Windhover's Commentary

Deals in Depth: December 2009 (IN VIVO)

IN VIVO

Astellas will be developing Ambit's FLT3 kinase blockers in the month's largest deal at $390 million. Sanofi-Aventis' move into the US OTC market was evident in its acquisition of Chattem for $2.1 billion. In one of the five biggest medical device acquisitions of 2009, Ethicon bought sinus surgical device company Acclarent for $785 million. Financing for biopharma companies increased dramatically to over $2 billion, most of which came from three $400 million-plus FOPOs. Device fundraising was down slightly in December, although diabetes management firm Intuity Medical impressed with its $64 million Series D round.

Pharmaceutical/Biotechnology Deal Statistics Quarterly, Q4 2009 (IN VIVO)

IN VIVO

Highlights from the Q4 2009 review of pharmaceutical and biotechnology dealmaking: Financing dollar volume was high with 108 financing deals bringing in close to $5 billion, with a big increase in public financings: IPOS and FOPOs together made up over half of the quarter's total dollar volume. Conversely VC rounds were down--accounting for only 18% of the Q4 aggregate. M&A was strong in Q4 with 27 transactions bringing in close to $8 billion-almost half of these were acquisitions of private biotechs. Deals with big earn-outs were also predominantly featured this quarter (and throughout the year). Alliances in Q4 reached an aggregate potential deal value (pre-commercialization monies) of $5.9 billion, a 46% increase over the previous quarter. Several Big Pharmas did multiple transactions, most notably GlaxoSmithKline PLC, which penned nine of its 20 in-licensing deals in the fourth quarter alone. Q4 also boasted 16 deals with up-front payments exceeding $50 million.

Medco Buys DNA Direct, Adding Genetic Testing Guidance and Decision Support Capacity (IN VIVO)

IN VIVO

During the past three years, Medco Health Solutions Inc. has focused its emerging personalized medicine business around pharmacogenomics--drug-related genetic testing. With the acquisition of privately held DNA Direct Inc., announced February 2, the pharmacy benefits manager is now branching out to include guidance and support for payors, providers, and patients to help ensure the appropriate use of the more than 2,000 currently marketed genetic and molecular diagnostic tests.

Ethicon Buys Acclarent: Can This Exit Open Up ENT? (IN VIVO)

IN VIVO

Traditionally, the ENT space has been a bit of a technology backwater in terms of device innovation. Indeed, it has been more than a decade since the last major ENT deal, which made Medtronic the sole major strategic player in the ENT space. That dynamic has now changed with J&J/Ethicon's acquisition of Acclarent. Now the question is whether this deal will help open up the ENT space to more M&A activity?

Novartis Splits Chair and CEO Positions, Names Joe Jimenez CEO (IN VIVO)

IN VIVO

In a move that was somewhat abrupt, but hardly surprising, Novartis AG in late January announced that Joe Jimenez, who currently runs Novartis Pharma AG, would become the company's CEO, effective February 1. Long-time chairman and CEO David Vasella will remain as chairman. The announcement brings some closure to a process that began officially more than a year ago, as Novartis worked to get its succession planning right

Best of The IN VIVO Blog (02/2010) (IN VIVO)

IN VIVO

A selection of our favorite blog posts from January 2010 about stories not covered elsewhere in this issue of IN VIVO. (See the original postings for free at http://invivoblog.blogspot.com/).

Orphaned No Longer: Big Pharma Embraces Drugs for Niche Markets (IN VIVO)

IN VIVO

Hit hard by late stage pipeline failures and the regulatory and reimbursement challenges of traditional primary care products, Big Pharmas are taking renewed interest in drugs for orphan diseases, where high unmet medical need offers the promise of premium pricing and there's potential to grow the market via approval in multiple indications.

Finsbury's Last Stand (IN VIVO)

IN VIVO

One of the most innovative and creative orthopedic implant designers, the UK's Finsbury's Orthopedics never quite built the sales and distribution capability to enable it to capture the full value of its designs. The company's recent sale to DePuy underscores how much the orthopedics industry has changed since its earliest days.

Building the New Generation of Drugs in Neurodegeneration (IN VIVO)

IN VIVO

Neurodegenerative diseases have emerged as one of the toughest and potentially most attractive frontiers in specialty drug development. Companies interested in the NDD space have the option of pursuing several strategies: disease-modifying therapies, symptom management therapies, or a hybrid approach, in which symptom-modifying drugs provide near-term revenues but also have longer-term potential for disease modification. Given the extraordinary difficulty associated with producing a successful disease-modifying new therapy, drugs aimed at treating symptoms are likely to dominate the NDD space for years. Licensors are rewarding developers with promising symptom modification programs with attractive deals.

