MassBio Member Company News

Hyaluron Contract Manufacturing Dons Denim for a Cause

Wed, 08 Oct 2008 12:00:00 EDT

Employees participate in Lee National Denim Day®, one of the largest single-day fundraisers in the fight against breast cancer

(Burlington, MA) - Friday, October 3, 2008 wasn't any ordinary casual day at Hyaluron Contract Manufacturing (HCM) of Burlington, Massachusetts. The denim worn on this day was not worn for comfort but for an important cause. One in eight women will be diagnosed with breast cancer in her lifetime. That's a startling statistic. Since 1996, Lee National Denim Day® has raised more than $70 million for the fight against breast cancer ... $5 at a time. Did you ever think of how little $5.00 could actually buy? You could buy a coffee and a donut on your way to work, buy about 1.5 gallons of gas, buy a glossy magazine, or help support some of the nation's most groundbreaking breast cancer research.

On Lee National Denim Day®, the HCM team wore jeans and donated at least $5 to the Women's Cancer Programs of the Entertainment Industry Foundation (EIF). They, along with Lee Jeans are bringing together world-class scientists to develop an early detection blood test and find less toxic, more effective treatments for breast cancer patients. Funds raised by HCM will support some of the most promising treatment and early detection research in the country.

Recently, HCM and several employees donated to one of their own employees who walked in the 3-day Boston Breast Cancer Walk. The pledge money raised by this fundraising event benefited the Susan G. Komen Breast Cancer Foundation to fund breast cancer research, education, screening and treatment programs, as well as the National Philanthropic Trust Breast Cancer Fund.

About Hyaluron Contract Manufacturing

Hyaluron Contract Manufacturing aseptically fills liquid and lyophilized products into syringes, vials, and custom containers. In addition to traditional formulations, HCM excels in process development scale up of difficult formulations including: emulsions; viscous gels; suspensions, liposomes, and proteins. For additional information please visit: www.hyaluron.com.

For questions about EIF's Women's Cancer Programs and information about breast cancer, visit eifoundation.org or call 800-426-0010.

Cubist Pharmaceuticals Opens New Research Facility at Lexington Headquarters (Business Wire 9/29/08)

Mon, 29 Sep 2008 09:00:00 EDT

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today opened a new, state-of-the-art, 35,000 square foot research facility at the company's headquarters. The laboratory will accommodate more than 100 employees focused on the discovery of important new molecules to treat serious diseases. Massachusetts Governor Deval Patrick attended the opening.

Chief Scientific Officer and Senior Vice President, Discovery & Non-clinical Development Steven Gilman, Ph.D., said of the new facility: "The additional lab space expands our discovery research and early development capabilities to meet our current and future needs. This progressive lab space provides for Cubist's expanding scientific community, and at the same time employs the latest environmentally-friendly construction techniques and advanced energy conservation management and materials."

"The expansion at Cubist marks the company's ongoing success, and highlights the strength of the life sciences industry in Massachusetts," said Governor Deval Patrick.

Cubist President and CEO Mike Bonney said, "I want to acknowledge Governor Patrick's commitment to the life sciences industry in Massachusetts. I also want to thank the Governor and the Legislature for their leadership in making the recently enacted Life Sciences Initiative a reality -- it is now clear that Massachusetts leads the nation with respect to its commitment to remain a key center for the life sciences industry. I also applaud the Governor and the Legislature for their foresight in recognizing the need for increased education in the sciences, a critical component in the landmark Life Sciences Initiative. Including in that legislation a $25 million fund to help provide support for workforce training, along with funding for research grants, fellowships, and other programs designed to support education and research in the life sciences will further enhance Massachusetts' position as a leader in life sciences."

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Cubist developed and commercialized CUBICIN(R) (daptomycin for injection), a Gram-positive first-in-class lipopeptide antibiotic. In the U.S. Cubist also promotes MERREM(R) I.V. (meropenem for injection), Astra Zeneca's established broad spectrum (carbapenem class) I.V. antibiotic. The Cubist product pipeline includes ecallantide, a recombinant human protein in Phase 2 clinical trials for the prevention of blood loss during cardiothoracic surgery, and pre-clinical programs that address unmet medical needs in Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.

