Biotechnology

WASHINGTON -- Senior members of Congress from both parties are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year. Prospects for the legislation have increased since Democrats took control of Congress this year. Consumer groups, employers and insurers are lobbying for the bill, which they see as a way to hold down health costs. The proposal faces formidable scientific and political obstacles.

U.S. grant to nurture city's biotechnology industry A large development project in East Baltimore will receive $2 million from the federal Economic Development Administration to help build a life sciences facility and biotechnology industry incubator, according to the offices of Sen. Barbara A. Mikulski and Rep. Elijah E. Cummings, whose district includes the development. The incubator will provide office space and wet labs for startup businesses that officials say they hope will nurture the city's nascent biotechnology industry.

WASHINGTON -- A long-running clash over the marketing of meat and milk from cloned animals is coming to a head in Washington as the government prepares to make a ruling that would allow the products to be sold to consumers for the first time. Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.

MedImmune Inc., the fast-growing Gaithersburg biotechnology company, said yesterday that it had won U.S. Food and Drug Administration approval for its $50 million manufacturing plant in Frederick.The plant, built with $13 million in state and county incentives, joins a small but growing list of Maryland biotechnology companies that manufacture drugs.MedImmune's 90,000-square-foot facility will be among the largest drug production plants in the state, employing 150 workers. To handle future MedImmune products, the plant was designed to produce several drugs at once.

Shares in MedImmune Inc. fell $5.0625, or 4 percent, to $115 yesterday after a top Merrill Lynch & Co. analyst lowered his ratings for the stock, saying the recent run-up in its price had made it overvalued. Earlier in the day, the shares were down as much as $14.125.Since mid-May, shares in the Gaithersburg-based biotechnology company, which split 2-for-1 Jan. 1, have more than doubled. MedImmune shares closed at a 52-week high of $120.625 Tuesday.Merrill Lynch biotechnology analyst Eric Hecht, whose industry ratings are closely watched, also lowered his ratings on Amgen Inc., Biogen Inc., Genzyme Corp.

Jennie C. Hunter-Cevera, a California-based researcher who has held a variety of posts in industry and academia, was named president of the University of Maryland Biotechnology Institute yesterday.Hunter-Cevera, 51, succeeds Rita R. Colwell, the institute's founder and first president, who left last year to become director of the National Science Foundation in Washington, D.C.A native of West Virginia, Hunter-Cevera has been head of the Center for Environmental Biotechnology at the Lawrence Berkeley National Laboratory in Berkeley, Calif.

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EntreMed Inc. said yesterday that it has received permission from the Food and Drug Administration to begin testing one of its much anticipated experimental anti-cancer drugs in humans, and expects the small trial to begin in September.The Rockville biotechnology company had not planned to seek FDA approval to test its Endostatin protein until September at the earliest. The experimental drug has shown promise in animal studies by blocking tumor growth.Dr. John W. Holaday, EntreMed's chairman, president and chief executive officer, said the company was able to move up the time frame because of an "aggressive development schedule," which included completing and compiling data from required animal testing earlier than anticipated.

Biotechnology giant Genentech Inc. has agreed to pay $50 million to settle a criminal lawsuit which alleged that it marketed a human growth hormone for unapproved uses during the 1980s and early 1990s.The criminal fine and restitution is one of the largest settlements in U.S. drug industry history and ends a Department of Justice investigation that began in 1995."We chose to settle the matter in order to avoid the cost and distraction of protracted litigation," Genentech Chief Executive Officer Arthur Levinson said in a statement.

For Maryland's booming biotechnology sector, 1999 should be a watershed year as a select number of companies either turn profitable or move experimental drugs and diagnostics into pivotal mid- and late-stage human trials."

The four friends began meeting on Monday nights three years ago, sharing drinks around a dinner table and refining their dream of launching a biotechnology company that would revolutionize the way tumor cells are tested for cancer. They crafted a business plan and, with the help of a state tax credit program for biotech startups, they raised $1 million from investors for their company, BioMarker Strategies LLC. Fast forward to 2009: BioMarker recently announced it has secured $1.7 million more in funding, including a major infusion from one of the city's largest charitable foundations.

