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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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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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USP Faces New Challenges

In anticipation of the 200th anniversary of the United States Pharmacopeia (USP) in 2020, the organization’s new leadership is taking a fresh look at its role in setting standards for pharmaceutical development and production and how that has been altered by new regulatory policies and industry globalization. USP chief executive officer Ron Piervincenzi is consulting with stakeholders, reviewing the organization’s operations, and examining options for growth and change as part of the agenda for the next USP convention in April 2015.

Piervincenzi comes to USP with training in bioengineering and expertise in management gained at McKinsey & Co., where he worked on multiple projects involving regulatory and medical affairs for many parties involved in USP activities, including manufacturers of drugs, dietary supplements, veterinary medicine, and foods. As the biomedical world has

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become more complex, notes USP president Timothy Franson, USP needs leadership with deep scientific understanding, as well as strong management skills and broad experience in stakeholder areas.

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Medicare Payment Data Raises Questions About Drug Costs

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FDA Wants You!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and CDER leaders are looking for experienced industry managers to help rebuild its staff.

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Many experienced FDA staffers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment of the agency,” explains Richard Moscicki, deputy director for science operations at CDER, who is leading its executive recruitment campaign. Moscicki formerly headed clinical development at Genzyme before coming to FDA in February 2013 and hopes to attract more people with similar backgrounds to public service. While some positions may be filled by internal candidates, Moscicki is looking to bring in people with leadership and management experience that may not exist at the agency.

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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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Obama Administration Halts Attack on Medicare Drug Plans

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year. The Centers for Medicare and Medicaid Services (CMS) had issued a proposed rule Jan. 10, 2014 to drop “protected” class status for antidepressants and immunosuppressants in 2015 and antipsychotics in 2016, and to limit the number of Part D plans an insurer can offer in each Medicare region. Insurers and pharmacy benefit managers (PBMs) backed the reduction in protected drug classes as a way to gain leverage in negotiating lower prices from manufacturers.

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Obama Budget Takes a Slap at Pharma

Despite a slight boost in funding for FDA and stronger

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