proteins

Developers tout protein manufacturing breakthrough

John Carroll — Mon, 16 Jun 2008 07:14:21 -0400

A joint venture between Crucell and DSM Biologics--Percivia--has produced a new, more efficient approach to manufacturing monoclonal antibodies and proteins. By relying on human cell lines rather than a traditional chemical approach, officials for the two companies say they can significantly cut the cost of manufacturing. And researchers for the joint venture say they achieved fermentation yields in human cells of 27 grams a liter--a record.

"This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6 platform," said Marco Cacciuttolo, CEO and President of Percivia. "We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production."

Less expensive manufacturing, they add, will allow developers to advance some new products to the market that would not have been able to generate a profit before.

- read the release

Targeted Genetics reports tgAAC94 data

Fri, 30 May 2008 06:59:55 -0400

Targeted Genetics is reporting results from an early-stage study of tgAAC94 for inflammatory arthritis. The drug uses a specially engineered virus to transport a gene. When working properly, the therapy produces proteins that eliminate the inflammatory molecules that cause arthritis. The company said that while the trial was not powered to show statistical significance, "tgAAC94 has the potential to improve disease symptoms that are refractory to other therapies, including systemic TNF antagonists." According to CEO H. Stewart Parker, "these clinical observations will help guide further clinical development."

A clinical trial of tgAAC94 was placed on hold last year after the death of a study participant, which threw a spotlight on the safety record of the whole gene therapy field. However, the FDA determined tgAAC94 was not to blame and the study continued.

- here's Targeted Genetics' release

Editor's note: This article has been corrected. The previous version inaccurately reported that the trial had failed. However, the trial was not set up to determine efficacy.

Biotech's next big opportunity: Follow-ons?

Thu, 24 Apr 2008 06:59:56 -0400

Follow-on biologics are often cited as major long-term threat to the biotech industry, which so far has not had to face a future where generic therapies are allowed to slice and dice the market for approved therapies. But new analysis from the RPM Report notes that biotech companies--along with the Big Pharma companies--may be much better positioned than generic drug developers to capitalize on the market.

The rationale is that developing follow-on proteins will demand exactly the kind of expertise that the biotech industry has on staff. Teva, meanwhile, has been on a buying spree and may be the only big generic developer that can compete in this space. Of course, before anyone produces follow-ons in the U.S. market, lawmakers have to agree on new legislation. And some proposals are calling for lengthy periods of exclusivity for biologics.

- read the analysis in the RPM Report

Syntaxin lands $33M for promising platform

Wed, 31 Oct 2007 07:59:55 -0400

The venture capital arm of GlaxoSmithKline, SR One, has co-led a $33 million venture round for the UK's Syntaxin--a developer focused on cell secretion. The Series B was also co-led by Life Science Partners. Syntaxin's technology is being used to develop proteins that can prevent a cell from secreting hormones or the signaling molecules the play a key role in disease.

"Syntaxin's discovery platform provides a unique approach to the development of a new class of biopharmaceutical products with potential application across a broad range of indications," said Deborah Harland, general partner at SR One.

- see this release for more

Regulators focusing on transgenic animals

Mon, 30 Jul 2007 06:59:55 -0400

Genetically engineered animals are producing a range of therapies for human use, and The New York Times catches up on the action at companies like GTC Biotherapeutics in Massachusetts, Pharmathene and Pharming. Developing drugs in this field has been a slow and laborious task, and the FDA is now developing new guidelines to help govern how animals are used to produce therapies. Questions are also being asked about the ultimate fate of these animals. Should they be sold for food?

- read the article from The New York Times

Related Articles:
Transgenic chickens used to manufacture proteins. Report
GTC inks new transgenics collaboration deal. Report
EMEA rejects GTC's therapy from modified goats. Report
Pharming gets orphan status for transgenic therapy. Report

FDA renews demand for more data on Kiacta

Wed, 18 Jul 2007 06:59:57 -0400

Analysts were left scratching their heads trying to determine if the FDA's second approvable letter for Neurochem's amyloidosis therapy Kiacta helped or hurt the company. The agency said that there was some efficacy data from Phase II and III but that more efficacy data would be needed for approval. The agency also said that new data submissions and pharmacokinetic studies could eliminate a requirement for a new trial. Amyloidosis is a rare disease characterized by the buildup of amyloid proteins in the body. Neurochem says it is preparing a consolidated efficacy report which it plans to submit in two months. But analysts were divided over whether the company could gain an approval without an entirely new trial--which could doom the drug.

