Results tagged “financial data” from Drugs & Medicaments

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

WASHINGTON -- The Bush administration yesterday proposed about a $100 million increase in the Food and Drug Administration's budget for fiscal 2008 that includes the first user fee for the generic drug industry as well a big boost in fees paid by brand-name pharmaceutical companies.

The FDA said the budget increase will be devoted to improving the screening and safety of new drugs; stepped-up oversight of medical devices; strengthening of food safety in light of recent food- borne outbreaks; and more timely reviews and approvals of lower-cost generic drugs.

The President's blueprint calls for $2.1 billion in overall FDA spending during fiscal 2008, up from a projected $2 billion for the current fiscal year.

In an unsourced story, French financial newsletter La Lettre de l'Expansion said a pre-merger deal is thought to have been signed last week.

In Frankfurt trading, shares of Bristol-Myers Squibb jumped 7.5% to close at 21.66 ($27.99). On the New York Stock Exchange, Bristol shares soared $1.22, or 4.7%, to $27.43.

Shares of Sanofi-Aventis slipped 1.4% to finish at 69 euros ($89.16) in Paris. The company's U.S. traded shares lost 77 cents to $44.57 on the NYSE.

Lilly (LLY) published data showing that Gemzar doubled the median disease-free survival time in patients with pancreatic cancer whose pancreases were surgically removed. In a trial involving 368 patients, the median disease-free survival was 13.4 months in the Gemzar cohort and 6.9 months among those who did not receive chemotherapy. Also, the cancer recurred within 4 years in 92% of those who received no post-surgical drug treatment, but only in 74% of the Gemzar group. Lilly was 3 cents lower at $52.85.

Shire plc (SHPGY) received FDA approval for Lialda, its mesalamine drug with MMX technology. The drug is the only once-daily oral therapy for patients with active, mild to moderate ulcerative colitis. Shire expects to launch Lialda in Q1 of 2007. Shire rose 65 cents to $64.20.

GlaxoSmithKline (GSK) was given a $63 million HHS contract to develop pre-pandemic and pandemic flu vaccines. Glaxo is doing research that combines new adjuvants in combination with antigens to provoke a strong immune response. The goal would be to extend a limited supply of flu vaccines in the face of a pandemic. GSK will also ship 15.5 million treatment courses of flu-drug Relenza for the US stockpile. GSK gained 69 cents to end the day at $55.23.

Boasting its 20th consecutive profitable quarter, biotechnology powerhouse Genentech on Wednesday reported a 75 percent increase in net income for the fourth quarter of 2006, compared with the same period a year ago.

The South San Francisco company's net income for the three-month period that ended Dec. 31 totaled $594 million, or 55 cents a share. That was up from $339 million, or 31 cents a share, for the fourth quarter of 2005.

Aside from stock options or other special expenses unrelated to its ongoing operations, Genentech said it would have earned 61 cents a share, 5 cents more than what most analysts surveyed by Thomson Financial had predicted.

U.S. spending on health care hit nearly $2 trillion in 2005, fueled by the cost of hospital care, doctor fees and prescription drugs, government experts said in an annual report released on Tuesday.

Health-care spending grew 6.9 percent to about $1.99 trillion from about $1.86 trillion in 2004, a slower pace than the 7.9 percent increase a year earlier, the report by the National Health Statistics Group found. The increase outpaced a 3.4 percent rise in inflation in 2005.

The statistics group is part of the Centers for Medicare and Medicaid Services (CMS), the single largest payer for U.S. health care.

Biotech drug developer Peregrine Pharmaceuticals Inc. said Tuesday that a recently published animal study showed a technology it licenses could be effective in determining what cancer treatment works in a given patient sooner.

An animal study appearing in the Jan. 1 edition of Clinical Cancer Research showed that microbubbles used in mice being treated for pancreatic cancer allowed ultrasound imaging to determine whether cancer therapies designed to choke off the blood supply to tumors were working or not.

The study used the Vascular Targeting Agent technology that Peregrine licenses exclusively from the University of Texas from Southwestern Medical Center, which conducted the study appearing the journal.

