Life Sciences Catalyst beyond border
Washington, DC (September 8, 2015) – The Biotechnology Industry Organization (BIO) today officially announced that the 2016 World Congress on Industrial Biotechnology will be held April 17-20, 2016 in San Diego, California at the San Diego Convention Center. BIO is also announcing the call for papers for the event. Leaders from the biotechnology, bioenergy, chemical, consumer products manufacturing, and agricultural industries as well as academia and financial sectors are invited to submit proposals and individual papers beginning September 17, 2015.
“More than 400 biotechnology companies call San Diego their “home,” which makes it an exciting venue to host the world’s largest conference dedicated to promoting next-generation biobased products, renewable chemicals and biofuels,” stated Brent Erickson, Executive Vice President, Industrial and Environmental at BIO. “With California’s growing industrial biotech sector, BIO is excited to host the 2016 World Congress on Industrial Biotechnology in the center of it all.”
The 2015 World Congress on Industrial Biotechnology, held in Montréal, drew 1,200 industry leaders from 725 companies, 50 countries and 37 states, as well as the District of Columbia. Further, the 2015 World Congress hosted more than 1,400 partnering meetings, a 40% increase from the 2014 BIO World Congress.
The call for papers will open September 17 to invite submissions for breakout panels, breakout papers, posters, and Green Tech investor sessions. Leaders from the biotechnology industry, academia, and policy community are invited to offer an abstract or a proposal for a 15 minute presentation in any of the following program tracks:
Proposed papers and presentations should address any in a range of topics, including renewable chemicals, algae for fuels and bioproducts, and chemicals, biobased products, biomass utilization, cellulosic biofuels, metabolic engineering, new chemical pathways, regional economic development, synthetic biology, regulatory issues, new feedstock crops and feedstock sustainability, aviation biofuels, genetically engineered crops, project finance, biopathways to bulk chemicals, enzyme development, green plastics, work force training and specialty chemicals.
For more information on the conference or to submit a proposal, please visit http://www.bio.org/worldcongress.
For assistance, please contact firstname.lastname@example.org.
In one of the largest sales of a San Diego County biotech company to date, Receptos has agreed to a $7.32 billion cash purchase by Celgene, a New Jersey-based cancer drug maker with an office in San Diego.
Celgene will gain a much-anticipated drug in clinical testing by Receptors for multiple sclerosis and ulcerative colitis. The drug, called ozanimod, is in a Phase 3 trial for relapsing multiple sclerosis.
Formerly called RPC1063, the drug's potential has helped propel Receptos into becoming a multibillion-dollar company since its initial public offering in 2013. Receptos shares have surged more than fivefold over the last year as ozanimod progressed in clinical testing.
The company agreed to pay $232 per share for Receptos, a 12 percent premium from Tuesday's closing price. The deal is expected to close this year.
Receptos and Celgene valued the deal at $7.2 billion excluding Receptos' cash on hand. That's larger than all but a few local biotech purchases, the biggest of which was the $13.6 billion purchase of Carlsbad's Life Technologies by Thermo Fisher Scientific in 2014.
Faheem Hasnain, Receptos' CEO, is highly regarded in the industry. Before Receptos, Hasnain led Facet Biotech, sold for $450 million cash to Abbott Laboratories in March 2010.
Facet developed Zenapax, an injectable drug for multiple sclerosis. The Receptos drug is taken orally.
Celgene, based in Summit, New Jersey, employs several hundred people in San Diego, said spokesman Greg Geissman. The workforce performs early stage research on identifying potential new drugs.
"We're very excited about this," Geissman said. "This is a great opportunity for us to continue to bolster this inflammation and immunology franchise."
Receptos has 68 employees, according to a profile on Yahoo Finance. Celgene is interested in keeping Receptos employees, but it's not clear how many will be retained, Geissman said.
Receptos reported about $2 billion in first-quarter sales of its drugs, which include the multiple myeloma treatments Revlimid and Pomalyst and breast and lung cancer drug Abraxane.
Revlimid, its top seller, is also used to treat severe anemia and mantle cell lymphoma.
The purchase of Receptos is part of a push to boost its sales of treatments for inflammatory and immune diseases. In 2014 Celgene launched its first drug in that category, the psoriasis and psoriatic arthritis treatment Otezla.
