santaris pharma
2 santaris pharma, kogle allé 6, dk - 2970 hørsholm, denmark .
in 2010, exiqon initiated arbitration proceedings to defend its business against santaris pharma .
said søren tulstrup, president and chief executive officer, santaris pharma a / s .
isis pharmaceuticals, inc. v. santaris pharma a / s corp. et al
bristol - myers squibb is teaming up with santaris pharma to discover and develop novel medicines using santaris pharma' s locked nucleic acid (lna) drug platform. santaris pharma is a biopharmaceutical company focused on developing medicines targeted to disease - related mrnas and micrornas .
for access to santaris pharma a / s lna technology for the development of rna - targeted drugs. santaris pharma a / s is eligible to receive milestone payments of up to
between santaris pharma a / s and wyeth, which was acquired by pfizer inc. under the terms of the original collaboration, santaris pharma a / s received an upfront payment of
said henrik ørum, vice president and chief scientific officer at santaris pharma a / s .
santaris pharma – according to an aug 4, 2014 press release, roche announced that it has agreed to acquire santaris pharma based near copenhagen, denmark. santaris pharma has pioneered its proprietary locked nucleic acid (lna) platform that has contributed to an emerging era of rna - targeting therapeutics .
santaris pharma owns the worldwide exclusive rights to develop innovative new drugs based on lna technology. santaris pharma and h. lundbeck will collaborate on the development of potential neurological drugs arising from the platform .
j. donald debethizy, president and ceo of santaris pharma, said, “roche and santaris pharma have complementary capabilities… the acquisition combines santaris pharma’s next - generation antisense technology and lna expertise with roche’s deep experience in disease biology, chemistry, drug safety, drug formulation, delivery, and development. ”
santaris pharma is a danish clinical stage biopharmaceutical company. the company was formed in 2003 and has the exclusive rights to lna technology, used to develop new classes of rna medicines, called rna antagonists. santaris pharma
“roche and santaris pharma have complementary capabilities that will help us realize breakthrough medicines, ” stated j. donald debethizy, president and ceo of santaris pharma. “the acquisition combines santaris pharma’s next - generation antisense technology and lna expertise with roche’s deep experience in disease biology, chemistry, drug safety, drug formulation, delivery, and development. ”
santaris pharma a / s announces expanded worldwide strategic alliance with pfizer inc. directed to development of rna - targeted med
santaris pharma a / s announces expanded worldwide strategic alliance with pfizer inc. directed to development of rna - targeted medicines
santaris pharma is a danish clinical stage biopharmaceutical company. the company was formed in 2003 and has the exclusive rights to lna technology, a 3rd generation antisense chemistry used to develop new classes of rna medicines, called rna antagonists. santaris pharma
santaris pharma a / s uses its proprietary locked nucleic acid (lna) platform and tissue - targeting expertise to pioneer next - generation antisense product candidates. santaris pharma is developing a diverse pipeline of lna therapeutics that influence the production or activity of select rna targets to address diseases that are difficult - to - treat with conventional drug modalities. santaris pharma’s innovation and leadership position has attracted multiple collaborations with leading global pharmaceutical companies. founded in 2003, santaris pharma is headquartered in denmark .
wyeth pharmaceuticals is continuing efforts to improve its capabilities in the formulation and delivery of rna through a strategic partnership with santaris pharma .
since gilde invested in santaris pharma, the company has advanced its product pipeline through the clinic and signed commercial collaboration agreements with glaxosmithkline, pfizer, bristol - myers squibb, roche and shire. santaris pharma was acquired by roche in 2014 for $ 450m .
santaris pharma randi krogsgaard, + 45 4517 9879 director, corporate communications cell: + 45 20488384 rmk @ urltoken www. urltoken
santaris pharma a / s announces expanded worldwide strategic alliance with pfizer inc. directed to development of rna - targeted med | fiercepharma
rana therapeutics, inc. and santaris pharma a / s announce agreement to develop rna - targeted medicines that selectively activate protein expression
exiqon had requested that santaris pharma be ordered to pay damages. however, the arbitration court did not find grounds for damages .
the award is the first program grant to be made by the atf and is the third and largest award from the danish atf to a santaris pharma led collaborative group. the three year program will enable santaris pharma to identify 3 - 5 new rna drug candidates. in 2006 and 2007 the atf made two separate project grants to santaris pharma and the university of copenhagen totaling approximately dkk 20m (
santaris pharma a / s announces expanded worldwide strategic alliance with pfizer inc. directed to development of rna - targeted medicines | mirna blog
we would like to thank our colleagues at santaris pharma and all our collaborators who have contributed to the miravirsen endeavor over the years .
equity investment in santaris pharma a / s. santaris pharma a / s continues to be eligible to receive milestones and royalties under the original alliance. pfizer has advanced several programs under the original collaboration and reached a number of early milestones since the inception of the collaboration .
roche announced that it has agreed to acquire santaris pharma. santaris pharma has pioneered its proprietary locked nucleic acid (lna) platform that has contributed to an emerging era of rna - targeting therapeutics. this new class of medicines has the potential to address difficult to treat ...
as the leader in developing lna - based drugs, santaris pharma a / s is very pleased that the uspto has ruled in favor of santaris pharma a / s and upheld the company' s' imanishi' patents ,
said soeren tulstrup, president and ceo of santaris pharma a / s .
