|May 2013, Volume XXIII, No. 3|
by Patti Charek
Industry News In Brief
After months of playing coy, the British drug maker Shire PLC says it plans to go forward with a $394 million expansion in Lexington that is expected to create 680 jobs over the next eight years, one of the largest economic development projects in the state. The decision is a coup for Governor Deval Patrick, who has been aggressively trying to encourage Shire and other life sciences companies to expand or move to Massachusetts. And it comes as Patrick is pressing legislators to approve the $1 billion life sciences initiative he proposed last year.
Shire executives said they were already committed to going forward with a portion of their project in Lexington. Shire's Human Genetic Therapies unit is based in Cambridge, but needs additional office and lab space nearby to accommodate its rapid growth. Shire, however, threatened to build the centerpiece of the expansion project, a pharmaceuticals manufacturing plant, in another state if Massachusetts didn't come up with an attractive enough incentive package.
Shire plans to renovate several buildings (some of which were formerly used as Raytheon headquarters before the defense contractor moved to Waltham four years ago) and build a manufacturing plant on Patriot Way in Lexington. The company currently has about 675 employees in Massachusetts and expects to have 1,350 - mostly in Lexington - by 2016. (Source: Todd Wallack, The Boston Globe, 14 February 2008)
An effort by the UMass to establish a leading repository of human embryonic stem cells is slated to be completed by April, according to UMass President Jack Wilson. The stem cell bank, to be housed within UMass Medical School, is expected to store hundreds of embryonic stem cell types to aid in research and development of new treatments. "It's really to establish Massachusetts as a global leader in stem cell research," Wilson said during a meeting at the Statehouse. "It's also important because it will help us to attract talent to Massachusetts."
The Massachusetts Life Sciences Center, a state agency created in 2006, has approved $8.2 million for the stem cell bank, and Kofi Jones, a spokeswoman for the state, said the agency and UMass are expected to finalize a contract soon.
In 2001, President Bush placed strict limits on federal funding for stem cell research. He limited funded research to already-existing stem cell lines derived from embryos created for reproductive purposes and no longer needed, citing ethical reasons for his decision. In a recent development, researchers at the University of Wisconsin published studies showing the ability to program the genes of human skin cells to produce cells in an embryonic-like state. While the discovery has the potential to answer the ethical debate, many scientists remain committed to developing treatments from stem cells taken from embryos. (Source: Ryan McBride, Mass High Tech, 1-7 February 2008)
Genzyme said it will license a promising new type of cholesterol drug from California-based Isis Pharmaceuticals and could eventually pay Isis more than $1.5 billion in milestone payments and half the profit from its sales. The deal for mipomersen, now in late-stage trials, is a validation of Isis' long quest to perfect a technology called antisense and employ it in potential blockbuster medicines.
The deal for the product, which Genzyme first hopes to introduce for patients with a genetic tendency toward high cholesterol, would entitle Isis to an initial 30 percent share of profits. Its profit share would rise to 50 percent once global annual sales reach $2 billion or more. "We believe it could prove to be the most effective lipid-lowering agent for high risk patients for whom conventional therapies are not sufficient," said Henri Termeer, Genzyme's chief executive. (Source: Reuters, The Boston Globe 8 January 2008)
Merck and Schering-Plough said their cholesterol pill Vytorin worked no better than an older, cheaper drug, in a study that looked at a rare population of patients with extremely high artery-clogging LDL cholesterol. The companies have three additional studies on Vytorin underway, involving more than 20,000 patients, that may resolve those issues. To get US marketing approval, the companies needed only to show that Vytorin lowered LDL, a standard measure for cholesterol drugs.
Schering-Plough spokesman Lee Davies said the Vytorin study wasn't definitive about whether the drug improves outcomes because it was looking at a rare population of patients with extremely high artery-clogging LDL cholesterol. "It was never intended to be a definitive study on outcomes," Davies said. "They both started at incredibly high LDL levels, so the patients were not brought to goal. If they were brought to goal, they might have had different outcomes."
(Source: Bloomberg News, The Boston Globe, 15 January 2008)
A research study sponsored by Schering-Plough shows that the company's new AIDS drug, designed to block the virus from entering human cells, suppressed infections in patients who did not respond to older medicines. A combination of drugs, including Schering-Plough's vicriviroc, held back the virus better than the combination of older medicines alone, the study found. The findings were presented at the Conference on Retroviruses and Opportunistic Infections in Boston.
Vicriviroc may become the second medicine, after Pfizer's Selzentry, in a new family of drugs that work by blocking the CCR5 receptor, a chemical doorway the virus uses to enter human cells. The drugs promise to give doctors a new weapon against resistant forms of the human immunodeficiency virus that causes AIDS. Vicriviroc, like Pfizer's drug, works by altering the shape of a protein on the surface of healthy human cells, making it impossible for HIV to get a good enough grip to enter. Before Selzentry won US approval in August 2007, the only so-called entry inhibitor available was Fuzeon. Fuzeon, made by Roche and Trimeris, is an injectable therapy while both Vicriviroc and Selzentry are pills.
