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moler
Please explain and show figures.
Echo20
VICL licenses PRE-CLINICAL
Vical Incorporated (Nasdaq:VICL) announced today a worldwide, nonexclusive license of its patented Vaxfectin® adjuvant to Cyvax, Inc., a privately held vaccine development company, for use in malaria vaccines. Financial terms of the agreement were not disclosed.
Vijay B. Samant, Vical's President and Chief Executive Officer, said, "We are pleased to expand our Vaxfectin® franchise with the license to Cyvax for malaria vaccines after entering into the initial Vaxfectin® license with Bristol-Myers Squibb for antibody production in the prior quarter. Vaxfectin® has an expansive range of potential applications as reflected by the scope of these licenses." Cyvax's Chief Executive Officer, Jonathan Markham, said, "After conducting a significant body of pre-clinical work, Cyvax elected to move forward with Vical's Vaxfectin® due to the robust enhancement in efficacy we observed with that adjuvant. The Vaxfectin® adjuvant also offers comparative advantages across a number of other important domains including safety, tolerability, and commercial scalability."
______________________________________________________________
TKMR has a new formula for EBOLA that is ten times more powerful!
I hope TKMR gets the first PHASE ONE CLINICAL TRIAL DONE and then works on the new formula.
The first PHASE ONE CLINICAL TRIAL could be enough to prove the platform of TKMR on EBOLA. That will set up the whole PLATFORM of TKMR.
TKMR has a few PHASE ONE CLINICAL TRIALS completed under formulas with ALNY that seem to have gone under the radars of many companies so far. Still those passing PHASE ONE are still proof of the TKMR PLATFORM.
I still want to see in writing (PR) that TKMR has received the $65 million dollars from ALNY and so the company TKMR is now worth at least $136 million dollars with 14 million shares.
Echo20
If TKMR announces the receipt of the $65 million dollars the company would then be worth $136 million dollars and so $9.7 dollars per share.
Are these figures correct?
Echo20
Talon Therapeutics Announces Publication of the Marqibo(R) (vinCRIStine sulfate LIPOSOME injection) RALLY Study in the Journal of Clinical Oncology (JCO)
GlobeNewswirePress Release: Talon Therapeutics, Inc. – Tue, Nov 27, 2012 9:00 AM EST
Data supported FDA accelerated approval of Marqibo (http://jco.ascopubs.org/)
Data published online ahead of print as a Rapid Communication
Data represents the per protocol, planned analysis based on established endpoints
SOUTH SAN FRANCISCO, Calif., Nov. 27, 2012 (GLOBE NEWSWIRE) -- Talon Therapeutics, Inc. (TLON), a biopharmaceutical company dedicated to developing leading oncology products, today announced the publication of the complete data from its Phase 2 RALLY Study of Marqibo in the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology (ASCO). The study results were published as a rapid communication and online ahead of in print. Marqibo received FDA accelerated approval in August of this year for treatment of adult patients with Philadelphia chromosome negative (Ph-) ALL in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.
"This publication highlights the heavily pre-treated nature of this relapsed and refractory adult ALL population," said Steven R. Deitcher, MD, President and CEO of Talon. "The results of this study, in their totality, show that Marqibo facilitates vincristine dose-intensification and achievement of complete responses. Despite universal prior vincristine treatment and residual neurotoxicity in most patients, Marqibo's adverse event profile was comparable to that historically observed with non-liposomal vincristine."
About RALLY
The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable patients at 22 sites in the U.S., Canada, Germany, and Israel. The primary objective of the RALLY clinical trial was to assess the efficacy of single-agent, once per week Marqibo 2.25 mg/m2 of actual patient body surface area as assessed by achievement of complete response (CR) or CR with incomplete blood count recovery (CRi). Secondary objectives included assessments of duration of CR/CRi, overall survival (OS), ability to undergo subsequent hematopoietic cell transplantation (HCT), safety, and pharmacokinetics. Marqibo was dosed weekly based on actual body surface area without any dose capping. The study population was defined as Philadelphia chromosome-negative adult patients in second or greater relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone HCT.
About Marqibo(R)
Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA-approved for ALL and Non-Hodgkin's Lymphoma (NHL) and is widely used in combination regimens for treatment for a variety of adult and pediatric hematologic and solid tumor malignancies. The Optisome(TM) nanoparticle encapsulation technology, utilized by Talon, has been shown to provide prolonged circulation of vincristine in the blood.
Marqibo has received orphan drug designation for the treatment of ALL from the FDA and from the European Medicines Agency (EMA). Talon intends to submit a Marketing Authorization Application to the EMA in 2013.
Important safety information and full prescribing information for Marqibo can be found at www.marqibo.com.
_________________________________________________________________
Marquibo gets an ORPHAN DESIGNATION.
Echo20
siRNA
Small interfering RNAs are a class of 20-25 nucleotide-long double-stranded RNA molecules involved in the RNA interference (RNAi) pathway and interferes with the expression of a specific gene.
Recombinant DNA experiments include inserting DNA encoding siRNA targeting the gene of interest into an expression vector.
http://ehs.unc.edu/training/self_study/recombinant/newcont.php?page=15#15
miRNA
microRNA (miRNA)
small RNAs containing 21 to 33 nucleotides that associated with multiple proteins in a RNA-induced silencing complex (RISC) that repress transcription of specific target mRNA by hybridizing to its 3' untranslated region.
http://medical-dictionary.thefreedictionary.com/microRNA+%28miRNA%29
Tekmira Acquires Worldwide License to Novel RNAi Technology
Tekmira and Marina Biotech Enter Into License Agreement for UNA Technology
GlobeNewswirePress Release: Tekmira Pharmaceuticals – 1 hour 5 minutes ago
VANCOUVER, British Columbia, Nov. 29, 2012 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (TKMR) (TKM.TO), a leading developer of RNA interference (RNAi) therapeutics, announced today that it has obtained a worldwide, non-exclusive license to a novel RNAi payload technology called Unlocked Nucleobase Analog (UNA) from Marina Biotech, Inc. (MRNA) for the development of RNAi therapeutics.
UNA technology can be used in the development of RNAi therapeutics, which treat disease by silencing specific disease causing genes. UNAs can be incorporated into RNAi drugs and have the potential to improve them by increasing their stability and reducing off-target effects.
"Our license to Marina's UNA technology expands and diversifies our foundation of technologies that enable us to develop RNAi therapeutics. With Tekmira's leading LNP delivery technology, a strong balance sheet, and access to multiple RNAi payload technologies, we are well positioned to aggressively advance multiple products into human clinical trials," said Dr. Mark J. Murray, Tekmira's President and CEO.
"We intend to leverage our expertise in LNP delivery and our broad understanding of therapeutic RNA payload design to optimize the use of UNA in our development pipeline, as well as provide pharmaceutical partners the opportunity to license UNAs combined with our LNP delivery technology to develop RNAi therapeutics," added Dr. Murray.
Under the license agreement, Tekmira has received worldwide, non-exclusive rights to Marina Biotech's UNA technology for the development of RNAi therapeutic products, and Marina will receive an upfront payment plus milestone and royalty payments on products developed by Tekmira that use UNA technology. Financial terms of the license agreement were not disclosed.
Unlocked Nucleobase Analogs (UNA) are acyclic ribonucleoside analogs in which the bond between C2' and C3' atoms is broken. This change in sugar structure renders this nucleoside analog very flexible. This characteristic is in contrast to the widely used locked nucleosides that lock the sugar conformation by a bridged bond between C2' and C4' atoms. The flexible nature of UNA reduces the binding affinity between two strands of an RNAi drug and gives unique characteristics to its genes silencing abilities. MARINA Biotech has demonstrated that UNA has the potential to improve RNAi therapeutics by increasing stability and reducing sense and antisense mediated off-target effects while retaining potency.
A PR on November 12 th stated the litigation was over and ten days
From then would be November 22.
TKMR should now have the $65 million dollars and
Be worth $136 million dollars.
There should be a jump to 9+.
ECHO20
The TEN DAYs should be up by now.
The money should be in the bank.
Echo20
Blockbuster news for TKMR??!!
Scientists Uncover a Novel Cooperative Effort to Stop Cancer Spread
ScienceDaily (Nov. 28, 2012) — Scientists from the Florida campus of The Scripps Research Institute (TSRI) have uncovered a group of what have been considered relatively minor regulators in the body that band together to suppress the spread of cancer from its primary site.
The discovery offers a fresh batch of possible therapeutic targets as well as new diagnostic tools with the potential to predict and inhibit the spread of cancer (metastasis) in patients suffering from the disease.
The research, published recently in The Journal of Biological Chemistry, was conducted by TSRI Professor Donald G. Phinney, a nationally recognized authority in the study of adult bone marrow-derived stem cells, and a postdoctoral fellow in his laboratory, Christopher L. Haga.
http://dx.doi.org/10.1074/jbc.M112.387761
In the new study, the scientists found that a cluster of seven microRNAs (miRNA) function cooperatively to repress a process known as epithelial-to-mesenchymal transition (EMT). While EMT is part of the normal biology of cell development in some parts of the body, the process has recently been implicated in two dangerous aspects of tumor growth -- tumor metastasis and the growth of drug-resistant cancer stem cells.
