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News in brief, June 14, 2007

The latest news in brief

Financial news

Generex initiated with "Market Outperform" rating
Rodman & Renshaw analysts have initiated coverage of Canada-based drug delivery company Generex Biotechnology with a "Market Outperform" rating. The target price was set to USD 6. In a research note, the analysts mention that the company's oral insulin, Oral-Lyn, has the potential to be a significant player in the non-injectable insulin market. The analysts expect Generex to generate over USD 600m in revenues from Oral-Lyn by 2013, due to the drug's strong product profile and potential high increase in the diabetic population worldwide. The company has a pipeline of an early-stage cancer vaccine and two other smaller products in diabetics.

GSK major Canada investment on the cards
The world's second biggest drug company, GlaxoSmithKline (GSK), is making its Laval Quebec vaccine research centre and Quebec City vaccine production plant into the hub which will run its North American vaccine business, according to local media reports. GSK is the largest bio-pharmaceutical employer in Canada and conducts more than 100 studies there each year, with the participation of about 10,500 patients. The figure represents 10 per cent of its global clinical testing operations. The company also has 3,300 employees in Canada, of which 1,800 are based in Quebec. GSK's Canadian clinical study programme includes an intravenous and oral drug to prevent nausea among cancer patients undergoing chemotherapy. Commercial products include influenza and meningitis C vaccines. The company is one of only two manufacturers of influenza vaccines in North America and the only one to produce its vaccine in Canada. The federal government has a contract with GSK to supply five million doses of its anti-viral drug, Relenza. Around 50m doses of Tamiflu have been purchased from Roche to create a national stockpile of antiviral drugs. It also signed a 10-year deal in 2001 for GSK to develop and manufacture a vaccine to combat avain flu or other flu subtype pandemic.

Strides fixes bond conversion price for FCCB issue
Indian pharmaceutical company Strides Arcolab has completed a USD 100m convertible bond issue and has also fixed an initial conversion price of INR 461.60 (USD 11.36) per share. The Foreign Currency Convertible Bonds (FCCBs) issue was for raising USD 75m. Barclays Capital, the lead manager to the issue, also had an option to increase the issue size by USD 25m. The initial conversion price per share represents a 34.2 per cent premium over the closing price of INR 342.7 (USD 8.44) on the National Stock Exchange. Application would be made for the bonds to be listed on the Singapore Stock Exchange and for the shares, to be issued upon conversion, on NSE and BSE, Strides said in a note to the Bombay Stock Exchange while announcing the terms for the issue due on 2012. The yield to maturity was fixed at 7.57 per cent and the bonds would be redeemed at 145.05 per cent at par on 27 June 2012, the company added. Barclays Capital was the bookrunner and lead manager for the offering and State Bank of India was the financial adviser to the issue. The shares of the company were trading at INR 331 (USD 8.15), down 3.2 per cent on BSE in early morning trade. Strides also revealed it had acquired Grandix Pharmaceuticals for INR 1bn (USD 24.7m), marking its first such acquisition on the Indian pharma market. The company, which financed the purchase by debt and internal resources said the deal would enable it to ramp-up its businesses and introduce its own products into the Indian market. Post acquisition the immediate plan is to leverage existing products of Grandix with Strides' R&D pipeline. It will increase field sales strength nationwide to 400 from July 2007.

Actavis says no to takeover bid from its own chairman
Actavis, the Iceland-based generics drug company, has rejected a EUR 0.98 a share offer from Novator, the investment vehicle of Bjorgolfur Thor Bjorgolfsson, Iceland's richest man, who already owns 38.5 per cent of Actavis. Novator may be buying Actavis, as its shares have traded below the offer price in recent weeks. Bjorgolfsson faces strong competition for Actavis if Stada Arzneimittel, a rival German generics drug company, also makes an offer. According to West LB analysts, a Stada bid could make sense as the EUR 3.3bn take-out price might be manageable, the geographic fit was excellent and it would bring increasing scale, particularly in Europe. The analysts noted that if Bjorgolfsson did turn Actavis private, he could also pursue a merger with Stada.