HIV has proven to be a formidable foe for drug designers because of its ability to mutate, develop new strains, and change its shape to force its way into human cells. The virus's attack begins when it attaches itself to a cell surface molecule, called a receptor, and uses one of its proteins to force its way into the cell. (Source: Bloomberg News, The Boston Globe, 4 February 2008)
Wyeth has said it is introducing a generic version of its blockbuster drug Protonix, signaling that the company has been unable reach a settlement with Israeli firm Teva Pharmaceutical Industries that would protect the heartburn drug's exclusivity. Teva, a big generic-drug maker, is embroiled in a lawsuit filed by Wyeth claiming a violation of Protonix's patent, which is set to expire in 2010. Teva introduced a generic version of the drug in December 2007, eating into Protonix's sales, but then agreed to temporarily halt selling its product, known as pantoprazole, while the companies engaged in settlement talks.
Protonix, one of Wyeth's top sellers, posted sales of $1.45 billion in the first nine months of 2007. Wyeth yesterday said its generic version would be distributed by Prasco Laboratories, a closely held Cincinnati company. Wyeth spokesman Doug Petkus said the company would continue its litigation with Teva and noted that Wyeth's move gives Teva the option to resume selling its version of Protonix.
A steep drop in Protonix sales, which would be expected in the face of generic competition, would deliver another blow to Wyeth, which has tried, unsuccessfully, to win approval of some new drugs, including Pristiq for menopause symptoms and bazedoxifene for osteoporosis. Wyeth has said it is considering reducing its work force by about 10 percent in the next three years, as it grapples with generic competition as well as the drug-pipeline setbacks. (Source: Sarah Rubenstein, The Wall Street Journal, 29 January 2008)
Inverness Medical Innovations, a Waltham-based maker of home pregnancy tests and fertility monitoring kits, said it would buy Matria Healthcare for $900 million to expand its disease management business and focus on bringing diagnostics into the home.
The acquisition of Matria would bolster Inverness' presence in disease management, where its focus is on women's health, oncology, and cardiology. Matria offers specialized oncology services and is a leading provider of programs for managing high-risk pregnancies. "What we're doing is improving the health and the life of the individual, while simultaneously helping to reduce healthcare costs by getting the patient more involved in their own treatment plan," said Inverness' chief executive, Ron Zwanziger.
The deal is the latest in a series of acquisitions for Inverness which includes disease management company Alere Medical, purchased in November for $302 million, and diagnostic tools provider Cholestech, purchased in September for $326 million. Also in November, the company announced plans to buy Paradigm Health for $230 million. Zwanziger told investors the company expects significant cost and revenue synergies as it combines Matria, Alere, and Paradigm Health into a new health management division. (Source: Reuters, The Boston Globe, 29 January 2008)
Lexington-based NitroMed is shutting down its effort to market and sell BiDil, the first drug approved for use in a single racial group. BiDil entered the market in 2005 to great fanfare after it was cleared as a congestive heart failure treatment for African-Americans. But the rollout of BiDil was stalled by insurers concerned about its price and doctors who were skeptical that the drug, a branded combination of two generic drugs, was an improvement. Others complained the lackluster sales of BiDil were evidence of continuing racial gaps in the health-care system.
NitroMed said it was discontinuing sales and promotional activities and eliminating 70 of the 90 jobs at the company. The company will continue to make BiDil available for patients. It also has retained investment-banking firm Cowen & Co. to advise it on strategic alternatives. NitroMed is still trying to develop a new version of BiDil, one that is taken once a day rather than three times. It said it has received positive reaction to the new formulation from the FDA. However, approval of a new formulation is still years away. (Source: David Armstrong, The Wall Street Journal, 16 January 2008)
David Epstein, president of Novartis Oncology, said he hopes the drug maker will be able to start selling four new cancer treatments by the year 2011. In an interview published in The Wall Street Journal, Epstein said he believes at least one of four Novartis pipeline cancer drugs could eventually achieve blockbuster status, with sales of $1 billion or more annually, if they are approved by the FDA.
The first new cancer drug Novartis aims to market is RAD001, Epstein said. The drug is being tested against endocrine tumors and renal-cell cancer and has shown recent success in treating lymphoma. Other Novartis oncology drug hopefuls include ASA404 for non-small-cell lung cancer, SOM230 for a rare group of neuroendocrine tumors and LBH589 for cutaneous T-cell lymphoma. Novartis and its UK biotech partner Antisoma PLC hit a snag in July when ASA404 failed in human tests against ovarian cancer.