MicroRNAs are tiny fragments of RNA found in all mammalian cells. They bind to messenger RNAs, a process that generally results in gene silencing. This cluster of miRNAs, located in a genetic region known as DLK1-DIO3, suppresses a specific signaling network in human cancers that primarily affect glands such as breast cancer.
"These results establish the DLKI-DIO3 miRNA cluster as a critical checkpoint regulating tumor growth and metastasis," said Phinney. "Our data shows that when this cluster is silenced, it accelerates tumorogenesis and proliferation by inducing EMT."
Silencing the DLK1-DIO3 genetic region is an early event for tumors, Phinney said, pointing out that micro-metastasis can be detected even in the early stages of breast cancer.
One of the seven miRNAs highlighted in the new study -- MiR-544 -- appears to be potent in its powers of inhibition, repressing cancer cell proliferation by inducing Ataxia telangiectasia mutated (ATM), a protein involved in stopping the cell cycle once DNA damage is detected.
"What's interesting is that MiR-544 blocks cell growth in every tumor cell line we've put it into, so we're looking at it as a potential therapeutic target," Phinney said.
Phinney noted that dozens of miRNAs exist in the same genetic region. "It's possible there are other clusters that work together to affect tumor growth and metastasis," he said.
C. L. Haga, D. G. Phinney. MicroRNAs in the imprinted DLKI-DIO3 region repress the Epithelial-to-Mesenchymal transition by targeting the TWIST1 signaling network. Journal of Biological Chemistry, 2012; DOI: 10.1074/jbc.M112.387761
http://dx.doi.org/10.1074/jbc.M112.387761
http://www.sciencedaily.com/releases/2012/11/121128122041.htm
Surf144
Nanopatent
With the winning money at TKMR the stated use is to go high technology on thirteen targets.
At NNVC the company had many target formulas and now is focusing on one to get to the FDA and Market.
Polaroid won one billion dollars from Kodak and used the money on high technology and it did not pay out (at leat in time) and they went broke.
TKMR needs to avoid any high tech splurges towards too many targets. That can be deadly. Maybe you can contact TKMR and Dr Murray in some manner on this topic that he will notice.
Court judgment winners and lottery winners need to care for their new money carefully.
Echo20
nanopatent
Did TKMR get the money from ALNY yet?
A judgment is one thing and getting the money is another.
Where are we on the ten days? Is that week days?
Echo20
When the $65 million dollars moves from ALNY to TKMR
there should be an upswing.
There should be an upswing just because the court case ended.
TKMR should be worth twice as much with the added $65 million dollars.
TKMR needs to concentrate on one or two drugs to get those to market and not get mired in thirteen new drug targets or it could loose money as did Polaroid when it won one billion dollars.
Echo20
If TKMR has lost $8 million dollars for eight years, the 65 million would make up for it.
There should be a jolt coming up here soon.
Echo20
65 million dollars from the judgment puts TKMR up almost 100% as it is worth $71 million dolllars.
Does that now put TKMR at $135 million?
First time profit?
TKMR should also go up due to the end of litigation.
TKMR went down fifty percent when the case with ALNY started.
Echo20
After the judgment ALNY stated they will have $200 million dollars at
The end of the year, so they will not go bankrupt.
65 million dollars plus $10 million dollars covers 4 to 5 years os losses by TKMR.
Now if TKMR gets. One or two drugs to MARKET and money. By 2015 it will
Be more profitfable.
Echo20
Nanopatent
65 million dollars is first time profit.
Bonanza.
Echo20
nanopatent
It would be nice if TKMR shoots upwards and NNVC stays lower....
Echo20
And Genzyme - Sanofi!
Ref:
October 22, 2012 06:00 AM Eastern Time
Alnylam and Genzyme Form Alliance to Develop and Commercialize RNAi Therapeutics in Asia
– Genzyme to Advance ALN-TTR02 and ALN-TTRsc Programs as Breakthrough Therapies for Patients with ATTR in Japan and in the Broader Asian Market
– Alnylam to Receive $22.5 Million in Upfront Payment in Addition to Milestone Payments and Royalties on Product Sales; Alnylam Maintains All Rights in U.S., Europe, and Rest of World –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that they have formed an exclusive alliance to develop and commercialize RNAi therapeutics targeting transthyretin (TTR) for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries. ATTR is a rare, debilitating, hereditary disease that damages the nervous system and heart, resulting in a life expectancy of 5 to 15 years.
“a major scientific breakthrough that happens once every decade or so”
“Our ALN-TTR program holds promise as a breakthrough therapy for the treatment of ATTR, a debilitating orphan disease. As the lead program in our ‘Alnylam 5x15’ product strategy, we also view this program as a key part of building Alnylam for the future,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “In this important collaboration, Genzyme will advance our ALN-TTR program with their proven capabilities in the Japanese and broader Asian market, while we maintain our plans to develop and commercialize this potential breakthrough medicine in the U.S., Europe, and rest of world. In addition, a key part of the value proposition in this alliance for Alnylam is the potential for significant royalty payments on sales of products.”
ATTR is an endemic disease in Japan, with a significant number of patients carrying the V30M TTR mutation which leads to onset of a severe form of ATTR known as familial amyloidotic polyneuropathy (FAP). Together, Alnylam and Genzyme intend to maximize the value of ALN-TTR worldwide by developing the program in FAP and other ATTR indications, such as familial amyloidotic cardiomyopathy (FAC) and senile systemic amyloidosis (SSA). Alnylam’s ALN-TTR program currently includes ALN-TTR02, which is in a Phase II clinical trial, and ALN-TTRsc, a subcutaneously administered RNAi therapeutic in late stage pre-clinical development.
Under the terms of the agreement, Genzyme will make an upfront cash payment of $22.5 million to Alnylam. The agreement also includes development milestone payments and tiered royalties expected to yield an effective rate in the mid-teens to mid-twenties on Genzyme’s sales of ALN-TTR products in their territory. In addition, each party will be responsible for the development and commercialization activities in their respective territories.
“We are encouraged by Alnylam’s progress with their ALN-TTR program and are excited by the potential for this innovative drug candidate to make a difference in the lives of patients with ATTR. The results to date demonstrate impressive clinical activity and support advancement of this promising therapeutic into pivotal studies and toward the market,” said David Meeker, M.D., President and Chief Executive Officer of Genzyme. “As we work to build our pipeline through both internal research and development, and through external collaborations, we look forward to working with Alnylam on this important program.”
Recently, Alnylam presented positive clinical results from its ALN-TTR02 Phase I trial demonstrating robust and unprecedented knockdown of serum TTR protein levels of up to 94%; the overall results were highly significant (p<0.00001 by ANOVA). Suppression of TTR, the disease-causing protein in ATTR, was found to be rapid, dose dependent, durable, and specific after just a single dose. The drug was generally safe and well tolerated in this Phase I study. Alnylam is currently enrolling patients in a Phase II multi-dose study of ALN-TTR02 in ATTR patients and aims to initiate a Phase III pivotal study of ALN-TTR02 by the end of 2013.
About ATTR
Transthyretin (TTR)-mediated amyloidosis (ATTR) is a hereditary, systemic disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier for thyroid hormones and retinol binding proteins. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. ATTR represents a major unmet medical need with significant morbidity and mortality; FAP affects approximately 10,000 people worldwide and FAC affects at least 40,000 people worldwide. FAP patients have a mean life expectancy of five to 15 years from symptom onset, and the only treatment options for early stage disease are liver transplantation and tafamidis (approved in Europe). As a result, there is a significant need for novel therapeutics to treat patients who have inherited mutations in the TTR gene.
About RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-AT3 for the treatment of hemophilia, ALN-PCS for the treatment of severe hypercholesterolemia, ALN-HPN for the treatment of refractory anemia, and ALN-TMP for the treatment of hemoglobinopathies. As part of its “Alnylam 5x15TM” strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in clinical development, including programs in advanced stages, on its own or with a partner by the end of 2015. Alnylam has additional partnered programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection, ALN-VSP for the treatment of liver cancers, and ALN-HTT for the treatment of Huntington’s disease. The company’s leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, Ascletis, Monsanto and Genzyme. In addition, Alnylam and Isis co-founded Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics; Regulus has formed partnerships with GlaxoSmithKline, Sanofi, AstraZeneca and Biogen Idec. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for applications in biologics manufacturing, including recombinant proteins and monoclonal antibodies. Alnylam’s VaxiRNA™ platform applies RNAi technology to improve the manufacturing processes for vaccines; GlaxoSmithKline is a collaborator in this effort. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 100 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and Cell. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information, please visit www.alnylam.com.
Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including without limitation, statements regarding Alnylam’s views with respect to the potential for RNAi therapeutics, including the potential for ALN-TTR02 and ALN-TTRsc, its expectations regarding the receipt upfront, and potential development milestone and royalty payments under the Genzyme agreement, its expectations regarding the market opportunity for ALN-TTR, including in Japan, its expectations with respect to the timing and success of its clinical trials for ALN-TTR02, including the possible initiation of a Phase III pivotal trial, and the expected timing of an IND filing for ALN-TTRsc, and Alnylam’s expectations regarding its “Alnylam 5x15” product strategy, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Genzyme’s ability to successfully advance ALN-TTR02 and/or ALN-TTRsc in Japan and other Asian countries including China, Australia, and India, as well as Alnylam’s ability to develop ALN-TTR02 and/or ALN-TTRsc in the rest of the world, resulting in the potential payment of development milestones and royalties to Alnylam, Alnylam’s ability to successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for these product candidates, which may not support further development of such product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials for such product candidates, obtaining, maintaining and protecting intellectual property, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, and Alnylam’s ability to establish and maintain strategic business alliances, including its collaboration with Genzyme, and new business initiatives, as well as those risks more fully discussed in the “Risk Factors” section of its most recent quarterly report on Form 10-Q on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Contacts
Alnylam Pharmaceuticals, Inc.
Cynthia Clayton, 617-551-8207
Vice President, Investor Relations and
Corporate Communications
or
Spectrum
Amanda Sellers (Media), 202-955-6222 x2597
or
Genzyme
Lori Gorski, 617-768-9344
Director
Corporate Communications
http://www.businesswire.com/news/home/20121022005196/en/Alnylam-Genzyme-Form-Alliance-Develop-Commercialize-RNAi
Tekmira – QuickView
16 November 2012
Investment summary: Litigation pays off
Canada’s Tekmira is well positioned to advance its internal RNAi drug candidates
and enter new partnerships following its eve-of-trial litigation settlement and
licensing deal with US RNAi giant Alnylam. The deal consolidates Tekmira’s
ownership of lipid nanoparticle (LNP) delivery IP and boosts its cash runway to
2015. Tekmira’s shares have surged 30% in the last 10 days in anticipation of and
following the settlement.
Tekmira obtains US$65-75m and regains control of LNP IP
Tekmira filed a suit against Alnylam in March 2011 for misuse of trade secrets for
LNP IP and MC3 lipids. The settlement gives Tekmira US$65m in cash, part of
which represents a buy-down of future potential royalties due from Alnylam, and an
additional US$10m in milestones, expected in 2013. Alnylam also transferred MC3
and LNP-related IP to Tekmira, leaving it with clear ownership of this technology and
the ability to sub-license in future platform-type deals.
Funding clears way for more ambitious drug development
Tekmira should now end the year with C$50m in cash, which puts it in a strong
position to advance its internal RNAi pipeline (now with up to 13 target licences).
TKM-PLK1 (which targets polo-like kinase 1) shows early activity in cancer (one
partial response and one stable disease among 23 subjects in dose escalation) and
a Phase II study is planned in 2013. The US DoD is funding TKM-Ebola (to use 10x
more potent LNPs), with an IND expected in H213.
Royalty stream potential from Alnylam, Talon and others
LNP is the only systemic RNAi delivery technology that has been validated in proofof-
concept trials (eg Alnylam’s ALN-TTR02 and ALN-PCS). Tekmira is expected to
receive royalties from RNAi drugs using its LNP delivery IP and single-digit royalties
from Talon’s Marqibo (liposomal vincristine, approved in relapsing Ph- ALL).
Valuation: 2012 EV of C$25-30m; room for upside
Assuming legal costs of US$15-20m, Tekmira should finish 2012 with C$48-53m in
cash. Given its ownership of LNP IP (out-licensing potential), promising pipeline and
a monetisable Marqibo stream, Tekmira has an attractive valuation and multiple
upside catalysts.
Tekmira is a Canadian biotech company
developing RNAi therapeutics. It holds key
patents for lipid nanoparticle (LNP) RNAi
drug delivery. Internal candidates include
TKM-PLK1 (Phase I, cancer) and TKMEbola.
The LNP IP is used in Alnylam’s
most advanced systemic RNAi candidates
(ALN-PCS, ALN-TTR02, and ALN-VSP).
Bull
Industry-leading LNP RNAi delivery IP.
TKM-PLK1 shows early signs of
efficacy.
Solid cash runway to 2015.
Bear
Early-stage internal candidates.
Litigation history in RNAi.
Long-term safety of LNPs not yet
established.
Analyst
Robin Davison +44 (0)20 3077 5737
healthcare@edisoninvestmentresearch.co.uk
EDISON QUICKVIEWS ARE NORMALLY
ONE-OFF PUBLICATIONS WITH NO
COMMITMENT TO WRITING ANY
FOLLOW UP. QUICKVIEW NOTES USE
CONSENSUS EARNINGS ESTIMATES.
http://www.baystreet.ca/articles/research_reports/edison/TekmiraQV161112.pdf
Tekmira Could Offer Stockholders Huge Rewards
November 15, 2012 | 1 commentby: C.R. Jackson | about: TKMR, includes: ALNY, ARDM.OB, BMY, MRK, TLON.OB Disclosure:
I have no positions in any stocks mentioned, but may initiate a long position in TKMR, ALNY over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)
On November 12, 2012, Tekmira Pharmaceuticals Corporation (TKMR) announced that they had settled litigation with Alnylam Pharmaceuticals, Inc. (ALNY). Tekmira shares rose from 9% to over 18% and ALNY shares rose over 5% on the day after the news. Tekmira also signed a new licensing agreement that restructures the relationship and provides clarity on intellectual property and licensing issues between the companies.
Tekmira, a $70M market cap, Vancouver, Canada-based RNA interference (RNAi) therapeutics development firm will receive $65 million within 10 days and is eligible to receive $10 million in near-term milestone payments expected to be received in 2013.
Tekmira's CEO, Mark J. Murray,Ph.D., was understandably elated.
"With our cash runway now extending into 2015, we are excited about our plans to aggressively advance multiple products into human clinical trials," Murray stated.
Alnyam seemed to be happy too.
"With this restructuring of our Tekmira relationship, we are gaining independence in our LNP manufacturing and decreasing the milestone and royalty burdens on several of our LNP-based products. Further, the companies have created clarity around the overall patent estate for LNP-based products, while ensuring Alnylam's full access to use this technology for our products in the future. Of course, we are also pleased to put this legal matter behind us and continue our focus on advancing RNAi therapeutics through clinical trials with the goal of bringing them to the market where we can make an impact in the lives of patients and their caregivers," said Barry Greene, President and Chief Operating Officer of Alnylam. "Alnylam plans to continue to advance RNAi therapeutic products as part of its 'Alnylam 5x15' product strategy with LNP delivery technologies - as employed with ALN-TTR02, ALN-PCS, and ALN-VSP, in addition to the use of the company's proprietary conjugate-based delivery technology - as employed with ALN-TTRsc, ALN-AT3, and other undisclosed programs."
Tekmira also expects that their lead oncology product, TKM-PLK1, will enter a phase two trial in 2013. The company will also continue to research their TKM-Ebola product in collaboration with the U.S. Department of Defense's Transformational Medical Technologies program, and develop other product candidates within their pipeline. In addition, the company is entitled to future royalty payments based on sales of Marqibo, which was approved by the US Food and Drug Administration (FDA) in August 2012 for adults with a rare form of leukemia known as Philadelphia chromosome negative acute lymphoblastic leukemia.
Marqibo
Marqibo (vinCRIStine sulfate LIPOSOME injection) is a liposomal formulation of the chemotherapy drug vincristine and two other liposomal chemotherapy products, Alocrest and Brakiva, which were licensed from Tekmira to Talon Therapeutics, Inc. (TLON.OB) in 2006. Talon is responsible for all future development of these products. On August 9, 2012, Tekmira disclosed that Talon received accelerated approval from the FDA for Marqibo for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. Tekmira received a $1 million milestone payment based on the FDA approval of Marqibo and is eligible to receive royalty payments based on Marqibo's commercial sales.
Managing illness at its genetic source by silencing genes via RNAi has demonstrated significant potential. In addition to delivery platform research and development, Tekmira is advancing its own RNAi therapeutic candidates.
Tekmira has worldwide licenses to Alnylam's core technology and intellectual property for the discovery, development and commercialization of RNAi products directed to eight RNAi gene targets-including three exclusive and five non-exclusive licenses. Five of the targets, ApoB (high cholesterol), PLK1 (oncology), TKM-Ebola, WEE1 (oncology) and CSN5 (oncology), have already been selected on a non-exclusive basis, and ALDH2 (alcohol dependence) was recently selected as an exclusive target.
TKM-PLK1
Tekmira's lead oncology product candidate is TKM-PLK1. In pre-clinical animal studies, TKM-PK1 was found to selectively kill cancer cells, while sparing normal cells in adjacent healthy tissue. TKM-PLK1 targets PLK1 (polo-like kinase 1). PLK1 is a protein involved in tumor cell proliferation and is a validated oncology target. Research has found that inhibition of PLK1 expression prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell.
