non-Hodgkin's lymphoma

Biovest wants accelerated approval for anti-cancer vax

Calisha Myers — Tue, 07 Oct 2008 15:14:05 -0400

Accentia Biopharmaceuticals' subsidiary Biovest International today announced positive results from its Phase 3 Fast-Tracked clinical trial of BiovaxID for the treatment of indolent follicular non-Hodgkin's lymphoma. The trials were halted in June upon analyses by the data monitoring board that revealed a significant survival rate for BiovaxID patients, versus the control arm. According to study data, at 36 months, 61 percent of BiovaxID patients were cancer-free, while only 37 percent of control patients were.

Rather than follow patients in both trial arms, Biovest will now petition for approval to offer all study participants treatment with the drug after analyses demonstrated that the vaccine prolongs cancer-free survival by 44 percent (nearly 14 months). "We believe that these strongly positive clinical results make it unethical to continue the trial as originally designed," said Biovest's Chairman and CEO, Dr. Steven Arikian. "In particular, we believe that we should offer BiovaxID to patients in the control arm who have not relapsed yet, and to patients in both arms who have relapsed but who can achieve another complete remission."

Biovest will seek Accelerated Approval from the FDA, and intends to apply for approval in Europe, Asia and Australia.

- read the Biovest release

SPOTLIGHT: Positive Velcade data fuels stock rise

Tue, 18 Sep 2007 06:59:53 -0400

Shares of Millennium Pharmaceuticals shot up this morning after the company announced that a late-stage trial of Velcade proved effective against multiple myeloma. Researchers stopped the trial so that all the participants could receive the drug, which is also being developed for non-Hodgkin's lymphoma. Release

SPOTLIGHT: Cell Therapeutics buys cancer drug

Thu, 16 Aug 2007 06:59:53 -0400

Cell Therapeutics has agreed to shell out $10 million up front and up to $20 million in milestones for the marketing and development rights of Biogen Idec's Zevalin, a cancer drug. The milestones kick in with the drug's approval as a first-line treatment for non-Hodgkin's lymphoma. Release

Genzyme reports successful late-stage stem cell study

Thu, 19 Jul 2007 06:59:55 -0400

Shares of Genzyme were buoyed slightly by the news that Mozobil hit primary and secondary goals in a late-stage trial for non-Hodgkin's lymphoma. The drug spurs the release of bone marrow stem cells into the blood so that they can be collected and used in a transplant. About six in 10 of the patients in the study demonstrated an increased stem cell count while 87 percent produced the necessary number of stem cells needed for a transplant. Applications for U.S. and European marketing approval is now expected in the first half of next year. Genzyme gained Mozobil when it bought out AnorMED earlier this year.

- read the release for more
- here's the AP report on the trial data

Related Articles:
Genzyme wins bidding war for AnorMED. Report
Genzyme to pursue rare hostile biotech bid. Report
Millennium to buy AnorMed for $515M. Report
Genzyme boosts AnorMed bid to $580M. Report

Press Release: Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkin’s Lymphoma

Maureen Martino — Wed, 24 Jan 2007 13:07:43 -0500

Biogen Idec Initiates Phase III Trial of Galiximab for Follicular Non-Hodgkin’s Lymphoma

CAMBRIDGE, Mass. -- Biogen Idec today announced that it has initiated a Phase III randomized, double-blind study of an investigational anti-CD80 monoclonal antibody, galiximab, for patients with lymphoma. The trial will compare treatment with galiximab in combination with rituximab (RITUXAN®) to rituximab in combination with placebo in patients with follicular non-Hodgkin’s lymphoma (NHL) that has relapsed or failed to respond to initial therapy.

The study is a registrational clinical trial being conducted under a Special Protocol Assessment granted by the U.S. Food and Drug Administration (FDA) in July 2006. The study enrolled the first patient in November 2006 at Loyola University Medical Center in Chicago, Ill. The study will ultimately enroll approximately 700 patients worldwide at more than 150 centers.

“The median survival time for patients with follicular non-Hodgkin’s lymphoma is 7-10 years, and relapses are common, therefore, we’re aiming to delay progression as long as possible,” said Patrick Stiff, M.D., the director of Loyola University Medical Center’s Cardinal Bernardin Cancer Center, and professor of medicine and pathology at Stritch School of Medicine, Loyola University Chicago. “Galiximab may offer an additional therapeutic option for patients, particularly for patients who have failed or relapsed on other therapies.”

Because the CD80 target is found uniformly on Reed–Sternberg cells, the malignant component of Hodgkin’s disease, as well as the majority of non-Hodgkin’s lymphomas, the company will explore expanded proof-of-concept clinical trials, which will begin in 2007, for other indications.