the uspto rulings affirm the strong intellectual property position of santaris pharma a / s as it continues to develop effective rna - targeted therapies with high affinity, target specificity and remarkable potency for a range of diseases both internally and with its partners .
santaris pharma a / s announced it has established operations in the united states. increasing interest, new collaborations and breakthrough advancements utilizing the company' s proprietary rna - based locked nucleic acid (lna) drug platform and drug discovery engine led santaris pharma a / s to ...
roche announced that it has agreed to acquire santaris pharma. santaris pharma has pioneered its proprietary locked nucleic acid (lna) platform that has contributed to an emerging era of rna - targeting therapeutics. this new class of medicines has the potential to address difficult to treat... more
exiqon a / s (nasdaq omx copenhagen: “exq”) today announced that the company has completed its litigation against santaris pharma a / s .
a drug for hepatitis c virus from santaris pharma shows effectiveness in reducing the potentially deadly virus in people, according to new clinical trial results .
santaris pharma a / s announced it has established operations in the united states. increasing interest, new collaborations and breakthrough advancements utilizing the company' s proprietary rna - based locked nucleic acid (lna) drug platform and drug discovery engine led santaris pharma a / s to... more
roche' s return to the field of rnai research looks to be complete, following its $ 450m deal to acquire denmark' s santaris pharma .
denmark - based santaris pharma a / s appoints leading rna industry expert art levin ph. d. as president of us operations and chief development officer
, phd, vice president and chief scientific officer of santaris pharma a / s .
santaris pharma a / s has dedicated its scientific know - how and expertise to advance lna - based chemistries into a versatile lna drug platform for the development of new rna - targeted drugs for human diseases .
roche announced that it will acquire santaris pharma, a private clinical stage biopharmaceutical firm focused on rna - targeted therapies, for up to $ 450 million .
santaris pharma will receive an up - front payment of $ 10 million, up to $ 90 million in potential milestone payments per product, and funding of ongoing discovery and research activities. in addition, santaris pharma will be eligible to receive royalties on the worldwide sales of all medicines arising from the alliance .
6m, $ 9m) towards the development of a high - throughput drug discovery platform for novel rna medicines. the project will be based on santaris pharma
during proceedings, santaris pharma submitted a counter claim against exiqon for damages in the amount of dkk 100 million. this claim was dismissed on substantive grounds .
hørsholm, denmark / san diego, california, january 09, 2014 —santaris pharma a / s, a privately held biopharmaceutical company, announced today that they have signed a worldwide strategic alliance with roche to discover and develop novel rna targeted medicines using santaris pharma' s proprietary locked nucleic acid (lna) drug platform .
roche has renewed its interest in gene silencing drugs, paying $ 250m (€187m) for santaris pharma including its ‘antisense’ locked nucleic acid (lna) platform .
“we are pleased that dr. levin has joined our management team to establish operations in the us and oversee global development programs for santaris pharma a / s, ”
the arbitration court also decided on the distribution of the costs of proceedings. santaris pharma was awarded partial costs of dkk 2 million payable by exiqon within 14 days .
roche plans to maintain santaris pharma’s operations in denmark, where the existing site will be renamed roche innovation center copenhagen. under the terms of the agreement, roche will make an upfront cash payment of $ 250 million to santaris pharma shareholders and make additional contingent payments of up to $ 200 million based on the achievement of certain predetermined milestones .
following today’s decision, it is clear that both exiqon and santaris pharma may supply lna™ products for the research and development of pharmaceutical products containing lna™ as the active ingredient .
santaris pharma discovers and develops rna - targeted therapies to treat infectious diseases and metabolic disorders. through its partnerships with pharmaceutical companies, santaris covers a range of therapeutic areas including cancer, cardiovascular disease, infectious and inflammatory diseases, and rare genetic disorders .
roche said it will retain santaris’ operations in denmark under the new name roche innovation center copenhagen. the acquisition of santaris is expected to be completed this month .
the second edition in our pharma social media series, the uk twitter ranking... .
neither santaris nor isis commented on the dispute for this article, citing ongoing litigation .
formed in 2003, santaris has not been short of big pharma interest in its technology, having sealed deals with companies such as bristol - myers squibb, glaxosmithkline, pfizer and shire .
navjot rai santaris pharma a / s, usa office: + 1 858 764 7066 (ext. 206) cell: + 1 619 723 5450 e - mail: nra @ urltoken
that history includes a patent dispute between santaris and isis, generally acknowledged as the pioneer behind antisense drugs. isis sued santaris in august 2011 over patent infringement claims. the u. s. patent and trademark office ruled in favor of santaris in november 2011 .
s messengerrna antagonists and microrna antagonists are being developed to silence mrnas and micrornas associated with various diseases, including cancer, metabolic disorders and viral infections. santaris pharma completed a euro 40m second round of equity financing in may 2006 and a euro 20m third round of equity financing in december 2007. santaris pharma has a global alliance with enzon pharmaceuticals of new jersey to develop and co - commercialise a series of santaris pharma rna antagonists for the treatment of cancer and a worldwide strategic alliance with glaxosmithkline for the discovery, development and commercialization of novel medicines against viral diseases .
the acquisition, which is subject to customary closing conditions, is expected to close in august 2014. roche plans to maintain santaris pharma’s operations in denmark, where the existing site will be renamed roche innovation center copenhagen. under the terms of the agreement, roche will make an upfront cash payment of usd 250 million to santaris pharma shareholders and make additional contingent payments of up to
the deal will see wyeth select rna targets that santaris will develop drug candidates for using its lna platform, with the pharma major responsible for the development and commercialisation of products arising from the alliance .
under the terms of the agreement, santaris pharma and roche will collaborate on the discovery of lna drugs against a multitude of targets across several disease areas. roche will be responsible for the subsequent development and commercialization of products arising from the alliance. santaris pharma will receive an upfront payment of $ 10 million in cash, up to $ 138m in potential pre - clinical, clinical, regulatory and sales milestones per product, and funding of ongoing discovery and research activities. in addition, santaris pharma will be eligible to receive royalties on the worldwide sales of all medicines arising from the alliance .
