Domain Invest

  • Subscribe to our RSS feed.
  • Twitter
  • StumbleUpon
  • Reddit
  • Facebook
  • Digg
Showing posts with label co-promotes. Show all posts
Showing posts with label co-promotes. Show all posts

Tuesday, 13 November 2007

Co-Promotes are Out. Extra Royalties are In

Posted on 08:50 by Unknown
Heave a sigh of relief, Big Pharma. Co-promotes are on the way out. At least, according to Ben Bonifant, VP at consultants Campbell Alliance, who was speaking on a panel at Bio-Europe in Hamburg on Monday.

Co-promotions with small biotech partners have been a bug-bear for Big Pharma ever since they’ve been forced to concede them—or at least options for them—in what remains a sellers’ market. As we reported in depth in this IN VIVO feature, Big Pharma hates the thought of sharing promotion with their (usually inexperienced) licensing partner. Launching a product is hard enough, goes the argument. We don’t need the distraction of trying to coordinate with and train relative novices.

Small wonder, perhaps, that many past examples of co-promotes—like the Eli Lilly/ICOS joint venture on erectile dysfunction drug Cialis—have turned into acquisitions. Indeed, Lilly got a good deal. Poor old ICOS put so much resource into its share of promoting Cialis that it wasn’t able to build up a supporting pipeline. The stock fell and Lilly struck. (No need to spell out the lessons in there.)

Nowadays, acquisitions may pre-empt a co-promote being put into practice at all. One of the last things Abgenix was doing before being snapped up by Amgen was preparing to trigger its co-promote option on panitumumab (Vectibix), according to Gayle Mills, former SVP Business Development at Abgenix, now EVP Business Operations at Roxro Pharma and the panel moderator. “I believe that this was the straw that broke the camel’s back,” she told the audience in Hamburg. (The original deal, which included a manufacturing component, was signed between Abgenix and Immunex in 2000.)

In future it may not get to that. Many newer generation biotechs are embracing a ‘let’s get to proof-of-concept and no further’ model, wherein co-promotion rights aren’t relevant anyway. Returns from Phase II deals are good enough, say their investors; why take on further cost, and risk?

Indeed. But no biotech should forget that relinquishing a co-promote—whatever the likelihood that it would be exercised—is a bargaining chip these days in any deal negotiation. What’s it worth? A couple of royalty points, at least, according to panellist Rob Wills, VP Alliance Management in Johnson & Johnson’s pharma group.

How does he know? Well, because when a smaller partner’s taken over, that’s about what Big Pharma might typically agree to give back in return for cancelling the co-promote. It’s all in the change-of-control clause, in other words.

As the panel pointed out, though, some biotechs may not want to wait for royalties (lovely as they are, falling straight to the bottom line, ‘n all that). They want earlier rewards—like some more upfront money, or beefier milestones. For now, “we don’t see situations where, if a co-promote is taken off the table, the biotech gets X more dollars,” noted one panelist. That could soon change.

Now granted, co-promotes—real, exercised ones--aren’t going to disappear completely. But there are other ways to share commercialization besides straight co-promotes. “It would be wiser to abandon the traditional view of a co-promotion and call it something else—such as a co-sell--taking away the idea that you’re co-launching the same drug,” proffered panellist Louis Scotti, VP Marketing and Business Development at Arena Pharmaceuticals. What he meant was, there’s scope for a smaller partner to come in later, a couple of years’ post-product launch, for instance. The partner can then add to the commercialization effort, perhaps by targeting a specific customer group, and avoids the costs and risks associated with setting up a sales force ready for regulatory approval--whose timing is notoriously uncertain.

There’s a good precedent for this model, pointed out Wills, albeit an old one. In Alza’s deal with Janssen on opioid patch Duragesic (before Alza became part of J&J), Alza came in three years’ post-launch, making incremental calls to a specialist audience. Look out for similar set-ups in future, remarked panellist Timothy McBride, SVP Business Development for Cerimon. “We envisage promotion based on specialist markets, with Big Pharma going to the broader audience,” he said, although without commenting on timing.
Read More
Posted in alliances, co-promotes, mergers and acquisitions, royalties | No comments

Wednesday, 10 October 2007

$80 million upfront? About Average

Posted on 13:20 by Unknown
So Synta’s PR firm were pushing today’s deal with GlaxoSmithKline at us as “one of the biggest product deals this year” and indeed “among the largest in the industry”…and it’s true, the $80 million cash up front deal for an anti-cancer compound that’s entering Phase III isn’t at all bad.

