2 key insights from the patent-approval overhaul

Starting last fall and stretching through mid-2013, the U.S. has been overhauling the patent-approval process for the first time since 1952.

The biggest change:

Our first-to-invent system, which favors creators, will become a first-to-file system, which favors whoever files first.

Uncle Sam says the reform will speed innovation. Experts checked the numbers in a recent article in FAST COMPANY.  There were two particular insights relevant to brand innovators:

1. GOOD FOR INNOVATION—Shorter average patent wait time. 34 months and going down. Startups that qualify for the new fast-track option get their patents reviewed in as little as 12 months, which makes it easier to bring their products to market.
2. BAD FOR INNOVATION—Fewer patents issued to noncorporate inventors. 31,923 in 2010 and going down. When Canada switched to a first-to-file system in 1989, the race to file intensified--and individual inventors were put at a disadvantage (compared to big firms with lots of resources). A similar scenario could play out in the U.S.

You can read the full analysis at www.fastcompany.com/magazine

 

"21st century...the century of biomedicine" - Lilly CEO Lechleiter

"Wealth follows health, and it ain't the other way around," said John Lechleiter, the CEO and chairman of the drug maker Eli Lilly & Co.

Mr. Lechleiter explains, "There's no better investment that we can make than in biomedical research and in our health.  I believe this will be the biomedical century.  We'll look back a hundred years from now and say the 20th century was the century of chemistry and physics, and the 21st century was the century of biomedicine."

"The challenge or the opportunity we have is that never before has the science and our knowledge base been riper for exploitation," Mr. Lechleiter adds during his interview with The Wall Street Journal.

Read the complete story by clicking to http://online.wsj.com 

12 Boston area biotechs profiled for their acquisition appeal

These days, Stinson Brand Innovation has been doing a lot more business in Boston.  So we’ve been following the deals (and talk of deals) in the area.

Here’s a look at what the Boston Globe recently said about the trend.

Genzyme Corp., which is locked in merger talks with French drug maker Sanofi-Aventis SA, is not the first major Massachusetts biotechnology company to be pursued by a major pharmaceutical company. And it likely will not be the last.

Analysts and industry executives note that drug makers and other life sciences companies have engineered a flurry of billion-dollar merger deals over the past few years as they try to expand their product lines, acquire cutting-edge technologies, and move into new markets — a trend that does not show any signs of letting up.

Last year alone, Thomson Reuters, a business information firm, tracked more than 1,400 life sciences mergers worldwide. They totaled about $206 billion, including 46 deals worth more than $5 billion in Massachusetts. In October, for instance, Japanese drug maker Dainippon Sumitomo Pharma Co. scooped up Sepracor Inc., the Marlborough company behind the Lunesta sleep aid, for $2.4 billion.

“It’s reality,’’ said Robert Coughlin, president of the Massachusetts Biotechnology Council, a trade organization based in Cambridge. “The industry is going through a roll-up and a consolidation.’’

And the deals keep coming. Last month, German pharmaceutical giant Merck KGaA completed its purchase of Millipore, a Billerica life sciences company, for $6.9 billion. Genzyme, the Cambridge company which has also reportedly received inquiries from other potential suitors, could ultimately fetch more than $20 billion.

Many of the biggest potential deals, such as Sanofi’s pursuit of Genzyme, involve giant pharmaceutical companies trying to buy mid-to-large biotech firms to lift their product portfolio as patents on blockbuster drugs expire.

“They have a lot of cash, but they are running out of product,’’ said Simos Simeonidis, a biotechnology analyst with Rodman & Renshaw LLC in New York.

Simeonidis predicted that pharmaceutical companies are most likely to buy companies that already have products on the market, such as Biogen Idec Inc. of Weston, or those that are close to winning approval for major drugs, such as Vertex Pharmaceuticals Inc. in Cambridge. Other prominent local firms with drugs on the market include Alkermes Inc. of Waltham, Amag Pharmaceuticals Inc. in Lexington, and Cubist Pharmaceuticals Inc. in Lexington.

