"Report slams Genzyme’s MS drug on eve of hearing" by Deirdre Fernandes | Globe Staff, November 09, 2013
The future of a key multiple sclerosis drug developed by Cambridge biotech Genzyme was put in doubt Friday after federal regulators suggested it could be too dangerous to approve because of what they believe are the treatment’s limited benefits.
The drug, Lemtrada, was pivotal to sealing French drug maker Sanofi SA’s $20.1 billion purchase of Genzyme Corp. in 2011. Sanofi is counting on it and other new treatments to rejuvenate the global drug giant’s sales.
Until Friday, approval from the Food and Drug Administration seemed likely, especially since European regulators in September signed off on the sale of Lemtrada overseas. But an FDA staff report — prepared in advance of a Wednesday advisory panel meeting to consider whether to recommend Lemtrada’s sale in the United States — indicates Genzyme now faces a major hurdle.
The report said the drug has “serious and potentially fatal safety issues,” including a risk of cancer. While such staff reviews are not binding, advisory panels — made up of prominent medical specialists — give them significant consideration.
“That’s like a death sentence,” Fabian Wenner, an analyst with Kepler Cheuvreaux in Zurich, said of the report....
Maybe the move will commute a few.
The shadow over the MS treatment marked the fourth major setback in recent weeks for a Massachusetts biotechnology company.
On Thursday, Ariad Pharmaceuticals Inc. laid off 160 people, about 40 percent of its US workforce, after the Cambridge company pulled its leukemia pill from the market because some patients taking the drug suffered blood clots and heart problems.
Related:
Ariad puts hold on move to Kendall Square
Ariad halts US sales of key drug
Ariad Pharmaceuticals sets ‘poison pill’ provision
Troubled Ariad cuts 40 percent of US workforce
Looks like Ariad may be all done.
ImmunoGen Inc., a Waltham biotech, on Tuesday stopped a mid-stage study of a drug to treat small-cell lung cancer after it was linked to infections and infection-related deaths.
Related:
ImmunoGen climbs on Novartis deal
ImmunoGen stops study of drug candidate for small-cell lung cancer
Test of cancer drug ends badly for ImmunoGen
Slow Saturday Specials: The Morning After
Earlier, Vertex Pharmaceuticals Inc., which is scheduled to move from Cambridge to an expansive headquarters on the Boston waterfront next month, cut 370 jobs, including 175 in Massachusetts, because of a dramatic drop in sales of its hepatitis C drug....
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Look who got out alive:
"Two years after he sold the biotechnology company Genzyme Corp. to a French pharmaceutical giant, Henri A. Termeer isn’t exactly settling into the comforts of retirement at his seaside homes north of Boston and in Maine. The 66-year-old Termeer, who left the Cambridge company in April 2011, certainly doesn’t need to keep working for financial reasons. He cashed in Genzyme shares worth at least $145.9 million and walked off with a $12.5 million severance package."
The Globe caught up with him at the recent J.P. Morgan Healthcare Conference — the life sciences industry’s premiere investment gathering.
I wonder if Genzyme is still an Icahn now.
One who is no longer:
"Vertex will cut 370 jobs, repay tax credits from Mass.; Falling sales of hepatitis drug slow burgeoning Cambridge biotech" by Robert Weisman | Globe Staff, October 30, 2013
More than any biotechnology company, Vertex Pharmaceuticals Inc. has symbolized the industry’s explosive growth in the Boston area. Over the past two years, it won back-to-back approvals to sell drugs for hepatitis C and cystic fibrosis, emerging as a Wall Street favorite.
But on Tuesday that momentum stalled. Less than two months before Vertex plans to move 1,300 employees from Cambridge into a gleaming, new $800 million headquarters on the South Boston Waterfront, the company acknowledged it misjudged the market for its lead drug, a hepatitis C pill called Incivek.
With the drug’s sales dropping sharply, Vertex said it is cutting about 17 percent of its total workforce, or 370 jobs — including 175 in Massachusetts — and will return $4.4 million in state tax incentives it received for promising to create jobs.
The company may yet become an anchor of the state biotech sector. But to do so, executives will need to make good on their plans to build a multi-drug pipeline — something few in the high-risk biotech business have done. The first test will be winning approval for a portfolio of cystic fibrosis drugs.
“Vertex has clearly emerged as the world leader in developing new drugs for cystic fibrosis,” said biotech analyst Mark Schoenebaum, senior managing director for the investment research firm ISI Group in New York. “However, they have just as clearly lost their leadership position in hepatitis C. Thus, it makes sense for the company to focus on cystic fibrosis.”
But the new focus didn’t lessen the blow Tuesday when the Incivek-related job cuts — Vertex’s first major round of reductions in a decade — were announced to employees. The move “represents perhaps the most difficult choice for a company to make,” Vertex chief executive Jeffrey Leiden told analysts in a conference call. “The hepatitis C market, however, has changed very rapidly.”
