|May 2013, Volume XXIII, No. 3|
Industry News In Brief
by Patti Charek
Pfizer, the world's biggest drug maker, has announced that it is buying Wyeth in a $68 billion deal that will quickly boost Pfizer's revenue and profit and transform it into a more diversified company, a one-stop shop for vaccines, biotech drugs, traditional pills, and nonprescription products for both people and animals. The cash-and-stock deal, one of the biggest in the history of the drug industry, is expected to close late in the third quarter or in the fourth quarter.
The acquisition will also significantly expand Pfizer's presence in the Boston area. The company, whose roster is topped by the best-selling cholesterol treatment Lipitor, has about 400 employees in Massachusetts, including 140 who work at the Pfizer Research Technology Center and Regenerative Medicine unit in Cambridge, said company spokesman Jack Cox. "One of Pfizer's strategic priorities is to become a top-tier player in biotherapeutics and vaccines. The work we are doing in Cambridge and the acquisition of Wyeth accelerates our ability to pursue these goals," Cox said.
Wyeth is already one of the state's top biotechnology employers, with 2,400 workers, including about 700 at its oncology research center in Cambridge and 1,700 employees at its manufacturing plant in Andover. The company had pledged to add 100 positions in exchange for recent highway improvements near the Andover manufacturing facility, which makes bone morphogenic protein (BMP), the hemophilia treatment BeneFIX, and Herceptin for Genentech. Wyeth also plans to make the pneumonia vaccine Prevnar 13 in Andover once it wins approval from the FDA, said Wyeth spokesman Doug Petkus.
Officials at both companies said no decisions have been made regarding job cuts or additions at their Massachusetts facilities. (Source: Jenn Abelson, The Boston Globe, 27 January, 2009)
Biogen Idec will move its headquarters from Cambridge to an office building being built in Weston adjacent to Rtes 20 and 128. The 350,000-square-foot building, which the company plans to move into in 2010, marks the largest lease deal in Boston's suburbs this year. Biogen Idec said it will save money by moving management and administrative functions to the suburbs. The company is likely to pay an annual lease rate of close to $45 a square foot, while space in Cambridge can cost more than $60 a square foot.
Between 400 and 600 employees will move to the new building in Weston. Biogen Idec has 1,800 employees in Massachusetts and 4,500 worldwide. The company now occupies about 960,000 square feet in Cambridge, including space for offices, manufacturing and research. After the Weston move, the Cambridge headquarters on Main Street near Kendall Square will initially remain vacant. Over time, however, the company will convert about 375,000 square feet of office space into laboratory facilities, expanding Biogen Idec's R&D presence in the heart of the state's biotech cluster. (Source: Jeffrey Krasner, The Boston Globe, 3 December, 2008)
The FDA has approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels. Vasovist Injection is manufactured by EPIX Pharmaceuticals of Lexington, Massachusetts.
Although MRA can be performed without the use of a contrast imaging agent, Vasovist administration provides a clearer image in patients who are suspected of having blockages or other problems with the blood vessels in their abdomen or limbs. The MRA is performed using magnetic resonance imaging (MRI), which relies on magnetic fields to create highly detailed images of the inside the body. The active substance in Vasovist is gadolinium, a rare earth metal element that is detected by MRI scanners. When injected, gadoliunium interacts with water molecules in the body, giving a stronger signal and, in turn, a better picture.
When blood vessels are scanned using MRA without any contrast, radiologists are unable to interpret the images about 10 to 30 percent of the time. As a result, radiologists have typically used X-rays to detect blood vessel abnormalities. But this is a lengthy procedure and requires sticking a needle into an artery to inject the X-ray dye, a procedure with potential risk for the patient. (Source: FDA Web Site, 24 December, 2008)
Merck will start a new unit to copy biotech medicines, becoming the first big US maker of conventional drugs to leap into the $94 billion market for treatments based on living cells. Merck will invest $1.5 billion in its new BioVentures division by 2015 and a "substantial amount" after that as it begins selling at least six new biologic generic medicines by 2017, said Merck's president of research, Peter Kim, at a meeting with analysts.
