Having seen Bristol-Myers Squibb and Gilead Sciences win approval for their Atripla combination pill for the treatment of HIV, analysts have predicted that the drug will become a popular choice for people diagnosed with the virus. Atripla, which combines three HIV drugs, is the first to offer patients a convenient single pill, once-a-day, treatment regimen.

Merck & Co received a boost this week after a jury in New Jersey said that the withdrawn painkiller Vioxx did not cause the plaintiff's heart attack. The company, which has pledged to fight the approximately 16,000 Vioxx cases on an individual basis, will be encouraged by the precedent set in this case.

Finally, Bayer AG has moved closer to the completion of its E17 billion takeover of Schering AG, while Novartis announced that it has now acquired 75% of shares in UK biotech company NeuTech.

Edited by
Tom Neilson

LATEST COMMENT

Novartis: Tasigna filing brought forward

Novartis has brought forward its intended filing date for cancer drug candidate Tasigna.

Following the approval of Bristol-Myers Squibb's Sprycel in June, Novartis has brought forward its intended filing date for Tasigna to late 2006. Both drugs are capable of overcoming Gleevec resistance, marking a significant breakthrough for cancer patients. Given this, and the fact that Novartis has relevant market experience thanks to Gleevec, Tasigna could prove a worthy opponent for Sprycel. Read full article
Company information: Novartis AG, Bristol-Myers Squibb Company


Teva/Eisai: the end of an alliance

Teva and Eisai have ended a US co-promotion agreement for Parkinson's disease drug Azilect.

Israel's Teva and Japan's Eisai have mutually agreed to end their collaboration to co-promote Teva's Parkinson's disease drug Azilect in the US. While the abrupt end of the alliance raises questions over Azilect's sales potential in this new market, the loss of Eisai as a marketing partner is not expected to prove too detrimental to Teva. Read full article
Company information: Teva Pharmaceutical Industries, Eisai Co., Ltd.

Bristol-Myers Squibb/Sanofi-Aventis: Plavix deal under threat

It has emerged that FTC sanctions could threaten a patent deal for blockbuster anticoagulant Plavix.

Bristol-Myers Squibb and Sanofi-Aventis' proposed settlement with generics firm Apotex, designed to end the companies' dispute over Plavix' US patent protection, has been called into question. It appears the deal could contravene an agreement BMS made with US regulators in 2003. Investors will be worried that, if the pact collapses, conflict over the blockbuster drug's key patent could resurface. Read full article
Company information: Bristol-Myers Squibb Company, Sanofi-Aventis Group


Santarus: Zegerid to act fast on revenues

The recent launch of Zegerid capsules is expected to drive near-term growth for Santarus.

Although the powder formulation of Santarus' gastroesophageal reflux disease drug Zegerid has not made much of an impact in the market, the recent FDA approval of a new capsule formulation could be about to improve matters. As a result, US Zegerid revenues are expected to grow to $229 million in 2010, slightly ahead of Wall Street consensus. Read full article


Roche: Avastin continues to march on

Roche has filed for European approval of Avastin as a first-line advanced breast cancer treatment.

Roche has submitted a marketing authorization application to the European Medicines Agency for Avastin in previously untreated advanced breast cancer. This is yet more good news for Avastin, which, already approved in colorectal cancer, filed in non-small cell lung cancer and in phase III trials for hormone-refractory prostate cancer, is set to dominate the cancer market for years to come. Read full article
Company information: Roche Holding AG, Genentech, Inc.

ANALYST'S VIEW

Urinary incontinence: common problem, not commonly reported

Despite not being a widely acknowledged affliction, urinary incontinence (UI) is a relatively common condition, with up to 23% of the female population suffering from one form alone. Yet despite the significant impact UI can have on the quality of life of the sufferers, according to a new report, approximately half of sufferers neither seek treatment nor report the problem to a physician.

UI is defined as "the complaint of any involuntary leakage of urine" and can be divided into three main subtypes: urge urinary incontinence (UUI), stress urinary incontinence (SUI) and mixed (urge and stress) urinary incontinence (MUI).

UI is a common condition, with physicians interviewed by Datamonitor estimating that 18.1%, 21.2% and 22.9% of the female population suffer from UUI, MUI and SUI, respectively. UI can affect all age groups; however, differences in the underlying causes and risk factors for each subtype of UI mean a slightly different age distribution is observed in each patient cohort. Whereas SUI is often observed in younger women, UUI and MUI are observed more frequently with increasing age.

However, despite the widespread nature of the condition, many sufferers do not present to a physician. UI can have a profound impact on quality of life and symptoms such as unpredictable urges, frequency, and urine leakage can be extremely distressing for sufferers. Many sufferers worry about the symptoms and this frequently results in them modifying their lifestyle and restricting their activities.

This reluctance to seek help means that many individuals suffer in silence and try to cope by using behavioral modifications such as limiting trips, fluids and routine activities; and/or by using widely available absorbent products. Although these products may help sufferers live with the problem, such strategies neither treat nor cure UI.

