Posts Tagged: "pharmaceuticals"

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.

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.

On its face, the new guidance seems to urge examiners to develop well-reasoned, substantive rejections rather than conclusory rejections which provide little basis for applicants to advance applications toward allowance, particularly in the complex areas of vaccines, diagnostics, methods of treatment, and screening for genetic alterations, where the new examples are focused. Furthermore, compared with prior guidance, the new examples include more claims that are considered patent eligible subject matter. Some observers believe this may be an effort by the patent office to dispel hesitation that examiners have apparently had in drawing conclusions of patent eligibility when examining claims.

Given the importance of intellectual property rights to economic growth and technological development, as well as the wider benefits of biopharmaceutical research, the provisions found in the recently negotiated Trans-Pacific Partnership (TPP) Agreement to protect biologic medicines are disappointing… As clinical trials become increasingly costly, these costs are increasingly born by the biopharmaceutical industry. A recent study from the Johns Hopkins Bloomberg School of Public Health calculates that the biopharmaceutical drug and medical device industry now funds six times more clinical trials than the federal government.

As we await the decision from the National Institutes of Health (NIH) on the petition backed by Senator Bernie Sanders and others urging that the march in provision of the Bayh-Dole Act be used to control drug prices, it’s worthwhile to recall the time the agency followed similar advice….Note from the beginning the trigger for marching in was a failure to work towards commercialization and the word “reasonable” applied to royalty rates, not the cost of a product… To understand the original intent, recall that march in rights were designed to prevent companies from licensing federally supported inventions to suppress them. Otherwise, the government can march in. That’s how march in rights have worked since 1947.

Migraines are the result of a hereditary neurological disorder which causes certain areas of the brain to become over-excited, creating the throbbing pain and increased sensitivity to lights, smells or sounds which characterize a migraine attack. Not much is known about the brain chemistry that directly causes a migraine, although it’s generally understood that hormonal fluctuations or environmental stimuli can act as triggers. News of successful mid-stage trials for a migraine treatment developed by Alder Biopharmaceuticals Inc. has been greeted with a warm welcome from news media. The results of the trial show that an injectable treatment known as ALD403 administered four times over the course of a year reduced patient suffering from chronic migraines.

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.

The Medical Innovation Prize Act of 2007, submitted by Senator Bernie Sanders (D-VT), would have effectively done away with patent rights for pharmaceutical drugs approved by the Food and Drug Administration (FDA). The bill would have allowed anyone in compliance with FDA requirements “to manufacture, distribute, or sell an approved medicine.” The bill says it would have continued to spur innovation by establishing a fund for medical innovation prizes. It would have required the Board of Trustees for the newly created Fund to award prize payments of unspecified amounts for medical innovations relating to a drug, biological product, or manufacturing process. In order to be an eligible award recipient one would have to be the first person to receive market clearance or be the holder of an issued patent.

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.

The number of these potentially anticompetitive deals has fallen significantly following the Supreme Court’s landmark antitrust decision in FTC v. Actavis in 2013. The total number of such deals filed with the FTC has dropped to 21 in FY 2014 from 29 in FY 2013, and 40 in FY 2012 prior to the Actavis ruling. The FTC staff report for FY 2014 represents the first annual snapshot of such deals following the Actavis decision.

According to Thomson Reuters 2015 list of Top 100 Global Innovators, Amazon and several other established players in mature markets are proving that it’s not just start-ups that have the potential to upend traditional business models and reinvent our world. In fact, several of the companies new to this year’s ranking of top innovators have been around a lot longer than Amazon, among them: Boehringer Ingelheim, Chevron, Exxon Mobil, Johnson Controls, Thales, and Yamaha.

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.

Globally there are approximately 7,000 medicines in development to treat and cure a wide variety of diseases. Of these, more than 5,000 are in development in the United States. It’s difficult to argue that the strength and success of the U.S. biopharmaceutical industry is uncorrelated with the IP protection available here. It is, therefore, disappointing that the recently negotiated Trans-Pacific Partnership (TPP) Trade Agreement fails to deliver sufficient IP protection for biologics. Much of the continuing controversy plaguing the TPP Agreement surrounds data exclusivity protection for biologic medicines and the future of the agreement may hinge on precisely this issue.

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.