Windhover's Commentary

Women's Health: Building Interventional Gynecology (Medtech Insight)

Medtech Insight

This article was adapted from "Building Interventional Gynecology," which appeared in START-UP, June 2010.

Seeking New Options for Prostate Cancer (Medtech Insight)

Medtech Insight

Recent reports questioning the benefits of early prostate cancer diagnosis and treatment have raised an industry-wide debate that has been fueled by the limitations of prostate-specific antigen tests, currently the standard of care for early prostate cancer detection. While the industry searches to improve the use of PSA tests, urologists are asking, "are we over treating our patients?" That question was repeatedly voiced in a number of forums at the American Urological Association's 2010 Annual Meeting. As for a definitive answer to the question, it is a somewhat difficult task to get individual physicians to admit they are personally over treating patients; however, there is definitely a consensus-and a concern-that more patients than necessary are receiving treatments that put them at risk of serious side effects.

The Artificial Disc Bust: Lessons Learned (Medtech Insight)

Medtech Insight

The artificial disc market, at least in the US, has yet to take off. In 2009, sales of artificial discs reached close to $150 million a far cry from the $1+ billion projected in 2005. So what happened and what does the future hold?

ASMBS Highlights New Developments in Bariatric Surgery (Medtech Insight)

Medtech Insight

A record-breaking attendance at 2010's meeting of the American Society for Metabolic and Bariatric Surgery marked the growing interest in new ways to address the issue of obesity. Currently, less than 1% of a potential US patient population of 15 million who might benefit from bariatric surgery actually undergo the procedure, and surgeons are scrambling to understand why and to identify new, less invasive approaches that might help them better penetrate this enormous patient pool.

Wound Care: Finding a Niche (Medtech Insight)

Medtech Insight

The relatively open nature of the wound care market has created a golden opportunity for manufacturers to step up and introduce a variety of new products, although rarely is new a signal of true innovation in this space. And that, in turn, has created a broad, diverse, and fragmented industry, as demonstrated by the packed exhibit hall at the April 2010 meeting of the Symposium on Advanced Wound Care and the Wound Healing Society.

Changing Times Raise Barriers to Device Innovation (Medtech Insight)

Medtech Insight

While legal considerations play a role in determining if or how soon use of a medical device is adopted, other factors are now just as important and in some cases more important in influencing a provider�s product selection process.

Market & Industry Briefs (Medtech Insight)

Medtech Insight

Brief summaries of recent medtech market and industry developments. This month we cover trial results for PFO closure devices, the launch of Edwards Lifesciences' transcatheter valve, Accumetrics' push for platelet testing, J&J's acquisition of Micrus, the slowdown in the hip and knee market, and the new federal rule on covering preventive screening

Deals Update (Medtech Insight)

Medtech Insight

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

Clinical Edge (Medtech Insight)

Medtech Insight

Brief summaries of recent advances in device research and clinical trials. This month we survey new advances in diabetes research.

Start-Up News (Medtech Insight)

Medtech Insight

Noteworthy news from medtech start-ups. This month we profile NonWoTecc, which is developing synthetic, biomimetic vascular grafts and Valam, which is developing laser technology to treat chronic rhinosinusitis

Deals in Depth: May 2010 (IN VIVO)

IN VIVO

Alliance leaders included GSK's �73.9 million investment in new partner Dong-A Pharmaceutical and Medtronic's $70 million investment in cardiovascular device company BioControl. Abbott led biopharma M&A activity with its $3.7 billion purchase of Piramal's healthcare solutions business. In devices, Endo paid $221 million up front for HealthTronics. Roughly 30 percent of the month's $953 million in biopharma fundraising came from Salix's $291 million debt deal. No public device dollars were realized in May, though 11 companies completed venture rounds.

Biogen Idec Taps Exelixis' Scangos To Be New CEO (IN VIVO)

IN VIVO

Exelixis�s long-time CEO George Scangos, PhD, is taking the the helm of Biogen Idec. The move is counterintuitive, both for the commercial stage Biogen and for Scangos, whose career has largely been focused on research and early development and free of activist shareholder pressure.

European Cost Concerns May Impact Devices (IN VIVO)

IN VIVO

Medical device makers may have more difficult time selling in Europe than they'd anticipated as concerns over the economy and costs take hold, according to one analysis.

