First New IV Antihypertensive Treatment Approved in Ten Years

August 4, 2008, The Medicines Company announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Cleviprex, a novel IV antihypertensive, represents an advancement over currently available therapies, providing rapid and precise control of blood pressure in the critical care setting. Backed by comprehensive data in the emergency department, operating room and intensive care unit, Cleviprex offers physicians an important new therapeutic option for the management of blood pressure.

“Recent clinical findings highlight the relationship between controlling acute blood pressure and lower risk of adverse outcomes,” said Robert Califf, MD, Professor of Medicine and Vice Chancellor for Research, Duke University. “With the approval of Cleviprex, physicians have a new treatment option for intensive control of blood pressure that may advance the standard of care in the operating room, the intensive care unit and the emergency department.”

Cleviprex has a rapid onset and offset of action and can be titrated for precise blood pressure control. Unlike many current IV antihypertensive agents, which are metabolized by the kidney and/or liver, Cleviprex is metabolized in the blood and tissues and does not accumulate in the body.

“In the last decade, there have been no new IV antihypertensive agents introduced to the market,” said John Kelley, President and Chief Operating Officer of The Medicines Company. “Cleviprex presents physicians with a valuable option to effectively treat a broad array of patients who need rapid and precise blood pressure control.”

“With the approval of Cleviprex, The Medicines Company continues to deliver on its vision of advancing innovation in the critical care setting,” said Clive Meanwell, Chief Executive Officer of The Medicines Company.

Blood Pressure Management in Critical Care Settings

Poorly controlled blood pressure can be a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. Poorly controlled blood pressure can occur in a broad range of patients; it is frequently found in patients undergoing surgery and in patients presenting in the emergency department.

About Cleviprex

Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (>2%) seen with Cleviprex are headache, nausea and vomiting. Please see full prescribing information available at


About The Medicines Company

The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, as well as Cleviprex™ (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has one product, cangrelor, in late-stage development. The Company’s website is

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “believes,” “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company’s products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company’s periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company’s Quarterly Report on Form 10-Q filed on May 12, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
WeissComm Partners
Barri Winiarski, 212-301-7209
The Medicines Company
Robyn Brown, 973-656-1616

– Approvals consistent with current US treatment guidelines to start appropriate patients on combination therapies

EAST HANOVER, N.J., August 04, 2008 /PRNewswire/ — The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT(R) (valsartan and hydrochlorothiazide) and Exforge(R) (amlodipine and valsartan), as initial or ‘first-line’ therapies in patients likely to need multiple drugs to achieve their blood pressure goals.

The FDA approval of Diovan HCT and Exforge for first-line use reinforces current US guideline recommendations to start appropriate patients on combination therapy. Research suggests that up to 80% of patients may need multiple medications to help them reach blood pressure goals.

“These approvals provide flexibility and confidence to physicians to use well-proven and well-accepted therapies as first-line treatment,” said Kenneth Jamerson, MD, Professor of Medicine, Department of Cardiovascular Medicine, Healthcare System. “Patients may also benefit by getting their blood pressure effectively and quickly under control with a single pill and fewer co-pays.”

With the approvals, healthcare professionals will have simplified treatment strategies to help control high blood pressure with Diovan HCT and Exforge. In patients who are likely to need multiple drugs to achieve blood pressure goals, using single-pill combination medications first-line will help eliminate the added steps of starting on a single medication, increasing the dose and then adding on another medication.

The multiple steps often used in clinical practice may delay the time it takes to reach blood pressure goals, which may create patient frustration and a sense of failure. In addition, the first-line use of single-pill combination medications in patients who are likely to need multiple treatments to reach goal may reduce their pill burden and co-pays.

High blood pressure affects approximately 73 million adult Americans, and one in four adults worldwide. It is one of the most important, but treatable, risk factors for cardiovascular disease — the world’s leading cause of death.