“Galiximab represents a new approach with the potential to benefit patients with NHL,” said David Parkinson, senior vice president, Oncology Research and Development, Biogen Idec. “Galiximab, together with our anti-CD23 monoclonal antibody (lumiliximab) for chronic lymphocytic leukemia, demonstrates Biogen Idec’s leadership in development of therapies for hematological malignancies. The safety profile of galiximab in the early studies, along with its hypothesized novel mechanism with RITUXAN, suggests the potential for a new era of combination antibody therapies as treatments for lymphoma.”

About the Study

The TARGET NHL Trial (Targeted Antibody Therapy with RITUXAN and Galiximab Efficacy Trial) is a randomized, double-blind, global multi-center study (114-NH-301) of galiximab in combination with rituximab compared with rituximab in combination with placebo. The primary study objective is to compare the clinical benefit of each treatment arm in subjects with relapsed or refractory, follicular NHL. Progression-free survival (PFS) is the primary study endpoint. An open-label retreatment study (114-NH-302) with galiximab in combination with rituximab, will be available to subjects who progress on 114-NH-301 after experiencing at least a partial response (PR) with a time to progression (TTP) of six months or greater in either arm of the study.

About Non-Hodgkin's Lymphoma

Non-Hodgkin’s lymphoma (NHL), a cancer affecting the lymphatic system, has had the second-fastest rate of increase of all malignancies in the United States. The incidence has nearly doubled over the past 30 years. It is estimated that 360,000 Americans are currently living with NHL, and about 58,000 new cases are expected to occur in the United States this year. Of those diagnosed with NHL, about 30 percent of patients have a slow-growing but incurable (low-grade) form of the disease – the most common type is called follicular lymphoma (FL). Although FL progresses slowly, it is ultimately fatal with a median survival time of 7-10 years. In addition, relapse is common, and less than half of FL patients who experience a relapse will survive for five years.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Biogen Idec Safe Harbor

This press release contains forward-looking statements regarding the development of galiximab and as a potential treatment for various indications. These statements are based on the companies' current beliefs and expectation. Drug development involves a high degree of risk. Factors which could cause actual results to differ materially from the companies' current expectations include: the risk that unexpected concerns may arise from additional data or analysis, that regulatory authorities may require additional information, further studies, or may fail to approve the drug, or that the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic reports of Biogen Idec Inc. filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Seattle Genetics shares soar on Genentech pact

Sun, 07 Jan 2007 19:01:38 -0500

Shares of Seattle Genetics shot up 31.5 percent this morning after it announced that it would gain $60 million up front and more than $800 million in potential milestones from Genentech from its newly signed development pact for SGN-40. Genentech is committed to pay $20 million of those milestones payments in the first two years of the agreement as Seattle Genetics is reimbursed for clinical trials. The therapy is an early-stage cancer treatment being studied for multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin's lymphoma.

- check out the release on the deal with Genentech

ALSO: Seattle Genetics has also signed a joint research agreement with Agensys to develop antibody-drug conjugate therapies for cancer. Release

Related Article:
Genentech inks $300M pact with Swiss biotech. Report
Genentech strikes $919M deal to buy Tanox. Report

New warning issued on Rituxan for lupus

Mon, 18 Dec 2006 19:01:34 -0500

Biogen Idec and Genentech have warned doctors that two patients taking Rituxan for lupus have died of a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Rituxan is approved for non-Hodgkin's lymphoma and rheumatoid arthritis and cancer patients have already been warned about their risk of PML. One analyst noted that the new risk for lupus may make it harder for the companies to gain approval to use Rituxan for lupus and M.S. Biogen Idec has also had to deal with the risk of PML raised by its MS drug Tysabri. That drug was withdrawn until a new safety program was assembled.

- read the FDA's warning on the drug
- here's the report from The New York Times

Related Articles:
Rituxan data encourages researchers. Report
FDA approves Rituxan for rheumatoid arthritis. Report
FDA allows Tysabri back on the market. Report

Shire, New River shares surge on FDA approval

Sun, 08 Oct 2006 20:01:37 -0400

Shares of Shire and New River Pharmaceuticals were on the rise this morning as investors responded to the news that the FDA had approved NRP104, its next generation version of the popular ADHD drug Adderall. New River shares soared 51 percent in early trading as investors considered the impact of a milestone payment of up to $300 million and $100 million in annual bonuses if the drug breaks the billion-dollar revenue mark. Analysts were particularly bullish about the FDA's signal that no new studies would be needed to clear a market launch. Discussions about labeling requirements are in the works, but there's nothing in the approval that would indicate the developers can't make or beat their goal to launch NRP104 in the second quarter of next year.

