Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.   AstraZeneca is seeking an FDA approval of Brilinta primarily on the basis of data from PLATO (a study of Platelet Inhibition and Patient Outcomes), a late-stage 18,624 patient trial, that showed that Brilinta was more effective than Plavix in treating patients with acute coronary syndrome (ACS) in 43 countries. Brilinta treatment resulted in a reduction of cardiovascular events (CV death, MI or ...

Bristol-Myers Squibb Co. (BMY) intends to split its 83.1% holding in the Nutritional segment which operates under its subsidiary Mead Johnson and develops infant formulas such as Enfamil and other nutritional products. The move is aimed to enable the company to concentrate on its core biopharmaceutical business. The transaction is expected to be accretive to earnings beginning in 2010.  Under the terms of the deal, Bristol-Myers shareholders can exchange some, none or all of their shares of the company for shares of Mead Johnson common stock tax-free and at a discount. On completion, the exchange offer would enable Bristol-Myers to dispose of its entire holding interest in Mead Johnson.  For every $1 of Bristol-Myers stock exchanged, stockholders will get approximately $1.11 worth of Mead shares. The offer is set to expire on Dec 14, unless extended or terminated. Bristol-Myers owns 170 million shares of Mead Johnson. ...

Earlier this week, Isis Pharmaceuticals, Inc. (ISIS) reported positive top-line results on its type II diabetes candidate, ISIS-113715. Results from the phase II study showed consistent and statistically significant reductions in multiple short and intermediate measures of glucose control. Besides lowering blood glucose, the candidate also caused statistically significant and clinically meaningful reductions in low-density lipoprotein (LDL) cholesterol.   Importantly, a tendency towards weight loss was observed without strict dietary control. The candidate’s safety profile was favorable with no clinically significant adverse effects being observed. Full results will be presented at an upcoming medical meeting.   ISIS-113715 is a novel insulin sensitizer that reduces the expression of protein tyrosine phosphatase-1B (PTP-1B). The candidate’s ability to normalize glucose without exacerbating hypoglycemia, and reduce LDL-C levels and weight could provide patients who are obese and at high cardiovascular risk with a new treatment option.   ISIS-113715 has been developed using ...

Amylin Pharmaceuticals (AMLN) reported a loss of 19 cents per share in the third quarter, which was narrower than the Zacks Consensus Estimate of a loss of 30 cents. In the prior-year period, the company had incurred a loss of 47 cents. Total revenues for the quarter were $211.2 million, down 3.3% year over year.   Revenues consisted of $192.9 million in product sales and $18.3 million in collaborative payments from partner Eli Lilly (LLY). Product sales comprised $171.1 million in sales of Byetta and $21.8 million in sales of Symlin. Byetta sales declined both on a yearly and sequential basis. The company attributed the sequential decline in Byetta sales to an increase in wholesaler stocking in the previous quarter. We believe Byetta continues to be affected by safety issues surrounding the use of the drug.   Selling, general and administrative expenses decreased to $80.1 million from ...

• Eli Lilly (NYSE:LLY) reported third quarter earnings of $1.20 a share, 18 cents ahead of Zacks estimates, on third quarter revenues of $5.56 billion.  The company said, "Our performance in the third quarter once again was driven by volume-based sales growth, improving gross margins and tight control of operating expenses, allowing us to deliver very attractive earnings growth"

• Yahoo (NASDAQ:YHOO) results beat Zacks estimates of 7 cents, coming in at 13 cents, as the company’s operations benefitted from cost-cutting measures; revenues held steady with last quarter's at $1.13 billion.  According to CFO Morse, "There's a change occurring in Yahoo, that will value that kind of work - that good old-fashioned, get-your-hands-dirty kind of find ways to take costs down or make sure that they don't go up as much as they otherwise would have - type work"

• SanDisk (NASDAQ:SNDK) results also beat projections on earnings of 75 cents, well

...

A tepid report on housing starts sent stocks into a tizzy and major indexes slipped from their year highs as solid earnings reports from Apple Inc. to Caterpillar were overlooked by anxious investors.  A rebound in dollar from its 14-month lows also added to the downward pressure and hurt commodities, sending energy and material shares lower. 