Tekmira's pre-clinical studies have demonstrated that a single, systemic intravenous administration of TKM-PLK1 blocked PLK1 expression in liver tumors causing extensive tumor cell death. After repeat dosing, there was a significant inhibition of tumor growth as well as prolonged survival without evidence of the toxicities often associated with oncology drugs. The TKM-PLK1 anti-tumor efficacy results were confirmed to be the result of silencing PLK1 via RNA interference.
In December 2010, Tekmira announced the initiation of patient dosing in a phase one human clinical trial for TKM-PLK1 in patients with advanced solid tumors. The phase one clinical trial, conducted at oncology centers in the United States, is an open label, multi-dose, dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1. Researchers also hope to be able to determine the maximum tolerated dose, measure tumor response and the pharmacodynamic effects of TKM-PLK1 in patients providing biopsies.
TKM-PLK1 has been administered to 23 patients with a total of 128 doses administered. On August 14, 2012, Tekmira released interim results from the TKM-PLK1 phase one study which found that its RNAi compound TKM-PLK1 in patients with advanced solid tumors were showing promising signs of drug activity. The company anticipates initiating a phase two clinical trial in 2013.
Alnylam no longer has "opt-in" rights to TKM-PLK1. Tekmira now holds all development and commercialization rights related to TKM-PLK1.
TKM-Ebola
The Zaire species of Ebola virus (ZEBOV) is associated with periodic outbreaks of hemorrhagic fever in human populations with mortality rates reaching 90%. There are no approved treatments for Ebola or other hemorrhagic fever viruses.
On August 6, 2012, Tekmira announced that it had received a temporary stop-work order from the U.S. Department of Defense (USDOD) with respect to Tekmira's TKM-Ebola program, which is funded under the Transformational Medical Technologies (TMT) program. On October 2, 2012, Tekmira disclosed that the temporary stop-work order was lifted by the USDOD and Tekmira will continue development of the TKM-Ebola product
Tekmira submitted a modification request to the existing contract to the USDOD in order to integrate recent advancements in LNP formulation and manufacturing technology in the TKM-Ebola development program. The program will utilize an LNP formulation that is significantly more potent (over 10 times) than previous formulations and other LNP formulations currently being evaluated in clinical trials. Tekmira has initiated pre-clinical and chemistry, manufacturing and control studies that support the use of these improvements in the program. This development strategy will be accommodated by modifications to the existing contract, allowing both Tekmira and TMT to benefit from the significant advancements in LNP formulation technology made by Tekmira since the commencement of the TMT-funded program in July 2010. Tekmira expects that the LNP formulation work will be completed and submitted to the FDA in the second half of 2013 in order to initiate a new phase one clinical trial.
ALN-VSP
ALN-VSP is being developed by Alynam as a treatment for liver cancers, including hepatocellular carcinoma and other solid tumors with liver involvement. ALN-VSP is the first RNAi therapeutic using Tekmira's SNALP technology to be evaluated in humans. Tekmira is entitled to receive a $5 million milestone payment related to the initiation of clinical trials for ALN-VSP in China, which is expected to occur in 2013.
ALN-TTR02
Tekmira is also entitled to a $5 million payment upon ALN-TTR02 entering a pivotal trial. In July 2012, Alynam reported the results of a phase one clinical trial that found that the administration of ALN-TTR02 resulted in a "robust knockdown" of serum TTR protein levels of up to 94%. Knockdown of TTR, the disease-causing protein in ATTR, was found to be rapid, dose dependent, durable, and specific after just a single dose. ALN-TTR02 was found to be generally safe and well tolerated.
Transthyretin (TTR)-mediated amyloidosis (ATTR) is a hereditary, systemic disease caused by mutations in the TTR gene. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy.
ALN-TTR02 is a systemically delivered RNAi therapeutic being developed for the treatment of ATTR. Transthyretin (TTR)-mediated amyloidosis (ATTR) is a hereditary, systemic disease caused by mutations in the TTR gene. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy.
ALN-PCS
Alnylam is developing ALN-PCS, an RNAi therapeutic for the treatment of hypercholesterolemia, or high levels of cholesterol in the blood. Hypercholesterolemia contributes to many diseases, most notably cardiovascular disease, which is the leading cause of death in the United States.
Alnylam reported results that showed that administration of a single dose of ALN-PCS, in the absence of concomitant lipid-lowering agents such as statins, resulted in statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of low-density lipoprotein cholesterol (LDL-C), or "bad cholesterol," of up to 50%. ALN-PCS was shown to be safe and well tolerated in this study.
On September 26, 2011, Alnylam announced the initiation of a phase one clinical trial for ALN-PCS which triggered a $500,000 milestone payment to Tekmira. Tekmira is eligible to receive royalty payments based on commercial sales of ALN-PCS. Tekmira is eligible to receive royalty payments based on commercial sales of ALN-PCS.
Other LNP-Enabled Products
Tekmira is eligible to receive up to an aggregate of $16 million in milestones and royalties for each additional LNP-based product developed by Alnylam.
Partner-based Programs
In addition to Tekmira's agreements with Alnylam, the company has an agreement with Merck (MRK) whereby Merck has access to certain Tekmira delivery technology for the delivery of small interfering RNAs (siRNAs). Currently, there is no active research program underway with Merck (MRK). However, Tekmira is eligible to receive up to $17 million in milestones and royalties on each and every RNAi product that Merck advances using Tekmira's technology.
In the second quarter of 2010, Tekmira entered into a multi-year, target validation agreement with Bristol-Myers Squibb (BMY). Tekmira will provide LNP formulations of siRNA provided by Bristol-Myers Squibb to silence target genes of interest. Bristol-Myers paid Tekmira $3 million concurrent with the signing of the agreement. Bristol-Myers Squibb will share the target validation data it generates and Tekmira can use this data to develop its own RNAi therapeutic products. In May 2011, Tekmira announced a further expansion of the collaboration to include broader applications of Tekmira's LNP technology and additional target validation work.
In July 2010, Tekmira was awarded up to a $140 million contract with the United States Government's Transformational Medical Technologies (TMT) Program, to advance an RNAi therapeutic, TKM-Ebola, to treat Ebola virus infection. In the initial phase of the contract Tekmira is eligible to receive up to $34.7 million over the next three years. This initial funding is for the development of TKM-Ebola through pre-clinical development, filing of an Investigational New Drug (IND) application with the FDA, and completion of a Phase 1 human safety clinical trial. In February 2012, Tekmira initiated its TKM-Ebola phase one clinical trial.
In August 2011, Tekmira obtained an exclusive worldwide license to Halo-Bio's multivalent ribonucleic acid ((MV-RNA)) technology. Under this collaboration, Tekmira can work together with Halo- Bio to design and develop MV-RNA molecules directed at gene targets of interest to us and to combine MV-RNA molecules with our LNP technology to develop therapeutic products. MV-RNA technology comprises single macromolecules capable of mediating RNAi at multiple unique target sites. MV-RNA can target three sites on a single gene or up to three separate genes simultaneously. Tekmira has already successfully demonstrated multi-gene knockdown using MV-RNA enabled by proprietary LNP formulations.
Talon Therapeutics, Inc. is developing three targeted chemotherapy products under a license agreement with Tekmira. Marqibo, which is a liposomal formulation of the chemotherapy drug vincristine, along with two other liposomal chemotherapy products - Alocrest (liposomal formulation of the chemotherapy drug vinorelbine) and Brakiva (liposomal formulation of the chemotherapy drug topotecan) - were licensed from Tekmira to Talon in 2006. Tekmira is eligible to receive milestone payments as well as royalties on product sales. In September 2011, Talon announced its NDA for Marqibo had been accepted for filing by the FDA. In August 2012, Talon announced that Marqibo (vinCRIStine sulfate LIPOSOME injection) had received accelerated approval from the FDA for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. Talon is responsible for all future development of Marqibo. Tekmira will receive a $1 million milestone payment based on the FDA's approval of Marqibo and will receive royalty payments based on Marqibo's commercial sales.
Tekmira has a licensing agreement with Aradigm (ARDM.OB) under which Aradigm licensed certain liposomal technology for delivery of the antibiotic ciprofloxacin. Tekmira is entitled to receive milestone payments and royalties on product sales for any products advanced by Aradigm that use Tekmira's technology
Finances
For the first nine months of 2012 (year-to-date (YTD) 2012) Tekmira's net loss was $8.5 million ($0.63 per common share) as compared to a net loss of $8.1 million ($0.73 per common share) for YTD 2011. For Q3 2012, net loss was $3.4 million ($0.25 per common share) as compared to a Q3 2011 net loss of $1.5 million ($0.12 per common share).
Revenue was $3 million in Q3 2012 as compared to $4.2 million in Q3 2011.
On July 14, 2010, Tekmira signed a contract with the United States Government to advance an RNAi therapeutic utilizing Tekmira's LNP technology to treat Ebola virus infection. Under the contract Tekmira is being reimbursed for costs incurred, including an allocation of overheads, and is being paid an incentive fee. U.S. Government revenue was $1.9 million in Q3 2012 as compared to $2.0 million in Q3 2011.
