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Alan Camilleri, chairman of Malta Enterprise—the government agency responsible for facilitating and stimulating the economic development of Malta—recalls the words of a foreign investor, who had a taken stake in Maltese business. The investor imagined what he would say to other potential promoters, if asked whether they should put their finances into some venture on the island. Camilleri remembers: "He would bluntly tell them, 'Why 

This confidence is true of a great many foreigners that have undertaken projects in Malta. Once initially enamored by the island, they stay, and they grow. Over the past decades, the Mediterranean nation has actively positioned itself as an appealing epicenter for global interest. Its efforts have not gone unnoticed. Tonio Fenech, the Minister of Finance, the Economy, and Investment, notes that in 2008, 

 magazine ranked Malta as the fifth most tax-friendly country in the world, and the single most attractive country in the European Union in terms of taxes and social contributions paid out by companies. In that same year, the World Economic Forum named Malta the 27th most networked economy in the world; the Global Financial Centers Index (GFCI) identified it as one of the top three financial centers likely to increase in importance over the next three years; and the GFCI further listed it among the financial centers where operators might think of opening in the next five years. These accolades begin to suggest why entrepreneurs relish Maltese prospects.  

The Malta pharmaceutical industry is a prominent example of the international investment momentum taking hold in the country. It is an industry that already employs over 1,000 people and exports more than €150 million ($205 million) in products per year—to Europe, and even beyond. "Most notably," Camilleri says, "Malta is experiencing significant expansion of current operators, and this is a sign of confidence in the local environment." 

 Alan Camilleri, Executive Chairman of Malta Enterprise			

This local environment is marked by an attractive legislative framework, championed by Malta Enterprise. In particular, the Business Promotion Act and the Malta Enterprise Act are helping to position Malta as one of the most progressive and proactive business environments in the world. Pharmaceutical players that come to the island enjoy low taxes, financial support and loan guarantees, logistical and workforce training assistance, and even ready-built factories provided by Malta Enterprise. An imperative legislative point centers on the inclusion of the Bolar Exemption in Maltese law: This provision allows third-party companies to conduct clinical trials and commercial testing on patented medications—with the intention of improving on the patent or producing a cheaper generic version—before the drug patent expires. In an industry where speed to market is crucial, generics companies situated on the island can complete preparatory testing in advance, and bring their products immediately after patent termination. The Bolar Exemption is instrumental in the consequent proliferation of generics manufacturers in the country, and Malta currently has more than 15 such operators, from all over the world.  

The island also prominently invests in its infrastructure and human resources. For example, the Maltese have recently invested in a €20 million ($27 million) Life Sciences Park, and Finance Minister Fenech notes that the government "works very closely with the University of Malta, other private universities, and the Malta College of Arts, Science, & Technology, so that, in tandem with industry, the necessary academic formation is provided" for the sciences. This academic emphasis equates to a highly skilled work force, with a much-needed English proficiency.  

Malta uses its small size to its advantage: Camilleri explains that, beyond even the Bolar Exemption, Malta's small market size helps generics players because most foreigners do not bother to register additional patents uniquely for the island. Compactness also facilitates swift and efficient decision-making, according to Finance Minister Fenech. And because of its small size, Malta enjoys well-developed infrastructure, and long-term stability. 

Tonio Fenech, Minister of Finance, the Economy, and Investment			

Finally, Malta is strategically located, with easy access to Europe and North Africa. If one considers its location together with its competitive costs, it becomes quite apparent that Malta is, in the words of Camilleri, "a unique hub for combining testing, R&D, manufacturing, production, and batch release of pharmaceuticals," a happy hunting ground for any pharma player.  

Malta investors, elucidating their operations on the island, demonstrate that commercial reality robustly corresponds with the intentions of the national government. Sergio Vella, managing director of Actavis Malta—a division of one of the largest generics manufacturers in the world—explains the rationale that his company employed in choosing the island for a large-scale facility. He concedes that the Bolar provision is a first enticement. But Vella explicates the more decisively persuasive factors: "strong fiscal and legislative incentives;" the "quality and talent of the people;" the renowned regulatory system; the "extremely supportive and proactive local authorities;" and Malta's recent EU membership. 

Sergio Vella, Country Manager, Actavis			

Other pharmaceutical companies in Malta reiterate and expand upon Actavis's praise. Ian Restall, general manager of Metallform Malta—part of the German Metallform GmbH, a manufacturer of precision medical instruments—believes that his employees produce a superior output that is "as good as it is in Germany"—sound tribute, given the distinguished German manufacturing tradition.  