Novartis' Gleevec, a treatment for chronic myeloid leukemia (CML), is the drugmaker's top-selling cancer drug and second-best selling product overall with sales of $2.55 billion in 2006.
Novartis's focus on oncology products could eventually help the company recover from some of the hits suffered by key products in 2007. (Source: Stephen McGuire, Medical Marketing & Media, 5 December 2007)
Cambridge-based biotech Dyax Corp. has entered into a license agreement with Paris-based Sanofi-Aventis that gives an exclusive worldwide license to them for Dyax's tumor-fighting monoclonal antibody DX-2240. The two firms have also penned a second, nonexclusive license to Dyax's proprietary antibody phage-display technology.
The two agreements make Dyax eligible to receive up to $500 million in license fees and milestone payments if the first five antibody candidates, including DX-2240, become commercial successes. Dyax is set to receive $25 million in 2008. In addition, Dyax is eligible to receive royalties from commercial sales of DX-2240 and other antibodies developed by Sanofi-Aventis. (Source: Mass High Tech, 15-21 February 2008)
Cambridge-based Curis reported that its partner Genentech plans to move a drug candidate the two firms are collaborating on into midstage development during the first half of 2008. The company said the drug candidate would be aimed at targeting one or more types of solid tumor. The collaboration focuses on developing cancer treatments based on Curis' technology. Curis will be eligible for a milestone payment when San Francisco-based Genentech starts its Phase 2 clinical trial and is also eligible for future payments. (Source: Mass High Tech, 14-20 December 2007)
Cambridge biotech Acceleron Pharma has struck a pair of deals with pharmaceutical firm Celgene that could bring nearly $1.9 billion in payments to Acceleron. The two firms have agreed to jointly develop and market Acceleron's lead bone-forming protein, called ACE-011, now in Phase 1 clinical trials. And Celgene has optioned three of Acceleron's discovery-stage programs in a separate agreement.
In the deal related to ACE-011, Celgene has agreed to pay an initial fee of $50 million to Acceleron and to make a $5 million equity investment in the privately held Cambridge biotech. Both companies would share costs to develop Acceleron's bone-forming agents, and Acceleron is eligible for $510 million in milestone payments as well as royalties on potential sales of the proteins. Celgene, based in Summit, NJ, would also buy at least $7 million in Acceleron common stock if the biotech has an initial public offering. The deal is subject to standard closing conditions.
Acceleron could also receive up to $1.3 billion in payments from Celgene in connection with the development of the three discovery-stage programs focused on cancer and cancer-related bone loss. The biotech would also receive royalties from Celgene on potential sales of the drugs. (Source: Mass High Tech, 22-28 February 2008)
RXi Pharmaceuticals has signed a 20-month lease at the Worcester Polytechnic Institute Life Sciences and Bioengineering Center, with the option to become the lead tenant of a future 100,000-square-foot building in the construction planning stages at Gateway Park in Worcester. The company, founded by Nobel Laureate Craig Mello of UMass Medical, is one of several firms that have signed on as potential future tenants of the rapidly expanding Gateway Park.
RXi Pharmaceuticals was created to develop therapeutics for the treatment of human disease employing the RNA interference (RNAi) technology co-discovered by Dr. Mello. RNAi technology can help determine the function of particular genes in the body and also potentially lead to the development of new RNAi-based drugs. Using RNAi to turn off defective genes opens the door for an entirely new class of drugs to potentially treat cancer, diabetes, Alzheimer's, ALS, and many other diseases. (Source: Mass High Tech, 2-8 November 2007)
Israeli generic-drug giant Teva Pharmaceutical Industries has agreed to acquire CoGenesys Inc. for $400 million in cash. The deal is likely to stoke the debate about the role generic-drug makers should play in the emerging market for biological therapies.
CoGenesys, a closely-held spinoff of Human Genome Sciences, would give Jerusalem-based Teva a foothold in the market for biologic therapies. Unlike "small-molecule" drugs, which typically are made through well-proven steps in the form of pills, biologics are proteins manufactured in living cells. CoGenesys' pipeline of biologic drugs includes treatments for cardiovascular disease, cancer and autoimmune disorders.
Biologic drugs have become a source of deep tension between biotech companies and generic-drug makers such as Teva. The companies that develop the drugs argue that biologics are far harder to manufacture, and that it is very difficult to show whether copycat versions are as effective. But that hasn't stopped generic-drug companies from devoting significant resources to the development of generic biologics, which industry experts expect to enter the US market in about five years.