In August 2012, the Company announced that it had received a temporary stop-work order from the U.S. Government in respect of its TKM-Ebola contract. On October 2, 2012, Tekmira announced that the stop-work order had been lifted and work was to be resumed. As a result of the stop-work order, U.S. Government revenue was lower than the Company had forecasted for Q3 2012 and YTD 2012.
In Q3 2012, the Company earned a $1 million milestone payment from Talon Therapeutics, Inc. based on the FDA approval of Marqibo and will receive royalty payments based on Marqibo's commercial sales.
Research, development, collaborations and contracts expenses were $3.1 million in Q3 2012 as compared to $4.4 million in Q3 2011.
Third-party expenses on the TKM-Ebola program and Alnylam manufacturing were considerably lower in Q3 2012 as compared to Q3 2011.
Spending on Tekmira's internal research programs was reduced as the Company focused on TKM-Ebola, TKM-PLK1 and its litigation against Alnylam and AlCana.
General and administrative expenses were $1.5 million in Q3 2012 as compared to $1.2 million in Q3 2011. This increase in Q3 2012 largely relates to legal fees incurred in respect of Tekmira's lawsuit against Alnylam and AlCana.
As at September 30, 2012, the Company had a contingent obligation to Orrick, Herrington and Sutcliffe LLP, lead legal counsel for the lawsuit against Alnylam and AlCana of $15,887,877). As a result of the settlement of the litigation between Tekmira and Alnylam plus costs incurred after September 30, 2012, are now payable to Orrick and will be recorded in Q4 2012.
Conclusion: Strong Buy
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNA interference therapeutics (RNAi therapeutics) and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs.
RNAi therapeutics have the potential to treat a broad number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, Stanford University's Andrew Z. Fire and University of Massachusetts' Craig C. Mello, were awarded the 2006 Nobel Prize for Physiology or Medicine "for their discovery of RNA interference - gene silencing by double-stranded RNA," a gene silencing mechanism used by all cells.
RNAi therapeutics, such as "siRNAs," require delivery technology to be effective systemically. Tekmira's LNP technology is probably the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's LNP formulations are manufactured by a proprietary method and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application. Tekmira may be small, but this company has a big lead in RNAi therapeutics that could translate into significant rewards to shareholders who invest at this stage of their promising development.
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TKMR
Echo20
Alnylam Pharmaceuticals' CEO Discusses Restructuring of Relationship with Tekmira (Transcript)
November 16, 2012
Executives
Cynthia Clayton – VP, IR and Corporate Communications
John Maraganore – CEO
Laurence Reid – SVP and Chief Business Officer
Analysts
Alan Carr – Needham & Company
Marko Kozul – Leerink Swann
Mike King – Dawson James Securities
Alnylam Pharmaceuticals Inc. (ALNY) Restructuring of Relationship with Tekmira Conference Call November 13, 2012 8:00 AM ET
Operator
Ladies and gentlemen, thank you for standing by. Welcome to the Alnylam Pharmaceuticals Conference Call. There will be a question-and-answer session to follow. Please be advised that this call is being taped at the company’s request. I would now like to turn the call over to the company. Please proceed.
Cynthia Clayton
Good morning. I’m Cynthia Clayton, Vice President, Investor Relations and Corporate Communications at Alnylam. With me today are John Maraganore, our Chief Executive Officer, and Laurence Reid, our Senior Vice President and Chief Business Officer. Barry Greene, our President and Chief Operating Officer, and Mike Mason, our Vice President of Finance and Treasurer, are participating in an investor conference in New York this morning and are unable to attend to the call.
During today’s call, John will provide some initial context on the restructuring of our relationship with Tekmira, Laurence will review the details of the agreements, then John will come back to review our goals and guidance for the remainder of the year and we will then turn the call over to you for your questions.
Before we begin, I would like to remind you that this call will contain remarks concerning Alnylam’s future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent quarterly report on file with the SEC.
In addition, any forward-looking statements represent our views only as of the date of this recording and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.
I will now turn the call over to John.
John Maraganore
Thanks, Cynthia, and thank you, everyone, for joining us this morning. As I’m sure many of you saw from our press release last night, we have restructured our relationship with Tekmira and resolved all litigation. Laurence will provide you with more specifics in just a moment, but I wanted to start by saying that we believe that we have restructured our Tekmira relationship in a very favorable manner for Alnylam. We also are pleased to put this legal matter behind us. And of course, our focus will continue to be on the execution of our mission of advancing RNAi therapeutics through clinical trials and to the market where we can make an impact in the lives of patients and their caregivers.
Clearly, in recent months, we have made excellent progress in this regard and we aim to continue that as we advance our pipeline of innovative medicines. Indeed, we are committed to advancing RNAi therapeutic products as part of our Alnylam 5x15 product strategy with LNP delivery technologies as employed with ALN-TTR02, ALN-PCS and ALN-VSP, in addition to the use of the company’s proprietary conjugate-based delivery technology which enables subcutaneous dose administration as employed with ALN-TTR subcu, ALN-AT3, among other programs.
I’ll now turn the call over to Laurence and go through specifics on the restructuring. Laurence?
Laurence Reid
Thank you, John. Good morning, everybody. With this restructuring of our Tekmira relationship, we’re gaining independence in our LNP manufacturing and significantly decreasing the milestone and royalty burdens on the LNP-based products in our pipeline. Further, by consolidating certain IP elements, we’re ensuring a stronger overall patent estate for LNP-based products while retaining Alnylam’s full and unfettered access to this technology both alone and with partners for our products in the future.
More specifically, in a new license agreement signed yesterday with Tekmira, we’ve consolidated certain IP elements related to LNP technology. Certain patents and patent applications, including the MC3 lipid family, will be assigned by Alnylam to Tekmira. However, Alnylam retains full rights to use this IP for advancing RNAi therapeutic products to the market, including the right to sublicense those products. Alnylam has also agreed to grant five additional non-exclusive therapeutic licenses to Tekmira and Alnylam intellectual property.
In addition, we’ve elected to buy out our manufacturing obligations to Tekmira with respect to our LNP-based pipeline programs. We will make a one-time payment of $30 million to Tekmira and, in return, we will have the right to manufacture our own LNP-based products going forward, either ourselves or with a third-party contractor. In fact, we’ve established at Alnylam our own GMP capabilities and process for our own LNP-based products and we intend to deploy this capability for the advancement of ALN-TTR02 into Phase III clinical trials. These manufacturing plans have actually been anticipated for the last year, and we continue to expect the start of those Phase III trials by the end of 2013 without any delay.
Also under the agreement, we’ve elected to buy down certain future potential milestone payments at a significant portion of the future royalties on our ALN-TTR02, ALN-PCS and ALN-VSP programs. We will make a one-time payment of $35 million to Tekmira in association with the termination of the prior license agreements, as well as a buydown of future potential milestone payments, and a significant portion of potential royalty payments on these three LNP-based products.
Tekmira will remain eligible to receive up to $10 million in aggregate contingent milestone payments related to advancement of ALN-VSP and ALN-TTR02. It’s worth noting that these milestone payments will become the only potential milestones associated with our ALN-VSP, ALN-PCS and ALN-TTR02 products.
Alnylam will otherwise continue to be obligated to pay Tekmira potential milestones and royalties on other future LNP-based products. And Tekmira will be continued to be obligated to pay Alnylam potential milestones and royalties on certain RNAi therapeutics developed under its licenses from Alnylam and those are on terms that are identical to the original license agreements.
Finally and importantly, all ongoing litigation between Alnylam and Tekmira has been settled, and this allows us to continue to focus our efforts on advancing innovative medicines to patients. We’ve also agreed to a resolution of the interference proceeding related to an Alnylam-owned patent directed to a component in ALN-VSP. In addition, Tekmira and AlCana have agreed to drop their claims and counterclaims in both the Massachusetts and British Columbia lawsuits.
Importantly, the parties have agreed to strong language in the new agreements that makes any future litigation between the parties highly unlikely.
Finally, aside from obligations related to the new license agreement, we will have no relationship with Tekmira in the future.
With that, I’ll turn the call back over to John for a review of our goals and guidance for the remainder of the year and then I’m very happy to take any questions you have related to the specifics of the licensing agreements.
John Maraganore
Thanks, Laurence. And congrats to you, Barry and the rest of our team for getting this done. As Laurence detailed for you, we will incur a $65 million charge to operating expenses during the fourth quarter of 2012 related to the restructuring of license agreements with Tekmira.
As a result of the payments being made in connection with this restructuring, we are revising our financial guidance to end 2012 with greater than $215 million in cash. We believe this continues to represent a very solid balance sheet and we remain very well positioned to execute on our goals, which include advancing ALN-TTR02 through the current Phase II trial with data in mid-2013 and the goal of starting our pivotal study by the end of 2013; filing an IND for ALN-TTR subcu, our first GalNAc-conjugated siRNA to enter clinical studies, by the end of this year with data in 2013; filing an IND for ALN-AT3, another GalNAc-conjugated siRNA that enables subcutaneous dose administration for the treatment of hemophilia, and we expect to file that IND in 2013; partnering our ALN-PCS program as part of the start of Phase II; and advancing our other Alnylam 5x15 programs toward Phase I with partnerships that we aim to form; in addition to forming additional partnerships on programs and technology; and ending the year with over $215 million in cash.
