Life Sciences Catalyst beyond border
Sequenom ($SQNM) suffered a stinging defeat in its patent battle against Roche's ($RHHBY) Ariosa Diagnostics unit, as a U.S. appeals court ruled that the company's patent for its noninvasive prenatal test was invalid.
The U.S. Court of Appeals for the Federal Circuit in the District of Columbia tossed out a patent for Sequenom's fetal DNA screening test, saying the DNA's presence fell under the U.S. Supreme Court's rule against patenting natural phenomena, Reuters reports. The decision upholds a ruling by a lower federal court in California and lets Ariosa off the hook for infringement–a potentially costly blow for Sequenom as it vies for a piece of a prenatal testing industry set to grow to $3.6 billion by 2019.
San Diego, CA-based Sequenom's test uses DNA from previously discarded maternal blood samples to look for fetal characteristics such as gender, avoiding the need for more invasive testing. While the appeals court deemed the test "a positive and valuable contribution to science," it still didn't think its technology warranted a patent, according to the Reuters story. One of the three justices on the appeals panel said he thought Sequenom should have been allowed to keep the patent, but broad wording in one of the Supreme Court's precedents forced him to invalidate the patent.
But Sequenom is not going down without a fight. The company "is considering its options for further appeal" and "believes that the ruling has little business impact," it said in a statement, especially in light of its pooling agreement with rival Illumina ($ILMN). In December, the companies settled the score in their ongoing patent feud, agreeing to resolve all pending infringement claims and pool their resources to develop noninvasive prenatal tests. Sequenom got $50 million up front as part of the deal, and royalty payments on sales of the companies' in vitro prenatal diagnostic kits.
Meanwhile, Ariosa faces patent woes on another front. Last month, Illumina slapped the prenatal testing giant with a patent infringement suit for technology used in its Harmony Prenatal Test. Harmony screens for Down syndrome, Edwards syndrome and Patau syndrome in cell-free DNA, a method unique to that used by other companies, Ariosa claims. But Illumina struck back, saying the company's tests directly infringe on its technology.
This year's Biotechnology Industry Organization's convention in Philadelphia was on familiar ground for Joe Panetta, CEO of San Diego-based Biocom, who grew up in the region.
Panetta talked with David Schull of Russo Partners on location about the convention's themes, and its return to San Diego in 2017, which hosted the convention in 2014.
Joe Panetta at BIO 2015:
BIO meets next year in San Francisco, Panetta noted, and Biocom plans to take advantage of that.
"We see this as a two-year opportunity for San Diego," Panetta said. "Next year BIO will be in San Francisco, but our San Diego Biocom group will have a very strong influence on that meeting, and of course we'll be in San Diego the following year."
Those meetings will stress aspects of the biotech industry that play to San Diego's strengths, including big data, wireless health and targeted therapeutics.
At the 2015 Philadelphia meeting, digital health and personalized medicine were among the topics that resonate with San Diego biotechs, Panetta said.
SOURCE: UT SAN DIEGO http://www.utsandiego.com/news/2015/jun/20/bio-convention-back-to-san-diego/
Once again this year, the Jury rewarded 9 exceptional ladies within 9 categories including the Prize “Coup de Coeur” from the editorial committee of “Objectif Languedoc-Roussillon”.
This prestigious event took place on Thursday 11 June 2015 at the Domaine de Verchant near Montpellier and gathered almost 300 political and economical leaders.
Amazon.com Inc is in a race against Google Inc to store data on human DNA, seeking both bragging rights in helping scientists make new medical discoveries and market share in a business that may be worth $1 billion a year by 2018.
Academic institutions and healthcare companies are picking sides between their cloud computing offerings – Google Genomics or Amazon Web Services – spurring the two to one-up each other as they win high-profile genomics business, according to interviews with researchers, industry consultants and analysts.