To get there, the generic-drug makers will have to convince regulators and Congress that they are capable of manufacturing the treatments with the same standards of quality and reliability as mainstream biotechs. Currently, there is no legislative pathway for generic biologics to gain approval, though congressional efforts in this direction are under way. (Source: Matthew Karnitschnig and Heather Won Tesoriero, The Wall Street Journal, 22 January 2008)
Genzyme said it has resolved a problem with Framingham's sewage system, allowing the Cambridge company to go ahead with plans to build a $260 million drug manufacturing plant there. The biotech warned late last year that it might be forced to build the plant in another town or state, because Framingham's aging sewage and water system would not be able to handle the added load from Genzyme's facility without a $12.9 million upgrade.
Though Framingham and Massachusetts officials both promised to work to secure state funding for the project, company executives said they couldn't afford to wait much longer for the state to make a commitment. And even if the funding eventually came through, Genzyme managers worried the sewage project wouldn't be finished by the time the manufacturing plant was ready to open in 2010, prompting them to begin considering alternative sites.
But Genzyme executives said they believe they have found a solution - upgrading a small portion of the system first, taking less time and for a fraction of the cost. Genzyme estimated the partial work - enough to support the plant - would cost roughly $1 to $2 million. In addition, Genzyme officials said they have received a verbal commitment from the Massachusetts Office of Business Development to provide $250,000 in interim funding to the town to immediately begin design work on the sewage project, while state and local officials have pledged to keep working to secure the rest of funding as part of Governor Patrick's $1 billion life sciences bill.
"We have arrived at a point where we are confident we can move forward with the project," said Henry Fitzgerald, vice president of facility operations. He said the company is no longer considering building elsewhere.
Genzyme said the Framingham project would create 300 jobs and include 300,000 square feet of office, laboratory, manufacturing and purification space. It would be similar in size to the plant Genzyme built in Allston 12 years ago, before that plant was expanded. Genzyme already has 4,500 employees in Massachusetts, making it the state's largest biotech employer. (Source: Todd Wallack, The Boston Globe, 19 January 2008)
The FDA has given Biogen Idec good news about one of its key drugs: Tysabri, a treatment for multiple sclerosis, won approval for use against Crohn's disease, another debilitating illness.
The move comes six months after an FDA advisory panel voted 12 to 3 to recommend the drug's approval to treat some forms of Crohn's, a chronic inflammatory disease of the intestinal tract.
Biogen Idec temporarily shelved the drug three years ago after it was linked to a rare brain disease. The company says there have not been any additional cases of the disease since sales resumed in 2006, with new guidance on how it should be used. But some doctors remain wary of the treatment, even though it has been shown to be highly effective in some patients.
The FDA decision does carry some caveats. Specifically, the agency approved the drug to treat patients with moderate to serious cases of the disease who can't be treated effectively with other drugs, such as steroids. The label will also carry safety warnings to reduce the risk that patients will contract the brain disease or other infections. Despite the safety concerns, Biogen Idec has predicted Tysabri will eventually become a major source of revenue. This month, the company reaffirmed predictions it will be used by 100,000 patients by the end of 2010, up from more than 21,000 at the end of 2007.
About 500,000 people in the US suffer from Crohn's, but it is unclear how many of them will qualify to use Tysabri. The disease frequently causes diarrhea and abdominal cramps; symptoms can also include fever, bleeding, and weight loss and there is no cure. The drug should be available for Crohn's patients by the end of February 2008. (Source: Todd Wallack, The Boston Globe, 15 January 2008)
Alkermes announced it plans to cut about 150 jobs, or 18 percent of its workforce, and shut down its Chelsea manufacturing plant, two weeks after Eli Lilly canceled trials of AIR, an inhaled insulin system the two companies had been developing in partnership. Both companies said the decision to halt development of the product was not based on safety issues. According to Alkermes spokesperson Rebecca Peterson, Alkermes will try to use the technology to develop inhalable treatments for other diseases such as chronic obstructive pulmonary disease (COPD).
Lilly's action followed similar decisions by two other major players in the inhaled insulin field. In October 2007, Pfizer shelved Exubera, despite spending close to $3 billion developing and marketing the product; and Novo Nordisk of Denmark followed suit by halting development of its own version of inhalable insulin after studying the Exubera failure. "Pfizer's and Novo's decisions caused us to re-evaluate the marketplace," said an Eli Lilly spokesperson, who added the company was also concerned about its prospects with US regulators.
California biotech Mannkind Corp. is still actively developing an insulin inhaler which is in Phase III studies and which the company expects to submit for FDA approval by the end of the year. If successful, new diabetes drugs have the potential to generate billions of dollars in sales. In the US alone, about 21 million people are thought to have diabetes and many of them take insulin regularly to help control their blood-sugar levels. (Source: Avery Johnson, The Wall Street Journal, 8-9 March 2008 and Todd Wallack, The Boston Globe, 18 January and 20 March 2008)
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