protein

SPOTLIGHT: Anesiva inks $114M licensing deal

Thu, 05 Jun 2008 06:59:53 -0400

Transcription Factor Therapeutics has licensed the worldwide rights to Anesiva's NF-kB Decoy program, which includes the clinical drug candidate Avrina. NF-kB Transcription Factor Decoy inhibits NF-kappa B, a protein implicated in the inflammatory cascade in diseases such as inflammatory bowel disease (IBD), eczema, rheumatoid arthritis, and asthma. Anesiva gets an upfront fee and up to $114 million in milestone payments if two products are developed. Release

Battelle Ventures, Apax Partners spin off companies

Wed, 04 Jun 2008 06:59:54 -0400

There are two new spin-offs to announce today. First, Battelle Ventures has spun out regenerative medicine start-up NellOne Therapeutics from the U.S. Department of Energy's Oak Ridge National Laboratory. NellOne gets an initial investment of $1.5 million, which will be tranched based on key technical milestones.

Meanwhile, Sense Proteomic has been spun out as a biomarker discovery company; previously it was a subsidiary of Procognia, which makes bioscience tools. Apax Partners is backing the new company. Sense Proteomic will be using its protein array platform to discover panels of auto-antibody biomarkers in cancer and autoimmune diseases.

- see the release on NellOne
- here's the announcement on Sense Proteomic

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Sanofi Pasteur plans C$100M R&D facility in Canada

Wed, 16 Apr 2008 06:59:56 -0400

Score one win for Ontario province in the field of economic development. Sanofi Pasteur, the vaccine arm of Sanofi-Aventis, will build a C$100 million R&D facility in Toronto with the province chipping in C$13.9 million through its Biopharmaceutical Investment Program.

Researchers will target pediatric combination vaccines, pneumococcal protein vaccines and cancer vaccines. Look for the grand opening in 2010.

- check out the AFX report

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Amgen wins a key approval for platelet therapy

Thu, 13 Mar 2008 07:59:57 -0400

Amgen got some much-needed good news yesterday after an FDA panel endorsed the approval of Nplate, its drug for a rare blood disorder. The expert group backed Nplate, saying that its benefits in treating chronic immune thrombocytopenia purpura, or ITP, outweighed the risks posed by the injectable drug. The market potential for Nplate, though, is limited. One analyst estimated that Nplate is likely to earn only about $117 million a year. Still, that's a plus sign after a turbulent period that's seen plenty of minuses for Amgen. Nplate is an engineered version of a protein that spurs platelet production.

- here's the release
- check out the AP report

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Wyeth dumps once-promising Curis collaboration

Mon, 10 Mar 2008 07:59:54 -0400

Back in 2004, Wyeth considered a project with Curis to develop small molecule and protein Hedgehog agonists--which promised new therapies for stroke and cardiovascular ailments--worth potentially more than $170 million in milestone payments.

That was then.

This morning, Curis announced that Wyeth is pulling out of the pact. "Our speculation is that Wyeth has decided to re-prioritize," a Curis spokesman told the Boston Globe. Curis pocketed a $3 million upfront payment in the Wyeth deal. Since then, Curis has repositioned itself as well, focusing on new cancer therapies.

- see this release from Curis
- read the story in the Boston Globe

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Panacos surges on HIV response data

Thu, 06 Mar 2008 06:59:56 -0500

Shares of Panacos shot up yesterday when the drug developer reported that it discovered factors that predict response to bevirimat, its lead HIV maturation inhibitor. Patients who had few mutations on the HIV Gag protein were more likely to respond to bevirimat. When researchers analyzed data from a recent Phase II trial, they found that about 50 percent of the 100 patients studied have these specific changes in Gag. "In a very short period of time we have made a number of significant discoveries with regard to bevirimat. We can specifically target the patients who will respond well to bevirimat in advance. In that population, we have seen a dramatic treatment response," noted Alan W. Dunton, Panacos' President and CEO. Simple genotype test will help determine which patients benefit from bevirimat; additional trials will be needed to test the drug in this group.

- see this release
- read the BusinessWeek article for more

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Amgen CEO touts blockbuster potential of D-mab

Thu, 14 Feb 2008 06:59:54 -0500

Amgen CEO Kevin Sharer dropped by The Wall Street Journal to tout the company's chances in developing denosumab (D-mab) into a badly needed blockbuster. The discovery program began in an Amgen lab when researchers observed that one of the knockout mice it had developed during gene disabling research work had grown huge. "We noticed, hey that's a really big mouse," Sharer told the Journal. "It's really got big bones."

