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Results of the study, which were presented today at the American Psychiatric Association (APA) meeting in Washington, D.C., found that 6 months after the procedure, 56 percent of the patients experienced at least a 40 percent decrease in depressive symptoms. Patient’s symptoms were measured using a standardized test called the Hamilton Rating Scale for Depression.

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Results were presented by Sidney Kennedy, M.D., psychiatrist-in-chief with the University Health Network in Toronto. “Severe depression destroys a person’s ability to be productive and have a normal quality of life,” said Dr. Kennedy. “The results from this study are very promising, and we are hopeful that our research will lead to a therapy that can help these patients.”

Prior to beginning the study, all patients were classified as having severe depression after multiple treatments – such as medications, psychotherapy and electroconvulsive therapy – had failed to provide sustained relief from depression. Each study patient had tried a minimum of 12 depression medications over his or her lifetime.

DBS was targeted at an area of the brain known as Brodmann Area 25, which appears to become overactive when people are profoundly sad and depressed. Conducted at three leading Canadian academic medical centers, the study expands and supports the groundbreaking research of Helen Mayberg, M.D., and Andres Lozano, M.D., which was published in Neuron in March 2005.

On average, the 20 study participants had suffered from depression for more than 20 years; they were disabled and unable to work at the time of enrollment. The study also found that:

• At their most recent psychiatric evaluation, 78 percent of the patients experienced at least a 40 percent decrease in depressive symptoms.
• Three of the study patients are considered to be in remission.
• Eight patients have re-engaged in life activities such as work, school, relationships and travel.

In the study, DBS was delivered through the St. Jude Medical Libra^® Deep Brain Stimulation System, which delivers mild electrical current from a device implanted near the collarbone; the device is connected to small electrical leads placed at specific targets in the brain.

“These results are important as they help establish the body of evidence that will continue to move depression research forward,” said Chris Chavez, president of the St. Jude Medical ANS Division. “We are committed to leading the development of products that can make life better for patients suffering from this debilitating condition.”

Based on the results of this research, St. Jude Medical announced the BROADEN^TM (BROdmann Area 25 DEep brain Neuromodulation) study in February 2008, to further investigate the use of DBS for major depressive disorder. A controlled, multi-center, blinded clinical study, BROADEN is being conducted in the U.S. under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).

St. Jude Medical owns the intellectual property rights and has various patents issued and pending for the use of neurostimulation at Brodmann Area 25. For more information about this clinical trial, call toll-free 866-787-4332 or visit www.BROADENstudy.com.

According to the National Advisory Mental Health Council, of the 21 million adult Americans who suffer from depression, approximately 4 million live with severe depression that does not respond to medications, psychotherapy and, in certain cases, electroconvulsive therapy.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 12,000 people worldwide. For more information, please visit www.sjm.com.

About the ANS Division of St. Jude Medical

The ANS Division (Advanced Neuromodulation Systems) became a part of St. Jude Medical in 2005. The ANS Division is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders (www.ans-medical.com).

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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In a clinical test, Novartis, which has about 2,000 employees in Massachusetts, compared its drug candidate Menveo against a vaccine already on the market called Menactra.

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Sales people will be notified by the end of this month and will leave by the end of July, the Whitehouse Station, New Jersey-based company said today in a statement. Merck has cut 8,100 jobs globally since beginning a restructure in late 2005, according to regulatory filings through March 31.

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“This financing underscores our ability to make significant progress towards the clinic and eventual product commercialization,” commented Haru Morita, President and Chief Executive Officer of REGiMMUNE. “To thrive as REGiMMUNE has, in a very difficult business environment for many biotech companies in Japan, is a particularly great achievement.”

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New and existing investors include NIF SMBC Ventures Co., Ltd.; CSK Venture Capital Co., Ltd.; Japan Asia Investment Co., Ltd. and Yasuda Enterprise Development Co., Ltd.

The company’s proprietary technology platform, MultiVax, induces antigen-specific immune tolerance via induction of Tregs, a T-cell subset that plays a central role in controlling immune responses to self-antigens and pathogens when administered at the time of exposure to disease-causing antigens. Because of its specificity in targeting immune suppression, MultiVax is anticipated to exhibit higher efficacies with more favorable safety profiles over current immunomodulatory drugs.

RGI-2001 for GvHD

REGiMMUNE plans to start development of its MultiVax product RGI-2001 to treat GvHD following allogeneic stem cell transplantation (SCT) primarily for bone marrow transplants. A major clinical challenge associated with allogeneic SCT is to maintain a fine balance of the immune system to prevent GvHD, serious infection, and/or recurrence of malignancy. This balance is critical because intensive immune suppression will result in infection and recurrence of malignancy while insufficient immune suppression may cause GvHD.

Serious GvHD occurs in up to 40% of HLA-matched allogeneic SCT cases, and 100% in haploidentical, related allogeneic SCT. Current treatment is prophylactic use of immunosuppressants such as cyclosporine A. High-dose steroids are administered once GvHD occurs but the condition often progresses to steroid refractory status and there is no proven second-line therapy for steroid refractory GvHD. Prevention and treatment of GvHD thus represent high unmet medical needs addressing serious, life-threatening conditions. If alloantigen specific, selective immune suppression can be induced with RGI-2001, it would be possible to suppress GvHD while maintaining protective immune responses to infection and recurrence of malignancy.