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/ prnewswire / - - santaris pharma a / s, a clinical - stage biopharmaceutical company focused on the research and development of mrna and microrna targeted therapies, and pfizer inc. (nyse: pfe), today announced that the companies have expanded their collaboration directed to the development and commercialization of rna - targeted medicines using santaris pharma a / s locked nucleic acid (lna) drug platform .
the santaris pharma a / s lna drug platform is the only rna technology with both mrna and microrna targeted drugs in clinical trials, demonstrating the broad utility of the proprietary platform. the unique combination of small size and high affinity achievable with santaris pharma a / s lna technology allows lna - based drugs to potently and specifically inhibit rna targets in different tissues without the need for complex delivery vehicles .
roche has agreed to acquire santaris pharma, a pioneer in the emerging era of rna - targeting therapeutics via its proprietary locked nucleic acid (lna) platform. the acquisition, which is subject to customary closing conditions, is expected to close in august 2014. roche plans to maintain santaris pharma’s operations in denmark, where the existing site will be renamed roche innovation center copenhagen. under the terms of the agreement, roche will make an upfront cash payment of usd 250 million to santaris pharma shareholders and make additional contingent payments of up to usd 200 million based on the achievement of certain predetermined milestones .
law360, los angeles (february 27, 2014, 8: 24 pm est) - - a california federal judge on thursday refused to let santaris pharma a / s corp. off the hook in isis pharmaceuticals inc.' s infringement suit accusing santaris of leveraging isis' patented drug discovery development platform to sign multimillion - dollar development deals, saying santaris isn’t protected by a safe harbor statute .
we are delighted that isarna therapeutics selected santaris pharma as its partner, further validating that our lna drug platform is the technology - of - choice for developing rna - targeted medicines ,
said dr .
roche (six: ro, rog; otcqx: rhhby) announced today that it has agreed to acquire santaris pharma, a privately held biopharmaceutical company based near copenhagen, denmark. santaris pharma has pioneered its proprietary locked nucleic acid (lna) platform that has contributed to an emerging era of rna - targeting therapeutics. this new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas .
, chief scientific officer and vp business development of santaris pharma .
this deal is yet another example of our intention to add more alliances with biotechnology companies such as isarna therapeutics to our growing list of partners .
the acquisition, which is subject to customary closing conditions, is expected to close in august 2014. roche plans to maintain santaris pharma’s operations in denmark, where the existing site will be renamed roche innovation center copenhagen .
new york, may 1 (genomeweb news) - danish drug developer santaris pharma said today that it has created a microrna research consortium in partnership with the department for medical biochemistry and genetics at the university of copenhagen .
santaris pharma a / s has substantial intellectual property rights that includes ownership of more than 60 patent families which cover the lna chemistry, manufacturing, therapeutic uses in patients and animals and optimal drug designs and drug formats .
miragen is using santaris' lna technology to develop mirna - targeted therapies. miragen has a deal with
to spearhead the us expansion, santaris pharma a / s has appointed leading rna industry expert arthur a. levin, phd, as president of its us operations. in addition, dr. levin will hold global responsibility as vice president and chief development officer of santaris pharma a / s. dr. levin has 15 years of experience in rna - based research and more than 25 years of experience in the pharmaceutical industry. prior to joining santaris pharma a / s, dr. levin was senior vice president of drug development at isis pharmaceuticals where he was instrumental in advancing more than a dozen rna - based antisense drugs from basic research to clinical development .
announcing the alliance, president and ceo of santaris pharma, dr. don debethizy, said :
we are delighted that roche has deepened its commitment to the field of oligonucleotide therapeutics and we are obviously proud and honored that they have chosen santaris as their partner. this is a very important deal to santaris and we look forward to working closely with the roche teams in our joint pursuit of novel, breakthrough drugs .
santaris pharma is a clinical - stage biopharmaceutical company focused on developing a new class of drugs intended to switch off the expression of harmful genes. called rna antagonists, these new drugs are being developed by santaris and its corporate partners for the treatment of cancer and metabolic disorders. created in may 2003 and backed by a broad group of leading international life science venture capital investors, santaris pharma completed a euro 40m second round of equity financing in may 2006. in july 2006, the company entered into a global partnership with enzon pharmaceuticals of new jersey to co - develop and commercialise a series of santaris rna antagonists for improving the treatment of cancer .
the expansion of our collaboration with santaris pharma a / s demonstrates our strategic intention to partner with innovative biopharm / biotech companies to explore novel drug design technologies as a potential source for breakthrough therapeutics ,
said mikael dolsten, president of worldwide research and development at pfizer .