While it is easy to measure and can be successfully managed, nearly 40% of people treated for high blood pressure do not have the condition under control, underscoring the critical need for more effective treatment regimens. If left untreated, patients with high blood pressure are at risk of cardiovascular events, such as stroke, heart attack and heart failure, as well as kidney failure and eye problems. Diovan HCT and Exforge are approved to treat high blood pressure and are not approved to treat or prevent stroke, heart attack, heart failure, kidney failure or eye problems.

“We are very pleased that the FDA recognizes the therapeutic value and the need of some patients to start therapy with a single-pill combination,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “These approvals demonstrate our confidence in combination medications for this therapeutic category, while reinforcing the Novartis commitment to provide physicians with well-researched and effective treatments for high blood pressure.”

Diovan HCT combines in one tablet Diovan (valsartan), the world’s number one selling branded high blood pressure medication, and hydrochlorothiazide, a high blood pressure treatment from the diuretics drug class. Exforge is the first treatment to combine Diovan (an angiotensin receptor blocker, or ARB) and the calcium channel blocker (CCB) amlodipine besylate, two of the most commonly prescribed high blood pressure medications in their classes, into a convenient, once-daily single tablet.

The Diovan HCT and Exforge first-line approvals were based on several clinical trials in approximately 2,000 and 3,500 patients, respectively, in which both products demonstrated efficacy and tolerability in patients with mild-to-severe high blood pressure.

Diovan HCT was approved in the US in 1998 for second-line treatment of high blood pressure and over five million patients have been prescribed the medicine. Exforge was approved in 2007 and since its introduction last year, over one million prescriptions have been filled.

Novartis is focused on improving the lives of the hundreds of millions of people with cardiovascular and metabolic diseases. As a global leader in cardiovascular and metabolic health for nearly 50 years, Novartis provides innovative therapies and support programs to treat high blood pressure, a major public health issue.

The core of the Novartis portfolio is its cardiovascular medications for the treatment of high blood pressure. These include Diovan, the world’s most-prescribed ARB, Tekturna(R) (aliskiren), the first and only approved direct renin inhibitor, and Exforge, a single pill combining two leading high blood pressure medicines. Novartis is dedicated to helping physicians and patients improve cardiovascular and metabolic health through effective medicines, programs and an ongoing commitment to research.

Diovan, Diovan HCT, Tekturna, and Exforge are prescription medications for adults used to treat high blood pressure. They can be used alone or in combination with other high blood pressure medications. It is not known whether additional blood pressure reductions are present when Tekturna is used in combination with ACE inhibitors or beta blockers. Exforge and Diovan HCT may be used as the first medicine if your doctor decides you are likely to need more than one medicine to lower your high blood pressure.

Important Considerations:

What is the most important information I should know about Diovan, Diovan HCT, Tekturna, or Exforge?

If you become pregnant, stop taking Diovan, Diovan HCT, Tekturna, or Exforge and call your doctor right away. Diovan, Diovan HCT, Tekturna, or Exforge can harm an unborn baby causing injury and even death. If you plan to become pregnant, talk to your doctor about other treatment options to lower your blood pressure before taking Diovan, Diovan HCT, Tekturna, or Exforge.

Do not take Diovan HCT if you have a history of reduced urine output, or have allergic reactions to certain drugs known as sulfonamides. Tell your doctor about all your medical conditions and medicines you take, including liver or kidney problems, lupus or if you take lithium. Additionally, do not take Tekturna if you take cyclosporine.

Serious side effects could occur such as:
— low blood pressure
— kidney problems
— if you take Tekturna and develop an allergic reaction involving
swelling of the face, lips, throat, and/or tongue, which may cause
difficulty in breathing and swallowing stop taking the drug and contact
your doctor immediately.
— if you take Diovan HCT, a skin rash
— worsening chest pain with Exforge, especially in patients who already
have severe heart disease.

If you take Diovan HCT and have liver problems or lupus, these conditions may get worse.

If you take Diovan HCT tell your doctor if you develop any of the following signs of fluid and electrolyte problems: dry mouth, thirst, lack of energy, weakness, drowsiness, restlessness, confusion, seizures, muscle pain or cramps, muscle fatigue, very low urine output, fast heartbeat, or nausea or vomiting.

