Affymax: independent committee positive on anemia drug

* Independent committee recommends drug trial to continue

* Still sees NDA filing in 2010

Affymax Inc (AFFY.O) said an independent data monitoring committee recommended the continuation of the company's late-stage trials of its experimental drug to treat anemia in chronic renal failure patients.

The biotechnology company, which is co-developing the drug Hematide with Japan's Takeda Pharmaceutical Co Ltd (4502.T), said the committee informed Affymax that safety data from two late-stage studies, called EMERALD and PEARL, support continuation of the studies.

Last August, Affymax and Takeda said they would stop developing the drug for the treatment of chemotherapy-induced anemia due to uncertain regulatory landscapes.

Hematide, a synthetic drug that would compete with biologic anemia medicines that have faced restrictions over safety and potential overuse concerns, is administered just once a month.

That could be a major advantage over current standard treatments from Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N), which are given with dialysis about three times a week.

Affymax said it still expects to file for regulatory approval of the drug in 2010.

Shares of the company closed at $18.30 Friday on Nasdaq.

FDA Approves Drug for Renal Failure Anemia

The U.S. Food and Drug Administration has approved Aranesp (darbepoetin alfa) by Amgen for the treatment of anemia associated with chronic renal failure. Aranesp requires fewer injections than the existing treatment for the condition, according to an Amgen release.

Aranesp was studied in 1,598 adults with chronic renal failure for a total of 942 patient years in 12 clinical trials. Results showed that patients receiving Aranesp consistently reached target hemoglobin levels and that Aranesp was well tolerated. Aranesp is contraindicated in patients with uncontrolled hypertension.

Dodd's wife serves on health care company boards

WASHINGTON — The wife of a senator playing a lead role on a national health care overhaul sits on the boards of three health care companies, one of several examples of lawmakers with ties to the medical industry.

Jackie Clegg Dodd, wife of Sen. Chris Dodd, serves on the boards of Javelin Pharmaceuticals Inc., Cardiome Pharma Corp., and Brookdale Senior Living, their Securities and Exchange Commission filings and Web sites show.

Sen. Dodd, D-Conn., is filling in for ailing Sen. Edward Kennedy, chairman of the Health, Education, Labor and Pensions Committee, which will soon start work on a health care bill.

Dodd, who as Senate Banking Committee chairman also has been an architect of the nation's financial industry and housing rescue plans, did not file a new disclosure report outlining his personal finances as most other senators did in May. The Senate was releasing those reports Friday.

Dodd sought a 90-day extension to file his report covering last year, giving him until mid-August to submit his report.

Other publicly available documents show Mrs. Dodd last year was one of the most highly compensated non-employee members of the Javelin Pharmaceuticals Inc. board, on which she has served since 2004. She earned $32,000 in fees and $109,587 in stock option awards last year, according to the company's SEC filings.

Mrs. Dodd earned $79,063 in fees from Cardiome in its last fiscal year, while Brookdale Senior Living gave her $122,231 in stock awards in 2008, their SEC filings show.

A complaint filed by Citizens for Responsibility and Ethics in Washington, a government watchdog group, led the Senate Ethics Committee to begin looking at mortgages that Dodd and Sen. Kent Conrad, D-N.D., received from Countrywide Financial Corp.

The controversy involved a Countrywide "VIP" program for "friends of Angelo," Countrywide's then-chief executive Angelo Mozilo. The SEC filed a lawsuit this month accusing Mozilo of civil fraud and illegal insider trading.

Both senators have denied any wrongdoing. Dodd's mortgages haven't appeared in his public financial disclosure reports and didn't have to because they were for non-rental homes; Conrad disclosed a Countrywide mortgage on a rental property but not one for a vacation home.

Dodd is not the only member of the Senate health committee with ties to health care interests:

_ Sen. Jay Rockefeller, D-W.Va., reported $15,001 to $50,000 in capital gains for his wife from the sale of a stake in Athenahealth Inc., a business services company that helps medical providers with billing and clinical operations.

Rockefeller is honorary chairman of the Alliance for Health Reform, a Washington nonprofit whose board includes representatives from the UnitedHealth Group health insurance company; AFL-CIO labor union; the AARP, which sells health insurance; St. John Health, a nonprofit health system that includes seven hospitals and 125 medical facilities in southeast Michigan; CIGNA Corp., an employer-sponsored benefits company; and the United Hospital Fund of New York.

Rockefeller also serves on the advisory board of the Children's Health Fund, a New York nonprofit focused on pediatric health care, and is an honorary board member of Beckley Health Right Inc., a nonprofit community medical clinic.

_ Sen. Tom Coburn, R-Okla., is a practicing physician. He reported slight business income, $268, from the Muskogee Allergy Clinic last year; $3,000 to $45,000 in stock in Affymetrix Inc., a biotechnology company and pioneer in genetic analysis; $1,000 to $15,000 in stock in Pfizer Inc., a pharmaceutical company; and a $1,000 to $15,000 interest in Thomas A. Coburn, Md., Inc.

Under Senate ethics rules, Coburn can't accept money from his patients.

_ Sen. Judd Gregg, R-N.H., disclosed $1,000 to $15,000 each in stock in pharmaceutical companies Merck & Co., and Pfizer, the Johnson & Johnson health care products company and Agilent Technologies, which is involved in the biomedical industry.

Some members of the Senate leadership also have financial ties to the health industry.

