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 »

CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Ian Haynes of 3C Integrity - Low ResFormer AstraZeneca engineer and serialization specialist, Ian Haynes, looks at the first practical step contract manufacturing organizations need to take to implement a compliance strategy ahead of the impending serialization deadline.

Increasing concerns are being expressed by industry observers and top-tier pharmaceutical manufacturers that contract manufacturing organizations (CMOs) will not be ready to comply with emerging track-and-trace requirements. 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

Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanIn Part 1 of this blog, Richard Freeman looked at some of the challenges faced by pharma firms today as a result of growing competition, regulation and globalization, and argued that more effective communication and collaboration was key to their continued success. Part 2 outlines how unified communications (UC) can help overcome some of these challenges.

Any UC deployment is about connecting people with one another (and with data) in a faster, richer, simpler way. Of course, no technology is a silver bullet, and a firm will only realize the full benefits if it is a truly collaborative organization, or making serious efforts to become one.

As well as the right type of culture, companies also need to have appropriate infrastructure in place to support such a solution. For example, getting different modes of communication such as voice, video, and text working together seamlessly requires the right underlying network and hardware. While that could be an in-house system, for smaller and mid-market firms, a hosted, cloud-based offering that allows you to avoid hefty set-up costs is often a more cost-effective and hassle-free option. Read more »

Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Guest blog by Richard Freeman, sales manager at MeetingZone

Rich FreemanFor an industry that saves millions of lives, pharma is sometimes unfairly perceived by the public as being aloof, unresponsive, or occasionally worse. People outside the sector rarely appreciate the difficulty and cost of bringing new drugs to market, particularly when it comes to rolling them out in emerging global markets such as China, India and Africa.

Although globalization offers the prospect of vastly expanding the market for pharmaceuticals, grasping that opportunity is easier said than done. For a start, firms must ensure they understand and comply with a plethora of ever-changing regulation that varies from country to country. They generally need to liaise with hospitals and other medical and regulatory bodies to conduct country-specific clinical trials, even where a drug has been tested and approved elsewhere. And they may also have to contend with differing cultural attitudes to Western medicine that require them to tailor their marketing efforts accordingly. Read more »

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.

Read more »

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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Clusters set to benefit from improved funding climate but IP rights are even more critical

Guest blog written by John Dean, partner and patent attorney at Withers & Rogers LLP.

Life sciences and biotech research clusters across the UK, including those linked to university research departments are benefiting from an improved funding climate and ongoing consolidation in the pharmaceutical sector. However, as big pharma companies increasingly vie for the best spin-out investment opportunities, those with strategic intellectual property plans are likely to find favour. Read more »

Supplier Audit Program Marks Progress

The Rx360 pharmaceutical supply chain consortium celebrated its first five years with an anniversary conference the week of June 5, 2014 in Washington, D.C. The conference featured key FDA officials and industry leaders. This collaborative effort to streamline and coordinate manufacturer audits of ingredient suppliers was launched in 2009 in response to the heparin adulteration crisis, which raised broad concerns about inadequate monitoring of the pharmaceutical supply chain by manufacturers.

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FDA, Drug Companies Struggle with Compassionate Use Requests

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval. As 7-year-old cancer patient Josh Hardy gained relief from a

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life-threatening infection following a bone marrow transplant thanks to Chimerix’ promising new antiviral drug brincidofovir, hundreds of patients turned to the Internet and social media to intensify pressure for similar compassionate access. The trend demonstrates the need for sponsors, health professionals and government regulators to find new ways to handle these difficult requests, while also supporting clinical research and biomedical R&D.

Biopharmaceutical companies receive dozens of requests for early access to promising therapies, but often turn them down. Clinical supplies usually are very limited, often just enough to conduct a study. Production costs for biologics are high, particularly for small firms struggling to finance complex research programs.

Moreover, sponsors fear that adverse events with patient populations outside a clinical trial could delay development and approval. And expanded access can interfere with clinical trial accrual; if patients can obtain treatment outside a regulated study, they won’t want to enroll in a trial where they risk getting a placebo or a less effective comparator drug.