It's also got really big market potential. Amgen believes that D-mab, which blocks the protein expressed by the gene knocked out in the mice, is worth at least a billion dollars a year, which would make up for some of the market it has lost in anemia drugs. Sharer also said that the drug would be priced closer to $1,000 a year--a fraction of the $10,000 a year tab that many biologics run.

- read the report in the Wall Street Journal

Related Articles:
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ALSO NOTED: Flamel inks licensing deal;Alfacell trial hits a milestone; and much more...

Wed, 12 Sep 2007 06:59:50 -0400

> France's Flamel Technologies gets an undisclosed upfront payment and a schedule of potential milestone payments after signing a licensing and development deal with Wyeth for using its technology to deliver a marketed protein. Release

> Alfacell Corporation has confirmed that 290 evaluable events--patient deaths--have occurred in the Phase IIIb clinical trial of its lead compound, ONCONASE, for unresectable malignant mesothelioma. Release

> Prana Biotechnology has raised $7 million in a private placement. Release

> What's a generic drug company to do? A federal judge refused Wyeth's request for an injunction against the launch generic Protonix, and Teva could start selling. But if Wyeth wins the patent case, then Teva would have to fork over three times its sales. Report

> An outbreak of foot-and-mouth disease in the UK has been contained after a government report pinned the blame for the outbreak on leaky pipes at the Institute for Animal Health's Pirbright site. Report

> The NIH has doled out $438 million for daring research projects. Report

> And Finally... Venture capitalists bet big on nanotechnology. Report

ALSO NOTED: FDA OKs human thrombin; A new cancer research company; Compugen inks drug pact; and much more...

Tue, 28 Aug 2007 06:59:50 -0400

> Shares of Omrix surged this morning on the news that the FDA had approved Evithrom, a protein used to control bleeding during surgery. This is the first human thrombin to gain approval since the '50s. Report

> Cancer Therapeutics CRC has begun operations by billing itself as one of the largest public/private partnerships of its type in the world. Working with AUD$148 million in funding over seven years, including AUD$37.6 million from the Australian Commonwealth Government, "CTx addresses the gap between Australia's excellent academic cancer research base and its ability to discovery and develop new drugs to treat cancer." Release

> Israel's Compugen says it has inked a research collaboration and commercialization option with Teva for its chronic inflammatory disease treatment candidate CGEN-54. Release

> Neuro-Hitech has named Dr. Gary Shearman president and CEO. Release

> CuraGen and TopoTarget have initiated patient dosing in a Phase I/II clinical trial evaluating belinostat (PXD101) in combination with the anthracycline idarubicin for the treatment of Acute Myeloid Leukemia. Release

> Biogen Idec says another month has gone by with no new reported cases of PML among Tysabri patients. PML is a rare brain disease that has been linked to the MS therapy. FiercePharma

> The FDA has accepted the marketing application from Merck and Schering-Plough for a drug combining allergy and asthma blockbusters Claritin and Singulair. FiercePharma

And Finally... A longevity gene may be the key to living past 100. Report

Press Release: Generex Biotechnology to Initiate Phase II Clinical Trial in Breast Cancer Patients

Maureen Martino — Thu, 01 Feb 2007 12:40:12 -0500

Generex Biotechnology to Initiate Phase II Clinical Trial in Breast Cancer Patients in Collaboration With United States Military's Cancer Institute

Positive Phase I Results Lead to Randomized Phase II Efficacy Studies

TORONTO-- Feb 1, 2007 -- Generex Biotechnology Corporation announced today that it has entered into a Phase II clinical trial using its novel peptide vaccine in breast cancer patients in conjunction with the United States Military Cancer Institute's (USMCI) Clinical Trials Group under a Clinical Trial Agreement. The immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express division in the United States.

The Phase II study will be a randomized, multi-center trial in patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene. These patients are at an increased risk for recurrence; therefore, the endpoint for this study will be a 50% reduction in the rate of relapse of disease at two years. The trial was designed to take advantage of changing paradigms (not yet adopted) for the study of therapeutic cancer vaccines, which proposes a two-phase rather than a three-phase clinical investigation strategy.

The parties initiated a Phase I trial of AE37 were initiated in April of 2005 and have shown good immunostimulatory activity while being safe and well tolerated.

The immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumor-associated protein that has been modified to enhance stimulation of CD4+ T helper cells. The target protein is encoded by the HER-2/neu oncogene, which has been found to be over-expressed in a variety of tumors including breast, ovarian, prostate, lung, colon, stomach and pancreas. Antigen-specific stimulation of T helper cells, as occurs after immunization with AE37, has been shown in prior studies to be critical for the immune system to mount an effective anti-tumor response.

AE37 is being tested under the direction of COL George Peoples, MD, Medical Corps, U.S. Army stationed at Brooke Army Medical Center. The study involves a collaboration with the USMCI, the Uniformed Services University of the Health Sciences (USU) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). Antigen Express has entered into a Clinical Trial Agreement with the Foundation to work with Dr. Peoples, USMCI, and USU to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer.

About Generex

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Press Release: Sarasota's Roskamp Institute Discovers New Class of Drugs That Can Impact Alzheimer's Disease

Maureen Martino — Fri, 26 Jan 2007 13:21:46 -0500

Sarasota's Roskamp Institute Discovers New Class of Drugs That Can Impact Alzheimer's Disease

Discovery Detailed in Neuroscience Letters

SARASOTA, Fla., January 25, 2007 -- The Roskamp Institute announced today the discovery of a new class of drugs that lower the production of the main pathological protein that causes Alzheimer's disease. The discovery is detailed in an article co-authored by Drs. Daniel Paris and Michael Mullan and currently appears in Neuroscience Letters.

The Roskamp Institute, which is devoted to finding treatments for Alzheimer's disease, has been researching drugs that have the potential to stop the production of B-amyloid.

"When B-amyloid builds up in humans, patients develop Alzheimer's disease," said Dr. Michael Mullan, Director of the Roskamp Institute. "By stopping its production we can potentially stop the disease. We have found a whole family of drugs that can stop the production of B-amyloid, giving many companies working on NF-kB inhibitors the opportunity to test these types of drugs in Alzheimer's."

NF-kB (a protein that occurs in all cells in the body) activity results in inflammatory responses due to the switching on of genes that encode proteins that are key in inflammation. NF-kB inhibitors are being developed widely in the pharmaceutical industry primarily for its use in inflammatory conditions such as Arthritis and, until now, have not been thought of as a potential treatment for Alzheimer's.

At the same time, many drug companies are searching for compounds that can lower or stop the production of B-amyloid. The finding that NF-kB controls B- amyloid production means that NF-kB inhibitors might be developed as anti- Alzheimer drugs. One such example is Celastrol, which is researched in the Roskamp Institute's publication, and is available as a food supplement but has never been formally tested in Alzheimer's.

"Although we have known about the important inflammatory role of NF-kB for a long time, we did not know that it controls B-amyloid production," said Dr. Daniel Paris, Senior Scientist of the Roskamp Institute. "This may be one way that the inflammation caused by B-amyloid leads to more B-amyloid being produced -- a positive feedback loop with awful consequences for the sufferer."

The publication details the NF-kB findings and explains why this family of drugs should be tested for their use in treating Alzheimer's disease patients.

For more information on the Roskamp Institute and to view the journal article in Neuroscience Letters, please visit us online at http://www.RoskampInstitute.com. The article can also be viewed directly at http://www.roskampinstitute.com/pdf/NF_kB_Publication.pdf.

CONTACT: Sarah Bascom, +1-850-222-2140 for Roskamp Institute

Web site: http://www.RoskampInstitute.com/

Researchers discovers new class of Alzheimer's drug

Thu, 25 Jan 2007 19:01:36 -0500

The Roskamp Institute has unveiled its research into a new class of drugs that is designed to reduce the production of the pathological protein linked to Alzheimer's. The finding that NF-kB controls B-amyloid production means that NF-kB inhibitors might be developed as anti-Alzheimer drugs. One such example is Celastrol, which is researched in the Roskamp Institute's publication, and is available as a food supplement but has never been formally tested in Alzheimer's.

- check out this release for more on the discovery

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SPOTLIGHT: Schering-Plough touts potential of new drug

Mon, 08 Jan 2007 19:01:33 -0500

Schering-Plough is bullish about its experimental anti-clotting drug, saying it could be a potentially transformational product that can significantly reduce the risk of heart attack and stroke without raising the risk of bleeding. The drug prevents thrombin, a clot-causing protein, from attaching to platelets. Report

Cytokinetics, Amgen ink heart drug deal

Tue, 02 Jan 2007 19:01:38 -0500

South San Francisco-based Cytokinetics has struck a deal to option its experimental heart failure drug to biotech giant Amgen in exchange for a $75 million payment and more than $600 million in development and sales milestones. The deal was revealed this morning in an exclusive article by New York Times biotech reporter Andrew Pollack. CK-1827452, which is about to enter Phase II, triggers a protein that causes the heart to contract as it pumps blood. About five million Americans suffer from cardiovascular disease characterized by insufficient blood flow. Under the terms of the deal, Amgen will pay another $50 million if it decides to exercise the option and take over development of the therapy. Cytokinetics pockets $42 million in cash and is selling $33 million of its shares to Amgen at a hefty 27 percent premium.