That growth is being propelled by, among other forces, the push for personalized medicine, which aims to base treatments on a patient's DNA profile. Making that a reality will require enormous quantities of data to reveal how particular genetic profiles respond to different treatments.
Already, universities and drug manufacturers are embarking on projects to sequence the genomes of hundreds of thousands of people.
The human genome is the full complement of DNA, or genetic material, a copy of which is found in nearly every cell of the body.
Clients view Google and Amazon as doing a better job storing genomics data than they can do using their own computers, keeping it secure, controlling costs and allowing it to be easily shared.
The cloud companies are going beyond storage to offer analytical functions that let scientists make sense of DNA data. Microsoft Corp and International Business Machines are also competing for a slice of the market. The "cloud" refers to data or software that physically resides in a server and is accessible via the internet, which allows users to access it without downloading it to their own computer.
Now an estimated $100 million to $300 million business globally, the cloud genomics market is expected to grow to $1 billion by 2018, said research analyst Daniel Ives of investment bank FBR Capital. By that time, the entire cloud market should have $50 billion to $75 billion in annual revenue, up from about $30 billion now.
"The cloud is the entire future of this field," Craig Venter, who led a private effort to sequence the human genome in the 1990s, said in an interview. His new company, San Diego-based Human Longevity Inc, recently tried to import genomic data from servers at the J. Craig Venter Institute in Rockville, Maryland.
The transmission was so slow, scientists had to resort to sending disks and thumb drives by FedEx and human messengers, or "sneakernet," he said. The company now uses Amazon Web Services.
So does a collaboration between Regeneron Pharmaceuticals Inc and Pennsylvania-based Geisinger Health Systems to sequence 250,000 genomes. Raw DNA data is uploaded to Amazon's cloud, where software from privately-held DNAnexus assembles the millions of chunks into the full, 3-billion-letter long genome.
DNAnexus's algorithms then determine where an individual genome differs from the "reference" human genome, the company’s chief scientist Dr. David Shaywitz said, in hopes of identifying new drug targets.
HOSTING FOR FREE
Showing how important Google and Amazon view this business, and how they hope to use existing customers to lure future ones, each is hosting well-known genomics datasets for free.
Neither company discloses the amount of genomics data it holds, but based on interviews with analysts and genomic scientists, as well as the companies' own announcements of what customers they’ve won, Amazon Web Services may be bigger.
Data from the "1000 Genomes Project," an international public-private effort that identified genetic variations found in at least 1 percent of humans, reside at both Amazon and Google "without charge," said Kathy Cravedi of the U.S. National Institutes of Health (NIH), one of the project's sponsors.
Other paying clients with a more specific focus are picking sides.
Google, for instance, won a project from the Autism Speaks foundation to collect and analyze the genomes of 10,000 affected children and their parents for clues to the genetic basis of autism.
Another customer is Tute Genomics, whose database of 8.5 billion human DNA variants can be searched for how frequently any given variant appears, what traits it's associated with and how people with a certain variant respond to particular drugs.
Amazon is hosting the Multiple Myeloma Research Foundation’s project to collect complete-genome sequences and other data from 1,000 patients to identify new drug targets. It also won the Alzheimer's Disease Sequencing Project, which has similar aims.
Amazon charges about $4 to $5 a month to store one full human genome, and Googleabout $3 to $5 a month. The companies also charge for data transfers or computing time, as when scientists run analytical software on stored data.
Amazon's database-analysis tool, Redshift, costs 25 cents an hour or $1,000 per terabyte per year, the company said. A terabyte is 1 trillion bytes, or 1,000 gigabytes, about enough to hold 300 hours of high-quality video.
Another part of the cloud services' pitch to would-be customers is that their analytic tools can fish out genetic gold – a drug target, say, or a DNA variant that strongly predicts disease risk – from a sea of data. Any discoveries made through such searches belong to the owners of the data.
"On the local university server it might take months to run a computationally-intense" analysis, said Alzheimer’s project leader Dr. Gerard Schellenberg of the University of Pennsylvania. "On Amazon, it's, 'how fast do you need it done?', and they do it."
