But What if I Drool?

A ton of resources at Big Pharma are devoted to developing or licensing drug delivery technologies, for sure. But here's a publicly funded organization putting its money where, well, where its mouth is.

European researchers are developing an orally implantable drug delivery system that could improve compliance in patients on a wide variety of therapies. According to the developers, IntelliDrug, the fake-molar implant works thusly:

The micro-system comprises a medication reservoir and release mechanism, a built-in intelligence, micro-sensors and micro-actuators. IntelliDrug device will be placed in the oral cavity. The medicine is contained in the small reservoir. It will be released in a controlled manner accordingly to patient’s needs, for periods lasting days, weeks or months. The device will be reloaded in a simple non-invasive way. The released medicine will be either absorbed by the oral mucosa or swallowed by the patient.

Actual implant sans toothbrush and smile.

Source: BBC (via Onpharma)

Galvus Misses Its Window; Is this All Good for Merck?

The Galvus delay is terrible news for Novartis.

Competitor Januvia, from Merck, has already seen the single best launch in recent memory for an anti-diabetes product. With a 40% share of new written scrips just four months after introduction, it may be the best launch of any new drug into a crowded category. Given its labelling -- “similar to that reported with placebo” -- doctors are rushing to prescribe what one clinician called a "no-brainer drug": zero training required in administering it; once-a-day dosing, with or without food, with or without any other medication. Once they're comfortable with Januvia, why would doctors switch to anything else, unless they're dramatically differentated?

Originally estimated to be three months behind Januvia, Galvus was already at a big timing disadvantage. Things are now much worse. Galvus seemed to have little differentiation over Januvia before (and therefore little chance of gaining a market-share advantage--now its only differentiation is negative: the skin lesions in primates, linked in FDA's mind to the toxicities seen with the drug at very high doses. That won't encourage doctors to try new patients on Galvus, particularly if, as a number of experts believe, Galvus' label--granted the drug's ultimately approved--comes with restrictions on use.

The potential time bomb for Merck is that Galvus' problems will redound to its detriment--just as the problems around Merck's own Vioxx KO'd Pfizer's Celebrex. FDA's metabolic division has been under severe scrutiny and it's possible they could do the cautious thing and start looking at lot more closely at Januvia. And when they do, will doctors too start thinking a lot more before prescribing what was once a no brainer?

Abbott Joins In: Sales Force too Kos-tly

The conversation over at Cafepharma is even more colorful than usual these days in the wake of news that Abbott is slashing 20% of its newly enlarged pharmaceutical sales force.

After it's $3.7 billion acquisition of Kos we expected Abbott to reduce headcount in sales--much the same way Lilly had little need for Icos' extra infrastructure after it acquired the company last year. Expect more companies to follow suit, as Big Pharma bulk up fading pipelines via acquisition of specialty pharmaceutical companies, or smaller companies with specialty pharma assets.

Shire nipped a potentially similar problem in the bud when it bought New River. Had the companies moved forward with their co-promotion agreement on Vyvanse (New River had previously opted in to this portion of the companies' deal), Shire would have found itself footing the bill for New River's 25% contribution to the cause.

Meanwhile, Abbott's axe falls this Wednesday.

First flagged up at Pharmalot

UPDATE: The AP is reporting that Abbott will also shed 200 jobs in R&D:

The majority of the 200 scientists and researchers to be cut will come from the company's offices in northern Illinois, Abbott spokesman Scott Stoffel said Monday night. The bulk will come from a research unit that deals with the early discovery of treatments for metabolic disorders such as obesity and diabetes, he said.

Right on Schedule

Over the weekend Shire announced approval of Vyvanse, its next-generation ADHD drug licensed from soon-to-be-acquired partner New River.

Once it is launched in the second quarter this year, Vyvanse should quickly inherit ADHD market share from Shire's current leader Adderall XR, for which a soft landing has already been orchestrated via a variety of authorized generics deals. But despite the new drug's approval, despite the $2.6 billion Shire paid for the 50% of Vyvanse it didn't already own, and despite all the talk of potential resistance to abuse, the FDA has recommended to the DEA that Vyvanse join the majority of ADHD drugs as a Schedule II controlled substance.

(editorial aside: is the DEA logo intentionally trippy?)

Shire isn't letting that get them down, and the decision--surely a disappointment to Shire--has been expected for some time. Quoth Shire CEO Matt Emmens in a statement announcing the approval: “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines."
But the authorities' equivocation here won't give Shire much wiggle-room on price and message.

Payday for RJ Kirk & New River

Once again, ally turns to buy.

Eager to land 100% of the two companies' profits from the soon-to-be-approved ADHD drug Vyvanse (formerly NRP-104), Shire Pharmaceuticals bought New River Pharmaceuticals today for $2.6 billion in cash. The broad smile of New River chairman, CEO and founder RJ Kirk, who owns 50.2% of the biotech, can now be seen from space.

Buying out the junior partner on a potential blockbuster is hardly unusual these days--see Lilly/Icos, Genentech/Tanox, and Amgen/Abgenix: partners can be expensive, as we've pointed out before. At $64 per share the deal is a solid one for Kirk and his fellow New River shareholders, though the acquisition premium hardly reaches the heights of previous deals in the space: 10% over New River's closing price on Friday, February 16th and 14% greater than the shares' average over the past four weeks.

Perhaps given New River's backstory, and the company's subsequent growth over the past two years, the size of the premium matters less than the company's spectacular takeout valuation. In the eight years from foundation to IPO, New River was largely funded by Kirk and other managers, acquaintances and friends, and toughed out a tricky IPO market in 2004 before finally raising public funds at $8 per share in a Dutch auction run by WR Hambrecht. Not bad.

Shire consolidates the value of Vyvanse, a probable blockbuster expected to launch in the second quarter of 2007 after FDA and DEA review. The drug has received two FDA approvable letters so far, the latter in December 2006.

Notably Shire is raising $2.3 billion in debt to pay for the transaction (along with a placing of new ordinary shares that should bring in around $800 million) leaving its roughly $470 million cash for additional in-licensing or acquisition deals.

New River's product candidates beyond Vyvanse, NRP290 (in phase II in acute pain) and NRP409 (preclinical, primary hypothyroidism) are non-core to Shire and likely to be out-licensed, though Matt Emmens, Shire's CEO, said today that no decisions have been made.