Other side effects of Diovan, Diovan HCT, Tekturna, or Exforge have generally been mild and brief. The most common side effects with Diovan and Diovan HCT are headache and dizziness. A side effect experienced by more patients taking Tekturna than patients taking a sugar pill was diarrhea. Side effects that occurred more frequently with Exforge than placebo are swelling of the hands, ankles, or feet; nasal congestion or sore throat; head or chest cold; and dizziness.

Please see full prescribing information about Diovan, Diovan HCT, Tekturna or Exforge at or contact Christine Cascio at 862-778-8026 or .

Manhattan Pharmaceuticals has announced top-line results from its Phase IIa clinical study of topical PTH (1-34) for the treatment of psoriasis

August 4, 2008 – This multi-center, randomized, double-blind, vehicle-controlled, parallel group study was designed to assess the safety and preliminary efficacy of two dose levels of topical PTH (1-34) for the treatment of mild to moderate plaque psoriasis.

While the study did achieve the primary safety objective, the data did not demonstrate a statistically significant improvement in the overall disease severity of treatment lesions or signs and symptoms of psoriasis as compared to the vehicle (placebo) gel.

Topical PTH (1-34) appeared to be well tolerated with no hypercalcemia or serious adverse events reported. Manhattan Pharmaceuticals intends to further analyze and asses these data in order to determine appropriate next steps for the program.

By Jacquelyn K. Beals, August 4, 2008, MEDSCAPE — The US Food and Drug Administration (FDA), as part of its Critical Path Initiative, has compiled a table of genomic biomarkers with established roles in drug response. The initiative, launched in 2004, encompasses the goal of identifying “patients likely to benefit from a treatment and patients more likely to respond adversely to a product,” according to FDA’s Office of Management, Budget Formulation and Presentation.

At present, about 10% of drugs approved by the FDA include pharmacogenomic information on their labels. Using genomic profiles, physicians can identify patients who will (or will not) respond to a given drug, those patients who metabolize drugs faster or slower than average, and individuals at risk for drug toxicity. Using clinically proven biomarkers in drug therapy decisions is an important step on the road to personalized medicine.

The table compiled by the FDA lists validated genomic biomarkers, along with links to pharmacogenetic information. For each biomarker, the table indicates whether pharmacogenomic testing is “required,” “recommended,” or for “information only” within the context of a specific drug.

Maraviroc (Selzentry, Pfizer) is one drug in the FDA table for which testing is required. As a CCR5 coreceptor antagonist used in patients with only CCR5-tropic HIV-1 detectable infection, the drug “blocks a specific receptor called CCR5 that CCR5-tropic HIV-1 uses to enter CD4 or T-cells,” states the table entry. HIV uses CCR5 or another protein, CXCR4, as receptors to enter cells. Because Selzentry is not effective against CXCR4-using virus, a test is required to determine whether the HIV infection is CCR5-tropic HIV-1, and whether the drug should be prescribed.

Another drug for which testing is required is trastuzumab (Herceptin, Genentech). Herceptin is a monoclonal antibody that binds strongly and selectively to the extracellular portion of HER2 (the human epidermal growth factor receptor 2 protein). HER2 is overexpressed in 25% to 30% of primary breast cancers, and studies have shown that Herceptin’s cytotoxicity is preferential against cells that overexpress HER2 compared with other cancer cells. The table entry advises: “Detection of HER2 protein over-expression is necessary for selection of patients appropriate for Herceptin therapy.”

The drugs in the preceding examples would have little, or very reduced, efficacy in patients who are not infected with CCR5-tropic HIV-1 or who do not overexpress HER2. In contrast, testing may be recommended to avoid the risk of excessive drug sensitivity or toxicity. Two drugs in this category are warfarin and rasburicase.

