IN VIVO from Elsevier Business Intelligence

Epizyme Builds A Cancer Company At Mach Speed

m.goodman@elsevier.com — Wed, 23 May 2012 00:06:00 -0400

Epizyme’s recent alliance with Celgene validates industry’s interest in histone methyltransferase inhibitors, a kinase-like class of epigenetic enzymes. Celgene’s willingness to cede US rights in return for access to preclinical assets belies HMTs’ novelty and helps to position Epizyme for potential success as a US-focused oncology company.

Cardionovum: As DEBs Heat Up, Who Needs The US Market?

d.cassak@elsevier.com — Wed, 23 May 2012 00:05:00 -0400

German serial entrepreneur Michael Orlowski achieved a successful exit in his first cardiovascular device company, EuroCor, by selling not to a US-based giant, but to an Indian conglomerate, Opto Circuits. His new company, Cardionovum, has developed a next-generation drug-eluting balloon whose novelty rests on a different approach to the coating technology designed to produce better drug-elution.

Ikaria’s Hybrid Business Model Taps Big Pharma Trends

w.diller@elsevier.com — Wed, 23 May 2012 00:03:00 -0400

Although Ikaria focuses on a highly specialized segment of the hospital market, its integrated business model offers insights into continuum of care strategies that pharma companies are evaluating in a reimbursement-focused world. The company’s promising strategy could get a boost from key trial read-outs as soon as late 2012.

Miramar Labs: Bringing A Traditional Device Model To Aesthetics

s.levin@elsevier.com — Wed, 23 May 2012 00:02:00 -0400

Miramar is employing a conventional product development strategy to create the first device therapy in an unconventional clinical space – hyperhidrosis, or excessive sweating. The key: a more rigorous clinical approach than usual in aesthetics.

Neuronetics Brightens Outlook For Neuro Devices

t.salemi@elsevier.com — Wed, 23 May 2012 00:01:00 -0400

Neuronetics Inc. forged a new specialty of sorts, the interventional psychiatrist. Unlike other interventional approaches, the externally applied NeuroStar delivers transcranial magnetic stimulation to the precise area of the brain responsible for intractable depression.

Execs On The Move, May 2012

rpaleski@att.net — Wed, 23 May 2012 00:00:00 -0400

Recent executive-level company changes and promotions in the biotech, pharmaceutical and medical device industries.

Out Of The Blocks, May 2012

n.dvorin@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

Brief profiles of these recently formed companies: Abionic, Alcresta, Avenir Medical, Avion Pharmaceuticals, Ground Fluor Pharmaceuticals and Milo Biotechnology.

Start-Up Previews, May 2012

n.dvorin@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

This Month's Profile Group, Hand Hygiene Surveillance Start-Ups, features profiles of BioVigil Systems, GLANTA, HanGenix and Proventix. Plus these Start-Ups Across Health Care: Cutting Edge Spine, Enterome, Molecular Dectecion and Transcatheter Technologies.

Orthofix Spin-Out Presents Another Opportunity For Private Equity

m.stuart@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

A handful of orthopedic companies are combating sluggish markets by sticking with what they know best – selling hip and knee implants. This has created a robust opportunity for private equity investors looking to build businesses in orthopedics peripheral markets.

Moving Beyond Cubicin: Cubist Sets The Stage For Long-Term Growth

j.merrill@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

Cubist has focused on marketing its sole drug, Cubicin, since the antibiotic was approved in 2003, but through business development and clinical progress, the biopharma is in the midst of a transformation.

The Inevitable Outcome: Diabetes Safety Model Expands To Weight Loss…And Beyond?

michael.mccaughan@previsionpolicy.com — Wed, 23 May 2012 00:00:00 -0400

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience – and what it might mean about regulatory expectations for other chronic drug classes in the future.

Deals Shaping The Medical Industry, May 2012

Wed, 23 May 2012 00:00:00 -0400

The Dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents.

Biopharma Quarterly Deal Statistics, Q1 2012

Wed, 23 May 2012 00:00:00 -0400

Biopharma financing totaled $3.7 billion in Q1 2012, $1 billion more than the previous quarter. A total of 22 M&As – with a potential value of $9.28 billion – were completed.

