Archive for the 'R&D' Category

From Generics to Supergenerics

VLUU L110  / Samsung L110The significant contribution that generic drugs make to health services across Europe cannot be denied. As Nick Haggar, president of the European Generic medicines Association (EGA) pointed out during the 20th EGA Annual Conference, held in Madrid, 25–27 June 2014, the generic drug industry offers value to healthcare by providing increased medicines access to patients (hence, saving lives) while helping governments maximize their healthcare budgets. And these benefits are in addition to the employment and investment opportunities created.

A standard generic drug contains the same active ingredient as the original branded product and is used to treat the same condition at the same dose but at a price that is typically 20% to 90% less than the patented drug. The EGA estimates that generic drugs saves patients and European healthcare systems approximately EUR 35 billion each year. Read more »

Ebola Outbreak Raises Ethical Issues

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened by the virus, and the death rate has escalated. The risk of harm from an untested treatment now is much less alarming than the prospect of infection, and the potential benefit of any effective treatment outweighs the need for regulatory caution.

Thus international and national authorities are working hard to facilitate access to experimental drugs and vaccines, despite a long history of distrust related to studying experimental treatments in Africa and other developing regions. Sponsors often face charges of using poor patients to test products that later will be unaffordable and unavailable. Authorities also question whether severely ill patients can make informed decisions about treatment options amid community fears of medical treatment. Vaccines raise added concerns, as they require widespread testing over long periods, often in healthy individuals and children. While the possibility of severe side effects from test drugs can generate a backlash against potential treatment, withholding therapy raises even more serious questions.

An important step was for the World Health Organization (WHO) to declare it ethical to use unproven therapies to try to contain the growing Ebola outbreak in West Africa. FDA similarly permitted a small biopharma company to distribute an experimental product that had been put on clinical hold due to concerns about a possible serious side effect.

These actions, though, raise similarly difficult questions about how to distribute the very limited supply of an experimental drug. Some experts cite the importance of treating children first. Others believe that patients with access to effective care are more likely to recover, making that a factor in using scarce medical resources.

Healthcare workers often get top priority, on the basis that doctors and nurses are needed to care for the sick, and that the prospect of treatment may encourage critical professionals to volunteer for service. But the treatment of two Westerners with the potentially effective drug Zmapp raised protests that the therapy was not available to sick Africans.

Data critical
One rationale for treating health professionals is that they are familiar with protocols and can understand the risks and the informed consent process. Treatment in a hospital setting also is more likely to support scientific assessment of an experimental regimen. One area of agreement is the importance of collecting and evaluating data on the safety and efficacy of experimental drugs used during the outbreak, and to share that data with all affected parties.

Researchers are continuing to assess factors related to the recovery of the two health workers who received Zmapp, acknowledging that they don’t know if that good result is are due to the drug, to effective care, or to other health factors. Treatment with this monoclonal antibody therapy produced by tiny Mapp Biopharmaceutical of San Diego may facilitate FDA approval of initial clinical trials, once the company can rebuild its exhausted supply.

Tekmira Pharmaceuticals of Canada may gain important safety information on its test product, TKM-Ebola, now that FDA converted a “full clinical hold” to a “partial hold” on its phase 1 trial, which permits the company to provide the drug to infected patients – but not to healthy volunteers — due to concerns about a potentially serious side effect.

While US and international authorities grapple with these ethical and logistical issues, manufacturers are struggling to ramp up production. Three centers in the US have capacity to quickly scale up production of a vaccine or therapy in response to an epidemic or biological threat and may be tapped to produce candidate vaccines.

A low-priority Ebola vaccine development project at GlaxoSmithKline’s Okairos unit now expects to move from preclinical development to clinical trials this year. Several small biotech firms are looking to gain needed funding to revive abandoned Ebola vaccine development programs. But optimistic statements from biopharma companies raise the risk of appearing “opportunistic” and  “self-promoting,” noted biotech commentator Adam Feuerstein in his “The Street” blog. A lethal outbreak of contagious disease provides an opportunity for biopharma companies to demonstrate their capacity to respond with innovative therapies, based on ethical and scientific factors, as opposed to the potential for financial gain.

by Jill Wechsler

Sandoz Wins Biosimilar Filing Race

After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the US healthcare market, and the impact these products will have on new drug development and product pricing and marketing.

