Bayer/Schering: done deal leaves Merck KGaA standing

Bayer Group has completed its acquisition of Schering AG.

Despite the looming deadline for acceptance and significant stumbling block posed by Merck KGaA, Bayer Group has successfully completed its $21 billion takeover of Berlin-based Schering AG. The deal creates Germany's leading healthcare company, and also provides Merck with an instant capital injection. However, Merck will itself need to look to acquisitions if it is to secure long-term growth. Read full article
Company information: Bayer AG, Merck KGaA, Schering AG

EULAR: Roche and BMS target RA market

Roche and Bristol-Myers Squibb have presented data supporting their respective RA drugs.

By presenting new data at the rheumatology conference currently being held in Amsterdam, Roche and Bristol-Myers Squibb are hoping to encourage uptake of their recently approved rheumatoid arthritis drugs. Although the data illustrates the addition of valuable new treatment options, an increasingly competitive market is set to limit the impact of Rituxan and Orencia in this indication. Read full article
Company information: Bristol-Myers Squibb Company, Roche Holding AG

ChemGenex: positive data unlikely to guarantee Ceflatonin success

Newly presented data supports the use of Ceflatonin as a treatment for chronic myeloid leukemia

A small clinical trial has shown an encouraging complete hematologic response rate when Ceflatonin is administered to chronic or accelerated phase CML patients following treatment failure of Gleevec or interferon. However, with Bristol-Myers Squibb's Sprycel is on the verge of being approved in this indication, Ceflatonin's future success on the market could be limited. Read full article
Company information: ChemGenex Pharmaceuticals Ltd, Bristol-Myers Squibb Company, Novartis AG

ANALYST'S VIEW

Depression sufferers still reluctant to see physician

While the number of individuals with major depressive disorder (MDD) is set to grow only minimally in next two decades, the condition still represents a key health risk, for both society and the individual. For example, MDD is a leading cause of disability and under-diagnosis remains a problem. Furthermore, the leading classes of MDD drugs have been linked to increased suicidality.

It's estimated that 34 million people suffer from MDD in the western world, but new research estimates that the number of individuals with MDD will grow only minimally in the next two decades, to 37 million by 2025.

Unlike a number of other global health issues such as cancer and Parkinson's disease, the aging nature of the world's population won't significantly increase the number of those suffering from MDD. However, that is not to say MDD isn't an extremely relevant health risk, for both society and the individual sufferer.

In fact, MDD has been estimated to be the leading cause of disability in the US and established market economies worldwide. While medication exists to treat MDD, getting patients to present to physicians and then be accurately diagnosed is an ongoing problem. Furthermore, the leading classes of drugs used to treat MDD have also been associated with increased risk of suicide.

Sufferers backward in coming forward

MDD is characterized by one or more major depressive episodes involving symptoms such as depressed mood and diminished interest or pleasure in work and social activities. Although the severity of symptoms varies with individuals and varies over time, MDD can cause clinically important distress and impair work, social or personal functioning.

Presentation rates vary significantly with the severity of MDD. However, what is known is that less than half of those with mild or moderate MDD present to a physician. This issue is likely related to the inherent nature of the illness, as depressed patients may become reclusive, choosing to remain at home rather than go out to seek help. In less severe cases, patients, or their friends and family, may consider it to just be part of the 'ups and downs' of normal life.
Read full article

Related research: Stakeholder Insight: Major Depressive Disorder - Duloxetine - Fulfilling An Unmet Need? priced $15,200

INDUSTRY NEWS

J&J ready to close $16 billion Pfizer deal
In a bid to bolster its household presence, healthcare conglomerate Johnson & Johnson (J&J) is ready to close a deal to buy Pfizer's consumer products unit, The New York Times has reported. Read full article
Company information: Johnson & Johnson, Pfizer Inc

HGS wins $165 million contract for anthrax drug
The US government is to pay Human Genome Sciences up to $165 million for 20,000 treatment courses of an investigational drug for the treatment and prevention of anthrax infection. Read full article
Company information: Human Genome Sciences Inc

Praecis fails to sell prostate cancer drug
Shares in Praecis Pharmaceuticals fell around 30% after the company failed in its attempts to sell the rights to its Plenaxis prostate cancer drug and announced that it will now withdraw the therapy from the market. Read full article
Company information: Praecis Pharmaceuticals Inc.

Schering-Plough to expand Latin American presence
Schering-Plough Corporation is to establish a subsidiary based in Sao Paulo, Brazil, to market its core products. The company will also restructure its agreement with Mantefarma, a privately held company in Brazil. Read full article
Company information: Schering-Plough Corporation

REGULATORY DEVELOPMENTS

Teva and Ranbaxy win FDA approval for generic Zocor
The FDA has granted approval for Teva and Ranbaxy to begin marketing generic versions of Merck & Co's blockbuster cholesterol drug, Zocor. Read full article
Company information: Teva Pharmaceutical Industries, Ranbaxy Laboratories, Merck & Co., Inc.