Medical Solutions to buy Geneservice for USD 7.7m
Medical Solutions, a UK-based diagnostics and healthcare group, has revealed it will acquire Geneservice for GBP 3.9m. Geneservice offers genomic products and technology services for applications in life sciences and clinical R&D. Revenue for the year to end February increased 35 per cent to GBP 2.4m. Medical Solutions said the acquisition was in line with its strategy to grow its healthcare and diagnostics business by enhancing its portfolio to include DNA- and RNA-based techniques. The company added there would be cost savings from the acquisition "largely based on the relocation of some or all of Geneservice's operations from Cambridge to Nottingham." Geneservice's CEO, Tom Weaver, will join Medical Solutions Board. Geneservice was spun out from the Medical Research Council facility of Cambridge University in August 2005 and employs approximately 35 people.

Industry news

J&J reveals growth strategies for pharmaceutical and consumer arms
J&J has underscored its commitment to the pharmaceutical and consumer businesses at a meeting with financial analysts, describing its broadly based healthcare business as "strong and poised for continued growth in the coming years". Senior leaders from the company outlined the current pharmaceutical and consumer business portfolios and growth strategies that will enable the company to capitalise on growing demand in the area of human health and well-being. Vice-chairman Christine Poon said the company believes it is uniquely positioned with its breadth of businesses and flexible operating model to outperform its competitors in a USD 4tn global market for health solutions. She discussed several early-stage ventures that illustrate how the company cultivates innovation across its broad base of businesses. The ventures are based on collaborative work that leverages capabilities and resources across the company's three business arms: consumer, pharmaceuticals and medical devices and diagnostics. Poon also described projects for retinitis pigmentosa, a treatment for uncontrolled bleeding, a therapy to fight cancer cells using a patient's own strengthened immune cells and a technology for "smart" consumer products that uses tiny molecules to attach substances onto the body and allow them to be removed easily.

BMS pleads guilty in Plavix case
US pharmaceutical company Bristol-Myers Squibb (BMS) has pleaded guilty to making false statements to a federal agency, ending an unusual criminal case involving its blockbuster blood-thinning drug Plavix (clopidogrel). The case, which ended on 12 June, involved accusations that the company had entered a secret deal to head off generic competition to Plavix, its biggest-selling product. The investigation began last summer with a search of the company's New York headquarters by federal agents and it led to the dismissal of CEO, Peter R Dolan. The investigation ended with relatively minor charges against the company. During a 30-minute hearing in federal court, Judge Ricardo M. Urbina fined BMS a mere USD 1m. The sentence had been worked out beforehand in an agreement between the company and the Justice Department's antitrust division. While the company pleaded guilty to making false statements, after the hearing it issued a statement saying that it was merely taking responsibility for the actions of one former executive.

PhRMA conducts counterfeiting study
Continuing its efforts to raise awareness about the dangers of drug counterfeiting, Pharmaceutical Research and Manufacturers of America (PhRMA) is publicising a new report from the Organisation for Economic Cooperation and Development which stresses the seriousness of the issue. The report, called "The Economic Impact of Pirating and Counterfeiting", is based on data from customs seizures in OECD countries. It includes pharmaceuticals among the categories of products that are counterfeited with the most serious results, calling fake drugs "a major problem" in Africa and also pointing to large seizures made in the EU and North America. "The OECD report reinforces PhRMA's concerns about this dangerous trend and the possibility of counterfeit medicines creeping into the US drug supply system, particularly if Congress opens the floodgates to imported medicines from abroad," PhRMA President & CEO Billy Tauzin said in a statement.

