Posts Tagged: "drugs"

Superbugs have powerful friends in high places. SCOTUS’s patent eligibility criteria emanating from Mayo/Alice’s mysterious “laws of nature” and credible reports of unremitting turndowns by USPTO applicants portend hard times commercializing much of this research, which means its development and testing may never make it to licensed distribution. In Congress, deficit scolds roll back much needed NIH funding while solons clamor for more military weapons that have long outlived their usefulness. Even sexy pandemics like Ebola, Pan Asian Flu, and Zika and competing with Biden moonshots and precision medicine initiatives are forced to forage for the fiscal nourishment they need to compete and commercialize their critical research.

Consumers suffer the scourge of high drug prices. Brand-name drug companies reap monopoly profits. But generic drugs, which promise lower prices, are often nowhere to be found. One reason is that brand firms have engaged in an array of conduct to block generics. In short: A sample is crucial. Without it, there is no generic.

Of particular interest in this deal is a drug in Celator’s pipeline is Vyxeos (cytarabine:daunorubicin), an injectable liposomal treatment for blood cancers, especially acute myeloid leukemia (AML). The treatment, which has received a Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for fast-tracked approval, recently achieved positive results in a Phase 3 trial. Patients with high-risk, or secondary, AML who received Vyxeos injections saw a significant increase in overall survival rates, 41.5 percent for Vyxeos-treated patients versus 27.6 percent for other patients in a year’s time.

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one for Allergan, which saw its overall revenues increase by 48 percent when compared to 2015’s first quarter; revenue for Allergan’s branded pharmaceutical divisions grew by 71 percent year-over-year. The company’s infectious disease division was not its most profitable and yet it saw the greatest amount of growth compared to the previous year. Teflaro entered the Allergan portfolio thanks to a series of acquisitions in the biopharma realm over the past few years. The pediatric anti-infective was first developed by Forest Laboratories, formerly of New York City, which was acquired by Actavis in February 2014 for a combination of cash and equity which reached a reported $25 billion.

We cannot know what biological killer will next emerge, when it will be born and where globalization’s winds will take it. But we do know that choking-off future private investment in future healthcare needs is foolhardy. And that is what will happen if the UN sanctions this finding. Investment hates uncertainty. And innovation dies without investment. The underdeveloped countries the Panel may seek to protect are often those that suffer first from epidemics like HIV /Aids, Ebola; and Zika. They will suffer first when the next biological scourge begins taking lives.

The pending report of the UN Secretary General’s High Level Panel on Access to Medicines not only attacks the patent system as predicted, but proposes giving the organization oversight of drug development. If you think United Nation functionaries would be more effective than entrepreneurs, you’ll be delighted. If you live in the real world where bureaucracy is the enemy of innovation, you don’t know whether to laugh or cry.

Biopharmaceutical innovation is difficult, expensive, time-consuming, and risky. More so now than ever. A 2014 study by Tufts University’s Center for the Study of Drug Development calculated that a mere one in eight (11.8%) of all drugs that enter clinical trials are ultimately approved by the U.S. Food and Drug Administration. The drug development gamble appears to be getting riskier. A report released on May 25th by the Biotechnology Innovation Organization (BIO), the biotechnology industry’s national trade group, finds that fewer than one in ten (9.6%) of drugs that enter clinical trials will gain approval by the U.S. Food and Drug Administration.

Improving access to needed medicines for those suffering the ravages of disease in developing countries is a serious issue. There are many factors contributing to the problem including poor transportation systems, lack of available health care and education, endemic poverty, trade barriers, systematic corruption and, of course, the cost of drugs. Yet the U.N. Secretary General’s High-Level Panel on Access to Medicines is focusing on the patent system as the source of the problem. The report is due next month. The Panel is to “address the policy incoherence between intellectual property laws and access to medicines.”