Amag chief executive Brian J.G. Pereira said his company, which markets a treatment for iron deficiency in patients with chronic kidney disease, wants to build “a strong and vibrant company for the long run,’’ rather than look for a quick sale. But like other publicly traded companies, Amag has an obligation to shareholders to consider any offers that come along, Pereira said. The other companies declined to comment or could not be reached.

In addition to Sanofi, Simeonidis said a number of other drug companies could potentially be interested in a large acquisition, including European firms such as GlaxoSmithKline PLC, Novartis AG, AstraZeneca PLC, and Bayer AG, as well as American companies, such as Pfizer Inc., Bristol-Myers Squibb Co., and Eli Lilly and Co. GlaxoSmithKline, Pfizer, and Johnson & Johnson have all been cited as potential buyers for Genzyme if talks with Sanofi break down.

Still, the majority of biotech companies, such as Alnylam Pharmaceuticals Inc. in Cambridge, are years away from bringing a drug to market, making them less attractive to bigger firms looking to boost sales.

Cowen & Co. analyst Eric Schmidt agreed that large pharmaceutical companies will continue to buy promising biotechs but doubted there would be a sharp increase in acquisitions because of a Genzyme deal.

That is because, Schmidt said, a lot can happen between initial talks and final approval. Last month, Charles River Laboratories International Inc., a Wilmington company, abandoned its $1.6 billion bid for a Chinese drug research company, WuXi PharmaTech Inc., after shareholders objected.

“There’s no such thing as a wave of mergers and acquisitions,’’ Schmidt said. “For this thing to happen, it almost has to be a perfect storm.’’

In addition to the interest in Genzyme, takeover speculation has swirled around Biogen Idec because of activist investor Carl C. Icahn’s involvement in the company. Icahn successfully prodded Biogen Idec into briefly putting itself up for sale two years ago, though the company later said it could not find a buyer. Icahn’s team has since won three seats on Biogen Idec’s board, leading to speculation that it could be ripe for a takeover.

Jan Wald, a Boston analyst for the Noble Financial Group, said there will also likely be more acquisitions of medical device makers as companies try to expand by moving into new areas or buying competitors. “With the stock market the way it has been, there are a lot of cheap companies and larger companies can take advantage,’’ Wald said.

In particular, Wald sees potential for more consolidation among companies that make lasers and other devices to treat cosmetic conditions, such as Palomar Medical Technologies Inc. in Burlington. Palomar did not respond to a request for comment.

Some investors have also questioned whether Boston Scientific Inc. in Natick, one of the largest medical device makers in the state, might also be acquired because its stock has declined sharply over the past few years. Boston Scientific declined to comment.

But Wald said Johnson & Johnson, the most likely buyer, is unlikely to launch a bid because the two firms have become such fierce rivals. “I think it’s a cultural mismatch,’’ Wald said.

10 top bio stories since BIO2010

As a way to look back on the BIO International Convention held in Chicago the first week of May, I asked the editors of the BIO SmartBrief to share with me their top 10 most-clicked stories from the past 30 days. Here’s a look at what biotech readers were most interested in reading:

1) Pathway Genomics picks Walgreens stores to sell genetic tests

Pathway Genomics is expected to announce today its plan to commercialize its saliva collection kits, genetic tests that are meant to help predict a person's risk for certain diseases, at 7,500 stores of Walgreens. "It's more consumer awareness than we could get from advertising online," said Jim Woodman, Pathway's vice president for corporate strategy. Some leaders in genetics say there is not enough information on genes' links to diseases to make the tests significant to consumers.

2) N.C. biotech, device startups compete for as much as $1B in tax credits

Early-stage biotech and medical-device firms in North Carolina are looking to participate in a $1 billion program that will provide tax credits and grants as part of the health reform law. Sam Taylor, president of the North Carolina Biosciences Organization, said the program will allow participating startups to get a 50% reimbursement for money they put into research and development.

3) Piglets are born with pluripotent stem cells in scientific breakthrough

Scientists bioengineered piglets to carry pluripotent stem cells by injecting the cells into a pig embryo. The cells were harvested from an embryolike cell, which was produced by infusing six genes into another pig's bone marrow cell. The researchers are optimistic that the effort will aid studies on human illnesses as well as in bioengineering livestock to benefit tissue transplants and food consumption.

