Replies to post #41247 on Biotech Values

[DewDiligence]

OctoPlus Reports 2006 Results

[Just listened to the company’s first-ever CC. Does anyone here follow this company? For more info on the phase-2 Locteron trial, please see #msg-16610930. Also see http://hugin.info/137076/R/1105270/198674.pdf for the financial tables.]

http://ir.octoplus.nl/index.cfm/site/Octoplus/pageid/0DE12867-E1C0-4365-CB4F58BD81D4200C/index.cfm

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15 Feb 2007, Leiden, the Netherlands

OctoPlus N.V. (“OctoPlus” or “the Company”) (Euronext: OCTO), the drug delivery and development company, announces today its annual results for the year ended 31 December 2006.

Highlights 2006

- 2 development-stage products progressed to Phase II clinical studies: Locteron, for the treatment of chronic hepatitis C, and OP-145 for the treatment of chronic middle ear infection

- Contract Development revenues increased 25%

- IPO on Euronext Amsterdam generated € 20 million (gross) in new capital

In the period, OctoPlus’ two lead development compounds were progressed into Phase II clinical studies. OP-145 Phase II patient recruitment was initiated in the second quarter, while approval to start Phase IIa for Locteron was gained in November and patient dosing commenced in January 2007. Both products have reported positive Phase I results in 2006. For OP-145, a commercial license agreement was signed with Green Cross, for the commercialisation of the product in the Republic of Korea.

OctoPlus’ Contract Development total gross revenues from formulation development and clinical trial material manufacturing increased by 25% to € 8,504k. This is the second consecutive year that OctoPlus’ Contract Development activities have grown more than 20%. 80% of external service revenues came from repeat-orders and long-term contracts, showing the loyalty in OctoPlus’ customer base. In order to better service the North-American market, a business development office was opened in the Boston area.

“This has been an excellent year for OctoPlus with significant progress across all of our key areas,” says Joost Holthuis, CEO. “Two mid-stage clinical trials have been initiated with our lead products and revenues from our Contract Development business have again shown strong growth. Our successful lPO demonstrated the strength of our business model. We are looking forward to building further value in 2007.”

Financials 2006

The table below outlines the key financial figures of the Company for the six-month period ended 31 December 2006 and 2005 and the full year 2006 and 2005. These financial figures, unaudited, are in accordance with International Financial Reporting Standards. A distinction has been made in this table between gross revenues, inter-segment revenues and consolidated (net) revenues. Gross revenues include inter-segment revenues for Contract Development supporting our Products & Drug Delivery division in the development of our own product pipeline, mainly for Locteron and OP-145. Contract Development generates most of the Company’s revenues, with additional revenues from license fees and subsidies generated by our Products & Drug Delivery division. Contract Development worked at full capacity in order to facilitate as much as possible requests from third parties as well as demands for our products under development.

Last six months ended 31 December 2006

Over the last six months of 2006, gross revenues showed an increase of 32% to € 4,762k (2005: € 3,613k). In preparation of our two Phase II clinical trials (Locteron and OP-145), the Company’s Products & Drug Delivery division received services (including formulation development and manufacturing of clinical trial material) from Contract Development for an amount of € 1,990k (2005: € 162k), resulting in a decrease of consolidated (net) revenues by 20% to € 2,772k (2005: € 3,451k).

Total operating costs increased by 13% to € 7,295k (2005: € 6,430k), mainly as a result of the growth of the Company.

Net loss for the period increased by 49% to € 4,564k (2005: net loss of € 3,070k).

Full year ended 31 December 2006

For the full year 2006, total gross revenues increased by 22% to € 8,996k (2005: € 7,383k), with inter-segment revenues growing from € 366k in 2005 to € 2,945k in 2006 as a result of Contract Development supporting our Products & Drug Delivery division in the preparation of our two Phase II clinical trials (Locteron and OP-145), which have both started in 2006. As a result, consolidated (net) revenues decreased by 14% to € 6,051k (2005: € 7,017k).