About REGiMMUNE

REGiMMUNE is a biotechnology company focused on the discovery, development and commercialization of immune regulatory therapeutics to treat life-threatening and debilitating conditions, including allergies, autoimmune diseases and inflammatory disorders. In addition to its potential for GvHD, MultiVax is a therapeutic candidate for autoimmune diseases such as Multiple Sclerosis (MS) and Systemic Lupus, in which down-regulation of and/or dysfunction of regulatory T-cells lead to serious up-regulation of immunity against the auto-antigen. reVax is the company’s second proprietary technology platform, which works by modulating the immune system by enhancing antigen-specific immune regulatory cells. This technique is expected to be useful in conditions such as Ragweed Allergy, Rheumatoid Arthritis and MS, where control of an abnormal immune response is desirable. reVax is being utilized to advance several compounds through clinical development and eventual commercialization of a broad range of products for REGiMMUNE and its partners. The company is headquartered in Tokyo, Japan and has a U.S. subsidiary in Mountain View, California. For more information, please visit www.regimmune.com.

CORAL GABLES, Fla., May 6 /PRNewswire/ — Stiefel Laboratories, Inc., the world’s largest independent pharmaceutical company specializing in dermatology, announced today that it has acquired ABR Invent and ABR Development, developers of the dermal filler Atlean(R).
Stiefel will acquire all shares of ABR Invent and ABR Development through a definitive stock purchase agreement. Both ABR Invent and ABR Development are legal entities based in France.

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“Stiefel Laboratories has been looking for the right dermal filler to add to our aesthetic portfolio for quite some time,” said Charles W. Stiefel, chairman and CEO, Stiefel Laboratories. “After conducting due diligence and extensive research, our team made an offer to ABR Development, a company whose innovation, expertise and product portfolio will significantly strengthen our position in the global aesthetics market. We are delighted that our proposal was accepted.”
Atlean(R) dermal filler is currently commercialized in France and Italy and distribution and manufacturing agreements for the product will remain in place throughout Europe. All sales representatives formerly employed by ABR Development will now become employees of Stiefel Laboratories.
Over the next 18 months, Stiefel plans to launch Atlean(R) dermal filler in multiple areas, including parts of Europe, Asia Pacific, Latin America and the Caribbean. The company will continue clinical development of Atlean(R) dermal filler in order to expeditiously submit the product for approval from the Food and Drug Administration (FDA) and other regulatory bodies around the world. Stiefel also expects to develop other products from the ABR portfolio.
According to Bill Humphries, president, Stiefel Laboratories, the company is optimistic that Atlean(R) dermal filler will be approved globally in key aesthetic markets.
“The use of dermal fillers is growing worldwide at a very rapid pace,” said Humphries. “Stiefel chose to add Atlean(R) dermal filler to our product portfolio so that we can submit a unique and broader offering of options to our valued physician partners and they can, in turn, offer these products to their patients.”
Atlean(R) dermal filler uses a combination of tricalcium phosphate particles (Beta-TCP) suspended in a hyaluronic acid gel. The injectable product is recommended for sculpting and remodelling the face.
Hyaluronic acid occurs naturally in skin tissue, transporting and delivering water to the skin, and contributing to its elasticity. As key ingredients in Atlean(R) dermal filler, hyaluronic acid facilitates an immediate and temporary volumizing effect, and the micro particles of Beta-TCP, by stimulating endogenous synthesis of collagen, contribute to the sustained effects of the product.
The acquisition of ABR gives Stiefel the opportunity to enter the rapidly growing dermal filler market, which is estimated to reach more than $1 billion in 2010 as more people around the world seek rejuvenation options rather than invasive surgery.
About Atlean(R) Dermal Filler
Atlean(R) dermal filler is a bio-resorbable sculpting and modeling dermal volumizer/filler with hyaluronic acid (HA) plus tricalcium phosphate (Beta-TCP) particles. Atlean(R) dermal filler is implanted subcutaneously or intra-dermally.
The gel contains micro-particles of TCP(R), a bio-compatible, biodegradable, immunologically inert, non-toxic, synthetic ceramic belonging to the calcium phosphate chemical family. It is capable of complete and controlled resorption.
Atlean(R) dermal filler has a CE-Mark granted in 2006 and it is commercialized in France and Italy.
About Stiefel Laboratories, Inc.
Founded in 1847, Stiefel Laboratories (a privately held company) is the world’s largest independent pharmaceutical company specializing in dermatology. The company manufactures and markets a variety of prescription and non-prescription dermatological products. Some of the newest and best- known brands include Duac(R) Topical Gel (clindamycin, 1% - benzoyl peroxide, 5%) available in the Duac(R) Care System (CS); Evoclin(R) (clindamycin phosphate) Foam, 1%; Luxiq(R) (betamethasone valerate) Foam, 0.12%; MimyX(R) Cream; Olux(R) (clobetasol propionate) Foam, 0.05% and Olux-E(TM) (clobetasol propionate) Foam, 0.05% also available in the Olux(R) / Olux-E(TM) COMPLETE PACK; Soriatane(R) (acitretin) Capsules available in the Soriatane(R) CK CONVENIENCE KIT; Verdeso(R) (desonide) Foam, 0.05%; Brevoxyl(R)-4 Creamy Wash (benzoyl peroxide 4%) and Brevoxyl(R)-8 Creamy Wash (benzoyl peroxide 8%) packaged in the Brevoxyl(R) Acne Wash Kit; Extina(R) (ketoconazole) Foam, 2%; Oilatum(R) Cleansing Bar; Physiogel(R) Cream; Stieprox(R) (ciclopirox olamine) Shampoo; REVALESKIN(TM) Skin Care Products; and Sarna(R) Lotion. Its wholly- owned global network is comprised of more than 30 subsidiaries, manufacturing plants in six countries, research and development facilities on four continents, and products marketed in more than 100 countries around the world.
Stiefel Laboratories supplements its R&D efforts by seeking strategic partnerships and acquisitions around the world. To learn more about Stiefel Laboratories, Inc. visit www.stiefel.com .
Source: Stiefel Laboratories, Inc.