we have been encouraged by the progress of our oligonucleotide collaboration with santaris pharma and are eager to explore this expanded partnership for potential additional lna - based drug projects .
hoersholm, denmark and san diego, jan. 4, 2011 / prnewswire / — santaris pharma a / s, a clinical - stage biopharmaceutical company focused on the research and development of mrna and microrna targeted therapies, and pfizer inc. (nyse: pfe), today announced that the companies have expanded their collaboration directed to the development and commercialization of rna - targeted medicines using santaris pharma a / s locked nucleic acid (lna) drug platform .
the expansion of our collaboration with santaris pharma a / s demonstrates our strategic intention to partner with innovative biopharm / biotech companies to explore novel drug design technologies as a potential source for breakthrough therapeutics ,
said mikael dolsten, president of worldwide research and development at pfizer. he added ,
we have been encouraged by the progress of our oligonucleotide collaboration with santaris pharma and are eager to explore this expanded partnership for potential additional lna - based drug projects .
according to maraganore, “in the 2005–2009 period, big pharma made big bets on rnai technology platforms. unfortunately, some of the big pharma technology efforts have not been so successful, at least as measured by ind filings, of which there are none. ”
he added, “the santaris investment story exemplifies forbion’s ability to select new potential disruptive platform technologies at an early stage, which drive a clear medical break - through. this deal for santaris further extends forbion’s solid track record. ”
santaris pharma a / s is a privately - held biopharmaceutical company focused on developing rna - based drugs targeted to disease - related mrnas and micrornas. utilizing the company’s proprietary locked nucleic acid (lna) drug platform and drug discovery engine, santaris pharma a / s provides fast and efficient generation of lead lna drug candidates. the company’s own research and development activities focus on infectious diseases and metabolic disorders while partnerships with major pharmaceutical companies include a range of therapeutic areas including cancer, rare genetic disorders and inflammatory diseases. santaris pharma a / s, founded in 2003, is headquartered in denmark with operations in the us. the company has strategic partnerships with enzon pharmaceuticals, glaxosmithkline, wyeth pharmaceuticals and shire plc. please visit urltoken for more information .
international biopharmaceutical company focused on the discovery and development of rna - targeted therapies for a range of diseases including metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders. (prnewsfoto / santaris pharma a / s) (prnewsfoto / )
ørum declined to say how much money his company was spending to license the drug from roche. the tavistock group did not respond to a request for comment. ørum was a longtime executive at santaris pharma, which was acquired by roche in 2014 .
unlike isis’ more recent big pharma deals with j & j, gsk, biogenidec, and astrazeneca, however, i expect this to involve less early development work by isis as some of this would be the obvious job of the former santaris crew .
roche completed its acquisition of partner santaris for $ 250 million in cash up front and up to $ 200 million in undisclosed milestones. in january, santaris and roche partnered to discover and develop rna - targeted drugs against ...
roche will acquire partner santaris for $ 250 million in cash up front and up to $ 200 million in undisclosed milestones. santaris is using its locked nucleic acid (lna) platform to develop antisense drug candidates. lead ...
“forbion recognized that santaris’ lna chemistries were the best in class antisense technology when the firm led the recapitalization of the company in 2006, ” said martien van osch, managing partner at forbion and board member of santaris pharma. “forbion has been a strong proponent of the company ever since, working closely with the management to promote the significant therapeutic potential of this new class of drugs .
increasing interest, new collaborations and breakthrough advancements utilizing the company’s proprietary rna - based locked nucleic acid (lna) drug platform and drug discovery engine led santaris pharma a / s, headquartered in denmark, to establish us - based operations in san diego, california .
in 2011, the swiss pharma giant sold its rna interference (rnai) pipeline, delivery technologies and research facility to arrowhead research corporation exiting .
santaris will receive an upfront payment and is eligible for development, regulatory and sales milestones. furthermore, santaris will receive a share of any sub - licensing revenues and royalties on worldwide sales of alliance products. no further financial details have been disclosed .
to wit, in 2011 isis sued santaris for infringing its rnaseh gapmer patents by santaris signing on big pharma partners regarding rnaseh therapeutics development. isis viewed this as a form of monetizing their ip and consequently sued. if decided in isis’ favor, the case would have been a notable departure from the long - held practice of shielding preclinical business and drug development under the safe harbor of the research exemption .
/ prnewswire / - - santaris pharma a / s and betaisarna therapeutics gmbh announced today that they have signed an agreement whereby isarna gains access to santaris' locked nucleic acid (lna) technology to further develop its next generation oligonucleotide product candidates. under the terms of the agreement, isarna obtains rights to utilize santaris pharma' s proprietary lna drug platform to discover, develop and commercialize immunotherapeutics targeted against the cytokine transforming growth factor beta1, beta2 and beta3 (tgf - beta). tgf - beta represents a critical pathway in oncology as its overexpression has been linked to progression and poor patient outcomes for various cancers and is suspected to play a role in other diseases as well .
we are confident that the unique features of the lna drug platform can achieve clinical breakthroughs and look forward to working closely with the bristol - myers squibb team ,
henrik oerum, ph. d. , santaris pharma' s cso and vp, business development commented .
roche innovation center copenhagen a / s is the home of rna therapeutics research (rtr) for roche pharma research and early development (pred) .
