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Zomig

Zolmitriptan is an oral, selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist, or triptan, for acute treatment of migraine attacks with or without aura. First launched in 1997, it is one of the second generation of triptan. It is available in tablet form, as a rapidly dissolving tablet that can be taken without water, and as a nasal spray.

People with migraines are often sensitive to artificial sweeteners, and should be aware that Zomg-ZMT (the dissolving tablet) contains aspartame, and hence conatin phenylalanine.

Zolmitriptan is marketed by AstraZeneca with the brand names Zomig, Zomigon (Greece & Argentina) and AscoTop (Germany).


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AstraZeneca rides Rx to success: packaging for the Anglo-Swedish drug giant focuses on information, patient-doctor relationship and compliance
From Food & Drug Packaging, 12/1/05 by Pan Demetrakakes

AstraZeneca's prescription for success is pretty basic: Make patient health the cornerstone of everything it does. The Anglo-Swedish pharmaceutical company is engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services.

It is one of the world's leading pharmaceutical companies with health care sales of over $21.4 billion and leading positions in sales of medications for cardiovascular disease, acid-related stomach disorders, cancer, psychiatric disorders and more. (See "From Arimidex to Zomig: AstraZeneca's major products" on page 28.)

AstraZeneca's packaging is designed with a combination of consumer information and distinctive brand markings to differentiate the product in a highly competitive marketplace. The success that the company has had with innovative packaging for its prescription products has led to Food & Drug Packaging naming AstraZeneca its Drug Packager of the Year.

With more than 15,000 people dedicated to AstraZeneca's manufacturing and packaging operations worldwide, the company is well positioned to serve as a leader in pharmaceutical packaging. "AstraZeneca is honored to be recognized by Food & Drug Packaging magazine as Drug Packager of the Year," says Ken Murtha, vice president of U.S. business operations. "We have teams around the world working every day to improve the design and functionality of AstraZeneca packaging, and this accomplishment is a result of our employees' commitment to enhancing patient health."

AstraZeneca does not deal with over-the-counter drugs, but packaging is still a competitive priority--a strategic one, according to Barrie Thorpe, executive vice president of global operations.

Kathy Monday, vice president for customer and technical operations, explains, "What I think is very unique is that within operations over the last five years, we have focused specifically on packaging as one of our strategic imperatives."

Because AstraZeneca is so heavily invested in improving patient health through its prescription medications, compliance is one of the most important functions of its packaging.

"We at AstraZeneca believe very strongly in putting the health of patients first, and part of this concept involves how well the patient is able to take the drug--how compliant are they to that medical therapy," says Murtha. "We feel that the package can have a positive impact on patient health outcomes."

Touchpoint

Physicians' samples and unit-of-use packaging are two formats where AstraZeneca is able to communicate with patients to ensure that they take medicine correctly.

"Packaging is really the most direct way we as a manufacturer touch that patient," says Meryl Weinreb, director of patient programs. "Particularly with a product sample--that is really the first touchpoint with the patient after the doctor has prescribed that medication, and it's a wonderful opportunity to begin a relationship with that patient."

That's one of the primary motivations behind the packaging of Arimidex, AstraZeneca's medication for breast cancer patients who have completed chemotherapy above. The physicians' sample for Arimidex includes a leaflet introducing the reader, not only to the medicine, but to the "In Your Corner" program, a chance to be included in monthly mailings about coping and living a full life after breast cancer.

Enhancing the physician-patient relationship is another important packaging goal, Weinreb says: "A well-informed patient is an adherent patient who knows why this medication has been prescribed, what it's expected to do, and what are the potential side effects that they need to be aware of--the risks and benefits." Having the information in writing helps reinforce what the doctor tells the patient during her visit, which may not all be retained from a primary conversation, she says.

Physician samples, of course, are important for another reason: as a tool to give both patients and physicians an opportunity to explore various treatment options, to find the right dose and medication for the right patient.

Direct-to-consumer (DTC) advertising has emerged in recent years as one of the most important channels for educating consumers about prescription medications. AstraZeneca uses DTC marketing campaigns for several products, including Crestor, a treatment for cholesterol reduction and Nexium, a treatment for acid reflux disease.

Despite its name, DTC requires communicating with the doctor almost as much as the patient because doctors are crucial in ensuring that patients adhere to their medications. And the shelves where doctors store samples have as many options as drugstore aisles. That's why AstraZeneca is actively making packaging enhancements that can improve the visibility of its physicians' samples.