Celgene Moves Into Solid Tumors With $2.9 Billion Abraxis Acquisition (IN VIVO)

IN VIVO

Celgene Corp. is acquiring Abraxane developer Abraxis BioScience and planning an aggressive development and marketing push for the novel nanoparticle formulation of paclitaxel, with the aim of driving the drug�s sales to $1 billion by 2015.

AstraZeneca's Motavizumab May Be The Canary In The Follow-On Coal Mine (IN VIVO)

IN VIVO

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC�s motavizumab, which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. This suggests the government agency�s standards may be changing on a range of issues, from comparative effectiveness to data integrity.

Device VCs Find New Hope in Old Exit Path (IN VIVO)

IN VIVO

An analysis of acquisitions of privately held venture-backed medical device companies delivers some signs of hope as well as important warnings for medical device VCs hoping to find a lucrative exit in this difficult market.

Personalizing Patient Care:Sanofi Recasts Its Diabetes Efforts (IN VIVO)

IN VIVO

In a bid to protect its most valuable product, Lantus, Sanofi�s new diabetes division intends to provide holistic solutions in an effort to help patients better manage their disease. Will it work?

Raising Robotics: An Interview With Intuitive's Lonnie Smith (IN VIVO)

IN VIVO

The tremendous success of Intuitive Surgical over the past two decades seems clearly to argue that robotics is more than a techy's pipedream. Intuitive has already revolutionized at least one procedure - laparoscopic prostatectomy - and it figures to make significant progress in a range of others, in men's health, women's health, and cardiovascular surgery, to name just a few relevant clinical spaces. Even more impressive has been its success as a publicly traded company; for much of the middle years of this decade, Intuitive's stock was the strongest performer among all medical device public offerings. And perhaps most interesting: until recently, Intuitive was virtually the only robotics company to achieve any kind of success at all. In Vivo interviews Lonnie Smith, the CEO of the company for much of the 1990s and 2000s, to whom much of the credit should go.

The Shake Up At Endo Pharma (IN VIVO)

IN VIVO

Endo Pharma CEO Dave Holveck is diversifying the company from its core pain franchise into seemingly unrelated fields. Critics argue that he's neglecting its core strengths and acquiring mediocre assets, but he says such moves are necessary to address marketplace shifts.

Creating a Winning Medtech Business Model for a Post-Reform World (IN VIVO)

IN VIVO

Together, the global financial crisis and health care reform could combine to dramatically alter the device industry's traditional business model. The result could be a variety of different models arising from shifting relationships with physicians and hospitals, with the winners being companies that adapt most effectively to this changing environment.

FDA Opens Up: Can Industry Live With Greater Transparency? (IN VIVO)

IN VIVO

Drug sponsors are finding little to like about FDA�s transparency initiative - especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency - and FDA�s interest in avoiding another Avandia - industry needs to decide whether this is a fight worth having. This article was originally published in the July/August 2010 issue of The RPM Report.

Selected Start-Ups (07/2010) (IN VIVO)

IN VIVO

In Vivo briefly describes these recently founded companies: Audax Medical, Calithera Biosciences, Fluence Therapeutics, Implandata Ophthalmic Products, Metagenomix and Virometix.

Start-Up Previews (07/2010) (IN VIVO)

IN VIVO

A preview of the emerging health care companies profiled in the current issue of Start-Up. This month's profile group, "Alzheimer's Start-Ups Face A Discovery And Clinical Crossroads," features profiles of AlzProtect, Axerion Therapeutics, Cognition Therapeutics and Galantos Pharma. "The Future of Laparoscopy: Single Incision, NOTES And Robots," features profiles of EndoControl, Ovesco Endoscopy, SurgiQuest and Virtual Incision. Plus these Start-Ups Across Health Care: Antabio, Beta-Stim, CMP Therapeutics, Elixir Medical, Kerecis, Optivia Biotechnology, Quanterix and reinnervate.

On the Move (Company Changes and Promotions 07/2010) (IN VIVO)

IN VIVO

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

Deals Shaping the Medical Industry (07/2010) (IN VIVO)

IN VIVO

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. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

reinnervate Ltd. (Start-Up)

Start-Up

reinnervate Ltd. is commercializing Alvetex, a three-dimensional scaffold for cell culture. By supporting cell cultures that are more representative of the original tissues, Alvetex cultures could help drug companies fail drugs at an earlier stage, and could reduce the numbers of animals required in testing, thereby saving money in drug development.