Receptos doesn't have any approved drugs on the market. The company expects results from late-stage trials of ozanimod in 2017 and 2018 and hopes to get the drug approved as a treatment for multiple sclerosis in 2018.
In addition to ulcerative colitis, Receptos is also studying ozanimod as a treatment for inflammatory bowel disease. The companies said they think its annual sales could reach $6 billion.
In extended trading, Receptos shares added 10 percent, or $21.17, to $228.35. The stock closed at $37.75 a year ago.
Celgene shares rose nearly 6 percent, or $7.07, to $129.92 in late trading. Last month Celgene agreed to invest about $1 billion in drug developer June Therapeutics Inc., mostly by buying stock. The companies plan to develop cancer and autoimmune disease treatments.
– Results Published in Journal of the American Medical Association –
SAN DIEGO–(BUSINESS WIRE)–
Illumina, Inc. (ILMN) today announced that a preliminary study retrospectively correlated 10 cases of occult maternal cancer among pregnant women receiving an “aneuploidy detected” or “aneuploidy suspected” positive results on the verifi® noninvasive Prenatal Test (NIPT)1 to discordant results of fetal karyotypes for the women, suggesting that discordant NIPT test results may be indicative of maternal cancer.
Maternal cancers sometimes leave tell-tale abnormal cell free DNA fragments in plasma. In 8 of 10 reported cancer cases, Illumina scientists and physicians reviewed all the genome-wide sequencing data and identified nonspecific copy-number changes across multiple chromosomes, suggesting that these changes, when present in a woman whose fetal karyotype tests as normal, might represent a signal to the clinician to probe for the presence of cancer.
The results of the study, entitled “Noninvasive Prenatal Testing and Incidental Detection of Occult Malignancies,” are available online today in The Journal of the American Medical Association and the full article can be accessed at broadcast.jamanetwork.com. The paper will be included in the July 14 print edition of JAMA.
“Abnormal tumor DNA, shed from maternal malignancies, can cause highly unusual NIPT results, including the findings of more than one chromosome abnormality detected,” commented Diana W. Bianchi, M.D., Executive Director of the Mother Infant Research Institute at Tufts Medical Center, and lead author of the publication. “All abnormal NIPT results should be confirmed with a diagnostic test, such as amniocentesis or chorionic villus sampling (CVS). If there is a difference between the fetal diagnostic test and the NIPT results, maternal cancer can be a rare but important underlying explanation. In order to provide the best maternal clinical care, this possibility should be considered, especially when multiple abnormalities of chromosome number are identified on the NIPT report.”
In a retrospective analysis of 125,426 noninvasive verifi® Prenatal Tests, 3,757 (three percent) were positive for one or more aneuploidies involving chromosomes 13, 18, 21, X or Y. As part of Illumina’s standard procedures, the laboratory contacts the referring physician to discuss all positive test results and to recommend a diagnostic procedure to obtain a confirmatory fetal karyotype. From this group of 3757 positive cases, 10 cases of maternal cancers were subsequently (between 3 and 39 weeks after NIPT) reported to the laboratory. At the time of NIPT these women were not diagnosed with cancer. In 3 cases the abnormal NIPT findings prompted a search for an underlying malignancy. Seven of these eight women had diagnostic tests that indicated a chromosomally-normal fetus, discordant with the NIPT test result. One woman did not undergo a diagnostic procedure.
Maternal cancers were most frequently associated with the rare NIPT finding of multiple aneuploidies that were discordant with the fetal karyotype. The cancer types were clinically diverse, including three cases of B cell lymphoma and single cases of T-cell leukemia, Hodgkin’s lymphoma, unspecified adenocarcinoma, leiomyosarcoma, and neuroendocrine, colorectal and anal carcinomas. The cancers ranged from stage II to metastatic disease (IV). In one case, after completion of treatment, the abnormal DNA signature became undetectable in follow-up testing.
