BIO CEO Company Snapshot: NuPathe Inc.

Posted under BD, BIO CEO, Blog, Business and Investments, business development, CNS disease, Companies, company snapshots, Diagnostics, Emerging Companies, Events, Funding, Medical Devices, Medical Supply, neuroscience, One-on-One's, Parkinson's, Partnering, Pharmaceuticals, Startups, underserved populations, Universities, Videos, What would George do? by biotechnow@bio.org (Biotechnology Industry Organization)

The Company Snapshots have returned for our next One-on-One Partnering event, the BIO CEO & Investor Conference, taking place in New York City this February.  The companies that will be profiled in these snapshots will all be presenting at the event, and we hope this provides the opportunity to learn more about them, and catch up on what’s new.

For our first Snapshot for the BIO CEO event, we’ve spoken with NuPathe Inc. about their priorities, challenges, and what you can expect from their company.

Company Snapshot

What are the short-term and long-term priorities for your company?

We develop innovative neuroscience treatments for the millions of people who suffer from neurologic diseases and disorders, far too many of whom are underserved by current treatments.  Our short-term focus is to gain FDA approval for and successfully launch our migraine patch product candidate, which has been clinically tested for the treatment of debilitating headache pain and migraine-related nausea.  Looking ahead, we plan to develop and commercialize valuable neurologic treatments across a range of therapeutic areas.

How does your company go about differentiating yourselves from the competition?

If approved by FDA, our migraine patch will be a perfect foundation product for our company because it would address the need for a better non-oral treatment for migraine patients.  We intend to use this foundation to help us advance our earlier stage pipeline product candidates for Parkinson’s disease, schizophrenia and bipolar disorder and to use our underlying technologies to build our current pipeline beyond current preclinical and clinical programs.

What is the most challenging part of raising money and seeking collaborations?

Clearly the challenges in accessing growth capital can negatively impact the pipeline of innovative therapies from both small and large pharmaceutical companies.  We believe these challenges offer an opportunity to simplify our approach to deliver tailored therapeutic solutions to underserved patient populations.  As an emerging company, this environment demands smart innovation – developing treatments and collaborations that not only improve on existing drugs or technologies but do so in a manner that truly meets a patient need.

Tell us something about your company that investors might not know.

Our earlier-stage pipeline includes two promising product candidates for global patient populations that utilize our LAD or long-acting delivery technology, a biodegradable implant that is injected subcutaneously to deliver the desired medication over a period of three to six months.  NP201, is being developed for the continuous symptomatic treatment of Parkinson’s disease with the delivery of ropinirole, a leading FDA-approved dopamine agonist, and is designed to potentially provide up to two months of continuous delivery.  NP202, being developed for schizophrenia and bipolar disorder, is designed to address patient noncompliance, a long-standing problem in the treatment of these conditions, by potentially providing three to six months of continuous delivery of an atypical antipsychotic.

~

Thanks to NuPathe for participating in the Company Snapshots, and don’t forget to catch their presentation at the event!  All presentation times will be posted on our 2012 Presenting Company list, and you can also find them in the One-on-One Partnering System.

Drug Discovery & Development: Partnering for Success…and Survival

Posted under Blog, Business of Biotech, Companies, Diagnostics, drug development, Emerging Companies, Funding, Medical Devices, Medical Supply, Partnering, Pharmaceuticals, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

There are pressures on Big Pharma and biotech emerging companies alike to engage in more creative deal making to ensure positive outcomes for both parties, Ted Agres writes in Drug Discovery and Development. While the number of deals has remained relatively flat in 2011, the dollar amount of individual deals has increased overall. Oncology remains the most sought after category, followed by CNS, anti-infectives, metabolic diseases, dermatology and cardiovascular.

Partnering activity at BIO events is on the rise, as well. At the 2012 BIO Business Forum during the BIO International Convention, BIO hosted an unprecedented number of partnering meetings – 21,183. The upcoming BIO CEO & Investor Conference is the largest investor conference focused on publicly-traded biotech companies and is expected to draw a significant amount of interest from attendees in partnering.

Check out the December 1 issue of Drug Discovery & Development for Ted Agres’ story on partnering.

The Critical Importance of International Patent Protection for Small Businesses

Posted under Blog, Companies, Diagnostics, Emerging Companies, Funding, Intellectual Property, Medical Devices, Medical Supply, patent, patent protection, Patently BIOtech, Pharmaceuticals, Public Policy, small business, Startups, U.S. Patent and Trademark Office, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

As part of the implementation of the Leahy-Smith America Invents Act, the U.S. Patent and Trademark Office (PTO) recently held two public hearing on international patent protection.  Stanley C. Erck, President and CEO of Novavax, Inc., testified on behalf of BIO in support of an initiative to reduce filing and prosecution costs for international patent protection of biotech inventions.

In his testimony, Mr. Erck explained the important role patents play in the biotechnology industry. The vast majority of BIO members do not yet have a product on the market and must raise the funds necessary to finance the long and expensive process to bring a new vaccine or therapy to market (an average of $1.2 billion over ten years, according to the Tufts Center for the Study of Drug Development).   Intellectual property, in the form of U.S. and international patents, is often the main assets of these small biotech companies.

The importance of international intellectual property protection has increased as biotech companies seek to expand the markets for their products.   Small biotechnology companies face unique challenges in securing international IP protection as biotechnology patent prosecution in foreign jurisdictions can be more expensive and complicated and subject to greater non-uniformity of the law than many other technologies.  The scope of patent claims and what is allowed can differ significantly from country to country, which further complicates and increases the cost of international patent filing for biotech inventions.  Without procedural or substantive harmonization, these problems are likely to increase costs for small biotechnology companies.

“For our small biotechnology businesses, securing IP protection can be as important as obtaining laboratory equipment, leasing space, or hiring creative, dedicated employees.  There is no reason, therefore, to exclude efforts to secure patent rights from publicly funded small business assistance programs that are available for more tangible assets such as capital equipment, hiring, or leasing space,” Mr. Erck testified.  “Securing international patent rights, a necessary protection for even the smallest biotech companies, can be an expensive proposition, so permitting public assistance programs to defray such expenses would give these companies greater flexibility to focus resources on important development efforts.”

BIO has urged the U.S. PTO to consider ways it can help small biotechnology companies file and prosecute patents internationally more efficiently, so that these companies can dedicate more resources to research, job creation, and product commercialization for the benefit of patients, farmers and other consumers.

A webcast of the hearing is available on the PTO website.