Cubist Safe Harbor

This press release contains forward-looking statements, including statements regarding Cubist's pipeline programs. There are many factors that could cause actual results to differ materially from those in these forward-looking statements. These factors include the following: (i) our ability to develop, manufacture and achieve commercial success for our product candidates; (ii) whether the U.S. Food and Drug Administration, or FDA, accepts proposed clinical trial protocols that may be achieved in a timely manner for our product candidates; (iii) our ability to conduct successful clinical trials in a timely manner; (iv) the clinical efficacy and safety of our product candidates as they relate to standards for regulatory approval and in comparison to competitive products; (v) our ability to finance our operations; (vi) our ability to adequately develop and maintain adequate protection for the intellectual property related to our pipeline candidates; and (vii) a variety of risks common to our industry, including ongoing regulatory review, public and investment community perception of the industry, legislative or regulatory changes, and our ability to attract and retain talented employees. Drug development involves a very high degree of risk. Success of a product candidate in early stage clinical trials or pre-clinical trials does not mean that subsequent trials will also be successful or that the candidate will be successfully commercialized. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in our most recent 10-K and 10-Q filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. These statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.

Source: Cubist Pharmaceuticals, Inc.

Contact: Cubist Pharmaceuticals, Inc. Eileen C. McIntyre, 781-860-8533 Senior Director, Corporate Communications eileen.mcintyre@cubist.com or Fleishman-Hillard, Inc. Jonathan R. Potter, 212-453-2406 potterj@fleishman.com

International Trade Show Opportunity

Wed, 24 Sep 2008 09:00:00 EDT

The Massachusetts Office of International Trade & Investment still has room in their booth at the Biotechnica show, running October 7th-9th in Hanover, Germany.

Biotechnica is an international trade show where the products & services of over 900 international exhibitors will be showcased. 45% of exhibitors manufacture laboratory equipment or consumables, 23% provide bio-informatics and 19% are involved in the sales and distribution of these products and services.

Biotechnica 2008 will focus on:

_ Equipment

_ Bio-informatics

_ Services

_ Solution-centered applications for nutrition, agriculture, pharmaceutical/medicine and the environment

Attendees: Biotechnica attracts more than 13,000 visitors from around the world. 88% of attendees are involved in the decision making process for their company.

Cost per company: US$ 2,800 (approximately 3 sq. meters)

Cost includes:

- Listing in the printed & online version of the official trade show catalogue if within deadline and short company profile in the Massachusetts Pavilion brochure

- Bilingual support staff

- Central information and message center

- E-mail services

- Two exhibitor entrance tickets

- Common storage area

If you are interested, contact:

Diana LaMuraglia
Tel: (617) 973-8650 Fax: (617) 227-3488
Email: Diana.LaMuraglia@state.ma.us

Space is limited. Applications are accepted in the order in which they are received.

Fox show Fringe will have a Massachusetts touch -
(Boston Business Journal 9/9/08)

Tue, 09 Sep 2008 14:00:00 EDT

Bay State life sciences company Millipore Corp. has gone Hollywood, and joined the cast of new Fox TV show "Fringe."

Billerica, Mass.-based Millipore (NYSE: MIL) provided some of its laboratory products for the show to make the background of some of the scenes more realistic. The company provides services and sells technology and tools for bioscience research and biopharmaceutical manufacturing.

Products that will be on the show include water purification, protein detection and air testing systems, according to an e-mail to company employees.

Fringe, which is about FBI agents and scientists who investigate freaky happenings, debuts Tuesday night at 8 p.m. Its producer is J.J. Abrams, co-creator of the ABC show "Lost."

Mark Hollmer - Boston Business Journal

Hyaluron Contract Manufacturing (HCM) Announces Tour of Facility

Wed, 03 Sep 2008 12:00:00 EDT

BURLINGTON, Massachusetts - On Wednesday, September 17, 2008 Hyaluron Contract Manufacturing (HCM) of Burlington, Massachusetts will be hosting a tour of their manufacturing facility in conjunction with The New England Chapter of the Parenteral Drug Association (PDA).