Another selling point is security. Universities are "generally pretty porous," said Ryan Permeh, chief scientist at cybersecurity company Cylance Inc, of Irvine, California, and the security of federal government computers is "not at the top of the class."
While academic and pharmaceutical research projects are the biggest customers for genomics cloud services, they will be overtaken by clinical applications in the next 10 years, said Google Genomics director of engineering David Glazer.
Individual doctors will regularly access a cloud service to understand how a patient's genetic profile affects his risk of various diseases or his likely response to medication.
"We are at that transition point now," Glazer said.
Matt Wood, general manager for Data Science at Amazon Web Services, sees cloud demand in genomics now as "a perfect storm," as the amount of data being created, the need for collaboration and the move of genomics into clinical care accelerate.
Experts on DNA and data say without access to the cloud, modern genomics would grind to a halt.
Bioinformatics expert Dr. Atul Butte of the University of California, San Francisco, said that now, when researchers at different universities are jointly working on NIH and other genomic data, they don't have to figure out how to make their computers talk to each other. In March, NIH cleared the way for major research on the cloud when it began allowing scientists to upload important genomic data.
The French government has unveiled a programme called ‘Tech Ticket’, which aims to encourage foreign start-ups to set up operations in the French capital. The package includes tens of thousands of euros in funding and assistance in finding business premises.
The scheme, which has a €5 million budget for the first year, will offer €12,000 grants per person for six months, renewable once, and a place for entrepreneurs in one of nine incubators, where they will get help with fundraising strategies and practice in pitching to investors. Other frills include a “help desk” on red tape and cheaper flights on Air France.
In return, start-ups must employ at least one French citizen. Last year unemployment in France hit record levels.
Some 50-handpicked entrepreneurs are expected to benefit from the first round, which begins next year. If the scheme is popular, it will be extended to other cities, the government says.
The initiative is part of a broader business creation strategy. Late last year, the government announced a €225 million fund to invest in start-up accelerators across the country.
Separately, French authorities are providing cash to bootstrap the Paris-based incubator Halle Freyssinet, which has designs on becoming the biggest in the world, with 1,000 start-ups.
Details on www.frenchtechticket.com
The Financial Times is citing two people close to the situation who say the French biotech is in the early stages of negotiations. And one of the paper's sources says Pfizer has stepped forward with an offer that would value Cellectis at as much as €1.5 billion ($1.6 billion).
Cellectis, which jumped to the Nasdaq in a $228 million IPO in March, is at work on a pipeline of so-called CAR-T therapies, which work by souping up T cells to better detect malignancies, thereby training the immune system to attack previously unseen cancers.
Last year, Pfizer signed an expansive deal with the company to get its hands on some CAR-T assets, paying $80 million up front and clearing the way for more than a dozen joint projects. Cellectis is due as much as $185 million in milestone payments for each successful CAR-T candidate, valuing the deal at as much as $2.8 billion. Pfizer also bought a 10% stake in the biotech.
Whether Pfizer would now want to take the plunge and buy Cellectis outright remains to be seen, but the U.S. pharma giant does have a penchant for spending big when it has ground to make up. Pfizer had long lagged its rivals in immuno-oncology when, last year, it handed Merck KGaA $850 million up front to collaborate on a promising checkpoint inhibitor. And Pfizer will pay its partner as much as $2 billion more under a rich deal designed to close the gap with Merck ($MRK), Bristol-Myers Squibb ($BMY), AstraZeneca ($AZN) and others.
As for Cellectis, in contrast to CAR-T leaders Novartis ($NVS), Juno Therapeutics ($JUNO) and Kite Pharma ($KITE), the biotech makes its treatments using off-the-shelf T cells harvested from third-party patients, a method the company believes will lead to safer therapeutics. The majority of players in the field craft their CAR-T therapies by taking a patient's own T cells, re-engineering them and re-infusing them.