In the case of warfarin, an anticoagulant, studies have shown that patients with specific variants of CYP2C9 (cytochrome P450) have a greater risk of bleeding. For allele CYP2C9*2, patients with at least 1 copy should receive 17% less warfarin per day than patients homozygous for the CYP2C9*1 allele. Patients with a copy of allele CYP2C9*3 should receive 37% less warfarin than the CYP2C9*1 homozygotes to avoid the risk of bleeding.

Rasburicase is used to treat patients with hematologic malignancies. Pretesting is recommended because patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may develop “severe hemolysis” when taking this drug, the FDA table notes. G6PD deficiency is more common in patients with Mediterranean or African heritage, and screening is strongly recommended for this population.

The FDA table is updated every few months as new drugs and genomic information become available; the version currently online was created September 15, 2006, and was most recently updated July 31, 2008. An FDA Consumer Health Information article, “How FDA Advances Personalized Medicine,” points out the challenges of incorporating pharmacogenomic testing into drug selection.

“Using a pharmacogenomic test to determine who will respond to a treatment or who should not get a treatment may narrow the market for certain drugs,” the article acknowledges. It may take years to identify all the genetic variations, and patients’ responses may depend not on a single gene but, rather, on multiple genes, as well as their interactions. Nevertheless, in its Critical Path Initiative, the FDA is working “to bring balance to an evolving science in a way that does not inhibit its growth.”

By Liz Szabo, USA TODAY – August 4, 2008 – Another study raises questions about the dangers of giving cough and cold medications to babies.

A “surprising” number of small children taken to the emergency room after they stop breathing or lose consciousness have over-the-counter cold medications in their systems, according to the authors of an article in today’s Pediatrics.

About 5% of patients like these under age 2 had the drugs in their urine, says Raymond Pitetti, associate director of pediatric emergency medicine at Children’s Hospital of Pittsburgh. None of their parents, however, admitted to giving the children medication or taking the cold products themselves, which could cause the drugs to pass into breastmilk.

Pitetti says his study — in which doctors performed toxicology tests on 274 children at the Pittsburgh hospital between 1997 and 2006 — strongly suggests that the cold medications caused the life-threatening events, in which the babies turned red or blue, stopped breathing, passed out or went limp. Although Pitetti says he can’t rule out that something else caused these symptoms, he notes that the ingredients in cold medications can make babies stop breathing.

“In that first month of life, their breathing systems aren’t very developed yet,” Pitetti says. “They’re very susceptible to harm, even at very low doses.”

Based on his study, Pitetti says emergency room doctors should perform toxicology tests on all children with these symptoms.

Mothers shouldn’t take cold medications while breastfeeding, Pitetti says. If mothers must take these medications, they should refrain from nursing for 24 hours, giving their babies formula or previously pumped breastmilk instead. To prevent accidental overdoses, people should keep a log of all medications, including common pain relievers such as Tylenol, given to babies. That can help both parents or other caregivers avoid giving a second dose too soon, especially if more than one person is caring for the baby.

In January, the Food and Drug Administration recommended that over-the-counter cough and cold medicines should not be given to children under age 2 because of the risk of “life-threatening side effects.” According to the American Academy of Pediatrics, cough and cold products may pose serious risks in these children, including death, convulsions, rapid heart rates and reduced levels of consciousness. Manufacturers have voluntarily withdrawn cough and cold products for children under age 2.

In October, an advisory panel to the FDA noted that these products aren’t effective in children under age 6 and shouldn’t be given to children that age.

About 7,000 children under age 11 — including 1,500 under age 2 — go to hospital emergency rooms each year after taking cold and cough medicines, according to the Centers for Disease Control and Prevention. About two-thirds of these children took the medicines without a parent or caregiver nearby. A recent CDC study found that cold and cough medicines caused the deaths of three babies under age 6 months, found dead in their homes, in 2005.

August 4, 2008, BUSINESS WIRE)–For the first time in the past 11 Verispan audit cycles, both managed care medical directors and pharmacy executives were in agreement about the company that best met their needs: Merck. Both managed care audiences ranked Merck first overall in the spring 2008 editions of Verispan’s Managed Care Medical Director Promotional Audit and Pharmacy Executive Promotional Audit.