But $80 million up front isn’t off the scale, either. In fact, it’s looking about average these days for an asset on the cusp of Phase III—Merck in July paid Ariad $75 million up front for its cancer compound, Novartis put the same on the table for Antisoma’s similar-stage oncology asset in April, and outside of cancer, GSK paid $75 million for XenoPort's Phase III RLS compound in February, Shire that same magic figure for Renovo’s late Phase II wound care treatment in June.

Indeed, $80 million even begins to look measly alongside the $102 million that GSK forked out for Genmab’s Phase III antibody, or the $165 million that Johnson & Johnson coughed up for ex-US rights only to Vertex’s then-Phase IIa Hepatitis C gem.

Ok, so these were outliers. Genmab’s contained the antibody premium; Vertex’s was special, too. But the point is, three-digit up front payments for late-stage assets will soon be common, so don’t waste the hyperbole.

And don’t forget to look behind the curtain, either. Milestones: “Up to $1.01 billion in potential payments," our PR friends say. We all know this trick, though. That’s the if-everything-goes-to-plan-across-all-indications-and-the-moon-goes-blue (or biodollar) figure. Think $135 million in pre-approval milestones.

This, according to Synta’s CEO Safi Bahcall, is more than enough to cover the costs of the compound’s Phase III trials and US submission, which Synta stays in charge of.

And that—control—is the bit that’s interesting in this deal; more interesting than the amount of cash that’s changing hands (most of which GSK can capitalize, incidentally--so it doesn't immediately hit the P&L and thus crimp any R&D budgets). Synta will pay for and finish Phase III, and take the compound past the US regulators for metastatic melanoma. That allows the biotech to boast about the “confidence GSK has in our ability to conduct a pivotal trial and register the drug,” as Bahcall explained. But it also allows GSK to hedge risk and be absolutely sure the compound gets past regulators in the first indication before committing any of the $300 million of potential commercial milestones, or much of the $450 million in potential development and regulatory milestones in other cancers.

Still, Bahcall’s right in saying that “it’s unusual, given GSK’s experience, that they allow us to take the lead” in development and regulatory. Typically Big Pharma would want to take the reins, re-do the Phase III trial design and start talking to regulators. (Especially, you might think, given recent biotech casualties at FDA like the one that hit GPC Biotech when it tried to get satraplatin past.) Not this time—no doubt the compound’s fairly straightforward clinical trial design, with an objective end-point of progression-free survival, helped.

And if Synta gets the drug past regulators, it gains credibility in the next stage of the relationship: co-commercialization. That feature’s about average, too, for deals these days—many biotechs want to have their own sales forces, despite all the future problems and complexities and costs those forces bring.

In reality, pharma-biotech co-promotes are usually a nightmare, as we discussed in this IN VIVO feature. But Bahcall’s confident that the partners have learnt from what’s gone before, with specific prescriptions and conditions for how the co-promote would work, plus measures to ensure that Synta doesn’t lose out on the tiered profit share, thought to start at 40% and rise to 50%, based on annual net sales. (Profit shares can bite small partners if pharma ramp up their cost of sales to reduce what’s left to distribute.)

There are also provisions in the deal, according to Bahcall, allowing for Synta to assume more responsibility for commercialization in the future—once the drug has been out there for a couple of years, for instance (IN VIVO Blog speculation, not his comment). In other indications, the partners will share development in and outside US, with Synta eligible for double-digit royalties on ex-US sales.

