Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Jennifer Markarian

Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer’s Detrol LA (tolterodine tartrate) extended-release (ER) capsules, pending final approval by FDA. 

, that it has settled its litigation against Mylan and its subsidiary, Mylan Pharmaceuticals, regarding Pfizer’s patents covering Detrol LA (tolterodine tartrate) extended-release capsules. According to the agreement, Mylan may begin to sell its generic version on Jan. 1, 2014, subject to final approval by FDA.

Mylan had submitted an abbreviated new drug application (ANDA) for 2- and 4-mg tolterodine tartrate ER capsules, which are the generic version of Detrol LA. The drug is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The agreement allows Mylan to launch the product as either an authorized generic or under its own ANDA, stated the company in a Sept. 7, 2012, 

. The agreements are subject to review by the US Federal Trade Commission and the US Department of Justice.

Articles

Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer's Detrol LA (tolterodine tartrate) extended-release capsules, pending final approval by FDA.

Pfizer Settles Patent Litigation with Mylan

	The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 

	In the meeting’s opening keynote address, Jane Lansing, vice-president of marketing at Emerson Process, urged marketing and sales professionals in the automation field to bridge the communication gap with their prospects and customers and adjust to how people today access and utilize the information they need. “We have younger personnel emerging on the scene,” said Lansing, according to the press release. “They do things differently, including the way they buy products, consult their peers, and use social networks. They live off their smart phones. Old-style marketing and sales will not work with this new audience.”  During sessions, experts addressed questions, such as, “How is your organization adapting to the speed of interactions on social networks?” and “What are the best tools for creating customer communities?”.

	Did you attend the ISA Summit?  We would like to hear your comments.  These “winds of change” apply to more than just automation marketing and sales.  For example, yesterday’s 

 by Stephanie Sutton describes a first-of-its-kind Facebook game developed by a pharmaceutical company.  What insights have you learned in adjusting to new ways of accessing and using information in your professional life?

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release.

Winds of Change at the International Society of Automation Summit

The Observational Medical Outcomes Partnership (OMOP), a public–private partnership managed by the nonprofit Foundation for the National Institutes of Health and chaired by FDA, conducts methodological research on the use of observational healthcare data in studying the effects of medical products. The OMOP executive board is seeking public feedback on the priorities, infrastructure tasks, and research tasks it has proposed for 2013–2016.  Comments are being collected via the 

“Receiving public feedback regarding OMOP’s work is vital to our success,” said OMOP executive board member, Ronald Krall, MD, in an Aug. 27, 2012 press release. “We want to make sure we hear every idea about how to use healthcare data to improve the safety and effectiveness of medical products.”

OMOP was formed in 2008, and the group’s research since then has affirmed its belief that the science of observational research requires an empirical and reproducible approach to methodology and systematic application.  OMOP’s research has generated empirical evidence about the ability of observational analysis methods to identify true risks of medical products and discriminate from false findings.  Experiments were designed to understand how an estimated effect from an observational study relates to the true relationship between medical product exposure and adverse events. 

Proposed priorities for upcoming research, described in the OMOP 

, include creating a foundation for the common representation of healthcare data, developing empirical evidence to support study of the association between medical interventions and adverse outcomes, developing empirical evidence to aid detection of unsuspected associations between medical events and interventions, and creating a framework for evidence-based decision making.

The Observational Medical Outcomes Partnership (OMOP), which is managed by the Foundation, desires feedback on proposed research priorities and tasks.

The Foundation for the National Institute of Health Seeks Public Comment

The increasing use of single-use (i.e., disposable) systems (SUS) in biopharmaceutical manufacturing is causing manufacturers and users to consider whether recycling is a viable alternative to landfill disposal or incineration. While the overall environmental footprint of disposables has already been shown to be lower than multiple-use systems in some cases, due to factors such as savings in cleaning water, industry members are taking a close look at disposal options that can further improve the sustainability of SUS. 

Many facilities send their SUS-waste to landfill and others incinerate, either in their own facilities or offsite, and even use cogeneration facilities to produce power, say SUS suppliers. Cogeneration (i.e., waste-to-energy) is considered more environmentally preferable than traditional incineration. Plastics components have a high energy value and can be burned, for example, in cement kilns, which require large amounts of energy and do use alternative fuels, such as plastics or vehicle tires. 

More recently, SUS suppliers and users have been moving toward recycling, which has become a more viable proposal now that the volumes of plastics used in SUS have increased, comments Jeffery Lee Craig, global director for business development and marketing at ATMI LifeSciences. A life-cycle analysis of SUS showed that recycling does reduce the carbon footprint, even over cogeneration, comments Johanna Jobin, sustainability manager at EMD Millipore.