No other US-based maker of brand-name medicines has jumped into generic biologics, a business not yet possible under US law. President Barack Obama supports making copies of biologic medicines available, and Congress is expected to debate next year how to establish a regulatory pathway to get such products on the market.
Generic drug makers can copy traditional, chemical-based medicines after patents expire, usually without extensive human testing. The FDA likely will require more testing for biologic copies. Merck needs new products as it braces to lose patent protection on $8 billion worth of medicines through 2012. (Source: Bloomberg News, The Boston Globe, 10 December, 2008)
Pfizer wants to sell to other drug makers 100 experimental medicines for conditions ranging from obesity to high cholesterol. The world's biggest drug maker is cleaning out its chemical compound closet and cutting 800 researchers, or 8 percent of its science staff, as it focuses on developing medicines to treat cancer, brain disorders, and pain, said Martin MacKay, the company's research chief. Some compounds Pfizer wants to sell have been tested on humans.
Pfizer is halting early-stage development of medicines for heart failure, high cholesterol, and obesity to focus on more profitable diseases. The research cuts add to the elimination of 1,200 scientists last year with the closing of Pfizer's Ann Arbor, Michigan laboratory. (Source: Bloomberg News, 14 January 2009)
Endo Pharmaceutical Holdings said that it will buy Lexington, Massachusetts-based Indevus Pharmaceuticals for $370 million upfront, or $4.50 per share, acquiring Indevus's urology and hormone drug candidates in the process. The upfront price represents a premium of 45.2 percent to Indevus's closing price of $3.08. The boards of both companies approved the deal, and Endo's tender offer for Indevus shares will remain open for 45 days. Endo could pay an additional $267 million, or $3 per share, if Indevus's long-acting testosterone drug candidate, Nebido, and its acromegaly treatment candidate, ocreotide, reach development and sales milestones. Chadds Ford, Pennsylvania-based Endo said the deal will decrease its profit in 2009 and add to its profit in 2010, although it did not detail the effects.
Indevus is developing Nebido to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The ocreotide implant is designed to treat acromegaly, a hormone disorder that can make the feet, hands, nose, and mouth grow to unusually large sizes. The company plans to send the FDA new data on Nebido in the first half of 2009, as it seeks approval to market the drug in the United States. Endo will pay up to $2 per share, depending on Nebido's regulatory approval and sales results. It will pay up to $1 per share if the FDA approves the ocreotide implant for sale.
Indevus is also hoping to relaunch its bladder-cancer drug, Valstar, in 2009. It was withdrawn from the market in 2002 after one of its inactive ingredients was determined to be unstable. The company is waiting for inspections of the third-party manufacturer of the drug to be completed.
Endo sells pain drugs including the Lidoderm patch, Opana, and Opana extended-release.
The company reported $913.2 million in revenue through the first three quarters of 2008, while Indevus posted $77.8 million in the fiscal year ended September 30th. (Source: Associated Press, 6 January 2009)
Synta Pharmaceuticals said it received $15 million from British drug maker GlaxoSmithKline PLC under a development agreement for the potential cancer treatment elesclomol. The Lexington biopharmaceutical company said it is eligible for a total of $585 million in milestone payments from Glaxo for making progress in the clinic or with regulatory filings. Elesclomol, which has not been approved in any market, is being studied as a treatment that triggers cancer cell death. (Source: The Boston Globe, 13 December 2008)
Cambridge biotech Targanta Therapeutics is being bought for about $42 million by Medicines Co., a New Jersey drug company. The sale comes after Targanta's lead drug candidate failed to win recommendation from a federal advisory panel in November and the stock price plunged. The drug, oritavancin, is an antibiotic intended to treat complex skin infections, but panelists said it has not yet been proven safe and effective. In December, the company said it was laying off 86 employees, about 75 percent of its workforce. Still, Medicines Co. is optimistic oritavancin will eventually win FDA approval. Medicines Co. also said Targanta shareholders may be entitled to receive additional cash payments if certain milestones for oritavancin are met. (Source: Chris Reidy, The Boston Globe, 14 January 2009)
Worcester biotech Advanced Cell Technology (ACT) and Korean biotech CHA Biotech Co. Ltd. have formed a new stem cell technology development company called Allied Cell Technology, to be based in Worcester. The international joint venture will use ACT's hemangioblast cell technology to develop human blood cells. The developments may be used to address the human blood shortage, particularly in military situations.