Weakness in share sent Treasury prices higher, with the 10-year closing up 13/32, to 102 11/32.  The yield fell to 3.34%, from 3.39% late Monday.  On Tuesday, the 30-stock Dow Jones industrial average fell 50.71 points, or 0.50%, to 10,041.48.  The broad Standard & Poor's 500-stock index retreated 6.85 points, or 0.62%, at 1,091.06 and the tech-heavy Nasdaq composite index lost 12.85 points, or 0.59%, to 2,163.47.  Market breadth was negative.  On the New York Stock Exchange, declining shares beat those that rose in price two to one on volume of 1.24 billion

...

Companies featured in this edition of the newsletter: CHIP, ENZ, GERS, IWEB, OMCM, ONEZ, XSNX

Markets hit fresh highs for ‘09 yet again last week, as the first round of earnings helped to assuage investor concerns that operating results would underpin robust gains in equities this year. All told, the Dow gained 130 points to end the week at 9995 after briefly cracking the 10,000 mark, gaining 1.3% on the week and extending its gains to 13.9% on the year. The Nasdaq gained 0.8% on the week to close at 2156, up 36.8% on the year, while the S&P 500 and Russell 2000 gained 1.5% and 0.2% respectively, bringing their YTD totals to 20.4% and 23.4%.

Earnings stole the spotlight last week as things got off to a strong start early with JP Morgan handily beating expectations calling for $0.51 per share, reporting earnings of $0.82 per share. Citigroup

...

Today, Dainippon Sumitomo and Sepracor (SEPR) have announced the successful completion of the initial share offering period, where almost 78.2% of Sepracor’s shares were tendered. The offer period has been extended to Oct 19, 2009, to enable other shareholders to tender their shares as well.  As a reminder, in September, the Japanese pharmaceutical company Dainippon Sumitomo Pharma Co had announced a deal to acquire Sepracor at $23 per share or $2.6 billion. However, soon after the announcement, shareholders of Sepracor filed a suit in a Delaware court against the company, citing the offered price as inadequate. They were seeking the court’s intervention to stop the deal and pay damages.  Additionally, certain aspects of the deal were against the interest of Sepracor’s shareholders. The deal included a $77.4 million termination fee and a “no solicitation" provision. Apart from restricting the possibility of any superior proposal, these provisions ...

Yesterday, Novartis Pharma AG (NVS) signed an agreement with Vanda Pharmaceuticals Inc. for the acquisition of exclusive US and Canadian rights to Fanapt (iloperidone), an oral medication that is approved by the US Food and Drug Administration (FDA) for the acute treatment of adults with schizophrenia.  Fanapt belongs to a new generation of schizophrenia drugs known as atypical antipsychotics. In addition to gaining exclusive commercialization rights to the oral formulation of Fanapt in the US and Canada, Novartis will also have exclusive rights to develop and commercialize a long-acting injectable (or depot) formulation of the medicine for these markets.  Vanda will receive an upfront payment of $200 million from Novartis. Besides this, the company will receive additional payments based on the achievement of defined development and commercial milestones. Vanda will also receive royalties on product sales. Vanda has retained rights to develop and commercialize Fanapt outside ...

Abbott Laboratories (NYSE: ABT) recently announced that the company will purchase the pharmaceutical arm of Belgium’s Solvay Group for $6.5 billion. This deal expands both the company’s product range and the company’s presence in fast-growing emerging countries, helping defer the effect of patent expiries and compensate for sluggish growth in its traditional markets, such as the United States.

We also have the recent $442 million paid by Johnson & Johnson (NYSE: JNJ) for 18% of Crucell ADR (NASDAQ: CRXL). This will give Johnson & Johnson the development rights on a flu vaccine designed to protect against all future strains of the virus. This deal confirms the company’s move into vaccines, alongside drugs and consumer products.

These deals are further confirmation of the consolidation trend that is occurring right now in the global pharmaceutical industry.

One major factor driving the consolidation trend is the slowdown in sales of pharmaceuticals, particularly in the United

...