Another generics company, the Spanish Corporación Medichem, has two facilities on the island, one for the manufacture of generic finished dosage forms—under the name Combino Pharm—and another for the development and manufacture of APIs, under the Medichem name. The Medichem plant manager, Dino Mangion, fondly remembers that the national administration greatly helped his company when Medichem first arrived, through "aid in the construction of facilities" and the supply of "professional advice and contacts."  

Mangion's counterpart at Combino Pharm, plant manager Patrizio Allegrucci, will agree with the sentiments of his colleagues—and add that, despite the seeming labor shortage inherent in a minute population, the government dynamically works with the pharmaceutical players, doing its "utmost to shorten the gap" by partnering with companies to "embark on specific training programs." 

Malta is a focal point of the global aspirations of its pharma enterprises. Actavis's Vella remarks, "The support and investment Actavis has received from its parent company is indicative of the faith they have in the local operations." Indeed, over the past six years, Actavis headquarters has invested about €50 million ($68 million) to develop and amplify its presence in the country—and it certainly capitalized on its investment. The generics it develops and manufactures in Malta are exported not only regionally, but also globally. And one of Malta's key functions is its capacity as a chief launch site for the group. 

The Maltese subsidiaries of Corporación Medichem, too, accentuate Malta's role in the global activities of their principals. Clearly, with the dual operations of two disparate plants, Corporación Medichem chose Malta as a global center to encompass a comprehensive range of services. Mangion asserts, "In 2009, the Malta site contributed about 8% of the company's sales. In 2011, this should increase to about 35%." These Maltese enterprises have grown, and will continue to grow. 

Metallform's Restall declares, "My advice would be to come to Malta!" He continues: "You'll stay—and if you stay, you will be successful." Foreign investors have no shortage of affection for this Mediterranean polestar. 

When asked if Malta is curbing its national trajectory by favoring generics manufacturing, Finance Minister Fenech disagrees, and points, convincingly, to the island's newest investment in innovation: the Life Sciences Park. 

The facility will be the site of advanced research laboratories in medicine, genetics, and biotechnology. It will house offices and common spaces for the exchange of ideas. It will accommodate a business incubation center for scientific enterprise. It will be the nascence, in Malta, of a veritable biotechnology industry. 

As may be expected, Malta Enterprise has a strong hand in the Park's formulation. When chairman Camilleri extrapolates some of the intended inhabitants of the facility, he mentions research institutes, technological firms, multinational startups, education centers, medical training centers, and formulation and testing companies, among others. An ambitious list, to be sure.  

According to Camilleri, the site will also "enhance the possibility of cluster investment, whereby a number of companies can be attracted through the presence of another company," working in a similar line. Finance Minister Fenech advocates the Park as a setting where scientifically minded youths, and seasoned researchers, can cultivate their studies without having to leave the country.  

Of course, while the Life Sciences Park may be the first aggregate, national approach to stimulate pharmaceutical advancement, it is not the only game in town. Take, for example, the Institute of Cellular Pharmacology (ICP), a research-based company that investigates plant extracts and their possible beneficence in human and animal applications. To date, their work has produced almost 30 theses and over 40 patents. 

ICP chose Malta for operations because they believe that, on the island, "Small is beautiful." To extrapolate: "Malta is a small village by global scale, yet it has all the amenities needed to undertake research found in much bigger states. All the tools needed to support research activities are found in a village square." The group finds that the proximity of these amenities "makes progress very rapid." 

Patrizio Allegrucci, Combino Pharm Plant Manager			

As other pharma players do, ICP invites investors to the island. In a place where small is beautiful, research, too, is experiencing a beautiful surge.   

Malta boasts a celebrated medical history, from the time of the Crusades. Today, Malta aims to draw to its facilities international patients seeking adept therapy outside of their own country, as the government advocates Health Tourism.  

St. James Hospital—headed by Dr. Josie Muscat, president and chairman—is leading this impetus. Muscat notes that St. James Hospital offers an inspiring range of medical services and facilities, and it is furnished with state-of-the-art equipment, including numerous advanced surgical instruments, and a superlative laboratory. "In short," Muscat says, "anything a patient requires is available at St. James."  

