Showing posts with label BioLineRx. Show all posts
Showing posts with label BioLineRx. Show all posts
Monday, August 20, 2012
Seeking Alpha: Is The Hep C Drug Pipeline Beginning To Crack?
Posted on 8/19/12 on Seeking Alpha.com. Commentary by Tiran Rothman from Bioassociate Consulting on the current state of affairs in HCV drug development. His feeling is that the troubles with the NS5A inhibitors may give formerly dark horse companies developing drugs with differing approaches to tackle the virus (mentioned are BioLineRx with it's BL-8020 entry inhibitor and Transgene's TG4040 therapeutic vaccine) a chance to shine.
Is The Hep C Drug Pipeline Beginning To Crack?
By Tiran Rothman
Another crack appeared today in the ultra-hype of next generation Hep C drugs. Idenix Pharmaceuticals (IDIX) released news that its Phase IIb trial with IDX184 was put on partial clinical hold by the FDA due to the recent cardiovascular toxicity experienced by a patient treated with a similar treatment developed by Bristol-Myers Squibb (BMY). Idenix's investors were quick to pull the trigger, sending the stock for a 40% nosedive.
Both Idenix's IDX184 and BMS's 094 are NS5 family inhibitors, which are the front line of Hep C drug candidates, destined to be part of an oral therapy regimen that will make the current use of interferon injections redundant. Even though there has been no evidence of cardiotoxicity in patients treated with IDX184, the FDA has expressed a concern regarding potential safety problems of the drug.
Gilead (GILD), the current leader in the next-gen Hep C drugs, is planning a Phase III study with a combination therapy of its NS5A and NS5B inhibitors. The FDA's recent caution regarding NS5 inhibitors might also affect Gilead's sprint toward the finish line. Novartis (NVS), which has recently joined the Hep C crowded waters with the $440m Enanta Pharmaceuticals deal, might also suffer from this new NS5-related safety issues.
About 180 million people worldwide are chronically infected with HCV. The global Hepatitis market was estimated at $6 billion in 2011 and is forecasted to grow to $20 billion until the end of the decade. The combination of this huge and growing market and insufficient efficacy of the current treatments has generated an immense interest among drug developers and quite a few deals.
The recent holdups in the NS5-related treatments suggest that the Hep C pipeline might need some variations. Several companies are developing alternative, non-NS5 inhibitor-related, Hep C treatments. Examples for such technologies are Transgene's (TRGNF.PK) TG4040 - a therapeutic Hep C vaccine based on a virus carrying and expressing three of the major Hepatitis C virus's non-structural proteins (NS3, NS4 and NS5B). TG4040 is currently in a phase II trial.
A different approach is taken by BioLineRx (BLRX) that develops BL-8020, an orally available treatment with a unique mechanism of action - inhibition of Hepatitis C virus-induced autophagy. In other words, BL-8020 acts on the host cell rather than the virus itself, thus greatly differentiating it from current and pipeline Hep C drugs. Preclinical studies have shown a synergistic effect of BL-8020, when combined with other anti-Hep C agents, which is likely to increase these agents' potency and reduce any adverse effects by enabling utilization of lower dosages.
With the current setbacks seen among Hep C pipeline frontrunners, additional rounds of licensing and acquisition deals in this area are expected, and companies that develop new and different approaches for Hep C treatment may greatly benefit from others' failures and should be closely watched by investors that follow this therapeutic field.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Wednesday, February 29, 2012
The Motley Fool comments on "The Hepatitis C Bubble"...
Posted 2/29/12 on The Motley Fool.com. Brian Orelli, PhD comments on investor 'irrational exuberance' within HCV drug developer stocks and urges caution. Having been in the pharma and biopharma industry since '93, I'm in Orelli's camp in erring on the side of fiscally conservative. The major of preclinical drugs - and even drugs in phase II development - never make it to market. That's never more been the case than in Hepatitis C drug development. The 'Phase II graveyard' of compounds that will never see the light of day is huge by any standard.
3 Signs of a Hepatitis C Bubble
By BRIAN ORELLI, PHD, THE MOTLEY FOOL
Posted 9:37PM 02/29/12 Investing
0 CommentsText Size A A A
Gilead Sciences' (NAS: GILD) purchase of Pharmasset and Bristol-Myers Squibb's takeout of Inhibitex threw gasoline on a fire that was already raging.
But higher values in and of themselves don't necessarily mean the indication is in a bubble that's sure to pop. You have to dig a little deeper. Here are three signs the enthusiasm might be getting a little extreme.