4) Intercell will purchase Cytos' technology for $20.1 million

Intercell agreed to pay $20.1 million to acquire Cytos' technology platform designed to prevent and treat infectious diseases. The deal is expected to help Intercell develop therapies for hospital-acquired infections and other conditions.

5) GSK suspends trial of drug formulated from red wine substance

GlaxoSmithKline stopped a clinical trial of SRT501, a compound derived from the red wine substance resveratrol, in multiple myeloma patients after some of them developed cast nephropathy. GSK, which is developing the drug with Sirtris Pharmaceuticals, said its decision comes "out of an abundance of caution" as it reviews clinical data further.

6) Major drugmakers pitch deals to smaller companies at BIO convention

Some of the biggest-name drugmakers took advantage of the BIO convention to ask smaller companies to consider a partnership or buyout. Genentech is looking for deals that would boost its nascent neuroscience and immunology units, and Bayer said it is pursuing "products that can be real breakthroughs" in fields such as cancer, neurology and ophthalmology.

7) GSK will be back in the acquisition game, CEO says

GlaxoSmithKline, which has abandoned five potential deals since October, is working on two small acquisitions, CEO Andrew Witty said. "We've done very few deals between October last year and the last couple of weeks because we saw a number of companies, but we couldn't get to a price that made sense for our shareholders," Witty said.

8) Genzyme unveils strategy for sustainable growth

CEO Henri Termeer said Genzyme is evaluating strategic options for its businesses in genetic testing, diagnostics and drug intermediates, saying the units do not fit in with the biotech firm's plan for sustainable growth. Genzyme also plans to buy back $2 billion in shares.

9) BIO conference focuses on effects of recession on biotech firms

The biotech industry saw a 25% decline in publicly traded firms as a result of the banking crisis in the U.S., according to data from the BIO conference in Chicago. BIO President and CEO Jim Greenwood said the lack of access to capital also resulted in the bankruptcy of 50 biotech companies. But some companies achieved success despite the recession, such as Dendreon with the approval of its prostate cancer vaccine Provenge.

10) Compound from broccoli zeroes in on breast cancer stem cells

U.S. scientists found that broccoli contains a compound, called sulforaphane, that attacks breast cancer stem cells. Experiments on mice with breast cancer showed that the compound was effective in reducing the population of stem cells without causing significant harm to normal cells.

8th annual Charlotte Biotechnology Conference: “uniting and leveraging resources to maintain and foster new developments”

The blog was submitted by Martin Stinson, our business development analyst in the Mid-Atlantic Region.

I was pleased to attend the 8th annual Charlotte Biotechnology Conference at the beautiful new Bioinformatics & Genomics Center on the campus of UNCC.  Sponsored by the Charlotte Research Institute, attendees included biotechnology and life sciences industry leaders, government and finance partners, as well as faculty and students from several surrounding colleges and universities.  Participants numbered well over 300, making this year’s event their largest ever.

With so many economic challenges in the U.S. and worldwide over the last 18 months, many of the presentations and discussions were related to uniting and leveraging resources to maintain and foster new developments in the biotechnology sector.

The consensus was that our region has done an outstanding job in collaborating and networking to overcome these challenges.  As a result, North Carolina is now #3 in the biotechnology field, trailing only California and Massachusetts.  While funding and resources may be somewhat more scarce than in the recent past, these are still very exciting times in the industry and many expect that renewed growth is not far away.

Specifically, the Greater Charlotte region is home to more than two dozen bioscience companies in a variety of fields including nutrition studies, nanotechnology, bioinformatics and computational biology. The region also has North Carolina’s largest concentration of biomedical device companies.

The keynote speaker was Dr. Anthony Atala, renowned surgeon and researcher from Wake Forest University.  Dr. Atala provided a fascinating look into the world of tissue engineering, regenerative medicine, and stem cell biology.  The advances in growing new human tissues and organs are absolutely incredible.  The work in this field by experts like Dr. Atala and others will certainly play a significant role in the medical profession’s ability to repair or replace substantially more diseased tissues and organs in the future.