Genentech's Avastin gets expanded approval
The FDA has expanded the approved indication for Genentech's anticancer drug Avastin by giving the go-ahead for the compound to be used, in combination with 5-FU-based chemotherapy, for the treatment of second-line metastatic colorectal cancer. Read full article
Company information: Genentech, Inc.

Sanofi-Aventis obesity drug wins European approval
The European Commission has given the green light for French drug maker Sanofi-Aventis to begin marketing its Acomplia treatment for obesity in all 25 member states. Read full article
Company information: Sanofi-Aventis Group

FDA approves Allergan's eye pressure drug
The FDA has approved Allergan's once-daily prescription eye drop Lumigan as a first-line treatment for elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension. Read full article
Company information: Allergan, Inc.

RESEARCH & DEVELOPMENT

Kos drug improves lipid control in trial
Kos Pharmaceuticals has announced results of a study that demonstrate that the addition of its Niaspan tablets to statin therapy achieved better lipid control for patients at high risk for heart attack than standard therapy. Read full article
Company information: Kos Pharmaceuticals Inc.

Merck insomnia drug posts positive data
Gaboxadol, an investigational drug being developed by Merck & Co and Denmark's H Lundbeck A/S, has been shown to improve deep sleep and key sleep measures in a phase II trial in adult patients with both primary and transient insomnia. Read full article
Company information: Merck & Co., Inc., H. Lundbeck A/S

Positive phase II for HGS lupus candidate
Human Genome Sciences' investigational drug candidate LymphoStat-B has posted positive results in a phase II trial evaluating the drug in the treatment of the debilitating autoimmune disease, lupus erythematosus. Read full article
Company information: Human Genome Sciences Inc

Dosing suspended in Anadys/Novartis hepatitis drug trial
Shares in Anadys Pharmaceutical's dropped around 50% after newly obtained data from animal studies prompted the company to suspend dosing in a phase Ib human trial of ANA975, the company's hepatitis C candidate being developed in collaboration with Novartis. Read full article
Company information: Novartis AG

ALLIANCES & LICENSING

Schering acquires Celera's CNS drug program
Schering AG has acquired Celera Genomics' cathepsin S inhibitor small molecule drug program for the treatment of autoimmune diseases for a potential $360 million if all milestones are met. Read full article
Company information: Celera Genomics, Schering AG

Celera Genomics and Medarex collaborate on oncology antibodies
Celera Genomics, an Applera Corporation business, and Medarex have formed a strategic collaboration to discover and develop fully human antibodies for the potential treatment of multiple cancer indications. Read full article
Company information: Celera Genomics, Medarex, Inc.

Transgene and NCI collaborate on melanoma treatment
Transgene, the France-based biopharmaceutical company, has entered into a collaboration with the National Cancer Institute for the development of novel melanoma treatments. Read full article
Company information: Transgene

Evotec and Roche form global alliance
Swiss drug maker Roche is collaborating with German biotech group Evotec to focus on CNS drug discovery, identifying inhibitors involved in the potential treatment of a range of diseases. Read full article
Company information: Roche Holding AG, Evotec OAI AG

MONTHLY RANKINGS

Rheumatoid arthritis drugs: leading US brands

The current rheumatoid arthritis (RA) treatment approach revolves around non-steroidal anti-inflammatory drug (NSAID) use for the relief of inflammation and pain, and traditional disease modifying anti-rheumatic drugs (DMARDS) for slowing the progression of the disease. DMARDs are being used earlier and earlier in the disease, with primary care physicians also beginning to prescribe them.

The global RA market has experienced extraordinary growth over the last decade. Indeed, this market, which was valued at $4.1 billion in 2004, shows no hint of decline, thanks to the explosion in new DMARDS since the late 1990s.

Some of today's leading treatments available in the US market include the biologics Enbrel (etanercept), a subcutaneously administered TNF inhibitor marketed by Wyeth and Amgen; Remicade (infliximab), an IV TNF-alpha inhibitor marketed by Centocor; Humira (adalimumab), a subcutaneously TNF-alpha inhibitor marketed by Abbott; and Kineret (anakinra), an IL-1 inhibitor marketed by Amgen.

Top-selling traditional DMARDs, meanwhile, include Arava (leflunomide), which is marketed by Sanofi-Aventis, and Neoral/Sandimmune (cyclosporine), which is marketed by Novartis.

The table below shows the top 5 DMARD brands sales in RA in 2004.