Don't get us wrong: for all our talk of 'average', Synta’s got a good deal, all the more so given it’s the company’s first. Shareholders started celebrating earlier this week on deal speculation. They needed a party; Synta’s shares have done very little since its February IPO.
Read More
Posted in alliances, co-promotes, GSK, oncology | No comments

Friday, 28 September 2007

Co-promotes: No Longer Biotech’s Holy Grail

Posted on 14:20 by Unknown
You could see it coming. Well, kind of. Idenix on Friday snuck out the news that it was bailing out of its US and European co-promote with Novartis on its Hep B drug Tyzeka (Sebivo in Europe).

Co-promotes have until recently been most biotech’s holy grail, and co-promote options, at least, a sine qua non of much of recent licensing activity with larger pharma. It’s all part of that fully-integrated, ‘we-want-to-become-the-next-Genentech’ dream; we wrote about whether the dream made real-world commercial sense in IN VIVO in April.

We also pointed to data showing that barely more than a tenth of biotech-pharma co-promote plans become reality. When they do, they can be a nightmare--there was certainly no love lost between ICOS and Eli Lilly over Cialis before that (inevitable) acquisition.

Now of course, Big Pharma would say that co-promotes are a nightmare: they don’t like diluting their control over commercialization—which is, for all the talk of value inflection points throughout drug development, where the actual money comes from. But some of the arguments they put forward are sound: commercialization costs a helluva lot, even for so-called specialist sales forces, it’s increasingly complex as regulatory and reimbursement hurdles multiply, and, frankly, biotechs would make more profits by securing a good royalty share.

Idenix seems to have come to at least some of those conclusions, too. The biotech needed to rein in after the failure of its Hep C candidate a couple of months back, and this move will save it $40-45 million a year, apparently, by laying off the Tyzeka sales staff. “We have changed our agreement for Tyzeka to a royalty stream arrangement,” said Idenix CEO Jean-Pierre Sommadossi in the release outlining a wider re-structuring at Idenix.


In the original deal, outlined here, Idenix received sales-linked payments only in territories not covered by the co-promote. Neither those, nor the level of the new royalty stream, is revealed, but we’re certainly talking levels far from the single-digit tokens that grateful biotech used to have to put up with.

Funny, though, the timing: just a day or two before the announcement, Susan Koppy, SVP business and corporate development at Idenix, was on a panel at Windhover’s Pharmaceutical Strategic Alliances conference in New York. (Read here and here, for examples of what you missed.) She described the co-promote with Novartis as “a true co-promote,” in response to a question about which of the partners effectively had control (don’t forget that Novartis owns 56% of Idenix). But then, she added: “The relationship may well evolve as we go forward.”

Indeed it has. And it’s a fair bet that the evolution of other biotech co-promotes, real or planned, will go the same way. Biotechs are discovering and developing the drugs right now and benefiting handsomely from that. “Stick to what you do best” applies to them, as much as to Big Pharma.
Read More
Posted in alliances, co-promotes, Novartis, PSA | No comments

Thursday, 9 August 2007

Another Co-Promote Bites the Dust

Posted on 06:30 by Unknown
When Merck and partner Neuromed yesterday pulled the plug on Phase II chronic pain treatment NMED-160/MK-6721, another co-promote bit the dust, too.

More proof, then, that most co-promote options built into today’s biotech-pharma licensing deals are just window-dressing—comfort cushions for biotech investors dreaming of drug revenues and spec pharma success. Earlier this year we laid out in IN VIVO some of the reasons why fewer than 10% of co-promotes actually turn into market-place reality.

That statistic reassures the Big Pharma partner—most of which hate the thought of sharing their commercial spoils with inexperienced biotech, even if some of them say otherwise. But the main reason co-promote promises don’t often become reality is product discontinuation, as in this case, which helps no-one.

Luckily for Neuromed, the aborted program, an N-type calcium channel blocker, wasn’t its lead. Not since April 2007 anyway, when the biotech licensed US rights to a Phase III extended-release opioid analgesic OROS Hydromorphone from Johnson & Johnson’s Alza.

This deal means Neuromed may yet fulfil its dream, shared with most other biotechs, of setting up its own specialist sales force. And Neuromed may yet get to co-promote products with Merck, since the 2006 deal granted the biotech the option to co-promote to US specialists any N-type calcium channel blockers emerging from the collaboration—and the partners say they’ll keep looking for others.