“pharma is becoming more modality agnostic instead of just summarily dismissing oligos as drugs. they are primarily now just looking at these agents as drugs. ”
over the now several decades–long history of nucleic acid therapeutics, big pharma has had an on - again, off - again relationship with the technology .
in october of this year, merck said it was restructuring r & d. the pharma did not say whether cuts will include its rnai platform .
/ prnewswire / - - santaris pharma a / s and rana therapeutics, inc. announced today that they have signed an agreement whereby rana gains access to santaris' locked nucleic acid (lna) technology to develop rna - targeted medicines. under the terms of the agreement, santaris will license its proprietary locked nucleic acid drug technology to rana for the development of lna - based drug candidates against up to 10 rana proprietary rna targets. the license granted by santaris includes access to proprietary chemistry capable of delivering potent single - stranded lna - based drug compounds. rana will apply the lna chemistry along with its proprietary technologies for selective protein activation to develop rna - targeted medicines. santaris will receive an upfront payment and is eligible for target nomination payments, development milestones and royalties on each product .
santaris pharma a / s recently achieved a breakthrough in medical science as the first company to advance a microrna - targeted therapy into human clinical trials. a single - dose phase 1 trial in healthy volunteers has now been completed and an additional phase 1 multiple ascending - dose study is planned. the drug spc3649 specifically targets microrna - 122 (mir - 122), a host factor for hepatitis c virus replication. in 2008, santaris pharma a / s published the results of successful microrna silencing with spc3649 in non - human primates in nature [ 1 ] .
new york (genomeweb) — isis pharmaceuticals and santaris pharma are currently negotiating a settlement to their roughly three - year - old patent - infringement lawsuit and believe there is
strong potential to settle
the litigation instead of going to trial, according to court documents filed this month .
wyeth has made an upfront payment of $ 7m in cash and a $ 10m equity investment in santaris. a further $ 83m may be paid in milestone payments for each of 10 potential targets. santaris will also receive worldwide royalties from products that reach the market .
last month, santaris pharma a / s announced a multi - year worldwide strategic alliance with shire plc to discover and develop new rna - based medicines to treat rare genetic disorders utilizing santaris pharma’s proprietary lna drug platform. this collaboration adds to the growing list of mrna and microrna drug discovery and development partnerships, which includes wyeth (delivery of lead candidates against up to ten targets), glaxosmithkline (four viral disease drug candidates) and enzon pharmaceuticals (eight cancer targets successfully delivered). operations in the us aim to support existing relationships and generate new licensing and partnership opportunities .
, cso & vp business development of santaris pharma a / s, said
santaris pharma' s lna drug platform provides the means to discover and develop novel drugs that potently and specifically bind rna - targets in previously inaccessible clinical pathways. usually, the objective is to inhibit the target to avoid protein synthesis, but in rana' s case the lna drugs will be developed to selectively activate protein expression. as such, our agreement with rana is yet another example of how we seek to leverage the broad applicability of our drug platform through partnerships with the pharmaceutical industry .
by way of background, isis sued santaris (a danish corporation not to be confused with isis’s fellow san diego - based firm santarus, recently bought by salix pharmaceuticals), accusing santaris of infringing isis patents to antisense compounds and methods of making the antisense compounds when santaris contracted to sell antisense drug discovery services and products to four pharmaceutical company customers in the united states. santaris moved for summary judgment on its affirmative defense that the alleged acts of infringement fell within the safe harbor provision of 35 u. s. c. § 271 .
the court denied santaris’s summary judgment motion, finding that santaris failed to provide undisputed evidence of the belief that the merck i court found was needed to properly claim the 271 (e) (1) safe harbor (see above quote). instead, the isis court stressed that santaris’s supporting declaration by one of its officers provided only a general description of the collaborations between santaris and its customers. this, the court found, did not provide any detailed analysis of santaris’s uses of the allegedly infringing compounds, methods and processes to establish they rose to the level of a reasonable belief, as contemplated by merck i, as to a patented compound’s way of achieving a particular biological effect and, thus, failed to show that santaris fell under the protection of the 271 (e) (1) safe harbor .
micrornas are a newly discovered class of small regulatory molecules which control many biological processes in cells. in addition, micrornas are implicated in many diseases, such as cancer, viral infections, cardiovascular disease and neurological disorders and, therefore, represent a new class of targets for therapeutic intervention. santaris pharma
micrornas are a newly discovered class of small regulatory molecules which control many biological processes in cells. in addition, micrornas have been implicated in many diseases, such as cancer, viral infections, cardiovascular disease and neurological disorders and, therefore, represent a new class of targets for therapeutic intervention. santaris pharma
the agreement will see roche make an upfront cash payment of $ 250m to santaris shareholders and then further, conditional, milestone payments of up to $ 200m. the deal is expected to close later this month, when santaris' danish operations will become the roche innovation center copenhagen .
santaris has developed its own flavor of antisense called locked nucleic acid technology, which the company claims is more effective in neutralizing targeted rna sequences .
according to krieg, “pharma is becoming more modality agnostic instead of just summarily dismissing oligos as drugs. they are primarily now just looking at these agents as drugs. ”
this gives the therapeutic increased potency, resistance to degradation, a long half life and ensures it is readily taken up by tissues, according to santaris .
santaris is based in denmark and performs research in san diego. it is unrelated to san diego - based santarus, which makes drugs for gastrointestinal ailments .