With that, I’d like to turn the call back over to the operator for your questions. Dalou?
Question-and-Answer Session
Operator
Thank you. (Operator Instructions) Thank you. The first question we have comes from the line of Alan Carr. Please go ahead, sir.
John Maraganore
Hi, Alan.
Alan Carr - Needham & Company
Good morning. Thanks for taking my questions.
John Maraganore
Absolutely. Good morning to you too.
Alan Carr - Needham & Company
One that I wanted to get out of the way real quick is so, Laurence, this was just a – you have a straight, basic, non-exclusive access to the Tekmira delivery technology now?
Laurence Reid
In simple terms, Alan, that’s exactly right, that we have non-exclusive access to all of the intellectual property, both that was historically licensed and that has been assigned under the agreement, and we get the right to use that across all targets and across our pipeline.
Alan Carr - Needham & Company
Okay. And then the other two questions that I wanted to ask were, one, you addressed this a little bit, but you’re bringing the manufacturing rights over to you now. Can you all, I guess, go over in a little bit more detail about how ready you are for that for both – it sounds like you’re ready for Phase III, but what’s involved for commercial?
And then the other question is, you mentioned strong language in the agreement regarding avoiding future litigation. I’m wondering if you can go over that too. Thanks.
John Maraganore
Thanks, Alan. Let me deal with the manufacturing question and then Laurence can deal with the question related to the agreement. As it relates to manufacturing, and for over a year now, Alan, in anticipation of our clear objectives to independently manufacture our products in light of Tekmira’s litigation, we have developed internal capabilities that are GMP-compliant for the manufacture of LNP-based products and have developed the proprietary process for the manufacture of those products.
We are deploying that capability currently with manufacture of ALN-TTR02 and we are in line and fully able to provide that material for the start of our Phase III trial which, again, will begin at the end of next year. In the meantime, our current trials are employing material that’s been used that was manufactured historically at Tekmira and, obviously, that’s proceeding quite nicely in the Phase II study. So capabilities exist.
Obviously, our partners at Genzyme are fully aware of those capabilities and, clearly, as part of the diligence they did on our deal, we’re very happy with what we’ve been able to generate with those capabilities. And we’ll be manufacturing not only for Alnylam that capability, but also for Genzyme from that capability. We expect that our manufacturing facility will enable supply of drug through clinical trials and at least through the early stages of commercialization. And obviously, as that continues, we’ll look at other considerations as to how we expand it beyond the early launch.
So that’s on manufacturing. And then, Laurence, do you want to handle the settlement question?
Laurence Reid
Yes, I think the important point – I’m not going to get into a lot of details – the important point is that both parties wanted to be very clear that we wanted to make sure there was no grounds left for future litigation between us, so the agreements are very clear on how we’re dealing with historical IP and know-how that’s been shared between the parties. And then there are specific mechanisms built into the documents that represent mechanisms to resolve future disputes and to ensure avoidance of future litigation and, essentially, to mutually disincentivize each other from going down those paths.
Alan Carr - Needham & Company
Okay. Thanks very much.
John Maraganore
Thanks, Alan.
Operator
Thank you. The next question comes from the line of Marko Kozul. Please go ahead, sir.
Marko Kozul - Leerink Swann
Hi, good morning. And congratulations on putting this behind you and refocusing fully on the pipeline initiatives.
John Maraganore
Great. Thank you, Marko. We agree.
Marko Kozul - Leerink Swann
Get in a quick question here. I see you’re paying down a significant amount of the future royalties and milestones related to the use of the MC3 lipid family. I was wondering if you could give us some sense of any continuing royalty that you might owe, for modeling purposes.
John Maraganore
Yes. Laurence, do you want to handle that?
Laurence Reid
So what we’re saying today is, so the historical terms on the licenses which will continue for LNP-based products other than the three that we talked about, we’ve historically characterized as low single digit. And then as part of the restructuring here and in return for the buydown payment, the royalties on ALN-VSP, ALN-PCS and ALN-TTR02 will then be significantly reduced below those figures. There are still royalties on those products, but they will be reduced from that initial starting level. And that’s as precise as we’re being in our public guidance on that, Marko.
John Maraganore
And, but, Marko, you could expect that with that type of payment related specifically to the buydown of those royalties, that it was a very significant buydown of those royalties.
Marko Kozul - Leerink Swann
Perfect. And I see in the release that it looks like Tekmira may owe you potential milestones and royalties on future candidates. Can you talk a little bit about that as well, please?
Laurence Reid
Correct. And those – this is Laurence here, Marko. Those figures are – they are identical to the figures that have historically existing in the arrangements between us, which we try to leave certain financial pieces of the agreements in place identically other than the buydown that John just articulated. And so, the royalties and milestones that Tekmira owes Alnylam are unchanged from the previous agreements.
Marko Kozul - Leerink Swann
Okay, great. And just one last housekeeping. The $10 million that you may still owe Tekmira, how is that split between VSP and TTR? Thanks.
John Maraganore
Laurence?
Laurence Reid
It’s split equally between those two products, and it’s two milestones – sorry, it’s one milestone on each product, both of which are associated with the future clinical development of those products.
Marko Kozul - Leerink Swann
Great. Thanks for taking the questions and congrats again. Thanks.
John Maraganore
Thanks, Marko.
Operator
Thank you. (Operator Instructions) And our next question comes from the line of Mike King. Please go ahead, sir.
Mike King - Dawson James Securities
Good morning, guys, and...
John Maraganore
Hey, Mike.
Mike King - Dawson James Securities
Hey, good morning, John. Congrats as well on getting this behind you. A couple of questions. First, on manufacturing, just to follow up on the previous questions, I wanted to know, I’ve never seen a pilot plant or anything at Alnylam; is this outsourced to a contractor? And what kind of flexibility do you have to kind of turn the spigot on and off should you want to either up or down titrate the amount of LNPs you need?
John Maraganore
Yes. So, Mike, next time you’re in town, we can show you the pilot plant. It’s not in the building. It’s in a different building where we have a lease sort of in the (inaudible) area around Cambridge. And it’s a capability that we’ve built up over the last year and is now fully engaged in the manufacture of LNPs. So, that is something which we’d be happy to see in the future.
And it is a capability that, again, we’re quite pleased with and will be important going forward. But it’s obviously one that gives us flexibility across the entirety of our pipeline, both for TTR02, but also for other LNP-bearing products, and it’s a capability that also, over time, we might expand to include the synthesis of our GalNAc-siRNAs which we’re currently doing with third-party manufacturers alone.
Mike King - Dawson James Securities
Okay. Yes, you anticipated my next question, so that’s great. And then should we expect any significant CapEx that might accompany the necessity to ramp that facility in the future or...?
John Maraganore
It’s already been spent, Mike.
Mike King - Dawson James Securities
Okay. Great.
John Maraganore
That’s already in the numbers that you’ve seen, and it was part of our important investment this year for sure.
Mike King - Dawson James Securities
Okay. And just as one final question with regard to – GalNAc is not covered under this in any circumstances, correct?
John Maraganore
No, no. Not at all. Not at all. GalNAc-siRNAs are completely proprietary to Alnylam, no third parties whatsoever.
Mike King - Dawson James Securities
Okay, great. Thanks, guys.
Operator
Thank you. Sir, we have no further question in the queue. So now I’ll turn the call back to Alnylam for closing remarks. Thank you.
John Maraganore
Right. Well, thanks, everyone. We’re delighted to put this matter behind us. And we are focusing on our continued advancement of RNAi therapeutics to patients. Thanks very much and have a great rest of day. Bye-bye.
Operator
Thank you, ladies and gentlemen, for your participation in today’s conference call. You may now disconnect. Have a great day. Thank you.
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http://seekingalpha.com/article/1012911-alnylam-pharmaceuticals-ceo-discusses-restructuring-of-relationship-with-tekmira-transcript?part=single
dougwur
OK,
Echo20
Echo, thanks for the head's up on this in your PM. Looks promising.
Will do some more DD and probably go with a starter position.
THANKS AGAIN. Doug
nanopatent,
TKMR is also close to Bristol Meyers and Merck.
Echo20
I expect deals with Genentech-Roche and all the rest of the biggies soon. Where will Tekmira go? Much higher.
Ref:
nanopatent,
When the court case started TKMR was around $7.00 a share.
Then the TKMR stock price fell to $3.50 after the court case was initiated. 50% drop due to the court case.
Now the litigations are over and TKMR could go up 100% just due to the court case being over.
TIme will tell.
All CLEAR on the LITIGATIONS.