But with NMED-160/MK-6721 gone, at least in pain, Neuromed will miss out on at least $202 million in milestones, and possibly more. It also paid $30 million up front for OROS. That product had better make it onto the US market (it's approved in Europe, but still not in the US, seven years after an approvable letter ). Otherwise private Neuromed may be in danger of biting the dust, too.
Read More
Posted in alliances, clinical development, co-promotes, Merck, pain | No comments

Tuesday, 19 June 2007

Size Matters for Specialist Drugs, Too

Posted on 07:58 by Unknown
Sales force size, that is. ZymoGenetics’ ex-US commercialization deal with Bayer HealthCare on lead recombinant human thrombin didn’t come as a huge surprise: the west-coast biotech had always said it would seek a partner ex-US.

But what was interesting about today’s deal was that Bayer also gets to co-promote rThrombin in the US for the first three years post-launch, in exchange for up to 20% sales commission plus bonus payments up to $20 million. Now, this is a specialist drug, sure—it was filed in December 2006 as a safer alternative to bovine thrombin for use in helping control bleeding during surgery, and the entire US market is today worth only $250 million or so.

But ZymoGenetics isn’t the only one going after it (which, incidentally, says much about the growing competition even for niche products). It shouldn’t have too much trouble displacing King Pharmaceuticals’ bovine-derived product Thrombin-JMI, given the recombinant drug’s superior safety and convenience. Bovine thrombin has a black box warning due to immunogenicity, which doesn’t affect rThrombin; the Zymo product can be stored for two years at room temperature, unlike some plasma-derived drugs.

But Johnson & Johnson is also on the loose, thanks to a 2004 deal granting the Big Pharma European and then North American rights to Omrix Biopharmaceuticals’ human blood-plasma derived thrombin, which, like rThrombin, is due for approval later this year.

Zymo argues that surgeons don’t like human plasma derived products either, and that the Omrix drug will also likely carry a warning. But a battle pitting Johnson & Johnson versus Zymo's planned 50-strong US sales force looked too one-sided, whatever the products. That helps explain why Zymo’s share price has remained so muted this year.

It also helps explain why Zymo agreed to the three-year US co-promote--even though it was earlier firm in its intention “to commercialize rThrombin in the US on our own”.

Zymo will still be in charge of US pricing and commercialization, and will book US sales. But Bayer’s added muscle will allow Zymo to quickly penetrate the market, converting a maximum number of hospitals to recombinant thrombin as fast as possible, and also countering any threat from J&J. With the support of Bayer’s 70 US sales reps and 25 scientific liaisons, “we’ll have the largest field force in the hemostasis market,” Zymo's president and CEO Bruce Carter said on the conference call following the deal's annoucement, “as well as what we believe to be a superior product.”

As for Bayer: it has long abandoned global, Big-Pharma style ambition in favor of a more specialist focus. Like other mid-sized pharma, it has tried to position itself as a flexible partner that’s willing to consider ex-US rights only—and let’s face it, that’s increasingly all that’s on offer in today’s sellers’ market, as we've discussed in previous IN VIVO articles.

But the Zymo partnership offers a glimpse of how mid-cap pharma may now be able to leverage the size they do have—relative to many a biotechs, anyway—to secure what are effectively global product deals for products with (relatively) low risk.

And the cost isn’t bad either: Bayer pays Zymo $30 million up front, $40 million on approval, and up to $128 million in milestones, most of which are sales based. Ex-US, it’s in charge, and pays Zymo double-digit royalties.
Read More
Posted in alliances, co-promotes, sales forces, spec pharma, ZymoGenetics | No comments
Older Posts Home
Subscribe to: Posts (Atom)