Collaborations news

Kissei and Eisai sign to co-develop and commercialise Glufast
Japanese pharmaceutical companies Kissei Pharmaceutical and Eisai have signed a license agreement for Glufast (mitiglinide), a rapid-acting insulin secretagogue originally created and developed by Kissei. Eisai gained the exclusive development and commercialisation rights for Glufast in a total of 10 Association of Southeast Asian Nations (ASEAN) countries from Kissei. Glufast has been marketed in Japan since 2004 and lowers increased post-meal blood glucose levels by improving insulin secretion close to a natural pattern with a faster onset of action than sulfonylurea insulin secretion stimulants (SU drugs). Kissei is developing in-house products including Glufast and Urief, a drug for improvement of dysuria, globally through out-licensing. Glufast has been marketed in South Korea and is in development in other regions including North, Central and South America, India and the Middle East by licensing out its development and commercialisation rights to other companies. Eisai's business strategy is to develop new businesses in ASEAN countries with global products including Aricept, the treatment of Alzheimer's disease, and a proton pump inhibitor Pariet, together with in-licensing products from its business partners. In particular, Eisai has a strong marketing infrastructure established with the peripheral neuropathy treatment Methycobal in the area of diabetes and other metabolic disorders.

Thermo Fisher signs marketing agreement with Megaware
 US-based laboratory and research service provider, Thermo Fisher Scientific (TFS), has announced a strategic partnership with software products and services company Megaware, to deliver a new bioanalysis/ equivalence solution and joint support services for pharmaceutical, biotech and Contract Research Organisations (CROs). TFS and Megaware will market a new comprehensive end-to-end software solution which provides bioequivalence functionality on a single platform to help speed up and manage clinical trials. The new solution offers higher throughput, greater levels of compliance and standardisation of bioequivalence processes. TFS says that rapid market growth in generic drug production is driving the requirement for fast efficient bioequivalence studies to meet FDA Abbreviated New Drug Applications guidelines (ANDA). The two companies will work together closely to target the market for bioanalysis/ equivalence studies, initially in India and thereafter across the Far East and other markets. The consultancy firm McKinsey estimates that US and EU pharmaceutical companies will spend USD 1.5bn per year on clinical trials in India by 2010. Thermo Fisher and Megaware will jointly sell, market and support the new solution in the field.

Kurve and Schering-Plough sign expanded technology agreement
Kurve Technology, a leading developer of nasal drug delivery devices, and Schering-Plough (S-P), a global science-based health care company, have announced a new agreement which further expands S-P's evaluation of, and option for exclusivity rights to, Kurve's Controlled Particle Dispersion platform from a single field to multiple fields of use. Kurve's Controlled Particle Dispersion (CPD) contains six critical-to-function design parameters that enable modification of deposition and droplet characteristics. The result is a flexible intranasal technology platform that can deliver virtually any liquid drug -solution or suspension - regardless of formulation characteristics, including viscosity, surface tension or molecule size. CPD enables pharmaceutical companies to deliver topical, systemic, nose-to-brain drugs and vaccines with minimal peripheral deposition to the lungs and stomach. CPD powers Kurve Technology's ViaNase electronic atomiser product line.

Archemix and Takeda to enter into collaboration
Takeda, Japanís largest pharmaceutical company, has signed a multi-year, three target agreement with US-based Archemix to focus on the discovery, development and commercialisation of first-in-class aptamer-based therapeutics. Per the agreement, Archemix will receive an upfront payment of USD 6m from Takeda to discover and generate product candidates to three disease-associated targets identified by Takeda. Takeda gain exclusive, worldwide rights for research, development, manufacturing and commercialisation for any resulting aptamer-based products. Archemix will also receive committed research funding and research and clinical development milestone payments for each target selected for therapeutic development. Archemix will also earn royalties and milestones on worldwide sales of the developed aptamers commercialised by Takeda. Detailed financial terms were undisclosed.

Regulatory and approvals news

Remicade wins EU approval for paediatric Crohn's disease
The EU Commission has approved a new indication for US-based Centocor's Remicade (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in paediatric patients aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immuno-modulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. The approval follows a positive opinion granted in March 2007 by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA). Infliximab is the first and only biologic therapy approved in the EU for the treatment of paediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhoea, fever, abdominal pain, weight loss and, in some patients, delayed development and stunted growth.