“This study shows that NIPTs that use whole genome sequencing techniques may have the ability to detect some cancer signatures under certain conditions,” said Dr. Rick Klausner, Illumina’s Chief Medical Officer. “The sensitivity and specificity of the verifi Prenatal Test to detect cancer is not currently known, and further studies will be required to develop a test for this specific purpose. We have published these results to help clinicians improve overall patient care by considering the possibility of maternal cancer if there is discordance between positive NIPT results and a normal fetal karyotype. We also want to encourage health care providers to contact the clinical sequencing laboratory with follow-up information on abnormal NIPT results that show concordance as well as discordance with fetal karyotype, including cancers diagnosed in pregnant women, so that we can better understand the nonspecific patterns of DNA changes that precede clinical symptoms.”
The Illumina verifi® Prenatal Test analyzes genetic material (cfDNA) from a pregnant woman’s blood to look for too few or too many copies of chromosomes in the mother and baby, or babies in the case of twins. Missing or extra copies of chromosomes are referred to as “aneuploidies” and may be related to conditions in pregnancy such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome) or sex chromosome (X and Y) associated conditions.
Source: Results from Journal of the American Medical Association, published by BusinessWire
The Paoli Calmettes Institute (IPC), a private not-for-profit comprehensive cancer center in Marseille, France, has initiated a collaboration with Innate Pharma SA (Euronext Paris: FR0010331421 – IPH), a biopharmaceutical company based in Marseille, to conduct translational research aimed at identifying specific populations of patients with hematological cancers who may benefit most from treatment with Innate Pharma’s novel proprietary antibodies, and to identify associated biomarkers.
Nicolai Wagtmann, Chief Science Officer of Innate Pharma, said: “This agreement strengthens our translational research capabilities, at the core of our drug development process. IPC is a leading center in hematology-oncology with deep understanding in immunology and capabilities in immune monitoring. Early-stage testing of Innate Pharma’s promising antibodies on patient samples will greatly optimize subsequent clinical development by better identifying the most relevant indications, patient populations and biomarkers”.
Pr. Patrice Viens, Chief Executive Officer of IPC, stated that “This new R&D collaboration with Innate Pharma further expands a long-lasting relationship which started with lirilumab, a fully human monoclonal antibody blocking the interaction between Killer-cell immunoglobulin-like receptors (KIR) on NK cells with their ligands on tumor cells. IPC conducted the “first-in-man study” of lirilumab and continues to be involved in the development of this drug. IPC and Innate Pharma are also involved in other partnerships within the frame of the Marseille SIRIC* and of Marseille Immunopole **”.
The collaboration will operate under the direction of Pr. Daniel Olive, Head of the Immunity and Cancer research team and of the immune monitoring platform at IPC, and Pascale André, Senior Director, R&D, at Innate Pharma. It will also involve drug-discovery research teams and experts in translational research at IPC, including Pr. Norbert Vey and Pr. Anthony Gonçalvès, and other scientists with expertise in converting promising drug discoveries into clinical treatments for cancer patients.
Under the terms of the collaboration agreement, IPC will test Innate Pharma’s new therapeutic antibodies in immuno-oncology using IPC’s extensive biological resource collection. Innate Pharma’s antibodies are designed to block immune checkpoints, one of the most promising classes of drugs in oncology. These immune checkpoints interfere with the natural defense mechanisms of our immune system against cancer and regulate immunosuppressive mechanisms. Their blockade can unleash the patient’s immune system to recognize and eliminate cancer cells. However, only a fraction of patients respond to current immune checkpoint inhibitors, and identifying the population of patients most likely to respond to various checkpoint blockers would be of great interest. This R&D collaboration will facilitate the development of novel therapeutic antibodies by identifying the best suited patient population and indications for a given drug.
* The Marseille SIRIC is the site for integrated cancer research focused on breast cancer, leukemia and myelodystrophy, glioma and pancreatic cancer funded by the French National Cancer Institute, which brings together IPC, the Assistance Publique – Hôpitaux de Marseille (AP-HM) and their associated research centers.
** Marseille Immunopole is a unique collaborative ecosystem for therapeutic innovation in immunology, integrating all the skills from academic to clinic. It aims to make Marseille the European capital of the R&D of immune-based therapy
The 2011 breast implant controversy, where the French company PIP produced defective breast implants made from cheap industrial silicone, has since put the Medical Device Approval process in the EU under the microscope. As a result of this scrutiny, many had raised the question of whether a European-wide, “FDA” style approval process should be adopted for medical devices.