Allied Cell Technology will be majority owned by CHA, with ACT licensing its technology for a $500K license fee from CHA, the companies reported. ACT will also work to pull in funding grants for the new joint venture. Leading the new company will be Young Chung, as well as Shi-Jiang Lu and the ACT hemangioblast team. Robert Lanza of ACT will serve as the chief scientific advisor of Allied Cell Technology.
ACT is operating on a limited budget, but has reduced its debt from $49 million to $13 million in the last three years, according to CEO William M. Caldwell IV. To cut operating expenses, the company announced its plans to close a Charlestown research facility and Alameda, California headquarters; the plan relocates the ACT headquarters to its founding city of Worcester. (Source: Mass High Tech, 5-11 December, 2008)
Merrimack Pharmaceuticals has expanded by 18,748 square feet of additional laboratory and office space in Building 600/700 at One Kendall Square in Cambridge. The company will now occupy 50,495 total square feet in the complex, where Merrimack will renovate former Genzyme lab space on the fourth floor, and is expected to move in April 2009. Merrimack Pharmaceuticals is a biotechnology company focused on the discovery and development of novel treatments for autoimmune disease and cancer. Built in 1916, Building 600/700 is a 234,631-square-foot, five-story, Class A research facility that houses both lab space and office space.
BIND Biosciences has subleased 26,148 square feet of lab and office space from Alkermes at the University Park at MIT, located at 64 Sidney Street in Cambridge. BIND Biosciences is a privately held biopharmaceutical company that is developing a new class of targeted therapeutics based on multifunctional nanoparticles. (Source: Mass High Tech, 2-8 January, 2009)
Vertex Pharmaceuticals, a Cambridge biotech that once was looking to relocate to the South Boston waterfront, has instead extended the leases for its headquarters for five years. The company - which is developing a drug to treat hepatitis C and HIV infections - had been considering moving into a proposed office building at Fan Pier. That deal stalled late last year as the developer struggled to obtain financing for the project as a result of the credit crisis and slowing economy. The renewed leases, which will run through 2015, cover approximately 292,000 square feet of space at 130 Waverly Street and 200 Sidney Street. Spokesman Zachry Barber said the lease extensions still give the company the opportunity to reach its goal of consolidating from nine buildings in Cambridge into one campus. (Source: Erin Ailworth, The Boston Globe, 16 January, 2009)
New England biotech executives and experts know there is strength in numbers so they created a new regional organization called the New England Biotech Association, according to its first chair person Paula Newton, who is also president of the New Hampshire Bio/Medical Council.
The new group is made up of biotechnology associations from each New England state, the national Biotechnology Industry Organization, biotechnology companies, universities and other groups that support the biotechnology industry. "We'll be a larger force to be reckoned with," Newton said.
"When we know there are matters before the US House or Senate, we can go as a group and speak on the issues, which will mean much more than going as individuals," she said.
The group's bylaws call for an elected 20-member board of directors, with 16 of those seats now full. The vice chair is Paul Pescatello of Connecticut United for Research Excellence and the treasurer is Kathie Shields of the Rhode Island BioGroup. Also on the board are Maria Cahill, of Abbott Laboratories in Worcester, Robert Coughlin of the Massachusetts Biotech Council and Christopher Anderson of the Mass High Tech Council. (Source: Eileen Kennedy, Worcester Business Journal, 24 November 2008)
Forma Therapeutics, a stealth biotech start-up trying to develop cancer drugs, is lifting its corporate veil. The one-year-old Cambridge company, which has previously been secretive about its mission and finances, plans to disclose it has raised $25 million in venture capital, grants, loans, and other funding over the past year - a feat that has become increasingly rare as the economy slid into recession, the stock market plunged, and the market for initial public offerings disintegrated. The economic turmoil has forced many venture capital firms to divert money from promising start-ups to later-stage companies frozen out of the public markets. "It's been a very challenging economic environment to do fund-raising," said Steven Tregay, Forma's chief executive.