The New England Chapter of the PDA, as part of their local meeting, is offering a tour of Hyaluron Contract Manufacturing's facility in Burlington, Massachusetts. Those participating will have the unique opportunity to view the latest developments and state-of-the-art equipment of an aseptic formulation/filling company. The tour will provide an inside look at HCM's three aseptic fill suites: Aseptic Fill Suite I houses the lyophilization unit - the BOC Edwards Lyomax3 and the INOVA VFVM-3031 Vial Filler; Aseptic Fill Suite II includes the INOVA H3-5V Commercial Scale Syringe Filler and Aseptic Fill Suite III contains the INOVA SV-122 Syringe Filler.

Tour guides will provide explanations about the equipment and answer any questions. To register for this event visit the PDA website at http://pdachapters.org/newengland and click on "Upcoming Events".

About Hyaluron Contract Manufacturing Hyaluron Contract Manufacturing aseptically fills and lyophilizes products into syringes, vials, and custom containers. In addition to traditional formulations, HCM excels in process development scale up of difficult formulations including: emulsions; viscous gels; suspensions, liposomes, and proteins. For additional information please visit www.hyaluron.com.

Leaders nip, tuck healthcare policy - (Boston Globe - 8/11/08)

Mon, 11 Aug 2008 13:31:00 EDT

Limits enacted on drug firm gifts

Governor Deval Patrick yesterday signed into law one of the nation's strictest limits on gifts given to medical professionals by drug salespeople, the most contentious measure contained in a broad package intended to improve healthcare safety and curb skyrocketing costs.

The new law also provides $25 million to promote electronic medical record-keeping in doctors' offices, requires the state university to graduate more primary care doctors, and gives regulators the power to hold hearings when health insurers want to raise premiums.

Critics of the pharmaceutical industry had hoped to ban gift-giving altogether, arguing that the drug company largesse interferes with doctors' judgment in deciding which drugs to prescribe. But the bill that the Legislature sent the governor bans only certain types of gifts such as sports tickets and free travel, and requires that pharmaceutical and medical device-making firms publicly disclose gifts worth more than $50.

"The good news is that it prevents some of the most abusive gift-giving," said Senator Mark Montigny, a New Bedford Democrat who has pushed for years to ban gift-giving. "If I didn't feel that it was beyond a half a loaf of victory, I would not have signed on."

The changes come amid intense focus on the cost and quality of healthcare, which consumes one in every six dollars spent in Massachusetts. Two years ago, landmark legislation required almost everyone in the Commonwealth to have insurance. But the law has been so successful - prompting an estimated 345,000 people statewide to obtain insurance - that it has been far more expensive than expected, forcing Patrick to sign a bill last week raising more than $100 million in state funds and fees on private companies to help foot the bill.

Patrick's Human Services Secretary JudyAnn Bigby said that while universal health insurance is an important goal, the current system is lacking if everyone cannot get access to quality care, or premiums and out-of-pocket costs become too costly for patients.

"We have to make sure that people have access to high quality care and that we are being efficient in the way we pay for that care and that we are paying for the right things," Bigby said in an interview. The law Patrick signed yesterday "puts the challenge to those of us who have to implement it to do more planning."

The new law, based on legislation championed by Senate President Therese Murray of Plymouth, contains several initiatives intended to increase the number of primary-care doctors, who make the initial decisions as to how patients will be cared for. Although Massachusetts has the most primary-care doctors per capita in the country, Bigby said there is evidence that there aren't enough to handle the workload, especially as the number of people covered by insurance swells.

In response, the law directs the University of Massachusetts Medical School in Worcester to increase class size so that it can graduate more primary care doctors, Bigby said. In addition, the law calls for better training of primary care doctors and aids some of them in repaying medical school loans.

The law also establishes an institute to award grants to doctors and hospitals seeking to increase their use of computer technology. Electronic medical records systems typically cost $30,000 or more, which has slowed the healthcare industry's adoption of technology that most people agree improves both safety and efficiency.

In addition, the law gives the state more oversight of health insurance rates than regulators have had in more than a decade. Now, both the Division of Insurance and an office under Bigby's control can require health insurers to publicly justify rate increases.

But the limits on drug industry gift-giving drew the most attention.