Low-cost home phone service available Maryland residents who receive public assistance such as food stamps or supplemental security income may also qualify for low-cost home telephone service. Staff from the state Public Service Commission and Verizon will be available from noon to 2 p.m. Wednesday in Baltimore to help people sign up for Lifeline Assistance or Link-Up America, also known as Tel-Life. Link-Up America provides state and federal money to hook up telephone service. With Lifeline Assistance, basic monthly telephone service can cost just 66 cents a month, including 30 telephone calls.

Edgerley, state economic development chief, resigns The state's economic development secretary, David Edgerley, resigned last night, saying he wants to pursue a career in the private sector or education. Edgerley's resignation comes after Gov. Martin O'Malley sought to reorganize his agency, the Department of Business and Economic Development, a process that emphasized efforts for the biotechnology industry and international trade and consolidated some functions. O'Malley issued a statement thanking Edgerley for his service and for his help in launching an initiative to expand the biotechnology industry in the state.

The biotechnology company, Genentech, as expected, turned down a buyout offer yesterday from its majority owner Roche, saying the bid of $89 a share was far too low. But in a statement, a special committee of Genentech's board said it would consider a higher offer, which some analysts took as suggesting a deal would eventually be done. The committee also approved a "broad-based" employee retention program, an indication that Genentech executives, and Roche executives as well, were worried that employees would leave amid the uncertainty of whether Genentech might lose its status as an independent company.

A man arrested near the University of Maryland, Baltimore campus Tuesday after a police officer said he was carrying a makeshift explosive device was charged yesterday with assault, reckless endangerment and concealing a deadly weapon. Baltimore police spokesman Sterling Clifford identified the suspect as Dallas Jermaine Smith, 22, who has no fixed address. A District Court commissioner yesterday ordered Smith to be held without bail; his next court appearance has not been set. Clifford said that a university officer stopped the man in the 800 block of W. Baltimore St. on Tuesday morning because he was clutching his side as if he was trying to hide a weapon.

Mark A. Vulcan - a tax attorney and CPA - had something of a rock star moment when he rolled into work at the Maryland Department of Business and Economic Development's Baltimore offices yesterday morning just before 8. There, crowding in the lobby at 217 E. Redwood St., were more than a dozen slightly bedraggled biotech executives, some of whom had slept on the sidewalk, and all of whom wanted an audience with Vulcan. At 9 a.m., he began accepting applications for a state tax credit program worth up to $250,000 apiece for eligible biotechnology business investors.

In trumpeting his new biotechnology initiative last week, Gov. Martin O'Malley used the word "leverage" eight times to describe the nine-point plan. Clearly, a governor proposing a new, billion-dollar program during a time of fiscal austerity wants Marylanders to see this spending as an investment - one expected to produce a healthy return. He makes a strong case: If figures from the state Department of Business and Economic Development are correct, the state's $1.1 billion commitment will attract an estimated $6.3 billion in federal and private-sector money.

Three days after Gov. Martin O'Malley announced a $1.1 billion initiative for the biotechnology industry, Comptroller Peter Franchot announced yesterday that he would advocate that the state pension fund to invest about $1 billion in life sciences and "green" technology such as renewable energy and environmentally sensitive building materials. Franchot, who is vice chairman of the Maryland State Retirement and Pension System, said he would recommend that about $500 million be invested in the biotechnology industry, particularly in Maryland.

Gov. Martin O'Malley unveiled yesterday a proposal to invest $1.1 billion over the next decade to cement Maryland's status as a pre-eminent hub for biotechnology research, including stem-cell studies aimed at finding breakthrough medical advances. The funding, which would build on existing tax credits and grant programs, would be used to create a biotechnology center, finance capital projects and make equity investments in start-up companies. O'Malley, a Democrat, said the money could transform Maryland - where the human genome was mapped in 2001 - into a global leader in personalized medicine or the use of genetics to tailor treatments.

WASHINGTON -- A long-running clash over the marketing of meat and milk from cloned animals is coming to a head in Washington as the government prepares to make a ruling that would allow the products to be sold to consumers for the first time. Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.