- read the AP report

Related Articles:
Investors push up Neurochem stock on data review. Report
Neurochem asked to put up more Kiacta data. Report

Press Release: Crucell N.V. Announces STAR(TM) Research License Agreement With Novo Nordisk

Maureen Martino — Tue, 16 Jan 2007 11:12:51 -0500

Crucell N.V. Announces STAR(TM) Research License Agreement With Novo Nordisk

Leiden, The Netherlands, 16 January 2007 - Dutch biotechnology company Crucell N.V. announced today that it has signed a non-exclusive STAR(TM) research license agreement for the production of monoclonal antibodies with Bagsvaerd, Denmark-based Novo Nordisk A/S. Novo Nordisk A/S intends to evaluate the STAR(TM) technology using its proprietary mammalian CHO cell line along with its antibodies. Under the terms of the agreement, Novo Nordisk A/S will pay a license issuance fee, a success-based fee and annual maintenance fees provided the license is extended upon evaluation. Financial details of the deal were not disclosed.

About Star Technology

Crucell's STAR(TM) technology is useful for increasing production of recombinant antibodies and therapeutic proteins on mammalian cell lines. STAR(TM) technology supports high yield antibody and protein production. Using Crucell's STAR(TM) technology, high levels of protein can be generated. This has been demonstrated in several CHO derivatives for numerous proteins and different antibodies. Under standard non-optimized cell culture conditions using commercially available medium, specific productivity levels ranging between 25 and 50 pg/cell/day are easily achieved with screening of only up to 25 clones. Therefore Crucell's STAR(TM) technology is also ideal for stable bulk transfections to rapidly obtain adequate levels of protein for immunization, target discovery processes, protein characterization, or optimization and validation of downstream processes such as protein purification.

About Crucell

Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a biotechnology company focused on research, development and worldwide marketing of vaccines and antibodies that prevent and treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases, and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminium-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several Crucell products based on its unique PER.C6® production technology. The Company licenses this and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi aventis, GSK and Merck & Co. Crucell is headquartered in Leiden (the Netherlands), with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the US. The Company employs over a 1000 people. For more information, please visit www.crucell.com.

About Novo Nordisk

Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 23,000 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit www.novonordisk.com

Forward-looking statements

This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on July 6, 2006, and the section entitled "Risk Factors". The Company prepares its financial statements under generally accepted accounting principles in the United States (US GAAP) and Europe (IFRS).

For further information please contact:

Crucell N.V. For Crucell in the US: Leonard Kruimer Redington, Inc. Chief Financial Officer Thomas Redington Tel. +31-(0)71-524 8722 Tel. +1 212-926-1733 Leonard.Kruimer@crucell.com tredington@redingtoninc.com

Press Release: FivePrime Enters Osteoarthritis and Pulmonary Fibrosis Collaboration With Centocor

Maureen Martino — Wed, 03 Jan 2007 12:31:24 -0500

FivePrime Enters Osteoarthritis and Pulmonary Fibrosis Collaboration With Centocor

SAN FRANCISCO -- Five Prime Therapeutics, Inc. today announced a worldwide collaborative research and license agreement with Centocor Research and Development Inc. The collaboration will focus on novel therapeutic products to treat osteoarthritis and pulmonary fibrosis. Under the collaboration, FivePrime will screen its comprehensive protein library against cell-based assays directed to osteoarthritis and fibrosis and Centocor will have exclusive rights to the proteins and targets identified in these screens.

FivePrime will receive an upfront payment of $15 million, comprised of cash and an equity investment by Johnson and Johnson Development Corporation (JJDC), and two years research funding from Centocor. Centocor will have exclusive worldwide rights to develop and commercialize products and targets discovered during the research term in exchange for future milestones and royalties. Further details of the agreement have not been disclosed.

“With Centocor as a partner in these disease areas, we should be able to move the products of our discovery platform into clinical trials faster and more effectively,” commented Lewis T. “Rusty” Williams, FivePrime’s founder and Executive Chairman.

“Centocor has a long-standing commitment to innovative biotherapeutics,” added Gail Maderis, President and CEO of FivePrime. “We are extremely pleased to be working with a group that shares our enthusiasm for the tremendous potential of novel biologic therapies. Additionally, we welcome JJDC to our premier group of investors.”