Echo20
Alnylam stock rises on $65M Tekmira settlement
By Don Seiffert
Tuesday, November 13, 2012
Stock value at Alnylam Pharmaceuticals Inc. (Nasdaq: ALNY) rose more than 5 percent Tuesday after the news that the company paid $65 million to settle an ongoing lawsuit and agree to a new licensing deal with Canadian partner, Tekmira Pharmaceuticals Corp.
The new agreement involves a lawsuit that began in March 2011, in which Tekmira alleged “misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising” with regard to a 2009 agreement between the two companies to research lipid nanoparticle (LNP) technology, a delivery system for the so-called “gene silencing” therapies (known as RNAi) which both companies are developing.
Cambridge-based Alnylam said it will now independently manufacture its LNP-based RNAi therapeutic products, and will buy down certain potential milestone payments and a significant portion of future potential royalties for its ALN-VSP, ALN-PCS, and ALN-TTR02 programs.
As part of the new agreement, Alnylam said it will make $65 million in one-time payments to Tekmira, including $30 million for the rights to manufacture its own LNP-based products, which it plans to use to advance ALN-TTR02 into Phase 3 clinical trials by the end of 2013. Alnylam is also paying $35 million to buy-down certain future potential milestone and royalty payments for its ALN-VSP, ALN-PCS, and ALN-TTR02 LNP-based products. Tekmira may also get another $10 million in milestone payments. Alnylam will continue to pay Tekmira milestones and royalties on all other future LNP-based products, while Tekmira will pay Alnylam milestones and royalties on certain RNAi therapeutic products, under the terms of its original license agreement.
Alnylam lowered its financial guidance for the year in light of the $65 million payments, saying it now expects to end 2012 with more than $215 million in cash. Just last week in its third quarter report, the company had raised its estimate to $280 million from $250 million.
“With this restructuring of our Tekmira relationship, we are gaining independence in our LNP manufacturing and decreasing the milestone and royalty burdens on several of our LNP-based products,” said Barry Greene, president and COO of Alnylam in a statement. “Further, the companies have created clarity around the overall patent estate for LNP-based products, while ensuring Alnylam’s full access to use this technology for our products in the future.”
For its part, Mark J. Murray, Tekmira’s President and CEO, also claimed the settlement as a victory, saying in a statement that “today’s announcement provides assurances for our stakeholders that we accomplished what we set out to do when we initiated this litigation. We now have clarity around the intellectual property that protects our lipid nanoparticle (LNP) technology and a cash payment that will enable us to continue the execution of our business plan into 2015.”
Alnylam stock rose to $17 as of 2 p.m. Tuesday.
http://www.masshightech.com/stories/2012/11/12/daily19-Alnylam-stock-rises-on-65M-Tekmira-settlement.html
--$35-- Love that much more than --$12--!
New $35 target from this analyst ......
http://finance.yahoo.com/news/tiny-tekmira-lands-65m-settlement-124603532.html
7:49AM Tekmira Pharma announced a $65 mln settlement plus $10 mln in near-term milestone payments from Alnylam (ALNY) (TKMR) 5.12 : TKMR will receive $65 million within 10 days and is eligible to receive $10 million in near-term milestone payments expected to be received in 2013. For the speculators who were betting on a positive outcome for the pending trial, the impact should be understandibly positive.
2:33AM Alnylam Pharma and Tekmira (TKMR) restructure relationship and settle all litigation (ALNY) 16.12 : Alnylam Pharmaceuticals (ALNY) announce that they and Tekmira Pharmaceuticals (TKMR) have restructured their relationship with a new licensing agreement and have resolved all litigation between the parties in a settlement agreement. The new license agreement consolidates and clarifies certain intellectual property elements related to lipid nanoparticle technology for RNAi therapeutics. Further, Alnylam has elected to independently manufacture its LNP-based RNAi therapeutic products and to buy-down certain future potential milestone payments and a significant portion of future potential royalties for its ALN-VSP, ALN-PCS, and ALN-TTR02 programs. The settlement of all ongoing litigation between the two companies allows Alnylam to continue to focus its efforts on advancing innovative medicines to patients. In addition, Alnylam has elected to buy out its manufacturing obligations to Tekmira with respect to its LNP-based pipeline programs. Alnylam will make a one-time payment of $30 million to Tekmira in order to have the rights to manufacture its own LNP-based products going forward. Further, Alnylam has elected to buy-down certain future potential milestone and royalty payments due to Tekmira for its ALN-VSP, ALN-PCS, and ALN-TTR02 LNP-based products. Specifically, Alnylam will make a one-time payment of $35 mln to Tekmira in association with the termination of the prior license agreements between the companies and the significant reduction in milestone and royalty payments for its ALN-VSP, ALN-PCS, and ALN-TTR02 products. Tekmira will also be eligible to receive an additional $10 mln in aggregate in contingent milestone payments related to advancement of ALN-VSP and ALN-TTR02 products, which now represent the only potential milestones for ALN-VSP, ALN-PCS and ALN-TTR02 products.
LOL- thanks- I actually decided to sell pre-market- ya know, a bird in the hand....................thanks WILD :)
+$3 at the open = $8.
Or wait 6 months.
Do you have any idea where this stock should now be valued with the agreement? Thanks :) WILD
Tekmira Pharmaceuticals Corporation
Tekmira and Alnylam Restructure Relationship and Settle All Litigation
VANCOUVER, British Columbia, Nov. 12, 2012 (GLOBE NEWSWIRE) -- Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM) today announced that it has entered into a settlement agreement with Alnylam Pharmaceuticals, Inc. that resolves all litigation between the companies, and has signed a new licensing agreement that restructures the relationship and provides clarity on all intellectual property and licensing issues between the companies. As a result of the restructuring and new agreements, Tekmira will receive $65 million within 10 days and is eligible to receive $10 million in near-term milestone payments expected to be received in 2013.
"Today's announcement provides assurances for our stakeholders that we accomplished what we set out to do when we initiated this litigation. We now have clarity around the intellectual property that protects our lipid nanoparticle (LNP) technology and a cash payment that will enable us to continue the execution of our business plan into 2015," said Dr. Mark J. Murray, Tekmira's President and CEO.
"Tekmira is entering an exciting new era of growth and development. Clarity of rights and ownership around our LNP intellectual property — the leading technology for the systemic delivery of RNAi therapeutics — combined with a strong balance sheet should strengthen our ability to invest in, advance and expand our own product pipeline. We also look forward to establishing new business relationships with pharmaceutical partners driven by intellectual property certainty and recent promising clinical data validating the therapeutic utility of LNP-enabled products," added Dr. Murray.
As part of this settlement and restructuring, all previous agreements between the companies are terminated and a new license agreement has been established that provides clear terms outlining Tekmira's LNP intellectual property. Under the terms of the new license agreement:
Alnylam will transfer all agreed-upon patents and patent applications related to LNP technology for the systemic delivery of RNAi therapeutic products, including the MC3 lipid family, to Tekmira, who will own and control prosecution of this intellectual property portfolio. Tekmira is the only company able to sublicense LNP intellectual property in future platform-type relationships.
Tekmira will receive a total of $65 million in cash payments within 10 days. This includes $30 million associated with the termination of the manufacturing agreement and $35 million associated with the termination of the previous license agreements, as well as a modification of the milestone and royalty schedules associated with Alnylam's ALN-VSP, ALN-PCS, and ALN-TTR02 programs.
Tekmira is also eligible to receive an additional $10 million in near-term milestones, comprised of a $5 million payment upon ALN-TTR02 entering a pivotal trial and a $5 million payment related to initiation of clinical trials for ALN-VSP in China. Both near-term milestones are expected to occur in 2013.
Alnylam no longer has "opt-in" rights to Tekmira's lead oncology product, TKM-PLK1; Tekmira now holds all development and commercialization rights related TKM-PLK1, which is expected to enter Phase 2 clinical trials in 2013.
In addition to its eight existing InterfeRx licenses, Tekmira will receive five additional non-exclusive licenses to develop and commercialize RNAi therapeutics based on Alnylam's siRNA payload technology. Tekmira will pay Alnylam milestones and royalties for these products.
Alnylam has a license to use Tekmira's intellectual property to develop and commercialize products, including ALN-TTR02, ALN-VSP, ALN-PCS, and other LNP-enabled products. Alnylam has rights to sublicense Tekmira's LNP technology if it is part of a product sublicense. Tekmira remains eligible for milestone and royalty payments as Alnylam's LNP-enabled products are developed and commercialized.
Alnylam and Tekmira have agreed to settle all ongoing litigation between the parties. The parties have also agreed to a resolution of the interference proceeding related to Alnylam-owned US Patent No. 7,718,629 directed to an siRNA component in ALN-VSP. Finally, the parties have agreed to a covenant not to sue on matters related to the current dispute in the future, which includes liquidated damages to be paid if the covenant is breached, and have also agreed to resolve any future disputes that might arise over the next three years with binding arbitration.
Tekmira and AlCana Technologies, Inc. have also agreed to settle all ongoing litigation between the parties. Tekmira expects to enter into a cross license agreement with AlCana which will include milestone and royalty payments, and AlCana has agreed not to compete in the RNAi field for five years.
