OSI to benefit from uses for cancer drug-Barron's

NEW YORK, - OSI Pharmaceuticals (OSIP.O) shares could benefit as the Melville, N.Y.-based company expands the uses of its lung-cancer drug, Barron's said.

OSI's sales of Tarceva, the second-largest oral anti-cancer drug, hit $1 billion last year.

OSI trades for about $32 a share, about 18 times next year's earnings, Barron's said, projecting it could rally to $45 a share in the coming year with the help of Tarceva.

Pharmaceutical company's move to Ardsley cheers biotech execs

News that OSI Pharmaceuticals Inc. is coming to Ardsley was greeted by regional biotech executives this week with the enthusiasm of playoff-hungry baseball pros whose team's owner just acquired a hot slugger.

The leading drug company on Long Island, OSI will join a lineup of biotechs in the Lower Hudson Valley and strengthen the region's reputation as a hub for innovation in the industry, the executives said. At stake are well-paying jobs - the state average was more than $68,000 in 2006, an industry report said - in a field that's seen as critical to the new economy.

The industry provided more than 17,000 jobs directly and in related fields in Westchester and Rockland counties in 2006, according to the report this year by Archstone Consulting LLC.

The two counties host 61 companies, including publicly-traded Regeneron Pharmaceuticals Inc. and Progenics Pharmaceuticals Inc. at The Landmark at Eastview, and Acorda Therapeutics Inc. in Hawthorne.

"There is a lot of synergy, but you need a critical mass," said Dr. Ron Cohen, chief executive officer at Acorda and the former chairman of the New York Biotechnology Association.

"I think that with OSI coming here, to me it feels like the missing piece," he said. "Now you really have an opportunity to create a buzz around successful biotechnology anchor tenants, if you will. That's what you really need to get the level of interest from other biotech CEOs, from would-be entrepreneurs, from venture capitalists who can now start thinking, 'Hey, I ought to consider Westchester and maybe I won't go to New Jersey, maybe I won't go to Pennsylvania.' "

With a market cap of $1.64 billion, OSI has what many startups dream of - profits and a product with a proven track record.

The company had operating income last year of $137.3 million on sales of $379.4 million. Most of the revenue came from Tarceva, a treatment for lung and pancreatic cancer that produced worldwide sales of $1.1 billion last year for OSI and its partners.

Pharmaceutical company moving headquarters to Greenburgh

GREENBURGH - Biotechnology company OSI Pharmaceuticals announced today it will move its headquarters to a 43-acre site in town that has been vacant for four years.

OSI will consolidate its domestic operations and move from Melville, Long Island, to 410-460 Saw Mill River Road, the former site of the Purdue Pharma laboratory at Ardsley Park Science & Technology Center that closed in 2005.

Town Supervisor Paul Feiner said the company plans to construct another building there and add 400 jobs within the next five years.

"It's a win-win-win," he said. "It stops the bleeding of certioraris in the Ardsley school district."

He was referring to land owners that have their assessments - and therefore their property-tax bills - lowered after legally challenging them.

Feiner said the new business will also generate at least $1 million in revenue for the town from renovation and building-permit fees, as well as stimulate the local business and real-estate market.

"In these tough economic times, it's so exciting," he said. "It puts Greenburgh on the map as a biotech community in the area."

Greenburgh resident Mike Edelman said he is generally in favor of attracting new businesses, but the community has become more dense since Purdue Pharma operated there.

"This is going to do far more damage, in terms of traffic, than the taxes it mitigates," he said. "The infrastructure doesn't support it at this time."

Construction and renovation at the site are planned to begin as early as next month. Some 200 employees from Colorado, New Jersey and Long Island would relocate in the fall, Feiner said.

The property's current assessed value is $32 million. OSI is paying $27 million for it, town officials said.

The Greenburgh Town Board has invited Pierre Legault, OSI's executive vice president and chief financial officer, to its meeting at 7:30 tomorrow night.

OSI Pharmaceuticals closing 145-person Boulder office

Pharmaceutical company consolidating U.S. operations to one campus

BOULDER, Colo. — OSI Pharmaceuticals Inc. is closing its 145-employee Boulder office as part of plans to consolidate its U.S. operations to a single campus in New York, officials announced this week.

Officials for the Melville, N.Y.-based drugmaker said the consolidation — which will affect 350 people who work in Melville; Farmingdale, N.Y.; Boulder; and Cedar Knolls, N.J. — is intended to “simplify” its business operations.

“The past 10 years has been a remarkable journey as the company has successfully brought its first oncology product, Tarceva to market and taken the business profitable,” Colin Goddard, OSI’s chief executive, said in a news release. “Nonetheless, we have recognized that we will only truly capture the full strategic value of our oncology franchise if we simplify our business by bringing together all the elements of our U.S. operations onto a single site.”

OSI’s diabetes and obesity franchise in Oxford, England, will remain operational.

About 145 people work at OSI’s Boulder office, according to employment information recently provided to the Camera. OSI has yet to file a notice with Colorado’s labor department under the Worker Adjustment and Retraining Notification Act, said Bill Thoennes, a spokesman for the Colorado Department of Labor and Employment.

The local employees will be offered relocation packages to work in New York, OSI officials said.

OSI recently purchased a 43-acre site that includes 400,000 square feet of existing office space in the village of Ardsley, N.Y., for $27 million and expects to begin the consolidation later this year, officials said in a news release. The company received incentives from the state of New York in connection with the move to Ardsley, about 20 miles north of Manhattan, OSI officials added.

