Biolex Therapeutics Sells LEX System to Synthon and Initiates Sale of Locteron(R)

PITTSBORO, NC--(Marketwire - May 07, 2012) - Biolex Therapeutics, Inc. announced that it has sold its LEX System, a proprietary platform for the development and production of biologics, to Synthon, a Netherlands-based specialty pharmaceutical company. Also included in the sale were two preclinical product candidates uniquely enabled by the LEX System: BLX-301, a humanized and glyco-optimized anti-CD20 antibody for the treatment of non-Hodgkin’s B-cell lymphoma and other B-cell malignancies; and BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients. Financial terms of the sale will not be disclosed.

Locteron Sale
Biolex also announces that it has initiated the sale of its remaining Phase-3 ready asset, Locteron® controlled-release interferon for the treatment of HCV and HBV.

Locteron, controlled-release interferon alpha 2b, is designed to offer key advantages compared to currently approved interferon products. In Phase 2b clinical trials in hepatitis C (HCV) Locteron demonstrated statistically significant reductions in flu-like symptoms, reduced rates of depression, and cutting in half the number of injections required compared to pegylated interferon. It is estimated that current worldwide sales of interferon are approximately $2.5 billion. Flu-like symptoms and depression are the two most important side effects of interferon and limit treatment adherence.

Locteron incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks. This is considerably more convenient than the currently approved interferon products, Pegasys® and PEG-Intron®, each of which are immediate release and require dosing every week. More importantly, Locteron’s controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons. This controlled-release mechanism is designed to reduce the frequency and severity of flu-like symptoms and depression commonly experienced by patients treated with pegylated interferons.

“We believe that even if all-oral interferon-free regimens are eventually approved, a Locteron-containing regimen will achieve at least equal efficacy (SVR rate), but likely with a shorter duration of treatment that is well tolerated by patients. A regimen with Locteron will be much more cost-effective, and in a payer driven world, that means it will be preferentially reimbursed,” said Jan Turek, President and Chief Executive Officer of Biolex. “Many countries may require the use of a more cost-effective interferon-containing regimen as first-line therapy before reimbursing a more expensive interferon-free combination. There are already signs of this dynamic as several cost-effectiveness studies have recently been published that claim that using direct-acting anti-viral agents is not cost-effective for patients with a specific host genotype who are very interferon responsive. Beyond HCV, HBV is a smaller, albeit solid and growing opportunity for Locteron, as an interferon-based treatment in HBV can effectively provide a ‘cure’ by sero-conversion of the patient, a preferred outcome as opposed to the current chronic, life-long therapy keep HBV suppressed.”

Locteron has strong patent protection through 2028, and has worldwide freedom to operate (FTO). Biolex intends to sell the worldwide development and commercialization rights to Locteron.

Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

About Biolex Therapeutics
Biolex is a privately held biopharmaceutical company that developed the patented LEX System to manufacture follow-on biologics, hard-to-make therapeutic proteins and optimized monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company’s product candidates were designed to provide best-in-class efficacy/tolerability profiles while incorporating proven mechanisms of action. Biolex’s lead product candidate, Locteron, has completed five clinical trials, including two Phase 2b clinical trials for the treatment of chronic hepatitis C.