Posts Tagged: "drug development"

On June 7, 2021, the U.S. Food and Drug Administration (FDA) gave the green light to Aducanumab, a drug developed by Biogen to treat early stage Alzheimer’s, despite the controversies surrounding its efficacy. Biogen stock price increased 38.3% on the day, adding $16.5 billion to the company’s market value. The news rippled across the pharmaceutical industry and lifted stock prices of most Alzheimer’s drug developers. As an example, Eli Lilly stock price jumped 10.2% on June 7, or a hike of $18.6 billion in market cap, because the company also has a similar drug candidate. Subsequently, as the controversies over the Aducanumab approval deepened, Biogen had lost $7 billion in market value by September 9. With all of these multi-billion-dollar numbers, one can’t help but wonder: how much is an Alzheimer’s drug worth? This article tries to assess the market value of an Alzheimer’s drug. It first estimates the implied values of Alzheimer’s drugs by looking into stock market reactions to major events associated with Biogen’s Aducanumab and Eli Lilly’s Donanemab. As a sanity check to the values derived from the stock market, a discounted cash flow (DCF) analysis is conducted to evaluate whether the stock market valuations are rational.

NCATS is working with industry to de-risk promising therapies by helping to take them further down the development pipeline. But the key ingredient remains finding a private sector partner willing and able to assume the burden of commercial development, which dwarfs the amount of money the government spent on the underlying research. This investment can only be justified if the technology has strong patent protection… There’s a reason it’s called intellectual property. Ownership of inventions in the United States of America isn’t a gift from the king but the right of a free people to securely own what they create. That’s the driver of American entrepreneurs, who with proper support will astound centralized governments run by dictators for life with what they can do when turned loose. Restoring our patent system removes the leash holding them back. After that, watch out if you’re in their way.

Despite the difficulties, the private sector is far and away the best bet for developing the desperately needed medicines of the future. Government is a critical partner and can fund research at our universities and federal laboratories that can’t be done anywhere else. It can also remove some, but not all of the risk inherent in developing treatments for diseases lacking sufficient market size and stability to attract traditional investment. But it still requires a company willing to assume the burden of transforming a discovery into a product that can alleviate suffering.

Dr. Frances Ligler is a pioneer in biosensor activity and a member of the 2017 class of inductees into the National Inventors Hall of Fame. This New Years’ Eve 2017 marked the 26th anniversary of the issue of a foundational patent in the field of portable optical biosensors, devices which are more adept at providing biological analysis in the field and outside of clinical lab settings.

The European Union suffers from an investment deficit relative to other industrialized nations. A recent report by the European Commission emphasizes this impact, “the EU needs to put in place better incentives and conditions for businesses to innovate” in important areas such as market regulations, intellectual property rights protection, barriers to entrepreneurship, and ease of doing business. Given this, encouraging investment is essential to future growth. Weakening the IP incentives embedded in SPCs would be a step in the wrong direction.

The legal principles set out above, while seemingly straight-forward enough, leave ample room for case-specific interpretation and application when it comes to the question of whether the use of a claimed invention in connection with carrying out clinical trials will constitute an invalidating public use. Patent applications are typically filed early on in the process of developing and commercializing a pharmaceutical drug product. One reason for this approach is to secure the earliest possible filing date thereby pre-dating as much would-be prior art as possible. Such would-be prior art, however, is not limited to that published or otherwise emanating from others but also includes time bars such as the public use bar. The circumstances under which clinical trials involving administration of a drug product that occur prior to the critical date may constitute an invalidating public use is a murky area of the law and courts’ decisions in this area are highly dependent on the facts of the case before them.

The dangers of killer germs and superbugs are not limited to bird flu in China, Ebola in West Africa, Zika in South America and MERS in the Middle East… If we are to have a fighting chance against superbugs and pandemics, we must invest in innovation and safeguard the property rights that incentivize these discoveries. Short-sighted efforts to enervate existing intellectual property rights laws and policies will not only damage incentives to innovate, they may hand a victory to the superbugs.

A patent is not the only path to exclusivity. In fact, the FDA characterizes patents and “exclusivity” separately. “Exclusivity” refers to exclusive marketing rights granted by the FDA upon approval and was designed to promote a balance between new drug innovation and generic drug competition. Some differences are that patents can be issued or expire at any time – before, during or after FDA approval– while exclusivity attaches upon approval of a drug product. Further, some drugs have both patent and exclusivity protection while others have just one or neither… Make no mistake, it would be tremendously unwise to proceed sans patents. No patent means the generic can enter the market as soon as the FDA exclusivity period expires, and having a patent can extend the exclusivity period to the end of the patent term, often years later.

Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. Up to 2.5 million infections occur in the U.S. each year. It is also the leading cause of childhood hospitalization globally. Nearly all children are infected with the virus at least once by the age of two to three years, and many develop pulmonary disease and/or asthma that persists throughout adult life, making them susceptible to re-infection. RSV particularly dangerous for premature babies, children with preexisting health conditions and the elderly, and is responsible for 16,000 deaths each year in adults over 65.

While those in the military are often thanked for their service, let’s also thank researchers like Dr. Rosenberg and his colleagues who spend their lives trying to alleviate human suffering. But that can only happen when their discoveries are commercialized– otherwise they are merely generating interesting research papers. Rather than deserved accolades, NCI and Kite Pharma got a pie in the face from the NY Times.

With the Cures Act now signed into law, the incoming Trump administration has an opportunity to advance the broad-spectrum medical countermeasure goal set forth by the U.S. Department of Health and Human Services (HHS) 2015 Public Health Emergency Medical Countermeasure Enterprise, otherwise known as PHEMCE. If achieved, the PHEMCE broad-spectrum goal would spur the advancement of innovative therapeutics to defend against the many pathogens that are not addressed with traditional disease-specific drugs or vaccines approved by the FDA.

Bayh-Dole is running on autopilot without Executive branch oversight and U.S. patents are no longer the world’s gold standard. Without a course correction, we could be headed back to the bad old days… Bayh-Dole has become a driver of the U.S. economy. Every day of the year universities form two new companies and two new products from their inventions are commercialized. University spin out companies tend to stay in state becoming significant contributors to the regional economy… Bayh-Dole is a recognized best practice. The Chinese have adopted it while strengthening their patent system to better compete with us.

We create two new companies around academic inventions every day of the year. The critical role such companies play in drug development is clear. The successful integration of public research institutions into the economy is based on the Bayh-Dole Act, which inserted the incentives of patent ownership into the government R&D system. Not a single new drug had been developed from NIH funded research under the patent destroying policies preceding Bayh-Dole. No one is going to spend billions of dollars and more than a decade of effort turning early stage inventions into new drugs or fund a life science startup company without strong patent protection. Yet the patent system and Bayh-Dole are precisely what the critics seek to undermine.

The focus of the political advocates pushing march-in may be lower drug costs. But the long-term costs of ripping apart IP rights are far higher and more fundamental than advocates acknowledge. The long-term price of exercising these exceptional prerogatives could include creating a crisis in confidence over use of federally funded research discoveries, dried-up private investments where basic research has federally funded fingerprints, hesitation to commercialize university research, and a corresponding drop in start-ups, new products, economic development and technological advancements. March-in could effectively repeal Bayh-Dole.