- check out the press release for more
- here's the article on the pact in The New York Times

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Oxford BioMedica says licensing talks heating up

Wed, 08 Nov 2006 19:01:38 -0500

Oxford BioMedica says its in talks with four other companies interested in collaborating on the development of its cancer drug TroVax, its lead therapy. And they added that one major pharma company has already completed due diligence on the drug, which is starting Phase III. A spokesman for the company said that their goal was to bring all four companies interested in TroVax up to the same level, which certainly sounds as if they'd like to get the serious bidders to the table as swiftly as possible. Oxford BioMedica also offered up more positive data from a Phase II trial of TroVax.

- here's a report on the licensing talks from the Oxford Mail
- and here's more on the new trial data

Related Article:
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Enrollment halted as researchers study safety signal

Tue, 24 Oct 2006 20:01:34 -0400

Potential safety issues have prompted Forest Laboratories and its development partner, Germany's Paion, to halt enrolling patients in a late-stage trial of a compound that mimics a protein found in bat saliva. The independent monitoring committee says they want time to analyze more of the data from the drug, desmoteplase, to evaluate a "safety signal." No other details were provided. Desmoteplase is a clot-dissolving protein intended as a treatment for stroke.

- see the release on the trial

Standards on biotech patents get tougher

Mon, 25 Sep 2006 20:01:36 -0400

With the number of patents on gene-related discoveries soaring, IP experts say that the process of gaining a patent has become much more complex. Isolating and sequencing a protein won't cut it anymore, say attorneys. You now have to demonstrate a "credible utility" outlining what it can do. Biotech patent applications are considered a prime reason why the total number of patent filings in the U.S. hit 409,500 last year. And many of these patents are out to protect new therapies rather than genetic links to disease.

- read the Boston Business Journal report on biotech patents

Pivotal Thrombin trial a success for ZymoGenetics

Tue, 05 Sep 2006 20:01:38 -0400

Seattle-based ZymoGenetics announced that a pivotal Phase III study of Thrombin showed that it was as effective in stopping surgical bleeding as the standard therapy while also proving safer. A total of 1.5 percent of the patients taking Thrombin among the 411 volunteers in the trial developed antibodies against Thrombin compared to 22 percent of volunteers taking a cow-blood based therapy. An antibody reaction can trigger bleeding.

Thrombin is a protein made through gene-splicing that mimics a human clotting protein. ZymoGenetics CEO Bruce Carter said that the company is on schedule to ask for FDA approval later this year and bring a product to market in 2007. Recent surveys have indicated that doctors prefer engineered proteins over proteins derived from either humans or animals. If so, ZymoGenetics would be well positioned to grab a commanding share of the market. The company's shares were buoyed by the news in overnight trading.

- read this article on the trial from the Seattle Times

FDA approves Shire's pricey Elaprase

Mon, 24 Jul 2006 20:01:39 -0400

Shire has received FDA approval for the first therapy designated for Hunter syndrome, a rare disorder that is linked to potentially fatal growth problems in children. Only about 500 people in the U.S. are afflicted by Hunter syndrome and about 100 of them have been involved in the clinical testing of Elaprase. Shire says it expects to market the drug for a cost of $300,000 a year, making it one of the most expensive medications on the market. Elaprase is an enzyme replacement therapy which injects a critically needed protein into the patient's bloodstream. These therapies are frequently targeted at tiny patient groups and are priced to bring in a significant amount of cash.

- read the article on Elaprase from The Boston Globe

Researchers say Gleevec linked to heart damage

Sun, 23 Jul 2006 20:01:38 -0400

A team of researchers has concluded that the cancer drug Gleevec may cause serious heart damage. They found evidence that imatinib was linked to the heart failure experienced by 10 patients. But rather than stop taking the leukemia treatment, the scientists say that patients and doctors need to carefully monitor for heart damage. Gleevec has proven to be a very powerful therapy for combating chronic myelogenous leukemia by halting the work of a protein called Bcr-Abl.

- read the report on Gleevec from The Boston Globe