Since spring 2003, Merck had ranked between second and 10th overall in the Managed Care Medical Director Promotional Audit. The overall ranking is calculated by Verispan based on five assessment areas: clinical objectivity, value-added services, disease management, account personnel and corporate approach.

Between fall 2007 and spring 2008, Merck’s net score improved in all five assessment categories, and by spring 2008, the company was ranked No. 1 in all five. The company’s most notable improvement appeared in disease management, where Merck improved its net score by 6 points.

One medical director who listed Merck as best for disease management commented, “Experience end to end.” Others said, “They have been helpful in the asthma and diabetes areas with excellent implementation”; and “very flexible and excellent support.”

In the account personnel category, Merck rose from No. 2 in fall 2007 to the top spot in spring 2008. Medical directors praised the company in the following ways: “Highly professional and knowledgeable reps that follow through”; and “good understanding of managed care.”

The overall Managed Care Pharmacy Executive Promotional Audit ranking is calculated by Verispan based on four assessment areas: contracts, value-added services, account personnel and corporate approach. Merck was ranked first for both value-added services and account personnel in the spring 2008 study.

Previously ranked No. 2 in the account personnel category, Merck’s experience, communication and knowledge were cited as the company’s strengths in spring 2008. For example, one pharmacy executive noted, “National account manager is extremely responsive to our needs for a quick turnaround on a formulary contract; well-seasoned individual within Merck that gets the appropriate people on the phone to make a decision.” Another pharmacy executive said, “Has called on us for a long time; is very knowledgeable about us and the managed care industry.”

Former overall leader Novartis, now in second place, led the industry in corporate approach with 13 net mentions. One pharmacy executive who listed Novartis as best for corporate approach said, “I believe Novartis corporate understands the market and is willing to adjust to make themselves a better partner for the future; they seem to support their account personnel very well and give them autonomy to make key decisions.”

About the Audits

Verispan’s Managed Care Pharmacy Executive Promotional Audit is based on the responses of pharmacy executives who represent a large portion of American lives covered by HMOs. These influential executives reported promotional activity by pharmaceutical firms over an 8-week period in spring 2008. They also rated pharmaceutical companies on their ability to meet managed care’s needs in five areas: contracts, value-added services, account personnel, corporate approach and Medicare Part D. The Medicare Part D evaluation is not included in the aggregated overall ranking.

Verispan’s Managed Care Medical Director Promotional Audit is based on the responses of medical directors who represent a large portion of American lives covered by HMOs. These medical directors reported promotional activity by pharmaceutical firms over an 8-week period in spring 2008. They also rated pharmaceutical companies on their ability to meet the managed care industry’s needs in five areas: clinical objectivity, value-added services, disease management, account personnel and corporate approach.

For more information on the Managed Care Pharmacy Executive Promotional Audit, or Managed Care Medical Director Promotional Audit or other Verispan managed and institutional market products, please contact Keith Mandia or Emily Dorf at (800) 982-5613; e-mail: or

About Verispan

Verispan was purchased recently by Surveillance Data Incorporated (SDI). Verispan, a healthcare informatics company, provides a broad array of information products and services to the healthcare industry, including sales targeting and compensation products; market research audits; healthcare profiles; comprehensive managed care offerings; data integration, warehousing and mining; data analysis and consulting; direct mail; list services; disease management studies; clinical trial investigator targeting and protocol recruitment evaluation; healthcare outcomes; and cost/benefit analyses, among many others. Verispan is a leading provider of patient-centric longitudinal data, with dozens of products used by clients spanning the industry.

Located in Yardley, Pa., Verispan employs over 500 dedicated healthcare information professionals. The company’s Web site is

About SDI

Since 1982, SDI has been delivering the most innovative healthcare data products and analytic services on the market to the pharmaceutical, biotech, healthcare, medical device, and consumer packaged goods industries. SDI is a leading provider of de-identified patient-level data, as well as real-time localized disease and treatment surveillance and modeling data. SDI takes a consultative approach to designing the best analyses for its clients, combined with expert study execution and analytical expertise to produce superior insights. Its current roster of client companies in the pharmaceutical/biotech sector includes all of the top 20 firms. For more information visit or call 610.834.0800.