About RNAi and Tekmira's LNP Technology
RNAi therapeutics have the potential to treat a broad number of human diseases by "silencing" disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as "siRNAs," require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira's LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira's LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira's LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Alnylam RNAi Technology
Tekmira has licenses to Alnylam RNAi intellectual property for certain siRNA programs.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
The Tekmira Pharmaceuticals logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8319
Forward-Looking Statements and Information
This news release contains "forward-looking statements" or "forward-looking information" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Forward-looking statements are generally identifiable by use of the words "believes," "may," "plans," "will," "anticipates," "intends," "budgets," "could," "estimates," "expects," "forecasts," "projects" and similar expressions, and the negative of such expressions. Forward-looking statements in this news release include statements about the settlement to resolve all litigation between Tekmira and Alnylam Pharmaceuticals, Inc. and AlCana Technologies, Inc., including the patent infringement lawsuit; statements about the quantum and timing of Tekmira's expected payments related to the settlement agreement and new licensing agreement with Alnylam; statements about Tekmira's expected payments funding the continued execution of its business plan into 2015; Tekmira's ability to invest in, advance and expand its product pipeline; the establishment of new business relationships with pharmaceutical partners; clinical data validating the therapeutic utility of LNP-enabled products; expected timing of Phase 2 clinical trials for TKM-PLK1; milestones and royalty payments from Alnylam's LNP-enabled products; the additional five non-exclusive InterfeRx licenses; future disputes and mechanisms for resolution of disputes with Alnylam; Tekmira's expectations of entering into a cross license agreement with AlCana, which includes anticipated milestone and royalty payments and an expected agreement for AlCana not to compete in the RNAi field for five years; and Tekmira's strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs; the future royalty payments expected from the ALN-TTR, ALN-VSP, ALN-PCS and other LNP-enabled product development programs of Alnylam; and Tekmira's expectations with respect to existing and future agreements with third parties.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP's status as a leading RNAi delivery technology; the timing and results of clinical data releases and use of LNP technology by Tekmira's development partners and licensees; the time required to complete research and product development activities; the timing and quantum of payments to be received under contracts with Tekmira's partners including Alnylam and others; the timing of receipt of an immediate payment of $65 million and $10 million in additional milestone payments from Alnylam expected in 2013; Tekmira's receipt of five additional non-exclusive InterfeRx licenses; Tekmira's financial position and its ability to execute on its business strategy; and Tekmira's ability to protect its intellectual property rights and not to infringe on the intellectual property rights of others. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: expected payments related to the licensing agreement between Tekmira and Alnylam may not be received in the quantum and on the timing currently anticipated, or at all; payments received from the settlement may not be sufficient to fund Tekmira's continued business plan as currently anticipated; Tekmira may never invest in, advance or expand its product pipeline; Tekmira may not be able to establish new business relationships with pharmaceutical partners; LNP-enabled products may have no therapeutic utility; TKM-PLK1 may never enter into Phase 2 clinical trials; Tekmira may never receive milestones or royalty payments from Alnylam; Tekmira may not receive any additional non-exclusive InterfeRx licenses; the possibility that Tekmira does not enter into a cross license agreement with AlCana on the terms currently anticipated, or all; the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; difficulties or delays in the progress, timing and results of clinical trials; future operating results are uncertain and likely to fluctuate; economic and capital market conditions; Tekmira's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmira's research and development capabilities and resources will not meet current or expected demand; Tekmira's development partners and licensees conducting clinical trial, development programs and joint venture strategic alliances will not result in expected results on a timely basis, or at all; anticipated payments under contracts with Tekmira's collaborative partners may not be received by Tekmira on a timely basis, or at all, or in the quantum expected by Tekmira; Tekmira's products may not prove to be effective in the treatment of cancer and infectious disease; and the possibility that Tekmira has not sufficiently budgeted for expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira's annual report on Form 20-F for the year ended December 31, 2011 (Annual Report), which is available at www.sedar.com or at www.sec.gov/edgar.shtml. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
CONTACT: TEKMIRA
Investors
Jodi Regts
Director, Investor Relations
Phone: 604-419-3234
Email: jregts@tekmirapharm.com
Media
David Ryan
Longview Communications Inc.
Phone: 416-649-8007
Email: dryan@longviewcomms.ca
Sent to Dr Murray of TKMR:
_______________________________________________________________
Dr Murray
Tekmira Pharmaceutical
11-11-2012
Court Case in Boston
on November 14th, 2012
Sirs,
There is potential that Massachusetts will tend to side with Massachusetts companies in court cases.
Analym might try to get state sympathy even if they have to throw themselves on the mercy of the state of Massachusetts and even admit to any charges.
The governor could already have limits on the fines in the case that Analym has to pay.
In the Kodak VS Polaroid case Polaroid (who won) was in Massachusetts.
In the Astra Zenica case against Pharmacea there was and is an Astra Zenica location in Westboro, Massachusetts. I am pretty sure Astra Zenica won but the results are missing as UpJon bought Pharmacea in the middle of that case.
The state of Massachusetts could have many added people to influence that case on Wednesday.
FYI.
Confidential,
Echo20
Nanopatent
I just remembered that on the case of Astra Zenica VS Pharmacea tht the Westboro Massachusetts Division of Astra Zenica looked like it was going to win hands down against Pharmacea.
UpJon bought Pharmacea and the results have not been found.
Massachusetts could back Massachusetts Companies in court.
This could be tougher than it looks going in.
Money is not easily won at this time.
Echo20
Anybody in charge but the present crew will be an improvement at Alnylam - no matter if it is Sanofi or Novartis or ANYBODY else!
nanopatent
I also want a good verdict in favor of TKMR.
There could be though a lot of state sympathy towards ALNY as that is a state company in Massachusetts and the state could back their own companies.Polaroid was in Massachusetts and they won a large verdict.
Even the governor does not want ALNY to get too high of a fine.
ALNY is worth over one billion dollars.
They have an orphan designation on one drug and that can be worth hundreds of millions of dollars.
They are working with Sanofil and they could buy both companies if they wanted to.
To them it might be cheaper to buy TKMR than to have ALNY pay huge fines.
I do not see ALNY going bankrupt over this case.They could and then get bought by Sanofil.
A very interesting week.
Waited for a very long time.
Echo20
I trust that the jury will pull for the little guy, as they usually do, and teach ALNY a very valuable and expensive lesson.
'lspade101'
The trial is to start on November 14th. That is all I know.
The case in Massachusetts is to go first before the case in British Columbia.
Echo20
......thank you Echo20 and will catch up on the story over the weekend.I have a moderate position here and need to get on top of things once again
wsgalvanize
Just read the PRs on TKMR, they tell the whole story.
Noe the court case is up on November 14th.
TKMR went down fifty percent when the court case started. So it could go up to around $7.00 just by the court case ending.
With a good win on the 14th TKMR could move up considerably.
The EBOLA PHASE ONE clinical trials are around eight months into progress and that could pass any time now. Many companies and formulas are picked up after successfully passing Phase One Clinical Trials.
Talon Pharmaceutical has recently gotten and FDA approval for its medicine and they are associated with TKMR!
This is a good time for TKMR.
Echo20
...........do you have a price target for TKMR.I've been holding this for years and lost track of the story from time to time.No excuse just lost interest in things after my wife's passing a few yrs back.Any help here would be appreciated........
A Break-Out For Tekmira Ahead of Next Week's Trial Against Alnylam Pharmaceuticals?
2 hours 26 minutes ago - Thomson Reuters One
By M.E. Garza
Despite a dismal Wednesday which saw the Dow close down 313 points, shares of Tekmira Pharmaceuticals (Nasdaq: TKMR) (TSX: TKM) closed up +5.61% and continued higher after hours to $4.50 on three times the average daily volume.
______________________________________________________________
Looking much better.
Echo20
News is building up somewhere.
Could that be the court case?
Phase One Ebola passing?
An Orphan designation?
Success at Talon Pharmaceutical?
Buyers?
Echo20
Watching this one. Some pretty big swings.
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http://www.tekmirapharm.com/Home.asp
http://finance.yahoo.com/q/ks?s=TKMR+Key+Statistics
Tekmira Pharmaceuticals Corp., a biopharmaceutical company, focuses on advancing ribonucleic acid (RNA) interference therapeutics and providing its lipid nanoparticle delivery technology to pharmaceutical partners. Its lead internal product candidates include apolipoprotein B (ApoB) stable nucleic acid lipid particles (SNALP) for the treatment of high cholesterol and polo-like kinase 1 (PLK1) SNALP for the treatment of cancer. The company has various collaborative and licensing agreements with Alnylam Pharmaceuticals, Inc.; Roche; Bristol-Myers Squibb Company; Hana Biosciences, Inc.; Merck & Co., Inc.; and Aradigm Corporation. Tekmira Pharmaceuticals Corp. was formerly a subsidiary of Primary Corp. Tekmira Pharmaceuticals Corp. is headquartered in Burnaby, Canada.
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