Popular Posts

  • Ventana Accepts $3.4 Billion
    Roche finally nabs its man. Or in this case, its diagnostics company. All it took was an extra $14.50 per share. From the companies' pre...
  • Merck: Embracing Externalization, From the Top Down
    Updated Below . One business magazine greeted the tenure of Dick Clark as Merck's new CEO in 2005 with the instruction to "say hel...
  • While You Were Coming Back
    It would be wrong for us not to mention the Red Sox in this space, the Boston nine having completed their three-game comback victory over th...
  • Private Equity Goes Public
    One of the simplest metrics we have to measure interest in a company or industry is just how jammed the rooms are at the JP Morgan conferenc...
  • While You Were Going to California
    Before the eyes of the healthcare world turn to the overcrowded hallways of the Westin St. Francis, here's a quick roundup of the weeken...
  • High Noon at Myogen
    Most VC meetings provide a feel-good story for the portfolio CEOs—usually a variation on the business resurrection theme. The Atlas Venture ...
  • Unusual Suspects: If Pfizer Decides to Really Rattle the R&D Cages
    Yesterday, we listed a group of people -- we called them the usual suspects -- that we think Pfizer will try to woo if it ends up turning to...
  • Avandia and Rezulin: Parallels that Should Make GSK Nervous
    History doesn’t repeat itself but it does rhyme. That old Mark Twain saying must be making GlaxoSmithKline sweat as Avandia is starting to ...
  • While You Were Watching the Upsets
    This weekend we were in Cardiff for the Rugby World Cup quarterfinal between France and New Zealand, which saw France upsetting the favorite...
  • Deals of the Week: New Year's Resolutions
    It's day four of the New Year and you've already broken that resolution to exercise, eat better, or spend more time with the family....

Categories

  • Abbott
  • activist shareholders
  • ADHD
  • advisory committees
  • alliances
  • Alnylam
  • Alzheimer's disease
  • Amgen
  • Andrew von Eschenbach
  • Andrew Witty
  • Astellas
  • AstraZeneca
  • Avandia
  • Avastin
  • Barack Obama
  • Barr
  • Bayer
  • Big Pharma
  • BIO
  • Biogen Idec
  • biologics
  • biosimilars
  • blogging
  • BMS
  • Boston Scientific
  • brand names
  • business development
  • business models
  • cancer vaccines
  • Carl Icahn
  • CBO
  • CDER
  • Celgene
  • Cephalon
  • China
  • clinical development
  • CMS
  • co-promotes
  • comparative effectiveness
  • conference
  • Congress
  • consumer genomics
  • corporate culture
  • corporate governance
  • corporate venture capital
  • CVS Caremark
  • Cytyc
  • David Kessler
  • deals of the week
  • debt financing
  • Diabetes
  • diagnostics
  • Dick Clark
  • drug approvals
  • drug delivery
  • drug discovery
  • drug eluting stents
  • Drug Pricing
  • drug safety
  • drug samples
  • DTC Advertising
  • e-health
  • Eisai
  • Elan
  • Eli Lilly
  • Emphasys
  • emphysema
  • Endo
  • epo
  • Euro-Biotech Forum
  • Exits
  • Exubera
  • FDA
  • FDA/CMS Summit
  • FDAAA
  • Film and TV
  • financing
  • FOBs
  • Forest Labs
  • Galvus
  • gene therapy
  • Genentech
  • General Electric
  • generics
  • Genzyme
  • Gleevec
  • Google
  • GSK
  • Guidant
  • haircuts
  • Happy Holidays
  • HCV
  • Headhunting
  • Health Care Reform
  • hedge funds
  • Henry Waxman
  • hGH
  • HHS
  • Hillary Clinton
  • Hologic
  • hostile takeovers
  • hypertension
  • ImClone
  • IMS Health
  • In vitro diagnostics
  • In3
  • India
  • insomnia
  • instrumentation
  • insulin
  • Inverness
  • IP
  • IPO
  • IPO pricing
  • Isis Pharmaceuticals
  • Israel
  • IT
  • JAMA
  • Januvia
  • Japan
  • John McCain
  • Johnson and Johnson
  • JP Morgan
  • LaMattina
  • lawsuits
  • layoffs
  • legislation
  • Life-Cycle Management
  • Lipitor
  • Lucentis
  • management succession
  • Mark McClellan
  • marketing
  • Martin Mackay
  • medical devices
  • Medicare
  • Medicare Part D
  • Medimmune
  • Medtech Insight
  • Medtronic
  • Merck
  • Merck-Serono
  • mergers and acquisitions
  • Michael McCaughan
  • Millennium
  • mmm beer
  • MRI
  • multiple sclerosis
  • music
  • nanotechnology
  • NEJM
  • new drug approvals
  • new funds
  • NICE
  • NicOx
  • NIH
  • Nobel Prize
  • Novartis
  • Novo Nordisk
  • Nycomed
  • off-label promotion
  • oncology
  • ophthalmology
  • Orthopedics
  • osteoporosis
  • OTC drugs
  • Out-Partnering
  • Oxycontin
  • pain
  • Part D
  • Patient Advocacy
  • PDUFA
  • personalized medicine
  • Pfizer
  • pharmacy benefits
  • PhRMA
  • politics
  • poll results
  • PR
  • prasugrel
  • Presidential Election
  • Press Release of the Week
  • Primary Care
  • private equity
  • Procter and Gamble
  • PSA
  • Purdue Pharma
  • rare diseases
  • reimbursement
  • research and development productivity
  • research and development strategies
  • reverse mergers
  • rimonabant
  • RiskMAP
  • RNAi
  • Roche
  • Roger Longman
  • royalties
  • sales forces
  • Sanofi-aventis
  • Schering-Plough
  • Science Matters
  • Sepracor
  • shameless self-promotion
  • share buybacks
  • Shire
  • Sirtris
  • Smith and Nephew
  • Solvay
  • SPACs
  • spec pharma
  • spin-outs
  • sports
  • Start-Up
  • statins
  • Steve Nissen
  • Stryker
  • Supreme Court
  • Takeda
  • Teva
  • Thanksgiving
  • The RPM Report
  • UCB
  • vaccines
  • Velcade
  • Ventana
  • venture capital
  • venture debt
  • Venture Round
  • Vertex
  • Vioxx
  • Vytorin
  • Wacky World of Generics
  • While You Were ...
  • Wyeth
  • Zetia
  • Zimmer
  • ZymoGenetics