Datamonitor has found that the key reasons patients do not seek help is because they think that their condition is a normal part of aging/childbirth, they are too embarrassed to discuss their condition, and don't think that their condition is treatable or have not heard that it can be treated.

Such findings are worrying since there is little need for patients to suffer, because UI can normally be treated with simple interventions. However, the bigger issue here is the need for improved patient education, which is required to improve presentation rates.

This situation presents a great opportunity for pharmaceutical companies to become involved in awareness programs - promoting awareness of symptoms and treatment options.
Read full article

Related research: Management of Urinary Incontinence and Overactive Bladder - A Global Overview priced $15,200

INDUSTRY NEWS

Merck wins latest Vioxx liability case
Merck & Co has been found not guilty in a product liability case, after a New Jersey jury rejected claims of a long-term Vioxx user who blamed her heart attack on nearly three years of using the drug. Read full article
Company information: Merck & Co., Inc.

Forest successfully protects Lexapro patent
A US court has upheld a patent covering the active ingredient of Forest Laboratories antidepressant drug, Lexapro. The court said that the patent, which does not expire until 2012, is valid, enforceable and infringed by Teva's proposed generic product. Read full article
Company information: Forest Laboratories, Inc, Teva Pharmaceutical Industries

Bayer ready to complete Schering takeover
German drug maker Bayer has revealed that it now controls 92.4% of the shares in Schering AG and plans to acquire the remaining shares in due course. Read full article
Company information: Bayer AG, Schering AG

Novartis nears completion of NeuTec takeover
As part of its GBP305 million takeover of UK biotech company NeuTec, Novartis has acquired or received valid acceptances from shareholders for 75.4% of the company's share capital. Read full article
Company information: Novartis AG

Samaritan drug ad upsets Las Vegas officials
Las Vegas officials have reportedly been irked by Samaritan Pharmaceuticals' attempt to use the US city in a campaign for an HIV drug. Read full article
Company information: Samaritan Pharmaceuticals, Inc.

REGULATORY DEVELOPMENTS

FDA approves single pill HIV combo
The FDA has given the green light for Atripla, a treatment developed by Bristol-Myers Squibb and Gilead Sciences that combines three HIV drugs into a more convenient single pill once-a-day regimen. Read full article
Company information: Bristol-Myers Squibb Company, Gilead Sciences, Inc.

Merck's post-op nausea treatment gets FDA approval
The FDA has given Merck & Co clearance to market its Emend drug for the prevention of postoperative nausea and vomiting, one of the most common side effects associated with surgical procedures. Read full article
Company information: Merck & Co., Inc.

Glaxo diabetes drug approved as first-line treatment
GlaxoSmithKline's diabetes drug Avandamet has been approved by the FDA for use as a first-line treatment of type 2 diabetes as an adjunct to diet and exercise. Read full article
Company information: GlaxoSmithKline Plc

Roche's MabThera gets new EU lymphoma OK
The European Commission has approved Roche's MabThera as maintenance therapy for patients with relapsed or refractory follicular non-Hodgkin's lymphoma, a common form of lymphoma. Read full article
Company information: Roche Holding AG

RESEARCH & DEVELOPMENT

Valentis artery disease drug fails in phase II
Valentis has halted development of its lead drug candidate, VLTS 934 for peripheral arterial disease, after it failed to meet expectations in a phase IIb clinical trial. Read full article
Company information: Valentis, Inc.

Curis and Genentech halt development of skin cancer product
Curis and Genentech have halted a phase I trial evaluating a topically applied treatment for basal cell carcinoma, a common type of skin cancer, after the candidate failed to show the anticipated clinical activity. Read full article
Company information: Genentech, Inc., Curis, Inc.

Study shows Sanofi insomnia drug works long-term
Results from a study show that Sanofi-Aventis' insomnia drug Ambien CR is well-tolerated and effective in improving sleep onset and maintenance for up to six months in patients with chronic primary insomnia. Read full article
Company information: Sanofi-Aventis Group

Conjuchem places trial on hold after patient death
ConjuChem Biotechnologies has discontinued dosing in a mid phase trial of its investigational treatment for HIV lipodystrophy after the death of a patient involved in the trial. Read full article
Company information: ConjuChem Inc.

ALLIANCES & LICENSING

Actelion and Roche form autoimmune disease collaboration
Roche has agreed to pay up to $555 million for rights to jointly develop and commercialize Actelion's selective S1P1 receptor agonist, an immunomodulator with the potential for once-a-day oral dosing. Read full article
Company information: Roche Holding AG, Actelion Holding Ltd

P&G and Aryx in $435 million deal for stomach drug
In a deal which could eventually be worth as much as $435 million Aryx Therapeutics is to grant Procter & Gamble worldwide rights to develop and commercialize its ATI-7505 investigational treatment for gastrointestinal disorders. Read full article

University of Manchester and AstraZeneca sign major research deal
AstraZeneca and the UK's University of Manchester have entered into an agreement to enhance each organization's research into diseases such as cancer, inflammatory diseases, diabetes and obesity. Read full article
Company information: AstraZeneca PLC

Novartis and Myogen extend alliance
Novartis has extended its collaboration with Myogen for the discovery and development of novel drugs for the treatment of heart muscle disease. Read full article
Company information: Novartis AG

The Top 10 Generics Companies: Strategic insight, growth opportunities and competitive dynamics in the US and Europe

The generics sector has grown at a fast pace over the past few years, outperforming the pharmaceutical market as a whole; generic growth opportunities are significant, with an estimated $100bn worth of branded pharmaceutical products to go off patent by 2010, of which $21bn expire in 2006.