Montigny had hoped that, after failing twice, he might succeed in banning gift-giving between salespeople and healthcare professionals altogether. However, representatives of the drug and medical device industry successfully argued that the measure went too far, potentially banning money paid to doctors and hospitals to conduct medical research. Though the Senate passed the full ban, the House backed only restrictions.

Still, the limits in the law put Massachusetts at the forefront of states in cracking down on the use of financial incentives to persuade doctors to prescribe particular drugs or medical devices. In addition to banning some gifts and requiring disclosure of others, it calls for the state to develop a code of conduct for industry representatives that includes a $5,000 fine for each violation.

"I commend the governor for standing firmly on the side of the patient and the taxpayer," said Montigny.

But the pharmaceutical industry's trade group, called PhRMA, said state leaders could one day regret the limits, especially the public disclosure of gifts. The group said in a statement that researchers could be discouraged from doing important drug research if they fear their research grant will be put on a public list of gifts from industry.

"Governor Patrick's decision to sign [the limit on gift-giving] is deeply disappointing - and very likely damaging for medical partnerships, clinical research, and patients in Massachusetts," said PhRMA senior vice president Ken Johnson.

Scott Allen - Globe Staff

Biotech at risk for broadside hit - (Boston Herald 8/6/08)

Wed, 06 Aug 2008 13:03:00 EDT

Ethics bill would be malpractice.

On the last day of July, the Massachusetts Legislature passed the Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care. It's both a mouthful and a mess. If Gov. Deval Patrick doesn't veto the bill by Aug. 13, the law will put a needless chill on clinical research and pharmaceutical innovation in the commonwealth.

Among other provisions, the bill would require public disclosure when payments of $50 or more are made between pharmaceutical research firms and health-care providers. The information from these transactions - which includes physicians' names - would be posted on the Internet.

Transparency is generally a good thing. But publishing a list of doctors who have been involved in financial transactions through the state’s many academic research programs and clinical trials with pharmaceutical companies suggests that there is something wrong with these associations, even though the payments are neither illegal nor unethical.

According to the National Institutes of Health, there are currently 5,673 clinical trials being conducted in Massachusetts alone - and nearly 2,000 of them are recruiting patients. Many of these important programs could be threatened under the legislation. How many of the doctors and researchers already involved in trials might decide that the unwanted public attention is not worth their participation?

Also under such a regime, physicians and academic scientists who reside here - along with those who are contemplating a move to the Bay State - might decide to move elsewhere. If working with drug companies and biotechnology firms is viewed negatively, these folks could very well decide that Massachusetts’ research climate is too hostile.

Already, according to a Massachusetts Medical Society report, 24 percent of practicing physicians either have plans to leave the state, or are considering leaving, because of the practice environment.

Fears of biotechnology firms choosing to do business elsewhere are also real. And their absence would create a gaping hole. Biopharmaceutical companies employ nearly 55,000 people in Massachusetts, according to the Center for Labor Market Studies at Northeastern University. And that number has been growing. Whereas Massachusetts lost 100,000 private-sector jobs between 2000 and 2005, the biotechnology industry created 6,100 jobs.

When developing life-saving and life-enhancing medicines, drug companies depend on physicians and academic scientists. This legislation unwisely cuts into that indispensable relationship.cw-3

The legislation is also unnecessary, as when it comes to perceived conflicts of interest, the industry is already policing itself. Just this month, the pharmaceutical industry’s trade group issued a new code on interactions with health-care providers. It will take effect on Jan. 1.

Under the industry’s old guidelines, drug reps were allowed to give gifts of up to $100 to physicians. That’s why Lipitor post-it pads and Claritin letter-openers are so ubiquitous around doctors’ offices. The new rules, however, prohibit all but educational gifts.

And whereas the old rules allowed for drug reps to purchase “modest” and “occasional” meals for physicians, restaurant outings will no longer be permissible under the industry’s new plan. As if that weren’t enough, the pharmaceutical trade group is also instituting new regulations regarding the fees paid to doctors who work as industry consultants.

When a doctor decides which treatment to prescribe, free stationery and a burger at Applebees isn’t likely to be a major influence. Physicians are quite well paid, and they swear an oath to do what’s best for their patients. Even if they could be bribed, it would presumably take more than a few pieces of stationery. Doctors simply don’t base medical decisions on who gave the best paperweight.