Tryton Medical: Going Against the Flow in Bifurcated Stents (IN VIVO)

IN VIVO

Many device companies, large and small, have tried unsuccessfully to come up with a stent to treat bifurcated lesions, primarily by focusing on treating the main vessel. Tryton is taking a different approach: using a bare-metal device designed to treat the side branch. The company believes this contrarian strategy pairs perfectly with current drug-eluting stents, making them an ideal acquisition target for a large CV company.

Open to Innovation: A Conversation with Johnson & Johnson Pharma R&D Chief Paul Stoffels (IN VIVO)

IN VIVO

Johnson & Johnson believes its future success is directly dependent on its ability to access best-in-class science via more flexible, less risky partnerships. The health care giant's global head of pharmaceutical R&D, Paul Stoffels, explains in greater detail J&J's open innovation model.

Following the Money in Medical Devices (IN VIVO)

IN VIVO

Venture capitalists might cry poor, but, in fact, many leading firms have raised new funds over the past year, pooling more than $1.5 billion for medical device investments. The only question facing entrepreneurs and executives is: are they buying what you�re selling?

Selected Start-Ups (02/2010) (IN VIVO)

IN VIVO

In Vivo briefly describes these recently founded companies: Adenios, Amedrix, Cardialen, Crinetics Pharmaceuticals, Janisys and VitaPath Genetics.

Start-Up Previews (02/2010) (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, "New Antibody Platforms," features profiles of arGEN-X, Crescendo Biologics, Oligasis and Open Monoclonal Technology. Plus these Start-Ups Across Health Care: BioMarker Strategies, BMEYE, Clear Catheter Systesm, Epicardial Technologies and Optibrium.

On the Move (Company Changes and Promotions (02/2010) (IN VIVO)

IN VIVO

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

Deals Shaping The Medical Industry (02/2010) (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.

For Device VCs, the Eyes, Heart and Stomach Have It (Start-Up)

Start-Up

Anyone with access to the right data can tell you which technologies and medical specialties are commanding the highest valuations from device VCs. But what would it be worth to know which companies will be commanding the top prices in the next year? A survey of more than a dozen VCs--who participated with a promise of anonymity--with money to invest draws a very clear picture about what investment opportunities they might find worth fighting over and the areas they'll ignore.

Busy Times and Divergent Strategies for Celtic Pharma's Follow-On Funds (Start-Up)

Start-Up

The various Celtic funds (there are three, with two sprouting from the original Celtic Pharma I Holdings established in 2004) posted a very busy January, closing deals involving Kolltan Pharmaceuticals Inc., Cantab Pharmaceuticals PLC, Inspiration Biopharmaceuticals Inc. and PolyTherics Ltd. But the details of these transactions help illustrate how the two actively investing successor funds have established fundamentally different investment strategies, even if those strategies can overlap at times.

Essex Woodlands Partners With Lemaitre to Start White Pine (Start-Up)

Start-Up

Dan Lemaitre, who steered CoreValve into a record breaking acquisition by Medtronic, has joined with venture capitalist Guido Neels to form a new device company, White Pine Medical Inc. Neels' firm Essex Woodlands Health Ventures is backing Lemaitre with $50 million.

deCODE Re-Emerges: Can a Genomics Platform Model Work in Diagnostics? (Start-Up)

Start-Up

deCODE Genetics has emerged from bankruptcy with a streamlined, diagnostics-oriented business model. In the near term, the privately held firm expects to offer its genomics discovery capabilities on a service basis, echoing the original genomics platform specialists of the late 1990s, including deCODE itself, which did largely unsuccessful technology deals focused on using genetic insight to generate therapies. The difference? It is now using genetic information to assess disease risk and better manage patient health, a strategy it thinks will succeed as the field of personalized medicine diagnostics continues to gain traction.

Urology Devices Play to Large and Growing Procedure Volumes (Start-Up)

Start-Up

Last year saw a surprising number of investments in devices for urology but the development activity in this space should not be surprising, given that prostate disease-both prostate cancer and BPH-are diseases of aging, setting in after age 40 when hormonal changes may cause the prostate to enlarge. BPH, for example, affects more than 50% of men age 60 and older and 90% of men age 70 and older. Prostate cancer is the second-leading cause of carcinoma death in men. These demographic trends are reflected in the rapid growth in surgical procedures for the treatment of prostate disease, many of which are projected to grow at high double-digit rates in major global economies, according to a series of reports detailing surgical volumes and trends by country, published by the Medtech Insight division of Elsevier Business Intelligence.