Moreover, when foreign patients seek treatment at the St. James complex, they find not only cutting-edge resources, but also a wealth of comforting services. Muscat lauds the nearby hotels and Malta's welcoming atmosphere. The small island also offers accessible cultural attractions to compliment a patient's rehabilitation period—"making medical tourism true to its name." 

Muscat sees immense potential in Maltese medical tourism. The facilities, certainly, are already there, and the industry is starting slowly to convalesce as foreigners become assured of Malta's prowess in healthcare. Muscat is resolute, saying, "We are determined to make our island once again the hospital of the Mediterranean." Already a rising global player in pharmaceuticals, Malta aspires to lead in the field of healthcare as well. 

When interviewed, Malta Enterprise executive chairman Camilleri had some closing thoughts regarding the national pharmaceuticals sector. His message is uncomplicated, and sincere: "We are a small country, but we are quick to deliver, efficient, and offer specific competitive advantages to ensure the long-term sustainability of the industry. The vast majority of our foreign projects come to Malta, and then grow and consolidate through Malta." Maltese investors have and will attest to his words—and foreigners contentedly flourish praise on Malta. 

Malta too flourishes. It constantly advances its ambitions: Already a generics hub, it will also become a true research hub. Already satisfying the healthcare needs of its own, it will also satisfy those of the world. Its past and prospective initiatives, under the umbrella of the Government's Vision 2015, pave the way. 

Small is genuinely beautiful on this Mediterranean island. The aims of its people, certainly, are cosmic. These are Malta's parting words. 

Articles

The mediterranean nation has endeared itself to foreign businesses over the past decades, adtively positioning itself as an appealing epicenter of global pharma interest

Malta: A healthy location for the pharmaceutical industry

Everyone is preparing for a bumpy ride this year in Washington. The conventional wisdom is that President Obama has a year to enact new legislation before the political infighting becomes even more intense leading up to the 2012 presidential election. But the political tensions created by last November's mid-term elections make gridlock more likely. 

 Jill Wechsler Congressional Republicans will seek to cut the federal deficit by squeezing budgets at government agencies. Pressure to find more resources will intensify federal efforts to levy stiff fines on rule-breaking pharma companies and to impose higher user fees on industry. Challenges to the Obama administration's health reform program will create uncertainties about whether new fees and policies will be implemented as planned, or if manufacturers will have to pay stiffer rebates and taxes without gaining the millions of additional customers promised by a reformed health insurance system.  

One certainty is that Republican Congressional leaders will spend considerable time and energy grilling Obama administration officials on reform shortcomings. A Senate Finance Committee hearing during last November's lame duck Congressional session was short and fairly friendly to Donald Berwick, administrator of the Centers for Medicare and Medicaid Services (CMS). But House leaders will not be so gentle in the coming months.  

A prime Republican target is the Independent Payment Advisory Board (IPAB). It was established by the Affordable Care Act (ACA) to propose cost-cutting policies for Medicare under procedures that limit Congressional oversight and legal review. But pharmaceutical companies, as well as insurers, providers, and even consumers are leery that IPAB will cut costs arbitrarily and will require seniors to pay more.  

Despite these obstacles, a number of reform initiatives are moving forward. CMS is publicizing additional preventive care benefits for seniors, while the IRS has crafted a process to calculate hefty new taxes on pharma companies required by the ACA. FDA is examining a host of policy issues related to developing biosimilars, including standards for product naming and interchangeability and what falls under the definition of "publicly available information." And the governing board for the Patient Centered Outcomes Research Institute (PCORI) held its first meeting last November and plans to assess what research is going on in this field and what information gaps it can fill with early projects that can illuminate PCORI's role.   

A top priority for pharma companies is to renew the Prescription Drug User Fee Act (PDUFA), which has to be reauthorized by October 1, 2012, for FDA to continue collecting nearly $700 million in fees to support its review process for drugs and biologics. Although that legislative deadline may seem far away, FDA wants to have a PDUFA V plan ready for public review by fall in order to transmit it to Congress by early 2012; failure to reauthorize user fees by summer next year theoretically would force FDA to lay off hundreds of staffers and shut down the review process.  

In April 2010, FDA's Center for Drug Evaluation and Research (CDER) launched a two-year process for revising PDUFA. CDER director Janet Woodcock noted that 65 percent of human drug review funding comes from user fees, a situation that some critics claim makes the agency overly dependent on industry. Yet, despite some qualms about the current program, no one suggests that FDA curtail any activities or cancel the fees.  

