mention of those, on this slap-dash website.

As I say — this is quite a come-down for Mr. Hassan — yet, it does give us a very clear window, to where his head has always been: snagging the hucksters’ fast buck – then moving on, when the regulators show up. And show up, they will. [My guess is that his former GC, Sabatino, helped him get it on the shelves at Walgreens. But that’s just. . . a guess. And now, Sabatino has moved on to. . . Hertz, anyway. Revolving doors. . . .]

Note that Mr. Hassan is listed (by a laughingly-inane asterisk) as the “non-executive” chairman of this joint. I am sure the others associated with this company, genuinely want to help patients. They have simply put their careers in the hands of the wrong “expert” here. Mark my words, Fred will slip away, saying he had no real responsibility for any regulatory matter, when the FDA shows up for a site visit. His openly making of a medical claim (without accompanying proof, of any kind) in this YouTube “infomercial (this is truly priceless — so amateurish!) just gave FDA clear jurisdiction, trust that. [See it, at about 1:21 onward. . . in the video.] Fred is likely telling IBGard staffers that FDA has no right to come in and tell “us folks” what to do. He is just mistaken about that, in my experienced opinion. So it goes. Pretty. . . hilarious.


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