BRISBANE, Calif., Jan. 5 -- VaxGen Inc. announced today that it has restructured the company to significantly reduce operating costs and is actively pursuing avenues to enhance shareholder value through a strategic transaction.

Additionally, the company announced that Lance K. Gordon, Ph.D., has resigned as VaxGen's President, CEO and Executive Director. He will remain as an adviser to the company. VaxGen's Board of Directors unanimously appointed James P. Panek, VaxGen's Executive Vice President, as the company's new President and CEO and appointed him to fill the board vacancy left by Dr. Gordon.

"Lance Gordon was the architect of VaxGen's strategy to become a leader in biodefense and to develop its now significant capabilities in process development and GMP biopharmaceutical manufacturing," said Randall L-W. Caudill, Chairman of VaxGen's Board of Directors. "In addition, under his leadership, VaxGen played a pivotal role in the establishment of Celltrion, an undertaking which recently culminated in the realization of substantial financial benefit through the sale of VaxGen's holdings in Celltrion. The entire board thanks him for his contributions and wishes him the best in his future endeavors."

DARMSTADT, Germany (AFX) - Merck KGaA is considering selling its generics drugs business to focus on new medication, according to a report in Handelsblatt newspaper, citing sources.

Merck (nyse: MRK )'s generics unit could be worth around 4 bln eur, added the report.

The company's supervisory board has already given 'the green light' to look for a buyer, the report stated, citing sources.

Pfizer (PFE) is an enormous company with approximately $52B in sales per year, $12B in profit per year, and $180B market cap. The company has a large stable of prescription medications such as Lipitor, Norvasc, Zoloft, Viagra, Celebrex and others.

Lipitor is the number one selling prescription drug worldwide with over $12B in sales. Pfizer also has a gigantic research effort, spending several billion dollars per year to bring out more prescription medicines. Also, as seen by the purchases of Warner-Lambert and Pharmacia, Pfizer is willing to buy other companies to expand its product portfolio. Additionally, PFE often buys the rights to compounds being tested by much smaller companies.

By Robert Steyer, The Street.com

For the big drugmakers, next year could be the stock-market equivalent of Pushme-Pullyu, the two-headed creature of Doctor Doolittle fame that tried to go in different directions at the same time and ultimately got nowhere.

Maybe a little standing in place doesn't sound too bad to long-time investors in the sector, considering the management ousters, failed clinical trials and patent losses that have become commonplace.

Even better would be to find the 2007 edition of Merck, which despite mixed results on the Vioxx-litigation front turned in a gain of more than 30% this year, making it one of the best performers on the Dow Jones Industrial Average.

LONDON (Reuters) - SkyePharma (SKP.L) said on Wednesday that developing its biggest drug hope, Flutiform for asthma, was costing more than it expected and that it had arranged a new 35 million pound loan.

The drug delivery firm also said it was in exclusive talks with a potential buyer of its loss-making injectable drugs business and that it expected to reach a deal shortly.

SkyePharma has been hit by a string of delays in finding partners for its drugs and earlier this year a shareholder rebellion drove out founder and chairman Ian Gowrie-Smith.

LONDON & WALTHAM, Mass.--(BUSINESS WIRE) -- GlaxoSmithKline plc (GSK) and PRAECIS PHARMACEUTICALS INCORPORATED (Nasdaq: PRCS) announced today execution of a definitive agreement providing for GSK to acquire all outstanding shares of PRAECIS’ common stock for a cash purchase price of US $5.00 per share or a total of approximately $54.8 million for the entire equity interest of PRAECIS.

“PRAECIS has created novel therapeutic programs and innovative chemical-synthesis and screening technology that will complement our own discovery capabilities,” said Allen Oliff, Senior Vice President, Molecular Discovery Research, GSK.

Altus Pharmaceuticals Inc. will make at least $15 million in a new development deal signed with biotechnology giant Genentech Inc. to create treatments for human growth hormone deficiency.