Blog Archive

  • ▼  2008 (76)
    • ▼  February (25)
      • The Wacky World of Generics: Risperdal Edition
      • Botox, Friday Afternoon Press Calls and the Nissen...
      • AZ Makes Its Move in GI
      • Nektar Takes A Deep Breath
      • Sanofi Aventis: Sign of the Big Pharma Times?
      • The Blockbuster Model is Dead, Sort Of
      • Starring Role for Follow-On Biologics
      • While You Were Settling
      • Reputation Counts
      • Friday Night Lowlights: Don't Leave Town Early
      • FDA-CMS Parallel Reviews: A Mixed Bag
      • Deals of the Week: Winter of Our Discontent
      • Beijing Boost for Japanese Encephalitis Vaccine
      • Carl Icahn vs. Evil Corporate Governance
      • FDA’s Search for a Drug Chief Not Going Well: An I...
      • The Wacky World of Generics: Fosamax Edition
      • FDA’s Budget: “Maintain Momentum” or “Inadequate R...
      • White House Tries to Jump-Start Follow-On Biologics
      • Why Big Pharma Should Vote Democratic
      • The Wacky World of Generics: Protonix Edition
      • Perlmutter: We're Not Abandoning Japan
      • Amgen Cashes out of Japan; Follows Bristol's Risk ...
      • While You Were Eating Chili and Drinking Beer
      • Cervarix: Big Step for FDA; Can GSK Make the Decis...
      • Deals of the Week: Deal--or No Deal
    • ►  January (51)
  • ►  2007 (329)
    • ►  December (32)
    • ►  November (42)
    • ►  October (37)
    • ►  September (33)
    • ►  August (29)
    • ►  July (39)
    • ►  June (39)
    • ►  May (43)
    • ►  April (16)
    • ►  March (13)
    • ►  February (5)
    • ►  January (1)
  • ►  2006 (8)
    • ►  December (3)
    • ►  November (5)
Powered by Blogger.

About Me

Unknown
View my complete profile