Plavix is an anti-clot or blood thinner most prescribed to prevent heart attack or stroke.  It is also one of the best selling drugs in the world.  More than 50 million people in the U.S. have taken Plavix since it was approved by regulators in 1997.  It was discovered by French pharmaceutical company (then) Sanofi-Aventis and co-developed with Bristol-Myers Squibb.   In recent years, Plavix has accounted for roughly a third of BMS revenues and much less (7%) of Sanofi revenues.

Both BMS and Sanofi have worked to extend patent protection for the drug, yet time has finally run out as of today.  As noted, the loss will be felt much greater by BMS which is also facing a patent cliff with Avapro and an expiration of its deal with Otsuka Pharmaceuticals to market anti-psychotic Abilify.

None of this is news to BMS, who enacted the String of Pearls strategy in 2007 under then CEO Jim Cornelius to offset these predicted losses through their own pipeline and an aggressive yet calculated posture in business development.  It calls for the company “to accelerate the discovery and development of new therapies…with a suite of innovative alliances, partnerships and acquisitions with small and large companies”.

Jeremy Levin was the senior vice president of strategy, alliances and transactions, who famously branded & executed the String of Pearls strategy.  One problem:  he left the company earlier this year to become CEO of Teva Pharmaceuticals.  Bristol made 17 acquisitions over four years with Levin, including the 2009 purchase of Medarex, which gained the company the Yervoy skin cancer drug.

Too early to tell what the future looks like for Bristol Myers, yet today is day long dreaded within the company.

The diabetes market around the world is growing.  And, since its latest product approval, Amylin is in the cat bird’s seat.

Amylin has not commented on potential takeover bids since initial reports that Bristol-Myers Squibb made an offer last month.  Now, with Goldman Sachs and Credit Suisse dealing the cards, there are more than a handful of Big Pharma suitors edging to get a seat at the table.  According to Bloomberg, Pfizer, Astrazeneca, Sanofi, Takeda, Merck and Roche have all formally queued up to make a bid for Amylin.  WIth that many companies involved, the process (and the $ price) may get out of control.

With Bydureon as a newly approved GLP-1 diabetes treatment and a market cap hovering around $4B, this is the perfect ‘bolt-on’ acquisition that Big Pharma CEO’s have been pining for the past few years.  The fact that ‘first round bids’ are due before the end of May speaks to Amylin’s strategy to have leading contenders bidding against one another in June.

When Amylin parted from its decade-long Lilly partnership and went ‘all in’ late last year prior to Bydureon’s FDA approval, this was exactly the outcome Dan Bradbury was hoping for. In an interview with CNBC in January, Bradbury hinted at the company’s future prospects but not answering Mario Bartiromo’s direct questioning about a potential sale of the company.

Bloomberg

Below is a recent, well-written article in Forbes which correctly assumes that patent expiration and fewer drug approvals are driving the pharmaceutical industry to consolidate.  The stresses facing leading drug makers have turned the entire industry into a giant Monopoly board.

We’ve all witnessed the popularity of collaborations, acquisitions and licensing deals completed over the past two years.  Some are methodical and well executed.  Others are ridiculously speculative and obviously not well thought out.   To build a fundamental system through M&A designed to complement a weakening pipeline is one thing.   To bet billions on an early- to mid-stage hunch is another.

Forbes

After being rebuffed through an earlier offer to acquire Human Genome Sciences in April, GlaxoSmithKline will take its $2.6 billion tender offer directly to HGS shareholders through a hostile bid for the company.  “Shareholders should have the opportunity to decide for themselves on the merits of the offer,” according to GSK.

The move is designed to simplify GSK’s control over Benlysta for lupus, a drug partnered between the two companies.  Acquiring Human Genome would provide GSK with full revenue from Benlysta, instead of the current 50/50 share. There are also two other developing medicines between GSK and HGS, in diabetes and vascular therapy.

GSK is offering $13/share for HGS, an 80% premium to the stock price on April 18^th.  HGS value has been falling steadily from their 2011 peak but has since skyrocketed in response to the earlier ‘private’ bid by GSK, which was ultimately deemed too low by HGS’ Board.

With such a tight partnership with GSK, HGS has few if any other options to consider.  Whether friendly or hostile, this negotiation may play out over the coming several months.