Further information

MONTHLY RANKINGS

Generic cancer drugs: leading global markets

Over the next 10 years a significant number of key oncology products, some with blockbuster status, will lose patent protection, thus exposing billions of dollars to generic erosion. This is expected to drive astounding growth in the cancer generics market, which is expected to grow from a value of $1.3 billion in 2004 to $10.9 billion by 2014.

While obviously a major threat to the key pharmaceutical players and sales of their branded products, this presents significant opportunities to potential generic manufacturers. Furthermore, all classes of drugs are set to enjoy significant growth across the seven major markets, although potential players in the targeted therapies and supportive care products markets will have to wait for the relevant biogeneric legislation to be passed before they can begin reaping the rewards these markets have to offer.

In terms of regional sales, the US market unsurprisingly leads the way at present, with US cancer generics sales having reached $656 million in 2004. In contrast, the smallest of the seven major markets is Spain, which saw sales of just $45 million in the same period.

The table below ranks the top 5 cancer generics markets by sales in 2004.

COMPANY SPOTLIGHT

Takeda Pharmaceutical Company

Takeda has moved TAK-491 into phase II, thus accelerating the development of a follow-on product to its blockbuster hypertension drug Blopress, which now has two potential successors in phase II development. However, given the dynamics of the hypertension market and the fact that either Blopress successor would be a late entrant to the market, Takeda's investors must be worried.

Takeda has surprised industry insiders with its announcement to advance another angiotensin II receptor blocker (ARB) into phase II trials. With TAK-491 joining TAK-536 in mid-stage clinical development, Takeda's pipeline now contains two ARBs under clinical development for hypertension.

The company aims to bring an antihypertensive to market in time to stem the dramatic revenue erosion expected to result from the genericization of Blopress (candesartan), its current blockbuster antihypertensive. Blopress accrued $1.7 billion in global sales in the last business year but faces patent expiry in 2012. The decision to develop TAK-491 more or less in tandem with TAK-536 was taken with a view to reduce the risk of not being able to launch a timely successor to Blopress.

Takeda's hypertension franchise is undisputedly at risk from commercial decline, but it is debatable whether an antihypertensive of the ARB class will be able to avert the impending revenue erosion.

Even if TAK-536 or TAK-491 gain approval, by the time they enter the market, they will be eighth or ninth in their class and will face strong generic competition. In addition, a further threat will come from Novartis and Speedel's aliskiren, an innovative first-in-class agent likely to be supported by long-term outcome data by the time Takeda's hopefuls are launched.

At present, and in the absence of other clinically relevant information, either of Takeda's investigational ARBs seem unlikely to receive significant market uptake in 2012 and beyond unless they can distinguish themselves from both competing monotherapies and combination therapies.

Commercial success may be unlikely, but it is theoretically possible if Takeda's lead molecules can exploit a hitherto unknown interaction with the type 2 receptor that other ARBs have not been able to trigger.

For the moment, however, there are at least two reasons for investors to closely monitor TAK-491 and TAK-536's clinical performance. Firstly, the trials required to establish a Blopress successor will be very costly and drain Takeda's resources. Secondly, the reimbursement potential of a Blopress successor may be limited unless it can add comprehensively proven clinical benefit to established therapy paradigms.

Key facts

1-1, Doshomachi 4-chome
Chuo-ku
Osaka 540 8645
Japan

Tel: 81 6 6204 2111
Fax: 81 6 6204 2880

www.takeda.com

Tokyo Ticker: 4502
No. Employees: 14,592
Turnover: (JPY (Mn))1,086,400
Financial Year End: March

MARKET TRENDS

Pipeline management: Mid Pharma big on in-licensing
Mid Pharma companies, defined as pharmaceutical companies with annual revenues under $10 billion, currently rely heavily on externally sourced products, and this reliance is set to rise.
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Telehealth: a talking point in the UK
The rising cost of care and cheaper technology are driving interest in care at a distance, and, as a result, the telehealth market is set to see rapid expansion over the coming years.
Read full article

Biologics: a growing but threatened market
Although biologics, especially mAbs, will be the fastest growing product segment of the market in 2010, bio-similars and increasing numbers of competitor products pose a significant threat
Read full article

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

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

RESEARCH STORE

The Asthma, COPD & Allergic Rhinitis Market Outlook to 2011
11 July 2006
It is forecast that by 2011, the total prevalence of asthma across the seven major markets will be 58.8million sufferers or 8% of the population.

Commercial Insight Top 20 Cancer Therapeutics
3 July 2006
Overview of the current Top 20 cancer therapeutics market, including profiles of key products and events impacting each during 2005-15, and assessment of current and future opportunities and threats in the cancer market across the seven major pharmaceutical markets

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