santaris pharma announced that it has commenced a phase i human volunteer trial of spc3649 (lna - antimirtm - 122), the world' s first microrna medicine to be tested in man, according to the company. the study is being conducted by phaseonetrials a / s, copenhagen, and will include a maximum of 48 ...
what to look for: new collaborations are in the works. phase ii data will be a major milestone for santaris as it advances a variety of trials .
commenting on its acquisition by roche, santaris' president and ceo j. donald debethizy said the companies had complementary capabilities that will help them “realise breakthrough medicines” .
the drug produced only mild side effects, said michael r. hodges, vice president and chief medical officer of santaris, the study' s senior author .
santaris pharma announced that it has commenced a phase i human volunteer trial of spc3649 (lna - antimirtm - 122), the world' s first microrna medicine to be tested in man, according to the company. the study is being conducted by phaseonetrials a / s, copenhagen, and will include a maximum of 48... more
“these study results are the culmination of over 6 years of microrna research at santaris pharma a / s, ” said michael r. hodges, md, vice president and chief medical officer at santaris pharma a / s. “the results of this study highlight miravirsen’s exceptional high barrier to resistance, long duration of action and good tolerability. miravirsen would be especially suitable for treatment of hard - to - treat patients, for example those patients who have already failed treatment with pegylated - interferon and ribavirin combination or protease inhibitor triple therapy. ” dr. hodges continued, “longer treatment durations of miravirsen are currently being tested in clinical trials in subjects who have failed initial therapy for hcv infection. ”
john reed, head of roche pharma research and early development, said :
today there are many disease targets that are very challenging or even impossible to reach with small molecules or antibodies .
two years after pfizer ($ pfe) inherited wyeth' s discovery pact with denmark' s santaris, its researchers have decided to significantly up the ante on their deal. the pharma giant is handing over $ 14 million in an upfront fee and promising up to $ 600 million more in milestones to expand the deal to develop rna - targeted drugs .
the lna drug platform and drug discovery engine developed by santaris pharma combines the company' s lna chemistry with its targeted drug development capabilities to deliver lna - based drug candidates against rna targets, both mrna and microrna, for a range of diseases including infectious and inflammatory diseases, cardiometabolic disorders, cancer, and rare genetic disorders. the lna drug platform, according to santaris, overcomes the limitations of earlier antisense and sirna technologies to deliver potent single - stranded lna - based drug candidates across a multitude of disease states .
under the terms of the partnership the two companies will collaborate on the discovery, development and commercialisation of new medicines using santaris’ locked nucleic acid (lna) drug platform .
santaris claim that “ lna is the first true three - dimensional analogue of rna ​”, which can be incorporated into oligonucleotides to enhance binding affinity to complementary rna sequences .
at least seven companies developing oligonucleotide - based drugs have licensed the technology from or partnered with santaris, which has an internal pipeline of six antisense molecules in the clinic .
maraganore agreed. “rnai therapeutics partnerships will be focused on product alliances. pharma has recently grown their interest in the rna therapeutics space but with an interest in products, not technology, ” he said .
“the acquisition of santaris provides roche the unique opportunity to merge their deep expertise in disease biology, target selection, toxicology, formulation, and drug delivery with the most extensive experience in designing and producing lna oligonucleotides, a technology that roche believes will redefine rna - targeting medicine in the future, ” ​ a santaris spokesperson told in - pharmatechnologist. com .
the acquisition marks an acceleration in roche' s interest in both rnai research and santaris, after the two companies struck a more limited $ 148m discovery and development deal in january .
the court also cited the santaris officer’s previous statement to the pto that, “ (t) he majority of [ santaris' s ] collaborators have taken broad licenses to our proprietary lna platform in order to discover, develop, and commercialize new lna - based drugs against rna targets associated with disease, ” observing that the reference to selling “platform” technology so that another company could develop and discover drug candidates, suggested that santaris was using its technology for “basic research” not covered under the § 271 (e) (1) safe harbor .
santaris was the first company to bring a mirna - targeting molecule into the clinic. the company' s miravirsen, an lna - modified anti - mirna that targets hepatocyte mir - 122, is in phase ii testing to treat hcv. in 2013, santaris published phase iia data showing that miravirsen resulted in a dose - dependent reduction in hcv rna levels. 8
santaris claims its lna platform enables specific targeting and regulation of micrornas (mirnas) and messenger rnas (mrnas), which is an area wyeth has been making efforts to establish itself in .
naarden, the netherlands - 4 august 2014 - forbion capital partners, the leading dutch vc firm investing in world - class healthcare technologies announces the sale of its portfolio company, santaris pharma a / s for a total consideration of up to $ 450 million, of which an upfront cash payment of $ 250 million and additional contingent payments of up to $ 200 million based on the achievement of certain predetermined milestones .
s proprietary lna drug chemistry and the screening platform will be developed by a collaborative research consortium led by santaris pharma and the biotech research & innovation centre (bric) at the university of copenhagen. other members of the consortium are the nucleic acid centre (nac), university of southern denmark, h. lundbeck a / s, the danish headquartered pharmaceutical company and ribotask a / s, the danish reagents company .
hoersholm, denmark / san diego, california — santaris pharma a / s, a privately - held biopharmaceutical company focused on developing rna - based drugs targeted to disease - related mrnas and micrornas, today announced it has established operations in the united states. internally and through its partners, the company has a robust drug development pipeline including programs to treat metabolic disorders, infectious and inflammatory diseases, cancer and rare genetic disorders .