The social media phenomena raises serious ethical issues about whether hard decisions about who gets access to scarce therapies should be made on the basis of catchy publicity campaigns and political pressure, as opposed to who is most seriously ill and who is most likely to respond to treatment. Some consider lotteries or independent third parties as fairer ways to decide how to distribute a scarce, highly valuable resource. The prime ethical obligation of biotech companies, says the Biotechnology Industry Organization (BIO), is to develop safe and effective drugs as quickly as possible so that broad patient populations can benefit. Diversion of resources to deal with

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individual access requests can delay development and stymie efforts to achieve equitable distribution of limited supplies.

Regulatory challenges
FDA’s process for facilitating expanded access requests is a prime focus of reformers. The agency permits clinical trial sponsors to amend an investigational new drug application (IND) to grant patients access to experimental drugs for treatment purposes. Patients can’t apply for such access; the request has to come from the sponsor, physician investigator, or a qualified treating physician, either for a single patient or a small group (up to 100 patients). The expanded access IND requires evidence that the individual(s) have serious or life-threatening conditions, do not qualify to participate in a clinical trial, have no other treatment options available, and that potential benefits are likely to outweigh possible risks.

Details on the process are provided on FDA’s website and in a May 2013 Q&A guidance on expanded access to investigational drugs for treatment use. Jim

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Robinson, president of Astellas US, would like to see additional guidance on criteria for vetting requests for compassionate use, noting that demands for early access will only increase with some 3000 drugs in development for cancer and other serious conditions.

FDA’s Office of Health and Constituent Affairs, which provides information to health professionals and patients on expanded access policies and procedures, reports that the agency receives about 1000 expanded access INDs and access protocols each year and approves virtually all of them. The vetting process includes review by an Institutional Review Board to ensure adequate informed consent, and by the relevant new drug review division.

FDA officials sometimes convey patient requests to pharmaceutical companies and offer assistance to willing firms and physicians in filing necessary information and navigating the application process, explains Patient Liaison Program director Richard Klein. Because the purpose of these programs is treatment, and not research, sponsors don’t have to submit efficacy data from an expanded access study, but must report serious adverse events.

While FDA permits sponsors to charge patients for the cost of drugs provided under compassionate use, this provision is seldom used. Companies usually prefer to keep confidential information on production processes and costs, and limited supply is a larger concern than gaining revenue.

FDA’s desire for flexibility can be seen in its handling of the Chimerix case. Amidst the public demand for access to brincidofovir for Josh Hardy, FDA worked with Chimerix to approve a 20-patient open-label clinical trial for treatment of adenovirus infection in immunocompromised pediatric patients. The company thus avoided a massive open access program, and gained a strategy that it hopes will lead to a Phase 3 trial for this indication. Meanwhile, Chimerix is continuing its main development program (under new company leadership), which seeks accelerated approval of the drug for prevention of the more common cytomegalovirus (CMV) infection in adult bone marrow transplant patients. Chimerix launched its Phase 3 SUPPRESS trial last year at 40 transplant centers, with an eye to enrolling 450 patients, 150 receiving placebo; initial results are expected by mid-2015.

Although FDA and the sponsor addressed this compassionate use case successfully, there’s continued pressure for new approaches. A bill before Congress would permit the manufacture, importation, and distribution of unapproved investigational products to terminally ill patients. State legislatures are considering “right to try” bills, as seen in an Arizona measure that permits physicians to prescribe investigational drugs for certain terminally ill patients. Such proposals raise constitutional questions about the right of states to challenge federal drug approval policies, an issue central to past lawsuits challenging FDA interference in patient treatment.

Faster approval of important new medicines could address some early access concerns, a goal for regulators and sponsors alike. FDA held a public hearing in February 2013 on strategies for improving the accelerated approval process and whether FDA needs additional tools and authority to move promising therapies through the regulatory process, issues that will

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