Start-Up Quarterly Statistics, Q4 2009 (Start-Up)

Start-Up

Highlights from the Q4 2009 review of start-up dealmaking: Fundraising in the biopharma, medical device, and in vitro diagnostics industries totaled $976 million, an 88% increase from the previous quarter, and a 77% jump from Q4 2008's $551 million. Of the total fundraising, 66% or $640 million went to the biopharma industry. Compared with Q3 2009, device fundraising rose by 85% (from $113 million to $209 million) and diagnostics companies raised 72% more (from $74 million to $127 million). The fourth quarter of 2009 saw eight acquisitions, all of them in the biopharma industry. Big Pharmas were busy signing deals with start-ups--Sanofi-Aventis inked three while Roche and Novartis AG each signed two.

Despite Advances, Regenerative Medicine Faces Funding Crisis (Start-Up)

Start-Up

Stem-cell and regenerative medicine firms are scrambling to find business models to harness the field's nascent, rapidly evolving science. Companies deep into clinical trials are still looking for pharma partnerships. Earlier stage biotechs are trying to turn their platforms into research revenue as they look to non-profit, government, and private funding sources to advance their preclinical therapeutic programs. Whatever the model, worries abound that the financial woes of the next couple of years could blunt hard-earned momentum.

Device Investors Look for Gains in Pain (Start-Up)

Start-Up

In 2009, investors quietly invested in seven different start-ups develoipng devices for pain. Why the sudden interest? Interventional pain is on the rise as a specialty, large numbers of patients with chronic pain need better therapies, and relative to other emerging device sectors, pain offers large markets but lower clinical, regulatory and market risks.

Big Pharma's Appetite for Biologics Platforms Fuels New Company Creation (Start-Up)

Start-Up

With the industry on the cusp of a "me-better" era in biotherapies, Big Pharma has more incentive than ever to invest in novel platforms that can build better biologics. Start-Up profiles ArGEN-X, Crescendo Biologics, Oligasis and Open Monoclonal Technology

arGEN-X BV (Start-Up)

Start-Up

The days when drug makers could easily sign deals with front-running antibody developers are over, ended by acquisitions and exclusive arrangements for the most desirable targets. arGEN-X BV believes this is but one dynamic that will attract partners to its therapeutic antibody platform, which entails active immunization of llamas. To flaunt the diversity and potency of its "camelid" antibodies, ArGEN-X aims to raise antibodies to traditionally tough targets, such as membrane-bound proteins like GPCRs.

Crescendo Biologics Ltd. (Start-Up)

Start-Up

By now everyone knows that antibodies can make excellent drugs. What is far less certain, albeit widely hoped, is if antibody fragments will also succeed in the clinic. The first wave of candidates is only now entering early clinical trials. Crescendo Biologics Ltd. is one of many firms betting that smaller will prove better: it aims to tailor single-domain fragments and optimize them with a ribosome-display platform.

Oligasis Inc. (Start-Up)

Start-Up

Current technologies for increasing the biocompatibility of engineered antibodies, protein fragments, and other biological agents, such as PEGylation and various protein chaperones, have achieved a maximum half-life extension of about 60 to 80 hours. Frequent dose regimens remain necessary, holding back many potential products. Oligasis Inc. is developing a zwitterionic polymer structure as a conjugate it believes should increase any biological drug's half-life by as much four-fold over the current state of the art.

Open Monoclonal Technology Inc. (Start-Up)

Start-Up

From a scientific standpoint, there is little if any need for a new therapeutic antibody manufacturing platform: multiple existing ones generally work well, for those who have licensed rights. But Open Monoclonal Technology Inc. believes its rat-based system has a compelling business advantage: companies coming late to the field can access OMT's technology at relatively low cost, and use it for any targets they wish. OMT itself aims to leverage ownership of the platform to develop antibody "cocktails" or mixtures.

BioMarker Strategies LLC (Start-Up)

Start-Up

Targeted cancer drugs are all the rage--and with good reason--but it remains challenging to accurately predict which patients will respond to them. BioMarker Strategies LLC has developed SnapPath, an ex vivo biomarker system that disperses solid tumor tissue in media. It then exposes live cells to growth factors and other stimuli to induce them to produce phosphoproteins and other ex vivo biomarkers to reveal the functional circuitry of the patient's tumor cells.

BMEYE BV (Start-Up)

Start-Up

Nexfin from BMEYE BV is a noninvasive cardiovascular monitoring system that not only checks blood pressure--heartbeat to heartbeat--but also provides physicians with cardiac output and full hemodynamics data, measured with a finger cuff connected to a wrist unit, which is linked to a monitor.