A key component of the collaboration is FivePrime’s comprehensive, rapid protein discovery system. FivePrime’s protein screening library contains essentially all human secreted proteins and their receptors, including many that are unavailable in public collections. FivePrime screens its protein library in complex, primary cell assays with a level of precision, speed and thoroughness previously achievable only in small molecule screening. Using technologies for rapid in vivo validation of hits from its screens, FivePrime aims to reduce time from idea to an Investigational New Drug to less than three years.

About FivePrime

FivePrime is a privately held protein therapeutics discovery and development company located in San Francisco’s Mission Bay. Its proprietary discovery platform allows the rapid screening of the complete set of secreted proteins and their receptors in medically relevant, cell-based assays to identify new biotherapeutics. FivePrime is applying its high throughput biologics discovery system first in the areas of oncology, metabolic disease, immunology and regenerative medicine with lead proteins in pre-clinical development to treat cancer and type II diabetes. Earlier this year, FivePrime initiated a collaboration with Boehringer Ingelheim in the field of rheumatoid arthritis. Additional information on FivePrime can be found at www.fiveprime.com.

FivePrime scores $15M in collaboration pact

Tue, 02 Jan 2007 19:01:36 -0500

FivePrime Therapeutics has struck a deal to collaborate with Centocor Research and Development (a Johnson & Johnson company) on the development of new therapies for osteoarthritis and pulmonary fibrosis. Under the collaboration, FivePrime will screen its protein library against cell-based assays directed to osteoarthritis and fibrosis and Centocor will have exclusive rights to the proteins and targets identified in these screens. FivePrime will receive an upfront payment of $15 million in cash, an equity investment by J&J Development Corporation and two years research funding from Centocor. Centocor will have exclusive worldwide rights to develop and commercialize products and targets discovered during the research term in exchange for future milestones and royalties. Further details of the agreement weren't disclosed.

"With Centocor as a partner in these disease areas, we should be able to move the products of our discovery platform into clinical trials faster and more effectively," commented Lewis T. "Rusty" Williams, FivePrime's founder and executive chairman. FivePrime was a 2004 Fierce 15 company.

- check out the release on the deal

OncoGenex outlines plans for $48 million IPO

Wed, 13 Dec 2006 19:01:36 -0500

Canada's OncoGenex Technologies plans to raise up to $48 million in an IPO. The biotech has three products in development to inhibit the production of proteins linked to the resistance of treatments. The drug developer was founded in 2000 and has raised $35 million in venture capital. RBC Capital Markets will be the sole lead manager for the offering, and Needham & Company, Lazard Capital Markets, Canaccord Adams, and Susquehanna Financial Group are the co-managers.

- see this press release on the IPO
- here's the report from TechFinance.ca

Epix shares soar on $1.2B pact with GSK

Mon, 11 Dec 2006 19:01:38 -0500

Epix Pharmaceuticals, a small biotech based in Lexington, MA, saw its shares shoot up 46 percent this morning after it announced a $1.2 billion development pact with GlaxoSmithKline. Epix gets $35 million up front, half of it to buy three percent of its stock. And Glaxo gets access to Epix' work with a family of proteins called G-protein coupled receptors. The deal covers development of new therapies for Alzheimer's and other diseases. Epix, which earned $1.3 million in the third quarter, stands to gain $1.2 billion in milestone payments. Those milestones reflect the potential upside of a successful new therapy for Alzheimer's.

The deal marks a big endorsement for Epix and another indication that Glaxo intends using licensing and acquisitions to convince analysts that it has control of some future blockbusters. Glaxo announced just last week that it is buying Domantis and analysts say that more deals are likely in the near future.

- see the press release on the deal
- read the AFX report

Related Articles:
Epix anxiety drug fails in late-stage trial. Report
Epix to buy Predix in $90M merger. Report
Glaxo to buy Domantis for $453M. Report

Applied NeuroSolutions inks drug pact with Lilly

Mon, 27 Nov 2006 19:01:34 -0500

Applied NeuroSolutions has inked a development deal with Eli Lilly for new drugs to treat Alzheimer's. Applied NeuroSolutions gains $2 million up front along with research funds. And it stands to earn between $10 million and $20 million for each new therapy that is developed. Applied NeuroSolutions has been investigating the proteins that gather on neurons in Alzheimer's cases.