As Some VCs Run On Empty, Others Are Topping Off The Tank (Start-Up)

Start-Up

New money is increasingly hard to come by for life sciences venture capital firms. Start-Up tracks VCs to determine which firms have older vintage funds and which have plenty of fresh capital to invest.

Calithera Biosciences: UCSF Spin-out Takes $40 Million First Round (Start-Up)

Start-Up

An investor syndicate led by Morgenthaler Ventures has backed cancer drug researcher Calithera Biosciences Inc. with $40 million in Series A funding, intended to support development of small-molecule compounds that activate caspases.

TCT Medical Offers A New Model For Device Distribution In China (Start-Up)

Start-Up

China has become especially enticing as an unpenetrated, gigantic health care market, especially since the government in 2009 signed into effect a health care reform bill promising $125 billion over a three-year period to modernize the infrastructure of health care and provide insurance coverage to hundreds of millions of people. Medical device companies look to China as an enormous and rapidly growing market for medical disposables and equipment. However, the complex nature of the distribution infrastructure in China will make it difficult for companies to get a foothold. Headquartered in Beijing, TCT Medical Inc., which recently received $10 million in venture funding from Fidelity Asia Ventures and Fidelity Biosciences, its sister firm in the US, offers a potential solution for companies focused on women's health, and a model for the future.

Cadence, VCs Relieve J&J's Pain, Map Out A Clever Exit In The Process (Start-Up)

Start-Up

When J&J offered to sell its Ionsys pain-relief patch at a fire-sale price last year, Cadence Pharmaceuticals' management team saw a diamond in the rough. But the specialty pharma didn't have the cash or the focus to take on a new project. Enter Frazier Healthcare Ventures, which organized an investor syndicate that teamed with Cadence management on a deal with enough moving parts to make Rube Goldberg proud. The arrangement birthed Incline Therapeutics Inc., an independent, privately held start-up backed by $43.5 million in venture money.

Alzheimer's Start-Ups Face A Discovery And Clinical Crossroads (Start-Up)

Start-Up

With big Phase III failures heating debate about the amyloid hypothesis, small biotechs must convince investors that their early research is pointed in the right direction, and larger ones must design clinical trials with care. We profile four Alzheimer's-focused start-ups in this issue: AlzProtect, Axerion Therapeutics, Cognition Therapuetics and Galantos Pharma.

AlzProtect SAS (Start-Up)

Start-Up

AlzProtect SAS believes that Alzheimer's disease is caused by the loss of neuroprotective factors including APP intracellular domain and sAPP alpha, both of which are produced during the metabolism of amyloid precursor protein. The start-up is developing compounds that can stimulate the APP, increasing the production of neuroprotective compounds.

Axerion Therapeutics Inc. (Start-Up)

Start-Up

Axerion Therapeutics Inc.'s technology aims to block the binding of Amyloid beta to the prion protein PrP-C, a mechanism its scientists say is the toxic trigger behind neuronal death in Alzheimer's disease. Based at Yale University in New Haven, the team found that mice with AB plaques but no PrP-C showed no cognitive impairment. [A#2010900153]

Cognition Therapeutics Inc. (Start-Up)

Start-Up

Using proprietary assays, Cognition Therapeutics Inc. has discovered small-molecule, highly brain-penetrable drugs that block soluble toxic amyloid beta oligomers in their reactive form, rather than target amyloid beta plaque or expression of the monomer building blocks.

Galantos Pharma GMBH (Start-Up)

Start-Up

Galantos Pharma GMBH is developing a next-generation version of galantamine, an acetylcholinesterase inhibitor that's been on the market as a cognition enhancer since 2000 and went generic in 2008. Galantos' Memogain is a nasal-formulation galantamine prodrug that it says will permeate the blood-brain barrier more efficiently.

The Future of Laparoscopy: Single Incision, NOTES and Robots (Start-Up)

Start-Up

The skill sets of laparoscopy, endoscopy, robotics and even interventional cardiology are all converging to create least invasive surgeries that take laparoscopy as a point of departure but change how surgeons access the abdominal cavity. Start-ups are innovating to supply the new surgical instruments.