Just prior to his presentation, Dr. Atala showed a video called “Nano Girls”, a spoof on PhD candidates and their work in the lab, created by UNCC graduate student Kevin Major and his team.  For those of you in the mood for a good chuckle, check out this link:
http://graduateschool.uncc.edu/grad-life/news-and-events/152-nano-girls.html

Other topics and speakers included:

Future Trends in Biotechnology Funding

• Michael Luther, PhD, President, David H. Murdock Research Institute (DHMRI)
• June Blalock, Office of Technology Transfer, US Department of Agriculture
• Daniel Shaughnessy, PhD, Program Administrator, Susceptibility and Population Health Branch Division of Extramural Research and Training, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health 
• Joanne Tornow, PhD, Senior Advisor, Office of the Assistant Director, Directorate for the Biological Sciences, National Science Foundation
  

The State of Biotechnology in the Charlotte Region

• Mark Rumsey, News Host & Community Engagement Coordinator, WFAE-FM
• Simon Pedder, PhD, CEO and Founder, Chelsea Therapeutics International, Inc.
• Tammy Trexler-Whaley, Regional Manager, Economic Development, Duke Energy 
• Todd Wiebusch, CEO and Board President, Saebo, Inc.

Research Highlights

• Daniel B. Vorhaus, Attorney - Robinson, Bradshaw & Hinson - “Commercialization Strategies for Biotechnology, Pharmaceutical & Genomics Research”
• Mirsad Hadzikadic, PhD, Director - NC Complex Systems Institute, UNC Charlotte - “Complex Software Systems and 411fit.com”
• Jeffrey A. Kline, MD, Director - Emergency Medical Research, Carolinas Medical Center - “Commercializable Research from CMC” 
• Carol Cheatham, PhD, Assistant Professor - Nutrition Research Institute, UNC Chapel Hill - “Nutrition Impact on Pediatric Brain Development”
• Pinku Mukherjee, PhD, Irwin Belk Endowed Scholar for Cancer Research & Associate Professor of Biology, UNC Charlotte - “Pancreatic Cancer Progression and Metastasis”
  

San Diego's bio-pharma hub: where new ideas are emerging

We're always looking for more inspiration in our mission to accelerate
the adoption of new medical treatments.

So on a recent trip to San Diego, Melanie and I captured some photos of
biomedical research and education centers where scientists are working
to advance human health.









The centers are exploring new ideas in small molecules, genomics,
bioinformatics, high throughput screening, and structural biology. Their
efforts further translate the exciting discoveries being made every day
in laboratories into improved diagnostic and treatment technologies that
benefit all patients.

There are many examples of academia and industry joining as partners
with complementary expertise -- and the common goal of addressing unmet
medical needs. San Diego has an established history of partnerships that
facilitate the development of drugs and technologies based on research
discoveries. This approach set the foundation for San Diego's emergence
as a global biotechnology and pharmaceutical hub.

We at Stinson Brand Innovation are pleased to be working with many
companies in the region to support their efforts.

11 views on the question: “Which Biotech and Pharma companies would you say are growing the best during the economic down turn?”

Recently, Jonah Manning of BeAspired Inc. in Tallahassee, Florida asked “Which Biotech and Pharma companies would you say are growing the best during the economic down turn?”

Here are some the answers you might find interesting, plus a view from STINSON Brand Innovation.


Miguel Vilaplana, MD, MBA -- Biogen Idec, Amgen, Novo Nordisk, Pharmamar (Spanish), Life Technologies (for sure, Stem cells and anything related to cell culture etc. as Advancell; Spanish too...), Lonza (Stem cell department). However, how many of the medium-sized biotechs will survive after 2009? I do not know. Pfizer/Wyeth movement and Roche/Genentech hostile approach are telling us that M&A are just starting. Who is not able to stay without movement? Novartis, BMS (buy or be bought?), GSK, Merck ... We are going to see several movements there and some of the medium-sized pharma will have to buy or might be bought, and you can bet according to this parameters: total revenues, pipeline, sales force and manufacturing (being the first two, the most important I guess).