Related Research: Commercial Insight: Disease Modification in Rheumatoid Arthritis - The Biologics Boom

COMPANY SPOTLIGHT

ZymoGenetics, Inc.

ZymoGenetics has completed patient enrollment for a phase III pivotal clinical trial of recombinant human thrombin, or rhThrombin, as an aid to controlling blood loss during surgery. If the endpoints in the study are met, ZymoGenetics plans to submit a biologics licensing application (BLA) for rhThrombin to the FDA in late 2006.

The 400 patient pivotal phase III clinical trial was designed to compare rhThrombin to bovine thrombin, the currently marketed product, in four surgical settings and to evaluate the safety, efficacy and immunogenicity of the two products.

"This allows us to continue to pursue our plan for submission of a BLA to the FDA by year end and, we hope, to provide an effective and safe alternative for the control of surgical bleeding," said Dr Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics.

Meanwhile, ZymoGenetics and its collaborator Serono have presented favorable results at the seventh Annual European Congress of Rheumatology from a phase Ib clinical trial with TACI-Ig in 73 patients with rheumatoid arthritis.

TACI-Ig is a soluble fusion protein that neutralizes molecules implicated in the pathogenesis of several autoimmune diseases. TACI-Ig appeared to be well tolerated across the full range of dose levels and schedules tested.

Clear biologic effect was observed as patients showed schedule and dose dependent decreases in the levels of immunoglobulin (Ig) and serum rheumatoid factor levels. Although this study was not specifically designed to evaluate efficacy, encouraging trends were observed in ACR and DAS 28 scores, commonly used measurements of clinical benefit. Based on these promising results, ZymoGenetics and Serono expect to begin the phase II clinical program of TACI-Ig in patients with RA in the second half of 2006.

Key facts

1201 Eastlake Avenue East
Seattle
WA 98102-3702
United States

Tel: 1 206 442 6600
Fax: 1 206 442 6608

www.zymogenetics.com

NASDAQ National Market Ticker: ZGEN
No. Employees: 410
Turnover: (US$ Mn)36
Financial Year End: December

MARKET TRENDS

mAbs: new asthma therapies to drive the market
Overall, the mAb market is one of the fastest growing sectors in the pharmaceutical industry
Read full article

Big pharma turns to biologics for growth
Fuelled by the relative infancy of the market, biologics-derived sales generated by the big pharma peer set have grown rapidly in recent years
Read full article

Hypertension: innovation left to Novartis
Innovation is scare within antihypertensive R&D, with only Novartis looking likely to offer the first innovative hypertension treatment in over a decade when Rasilez hits the market in 2007.
Read full article

Endo: no pain, all gain for Lidoderm
Five years after its launch, Endo's Lidoderm, indicated for pain associated with post-herpetic neuralgia (PHN), continues to demonstrate strong growth.
Read full article

Influenza vaccines: pandemic threat to fuel market growth
The last few years have seen renewed interest in the vaccines market, with influenza treatments having a strong influence on this trend, partially fuelled by fear of an impending pandemic.
Read full article

RESEARCH STORE

The Pain Market Outlook to 2011
15 June 2006
The patient populations for neuropathic and nociceptive pain are large, and are driven by separate disease trends that necessitate pain relief; across the seven major markets in 2005

Mid Pharma Sector: In-licensing and other externalization strategies
14 June 2006
Learn which types of externalization strategy are responsible for the largest influx of product revenues to Mid Pharma

Management of Urinary Incontinence and Overactive Bladder - A Global Overview
14 June 2006
With significant unmet needs remaining in these markets, there are clear opportunities for new entrants

The Diabetes Market Outlook to 2011
19 May 2006
Type 2 diabetes is more prevalent than type 1 and is growing at a faster rate across the 7 major markets, with a forecast prevalence of 49.2m people in 2011, compared to 39.4m people in 2005.

Pipeline Insight: Antiarrhythmics - RSD1235 in a class of its own
17 May 2006
In-depth competitive analysis of the drugs and devices currently in development for the treatment of arrhythmia and their likely impact on currently marketed products

Pharmaceutical Growth Opportunities in the EU Accession States: Healthcare reform, market dynamics and key players
4 May 2006
A new report which provides in-depth insights into the competitive dynamics of the EU accession states

Directed Molecular Evolution: Product lifecycle management for biologics
4 May 2006
Understand how Directed Molecular Evolution can be applied in the discovery and development process to enhance the binding affinity and stability of biologic lead candidates

'Big Pharma' Turns to Biologics for Growth to 2010: Financial and strategic segmentation of the 'Big Pharma' sector by drug technology
4 May 2006
Be prepared for the end-of-decade acceleration in vaccine sales and scan the horizon for future technology waves, including nucleic acid therapeutics