In particular, sales of Incivek — which has treated over 100,000 patients worldwide and generated more than $2 billion in sales since it was introduced in May 2011 — have fallen faster than the drug maker anticipated. That is because doctors have encouraged many patients to wait for a new generation of treatments that work better and are easier to take. The drop fueled a wider-than-expected third-quarter loss and prompted Vertex to lower its revenue forecast for the year....
Other companies have also been forced to return state aid linked to hiring. Cambridge drug maker Genzyme Corp. and two smaller biotechs refunded a combined $6.6 million in tax incentives in 2011 because they did not create the number of jobs they promised. And early this year, battery firm A123 Systems paid back $3 million to cover part of a loan it received to expand operations and hire hundreds of workers....
Related: China Post as Easy as A to 123
They moved to China for a better Vieau?
“At this point, it’s very much a clinical development story for Vertex rather than a revenue growth story,” said biotech analyst Howard Liang, managing director at health care investment bank Leerink Swann.
Leiden said Incivek, the first drug developed solely by Vertex, has been a commercial success. But Vertex hired its Incivek sales force anticipating revenue would remain strong for several more years, he said. Instead, many doctors are advising patients to hold off taking Incivek, a pill used in combination with another drug that has to be injected, because a new generation of all-oral hepatitis C therapies could become available as early as next year.
“It absolutely makes sense to wait,” said Sue Simon, president of the Hepatitis C Association, a patient advocacy group in Scotch Plains, N.J., who said today’s drug combinations often cause side effects ranging from rashes to fatigue to muscle and joint pain. “The new drugs will be a walk in the park compared to the ones out now.”
The market for all-oral drugs is projected to be $10 billion to $20 billion annually. But rivals, such as Gilead Sciences and AbbVie Inc., appear to be ahead of Vertex in clinical development. While scientists at Vertex are working on an all-oral drug regimen to treat the hepatitis C virus, it is still in trials and won’t be ready for several years....
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Related: Vertex’s future hinges on push into new areas
Also see:
No Veracity at Vertex
Slow Saturday Special: Intel Tax Deal Was Dumb Idea
So are all tax subsidies.
Now for the good news:
"Natick biotech Karyopharm raises $109m" by Robert Weisman | Globe Staff, November 06, 2013
Shares of Karyopharm Therapeutics Inc., a four-year-old Natick company working on a drug that aids the body’s natural tumor-suppressing proteins, moved modestly higher in their first day of trading after the company raised $109 million in an initial public offering.
Karyopharm hopes to eventually develop a pipeline of drugs to treat cancers, inflammations, and other conditions....
Karyopharm became the ninth Massachusetts biotechnology company to complete an IPO this year, placing the state’s sector first in the nation in minting public companies....
Oh, yay.
Underwriting the offering were the Boston investment bank Leerink Swann, along with Bank of America Corp., Merrill Lynch, JMP Securities, and Oppenheimer & Co....
That makes me feel $ecure.
In a regulatory filing for its IPO registration, Karyopharm reported that it lost nearly $12.5 million on revenue of $366,000 during the first six months of 2013....
Well, you know, "it's never been easy to turn a profit in biotech."
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"Novartis to add 175 jobs in Cambridge, cut elsewhere" by Robert Weisman | Globe Staff, November 07, 2013
Once again, a cost-conscious big pharma company is axing research and development operations around the world — but hiring more scientists and drug developers in the Boston area.
This time it’s Swiss pharmaceutical giant Novartis AG, which plans to cut about 500 research jobs elsewhere while adding about 175 jobs at the company’s global research headquarters in Cambridge. The jobs at the Novartis Institutes for BioMedical Research here will include some new hires along with other researchers moving from Horsham, England, where Novartis is closing a respiratory diseases research site, and Emeryville, Calif., where it is shutting down a cancer research program.
Novartis will also be shuttering a small dermatology research site in Vienna and a unit at its San Diego campus that makes protein-based biologic drugs....
I'm sure those will all help the economic recovery in the area.
Novartis research chief Mark C. Fishman said of the restructuring, “It’s an attempt to reallocate resources in a more efficient way.”
The new positions in Cambridge will be a boost to the local life sciences sector at a time when another growing drug maker, Vertex Pharmaceuticals Inc., is eliminating 175 jobs because of a sharper-than-expected drop in sales of its lead drug to treat hepatitis C.
Novartis has become one of the largest biopharmaceutical players in the Boston area in recent years....
The move by Novartis is the latest in a string of cutbacks by global drug makers over the past few years — including Pfizer Inc., London-based AstraZeneca, Sanofi SA of France, and Shire PLC of Ireland.
Also see:
Pfizer agrees to $491m settlement
Lilly, Pfizer to work with Joslin on kidney failure treatments
Pfizer to relocate Alewife workers to Kendall Square
But while the companies have scaled back operations at other research locations, especially in Europe, their Massachusetts operations have largely been spared. Some drug makers, notably Pfizer and Sanofi, have grown local operations through consolidation elsewhere....
Their lo$$ is our gain!
Also see: With new tools, Novartis targets brain disease