- read the article on the approval from MarketWatch

PLUS: The FDA has approved Sepracor's Brovana for COPD. Report

ALSO: The FDA has approved Merck's Zolinza for non-Hodgkin's lymphoma in patients who have failed other therapies. Report

AND: The agency has approved J&J's Risperdal as a therapy for irritability in autistic children and adolescents. Report

Millennium to buy AnorMed for $515M

Tue, 26 Sep 2006 20:01:38 -0400

Cambridge, MA-based Millennium Pharmaceuticals has agreed to pay $515 million to buy Canada's AnorMed, beating out Genzyme for the company. Genzyme had put AnorMed in play with its $380 million offer, but AnorMed signaled from the start that it felt it was worth more. Millennium is buying a company with no approved products but an advanced stem cell therapy, Mozobil, for treating certain types of blood cancer. Mozobil releases bone marrow cells so that they can be harvested and used to treat multiple myeloma and non-Hodgkin's lymphoma. AnorMed's shares jumped 26 percent on the news. The company is still able to entertain higher offers, but could face a termination fee if they end up rejecting Millennium as well.

"This proposed acquisition is aligned with our goal to bring in products that accelerate revenue growth, leverage our oncology sales infrastructure and benefit from our development, regulatory and commercial expertise," said Millennium CEO Deborah Dunsire.

- read the report on the buyout from TheStreet.com

Genentech and Biogen Idec in talks over Rituxan

Thu, 03 Aug 2006 20:01:37 -0400

Genentech and Biogen Idec appear to be at loggerheads over how to develop the blockbuster Rituxan for new uses. Genentech says it will go ahead with plans to develop Rituxan as a therapy for rheumatoid arthritis and another inflammatory disease. But Biogen Idec says it must first approve of the development program. Dow Jones reports that little is known about the disagreement, and a spokesperson for Biogen Idec says they are trying to work things out. Rituxan has successfully completed a Phase I/II trial for R.A. and Genentech says it is ready to push ahead with a pivotal trial. Rituxan, which is approved for non-Hodgkin's lymphoma, earned $1.83 billion last year.

- check out the report on Rituxan from Dow Jones

Favrille wins fast-track designation for cancer drug Favld

Wed, 11 Jan 2006 19:01:37 -0500

Favrille has won the FDA's fast-track designation for Favld, a treatment for follicular B-cell non-Hodgkin's lymphoma following Rituxan. An ongoing Phase III trial of Favld should produce data on secondary endpoints late this year while primary endpoint data is expected in the second half of 2007. "This decision by the FDA has the potential to save us valuable time in the regulatory approval process, and also serves as an important acknowledgment of the potential for FavId in the treatment of B-cell follicular NHL," John P. Longenecker, Ph.D., CEO of Favrille.

- read this AP report for more information

SPOTLIGHT: Biogen warns on Zevalin

Sun, 30 Oct 2005 19:01:33 -0500

Biogen Idec has warned that patients taking Zevalin to treat non-Hodgkin's lymphoma can develop severe and sometimes fatal skin reactions. The information has been added to the drug's label and a warning letter has gone out to physicians. Report

FDA: Genitope must continue vaccine tests

Mon, 25 Jul 2005 20:01:39 -0400

Genitope's hopes of bringing its MyVax cancer vaccine to market quickly were dashed Monday when an independent board recommended that a clinical trial of its cancer vaccine continue. Although the 300-patient trial was scheduled to end in 2007, Genitope believed its vaccine might produce results sooner. The vaccine for an incurable form of non-Hodgkin's lymphoma, a blood cancer, is Genitope's most advanced product. The news took a bite out of its stock value this morning.

- read this story from the Los Angeles Times for more

DEALS: Actavis buys Amide Pharmaceuticals

Wed, 25 May 2005 20:01:32 -0400

Actavis buys Amide Pharmaceuticals

DEALS
WHO	WITH	WHAT	SCOOP
Bionomics	Iliad Chemicals	$9M buyout	The deal is intended to help beef up Bionomics' pipeline toward its goal of having two Phase II products and five preclinical programs by 2008.
Actavis	Amide Pharmaceuticals	$500M buyout	The buyout gives Actavis a much bigger beachhead in the American generics market, making it easier to sell generic drugs and introduce new pharmaceuticals.
Cephalon	Salmedix	$160M buyout	Researchers at Salmedix have been testing Treanda as both a treatment for non-Hodgkin's lymphoma for patients who have not responded to Rituxan and a complement to Rituxan.
Invitrogen	Caltag Laboratories	$20M buyout	The deal adds Caltag's library of antibodies to Invitrogen's rapidly expanding stockpile.
BioXell	Merck	$150M drug development pact	Merck has agreed to pay up to that amount to develop the company's lead product, TREM-1, which targets a receptor on specific immune cells.
Lexicon Genetics	Organon Labs	Drug collaboration	The research work will concentrate on 300 genes that encode therapeutic antibodies and proteins.