Pharma companies support user fees in general, but complain that multiple postmarketing requirements have slowed reviews and undermined approval time frames. Patient advocates, pharmacists, and doctors agreed that the proliferation of risk evaluation and mitigation strategies (REMS) make drug development more costly and complicates prescribing and dispensing. Consumer groups focused more on direct-to-consumer drug advertising, seeking user fee support for mandatory pre-review of DTC ads, clearer prescribing information, better protection of patients in clinical trials, and more comparative studies to ensure that new drugs are superior to those already on the market.  

FDA has been discussing these and other issues at meetings with manufacturers, patient and consumer groups, and healthcare professionals, part of a broad, transparent consultative process required by the FDA Amendments Act (FDAAA) of 2007. A main FDA goal for PDUFA V is to gain more flexibility in meeting review time frames, possibly by extending the review clock for more complex applications, such as those with REMS, that require advisory committee meetings, or that involve inspections of foreign manufacturing facilities. However, that could mean extensions for almost all important applications.  

The overarching issue is to what extent industry fees should fund FDA initiatives to improve drug development and regulatory science. FDA proposes to tap fees for more staff consultations on innovative clinical trial designs, on utilizing biomarkers in drug development, on complex manufacturing issues, and to standardize electronic submissions. The agency's wish list also seeks support for the Sentinel active surveillance system, meta-analysis standards, biomarker qualification, rare disease treatments, and improved dose selection and drug safety assessments. But this year's fee to process a new drug application (NDA) with clinical data already exceeds $1.5 million, and manufacturers fear that expanding the pool of activities supported by PDUFA would up the ante disproportionately.  

Because PDUFA is "must-pass" legislation, members of Congress are lining up with proposals for a broader FDA reform bill. Legislators want to refine the REMS program, curb drug advertising, expand drug re-importation, ban pay-for-delay deals between innovator and generics firms, require that drugs demonstrate comparative superiority, and grant FDA authority to pull drugs off the market and to issue subpoenas. Stay tuned for more.  

With healthcare consuming an ever-growing portion of federal and state budgets, authorities are looking hard to save money by cracking down on healthcare fraud and abuse. The Justice Department announced last November that it had recouped $3 billion in civil settlements and judgments last year, much of it from pharmaceutical companies. At the top of the list is Pfizer's $2.3 billion settlement for promoting unapproved drug uses, the largest healthcare fraud payment in history. AstraZeneca agreed to a $302 million civil settlement, Novartis paid $193 million, and Teva was hit with a $100 million fine.  

There's no sign of any letup: In October 2010, GlaxoSmithKline signed a $750 million settlement. Merck negotiated a $950 million deal with the Justice Department related to Vioxx. And last month brought in $421 million from Abbott, Boehringer Ingelheim, and B. Braun.  

Evidently dozens of pharma cases are under investigation, and the number will rise as layoffs breed dismissed workers eager to blow the whistle on former employers. Regulators and prosecutors are looking to convince CEOs that compliance with the rules is important by levying criminal charges against individual executives considered responsible for serious violations. The first shoe fell in November 2010 when the Justice Department charged a former GSK executive with making false statements and blocking an FDA investigation into off-label uses; the trial begins in February, and conviction could bring a jail term as well as fines.  

If the threat of jail doesn't compel manufacturers to clean up their acts, the prosecutors also are looking to ban companies committing fraud from doing business with Medicare and Medicaid. The HHS inspector general says it's aggressively pursuing exclusion penalties against executives who should or could have known of illegal behavior; the CEO of KV Pharmaceutical Co. was axed last year as a result, and more pharmaceutical executives may follow. 

's Washington correspondent. She can be reached at 

Columns

Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead

Politics & PDUFA

Digital has taken hold, mobile is growing rapidly, and print continues as a standard for marketing initiatives. So you might be asking yourself, which of these channels offers the most benefit, greatest reach, and best ROI? The answer is all of the above. But the challenge is in integrating them for greater impact. 

If your company's typical marketing efforts include running an e-mail campaign that drives recipients to an informational website, while for the same brand you have a separate campaign running a set of journal ads, as well as direct mail, all with separate vendors, tracking, and ROI grids ... you are not alone. However, the inefficiencies inherent with this traditional, segregated approach to campaigns will soon no longer be accepted by corporations or their customers.