The dilemma for developing countries is primarily a function of two things: lack of access to existing medicines and absence of innovation on the treatments and cures that are needed. Admittedly each of these can be linked to intellectual property rights, but poverty is at the heart of both issues. Fundamentally, drugs are not available because there is no market for them and the necessary market incentives are absent. To facilitate innovation, especially on ‘diseases of poverty’ the UN and member states need to commit to cultivating market incentives and removing obstacles.

Twitter’s popularity has not only benefited the legitimate side of the pharmaceutical industry. A study released in December, supported by both the Global Health Policy Institute and the Alliance for Safe Online Pharmacies, found an empirical link between all Twitter content and content aimed at the illicit drug sales. A survey of two week’s worth of posts shared on Twitter, involving the analysis of more than two million tweets, turned up 45,000 tweets which encouraged drug abuse. The survey found that more than three-quarters of tweets both pertaining to the non-medical use of prescription medications and including a hyperlink to a sales affiliate related to the anti-anxiety drug Valium.

The new year was hardly underway before Representative Lloyd Doggett (D-TX) and 50 of his House colleagues sent a letter to Health and Human Services Secretary Sylvia Burwell and NIH Director Francis Collins urging them to “march in” under the Bayh-Dole Act to control prices for drugs developed under the law. While the high cost of drugs is a legitimate concern, attempts to address the problem through technology transfer statutes would only guarantee that we will have fewer new drugs, not that they will be cheaper. The march-in provision is intended for instances when a licensee is not making good faith efforts to bring an invention to market or when national emergencies require that more product is needed than a licensee is capable of making, not to fix drug prices.

Pharmaceuticals is the industry sector where a strong patent system, promising substantial returns to successful innovation, is of paramount importance. Regrettably, the weakening of pharmaceutical patent rights through legislative means and antitrust lawsuits is symptomatic of a broader and more general policy attack that antitrust enforcers have directed against patents in recent years. Antitrust enforcers and legislators clearly need a few remedial lessons in the economics of innovation before their myopic meddling cripples the (up-to-now) highly successful American pharmaceutical sector and other key U.S. industries, which have stood as a testament to the value of strong patent rights.

Drugs for the treatment of late-stage cancers are less expensive to develop, in part because late-stage drugs extend patients’ lives for a shorter period of time such that clinical trials are concluded more quickly. This means that such drugs require less time to research, develop, test and bring to market than drugs that treat earlier stage cancers, providing the innovator with a longer effective patent life. In essence, less research and development investment is directed toward drugs that treat patient groups requiring lengthy clinical trials, those with longer commercialization lags… It’s worthwhile to ask whether a ‘one-size-fits-all’ patent policy is optimal. How we can think creatively about patent protection in an effort to incentivize the innovation we want and push the frontiers of modern medicine.

The idea of reducing drug prices through more government control is always simmering on the backburner and doesn’t require much to bring it to a full boil. Two recent actions turned up the heat to full blast. The response is often calls for more regulation, but ever increasing regulation benefits established players, which while inconvenienced, can afford to play the game. Start-ups can’t survive in endless oceans of red-tape that increase their costs while restricting market entry. Before rushing to impose more federal control, it might be wise to ask if government regulations inadvertently contribute to the problem.

On August 10th, the rights to sell Daraprim were bought from Impax Laboratories Inc. (NASDAQ:IPXL) of Hayward, CA, by Turing Pharmaceuticals, a privately held company with headquarters in New York City and Switzerland. Shortly after acquiring Daraprim, Turing CEO Martin Shkreli raised its price by more than 5,000 percent, from $13.50 per pill up to $750 per pill for a medication that’s not usually prescribed by itself; it’s typically part of a larger regimen for AIDS and cancer patients. As the result of public outcry, Shkreli announced several days ago that the price would drop from $750 a pill to some unspecified level. He pointed out that at $13.50 a pill the drug was not profitable to sell. Still, the damage has been done to an industry everyone loves to hate because drug prices in the U.S. are perceived to be outrageously high already.