Senate Minority Whip Jon Kyl, R-Ariz., reported $15,001 to $50,000 in stock in Amgen Inc., which develops medical therapeutics. Kyl's retirement account held stakes in several health care businesses, including the Wyeth, Bristol-Myers Squibb Co., GlaxoSmithKline, Pfizer and AstraZeneca pharmaceutical companies; medical provider Tenet Healthcare Corp.; CVS Caremark prescription and health services company; Genentech, a biotherapeutics manufacturer; and insurer MetLife Inc.

Two U.S. IPOs Lined Up For June

Two IPOs are lined up for the U.S. markets this month, with a medical data software company and a Chinese water treatment equipment supplier preparing to go public.

The first initial public offering that is expected, from New York-based Medidata Solutions Inc., is scheduled to begin trading June 18 on the Nasdaq under the symbol MDSO. The other, Beijing's Duoyuan Global Water Inc., is slated to launch on the New York Stock Exchange under the symbol DGW some time during the week of June 22. Both offerings are small; Medidata is seeking to raise as much as $82 million, while Duoyuan is aiming for $75 million.

So far, June appears to be shaping up as a repeat of April and May in terms of U.S. IPO volume; there were three deals completed in each of those months.

Medidata Solutions makes software that pharmaceutical and medical-device companies use to manage information from their clinical trials; its customers include Johnson & Johnson (JNJ), AstraZeneca PLC (AZN), Amgen Inc. (AMGN), Astellas Pharma Inc. (ALPMF) and Takeda Pharmaceutical Co. (TKPHF). Although its revenue has been rising rapidly, the company has a history of annual operating and net losses dating back to its inception.

Duoyuan Global Water, which distributes its water treatment equipment throughout 28 Chinese provinces, shows both revenue and profit gains. Revenue rose 40% on increased product demand and net income jumped 63% in 2008 compared to 2007. The company cites population growth and industrialization as factors that are driving demand for water treatment in the country.

UPDATE 1-IMS lowers global phamaceutical forecast for 2009

* IMS now sees global growth of 2.5-3.5 pct

* Sees $750 bln 2009 sales, down from prior $820 bln view

* US market to decline by 1-2 percent

* China set to become 3rd largest market in 2011

NEW YORK, - The worldwide economic crisis is taking a tougher-than-expected toll on the pharmaceutical market, according to the leading tracker of prescription drug data.

IMS Health Inc (RX.N) now expects the global pharmaceutical market to grow by an anemic 2.5 percent to 3.5 percent in 2009, down 2 percentage points from the forecast it issued six months earlier, and the lowest growth rate in at least 25 years.

"We see the worldwide financial crisis contributing to record-low sales growth this year," Murray Aitken, senior vice president for Healthcare Insight at IMS, said in a statement.

Traditionally considered more impervious to economic downturns than other sectors, the pharmaceutical industry is feeling the pinch this time. Sales in the world's largest market, the United States, are seen declining by 1 percent to 2 percent in 2009 -- the first decline since IMS started tracking U.S. sales data in 1957.

With the first quarter of the year in the books, IMS now foresees global pharmaceutical sales of $750 billion, down from the $820 billion it forecast for 2009 last October.

"To the now familiar factors impeding market growth, such as patent expirations, a slowdown in innovative product launches, and hurdles imposed by payers on market access, we can now overlay the economic downturn," Aitken said.

A Thomson Reuters health care survey released this week found that one in five U.S. households postponed or canceled medical care over the past year. IMS said it has seen a reduction in patients beginning chronic therapy regimens in areas such as diabetes, hypertension, insomnia and depression.

Patent expirations of a number of billion-dollar drugs in 2011 will impact U.S. growth to the end of the forecast period in 2013, according to IMS.

Many of the world's top selling medicines will face competition from cheaper generic versions over the next few years, including Pfizer Inc's (PFE.N) more than $12 billion a year cholesterol fighter Lipitor in 2011. Sales of branded drugs quickly evaporate when faced with generic versions.

Volatility in currency markets caused by the reeling global economy also impacted the projected global growth rate once local currencies were converted into U.S. dollars, IMS said.

The emerging pharmaceutical markets of China, Brazil, India, Korea, Mexico, Turkey and Russia are expected to see sales grow by 13 percent to 16 percent through 2013, IMS said.

The forecast sees China becoming the third-largest market by 2011, up from its current sixth place ranking.

By contrast, IMS sees a compound annual growth rate of just 1-4 percent through 2013 from the mature markets of Japan, France, Germany, Italy, Britain, Spain and Canada.

Overall, IMS projects global sales to rise by 3-6 percent a year on average through 2013.

Some two thirds of the 50 to 60 new medicines expected to be launched over the next two years will be specialist-driven drugs aimed at narrow patient populations, IMS predicted.

It sees six to 10 drugs with billion-dollar a year potential among the expected 2009 and 2010 launches. The likely winners cited by IMS include Eli Lilly and Co's (LLY.N) blood clot preventer prasugrel, Amgen Inc's (AMGN.O) osteoporosis treatment denosumab, Novo Nordisk's (NOVOb.CO) diabetes medicine liraglutide, and the Johnson & Johnson (JNJ.N) psoriasis treatment ustekinumab.

But predicting blockbusters can be a tricky proposition. There have been some high profile busts among drugs once listed as future 'can't miss' blockbusters, including the Sanofi-Aventis(SASY.PA) weight loss pill Acomplia, that proved to be a major disappointment, and a Pfizer cholesterol drug, torcetrapib, that never reached the market.