New Company to be Called Kowa Pharmaceuticals America

NAGOYA, Japan and MONTGOMERY, Ala., August 04, 2008 /PRNewswire/ — Kowa Company, Ltd., a privately-held company headquartered in Nagoya, Japan, today announced the acquisition of ProEthic Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company based in Montgomery, Alabama.

Effective September 1, 2008, ProEthic will change name to Kowa Pharmaceuticals America and will assume responsibility for all sales and marketing functions currently operating in Montgomery, Alabama. ProEthic’s clinical development group will transfer to Kowa Research Institute, which is located in Morrisville, North Carolina.

“The opportunity to enter the U.S. pharmaceutical market represents a significant step towards Kowa’s vision of creating a global pharmaceutical organization. Pharmaceuticals represent one of Kowa’s fastest growing businesses, and we are happy that Kowa Pharmaceuticals America will now be part of that plan,” said Yoshihiro Miwa, President and Chief Executive Officer of Kowa. “We are optimistic about the prospects that this acquisition will bring, and we will work closely with the company to ensure its future success.”

The first pharmaceutical product to be launched by the new company will be pitavastatin, a novel HMG CoA reductase inhibitor for the treatment of hyperlipidemia. Pitavastatin is sold in Japan, Korea and Thailand under the brand Livalo(R). Pitavastatin has recently completed Phase 3 clinical development in Europe and the United Sates.

“We are excited about the partnership with Kowa and the confidence they have shown in our management team and its ability to grow the company into becoming a leading provider of unique and effective pharmaceutical products,” said Carl Whatley, Chief Executive Officer of ProEthic. “We also look forward to the future launch of products from Kowa’s rich pipeline, currently in clinical development at Kowa Research Institute.”

About Kowa

Since its establishment in 1894, Kowa has grown into a multinational Japanese company actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science and information technology, textiles, machinery and various consumer products. During its long history, Kowa has consistently strived to meet the changing needs, and with its continuing entrepreneurial initiative, is determined to meet the needs of future generations. It is this commitment to consistency and initiative in an ever-changing world that Kowa vows to carry forward through each generation.

About ProEthic

ProEthic is a specialty pharmaceutical company focused primarily in the areas of cardiology, pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. Its lead product, Lipofen(R), is indicated as adjunctive therapy to diet to reduce elevated triglycerides and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

— Meda acquires Valeant’s pharmaceutical business in Western and Eastern Europe

– Consistent step in Meda’s growth strategy
– Sales level of 1 100 MSEK
– Organisation of 380 employees– Meda gains
– Russian entry with own organisation
– Significant market synergies in Eastern Europe
– Strengthened position in Western Europe, especially in the UK
– Enhanced position in key therapy areas, neurology and dermatology– Purchase price on a debt free basis 392 MUSD, equivalent to approx. 2 times sales

— New share issue of about 1 500 MSEK, 100% guaranteed by Stena AB

STOCKHOLM, Sweden, Aug. 4, 2008–(BUSINESS WIRE)–Regulatory News:Meda (STO:MEDAA) has signed an agreement to acquire Valeant’s pharmaceutical business in Western and Eastern Europe. The acquisition will benefit Meda in many different respects, both short term and long term. It will give Meda the entry into Russia. In Eastern Europe, it means a potential for significant market synergies with products in Meda’s existing pipeline. In Western Europe, Meda’s position will be strengthened, especially in the UK. The majority of the acquired products are also within Meda’s key therapy areas; neurology and dermatology, which in-line with the company’s focused approach will offer good synergies.

The total sales level of the acquired business is 1 100 MSEK, of which Eastern Europe account for 200 MSEK. Major markets are Germany, UK, Italy, Spain and Russia, both in terms of sales and employees. Total headcount is 380 employees. The 230 employees in marketing and sales primarily visit specialists within dermatology and neurology. The regional headquarter is based in Basingstoke, UK.