With the unforeseen leak of the draft report from the Council of Europe on June 11th, it seems that the answer behind a proposal for centralisation is now a resounding ‘no.’ The proposed regulation put forward by the Latvian presidency and corroborated by many of the Member States discussed the placing, making available and putting into service medical devices on the market. This will be seen as welcome news for American companies seeking EU commercialisation while they are undergoing the arduous FDA process.
For quite some time, it had been suggested that EU institutions should look into ways that would help tighten safety of medical devices. Some lawmakers had therefore felt that in order to solve the problem of a lax EU system, Europe needed a model which resembles the FDA; a US-centralized approval model rather than the current decentralized one, where each country sets its own legal and safety requirements, would be the only answer.
It seems that leaving the decision and approval process in the hands of Notified Authorities is still plausible. As stated in Article 28 of the proposed regulation “a member state that intends to designate a conformity assessment body as a notified body […] to carry out conformity assessment activities […] shall nominate an authority […] for the assessment, designation and notification” of medical devices.
This is further reiterated in Annex VIII allowing the nominated authority to still oversee and work with notified bodies, who will in turn work with manufacturers on the approval process.
The outlined proposals in Chapter VI in regards to clinical evaluations and investigations also stress a more thorough process with the addition that “the Commission, in collaboration with the Member States, shall […] set up, manage and maintain an electronic system”.
The discussions that took place on June 19th were set to begin the formal review of the proposal into the Trilogue between the Commission, EU Parliament and Member States.
Although it may seem at first glance an approach to allow the ‘old ways’, it actually paves a way into making a leap from the current directive into differentiating itself from the pharmaceutical industry so that it is, in its own right, specific for medical devices.
The proposal does not ‘shy away’ from a centralized system because of bureaucracy or financial implications, but merely that a bulky process like that of the FDA is not necessarily the correct model for the EU. It instead provides a means for tighter regulations without necessarily adding delays to its nimble approval process.
Going forward, the Trilogue will most likely begin in September for proposed adoption by mid-2016 and full implementation in all Member States by 2019.
June 22, 2015 by Dr. Sunni Patel, medeuronet clinical scientist
BIO 2015 Sets Record – 29,279 Partnering Meetings in Philadelphia. Biotechnology Industry Organization to Become Biotechnology Innovation Organization in Early 2016. 15,858 Industry Leaders Attended World's Largest Biotech Gathering
Philadelphia, PA (June 18, 2015) – The 2015 BIO International Convention, where the global biotech community meets, connecting the people, companies and innovations that help to fulfill the promise of biotechnology through healing, fueling, and feeding the world, concluded today at the Pennsylvania Convention Center. This year’s Convention hosted 29,279 partnering meetings, a new record for the event. Organized by the Biotechnology Industry Organization (BIO), the event drew 15,858 industry leaders from 69 countries and 47 states, as well as the District of Columbia and Puerto Rico.
“This year’s BIO International Convention was a tremendous success, bringing to Philadelphia leaders in industry, government and academia from across the globe to pursue biotechnology’s potential to solve some of society’s most pressing problems,” said BIO President & CEO Jim Greenwood. “From our outstanding keynote speakers, to the record number of partnering meetings, the 2015 Convention was a resounding success. This event continues to provide biotech leaders with the opportunity to showcase the best of our industry and form connections and partnerships that will drive growth in the sector for years to come.”
BIO’s new Board Chair, Ron Cohen, CEO of Acorda Therapeutics, announced during Wednesday afternoon’s Keynote Luncheon that the Biotechnology Industry Organization would soon become the Biotechnology Innovation Organization, effective in early 2016.
The Convention featured dynamic keynotes from legendary journalist Tom Brokaw, leading digital health expert Eric Topol and internationally acclaimed jazz musician Wynton Marsalis. Educational programming included over 750 speakers and 125 sessions in 16 educational tracks which addressed the latest business opportunities, breakthroughs in medicine, diagnostics, the environment, energy production, food and agriculture and more. For session highlights and editorial, visit www.biotech-now.org/.