Massachusetts lawmakers are apparently convinced that drug companies are in cahoots with academic scientists and physicians. But in this rush to regulate, they may inadvertently harm patients and one of the state’s most-bustling industries.

Sally C. Pipes is president and CEO of the Pacific Research Institute and author of "Miracle Cure: How to Solve America's Health-Care Crisis and Why Canada Isn't the Answer."

Aptuit Consulting Inc. and Taiwan Liposome Company (TLC) Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months

Wed, 25 Jun 2008 12:00:00 EDT

Taipei, Taiwan and Greenwich, CT - June 25, 2008 - Taiwan Liposome Company (TLC) and Aptuit Consulting Inc., a subsidiary of Aptuit Inc., today announced that TLC's Lipotecan® cleared review by the U.S. Food and Drug Administration (FDA) following the filing of an Investigational New Drug (IND) application, the first anti-cancer drug from Taiwan to achieve this milestone. TLC will initiate a Phase 1 trial in patients with solid tumors in 3Q08. Lipotecan® is a chemically modified camptothecin designed to improve stability and potency and to minimize toxicity. Unlike other camptothecin-derived drugs that are used solely for chemotherapy, Lipotecan® has demonstrated effects as a chemotherapeutic and radio-sensitizer in preclinical animal studies. Aptuit Consulting, Aptuit's global pharmaceutical drug development consultancy, managed the IND-enabling studies from manufacturing through IND submission and is engaged in the Phase 1 program.

To view full article visit: http://www.aptuitconsulting.com/News/News%20Items/TLC%20Press%20Release.aspx

Hyaluron Contract Manufacturing (HCM) Announces Patent Approval

Tue, 24 Jun 2008 12:00:00 EDT

BURLINGTON, Massachusetts June 24, 2008 - Hyaluron, Inc. dba Hyaluron Contract Manufacturing (HCM) is pleased to announce the grant of a patent and the registration of a trademark for its proprietary process for aseptic online vacuum filling and online vacuum stoppering of low viscosity liquids in syringes. BUBBLE-FREE FILLING® enhances product stability for oxygen sensitive compounds where dissolved oxygen negatively impacts solution stability. BUBBLE-FREE FILLING® also provides additional assurances of sterility by reducing stopper movement as well as creating an unfavorable environment for the growth of aerobic micro-organisms.

HCM was able to develop the BUBBLE-FREE FILLING® method by re-engineering standard syringe filling equipment and creating a unique fluid handling and transfer process. HCM has another patent pending for a proprietary aseptic processing method for non-destructive testing of container/closure integrity. HCM is continually striving to improve the safety and effectiveness of drug delivery through its innovative processes.

About Hyaluron Contract Manufacturing

Hyaluron Contract Manufacturing aseptically fills liquid and lyophilized products into syringes, vials, and custom containers. In addition to traditional formulations, HCM excels in process development scale up of difficult formulations including: emulsions; viscous gels; suspensions, liposomes, and proteins. For additional information please visit: www.hyaluron.com and www.bubblefreefilling.com.

MBC Industry News from BusinessWire

Thu, 24 Apr 2008 16:10:00 EDT

MBC Industry News from BusinessWire

MassBio Member Company News

Hyaluron Contract Manufacturing Dons Denim for a Cause

Cubist Pharmaceuticals Opens New Research Facility at Lexington Headquarters (Business Wire 9/29/08)

International Trade Show Opportunity

Fox show Fringe will have a Massachusetts touch - (Boston Business Journal 9/9/08)

Hyaluron Contract Manufacturing (HCM) Announces Tour of Facility

Leaders nip, tuck healthcare policy - (Boston Globe - 8/11/08)

Biotech at risk for broadside hit - (Boston Herald 8/6/08)

Aptuit Consulting Inc. and Taiwan Liposome Company (TLC) Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months

Hyaluron Contract Manufacturing (HCM) Announces Patent Approval

MBC Industry News from BusinessWire

Fox show Fringe will have a Massachusetts touch -
(Boston Business Journal 9/9/08)