Preclinical fever
BioCryst Pharmaceuticals (NAS: BCRX) rose 12% in one day earlier this month after announcing data on its hep C drug, BCX5191. That's not weird -- drugmakers are supposed to go up when they release positive data.
But BCX5191 hasn't even made it into the clinic yet.
Early-stage success does tend to be a better predictor of approvability for hepatitis C drugs than it is for drugs treating other indications, but I'd be very cautious reading too much into the results, especially considering how many drugs are already in the clinic.
Acquisition exuberance
BioLineRx shares more than doubled at one point last month on 675 times the volume the day before apparently because the company licensed a hepatitis C drug BL-8020 from a privately held French biotech, Genoscience.
Did it get such a good deal that the company was instantly worth twice as much? Who knows? The terms of the deal weren't disclosed. It couldn't have been worth that much, though, considering BL-8020 hasn't made it to the clinic either. Then again, see above.
My guess is that investors jumped into BioLineRx because they think having a hepatitis C drug makes the biotech a takeout target. And considering the premiums we've seen thus far, the rewards could be plentiful if they continue.
Trading in tandem
Speaking of acquisition, Idenix Pharmaceuticals (NAS: IDIX) and Achillion Pharmaceuticals (NAS: ACHN) have been long-rumored acquisition targets, especially as Pharmasset and Inhibitex were taken out.
The drugmakers have traded virtually in tandem as investors have treated them identically, expecting both to be the next M&A victor.
But it's not like they have the same pipelines. There's no reason to think they have the same risk-reward profile. Losing perspective of the underlying asset is a sure sign of a bubble.
But will it pop?
There's no doubt there's a bubble: Valuations on hepatitis c drugs are much higher than any other drug. I'm unaware of any biotech without a drug on the market that has a valuation above $11 billion, the price that Gilead paid for Pharmasset.
But whether the bubble will pop is harder to know. I tend to think that investors and companies snapping up the assets will eventually come to the realization that the rewards at these insane levels don't justify the risks.
But it doesn't have to go down like that, I guess. There are a lot of patients infected with the virus who may not be identified and still more who know they're infected and choose to wait for the next generation of medications. And the cost of not ridding the patients of the virus is fairly high - hepatitis C is a leading cause of liver transplants -- so hep C drugmakers can justify fairly high prices.
The drugs could succeed in the clinic and patients could be identified, resulting in billions of dollars in sales and a justification of the high prices.
But even in that rosy picture, not every drug is going to work. And even if it's approved, there's no guarantee it'll actually get prescribed over the rivals. Just look at the competition between Vertex Pharmaceuticals (NAS: VRTX) and Merck, whose drugs launched at nearly the same time, but Incivek has sales five times higher than Victrelis.
Even if the entire hep C drug space doesn't pop, someone is going to be left holding the bag. Be careful out there.
Tuesday, February 7, 2012
BioLineRx in-licenses BL-8030, second generation HCV protease inhibitor...
Posted on 2/6/12 on Marketwatch.com. Jerusalem-based BioLineRx in-licenses HCV NS3 protease inhibitor BL-8030 from Genoscience and Georgia-based RFS Pharma to complement their recently in-licensed BL-8020. Both compounds have different and hopefully synergistic mechanisms of action. No hint on efficacy for BL-8030, but the press release touts a unique resistance profile, reduced toxicity and less potential for DDIs compared to the first gen PIs, Boceprevir and Telaprevir.
BioLineRx In-Licenses Second Oral Hepatitis C Treatment
Worldwide, exclusive deal signed with Genoscience and RFS Pharma for development and commercialization of BL-8030
JERUSALEM, Feb 06, 2012 (BUSINESS WIRE) -- --Advantages of BL-8030 include high specificity, improved resistance profile, reduced toxicity and potentially reduced drug-drug interactions
BioLineRx, a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C. The agreement includes upfront license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx's standard in-license agreements.
BL-8030 is a potent and selective second generation NS3 protease inhibitor. The NS3 protease is essential for the replication of the Hepatitis C virus (HCV) and is an important target for HCV therapies. BL-8030 has been shown to have excellent antiviral activity against various HCV genotypes. Pre-clinical studies have demonstrated an improved resistance profile against common protease inhibitor mutants, resulting in a lower probability that the virus will develop resistance to treatment. In addition, BL-8030 has demonstrated a good toxicity profile in pre-clinical studies, exhibiting specificity only to the viral protease and lack of activity against a relevant panel of human proteases as well as a clean profile versus human liver enzymes, which is expected to lead to less drug-drug interactions.