The top 15 largest international delegations included (in alphabetical order): Australia, Belgium, Brazil, Canada, China, France, Germany, India, Japan, Netherlands, South Korea, Spain, Switzerland, Taiwan, and the United Kingdom.
Several U.S. Governors attended this year’s event including Pennsylvania Governor Tom Wolf, Delaware Governor Jack Markell, and South Dakota Governor Dennis Daugaard. New Jersey Lieutenant Governor Kim Guadagno was also in attendance as well as numerous legislators from around the country.
The BIO Exhibition featured more than 1,800 exhibitors and covered over 150,000 square feet with 47 state, regional and international pavilions. The Innovation Zone, featuring SBIR grantees from the National Institutes of Health (NIH) and the National Science Foundation (NSF), as well as the Digital Health Zone, both doubled in size this year.
BIO would like to thank Philadelphia Mayor Michael Nutter and Pennsylvania Governor Tom Wolf for their hospitality and support leading up to and during the 2015 BIO International Convention. BIO also thanks our regional partners: BioNJ, the Delaware BioScience Association and Pennsylvania Bio.
“With the support of BioNJ, the Delaware BioScience Association and Pennsylvania Bio, our tri-state region was able to make this year's BIO 2015 convention in Philadelphia a tremendous success,” said Jack Ferguson, Philadelphia Convention & Visitors Bureau President & CEO. “We were grateful for the opportunity to showcase our wonderful Pennsylvania Convention Center, the hotels and hospitality offerings of our city and our region's life sciences assets, and we hope BIO comes back again in the near future.”
The 2016 BIO International Convention will take place June 6-9, 2016 in San Francisco, California at the Moscone Center. The 2017 BIO International Convention will take place June 19-22, 2017 in San Diego, California at the San Diego Convention Center. The 2018 BIO International Convention will take place June 4-7, 2018 in Boston, Massachusetts at the Boston Convention & Exhibition Center.
“I would like to thank the Philadelphia Convention & Visitor's Bureau and the Pennsylvania Convention Center for their leadership and assistance in making the 2015 BIO International Convention such a resounding success,” said Scott Whitaker, President of the BIO International Convention. “The 2015 BIO International Convention may be wrapping-up, but I know the entire biotech community is excited to be back in San Francisco in 2016, where we expect another great BIO Convention.”
The BIO International Convention helps support BIO programs and initiatives. BIO works throughout the year to create a policy environment that enables the industry to continue to fulfill its vision of bettering the world through biotechnology innovation.
The FDA’s approval March 6 of the first biosimilar drug for U.S. use helped shine a spotlight on European biotechnology, and not just because the biosimilar in question—Zarxio™, a variation of Amgen’s Neupogen (filgrastem)—will be marketed by the Sandoz unit of Swiss-based Novartis. As of March 10, Europe has 19 biosimilars authorized for patient use since 2006 (including Zarxio, which was approved as Zarzio in 2009).
Yet there’s much more to biotechnology in Europe than biosimilars. The continent, like the U.S., is home to numerous regional communities or “clusters” of biotechs, pharmaceutical employers, universities, and independent research institutions. As GEN remarked last year, Europe’s biotech leaders enjoy more than one strong region, while smaller nations market their entire country as a hub for life sciences activities. Thus, unlike the U.S., European clusters cannot practically be ranked solely by region.
And as in the U.S., there’s no central clearinghouse for statistical information using a single standard. So a list of European clusters is likely to include numerous larger bioclusters, though a few smaller clusters are notable enough to deserve mention: Norway’s Oslo Cancer Cluster, for example, is home to 66 biotech, pharma, and life sciences employers. That number is expected to increase once the cluster’s Innovation Park opens on August 24. The park will integrate the Oslo Cancer Cluster Incubator, Ullern High School, The Norwegian Cancer Registry, the Pathology unit, and bioinformatics unit at Oslo University Hospital and several biopharma businesses, from startups to bigger companies.
FDA approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen.
For more information, see below:
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:
- patients with cancer receiving myelosuppressive chemotherapy;
- patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
- patients with cancer undergoing bone marrow transplantation;
- patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
- patients with severe chronic neutropenia.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.
A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.
The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.
The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.
For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.
Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in Thousand Oaks, California.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: FDA News Release