Tregay formerly worked as managing director at the Novartis Option Fund - one of the venture funds run by Swiss drug maker Novartis AG - and persuaded the fund to become one of Forma's initial key investors. The other major investor is Bio*One Capital, a venture fund backed by the government of Singapore, where Forma has facilities.
Forma hopes to develop cancer-fighting drugs by using data from the Cancer Genome Atlas project, a collaboration of the National Cancer Institute and the National Human Genome Research Institute. As the project identifies new genes linked to cancer, Forma intends to use high-powered screening to find out whether any known compounds appear to be effective in controlling those genes.
Forma has about 42 employees, nearly half of whom work in Cambridge, with plans to grow to 55 to 60 by year-end. Three cofounders - Stuart Schreiber, Todd Golub, and Michael Foley - are connected to the Broad Institute in Cambridge, a research organization affiliated with MIT and Harvard. (Source: Todd Wallack, The Boston Globe, 6 January 2009)
Making its own Election Day news, Genzyme has struck a deal with Osiris Therapeutics of Columbia, Maryland to commercialize and develop two adult stem cell treatments in a variety of diseases. If all goes as planned, one of the two, called Prochymal, could become the first stem-cell therapy to be approved by the FDA. The treatment is in late-stage clinical trials for graft-versus-host-disease, a complication of bone marrow and cord blood transplants, and for the bowel disorder Crohn's disease. The results of those studies are expected in 2009. The other stem-cell treatment, Chondrogen, is in mid- to late-stage development for osteoarthritis of the knee. Both treatments are intended to control inflammation, regenerate damaged tissues, and to stymie scar formation, according to the companies.
Genzyme has agreed to pay Osiris $130 million ($75 million initially and $55 million in July 2009) in upfront fees and up to $1.25 billion in potential milestone payments to commercialize Prochymal and Chondrogen in markets outside the US and Canada. Osiris retains rights to market the treatments in U.S. and Canada.
This isn't Genzyme's first deal with Osiris. Last year the two firms agreed to partner on the development of Prochymal to treat radiation sickness, and in January 2008 the Department of Defense awarded the two firms a $224.7 million contract to develop the treatment for this purpose, the companies said. (Source: Ryan McBride, Xconomy, 4 November 2008)
The FDA has approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF) for treatment of adults with multiple myeloma or non-Hodgkin's lymphomas.
Multiple myeloma is cancer of the plasma cell, a cell in the bone marrow that produces antibodies to help fight infection and disease. Non-Hodgkin's lymphomas are a diverse group of blood cell cancers derived from lymphocytes, a type of white blood cell. Prior to receiving high-dose chemotherapy or radiation therapy, patients with these forms of cancer sometimes undergo a procedure known as apheresis in which blood stem cells are collected and stored for reinfusion after therapy.
G-CSF is commonly administered to help release and collect stem cells from the bone marrow. Mozobil is an injectable drug that, when used in combination with G-CSF, boosts the number of stem cells released from the bone marrow into the blood stream. (Source: FDA Web Site, 18 December, 2008)
Genzyme said the FDA has extended until February 28 its deadline for reviewing Genzyme's application to market a new version of Myozyme, a drug for Pompe disease that's manufactured at the company's Boston plant. The biotech giant already has permission to market Myozyme made at its smaller plant in Framingham but it's seeking approval to market the version made at its larger facility in Allston. Pompe disease is a progressive, debilitating, and life-threatening inherited disorder affecting approximately 2,000 people in the US. (Source: Todd Wallack, The Boston Globe, 18 November 2008)
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