With the continually evolving technology available, mixing a combination of multiple touch points across numerous channels with a consistent look and feel along with coordinated messages is quickly becoming the standard. The great thing about these integrated campaigns is that not only do they expand the reach of your marketing, but they are infinitely variable according to the needs and desires of the recipient, making it easier to efficiently and effectively market your products.  

The key to reaching customers in today's 24/7 marketing environment is delivering real-time communication with maximum relevance. Producing generic promotions are simply ineffective. By utilizing intelligent technology, you can achieve customization, brand control, and customer engagement.

Here are some considerations to take into account when developing a multichannel marketing campaign:  

 The first touch needs to be the most impactful and has the option of being introduced across multiple channels. Possible first touches for a campaign might include sending a direct mail piece to prospective clients, simultaneously sending an e-mail blast to current clients, or creating a brochure for the customer to pick up at a pharmacy or physician's office. While the options for a first touch vary, the one thing that every first touch must have is a call to action. The call to action can be a BRC card, a Personalized URL (PURL), a 2-D barcode that links to a customized mobile landing page, or any number of other points of contact you think might be how your customer wants to respond. The key is that the customer engages with the campaign in a way that is comfortable in order to obtain the additional information or services you are offering. 

 This engagement will most likely be where the call to action takes the customer. Typically, the second touch will be a customized landing page giving additional product or program information, either via traditional Web or mobile device. The purpose of the second touch is generally to drive the customer into a followup program consisting of multiple future interactions. The followup program could be a patient education newsletter, coupons for discounts on your product, or confirmations of an upcoming meeting. It all depends on the purpose of your campaign—and the options here are endless. 

 After the initial interaction with your customer in this type of campaign, there can be any number of followup items depending on the purpose or style of the multichannel campaign, including: a thank-you e-mail; direct mail to drive non-responders into the program; direct mail followup with responders; a newsletter; customized premium items (calendar books, note pads, etc.); additional website access; and periodic e-mail updates (patient information, reminders, etc.) 

The options for implementing a successful multichannel campaign are numerous, and with the correct execution, the impact potential and success rates for your campaigns can be greatly increased. Statistics have shown that including personalization in multichannel campaigns can have up to a 23.7 percent increase in response rates as well as generate as much as 23.4 percent in additional revenue.   

An effective, coordinated multichannel marketing campaign can be tailored to help achieve success for any marketing objective you may have. Here are two examples:  

This campaign could start with brochures and e-mails directed to patients taking Drug A. The e-mails are sent to patients the company has had contact with in past campaigns and are able to contact again. The brochures and e-mails drive customers to the company's website and mobile site via URL or 2-D barcode. Once they visit the website, the patient desiring further education and information on Drug A enters their information and agrees to the legal terms. This initiates another e-mail that is not only customized for the drug, but also personalized to the patient, and all touches from this point forward will contain the patient's name, personalized images around basic demographics, and interest information.  

A small magazine with information on the patient's disease as well as drug information is then sent along with a calendar that identifies the date that the patient indicated they began treatment, dates for refills, as well as reminders to see their physician for followup on their treatment. Additionally, the patient is given access to a symptom tracker app for their mobile device or a download for their home computer. Of course, with each touch it is essential to offer op-out options for the customers. 

Example 2: Invitations to a Program for Physicians 

A printed invitation is either directly mailed or delivered personally by a sales representative, inviting the physician to register for the program using either a 2-D barcode linked to a mobile registration page, a phone number provided on the invite, or by visiting a standard URL that takes the physician to a personalized registration page. After the physician registers, direct mail and e-mail blast reminders of the upcoming program are sent, and the physician is given the option to download meeting content and pertinent information to a mobile device. Once the program is completed, thank-you e-mails or cards can go out to attendees, as well as any followup surveys, questionnaires, or requests for additional information. 

There are additional considerations that should be kept in mind in order to assure the overall success of multichannel campaign programs. One is vendor selection if you are choosing to outsource production. Managing multiple vendors has the potential to be a nightmare when it comes to coordination. The solution is to find one partner that specializes in these specific campaigns and has invested in the technology to run the entire campaign under one roof from start to finish. Single vendor selection also simplifies overall reporting and measurement from the campaign and enables quick in-line changes that can enhance the efficacy of your campaign as well. 