Generic biotechnology drug bill date pushed back
The 13 June mark-up date for a Senate bill which would allow FDA to approve generic versions of biotechnology drugs has been pushed back a week, according to a spokesperson for Senate Health, Education, Labour and Pensions Committee Chair Edward Kennedy. The bill (S 623) was introduced earlier in 2007 by Senators Charles Schumer and Hillary Clinton. It would allow FDA to approve "comparable" and "interchangeable" generic versions of biotech medications through an "abbreviated" process. The legislation would not specifically require companies that seek to market generic biotech medications to conduct clinical trials, but it would allow FDA to require trials on a case-by-case basis (Kaiser Daily Health Policy Report, 4/13). Media reports say that the mark-up of the generic biotech bill was delayed by the immigration debate in the Senate.

FDA accepts priority review for Erbitux
ImClone Systems and Bristol-Myers Squibb (BMS) have confirmed that the FDA has accepted, for filing and review, a supplemental biologics license application (sBLA) for Erbitux (cetuximab). With this application, the companies seek to include evidence of improved overall survival in the product labelling for the drug in the third-line treatment of patients with metastatic colorectal cancer (mCRC). Both companies also announced that the sBLA has been granted a priority review. The likely FDA action date for the sBLA is early October 2007. If the sBLA is approved, Erbitux would be the only biologic therapy to demonstrate overall survival as a single agent in patients with metastatic colorectal cancer. The sBLA, which is based on results from a large, randomised, multi-centre, phase III trial, seeks to update the monotherapy indication to include patients with EGFR-expressing mCRC whose disease has progressed following, or who were not candidates to receive, irinotecan- or oxaliplatin-based chemotherapy. The sBLA also seeks to include data on overall survival relative to best supportive care. Currently, in mCRC, Erbitux is indicated as a monotherapy for EGFR-expressing mCRC patients who are intolerant to irinotecan-based therapy. The drug is also approved in combination for the treatment of EGFR-expressing, mCRC in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy; this combination indication would remain unchanged. These indications were approved based on objective response rates.

Teva wins court decision over generic Lotrel
Teva Pharmaceutical has revealed that the US District Court for the District of New Jersey vacated a temporary restraining order in effect since 23 May 2007 and denied a motion filed by Novartis for a preliminary injunction related to Teva's amlodipine besylate/ benazepril products, a generic version of Novartis' Lotrel. The court found that Novartis was not likely to succeed on its allegations of infringement. Teva intends to resume commercial shipments of its amlodipine besylate/ benazepril products immediately. Teva's amlodipine besylate/ benazepril products were approved by the FDA on 18 May, with Teva immediately commencing commercial shipment. Annual sales of the brand product were approximately USD 1.4bn in the US, according to IMS MIDAS data. As the first company to file an Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification, Teva was awarded 180 days marketing exclusivity from the date of initial shipment. Over 76 per cent of Teva's sales are in North America and Europe.

US to introduce FDA drug safety law
A House of Representatives subcommittee will introduce legislation giving the FDA more power to monitor prescription drug safety and side effects. In May, a similar bill was passed and this pending legislation will contain a number of provisions to that bill, including limits on consumer drug advertisements and symbols on newly approved medications to alert patients of possible risks involved with taking certain drugs. It "would strengthen FDA's post-marketing drug safety authority, provide greater transparency" among other changes, House Energy and Commerce Health Subcommittee Chairman said in a letter. The panel is planning to hold a hearing for the bill on 12 June and vote on the bill on 14 June. An interesting provision of the new bill would make it possible for the HSS to ban the advertising of drugs for up to a three year period. The FDA would also be required to review data for prescription drugs after they have been on the market for a seven-year period. If the bill makes it all the way to the President, it will need to match with the version that was approved by Senate in May.