Cambridge, Mass.-based Altus (Nasdaq: ALTU) announced on Wednesday that it would work with Calfornia-based Genentech (NYSE: DNA) to develop, manufacture and commercialize ALTU-238, Altus' once-per week formulation of human growth hormone.

The alliance focuses on a collaboration and licensing deal in North America, and Genentech will pay Altus $15 million up front; The company gets another $15 million through a Genentech investment in Altus stock. Altus can make up to $140 million more if the collaboration produces milestones in development and commercialization.

Danish biotechnology company Genmab A/S signed a deal Tuesday worth up to US$2.1 billion (€1.6 billion) with pharmaceutical giant GlaxoSmithKline PLC for the global commercialization of a leukemia treatment.

The agreement for the HuMax-CD20 antibody includes an initial license fee of 582 million kroner (€78 million; US$102 million), Glaxo buying a stake of just over 10 percent in Genmab and milestone payments totaling 9 billion kroner (€1.2 billion; US$1.6 billion).

GlaxoSmithKline will invest 2.03 billion kroner (€272 million) for the 4.47 million Genmab shares.

Analysts said the value of the deal was much higher than expected, and could mean that Genmab will be profitable as early as next year.

NEW BRUNSWICK, New Jersey (Reuters) - Bristol-Myers Squibb <BMY.N> said on Thursday it could seek approval for as many as three new cancer drugs by next year, including treatments for melanoma and cancers of the breast and bladder.

The company said it plans to seek approval next year for breast cancer drug ixabepilone and to seek approvals by late 2007 or 2008 for bladder cancer treatment vinflunine and melanoma drug ipilimumab.

CAMBRIDGE, Mass — Vertex Pharmaceuticals Inc. said Wednesday a safety analysis of its developing hepatitis C drug VX-950 showed 9 percent of the patients involved dropped out of the program because of adverse events including gastrointestinal disorders and rash.

The news sent shares of Vertex fell 62 cents to $38.78 in morning trading on the Nasdaq, following a drop in premarket trading.

The midstage study involved 250 patients, with the current interim data involving 74 patients for whom data was available at 12 weeks. Patients were given either the drug, called telaprevir, or placebo in combination with ribavirin. The safety study results showed that 9 percent discontinued treatment because of adverse events, with rash being the most common, compared with 3 percent of the patients taking placebo.

Shares of Pozen Inc. sank almost 15 percent Wednesday after the company said federal regulators have raised additional questions about its lead migraine treatment.

Less than two months after Pozen submitted what it called a "full response" to safety questions posed by the U.S. Food and Drug Administration about the migraine treatment Trexima, the federal agency has requested more data and analyses of the drug. Chapel Hill-based Pozen said Wednesday that the FDA has completed its review of the company's response to a June 8, 2006, approvable letter for Trexima and that the agency has "determined the response is not yet complete."

The drugmaker Merck & Co. is off to a strong start in its year-old program to cut costs, boost revenues and transform company operations, Chief Executive Officer Richard Clark said Tuesday.

The company this year launched five new vaccines and other medicines, all well received, without increasing its sales force, Clark told analysts at Merck's annual business briefing at headquarters in Whitehouse Station, N.J.

Merck is speeding up the time it takes to get experimental drugs through testing and onto the market, launching one of the five new products _ the diabetes drug Januvia _ about four years ahead of when it would have been approved under a traditional development schedule, he noted.

by Centinent Management

The pharma business is a risky undertaking, even for monster companies such as Pfizer (PFE). That was once again clearly demonstrated when Pfizer lost $20 billion in market capitalization last week, after it decided to withdraw its new compound torceptrapib. It is rumored that Pfizer lost an additional $1 billion in development costs on the drug, and the company spent almost 15 years focused on it. Other pharmas the size of Pfizer, the ones that have continued to operate consumer or generic divisions, rarely take hits this size.

The Pfizer case is by no means unique, however. Other big pharmaceutical companies have suffered similar setbacks when one of their key pipeline products failed in trials or showed signs of trouble. The torceptrapib case shows how even a few deaths can cause a company to abandon a promising drug. That is because a tainted drug is unlikely to become a blockbuster.