Variability in the campaign is also important to ensure overall success. Recently, a marketing campaign was launched for a drug that treats a condition mainly affecting women. The ads and Web page had images of women and were clearly directed solely to them. However, the information on the drug and disease said that a small percentage of men get the disease as well. This is a perfect example of a situation that could benefit from personalization, so that when a man indicates he wants further information he gets brochures that incorporate images of men. The ability to lay out a full campaign with the capacity to automatically fill in the applicable variables will only further the effectiveness of your cross-media campaign. 

Getting the right mix for today's customers and meeting the marketing goals for your products means incorporating cross-media, multichannels, and personalization into every marketing campaign. Having the ability to employ a robust approach when it comes to delivering your marketing messages will increase your flexibility and success, allowing your company to touch customers where they are, no matter where that may be. 

is Director of Business Development—Life Sciences Division for EarthColor. He can be reached at 

Incorporating the proper blend of media into your marketing initiatives will help to increase the flexibility and success of your campaigns

The Right Mix for 2011

As noted in our cover story this month, the consensus is that 2011 will be a tough year for pharma. It must confront the biggest breaking wave of patent expirations, while fiscal retrenchment has created an innovation cycle in reverse, as payers find new ways to curb the drugs bill. Risk-averse regulators are transforming old tools such as the FDA "complete response letter" into a registration parking lot, with no exit ramp to connect companies to a distracted—and increasingly impatient—community of clinicians and consumers. Finally, stiff competition within therapeutic classes has created unheard of rivalries among companies that once were happy to share the same watering hole.

So as the daylight recedes on January, let's inventory a few of what I call the "night stalkers"—issues that are likely to keep members of the C-suite awake beyond a sensible hour.  

 Claims for malfeasances ranging from off-label promotion to deceptive pricing continue to mount, with more than $10 billion in compliance charges imposed on Big Pharma over the past five years. With a return on investment of more than 100 to one, in terms of what it costs to litigate, US and European regulators are pushing the extraterritorial reach of enforcement legislation to cover a potentially rich new vein of graft in emerging markets. The scope of action has quietly spread to include criminal charges against individual executives; eventually, a Big Pharma company will be barred from doing business with US government programs. "Tops in Fraud" is a ruinous moniker for pharma—a business so dependent on basic issues of trust, integrity, quality, and safety. When will the industry address the problem from an industry-wide reputational, as opposed to a strictly legal, standpoint? 

 Governments, academia, activists, and the media—all skeptical of the profit motive as a driver of a built-in bias—are applying conflict-of-interest rules to marginalize its role in decisions on everything from publication of clinical trial results to participation in scientific panels that drive access to new medicines. This narrow view is a powerful force behind the industry's eroding reputation. Yet little has been done to confront and reverse the perception that since drug companies have that simple motive to market, their input on virtually every issue cannot be trusted.  

 Know-how and expertise are tangible assets for pharma, ones that should be allocated sparingly to partners who may one day be competitors. This dynamic is particularly evident in the emerging markets, where governments have materialized as formidable industrial policy negotiators in insisting that new innovations be shared with local partners as a condition for market access. When a drug multinational has to score a deal where it shares production with a local firm, transfers the necessary technology, and, after a fixed period hands over all remaining exclusive rights to the partner—as Merck recently did in Brazil—one has to ask: How truly different is this from a compulsory IP license that the industry has always characterized as theft?  

 There is an emerging social contract that in many ways treats the industry as a quasi-public utility, with pressure to make costly commitments normally not expected of a private enterprise. These now include revenue and profit give-backs that conform to government fiscal targets or post-marketing surveillance activity (i.e. REMS) that require extensive funding of work extending beyond the normal product life cycle marked by expiration of the patent term. Risk-sharing contracts and expectations of "total health solution" approaches in an era of personalized medicine are examples as well. These may all be positive in the abstract, but the net effect will be still more pressure on the bottom line in 2011 and beyond.  

From the Editor

"Tops in Fraud" is a ruinous moniker for pharma-a business so dependent on basic issues of trust, integrity, quality and safety

The Night Stalkers

It's a new year. Even pharma, with its glacial timelines, has its "Out with the old, in with the new" moment. Welcome 2011!  

It's a new year. Even pharma, with its glacial timelines, has its "Out with the old, in with the new" moment. Welcome to 2011!

The List: 2011

 magazine ranked Malta as the fifth most tax-friendly country in the world, and the single most attractive country in the European Union in terms of taxes and social contributions paid out by companies. In that same year, the World Economic Forum named Malta the 27th most networked economy in the world; the Global Financial Centers Index (GFCI) identified it as one of the top three financial centers likely to increase in importance over the next three years; and the GFCI further listed it among the financial centers where operators might think of opening in the next five years. These accolades begin to suggest why entrepreneurs relish Maltese prospects. 