BL-8030 was invented by Professor Philippe Halfon and his team at Genoscience and co-developed with assistance from scientists at RFS Pharma, LLC. Prof. Halfon, Co-Founder and President of Genoscience, is a specialist in molecular virology and infectious diseases, especially HIV, HPV (Human Papilloma Virus) and Hepatitis. In addition he is the founder of several biotechnology companies focusing on antiviral drug discovery and development including ACTgene, Alphabio and Genoscience. RFS Pharma was founded by Professor Raymond F. Schinazi; he currently serves as the Frances Winship Walters Professor of Pediatrics at Emory University. He is also a founder of Pharmasset, Idenix, Triangle and ActivBiotics Pharma.
Prof. Philippe Halfon said, "We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them on a second HCV project. There is clearly a huge unmet medical need in finding a safe and effective treatment for HCV, and based on pre-clinical results, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to become an important addition to HCV combination therapies and bring remedy to millions suffering from this devastating disease."
"We worked closely with the group at Genoscience to determine the optimum characteristic that led to the discovery of BL-8030 and related protease inhibitors," said Dr. Steven J. Coats, Senior Director of Chemistry at RFS Pharma.
"We are privileged and fortunate to partner with two world class groups in the development of viral therapeutics," said Dr. Kinneret Savitsky, CEO of BioLineRx. "Two years ago, we took a strategic decision to enter the dynamic and rapidly growing field of Hepatitis C. Since that time, we have evaluated numerous projects in the field. A year ago, we identified and decided to focus on the in-licensing of the two most promising candidates: BL-8020, which we've recently licensed, and now BL-8030. We will do our utmost to develop these promising drugs as swiftly as possible for the benefit of Hepatitis C infected individuals around the world."
About Hepatitis C
Hepatitis C is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According to the World Health Organization (WHO), up to 170 million people worldwide are chronically infected with HCV. In addition, HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The Hepatitis C market is growing rapidly and is forecasted to reach $16 billion in 2015 in the seven major markets (US, France, Germany, Italy, Spain, UK and Japan).
About BioLineRx
BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx's current portfolio consists of five clinical stage candidates: BL-1020 for schizophrenia has commenced a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark registration trial and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development and BL-7040 for treating Inflammatory Bowel Disease (IBD) has completed Phase I. In addition, BioLineRx has 13 products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases.
BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization.
For more information on BioLineRx, please visit www.biolinerx.com .
About Genoscience
Genoscience, a biopharmaceutical company located in Marseille, France, is focused on the development of new drugs for the treatment of viral diseases as HCV. Genoscience's innovative technology platform, which combines internal expertise in resistance with unique molecular modeling through its proprietary software (GenMol(TM)), allows for the development of highly targeted molecules, taking into account the phenomenon of resistance. For further information about Genoscience, please refer to http://www.genosciencepharma.com .
About RFS Pharma, LLC
RFS Pharma, LLC was founded in September 2004 and is located in a 26,500 sq. ft. state-of-the-art research facility in Tucker, Georgia. RFS Pharma is a privately owned biotech company committed to the discovery and development of antiviral agents and other human therapeutics. The company capitalizes on its expertise in nucleoside chemistry to develop drugs to combat infections caused by drug-resistant HIV and hepatitis viruses. RFS Pharma's lead product candidate is amdoxovir, which is in advanced Phase 2 clinical studies for the treatment of HIV-1 infections. In addition, the company has identified promising, early stage compounds for hepatitis infections, analogs that are effective against noroviruses, and has a proprietary novel nucleoside prodrug technology. For further information about RFS Pharma, please refer to our website, www.rfspharma.com .
Various statements in this release concerning BioLineRx's future expectations, plans and prospects, including, without limitation, statements relating to the ability to develop and commercialize the BL-8030 project, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's Form 20-F filed with the Securities and Exchange Commission on July 15, 2011. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
SOURCE: BioLineRx Ltd.
BioLineRx In-Licenses Second Oral Hepatitis C Treatment
Worldwide, exclusive deal signed with Genoscience and RFS Pharma for development and commercialization of BL-8030
JERUSALEM, Feb 06, 2012 (BUSINESS WIRE) -- --Advantages of BL-8030 include high specificity, improved resistance profile, reduced toxicity and potentially reduced drug-drug interactions
BioLineRx, a biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C. The agreement includes upfront license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx's standard in-license agreements.
