In The Field

Research

Survey Says Two Million US Adults Import Drugs without Prescriptions

Washington, DC (June 25)—More than five million US adults import prescription drugs from other countries, two million of them without an official prescription, according to a survey conducted by the Pharmaceutical Research and Manufacturers of America (PhRMA). Concerned about the number of counterfeit drugs entering the US, PhRMA launched the survey to determine who was importing prescription drugs and why.

The survey shows that importers tend to be under 35, a bit younger than nonimporters, and are more likely to be Hispanic and come from southern border states than are nonimporters. Contrary to popular wisdom, adults purchasing drugs from other countries do carry health insurance. Approximately 85% of the importers have policies for prescription drug insurance. However, importers typically spend more money out of pocket on prescription drugs during a 12-month period than do their nonimporting counterparts. Seventy-one percent of importers with medical coverage said their prescription-drug benefit was insufficient to cover their needs. In spite of these statistics, and quite unexpectedly, the survey also demonstrated that one in five importers has an annual income of $100,000 or more.

The top reason for drug importation was, not surprisingly, price, a motivator for more than 85% of the importers. More surprising, about half the importers lacked prescriptions for the drugs they wanted. The prescription drugs most often imported include drugs for infections requiring antibiotics, pain, allergies, hypertension, digestive problems, and high cholesterol.

While Canada is the single leading country exporting drugs to the United States, Canadian drugs account for less than half of all drugs coming from overseas. The majority of drugs came from other countries, or the importers were uncertain as to the country of origin of their imports.

In a statement published on the PhRMA website, the organization's President and CEO, Billy Tauzin said, "This study further confirms what the Food and Drug Administration has been saying all along—millions of Americans are circumventing the system and going to other sources to buy their medicine because they do not have a doctor's prescription for the medicine they want. Alarmingly, this behavior increases an individual's risk to being exposed to dangerous counterfeit medicines." -Michelle Hoffman

VACCINES

Sanofi Pasteur and MedImmune Awarded Contracts for Flu Vaccine Facilities

Washington, DC (June 14)—The US Department of Health and Human Services (HHS) awarded two contracts totaling $132.5 million to Sanofi Pasteur (Lyon, France) and MedImmune (Gaithersburg, MD) to retrofit their influenza-vaccine manufacturing facilities. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group (Paris), received a $77.4-million contract and plans to contribute an additional $25 million, and MedImmune was awarded $55.1 million and plans to contribute an additional $14 million. The overall project includes design, retrofit, and facility maintenance so that the companies can switch to pandemic influenza-vaccine manufacture upon a request from the government.

Sanofi plans to begin the design phase immediately, with the retrofit starting as soon as the new influenza-vaccine manufacturing facility is operational and licensed by the US Food and Drug Administration (Rockville, MD). The company's existing facility will be phased out and decommissioned for the retrofit. Once both facilities are validated, the company's capacity will increase threefold.

The contracts are part of HHS's Pandemic Preparedness Plan, which was issued in November 2005 and outlines public-health preparedness and response activities for an influenza pandemic. According to the World Health Organization (Geneva), 1–2.3 billion hospitalizations and 280,000–650,000 deaths could occur in the next influenza pandemic in industrialized nations alone. HHS hopes to stockpile enough prepandemic influenza vaccine for 20 million people. -Angie Drakulich

Biologics

Senators Draft Legislation for Follow-On Biologics Approval

Washington, DC (June 22)—Senators Orrin Hatch (R-UT), Edward Kennedy (D-MA), Michael Enzi (R-WY), and Hillary Clinton (D-NY) agreed on legislation that would authorize the US Food and Drug Administration (Rockville, MD) to approve follow-on versions of biologic therapies. The legislation establishes standards by which FDA would approve follow-on biologics, a means to quickly resolve patent disputes, and provide incentives that encourage innovation and the development of new therapies.

Announcing the legislation, titled the "Biologics Price Competition and Innovation Act of 2007," Senator Hatch stated that biologics are the future of medicine. He remarked, "Just as we did with Hatch–Waxman in 1984, we're giving incentives for both pioneer and generic drug firms. We're ensuring that we continue to get the latest medical breakthroughs while creating a clear pathway to get less expensive biologics on the market quickly."

The act would require an applicant to demonstrate the absence of clinically meaningful differences in safety, purity, and potency between its biosimilar product and the brand product. The demonstration includes analytical data, animal testing, and at least one clinical study, unless FDA determines this requirement is unnecessary.

Under the legislation, FDA could approve a biosimilar product as interchangeable, thus allowing it to be substituted for the brand product without the intervention of the prescribing healthcare provider. To demonstrate interchangeability would require evidence that the biosimilar product produces the same clinical result as the brand product in any patient and presents no additional risk in terms of safety or diminished efficacy if a patient changes between products.

As an incentive for the development of new biological products and interchangeable biosimilar products, the act grants 12 years of data exclusivity for the brand company, during which a biosimilar product may not be approved. The act also provides one year of exclusivity for the first interchangeable biological product.

The legislation outlines a process for identifying and resolving patents that the biosimilar product may infringe. The biosimilar applicant and the brand company together would identify the patents at issue and offer their opinions as to their validity. The two parties then would either agree to a list of these patents to be litigated first or exchange lists. The brand company must then sue the biosimilar applicant within 30 days to defend the patents. If a court decides that a patent is valid and was infringed by the biosimilar product before the 12-year data exclusivity has ended, the court must enjoin infringement of the patent until it expires. For identified patents not included in this initial litigation, the biosimilar applicant must give the brand company notice 180 days before it launches its product, and the brand company may then seek a preliminary injunction to block the launch. -Erik Greb

Regulation

FDA, EMEA, EC Extend Regulatory Collaboration Efforts

Rockville, MD (June 18)—The US Food and Drug Administration, the European Commission (Brussels), and the European Medicines Agency (London) agreed to extend cooperative activities to the areas of pediatrics and medicinal products for rare diseases (i.e., orphan drugs). These activities will include scientific dialogue about extensions of therapeutic indications and risk-management plans.