Monday outlined some of the questions that AstraZeneca asks in designing such packaging: "How can we be more innovative in how we position our product? How do we box them? How do we tray them? How do we ensure that the physician has easy access to it, understands what it is and can dose appropriately among all the other packages that are sitting there?"

Communicative packaging for physician's samples takes on added importance in AstraZeneca's case, because pharmaceutical sales specialists dedicate their time in the field to making face-to-face calls on doctors and arrange for delivery of samples separately, Murtha says.

"We are a sample-send-only company. We're the only one out there, and I'm very proud of that," Murtha says. "This philosophy frees our representatives up to have a dialogue with the physician." Once the physician asks for a sample, the sales force orders it through handheld devices that transmit directly to the warehouse, which ships the samples directly to the physician.

RFID's potential

Of course, packaging-related communications technology is very much on the minds of pharmaceutical manufacturers these days, in the form of radio frequency identification (RFID). The aims of RFID in the drug industry are notably different than for other consumer-packaged goods. In most markets, RFID's primary attraction is supply-chain tracking; in pharmaceuticals, it's product verification and ensuring a safe, effective product through protection against counterfeiting. (For a full discussion, see "With RFID, drugs go their own way" in Food & Drug Packaging, August, 2005, which is archived at www.fdp.com.)

AstraZeneca is looking at RFID as seriously as any other drug company, but executives are mindful of the technology's limitations in its current form. To be useful for product verification, RFID must be used on the unit level. Today's RFID systems just can't run fast enough, says Michael Forehand, senior manager for corporate packaging technical services.

"What's yet to be seen is whether the software and hardware can meet our production needs," Forehand says. "The technology isn't quite there yet to be able to write those tags at the speeds we would like to" on high-speed packaging lines. One possible solution--having the tags pre-encoded by the vendor--is not preferable for AstraZeneca, which prefers keeping that function inhouse.

AstraZeneca is taking a proactive approach to RFID. This includes active participation in the standards setting process, led through EPCglobal, and through the planned execution of a pilot in 2006. AstraZeneca plans to pilot RFID in 2006 using both RFID tags and bar codes to provide serialization. This pilot will include serialization to the lowest unit of sale, along with individual cases.

AstraZeneca already uses bar codes at the case level with certain wholesalers, Murtha says. "The concept will take it down to the bottle level," he says. "Because of the way we sell products--on a unit basis--we're going to have to track on a unit basis." If and when RFID technology matures sufficiently, it should be able to supplant bar codes, Murtha adds.

International efforts

AstraZeneca's status as an international corporation also has implications for packaging. The company generates just over half of its sales outside the United States. As a result of straddling several oceans, AstraZeneca must balance the advantages of sourcing packaging materials locally with the need to standardize manufacturing generally. This balance is especially important in pharmaceuticals, where manufacturing standardization is important for both quality control and regulatory compliance.

"At the global level, we set the strategy for sourcing, taking into account the needs of various markets, whether it be formulation or packaging. Within that, from a packaging perspective, we try to package as close to the customer as possible," Murtha says. "But at the same time, we have the opportunity, from a risk-mitigation standpoint, to have similar processes around the world. So in the event that we register products in more than one facility, which is quite common, we're able to convert easily in case we have a business interruption of that site. While we haven't had to do that, we still have that contingency in place."

Another company-wide initiative is streamlining in stock-keeping units (SKUs). The company must balance the need to provide the unit-of-use packaging that customers want with the need to keep inventories manageable. Globally, that's not a problem as long as AstraZeneca continues to get good information from its customers, says Thorpe.

"As long as you have a responsive supply chain responding to real demand, then it shouldn't really make any difference in terms of proliferation of the end units," Thorpe says. "In fact, it can give us information we can use to help us drive the supply chain even better. We're linking directly into the wholesalers and the onward use, so we're seeing more early the real demand signal."

Streamlining in U.S.

AstraZeneca's real push for streamlining SKUs is happening in the U.S., Murtha says.

"We have a massive program underway on range management, which is our way of looking at what is the right mix of packages to have," he says. "We don't want an explosion of SKUs available, because it makes us less cost-effective at the end of the day, and at the same time it does not necessarily get us to the customer impact we want."