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NIH Translational Research Partnership Yields Promising Therapy

A potential treatment for sickle cell disease has come through the “valley of death” of early-stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). The results of early clinical trials demonstrated sufficient effectiveness in addressing the underlying cause of this high-profile disease to attract commercial interest—in this case from Baxter International, which announced July 9, 2014 the acquisition of Massachusetts-based AesRx and its experimental drug Aes-103, a small-molecule, oral drug for sickle cell disease.

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Drug-Diagnostic Development Stymied by Payer Concerns

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by FDA with labeling that links prescribing to specific biomarker measures, health plan operators, providers, and payers

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frequently question the need to cover the added testing, according to analysis by Joshua Cohen of the Tufts Center for the Study of Drug Development (CSDD). Cohn noted at a recent CBI conference on “Precision Medicine and Companion Diagnostics” that only a few therapies have been approved by FDA

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FDA Gets More Funding

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in

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Under the new budget, the Center for Drug Evaluation and Research will receive nearly $1.3 billion for its operations and for field force activities related to drugs. The Center

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$338 million. Some of the agency’s added funds will support FDA consolidation at its White Oak campus and help maintain current buildings and facilities.

The Centers for Disease Controls and Prevention (CDC) similarly benefits from a budget increase of about 8 percent. CDC gains added funds to support biodefense programs that combat infectious disease and build national stockpiles of critical medicines.

But the National Institutes of Health (NIH) continues to suffer on the funding front. Congress set the NIH budget at nearly $30 billion, an increase of about $1 billion over its previous level. But the new amount is below the agency’s peak 2010 funding level that exceeded $31 billion. The

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Senate summary notes that added funding will support NIH’s new BRAIN initiative and research related to Alzheimer’s disease. But with inflation, NIH will be hard-pressed to fund much new research, let alone continue many of the discovery programs underway.

Under pressure to stop the funding logjam, Republicans stepped back from using the budget bill to take major whacks at Obamacare. The legislators pulled $1 billion from a new prevention fund established by the Affordable Care Act to support various health programs,

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and they cut funding by $10 million to the much criticized Independent Payment Advisory Board (IPAB), which may never become operational. The legislation also retains provisions that ban federal funding of abortions and of creating embryos for research purposes.

The higher budget level for FDA puts the agency in a good position to negotiate the appropriations process for fiscal year 2015, notes

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the Alliance for a Stronger FDA, which has led the fight to bolster FDA’s resources so it can meet its ever-growing mandates and assignments. The late action on the 2014 budget, though, may delay the administration’s 2015 budget roll-out for a month or so.

PDA Panel Proposes Limited Set of Metrics to Measure Quality Trends

If FDA is going to establish standards for assessing the quality of manufacturing sites and products, it should seek data on a few well-defined measures that reflect longer-term results and trends, rather than “snapshots of current numbers.” And such metrics should include more leading—vs. lagging—indicators to reflect a firm’s commitment to continuous improvement in production processes. Those recommendations come from a PDA “points to consider” paper, written to help FDA set standards to measure product quality and manufacturing capabilities.

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Innovation on the Rise among Indian Pharmaceutical Companies

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe. Read more »

FDA Approves Fewer New Drugs, But Acts Fast on Innovative Products

As expected, FDA approved only 27 new molecular entities (NMEs) in 2013. There was no late-December surge in approvals to bring the tally closer to the near record of 39 innovative new drugs approved in 2012. In addition, the Center for Biologics Evaluation and Research (CBER) approved eight novel products, including innovative influenza vaccines and a number of blood products.

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Delivering Complex Parenteral Formulations

Patricia Van Arnum PharmTech editorProgress in delivery science, manufacturing technologies, and commercialization are playing critical roles in advancing the development of complex parenteral drug formulations for new drug substances having a variety of formulation challenges. Unique formulation strategies and solutions are being investigated to extend the release of target peptides, proteins, nucleic acids, and small molecules for systemic, local, or cellular delivery. Pharmaceutical Technology will hold a live educational webcast, “Complex Parenteral Formulations for the Delivery of Peptides, Proteins, Nucleic Acids and Small Molecules,” on Thursday Nov. 21 from 10:00 to 11:00 AM EST, to examine the delivery science and product development of complex parenteral formulations. Read more »

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