Following its IPO, Cellectis said it planned to spend its proceeds getting four preclinical CAR-T candidates through Phase I trials, earmarking $26 million for manufacturing and $26 million more for work outside of oncology. The company's lead candidate, a Servier-partnered treatment for leukemia, is slated to enter the clinic this year.
The new generation of drugs hailed as a once-in-a-generation advance in treatment for cancer patients is also viewed as good news for the pharmaceutical industry – just when analysts had started to voice concerns that the pipeline of blockbuster treatments in development was starting to run dry.
Immunotherapy treatments, which use the body’s immune system to attack cancerous cells, could be as revolutionary as the arrival of chemotherapy was in the 1940s – and big pharma companies have been scrambling to get into a market that experts think could eventually be worth up to £26bn a year in sales.
“It is a really significant breakthrough” said Colin White, lead analyst for oncology at the research group Datamonitor Healthcare. “It is being seen as the third major breakthrough in cancer treatments: the first being chemotherapy, the second being targeted treatments and the third being immunotherapy.”
Scientists at the American Society for Clinical Oncology’s annual meeting in Chicago last weekend announced “spectacular” results from one clinical trial of patients with skin cancer. More than half the patients with advanced melanoma, many considered to have little time left, saw tumours shrink or brought under control using a combination of drugs – ipilimumab, known under the brand name Yervoy, and the as-yet unlicensed nivolumab, branded as Opdivo.
Since the start of 2014, there have been at least 44 corporate deals in the immuno-oncology market, according to Datamonitor, which tracks such transactions. One of the biggest was Pfizer’s $2.9bn collaboration with the French biotech company Cellectis.
On the rebound from its failed bid to buy AstraZeneca, Pfizer acquired a 10% stake in Cellectis and bought exclusive rights to develop immunotherapy drugs to fight 15 cancer targets. The American drugs multinational is rumoured to be interested in buying Cellectis outright, although both sides have so far declined to comment.
Another deal that got analysts excited was Bristol-Myers Squibb handing over $1.25bn to buy California-based Flexus in February – a company that was less than 18 months old and has no drugs being trialled. But Bristol-Myers Squibb already has a headstart in the immunotherapy race: its Yervoy and Opdivo brands are the two drugs that caused such a storm in Chicago last weekend.
Apart from Bristol-Myers, Merck is the only other company to have had an immunotherapy drug approved for the treatment of skin cancer. But Pfizer, Roche and a host of smaller biotech firms are racing to develop the therapies, which may work on a much broader range of cancers than previously thought.
When the UK drugs multinational AstraZeneca was fighting off the unwanted £63bn takeover attempt by Pfizer last year it warned that the cost-cutting likely to follow a takeover could delay the development of key drugs and cost lives. One of the key treatments Astra pointed to was in its immuno-oncology portfolio – ahuman monoclonal antibody known as MEDI4736.
One of the City’s top pharmaceuticals analysts described MEDI4736 as “the great white hope” of cancer treatments, while AstraZeneca’s head drug developer, Briggs Morrison, said it could “redefine cancer treatment” and rake in annual sales of £3.9bn.
Last year, Roche entered into a $1bn agreement with NewLink Genetics, the Iowa-based maker of the experimental Ebola vaccine, to develop immunotherapy treatments. The companies are developing an inhibitor (NLG919) designed to disrupt the mechanism by which tumours evade the patient’s immune system. NewLink has already tested similar products in patients with breast and prostate cancer.
In another sign of the booming market, companies are increasingly keen to keep their top scientific experts. Last week Bristol-Myers Squibb started legal proceedings against one of its key immunotherapy experts for allegedly violating confidentiality agreements. David Berman, a vice-president at BMS who has spent the last decade working on immunotherapy drugs, including Yervoy and Opdivo, has quit to join AstraZeneca and BMS has asked a Delaware court to stop Berman from joining AstraZeneca for a year and prevent him from ever using confidential information gained at BMS.
