| |
LOCTERON: New Interferon: Once Every Two weeks
|
| |
| |
OctoPlus has entered into a partnership with Biolex, Inc., a protein therapeutics company, to develop a controlled release formulation of recombinant human alfa interferon. The product, named LocteronT, combines OctoPlus' proprietary biodegradable PolyActiveT drug delivery technology with Biolex' BLX-883, a recombinant alfa interferon produced in its proprietary LEX SystemT. LocteronT is designed to be more convenient for patients than the current pegylated alfa interferon products on the market as it is expected to be administered every two weeks. Alfa interferon is a protein used to treat infectious diseases, such as Hepatitis C and B, and certain cancers. World-wide sales for alfa interferon in 2004 exceeded USD 3 billion.
In preclinical studies, Biolex has shown that BLX-883 is comparable to commercially available alfa interferon and that it can be produced cost-effectively using Biolex' proprietary LEXT System in the company's cGMP manufacturing facilities. Biolex recently announced the filing of an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration and the European equivalent, a Clinical Trial Application (CTA), for the initiation of clinical trials of BLX-883, an immediate release formulation of LocteronT.
OctoPlus has shown in preclinical studies that, when formulated with PolyActiveT, sustained alfa interferon levels in plasma can be achieved, for a period up to two weeks and longer, with a single injection. In contrast, all pegylated alfa interferon products currently on the market require weekly injections. OctoPlus has also demonstrated in these preclinical studies that alfa interferon, when formulated with PolyActiveT, is gradually released after injection, thus avoiding both high peak and low trough plasma levels. This key feature may result in an improved clinical profile for the drug candidate with possibly fewer side-effects.
http://www.octoplus.nl/default.asp?id=00075
Locteron, New Interferon: Once Every Two weeks
"Biolex's Series B Brings In $36M For Product Pipeline, Production"
By Jennifer Boggs
Bioworld Today
Sept 1, 2005
In its largest financing to date, Biolex Therapeutics Inc. raised $36 million to advance its lead product candidates and also support ongoing collaborations involving its plant-based protein production technology.
The oversubscribed Series B round was led by Polaris Venture Partners, of Boston. Biolex, which has brought in about $70 million to date, conducted its last financing in August 2003, raising $24.4 million.
Proceeds will be used mainly to advance the company's internal pipeline, starting with its lead product, Locteron, a controlled-release formulation of alfa interferon designed to treat hepatitis C. Locteron is expected to begin Phase I studies next quarter.
The formulation aims at offering "benefits to patients with regards to compliance and dosing," said Jan Turek, president and CEO of Pittsboro, N.C.-based Biolex. "Locteron is given once every two weeks, as opposed to the once-a-week pegylated formulation, and has fewer side effects."
Biolex is developing Locteron with OctoPlus Technologies NV, of Leiden, the Netherlands, in an agreement that calls for OctoPlus to combine its PolyActive technology to Biolex's recombinant human alfa interferon.
Following Locteron is Biolex's direct-acting fibrinolytic agent, BLX-155, which Turek described as "a super-clot-buster," to treat peripheral arterial occlusive disease. That product is set to enter preclinical development by the end of the year and move into the clinic in 2006.
"I believe these funds will drive the growth and valuation of the company," Turek told BioWorld Today. "By 2007, we should have one drug entering Phase III, at least one drug entering Phase II, and, hopefully, a few of our partnered programs will be ready to go into Phase I trials."
Biolex has several ongoing collaborations involving its LEX system, a technology portfolio designed to simplify the production of hard-to-make complex proteins and monoclonal antibodies. The largest of those deals involves Malvern, Pa.-based Centocor Inc., a unit of Johnson & Johnson, which paid Biolex an undisclosed up-front fee and pledged three years of funding in exchange for 10 proteins advanced using the LEX system. Under the agreement signed in March, Biolex stands to receive milestone payments for each protein developed, as well as supply fees and royalties from any product sales. (See BioWorld Today, March 22, 2005.)
Biolex's other collaborators include Debiopharm SA, of Lausanne, Switzerland, and Medarex Inc., of Princeton, N.J.
The LEX system uses the natural characteristics of the tiny, aquatic plant Lemna - also known as duckweed - combined with genetic engineering to develop proteins that previously have proved to be too difficult or expensive to make, Turek said.
The LEX system offers three main advantages, he added. The first is speed.
"We can go from a gene to an [investigational new drug application] in 18 months, faster than any other transgenic system," Turek said.
The second advantage, Turek said, is rapid development by using a simple and cost-effective process that can return high expression levels. And lastly, he said, "we believe our approach will be regulatory friendly for GMP manufacturing."
Biolex has about 15,000 square feet of manufacturing capability in Pittsboro, which includes bioprocessing units and areas for recovery and purification work. Funds from the recent financing and other sources also will go toward expanding the facility for the large-scale manufacturing capacity needed for Phase III testing and commercial-scale production.
"In the last eight months we have doubled the number of employees to just over 90," Turek said, "as part of our desire to advance the manufacturing capability."
During the past year and a half, Biolex has focused on consolidating intellectual property relating to plant-based antibody production. In April 2004, it acquired San Diego-based Epicyte Pharmaceutical Inc. to gain control of property to manufacture antibodies in plants, and then brought in IP associated with plant-made pharmaceuticals through the purchase of Lyon, France-based LemnaGene SA in July of that year. (See BioWorld Today, May 6, 2004.)
Along with Polaris, investors in the Series B round included Intersouth Partners, of Durham, N.C.; Quaker BioVentures, of Philadelphia; Johnson & Johnson Development Corp., of New Brunswick, N.J.; Mitsui and Co. Venture Partners, of New York; and Kitty Hawk Capital, of Charlotte, N.C.
Terry McGuire, a managing general partner at Polaris, will join the company's board in conjunction with the financing.
|
|
| |
| |
|
|
|
