Interestingly enough, the two biotech stories that I watch both had patent approval news today. They're similar in the sense that at some point in the future, both patents could potentially be extremely important or extremely useless; depending on factors surrounding how each company fares. Here's the news, what it means, and other upcoming catalysts to watch for these two companies.
Amarin Patent Approval Related to Combination Vascepa/Statin
Amarin announced this morning yet another patent for Vascepa, making this the 15th such patent to be issued (with 23 patent applications issued or allowed within the USPTO, and 30 more applications in place) for the company's prescription fish oil pill. Amarin, based in Ireland, said the following in their press release:
Amarin Corporation plc , a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 13/417,899 titled "Pharmaceutical Compositions Comprising EPA and a Cardiovascular Agent and Methods of Using the Same." This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results specifically those results seen in patients on statin therapy.
Why is Vascepa with statin therapy important? What makes this patent a bit different than some of the others?
"Through our findings from conversations with thought leaders and other clinicians during the launch of Vascepa, we've confirmed that many patients on therapies intended for lowering triglycerides are also on statins. The claims in this allowed application cover the administration of a pharmaceutical composition comprised of EPA in conjunction with a stain, using either a fixed or non-fixed dose, to lower triglycerides without increasing LDL-C, otherwise known as bad-cholesterol," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.
Amarin bulls will say this could mean everything because:
- If approved for its ANCHOR indication in December, this patent could be a key player in protecting Vascepa
- This adds to Amarin's ever expanding portfolio of patents on Vascepa, garnering it more credibility as a drug
- The addition of yet another patent is a very small step to continuing to separate Vascepa from other future fish-oil pills, which could theoretically increase the chance of a pharma company having to buyout Amarin, as opposed to competing with it
- In the future, should Vascepa find success during its launch, Amarin is going to need as many aspects of the drug patented to prevent cheap competition and pressure from other big pharmaceutical companies
Amarin bears will say this could mean nothing because:
- There are tons of patents that exist for items that never became viable or sold well
- Too much of the company's future is still predicated on the company's continued launch of Vascepa
- Too much of the company's future is still predicated on getting approval for their ANCHOR initiative in December
- A patent is not any type of guarantee of product success, and product success is what Amarin needs right now
Upcoming Amarin catalysts:
- Updated prescription data for Vascepa, following a dull report last week, available from IMS on Sunday, May 26th.
Celsion ThermoDox Patents Extend IP to 2026 in Main Markets
I've been covering Celsion (CLSN) since the beginning of January 2013, when it was anticipating its Phase III results for ThermoDox with RFA (radio frequency ablation). ThermoDox is a unique liposomal delivery method of getting doxorubicin to the site of cancer tumors being treated. Preliminary trials looked great and the idea behind ThermoDox was one that made sense: delivering a concentration of an often-used cancer drug to the site of the tumor by its liposomal transport system, and using heat to activate it en masse. They failed to meet their primary endpoint for their Phase III trials and have since been focusing on cutting cost, acquiring other technologies, post-hoc data analysis of the HEAT study, and resubmitting trial requests to the FDA in 2013.
This morning, Celsion announced additional patents for ThermoDox were granted in the four largest global liver cancer markets: China, Japan, South Korea, and Taiwan. The company's press release stated:
Celsion Corporation (NASDAQ: ) announced today that its proprietary patent application, "Method of Storing Nanoparticle Formulations," has now been granted in the four largest markets for liver cancer globally: China, Japan, South Korea and most recently Taiwan. Celsion holds an exclusive license agreement with Duke University for its temperature sensitive liposome technology which covers the ThermoDox® formulation. Celsion's newly issued patents pertain specifically to methods of storing stabilized, temperature-sensitive liposomal formulations and will assist in the protection of global rights by extending the overall term of the ThermoDox® patent portfolio to August 2026. The patents in these four countries, in addition to the previously granted patent for Australia, are the first five territories in this family which includes pending applications in the US, Europe and additional key commercial geographies.
The company goes on to reiterate that through the post-hoc HEAT study data, they are finding large ("although not statistically significant") subgroups that appear to have marked improvement in PFS (progression free survival) and OS (overall survival):
While the Phase III HEAT Study failed to meet its primary end point, progression free survival, Celsion has continued efforts to perform population subgroup analyses, and remains committed to evaluating ThermoDox® for the high-incidence liver cancer regions. The Company notes recent presentations at the 2013 World Conference on Interventional Oncology (WCIO) on May 16, 2013 which identified large, but not statistically significant, subgroups that appear to have clinical benefit when ThermoDox is combined with an optimized RFA procedure.
Celsion bulls will say this could mean everything because:
- If subgroup approval happens, this gives Celsion access to the largest liver cancer markets globally
- Allows future evaluation of Celsion's heat sensitive liposome technology, which could theoretically be used in other instances aside from cancer treatment
- It adds long-term value to the company's drug pipeline, most of which at this time is based around the heat sensitive liposome technology
- If approved in some facet, ThermoDox has patent protection in Hisun's market, whom Celsion states they still have a good relationship with and could feasibly work with again in the future
Celsion bears will say this could mean nothing because:
- If ThermoDox is not eventually approved in some facet, patents for these markets could be somewhat useless
- This is in addition to patents already issued for ThermoDox and essentially is all predicated on finding some use from the company's post-hoc analysis of the HEAT study
Upcoming Celsion catalysts:
- Potential coming updates on any of Celsion's 10 potential acquisitions
- Potential coming updates on further trials for ThermoDox
- Continued confidence from insiders buying
Only time will tell if these patents prove to be clutch pieces of the success puzzle for these two companies, or if they'll be filed somewhere into oblivion as each company fails to market and make money off of their IP. No matter which of these two companies you follow, bullish or bearish, I wish you the best of luck.