According to a prepared statement, the agreement "builds on the achievements in cooperation on vaccines, oncology, and pharmacogenomics" with the objective of "promoting and protecting public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner."

The European Union recently adopted legislation governing pediatric therapeutics. During a meeting with FDA in mid-June, the EU finalized its "Principles of Interactions" document, which aims to facilitate the timely exchange of scientific information and ethical issues. The meeting also involved a discussion of "upstream regulatory cooperation on new medicines legislation." Although no discussion details were released, the agencies announced plans to hold a meeting on a "Transatlantic Workshop on Administrative Simplification in Medicines in Regulation" on Nov. 28 in Brussels. -Maribel Rios

Reorganization

Abraxis BioScience Plans to Separate into Two Companies

Los Angeles, CA (July 2)—Abraxis BioScience, Inc. plans to separate its hospital-based product business, Abraxis Pharmaceutical Products (APP), from its proprietary products businesses, Abraxis Oncology and Abraxis Research, to form two public companies. Abraxis Pharmaceutical Products will become APP Inc., and Abraxis Oncology and Abraxis Research will become the new Abraxis BioScience.

"Strategic initiatives executed over the past few years, including the acquisition of global rights to Abraxane and the nab-technology platform, the acquisition of the AstraZeneca anesthesiaanalgesic portfolio and the acquisition of the Pfizer manufacturing facility in Puerto Rico, have accelerated the growth of two robust businesses with more than 1900 employees and combined revenues that are expected to approach $1 billion by the end of 2007," outlined Patrick Soon-Shiong, chairman and CEO of Abraxis BioScience, in a company release.

Following the separation of the businesses, each current shareholder will own one share of Abraxis Pharmaceutical Products, Inc. and one share of the new Abraxis BioScience for each share previously held. The transaction is expected to be completed in the fourth quarter of 2007, subject to customary closing conditions, the obtainment of a private-letter ruling from the Internal Revenue Service that that the separation will be tax-free to Abraxis BioScience and its shareholders, and other regulatory approvals.

Abraxis has received commitments for $1.45 billion of senior credit facilities comprising a funded $1.3-billion term loan and an unfunded $150-million revolving credit facility. A portion of the proceeds raised through the debt financing will be used to repay the current company's existing indebtedness, and approximately $1.0 billion will be transferred to the new Abraxis BioScience immediately before the separation. Detailed information about the separation of the businesses will be provided when the company files a Form 10 registration statement for the new Abraxis BioScience, which is expected to be filed in the third quarter of 2007.

APP to focus on injectables

Following the separation, APP will be one of the largest standalone publicly traded companies focused on injectable pharmaceuticals, according to the company, and will have approximately 1400 employees. APP expects to generate revenue growth in 2007 in the mid-teens over 2006 revenue of $583 million. The headquarters of APP will remain in Schaumburg, Illinois.

Soon-Shiong will remain as chairman and will serve as CEO of APP. Thomas H. Silberg will continue to lead APP as president. Frank Harmon will remain as executive vice-president and chief operating officer of APP. Key executive officer positions, as well as the board of directors, will be named before, or at the time of, the close of the transaction.

In 2006, APP had 10 abbreviated new drug application (ANDA) approvals. From 2001 to 2006, APP had 55 ANDA approvals. It has 29 ANDAs pending with the US Food and Drug and Administration (Rockville, MD) and more than 60 product candidates in various stages of development, according to the company.

The new Abraxis BioScience

The key technology platform of the new Abraxis Bioscience is its "nab" (nanoparticle-albumin bound) technology platform. The technology is commercialized in a nab-based form of the anticancer therapy paclitaxel.

Abraxis Bioscience is developing other nab-based products, which include nab-docetaxel (ABI-008), mTOR inhibitor nab-rapamycin (ABI-009), and the HSP90 inhibitor nab-17AAG (ABI-010). The investigational new drug application (IND) for ABI-009 is the third investigational product based on the company's nab technololgy.

Abraxis anticipates filing two additional IND submissions during the next 12 to 18 months for ABI-010 and nab-thiocolchicine dimer (ABI-011).

Soon-Shiong, who will remain as chairman and CEO of the new Abraxis BioScience, envisions that the new Abraxis BioScience will be positioned in personalized medicine. "The era of personalized medicine has arrived, and with the financial and scientific resources created as a result of this transaction, the new Abraxis BioScience will be uniquely positioned to forge new paradigms of drug discovery and personalized drug development," he said in the company release.

The new Abraxis BioScience, as a standalone publicly traded company, will have its headquarters in Los Angeles, California, and will employ more than 500 people. The executive committee of Abraxis BioScience will remain in their current positions. The new board of directors for this business will be determined before, or at the close of, the transaction. -Patricia Van Arnum

Company Notes

Cambridge, MA (June 7)—Genzyme Corp. is investing nearly $140 million in a new 140,000-ft² biomanufacturing plant in Lyon, France, to replace its smaller plant in nearby Marcy l'Etoile. The new plant, which will be used to manufacture Genzyme's transplantation treatment, "Thymoglobulin," will have more than twice the manufacturing capacity of the Marcy facility. Genzyme also is developing a plant in Belgium to produce monoclonal antibodies and proteins, and intends to expand its Allston Landing protein plant in Boston.