“I’m really glad that we have reached this deal with Valeant. This acquisition has a perfect fit with our operations in Europe. It also gives a very important contribution to our strategy to become stronger in Eastern Europe. We now get a foothold in Russia and we will use that platform to introduce many of our pipeline products. We also look forward to a long term collaboration in other areas with Valeant”, says Anders Lonner, CEO Meda.

Russian entry

The Russian pharmaceutical market is worth around 6 billion USD and growing rapidly. At present, only a few Meda products are sold in the Russian market. Valeant’s operation in Russia has grown quickly during the last years. A strong marketing organisation has been established and Meda’s plan is to expand this platform when Meda’s current and future products will be launched.


Meda foresees synergy effects both on cost and revenue side when integrating organisations in Western Europe. In Eastern Europe, Meda’s position in turnover will double. Several new countries in Eastern Europe are also entered, Russia being the largest. In these new markets, Meda will now be able to launch certain existing products and products from its pipeline through own organisations. Synergies within marketing will also be possible since both companies have complementary products in both neurology and dermatology.

Product portfolio

Valeant’s product portfolio consists of many well established products. The majority are specialist products in the key therapeutic areas; neurology and dermatology. A dominant part of the acquired products have strong trademarks and are well proven since a long time.


Mestinon (pyridostigmine bromide) is used in the treatment of myasthenia gravis. Myasthenia gravis is a chronic neuromuscular, autoimmune disorder that causes varying degrees of fatigable weakness in muscles. Sales during 2007 were about 210 MSEK.

Tasmar (tolcapone) is used in combination with levodopa and carbidopa for the treatment of patients with severe Parkinson’s disease. Sales during 2007 were approximately 40 MSEK. Market synergies exist with Meda’s Parlodel (treatment of Parkinson’s disease).


Solcoseryl (haemodialysate) is used for treating trophic disorders, dry and wet wounds. The product is used in a variety of medical fields that includes neurology and surgery. Sales during 2007 were approximately 140 MSEK.

Dermatix is a transparent, topical silicone gel that helps maintain the skin’s moisture balance, improving the appearance and size of scars. Sales during 2007 were approximately 80 MSEK.

Efudix is indicated for topical treatment of multiple actinic or solar keratosis and superficial basal cell carcinoma. Sales during 2007 were 50 MSEK and market synergies exist with Meda’s Aldara. Cancer

Cesamet (nabilone) is used for treating patients with chemotherapy-induced nausea and vomiting (CINV) who fails to respond adequately to conventional antiemetic treatments. Market synergies exist with Meda’s BEMA-Fentanyl which is in registration phase (treatment of breakthrough pain in cancer patients).

Financial effects and profitability

In line with earlier acquisitions, the intention is to quickly integrate Valeant into Meda and thereby create a stronger company. This will involve non-recurring restructuring costs that will affect the operating profit in the near term while the future profitability can increase.

The EBITDA margin of the acquired business was around 14% during 2007. As a consequence of the industrial integration, the ambition is to increase this to above 30%. Based on the proposed financing, and excluding non-recurring restructuring costs, the acquisition is expected to be accretive to Meda’s earnings per share already during 2009.

Financing and timetable

Meda will pay to Valeant 392 MUSD in cash on a debt free basis, which is equivalent to around 2 times sales for the acquired business. Closing of the transaction is dependent on antitrust approvals. Initially, the purchase will be financed via bank loans. Meda’s board of directors intends to take a decision to propose a new preferential-rights share issue for existing shareholders to raise approximately 1 500 MSEK. The details of this proposed issue will be announced before an extraordinary shareholders’ meeting. The new share issue is 100% guaranteed by Stena AB.

MEDA AB (publ) is an international specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company’s strategy. Meda is represented with own organisations in 26 countries and with more than 1 500 employees within marketing and sales. Meda’s products are sold in approximately 120 countries world-wide. The Meda share is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more, visit