Lilly loses Zyprexa patent challenges in Germany and Canada
Eli Lilly has lost court cases in Germany and Canada to preserve patent protection for Zyprexa (olanzapine) in these countries. Zyprexa, which is an antipsychotic compound for use in schizophrenia, bipolar disorder and other indications, racked up FY06 sales of USD 4.4bn, accounting for about a quarter of all Lilly's revenues. Lilly has said it does not expect the negative legal outcomes to affect its 2007 financial guidance. The unchanged financial guidance was as much a result of the US companies previously published ìvery conservativeî financial estimates, as the simple fact that Lilly has been appealing these decisions. The generic firms in question may wish to halt immediate production of their Zyprexa copies until the appeal decisions are made. Lilly has already won a US patent case regarding Zyprexa, and most of its US patents are safe until the 2011 expiry date. The Canadian decision could impact on US sales through cross-border importation of generic Zyprexa, if it becomes available in there. Lilly still holds onto its marketing exclusivity for the drug in Canada and Germany, however, so generic manufacturers are unlikely to risk launching their versions. In other news, Lilly has been reported as ìplanning to pour USD 100m into China over the next five years to expand its drug research capacity in a bid to tap into the country's talent poolî. According to local media reports, Lilly said it would primarily beef up its R&D activities in biology, chemistry and clinical research areas.

Medical education news

WebMD and CDC team up on breast cancer med education
WebMD has teamed with the Centers for Disease Control and Prevention (CDC) to educate clinicians on providing appropriate and timely care to women with early signs of breast cancer. In collaboration with Medscape from WebMD, a US-based provider of online medical information and education for doctors and other healthcare professionals, the CDC has developed an online continuing medical education (CME) programme entitled "Follow Up of Abnormal Clinical and Imaging Findings of the Breast: Five Self-Study Modules for Primary Care Clinicians." The programme has been endorsed by the American College of Obstetricians and Gynaecologists (ACOG), which will promote the activities among its membership base of more than 50,000 physicians and other healthcare providers. The curriculum was developed to train physicians on the latest evidence, protocols and guidelines around detecting breast cancer. Available to registered Medscape members at www.medscape.com/editorial/public/breastcancer-cdc, the activity consists of five modules: Breast Anatomy, Physiology, and Pathology; Health History and Clinical Breast Examination; Workup of Abnormal Clinical Findings; Follow up of Abnormal Imaging Findings: Biopsy Methods; and Risk Management.

GSK herpes education
GlaxoSmithKline (GSK) has partnered with the Detroit Department of Health, the American Social Health Association and the National Medical Association on a new educational campaign called "Say Yes to Knowing", which is intended to raise awareness about genital herpes among African Americans in the Detroit area. African Americans have a genital herpes infection rate of nearly one in two, the firm noted. However, according to a recent survey commissioned by GSK, about 85 per cent of African American adults in Detroit are unaware of the high infection rate, while about 80 per cent are unaware that having genital herpes triples the risk of becoming infected with HIV. The campaign, which will run through the end of the year, includes local print and radio advertising directing the public to a website, www.herpes411.com where they can find information on how to have an open and effective conversation about the disease with their doctors. It also includes materials such as brochures and posters that will be distributed to doctorsí offices. GSK makes the herpes treatment Valtrex (valacyclovir). FY06 sales of Valtrex rose 24 per cent to reach GBP 845m, with US sales up 30 per cent to GBP 600m, driven by patients switching to suppression therapy.

NHS news

NHS avoids repeating budget deficit
The UK's National Health Service (NHS) under spent its budget to the tune of GBP 510m in 2006, meeting the government imposed sanction to avoid a third year in debt, but causing arguments over the level of cuts implemented and their effects on the service. Health Secretary Patricia Hewitt unveiled data for FY07 in England last week and added that she would resign if the NHS overspent again. The amount of the unspent funding has angered NHS staff unions who want the money to go toward pay rises. At the same time, doctors' leaders at the British Medical Association (BMA) said cuts in services had been excessive. In February 2007, the Department of Health said the NHS was on target for a small surplus of GBP 13m for FY07 from a total budget of GBP 70bn. NHS managers will receive nearly 10 per cent more funding in FY07 and should achieve another surplus of around GBP 400m. Hewitt warned that the surplus cash would not mean that a salary increase for NHS staff and nurses would be paid in one go. She said a decision to phase-in the 2.5 per cent rise had been taken to protect the economy from the threat of high inflation and was unrelated to the NHS's financial health.