Alan Camilleri, Executive Chairman of Malta Enterprise			

 Tonio Fenech, Minister of Finance, the Economy, and Investment			

This local environment is marked by an attractive legislative framework, championed by Malta Enterprise. In particular, the Business Promotion Act and the Malta Enterprise Act are helping to position Malta as one of the most progressive and proactive business environments in the world. Pharmaceutical players that come to the island enjoy low taxes, financial support and loan guarantees, logistical and workforce training assistance, and even ready-built factories provided by Malta Enterprise. An imperative legislative point centers on the inclusion of the Bolar Exemption in Maltese law: This provision allows third-party companies to conduct clinical trials and commercial testing on patented medications—with the intention of improving on the patent or producing a cheaper generic version—before the drug patent expires. In an industry where speed to market is crucial, generics companies situated on the island can complete preparatory testing in advance, and bring their products immediately after patent termination. The Bolar Exemption is instrumental in the consequent proliferation of generics manufacturers in the country, and Malta currently has more than 15 such operators, from all over the world. 

The island also prominently invests in its infrastructure and human resources. For example, the Maltese have recently invested in a €20 million ($27 million) Life Sciences Park, and Finance Minister Fenech notes that the government "works very closely with the University of Malta, other private universities, and the Malta College of Arts, Science, & Technology, so that, in tandem with industry, the necessary academic formation is provided" for the sciences. This academic emphasis equates to a highly skilled work force, with a much-needed English proficiency. 

Malta uses its small size to its advantage: Camilleri explains that, beyond even the Bolar Exemption, Malta's small market size helps generics players because most foreigners do not bother to register additional patents uniquely for the island. Compactness also facilitates swift and efficient decision-making, according to Finance Minister Fenech. And because of its small size, Malta enjoys well-developed infrastructure, and long-term stability.			

Other pharmaceutical companies in Malta reiterate and expand upon Actavis's praise. Ian Restall, general manager of Metallform Malta—part of the German Metallform GmbH, a manufacturer of precision medical instruments—believes that his employees produce a superior output that is "as good as it is in Germany"—sound tribute, given the distinguished German manufacturing tradition. 

Patrizio Allegrucci, Combino Pharm Plant Manager 

Malta is a focal point of the global aspirations of its pharma enterprises. Actavis's Vella remarks, "The support and investment Actavis has received from its parent company is indicative of the faith they have in the local operations." Indeed, over the past six years, Actavis headquarters has invested about €50 million ($68 million) to develop and amplify its presence in the country—and it certainly capitalized on its investment. The generics it develops and manufactures in Malta are exported not only regionally, but also globally. And one of Malta's key functions is its capacity as a chief launch site for the group.  

The Maltese subsidiaries of Corporación Medichem, too, accentuate Malta's role in the global activities of their principals. Clearly, with the dual operations of two disparate plants, Corporación Medichem chose Malta as a global center to encompass a comprehensive range of services. Mangion asserts, "In 2009, the Malta site contributed about 8% of the company's sales. In 2011, this should increase to about 35%." These Maltese enterprises have grown, and will continue to grow.			

When asked if Malta is curbing its national trajectory by favoring generics manufacturing, Finance Minister Fenech disagrees, and points, convincingly, to the island's newest investment in innovation: the Life Sciences Park.  

The facility will be the site of advanced research laboratories in medicine, genetics, and biotechnology. It will house offices and common spaces for the exchange of ideas. It will accommodate a business incubation center for scientific enterprise. It will be the nascence, in Malta, of a veritable biotechnology industry.			

Of course, while the Life Sciences Park may be the first aggregate, national approach to stimulate pharmaceutical advancement, it is not the only game in town. Take, for example, the Institute of Cellular Pharmacology (ICP), a research-based company that investigates plant extracts and their possible beneficence in human and animal applications. To date, their work has produced almost 30 theses and over 40 patents.

This sponsored supplement was produced by Focus Reports 

For exclusive interviews and more info, please log onto  or write to 

Pharmaceutical Executive-01-01-2011

Malta: A healthy location for the pharmaceutical industry

Politics & PDUFA

The Right Mix for 2011

The Night Stalkers

The List: 2011

Malta: A Healthy Location for the Pharma Industry