Packaging will remain an AstraZeneca priority, as the company continues to develop its understanding of what its customers truly want from packaging, Monday says.

"There are a lot of people who thought there's not a lot you can do with packaging," Monday says. "You package your product in a white bottle and off it goes. Depending on the pack size, the end user may never see the AstraZeneca bottle. About five years ago that was the only answer we had. We've come a long way in truly appreciating what the physician wants in the sample closet. What do they need it to look like for brand and product recognition? What does the dispensing pharmacy really want? How can we help pharmacists best utilize shelf space? What does the patient want in their pocket? How do we support compliance with ease of use? How can we provide value to the patient through our packs? We've come a long way, and that has a lot to do with the fact that we have focused resources and time in this area. We are continuously thinking about the future, and not just the here and now."

Seroquel starter kit

Seroquel, one of AstraZeneca's flagship products, is used to treat schizophrenia and bipolar mania. Patients starting on it must follow a strict regimen with dosages that increase throughout the first week: 100 milligrams the first day, 200mg the second, and on up to 800mg by day seven.

The physician sample/starter package for Seroquel guides the patient through the regimen. The blister card includes 25mg, 100mg and 200mg pills. The Seroquel starter kit is packaged under contract at OSG Norwich Pharmaceuticals (www.norwichpharma.com). Making sure that the right pill gets into the fight blister is a priority.

The blisters are shaped to fit the pills, which differ in size. They are clustered in unique ways: the four 25mg tablets for day one are in a single strip, the 100mg tablets are in a rectangular pattern, and so on. This ensures that individual groups of blisters can fit only into the correct slots on the card. In addition, pills of differing strengths are blister packaged in entirely separate operations and are only combined in the final secondary packaging step and kept in separate rooms on the line until they're safely in the blisters.

AstraZeneca's main packaging team includes, from left: Kathy Monday, vice president for customer and technical operations; Rod Stull, the Newark facility's executive director and general manager; Barrie Thorpe, executive vice president of global operations; Ken Murtha, vice president of U.S. business operations; Mike Forehand, senior manager for corporate packaging technical services; and Tanya Harris, Newark's senior director of operations.

[ILLUSTRATION OMITTED]

Armidex starter kit

Arimidex is a treatment for post-menopausal women with early-stage breast cancer. The starter kit is an example of how branding can work for prescription medicine.

The package consists of a book-style paperboard box with a distinctive image of a woman with crossed pink boxing gloves--the Arimidex logo, symbolizing the fight against cancer. Inside the box, besides the bottle with the pills, is a booklet bearing the boxing-gloves image that explains the "In Your Corner" program. It's a monthly mailing of cancer-related topics: physical-fitness tips, humor and general advice on getting one's life back after cancer. It includes a postpaid card for registering with the program.

Crestor physician's sample

The physician's sample for Crestor, a treatment for high cholesterol, is an example of providing expanded space for information. The blister card, which holds seven tablets, is incorporated into a tri-fold wallet that includes information about the medicine and about cholesterol-related issues in general.

"This has come as a result of feedback from health care practitioners and physicians. They're looking for tools to be able to educate their patients, and we've done that with Crestor," says Kathy Monday, vice president for customer and technical operations. "We've given them the tools within the context of this wallet pack."

From Arimidex to Zomig: AstraZeneca's major products

AstraZeneca PLC, one of the world's leading pharmaceutical companies, was formed in the 1999 merger of Sweden's Astra AB and England's Zeneca Group PLC.

The company concentrates in six therapy areas that, collectively, constitute a majority of known diseases: cardiovascular, gastrointestinal, neuroscience, oncology, respiratory and inflammation. Major products include:

Arimidex, for breast cancer.

Crestor, for cholesterol reduction.

Merrem, an antibiotic.

Nexium, for acid reflux disease.

Pulmicort, for asthma control.

Seroquel, for severe psychiatric disorders.

Toprol XL, for hypertension and other cardiac conditions.

Zoladex, for prostate and breast cancer.

Zomig, for migraines.

AstraZeneca's status as a prescription-medicine manufacturer means that the company must keep a steady stream of products in its development pipeline. The company spent $3.8 billion on R&D in 2004,with 11 R&D centers in seven countries. AstraZeneca has more than 64,000 employees worldwide, 11,900 of whom work in R&D.

COPYRIGHT 2005 Stagnito Communications
COPYRIGHT 2006 Gale Group

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