People news

Acusphere appoints new senior vice-president
Drug delivery firm Acusphere has hired Patrick Gallagher as senior vice-president, of business development. Gallagher joins Acusphere with more than 25 years of pharmaceutical and healthcare business development, marketing and sales experience with leading companies, including Mylan Laboratories, Bristol-Myers Squibb and Johnson & Johnson. In his career, Gallagher has completed transactions totalling approximately USD 800m representing a wide variety of structures including in-licensing and out-licensing of product rights, co-promotion agreements, in-licensing of drug delivery technology, manufacturing supply agreements, joint ventures, divestitures and mergers and acquisitions. Gallagher's primary focus at Acusphere will be to evaluate licensing and partnering opportunities for Imagify, the company's lead product candidate, and other product candidates to further expand and fund the product pipeline.

New sleep research programme hire at Lilly
Eli Lilly has hired Dr Dale M Edgar to serve as executive director and chief scientific leader of Lilly's discovery sleep research programme. Edgar brings over 25 years of experience in the field of sleep research to Lilly's efforts to expand its research in this important disease state. He was formerly chief science and technology officer at Hypnion, a US-based biopharmaceutical company focused on treatments for sleep disorders. Edgar co-founded Hypnion with three other sleep and biological rhythms experts in 2000; Lilly subsequently acquired Hypnion in January 2007. Before founding Hypnion, Edgar was associate professor of psychiatry and behavioral sciences at Stanford University, and faculty investigator at the Stanford University Sleep Disorders Research Center in California.

Cadient appoints new vice-president for strategic innovation
Cadient Group, an interactive marketing agency serving the healthcare industry, has appointed Pete Dannenfelser as vice-president of strategic innovation. Dannenfelser brings more than 12 years experience in interactive marketing to the position and will be responsible for consulting to Cadient's client base on strategic best practices and contributing to Cadient senior management, operations and business development activities. Dannenfelser was the director of new channel development at Novartis, providing brand teams with a platform to discover, pilot and implement promotional innovations. He led cross-functional teams to analyse, execute and control innovative programmes across Novartis' marketing organisation, including projects in physician relationship management, multi-channel digital video and healthcare information technology. Dannenfelser will be based at Cadient Group headquarters in Pennsylvania and will report to recently appointed Chief Innovation Officer, William Reese. Dannenfelser has served on both domestic and global marketing teams for Johnson & Johnson Global Pharmaceutical Communications where he developed and implemented award-winning Internet strategies and tactics for the industry's leading brands.

Pharmatech new executive vice-president
Pharmatech Associates, a pharmaceutical and biotech manufacturing process company, has appointed of Warford S Reaney as executive vice-president of consulting and international operations. Reaney has more than 20 years of experience in managing the design, construction and operational qualification of biotech, biomedical, and R&D labs. His background includes overseeing the development and deployment of quality systems for biopharma organisations, and he is a specialist in cGMP integration. Reaney will leveraging his experience and expertise to spearhead the development efforts of Pharmatech's new International Consulting Group in Hyderabad, India, which will involve close collaboration with Pharmatech's strategic alliance partner, Aveta Lifesciences Private Limited, an India-based firm providing process, technical GMP and regulatory guidance to the Indian biopharma marketplace. Prior to becoming executive vice-president, Reaney was Pharmatech Associatesí senior vice-president of consulting and managing director of international operations.