Chris Pounds -- Myriad Genetics just announced our Q4 2008 numbers and saw ~50% annual revenue growth over 2007.


Belkis Castro & Mary Jo Miller -- I would have to add Novartis to the list of growing companies. I just read their press release today and they are showing growth and actually hiring. They have over 80+ openings just in the US. For a large Pharma company they seem to be adding value without having to cut personnel.


Lin Chen -- I'd say more globalized company will more likely to survive this wave of economic downturn. Those who focus their business in the U.S. will suffer more for sure.

Guido Tomás Rozenblum -- For sure those companies that doesn't need fundings from investment institutions. Interests are going high, therefore, companies with cash such as Novartis, Invitrogen, Pfizer or Roche they may go for a trip buying small start-ups at ridiculous prices to fill up their pipelines.


Thomas Beattie -- Genentech will continue to lead in innovation over next 10+ years if Roche tender is unsuccessful. Watch the data released over next 30+ days (DNA).


Karen Strauss -- I believe that the Contract Research Organizations (CRO) that work for the Biotech and Pharma Industry are doing well. With mergers there is a chance that a particular contract could be cancelled but they usually have a wide range of clients and are able to keep revenues up.


Mike L -- The companies that benefit most from the down turn are the medium to large Pharma companies with a lot of cash. Biotech and Pharma companies are going for fire sale prices. Secondly, since Pharma and Biotech are shedding RD staff left and right, CROs are gaining huge market share.


Amy Clausen -- MD Biosciences is also experiencing good growth. We are a contract research organization and drug development company. We are continually adding staff, new services as well as searching for drug development partners.


Mohankumar Sowlay -- In the current global macroenvironment, small but innovative biotechnology companies which do not have to go to the market in the immediate future for financing needs have a good chance to survive the economic downturn. The present cost structure of big pharmaceutical companies dictated by the conventional drug development model is unsustainably high leading to a wave of cost optimization strategies. On the other hand, shareholders and employees may benefit from those companies that invest in targeted biotherapeutics, molecular diagnostics and regenerative medicine as successful product candidates from these companies become attractive acquisition targets by Big pharma. The attraction of these products to big pharma is due to the prospect of high reimbursement rates from the payers and the urgency to buffet their dwindling product pipeline. In my opinion, look for signs of prudent management of research dollars through the enlistment of global partnership in clinical development and for eventual market cultivation in emerging markets. I regularly analyze these and other company and industry strategies both from a business development and M&A perspective.




At STINSON Brand Innovation, we’re admiring two companies: CSL Behring and BioMarin.

CSL Behring
Commenting on CSL’s outlook, Dr Brian McNamee, CEO, said in February, “To-date there has been little to no impact on our sales arising from the global financial crisis. This is consistent with a product portfolio of life saving therapies and essential vaccines. However, we remain vigilant as the situation develops. Potential risks to our outlook include pressures on healthcare spend, debtors risk, foreign exchange volatility and ongoing access to long term debt. However, in this difficult economic environment, we anticipate broadly stable market conditions for CSL’s group of businesses. Research and Development spend of $153 million in the first half is expected to be similar in the second half with total spend for the year between $300 million to $310 million on a reported currency basis. Vivaglobin® (subcutaneous Immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant patient growth. We have met key milestones in the approval process for increasing Privigen® manufacturing capacity. Specialty products, particularly Beriplex® P/N and Berinert® P, made a strong contribution.”



BioMarin

"All three of our commercial products are independently profitable, which helps fund the advancement of several promising programs including PEG-PAL for PKU and GALNS for MPS IVA. We are strategically developing earlier stage programs and looking for attractive later stage in-licensing or acquisition opportunities to ensure continued growth," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We feel confident in meeting our overall top and bottom line financial objectives for 2009.”

One BioMarin growth brand, for example, is KUVAN® (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU). Net product revenue was $15.5 million for the first quarter of 2009, compared to $5.8 million for the first quarter of 2008. The quantity of commercial tablets dispensed to patients, the best metric to track true patient demand, increased 9.5 percent in the first quarter of 2009 compared to the fourth quarter of 2008.