Clear Catheter Systems LLC (Start-Up)

Start-Up

Since the chest tubes used postoperatively to drain blood and fluid from around the patient's heart have a tendency to clog, surgeons often choose large tubes, which are often the most visible--and painful--reminder a patient has of his surgery. Clear Catheter Systems LLC is developing technology that has the potential to make heart-surgery recovery safer and perhaps less painful by using smaller diameter tubes and actively breaking up occluding material that can lead to serious complications.

Epicardial Technologies Inc. (Start-Up)

Start-Up

Epicardial Technologies Inc. is developing a technology platform designed to enable physicians to more easily perform percutaneous, catheter-based ablation of common heart rhythm abnormalities, from the inside or the outside surface of the heart, while protecting the structures surrounding the heart from serious damage or injury. The company says its products will enable electrophysiologists to do what only surgeons can currently accomplish-effectively ablate aberrant electrical signals on the heart's outside surface-without opening the chest.

Optibrium Ltd. (Start-Up)

Start-Up

Drug development is difficult and risky, and the timescales are long. Optibrium Ltd. has developed StarDrop, a software platform designed to support drug discovery by guiding decisions in the design and selection of potential drug candidates based on complex and uncertain data. Through chemical space visualization, supported by a visualization tool and probabilistic scoring, StarDrop compares candidate molecules against a weighted profile of required properties, and helps users to identify chemistries with a high chance of success in order to better focus their expensive in-house resources.

Emergings in Brief (Start-Up)

Start-Up

Brief profiles of these recently formed companies: Adenios, Amedrix, Cardialen and Janisys.

A Study in RAF: On-Target Effects Can be Surprisingly Fickle (Start-Up)

Start-Up

Two independent research teams have shown that current RAF inchibitors, a class of experimental targeted cancer drugs, may only work well in patients with one particular mutation - in an enzyme called BRAF. In other people, the drugs can actually contribute to the growth of tumors. The findings echo develoments earlier in the decade with EGFr inhibitors, which proved to be harmful to some patients until the mechanism of action was worked out and their use subsequently restricted.

On the Move: Who's Going Where in Biopharma and Medtech Start-Ups (Start-Up)

Start-Up

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

Recent Financings of Private Companies (2/10) (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.

Recent Tech Transfer Deals (2/10) (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.

Free Speech--0210 (The RPM Report)

The RPM Report

Industry executives from all sectors discuss the impact of the delay in health care reform

The Approval Rebound Begins (The RPM Report)

The RPM Report

The Center for Drug Evaluation & Research approved one more new molecular entity in 2009 than it did in 2008. But dig a little deeper and there is promising evidence that the approval trend is on an upward trajectory. It is far too early to declare a turnaround, but at least there are signs that the FDAAA era is translating into more products making it to market.

Kaiser Pushes Back on REMS: Acorda Listens; Will FDA? (The RPM Report)

The RPM Report

Kaiser recognizes that some sponsors are trying to use REMS to make an end-run around gatekeepers, and it is fighting back. The non-profit integrated care system wants FDA to help, filing a citizen petition that could profoundly affect commercialization of new products in the US. The recently approved MS drug Ampyra offers a case-in-point.

The Opioid REMS: Health Care Reform, One Class at a Time (The RPM Report)

The RPM Report

FDA is planning a spring meeting to discuss next steps in a class-wide Risk Evaluation & Mitigation Strategy for opioids. The outcome will redefine the rules of commercial success in the pain class-and provide a critical case study for how FDA's new regulatory tools may reshape other sectors over time. The good news: there appear to be new opportunities amid the change. The bad: industry is definitely not driving the process.

Re-Defining Innovation in Pain Therapy: A Conversation with King's Management Team (The RPM Report)

The RPM Report

King Pharmaceuticals is pursuing an interesting business model for pain therapy: driving abuse-resistance via continual innovation in formulation technology. It might be a home run in the current regulatory climate-provide King can stay on the right side of the regulators itself. We sat down with King CEO Brian Markison and Chief Scientist Eric Carter during the JP Morgan health care conference in January.

Avandia Revisited: Will New Findings Lead To Reevaluation of Drug Center's Structure? (The RPM Report)

The RPM Report

Senate Finance Committee report and internal FDA analysis on cardiovascular risks associated with GSK's Avandia may revive argument to split CDER into two groups of safety and efficacy reviewers.