BL-8030 is a potent and selective second generation NS3 protease inhibitor. The NS3 protease is essential for the replication of the Hepatitis C virus (HCV) and is an important target for HCV therapies. BL-8030 has been shown to have excellent antiviral activity against various HCV genotypes. Pre-clinical studies have demonstrated an improved resistance profile against common protease inhibitor mutants, resulting in a lower probability that the virus will develop resistance to treatment. In addition, BL-8030 has demonstrated a good toxicity profile in pre-clinical studies, exhibiting specificity only to the viral protease and lack of activity against a relevant panel of human proteases as well as a clean profile versus human liver enzymes, which is expected to lead to less drug-drug interactions.
BL-8030 was invented by Professor Philippe Halfon and his team at Genoscience and co-developed with assistance from scientists at RFS Pharma, LLC. Prof. Halfon, Co-Founder and President of Genoscience, is a specialist in molecular virology and infectious diseases, especially HIV, HPV (Human Papilloma Virus) and Hepatitis. In addition he is the founder of several biotechnology companies focusing on antiviral drug discovery and development including ACTgene, Alphabio and Genoscience. RFS Pharma was founded by Professor Raymond F. Schinazi; he currently serves as the Frances Winship Walters Professor of Pediatrics at Emory University. He is also a founder of Pharmasset, Idenix, Triangle and ActivBiotics Pharma.
Prof. Philippe Halfon said, "We were impressed by the drug development expertise of the BioLineRx team and are very pleased to collaborate with them on a second HCV project. There is clearly a huge unmet medical need in finding a safe and effective treatment for HCV, and based on pre-clinical results, we believe that our product, especially when combined with other available Hepatitis C drugs, has the potential to become an important addition to HCV combination therapies and bring remedy to millions suffering from this devastating disease."
"We worked closely with the group at Genoscience to determine the optimum characteristic that led to the discovery of BL-8030 and related protease inhibitors," said Dr. Steven J. Coats, Senior Director of Chemistry at RFS Pharma.
"We are privileged and fortunate to partner with two world class groups in the development of viral therapeutics," said Dr. Kinneret Savitsky, CEO of BioLineRx. "Two years ago, we took a strategic decision to enter the dynamic and rapidly growing field of Hepatitis C. Since that time, we have evaluated numerous projects in the field. A year ago, we identified and decided to focus on the in-licensing of the two most promising candidates: BL-8020, which we've recently licensed, and now BL-8030. We will do our utmost to develop these promising drugs as swiftly as possible for the benefit of Hepatitis C infected individuals around the world."
About Hepatitis C
Hepatitis C is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According to the World Health Organization (WHO), up to 170 million people worldwide are chronically infected with HCV. In addition, HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The Hepatitis C market is growing rapidly and is forecasted to reach $16 billion in 2015 in the seven major markets (US, France, Germany, Italy, Spain, UK and Japan).
About BioLineRx
BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx's current portfolio consists of five clinical stage candidates: BL-1020 for schizophrenia has commenced a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark registration trial and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million, in addition to sales royalties; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development and BL-7040 for treating Inflammatory Bowel Disease (IBD) has completed Phase I. In addition, BioLineRx has 13 products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, oncology, infectious diseases, cardiovascular and autoimmune diseases.
BioLineRx's business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government's Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization.
For more information on BioLineRx, please visit www.biolinerx.com .
About Genoscience
Genoscience, a biopharmaceutical company located in Marseille, France, is focused on the development of new drugs for the treatment of viral diseases as HCV. Genoscience's innovative technology platform, which combines internal expertise in resistance with unique molecular modeling through its proprietary software (GenMol(TM)), allows for the development of highly targeted molecules, taking into account the phenomenon of resistance. For further information about Genoscience, please refer to http://www.genosciencepharma.com .
About RFS Pharma, LLC
RFS Pharma, LLC was founded in September 2004 and is located in a 26,500 sq. ft. state-of-the-art research facility in Tucker, Georgia. RFS Pharma is a privately owned biotech company committed to the discovery and development of antiviral agents and other human therapeutics. The company capitalizes on its expertise in nucleoside chemistry to develop drugs to combat infections caused by drug-resistant HIV and hepatitis viruses. RFS Pharma's lead product candidate is amdoxovir, which is in advanced Phase 2 clinical studies for the treatment of HIV-1 infections. In addition, the company has identified promising, early stage compounds for hepatitis infections, analogs that are effective against noroviruses, and has a proprietary novel nucleoside prodrug technology. For further information about RFS Pharma, please refer to our website, www.rfspharma.com .
Various statements in this release concerning BioLineRx's future expectations, plans and prospects, including, without limitation, statements relating to the ability to develop and commercialize the BL-8030 project, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's Form 20-F filed with the Securities and Exchange Commission on July 15, 2011. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
SOURCE: BioLineRx Ltd.
Subscribe to:
Posts (Atom)
Posts