Porter Novelli names new US partners
Porter Novelli has named five new partners, including Lisa Davidson, a 15-year veteran of the agency who leads the New York healthcare client group. "Davidson has led numerous global healthcare clients and demonstrated particular expertise in creating consumer and professional health campaigns," the agency said. The other new partners are: Wendy Hagen, head of the Strategic Planning & Research group in Washington, DC; Wayne Moretto, finance director for Porter Novelli's Europe, Middle East and Africa region; Brad MacAfee, executive vice president, Porter Novelli Atlanta; and Frank Peters, managing partner of Porter Novelli's office in the Netherlands.

Palio hires more staff
Saratoga Springs, New York-based Palio Communications, a unit of inVentiv Health, has made four new hires: Michelle Brandriss, account supervisor; Adrianne Deihl, art buyer; Rafael Holguin, senior vice-president/director of design; and Mark Thompson, vice-president/senior brand planner. Brandriss was previously director of corporate accounts at Wurld Media, where she was responsible for client relations and account development, among other duties. Deihl was a staff producer at Mountain View Group, while Holguin was vice-president/ design director at Y Brand and GSW Worldwide, New York, overseeing brand identity development for clients such as Eli Lilly, Merck and Cephalon. Thompson most recently ran his own consulting business, but his resume also includes senior-level brand planner positions at Ogilvy & Mather, TBWA Chiat/Day and Campbell-Ewald. Palio also announced that it has become the agency of record for nearby Saratoga Hospital, with responsibility for developing and executing integrated consumer marketing and promotion programs including radio, TV, print and new media.

Pacific signs up new group supervisor for Botox account
Costa Mesa, California-based Pacific Communications has hired Jennifer Louie to serve as account group supervisor for the agency's Botox therapeutic account, giving her responsibility for leading professional promotions for US marketing and projects for the global marketing, clinical development, new technologies, and reimbursement groups. Louie was most recently an account director for GSW Worldwide. In addition to its cosmetic uses, Allergan's Botox is approved to treat cervical dystonia, blepharospasm, strabismus and severe underarm sweating.

Burson hires new multicultural MD
Burson-Marsteller has hired Mireille Grangenois to serve as managing director of the agency's Multicultural Practice, reporting to Patrick Ford, US president and CEO, and Tony Telloni, New York market leader. Grangenois was most recently vice-president for advertising at The Baltimore Sun, where she focused in part on building the newspaper's relationship with Maryland's African-American community. She has also held advertising and marketing positions at The Washington Post's interactive division and Philadelphia Newspapers. Earlier in her career, she was a journalist at USA Today and Business Week. In her new role at Burson, she will have responsibility "for building the firm's expertise in developing communications strategies designed to reach key multicultural communities such as Hispanics and African-Americans, among other multicultural audiences." She will also help to develop Burson's internal diversity strategy.

Iroko appoints new CMO and vice-president of R&D
Iroko Pharmaceutical has appointed Dr Susan Langer as CMO and vice-president of R&D. Langer will report to Iroko's President and CEO, John Vavricka. Langer has over 20 years of clinical development and regulatory strategy experience in the pharmaceutical industry. She also has global development expertise in numerous therapeutic areas including analgesia, neurosciences, cardiovascular diseases and diabetes. For the past 15 years, Langer has held various positions of increasing responsibility at Bristol-Myers Squibb (BMS). Most recently, she was the executive director of global pharmacovigilance and epidemiology for BMS. Iroko has also made additional appointments to the executive team: Veenita B Bleznak was appointed vice-president and general counsel effective on 4 June and will oversee all legal matters. She brings over 12 years of transactional, securities and venture investment experience. Humphrey Harte has been appointed vice-president of commercial operations Europe and will oversee commercial operations, strategic alliances, distribution and regional partnerships. His most recent position was vice-president of commercial operations Europe for Novartis Vaccines. Finally, Michael Spector was appointed vice-president of commercial operations international and North America and will oversee commercial operations. Spector has over 17 years of global pharmaceutical experience with significant operational experience in the US, Brazil and South Africa. Spector was vice-president of global product strategy for GSK.

14th June 2007

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