Recycling can, as expected, be used for nonhazardous waste, such as in upstream media and buffer preparation. Downstream components that have come into contact with biohazards, such as viruses, must go through a kill cycle, such as an autoclave, before disposal, notes Ken Baker, CEO of New Age Industries. Once decontaminated, however, these components can also be recycled, says Jobin. 

Both thermoplastic (e.g., polyethylene, nylon) and thermoset (e.g., silicone) components can be recycled although in different ways. Thermoplastics can be melted and reformed into new plastic parts like pallets and plastic lumber. Silicone, however, can be recracked and used in caulk, for example, says Baker. 

A big challenge for recycling has been the lack of infrastructure for collecting and disassembly, says Jobin. EMD Millipore began a pilot program this past year to identify the requirements for successful recycling and to better understand the logistics needed to develop a recycling infrastructure. EMD Millipore partnered with a third-party recycler, which collects and disassembles waste and recycles the plastic materials. Because many of the systems are made out of multiple plastic components that are difficult to separate, disassembly is currently done by hand, says Jobin. Although some of the bags and films are multiple layers (e.g., polyethylene, nylon, and ethylene vinyl alcohol copolymer), this has not presented a problem in the current recycling system. Other components, such as woven filter membranes attached to plastic frames, are a challenge to the disassembling and recycling process.   EMD Millipore, however, has been taking the lessons learned from these challenges and applying them in the company’s design for sustainability program.   “We have learned more about types of materials to use for easier recycling and how to design assemblies for easier disassembly at the end of life,” says Jobin. EMD Millipore’s pilot recycling program has had positive results so far, and the company hopes to scale up from the current East-Coast US operation to the rest of the US, and perhaps eventually to Europe. “The end-of-life aspect of SUS is particularly visible to the company’s employees and management and plays a role in its acceptance,” comments Jobin. Recycling also impacts each customer’s own sustainability programs. EMD Millipore estimates that one of its customers could recycle 11,000 lbs of SUS waste per month, which would boost its annual recycling rate by 5-7%.

At the recent Bio-Process Systems Alliance (BPSA) International Single-Use Summit in Washington DC, BPSA members agreed that recycling is important because it can have a significant, positive impact on sustainability. Now that volumes of SUS have increased and are expected to continue to grow, the industry needs to develop recycling as an option. 

Recycling is becoming a viable option for disposal of single-use systems.

Waste Management of Disposable Biopharmaceutical-Manufacturing Components

		Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration. “Silk stabilization has the potential to significantly change the way we store and deliver pharmaceuticals, especially in the developing world,” said research-paper author and Tufts doctoral student, Jeney Zhang, in a 

		Drugs can be loaded into silk fibroin, which contains nanoscale hydrophobic pockets that trap and immobilize bioactive biomolecules and protect them from moisture.  The silk can be made into films or other forms for non-refrigerated storage.

		The Tufts researchers, led by David L. Kaplan, PhD, found that silk stabilization preserved the efficacy of the measles, mumps, and rubella (MMR) vaccine, as well as penicillin and tetracycline, significantly better than other options such as collagen encapsulants, dried powders, and solutions. The researchers found, for example, no activity loss for penicillin stored in silk films at 60 C for 30 days, compared with total activity loss within 24 h for penicillin stored in solution at the same temperature.

		Kaplan’s lab also recently developed drug-infused microneedles made of silk, which are able to deliver precise amounts of drugs over time and without need for refrigeration. “This is an enormous added advantage that can potentially provide a lot of useful solutions to stabilization, distribution, and delivery,” said Kaplan in the release.

		It will be interesting to see how this innovation is used and what other problems can be solved with silk.

Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration.

Silk Protein Preserves Drugs Without Refrigeration

Zoetis, a subsidiary of Pfizer, filed a registration statement with the US Securities and Exchange Commission for a potential initial public offering (IPO) of Class A common stock, Pfizer announced in an Aug. 13, 2012

Details of the IPO, including the price and number of shares, have not yet been determined. The offering, however, is expected to represent an ownership stake of up to 20%.

Prior to the IPO completion, which is targeted for the first half of 2013, Pfizer will transfer its animal health business to Zoetis. The Pfizer Animal Health business unit works to discover, develop, manufacture, and commercialize animal health medicines and vaccines for both livestock and companion animals. 

Zoetis, a subsidiary of Pfizer, filed a registration statement with the US Securities and Exchange Commission for a potential initial public offering of Class A common stock.