EndoControl SAS (Start-Up)

Start-Up

EndoControl's founders bet there are large market applications where surgeons will want to reach for a single-function, low-cost robot to lend a helping hand. EndoControl has developed the ViKY system, a motorized endoscope holder compatible with any endoscope, that responds to a surgeon's voice or foot command.

Ovesco Endoscopy AG (Start-Up)

Start-Up

With technology licensed from the University of Tuebingen, Ovesco Endoscopy has set out to address one of the biggest challenges of NOTES procedures: achieving closure of the gastric wall while working through a flexible endoscope. Ovesco has developed a clipping system that imitates the mechanics - the geometry and force pattern - of a surgical suture, but with advantages.

SurgiQuest Inc. (Start-Up)

Start-Up

Fundamental technoloiges are still wanting to encourage the migration of surgeries to a single-incision approach. SurgiQuest has a proprietary platform that addresses a long list of limitations hampering surgical access through traditional trocars.

Virtual Incision Corp. (Start-Up)

Start-Up

The debate surrounding the future of minimally invasive surgery -- whether single-incision laparoscopy will prevail, or whether it is merely a stepping stone to a world of incisionless NOTES procedures - is not really relevant to Virtual Incision, a start-up developing mini surgical robots. The company's founders believe that in vivo robots will free a surgeon of any constraints due to the method of entering the body.

Antabio SAS (Start-Up)

Start-Up

Antabio SAS is taking an antivirulence rather than an antibiotic approach to treat gram-negative nosocomial infections. When combined with marketed antibiotics, the compounds in its pipeline have potential to target key virulence pathways in pathogenic bacteria, and thus reduce patient mortality and associated costs.

Beta-Stim Ltd. (Start-Up)

Start-Up

A new implantable device from Beta-Stim Ltd. is designed to eradicate type 2 diabetes. The start-up's Balance System provides electrical stimulation of the duodenum during food intake to reduce blood glucose levels. This profile was originally published in the June 2010 issue of Medtech Insight.

CMP Therapeutics Ltd. (Start-Up)

Start-Up

Chitin may be the second most common molecule on earth. It could be the source of a treatment for the common cold, too. So hope investors in CMP Therapeutics Ltd., which is developing a micronized nose-spray version of the polysaccharide chitin. The company is also using chitin as the basis for programs in novel allergy and asthma therapies, vaccine adjuvants, and nutritional products.

Elixir Medical Corp. (Start-Up)

Start-Up

Elixir Medical Corp. aims to address the shortcomings of current drug-eluting stents, such as late stent thrombosis, dual antiplatelet therapy duration and better efficacy in more complex disease. Elixir's technology innovations include what it describes as the thinnest durable biocompatible polymer coating, an ultra-thin biodegradable polymer coating and a fully biodegradable drug eluting stent.

Kerecis Ltd. (Start-Up)

Start-Up

The Marigen Lipid Enhanced Matrix from Kerecis Ltd. is derived from fish skin and has been shown to effectively improve the healing of wounds and surgical cuts. The company says that Marigen offers significant advantages over existing human and porcine-derived products, including improved manufacturing economics, lower risk of disease transfer and the promise of better clinical outcomes.

Optivia Biotechnology Inc. (Start-Up)

Start-Up

Optivia Biotechnology Inc. is positioned to help drug developers address clinically significant transporter-related drug-drug interactions. In addition to its polarized mammalian cell assay, it is developing a platform for studying transporter biology and optimizing drug discovery and development.

Quanterix Corp. (Start-Up)

Start-Up

Quanterix Corp. has applied fiber optic technology to immunodiagnostics to create a dramatic improvement in sensitivity based on single molecule counting. The company intends to use its platform to develop in vitro diagnostics for several clinical applications, beginning with prostate cancer and Alzheimer's disease.

Emergings In Brief (07/2010) (Start-Up)

Start-Up

Brief profiles of these recently formed companies: Audax Medical, Fluence Therapeutics, Implandata Ophthalmic Products and Metagenomix.

On The Move: Who's Going Where In Biopharma And Medtech Start-Ups (07/2010) (Start-Up)

Start-Up

Recent executive-level hires and director appointments at venture capital firms and biopharma and medtech start-ups.