Hologic Grabs Gen-Probe

m.ratner@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

Women’s health-focused Hologic is buying molecular diagnostics provider Gen-Probe for $3.7 billion in cash. Adding Gen-Probe’s automated instrument platforms gives Hologic critical mass in the molecular diagnostics market while allowing it to maintain its core focus on women’s health.

Deals In Depth: March 2012

a.micklus@elsevier.com — Wed, 23 May 2012 00:00:00 -0400

Glaxo sold a European portfolio of non-core OTC products to Omega Pharma for $614 million. Device companies Zoll Medical and Cameron Health were acquired in two separate billion-dollar-plus deals.

IN³ Medical Device 360° Boston

Sun, 29 Apr 2012 00:00:00 -0400

Publisher’s Spotlight: Elsevier Business Intelligence is pleased to invite you and your team to join us for Investment in Innovation (IN³) Medical Device 360° Conference, being held June 27-29, 2012 at the beautiful Hyatt Regency Boston in Boston, MA.

J&J’s New Path Forward – An Interview With Alex Gorsky

d.cassak@elsevier.com — Thu, 26 Apr 2012 00:00:00 -0400

In his last interview before becoming CEO of Johnson & Johnson, Alex Gorsky talks about the changes that J&J has made recently in its medical device business and discusses his upcoming promotion to head of all of J&J.

MS Boon: Many Drugs On The Way, But Will Payors Swallow The Cost?

j.merrill@elsevier.com — Mon, 23 Apr 2012 00:05:00 -0400

Several new drugs for multiple sclerosis could launch within the next two years, but amid escalating drug costs, payors are taking a harder look at the therapeutic category. New drugs will face increasing reimbursement hurdles, as payors implement the first prior authorization and step therapy protocols and look for ways to implement further cost reductions.

Symetis: Well-Positioned Next-Generation TAVI Player

s.levin@elsevier.com — Mon, 23 Apr 2012 00:04:00 -0400

Now among the most promising of an emerging group of second-generation transcatheter aortic valve implantation (TAVI) companies, Symetis didn’t start out that way. It began as a cell therapy company, but its initial technology failed.

Smaller Players See Opportunity In Large Joints

t.salemi@elsevier.com — Mon, 23 Apr 2012 00:03:00 -0400

The business of selling hip and knee implants is dominated by five principal players whose grips have been impossible to break as surgeons have become comfortable working with these market leaders. But health care reform, the sagging economy and other external interferences are putting pressures on hospitals to save money wherever they can, and these pressures could create openings for smaller players.

Branded Life After Lipitor: Pharma Targets Unmet Needs In Dyslipidemia

e.hayes@elsevier.com — Mon, 23 Apr 2012 00:02:00 -0400

Statins represent a high standard of care for managing high blood cholesterol, bolstered by a strong evidence base, but new targets like PCSK9 and CETP are nevertheless stealing the spotlight nowadays. Whether new drugs, if they make it to market, will be used beyond narrow, targeted population segments is uncertain and will depend on results from large-scale outcomes studies showing significant efficacy and, importantly, reassurance of a solid safety profile.

Deals In Depth: February 2012

a.micklus@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

Pfizer and Zhejiang Hisun Pharmaceutical together invested $545 million to create a Chinese generics joint venture. Dainippon Sumitomo Pharma expanded its cancer pipeline though the acquisition of Boston Biomedical.

Execs On The Move, April 2012

rpaleski@att.net — Mon, 23 Apr 2012 00:00:00 -0400

Recent executive-level company changes and promotions in the biotech, pharmaceutical and medical device industries.

Merck, GSK, J&J Broaden Strategic LP Relationships, External Discovery Initiatives

Mon, 23 Apr 2012 00:00:00 -0400

In the latest examples of biotech VCs and Big Pharma joining forces to prospect for products, Index Ventures announced in March that it had raised a new €150 million life sciences venture fund, Index Life VI, and said that GSK and J&J had committed a combined 50% of the fund’s total capital. Three weeks later Merck said it added early-stage life science venture firm Flagship Ventures to the roster of venture funds it has joined as a limited partner.

Covidien Acquisitions Keeps Buying Spree Alive

t.salemi@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

Since its spin-out from Tyco, Covidien has spent close to $5 billion acquiring public and privately held device companies, with more than $1 billion of that being spent just over the past six months. The string of purchases bulked up every one of Covidien’s existing medical device businesses.