ABC News

Congress will vote on the proposed future for FDA User Fee Agreements sometime this summer, comically referred to by one Congressman as the ‘oofahs’ (re:  PDUFA, MDUFMA, BSUFA, etc.).    More on that legislative process (which has been ongoing for almost a year) with updates from September, January and February.

Now we are learning that buried in bill is a proposal supported by the FDA to provide a cheaper and quicker way to approve breakthrough therapies early in development cycle.  The agency would be able to identify such treatments and work with drug makers to speed up clinical study.

MSNBC/Reuters

This week is all about fat people for the life sciences industry.  As we reported in an earlier post, this week marks a critical point for FDA in their panel review of weight loss drugs which could set the stage for a handful of different manufacturers with pending applications.

Also this week, the American Journal of Preventative Medicine reported that  42% of Americans are expected to be categorized as obese by 2030.   That is an additional 32 million fat people.

So to top off the week, researchers at Rice University have developed a technology that is a sign of the times.  A suction cup device to lift the fat of obese patients off an operating room table so surgeons can better perform their procedures.  Seriously?   Seriously.

Another diet pill is preparing to step before the FDA for review.  And, there’s some conveniently timed PR supporting its approval.

According to the American Journal of Preventative Medicine, 42% of Americans are expected to be categorized as obese by 2030.   The report also predicts that the number of severely obese Americans (>100 lbs) could almost double to 11% of the population. Those percentage increases would equate to an additional 32 million fat people.

Now, cue the FDA and a bid from Arena Pharmaceuticals through a diet pill called Lorqess.  The FDA denied approval in 2010 partly due to potential side effects and questions regarding efficacy.  Arena and its investors are bullish this time around.  Also in the queue is Qnexa from Vivus, another potential weight loss treatment whose review was pushed back three months to July 17^th.

The advisory panel is set for this Thursday with much anticipation, including a few media (The Street) live blogging the hearing.  Will the FDA hold its position from the fall of 2010, when Vivus, Orexigen and Area all had their leading weight loss treatments rebuffed?  Or will one or more finally be granted an approval?

Update 5/11: The advisory panel of experts voted 18 to 4 (with one abstention) for approval, saying the drug’s benefits “outweigh the potential risks when used long term” for people battling excess weight, the Associated Press reports.  Final decision by the FDA is expected late next month.  If the agency were to give the nod to the drug, lorcaserin would become the first new weight-loss pill made available to Americans in a decade.  WSJ

With Stryker CEO Steve MacMillan stepping down, Advamed needed a new chairman for next year.  CEO Dave Dvorak from Zimmer stepped up.

Now, fresh into the role Dvorak has announced his plan to help address economic and regulatory issues facing the medical technology industry.  Some might offer that there has been no more important period for AdvaMed and other leading industry lobbying groups (PhRMA, BIO) than now.  Regulatory issues abound between the industry & FDA.  Obamacare has struck a nerve with a excise tax penalty for all medical device makers set to begin next year.  Meanwhile, legislation in Congress is abound with life sciences-related ramifications.

Dvorak has always been an visible participant within AdvaMed.  Now, together with AdvaMed President Stephen Ubl, its his turn to lead the charge.

MassDevice.com (Boston)

Smith & Nephew has spawned a new kid on the block, by launching a previously announced spinoff with Bioventus, formerly the biologics division of the company.  Bioventus is a joint venture with Essex Woodlands that is headquartered in Durham with roughly $250M in revenue.  Led by CEO Mark Augusti, much of the management team has migrated from S&N and the company is positioned now as a flexible, innovative 500-person startup better suited to meeting the needs of the market in orthobiologics.

Also this week, Smith & Nephew finalized its acquisition of Kalypto Medical, which will allow it to expand its wound therapy business.  Kalypto Medical is the manufacturer of the NPD 1000, a portable, ambulatory Negative Pressure Wound Therapy (NPWT) system.   Since 2006, Smith & Nephew has invested in NPWT to compete against Kinetic Concepts.

BeckersASC.com

BeckersOrthopedicAndSpine.com

While the biggest of Big Pharma have been toiling with pipelines & patent cliffs, a few have been quietly accelerating their growth in comparison. Allergan reported earnings this morning; and, in a conversation with CEO David Pyott, CNBC discussed Botox, its current and future potential, and the success of the company in an otherwise challenged economy. Most notable: Botox therapeutic indications will soon outpace its use in the cosmetic market with additional approvals in migraine, over-active bladder, and other neuro-related disorders for which the drug is a strong treatment.