- see this release on the development deal

Related Article:
Applied NeuroSolutions appoints Ellen R. Hoffing as president and CEO. Report

DeCode IDs tablet problem, suspends pivotal trial

Thu, 05 Oct 2006 20:01:38 -0400

Iceland's deCode Genetics has suspended a late-stage trial of the heart attack prevention drug veliflapon after determining that the tablets being used weren't dissolving properly. Researchers were concerned that the faulty tablets would have skewed the data on the drug. The developer announced that it had notified the FDA and was looking at alternative manufacturing sources to resolve the issue. Veliflapon is directed at two genes which contain proteins linked to an elevated risk of heart attack. Another compound with a similar target is in early trials.

- read the report on deCode from Hemscott

Allerca tweaks gland to create allergy-free cat

Thu, 05 Oct 2006 20:01:37 -0400

The San Diego-based biotech Allerca is preparing to roll out a new product specifically designed for animal lovers: A hypoallergenic cat. Their cats were bred to eliminate a gland that produces proteins that trigger allergies and will sell for $4,000. Think that's too expensive? Customers have been on a two-year waiting list with new buyers expected to have to stand in line for 12 to 15 months.

- read The New York Times article

Amgen pockets Avidia in $380M acquisition

Thu, 28 Sep 2006 20:01:38 -0400

Biotech giant Amgen is buying Avidia for $290 million in cash and up to $90 million more in milestone payments. The deal nets Amgen a Phase I product--an inhibitor of interleukin 6 for inflammation and autoimmune diseases--and Avidia's technology in Avimer proteins. As Avidia explains it, its researchers focus on biotherapeutics consisting of single protein chains composed of modular binding domains, like beads on a string. This platform can be used to create multiple, protein-based therapeutics. Each bead is designed to bind to a particular target site, thus increasing the relative amount of the drug where it's most needed and decreasing the amount of the drug where it's not desired, creating more favorable safety profiles

"The Avimer technology is among the most attractive protein-based technologies currently under development," said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president for research and development. "Avimers may have several advantages as therapeutic products in terms of biological activity, tissue distribution, reduced immunogenicity and improved manufacturing efficiencies."

- see the release on the deal

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

Sirna posts positive data on RNAi therapy

Thu, 10 Aug 2006 20:01:37 -0400

Sirna Therapeutics posted positive data from an early stage trial of its experimental therapy for macular degeneration. Sirna-027 demonstrated its ability to ward off loss of vision in 24 of 26 patients with wet, age-related macular degeneration. Sirna has been focused on developing a therapy using RNAi technology, which stops cells from making proteins that--in this case--damage the eye. In this case the therapy is intended to prevent the development of blood vessels in the retina. Sirna inked a $250 million licensing deal on its RNAi work with Allergan last year. "This is the first demonstration of biological activity of a chemically optimized siRNA in humans," said Sirna CMO Roberto Guerciolini.

- read the San Francisco Chronicle article on Sirna and RNAi

Novartis pushes Gleevec for rare cancers

Sun, 09 Apr 2006 20:01:36 -0400

Novartis has asked the FDA and EMEA to approve Gleevec for four rare forms of cancer. These include Dermatofibrosarcoma protuberans, or DFSP, a type of tumor that begins as a hard lump in the skin, and three kinds of blood cancer. Due to the rarity of these diseases the company was unable to carry out the large-scale Phase III trials that are usually a prerequisite for requesting additional indications for a drug. Gleevec has already been approved for myeloid leukemia and a type of stomach cancer.

The diversity of these indications suggests future treatments might focus more on the underlying genetic mutations that cause cancer rather than on the part of the body the cancer affects. "One day, cancer may no longer be classified by site, or even by single genes or proteins, but instead by the way in which the cancer is expressed. This could potentially give rise to more targeted treatment options such as Gleevec."

- read this article from The Wall Street Journal for more (sub. req.)

PerkinElmer buys Agilix' proteomics technology

Thu, 09 Mar 2006 19:01:35 -0500

PerkinElmer has acquired the proteomics technology developed by Agilix Corporation. Agilix has developed labeling technology using isobaric mass tags that allows for the simultaneous quantification of molecules, such as proteins, from multiple samples.

"The Agilix multiplex protein labeling technology represents a breakthrough in quantitative proteomics. This leading-edge technology reduces the process workflow in proteomics analysis, and enables more accurate studies in protein expression kinetics and pharmacodynamics," said Neil Cook, chief scientific officer, PerkinElmer Life and Analytical Sciences.

- here's the release

SPOTLIGHT: Lexicon gains $20M in milestones

Mon, 19 Dec 2005 19:01:33 -0500

Lexicon Genetics has received two milestone payments totaling $20 million from Genentech for their collaboration on drug development. The payments cover their work in proteins and antibodies. Report