How GSK Is Driving Early Stage Research In Its DPUs

j.davis@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

Most of GlaxoSmithKline's early stage research organizations, discovery performance units, survive a three-year review cycle, with co-localization, monetary incentives and career support leading a change of culture.

Scant Intersection Between Patient-Centered Outcomes Research And Personalized Medicine’s Needs

m.ratner@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

On its face, comparative effectiveness research and its new cousin, patient-centered outcomes research, would seem to support, if not enable, personalized medicine. But as currently established in the US, there is little conceptual overlap.

Deals Shaping The Medical Industry, April 2012

Mon, 23 Apr 2012 00:00:00 -0400

St. Jude Tries To Get Ahead Of Questions On Durata ICD Leads

d.filmore@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

St. Jude Medical hopes an independent analysis of its Optim-insulated Durata leads will address questions from the clinical community based on concerns with its earlier-generation Riata devices.

Out Of The Blocks, April 2012

n.dvorin@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

Brief profiles of these recently formed companies: 3D Biomatrix, ADC Therapeutics, GeneCentric Diagnostics, IDx, InControl Medical and Intrepid Therapeutics.

Start-Up Previews, April 2012

n.dvorin@elsevier.com — Mon, 23 Apr 2012 00:00:00 -0400

This Month's Profile Group, Vaccine Investment Gets A Shot In The Arm, features profiles of Genocea Biosciences, Imaxio, Selecta Biosciences and TremRx. Plus these Start-Ups Across Health Care: Bluegrass Vascular Technologies, Haldor Advanced Technologies and Targovax.

Finally A FIBCO, Regeneron Sets Its Sights On Eylea And Beyond

w.diller@elsevier.com — Mon, 26 Mar 2012 00:05:00 -0400

The better-than-expected performance of Regeneron’s first significant commercial drug, Eylea, has fueled the company’s ambitions to build a sustainable, risk-adjusted portfolio based on a mix of best-in-class and first-in-class new drugs. Getting to this point took a mixture of perseverance, astute science, opportunism, and savvy partnering.

Can Simpirica Simplify Spine Stabilization?

t.salemi@elsevier.com — Mon, 26 Mar 2012 00:04:00 -0400

Founded at the height of the spine industry’s surge, Simpirica Spine Inc. has developed a dynamic stabilization device that is reminiscent in its simplicity and novelty of past interspinous spacers. The company will soon embark on a 400-patient pivotal trial in the US testing its LimiFlex against posterolateral fusion in treating degenerative spondylolisthesis.

MD Start – Can Medtech Incubators Work In Europe?

d.cassak@elsevier.com — Mon, 26 Mar 2012 00:03:00 -0400

Europe has historically been rich in physicians with innovative ideas but has lagged in turning those ideas into novel devices. MD Start, a new incubator, backed by a group of leading device companies and VC firms, hopes to turn those ideas into viable companies.

Europe For Pharma Mid-Caps: Tough But Necessary

m.senior@elsevier.com — Mon, 26 Mar 2012 00:01:00 -0400

Europe’s growing reimbursement hurdles and falling prices, compounded by a currency and sovereign debt crisis, mean the region’s no longer a strategic priority for Big Pharma. But while major pharmaceutical firms have sufficient scale and reach to continue to move jobs abroad and step up their emerging markets activities if conditions don’t improve closer to home, most of the rest of industry’s smaller commercial players – including the Big Biotechs – don’t.

Ensuring Big Pharma Doesn’t Turn Specialty Markets Into Primary Care

vmittal@healthadvances.com — Mon, 26 Mar 2012 00:00:00 -0400

Lured by the success of Abbott in rheumatology, Novartis in oncology, and Genzyme in orphan/genetic diseases, pharmaceutical manufacturers have turned their collective sights on specialist-driven markets. But payor pressure is ballooning and as examples in these hotly competitive areas demonstrate, to truly succeed in specialist markets, companies cannot rely on a ‘follower’ strategy.