developed using santaris pharma a / s proprietary locked nucleic acid (lna) drug platform, miravirsen is an inhibitor of mir - 122, a liver specific microrna that the hepatitis c virus requires for replication. miravirsen is designed to recognize and sequester mir - 122, making it unavailable to the hepatitis c virus. as a result, the replication of the virus is effectively inhibited and the level of hepatitis c virus is profoundly reduced .
santaris got $ 17 million in cash and equity from wyeth for their original pact struck in early 2009. the revised deal includes potential royalty payments for drugs promising to hit up to 10 rna targets .
nevertheless, although accepting some of santaris’s legal arguments, the isis court cited santaris’s failure to provide undisputed evidence of such knowledge or belief in denying santaris’s summary judgment motion. the court found instead that fact issues remained as to whether santaris' s collaboration agreements were
reasonably related
to the type of information submitted to the fda—that is, whether it was
objectively reasonable for a party in [ santaris' s ]... situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the fda would decide whether to approve the product in question
[ citing merck i, 545 u. s. at 200 - 01 (district court jury instruction) ]. accordingly, the court found that this fact question regarding what was reasonable, should be left to the trier of fact, as is customary for most questions involving a question of what is reasonable .
called miravirsen, the drug reduced the virus by a factor of 100 to 1, 000 in the phase 2a trial, santaris said. study results were published wednesday in the new england journal of medicine .
the swiss company, which exited the rnai field in 2010 as part of an r & d restructure, believes santaris' rna - targeting technology could underpin the discovery and development of a new class of medicines .
santaris' pipeline of rnai - or' gene silencing' - drugs are based on its locked nucleic acid (lna) platform and its lead candidate is miravirasen, a novel hepatitis c treatment in phase ii trials .
, ceo of isarna therapeutics said :
in optimizing our cancer immunotherapeutics, we see santaris' lna approach as a unique enabling technology to support the efficacy profile of our novel products targeted at breakthrough status diseases .
under the agreement of the transaction, roche will make an upfront payment of $ 250 million in cash to santaris’ shareholders as well as up to $ 250 million in additional contingent payments once specific predetermined milestones are met .
every drug is targeted at a precise rna sequence in messenger or microrna ,
says mccullagh. for mccullagh, the whole field offers an opportunity that can one day rival monoclonal antibodies. and that message has not been lost in the pharma world .
shire’s business development and licensing team scooped the award, this year for the pace and strength of its activities, including the acquisition of viropharma (jan 2014; $ 4. 2bn), lumena pharmaceuticals (may 2014; $ 260m) and fibrotech (may 2014, $ 75m). its portfolio was expanded by licencing agt - 182 from armagen (jul 2104; $ 225m) and rebalanced by selling distribution rights for estrace to trimel pharma (july 2014; $ 41m) and dermagraft to organogenesis (jan 2014; $ 300m). partnerships were also inked with prasco labs (fosrenol distribution; oct 2013), santaris pharma (lna drugs; aug 2013) and argen - x (drug discovery partnership; june 2014) .
such therapies offer a number of benefits over traditional small molecule and monoclonal antibody approaches, according to santaris, including reducing candidate failure due to pharmacokinetic / toxicology predictability, and increased chemistry, manufacturing and control (cmc) efficiency .
dr. john reed, head of pharma research and early development (pred) at roche stated :
we are very pleased with our new partnership with santaris. we believe the lna drug platform provides the means to discover novel drugs against a range of targets of high clinical relevance that are difficult – or impossible - to target with other drug platforms. as such, the partnership will increase our ability to discover and develop important novel medicines that can address significant unmet needs in critical therapeutic areas
.
exiqon’s product offering includes lna™ amidites and lna™ oligonucleotides for the research and development of pharmaceutical products. exiqon has the exclusive right to supply such products except for use in the research and development of pharmaceutical products containing lna™ as the active ingredient. today’s decision by the arbitration court establishes exiqon’s non - exclusive right to supply these products also for the research and development of pharmaceutical products containing lna™ as the active ingredient. santaris pharma’s request that exiqon should be prevented from supplying lna™ products for such use was dismissed .
). the positive rulings by the united states patent and trademark office (uspto) cover two key santaris pharma a / s
imanishi
patents, u. s. pat. no. 6, 268, 490 (the
' 490 patent
) and u. s. pat. no. 6, 770, 748, (the
' 748 patent
), which claim rights to the locked nucleic acid (lna) or bicyclic nucleic acid (bna) chemical structure used for developing antisense molecules .
the united states patent and trademark office (uspto) revoked the ex parte re - examination of the' 490 patent and provided a notice of intent to issue a reexamination certificate that confirms the patentability of all claims of the' 490 patent owned by santaris pharma a / s and is not subject to appeal. in addition, the uspto issued an action closing prosecution in the inter - partes re - examination of' 748 patent, which is a continuation - in - part of the ‟490 patent, confirming all of the original claims .
the expanded alliance with pfizer is a result of our successful collaboration over the last two years and provides further evidence that our lna drug platform is rapidly becoming the technology - of - choice for partners interested in developing rna - targeted medicines ,
said soeren tulstrup, president and ceo of santaris pharma a / s .
the lna drug platform is well positioned to deliver viable drug candidates today, and we are excited to expand our relationship with pfizer to pursue our goal of making rna - targeted drugs for important diseases a reality .