Recent Tech Transfer Deals (07/2010) (Start-Up)

Start-Up

Our monthly update on technology transfer deals--licensing agreements between companies and universities or other research institutions--in the fields of life sciences, including pharmaceuticals, medical devices, in vitro diagnostics and research/analytical instrumentation and reagents.

Recent Financings of Private Companies (07/10) (Start-Up)

Start-Up

Start-Up's monthly comprehensive review of emerging life science companies that have received venture funding during the month, including companies in the pharmaceutical, medical device, diagnostic and research instrumentation and reagent sectors.

Free Speech (The RPM Report)

The RPM Report

Antibiotic Development Incentive Menu: Options Getting Longer (The RPM Report)

The RPM Report

Congress continues to look at ways to stimulate more research on anti-infectives. The list of potential incentives gets longer each time another drug category wins a new form of incentive. None of the ideas has succeeded yet in coalescing a political consensus; but potential legislative vehicles are out there.

A Painful Decision for King and Acura (The RPM Report)

The RPM Report

An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do.

Going Around in Circles (The RPM Report)

The RPM Report

Early on in the committee discussion of Acurox, FDA made its feelings about the product clear. Here is a transcript of the exchange between two committee members and two FDA officials on the key question about the King application: what exactly should be required to allow inclusion of niacin in the formulation with the goal of provoking adverse effects in abusers of immediate release oxycodone.

Ladies & Gentlemen of the Jury...I Mean Advisory Committee (The RPM Report)

The RPM Report

When King Pharmaceuticals Inc. Chief Scientific Officer Eric Carter concluded his presentation during the April 22 advisory committee review of the novel oxycodone/niacin formulation Remoxy, he sounded almost like an attorney making a closing argument before a jury.

FDA and Foreign Trial Monitoring: What the OIG Report Said-And What It Didn't (The RPM Report)

The RPM Report

Disease Awareness Information: The Xiaflex Dupuytren's Dilemma (The RPM Report)

The RPM Report

Is FDA trying effectively to ban the practice of providing disease awareness information in promotoional materials? A recent letter to Auxilium on promotional materials for the company's drug for Dupuytren Disease (Xiaflex) suggests FDA is still looking closely at how companies describe disease states compared to a product's labeled indications.

FDA Opens Up: Can Industry Live With Greater Transparency? (The RPM Report)

The RPM Report

Drug sponsors are finding little to like about FDA's transparency initiative-especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency-and FDA's interest in avoiding another Avandia-industry needs to decide whether this is a fight worth having.

Transparency in Action: FDA Comments on Pirfenidone (The RPM Report)

The RPM Report

While FDA's proposed transparency initiative is still under discussion, there are signs that the agency is already taking a more liberal view of its disclosure polices. InterMune's pirfenidone is a case in point.

The New Part D: "Dollars for Donuts" Becomes Discounts For Data (The RPM Report)

The RPM Report

The pharmaceutical industry's 50% donut hole discount worked out exactly as planned in the context of shaping the health care reform debate. The implementation of the new program is a different story. The program created by CMS doesn't look anything like industry would have hoped-but manufacturers have no choice but to play by CMS' rules, and try to make it work for them anyway.

The President Talks Prescription Drugs (The RPM Report)

The RPM Report

President Obama hosted a �town hall� discussion on health care reform and senior citizens June 8. Not surprisingly, the plan to fill in the Medicare Part D donut hole was touched on several times. If manufacturers expected credit for giving a 50% discount, they didn�t get it. They did, however, hear some unwelcome discussion of ideas like price negotiation. On the other hand, the President stressed the role of health care reform in assuring access to drugs. Excerpts from the official White House transcript.

Dendreon vs. CMS:Controversy Is Bigger Than One Product (The RPM Report)

The RPM Report

It appeared as though the controversy over the level of efficacy and benefit from the prostate cancer immunotherapy Provenge ended when the drug was approved by FDA at the end of April. The FDA approval may have just been the halfway point in the product's route through government agencies to the commercial market. Now Medicare is questioning whether the government should pay for the new therapy. The CMS decision is just as important to the biopharmaceutical industry as it is to Dendreon.

Congress and Continuing Medical Education: Last Chance for Self-Policing (The RPM Report)

The RPM Report

Senate Finance Committee minority staff investigator Paul Thacker has been a leading figure behind the effort to make public the recipients of pharma funding and grants. Here are his thoughts from a recent conference on the future of industry funded CME.