But the biggest question for healthcare executives interested in buying these treatments comes back to cost.
“These drugs cost too much,” Leonard Saltz, chief of gastrointestinal oncology at the Memorial Sloan Kettering Cancer Center, told delegates in Chicago in a widely discussed presentation reported by the Wall Street Journal.
He is concerned about the cost of the melanoma treatment developed by BMS. The combination of Yervoy and Opdivo would help patients live for almost a year without their disease getting worse, something “truly remarkable for a disease that five years ago we thought was virtually untreatable”, he said. But the drugs would cost $295,000 a patient – an “unsustainable” sum, he said.
“Cancer-drug prices are not related to the value of the drug … Prices are based on what has come before and what the seller believes the market will bear.”
After a 2-day visit to the region from a delegation of American health and biotechnology companies from southern California, it is now time to take stock and follow up on professional exchanges between San Diego and Provence. Provence Promotion and a group of economic players know their game partners well. These field missions are organized yearly together with the California-based French Bio Beach association, with official support from the Provence-Alpes-Côte d’Azur Regional Council since 2013 under the joint banner “South Bio Alliance”. A wrap-up and outlooks following the 2015 edition…
Market opportunities, technological and scientific partnerships and the opening of European subsidiaries – these were the needs that the American companies expressed during their field visit. The delegation, which included entities ranging from SMEs to major groups, followed a tightly packed but well planned program during their 2-day visit from April 29 to 30, and were rapidly able to get an idea of the Aix-Marseilles region’s potential in terms of medical research and innovation in their fields of interest: cancer, obesity, cytometry…
Their first important stop was at Luminy in Marseilles, which houses the immunology center and various landmark companies in the health sector. Innate Pharma, which has just signed a contract with the British AstraZeneca for cancer treatment through immunotherapy, or HalioDx that is currently carrying out a survey among 3,000 patients in 25 European centers to test diagnostic kits for immune-oncology, caught their interest, as did the presentation of MI-mAbs, a preindustrial demonstrator in which Sanofi has confirmed its commitment alongside various local stakeholders to accelerate the development of new immunotherapy antibodies (€19 million investment).
The delegation continued their discovery of research and innovations in Marseilles at La Timone Hospital (AP-HM) in the development and Clinical Research and Innovation departments. With the building of the largest infection center in Europe (€70 million investment), La Timone will increase its international status. On the subject of development, Satt Sud-Est presented its programs to further the transfer of academic-research innovations towards international markets.
At the Institut Paoli Calmette (IPC), a center of excellence in cancer research, the delegation was received by Dr Jean-Frédéric Saunière, coordinator of translational research teams, who reminded them that the institute focuses consistently on new technologies and has a spin-off incubator for the development of new cancer drugs and therapies.
Other topics like legislation, labor law and research tax credit were broached in order to demonstrate the amount of flexibility that there is to carry out projects with the help of benefits and support. Fighting preconceived notions and changing the perception that Americans have of France are also part of Provence Promotion’s missions as an economic development agency.
Biocom, one of the most important life-sciences associations in the world that represents more than 650 biotechnology companies as well as pharmaceutical product and medical and diagnostic equipment manufacturers throughout South California, participated for the second time. Having joined forces in 2014 with Eurobiomed, the competitiveness cluster in the south of France, they are continuing and will reinforce joint projects in the scope of their cooperation.
Thanks to the good understanding and affinity between the two regions, there is also the possibility of getting sport-related projects off the ground.
Note that American companies are the first to come and invest in Provence. In 2014, they represented 20% of all companies located in Provence-Alpes-Côte d’Azur. In 2014, they represented 20% of all the foreign companies set up in Provence-Alpes-Côte d’Azur. In the scope of its prospecting missions, Provence Promotion prepares an upcoming visit to the United States in order to participate in the Bio-international Convention taking place in Philadelphia this year.