New Ecosystems In Pharma: Maturing Markets Mean New Models Are Needed

Mon, 26 Mar 2012 00:00:00 -0400

Success in the pharmaceutical industry requires new thinking about segmentation of drug markets and new insight into how the opportunity for pharma companies is changing. Oliver Wyman’s ecosystems framework attempts to determine where unmet medical need, innovation, and a strong value proposition for payors reside.

Heart Failure Devices: Raising Roadblocks To Readmission

m.thompson@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

A new Medicare cost-control program aimed at reducing costly hospital readmissions has heart failure squarely in the cross-hairs, and the consequences could mean hundreds of thousands of dollars in lost Medicare revenue for hospitals that fail to meet the new readmission standards. As a result, providers are scrambling to implement programs to assess and reduce heart failure readmissions, and a growing number of device companies are touting a variety of technologies they believe could help them achieve that goal.

Institutionalizing Externalization At Big Pharma – The Third Leg

Mon, 26 Mar 2012 00:00:00 -0400

The pharmaceutical industry has a hard time saying goodbye to strategic assets. In fact, it’s much more adept at welcoming new ones: diversification – either geographic or into areas beyond pure-play pharmaceuticals – has become commonplace.

InMedica: Slovenian Device Incubator Looks To Fill Infrastructure Gap

d.cassak@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

One of the major challenges faced by a European medtech start-up community that is already arguably undersized has been a lack of infrastructure. A group of medical device executives are trying to address that problem through the launch of an incubator, InMedica, built upon a network of support services that is integrally connected to the incubator, in effect forming its own medical device cluster in the unlikely setting of Slovenia, a country of two million people in south central Europe.

Industry, FDA Agree On Draft User Fee Commitment Letter

rebecca.kern@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

Draft commitment and legislative language come one month after agreement “in principle” on MDUFA III reauthorization.

Hospital Budgets On The Rise As Purchasing Patterns Shift, Survey Finds

m.hogan@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

More than 60% of hospital executives surveyed expect to see increased budgets for overall hospital spending in 2012. However, federal mandates related to health care reform are influencing hospital’s strategic initiatives and their purchasing patterns, according to a recent hospital survey.

Device and Diagnostics Dealmaking Quarterly Statistics, Q4 2011

Mon, 26 Mar 2012 00:00:00 -0400

Medical device companies raised $800 million in the fourth quarter of 2011, and venture capital represented half of that amount. Just over $4 billion was spent to acquire medical device companies, down 50% from Q3’s $8 billion.

Deals In Depth: January 2012

a.micklus@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

Forma Therapeutics penned an $815 million oncology drug discovery alliance with BI. BMS and Amgen spent over $1 billion each to purchase Inhibitex and Micromet, respectively.

Out Of The Blocks, March 2012

n.dvorin@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

Brief profiles of these recently formed companies: Achelios Therapeutics, EternoGen, QI Healthcare, Retrophin, Synchroneuron and TeraBAT.

Start-Up Previews, March 2012

n.dvorin@elsevier.com — Mon, 26 Mar 2012 00:00:00 -0400

This Month's Profile Group, Surgical Incision Closure Start-Ups, features profiles of EndoEvolution, ZipLine Medical and ZSX Medical. Plus these Start-Ups Across Health Care: Foundation Medicine, PMD Healthcare, VasoStitch and Virttu Biologics.

Execs On The Move, March 2012

rpaleski@att.net — Mon, 26 Mar 2012 00:00:00 -0400

Recent executive-level company changes and promotions in the biotech, pharmaceutical, and medical device industries.

Deals Shaping The Medical Industry (03/2012)

Mon, 26 Mar 2012 00:00:00 -0400

IN³ Medical Device 360° 2012 - London

Thu, 08 Mar 2012 00:00:00 -0500

Publisher’s Spotlight: Elsevier Business Intelligence is pleased to invite you and your team to join us for The Investment in Innovation (IN³) Medical Device 360° Conference, being held April 25 - 26, 2012 at the beautiful Millennium Gloucester Hotel & Conference Centre in London Kensington.

Attack Of The Hair Restoration Robot

t.salemi@elsevier.com — Fri, 24 Feb 2012 01:00:00 -0500

Robots invaded the operating room years ago, providing surgeons with high precision tools to perform a wide range of procedures from prostatectomies to partial knee replacements. Now, Restoration Robotics is hoping to take over the private practices of hair restoration surgeons.