santaris pharma a / s lna drug platform combines the company' s proprietary lna chemistry with its highly specialized and targeted drug development capabilities to rapidly deliver potent single - stranded lna - based drug candidates across a multitude of disease states including infectious and inflammatory diseases, cardiometabolic disorders, cancer, and rare genetic disorders. the unique combination of pharmaceutical properties, small size and very high affinity of lna - based drugs allows this new class of antisense drugs to potently and specifically inhibit rna - targets in many different tissues without the need for complex delivery vehicles .
this written announcement contains forward - looking statements, identified by the use of words such as
believes ,
expects ,
may ,
will ,
should
,
potential ,
anticipates ,
plans
or
intends
and similar expressions. such forward - looking statements involve risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in this announcement. such factors include, but are not limited to the timing, success and cost of clinical studies; the ability to obtain regulatory approval of products, market acceptance of and future demand for santaris pharma products and the impact of competitive products and pricing. these factors should be considered carefully and readers are cautioned not to place undue reliance on such forward - looking statements. no assurance can be given that the future results covered by the forward - looking statements will be achieved. all information in this press release is as of the date of this press release and santaris pharma does not intend to update this information .
one of the major challenges facing oligonucleotide therapeutics is the effective and broad delivery to target tissues. in the field of sirna therapeutics, both chemical modification and liposomal formulation are being widely explored as means to overcome this challenge. in this presentation, santaris pharma researchers show that in preclinical models short, single stranded lna oligonucleotides can be administered intravenously as naked molecules and are broadly taken up by a wide range of targeted tissues (e. g. , kidney, liver, bone marrow, spleen, intestine, skin, lymph nodes, and pancreas) .
in a comment, president and ceo of exiqon, lars kongsbak said: “ exiqon is committed to provide best in class products for the detection of nucleic acids using our lna™ technology. this has allowed us to become a leader in our markets, and serves as the foundation for exiqon’s commitment to develop, and help propel the development of, novel molecular diagnostic products, including companion diagnostics, for which we provide easy access to our proprietary technologies through licensing. proceedings against santaris pharma were an unfortunate, but necessary, step towards realizing our business goals. ”
fda - regulated firms - - drug, device, biologic or otherwise - - on both sides of the patent aisle concerned with the bounds of the “safe harbor” exception to patent infringement under 35 u. s. c. § 271 (e) (1) can learn several key lessons from the recent decision in isis pharmaceuticals, inc. v santaris pharma a / s corp. (hereafter: “ isis ”), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post - approval patent storms .
the scoop: santaris has been breaking new ground with its advancement of a microrna therapy into the clinic in late may. a successful proof - of - concept trial for hepatitis c is being billed as a potential medical breakthrough, offering a key to modulating networks of genes.
santaris pharma a/s is a biopharmaceutical company founded in 2003 in copenhagen , denmark with a small branch in san diego , california that opened in 2009 . created by a merger between cureon and pantheco , santaris pharma a/s has become a leading clinical-stage biopharmaceutical company that develops rna-targeted medicines using a locked nucleic acid ( lna ) drug platform and drug development engine . the company was acquired by roche in august 2014 . santaris has the worldwide exclusive intellectual property rights to the therapeutic applications of locked nucleic acid ( lna ) technology . this includes ownership of over 60 patent types , which range from the chemistry to manufacturing and from therapeutic uses to drug design . with their lna technology , santaris works on developing drugs for a wide range of diseases using microrna and mrna . their research focuses on infectious disease and metabolic disorders . they also work on collaborations with pharmaceuticals to develop drugs for rare genetic disorders , cancers , cardiovascular disease , and immune and inflammatory diseases . 
santaris pharma a/s is a biopharmaceutical company founded in 2003 in copenhagen, denmark with a small branch in san diego, california that opened in 2009. created by a merger between cureon and pantheco, santaris pharma a/s has become a leading clinical-stage biopharmaceutical company that develops rna-targeted medicines using a locked nucleic acid (lna) drug platform and drug development engine. the company was acquired by roche in august 2014. santaris has the worldwide exclusive intellectual property rights to the therapeutic applications of locked nucleic acid (lna) technology. this includes ownership of over 60 patent types, which range from the chemistry to manufacturing and from therapeutic uses to drug design. with their lna technology, santaris works on developing drugs for a wide range of diseases using microrna and mrna. their research focuses on infectious disease and metabolic disorders. they also work on collaborations with pharmaceuticals to develop drugs for rare genetic disorders, cancers, cardiovascular disease, and immune and inflammatory diseases.
santaris pharma a/s is a biopharmaceutical company founded in 2003 in copenhagen, denmark with a small branch in san diego, california that opened in 2009. created by a merger between cureon and pantheco, santaris pharma a/s has become a leading clinical-stage biopharmaceutical company that develops rna-targeted medicines using a locked nucleic acid (lna) drug platform and drug development engine. the company was acquired by roche in august 2014. santaris has the worldwide exclusive intellectual property rights to the therapeutic applications of locked nucleic acid (lna) technology. this includes ownership of over 60 patent types, which range from the chemistry to manufacturing and from therapeutic uses to drug design. with their lna technology, santaris works on developing drugs for a wide range of diseases using microrna and mrna. their research focuses on infectious disease and metabolic disorders. they also work on collaborations with pharmaceuticals to develop drugs for rare genetic disorders, cancers, cardiovascular disease, and immune and inflammatory diseases.