The Rebirth of A Niche Product: Three Silver Linings on the ESA REMS (The RPM Report)

The RPM Report

The long-awaited Risk Evaluation & Mitigation Strategy for Aranesp and Procrit is here. For the oncology indication, it requires provider training program enrollment. It may not seem like the best outcome for Amgen and J&J, but there are some upsides.

Medicare/Medicaid Prosecutions: Does More Money for Fraud Activities Translate Into More Mega-Settlements? (The RPM Report)

The RPM Report

From expanding health care coverage to collecting fees from miscreants, the lead story at HHS took a quick and sharp turn with the unveiling of the President's budget for fiscal 2011. HHS is setting high return standards for its fraud activities: $1.5 in net returns to the government for every dollar spent. Practically, that may drive HHS to press big pharma for big settlements.

A Time to Settle; A Time to Fight (The RPM Report)

The RPM Report

It seems like an odd time to fight with the government fraud investigators over false claims suits. The public perception of white-collar greed is back in vogue; more money is headed to the fraud investigators at HHS and the Justice Department, top government leaders are putting their public reputations at stake on big cash recoveries, and pharma settlement figures are steadily around $500 million or more.But J&J and Allergan look ready to fight back.

Who Won The Massachusetts Senate Election? (The RPM Report)

The RPM Report

Critics of Big Pharma's deal with the Obama Administration reacted with glee to the sudden collapse of the final reform bill in January. But for investors betting against reform, there was no payoff. The only winner may be uncertainty.

Three Takes on Health Care Reform (The RPM Report)

The RPM Report

Perspectives from top health care executives explaining the status of reform to investors.

Revive BioShield II: Bring Big Pharma Back Into Medical Countermeasures (The RPM Report)

The RPM Report

The legislative architect of BioShield II proposal that failed to make it into law in 2005 argues that the proposal remains the best approach for bringing experienced, well-funded medical product companies into the effort to protect the nation against bioterror attacks -- from other governments and from nature.

Dealmaking in 2009: A Look Back and A Glance Ahead (Medtech Insight)

Medtech Insight

This article was excerpted from "Top Device Stories of 2009: A Year of Economic Revival and Regulatory Risk," IN VIVO, January 2010.

A Boom in Devices for the Hearing Impaired (Medtech Insight)

Medtech Insight

Competition is spurring innovation in the hearing aid market and providers are excited at the prospect of adopting new products that can improve on existing treatments. The hottest area at the moment is implantable hearing aid devices. It's not a new concept, but it's one that many believe will command a significant share of the market.

Recent Trends in Hemodynamic Monitoring (Medtech Insight)

Medtech Insight

Growth in the hemodynamic monitoring market is being fueled by several factors, including the aging population and the increasing demand for less invasive and noninvasive technologies for measuring global parameters of oxygen delivery. While barriers to entry are high in the hemodynamic monitoring business, the prospect for future growth is significant.

Cardiac Imaging and CER: The Search for Efficiency (Medtech Insight)

Medtech Insight

Regardless of the final shape of health care reform legislation, there is little doubt that the swirling debate around that issue has highlighted an unambiguous need to reduce health system costs, increase efficiency, and improve patient outcomes. This is particularly true for high-cost diagnostics in crucial areas like cardiac care. The focus on fast-rising care costs has ratcheted up the pressure to reduce the number and fine-tune the quality of cardiac imaging procedures. And perhaps nothing signifies change in this area more than the introduction of comparative effectiveness research into the equation in the search for standards of care.

What's Next for NOTES? An Interview with Santiago Horgan, MD (Medtech Insight)

Medtech Insight

Medtech Insight interviews Santiago Horgan, MD, professor of surgery at the University of California, San Deigo School of Medicine and a leader in the emerging field of NOTES.

Market & Industry Briefs (Medtech Insight)

Medtech Insight

Brief summaries of recent medtech market and industry developments. This month we cover FDA's approval of Thoratec's HeartMate II VAD, the settlement of Boston Scentific and J&J's patent suits, a German appeals court's favorable ruling on Corevalve's transcatheter aortic heart valve system and the Obama administrations budget request for a national device registry.

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, including new findings linking migraines to cardiovascular disease, low levels of anti-PC antibody linked to stroke, transforming skin cells into neurons, nano-based injectable batteries, and new studies that question the benefits of GERD surgery and breast MRI.

Start-Up News (Medtech Insight)

Medtech Insight

Noteworthy news from medtech start-ups. This month we profile Clear Catheter Systems, which is developing active technology for clearing chest tubes, Kemeta, whose sensor measures the rate of fat burn, and Aardvark Medical, which is developing home-use technology for nasal irrigation and aspiration.