OSI (Nasdaq: OSIP, $27.88) expects to save more than $15 million a year when the consolidation is completed during the fourth quarter of 2010.

“We recognize that this decision has a significant impact on the lives of our employees, in particular, the employees in our Boulder office. All employees will be offered a position at the Ardsley, NY facility and we hope that as many people as possible will join us as we embark on a new and exciting phase for the Company,” according to an e-mailed statement attributed to Goddard.

“For those who choose not to stay with OSI after the Westchester (County) relocation or who are unable to do so, the company will offer a severance package.”

OSI did not disclose the details of the severance packages.

OSI has had a presence in Boulder since 2001, when it purchased Gilead’s Boulder offices and a pipeline of cancer-fighting clinical candidates for $200 million. Gilead acquired the operations two years earlier in its merger with the Boulder-bred NeXstar Pharmaceuticals Inc.

Local entrepreneur Larry Gold, now the CEO of Boulder-based SomaLogic, founded NeXstar.

OSI’s departure will have a near-term impact on Boulder, but should not have a lasting negative effect on the area’s biopharmaceutical industry, said Frances Draper, executive director of the Boulder Economic Council. While the area is losing a number of higher-paying jobs, she said she feels encouraged by the presence of other biotechnology firms and new technologies and companies coming out of the University of Colorado.

“I think it’s actually probably pretty unfortunate for OSI because here they could access a pretty good pool of employees,” she said.

There are about 16,000 people employed in the 380-company bioscience field in Colorado, according to the Colorado BioScience Association. The average employee salary in that field is $63,000, the association said.

John Collar, president and CEO of the Colorado BioScience Association, said OSI’s departure from the state does cause concern, but he echoed Draper’s comments about bioscience’s strength in Colorado.

“I think, overall, the folks will be in pretty good shape going forward,” he said.

OSI Pharmaceuticals to Provide a Summary of Data Presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) today announced it will host a live webcast to provide a summary of the Company’s data, including its flagship product Tarceva® (erlotinib), presented during the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, FL. The webcast will be hosted by Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals and OSI's Oncology Management Team. The webcast will begin at 7:30AM Eastern Time on Tuesday, June 2, 2009.

To access the live webcast via the internet, please log on to www.osip.com approximately 15 minutes before the start of the event to allow for any software downloads that may be necessary. Following the webcast, an archive will be available at the same address for fourteen days.

Tarceva Black Box Warns of Potentially Deadly Side Effects

Tarceva, a drug approved to treat lung and pancreatic cancers, has been linked to serious side effects including sometimes fatal digestive tract perforations and skin reactions, as well as eye problems. The complications linked to Tarceva have prompted the Food & Drug Administration (FDA) to mandate a black box warning for the drug’s label. A black box is the agency’s most serious type of safety alert.

Tarceva is one of a class of cancer drugs known as epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. These treatments are designed to block the EGFR protein, believed to play a role in cancer cell growth.

As a monotherapy, Tarceva is approved for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Just this past March, Genentech Inc. and OSI Pharmaceutical Inc., the makers of Tarceva, applied to have the drug approved as a first-line maintenance treatment for lung cancer.

The new Tarceva black box warning was announced by the FDA on Friday. In a letter dated April 2009, Genentech and OSI said that there had been reports of patients suffering gastrointestinal perforations while undergoing Tarceva therapy. This risk is greatest for patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease. According to the letter, some instances of perforation had been fatal.

The letter also said that some Tarceva patients had developed bullous, blistering and exfoliative skin conditions, which in some cases were suggestive of Stevens-Johnson syndrome or toxic epidermal necrolysis. Again, some of these cases resulted in deaths.

Finally, the letter warned that patients treated with Tarceva had experienced corneal perforation or ulceration. Other eye disorders including abnormal eyelash growth, keratoconjunctivitis sicca and keratitis, have also been observed with Tarceva treatment.

The letter did not say how many cases of patients with Tarceva complications were reported or how many patients died. More than 350,000 patients have been treated with Tarceva worldwide, and global sales of the drug topped $1 billion in 2008.

FDA notes side effects with Genentech cancer drug

Federal health regulators have alerted doctors to a range of side effects, including blistering skin and intestinal problems, seen in patients taking a drug used to treat cancer.
The Food and Drug Administration on Friday highlighted new warnings on Terceva, a daily pill from OSI Pharmaceuticals Inc. ( OSIP - news - people ) and Roche ( RHHBY.PK - news - people )-unit Genentech ( DNA - news - people ).
The label warns that some patients have experienced gastrointestinal perforation, in which a hole develops in the intestine or stomach. Some other patients developed blistering skin often seen in connection with toxic drug reactions. Some cases of both conditions were fatal, according to the FDA. The labeling advises doctors to discontinue use of the drug if either condition develops.
Additionally, the label notes that some patients developed scars and ulcers of the eye while taking the drug.
OSI Pharmaceuticals and Genentech notified physicians about the problems in an April letter.
Tarceva, has been approved to treat lung and pancreatic cancer. The drug was developed by OSI Pharmaceuticals Inc. and is sold by Genentech. Switzerland-based Roche agreed to buy South San Francisco-based Genentech in March.
Shares of OSI Pharmaceuticals Inc. fell 78 cents, or 2.4 percent, to close at $33.59 Friday.