Total operating costs increased by 27% to € 14,571k (2005: € 11,461k) as a result of the growth of the Company from 110 employees per 31 December 2005 to 139 employees per 31 December 2006 as well as an increase in expenditures for our pre-clinical and clinical studies.

Net loss for 2006 was € 8,665k, an increase of 106% compared to the net loss of € 4,209k for the year 2005.

Equity and cash flow

The Company raised € 20 million (gross) through its IPO on 4 October 2006. 4,301,076 new shares were issued at a price of € 4.65 per share. Earlier in the year, new shares were issued for an additional € 750k related to a second tranche of the January 2005 investment agreement and an additional € 104k was received as part of employees exercising options. In total, equity increased with € 17,966k in 2006 as a result of newly issued shares.

The Company started the year 2006 with a cash and cash equivalents balance (net of bank overdrafts) of € 9,230k. A total of € 6,410k was used during the year for OctoPlus’ operating activities and (as described above) € 17,966k was received as a result of new shares issued during the year. € 1,233k was used for the Company’s remaining investing and financing activities in 2006 resulting in a 112% increase of our cash and cash equivalents (including deposits and net of bank overdrafts) from € 9,230k per 31 December 2005 to € 19,553k per 31 December 2006.

Outlook 2007

The Contract Development order book is higher than at the same stage in 2006 and supports our revenue targets for 2007. The Company expects to generate more Contract Development revenues but expenditures will also increase as investments in the product pipeline continue.

Major milestones to be expected in 2007 are the results from the ongoing Locteron Phase IIa trial, expected mid-2007, and the data for the ongoing OP-145 Phase II study, expected late 2007.

Annual report and Annual General Meeting of Shareholders

OctoPlus will publish its Annual Report 2006 on 30 March 2007. The report will also be available on the Company’s website www.octoplus.nl.

The Annual General Meeting of Shareholders will take place at Naturalis in Leiden on 24 April 2007 at 14:00 Central European Time (CET).

Conference call and webcast presentation

On February 15, OctoPlus will hold a conference call at 09:30 CET. This event can also be followed during a live audio webcast via OctoPlus’ website www.octoplus.nl. If you would like to participate in the conference call, please dial in on telephone number [phone].

After the presentation of the results, Joost Holthuis, CEO of OctoPlus and Hans Pauli, CFO, will be available to answer questions. After the event, the webcast will be available for replay on the Company’s website.

About OctoPlus

OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the development of improved pharmaceutical products that are based on its proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics and other drugs.

OctoPlus is also a leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industry, with a focus on difficult to formulate active pharmaceutical ingredients in injectable formulations. The earnings and expertise that OctoPlus derives from rendering formulation and manufacturing services help to support its own drug development programs.

OctoPlus is listed on Euronext Amsterdam under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.
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[DewDiligence]

Biolex Therapeutics Researchers Present Preclinical Data for Direct-Acting Thrombolytic BLX-155 at Scientific Conference

[Biolex is an intriguing private company that manufactures protein drugs using transgenic plants. Their lead compound is Locteron, an interferon alpha for HCV being developed with OctoPlus.]

http://biz.yahoo.com/iw/070301/0221491.html

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Thursday March 1, 9:00 am ET

First Protein Expression System to Produce Commercially Viable Levels of Full-Length Recombinant Plasmin

PITTSBORO, NC--(MARKET WIRE)--Mar 1, 2007 -- Biolex Therapeutics researchers presented data at the 51st Annual Congress of the German Society of Thrombosis and Haemostasis Research in Dresden, Germany demonstrating the successful production of full-length recombinant human plasmin (BLX-155) using the Company's proprietary LEX System(SM), a milestone never achieved at commercially viable levels with any existing protein expression system. Plasmin is the key enzyme in the human body that dissolves the fibrin component of blood clots. The development of a recombinant version of plasmin provides a potential best-in-class product profile for the Company's BLX-155 drug candidate.

Market Need for Recombinant Plasmin (BLX-155)

BLX-155, a full-length recombinant plasmin, is a direct-acting thrombolytic agent designed to dissolve blood clots in patients with acute peripheral arterial disease, deep vein thrombosis, and catheter occlusion, for whom safe and effective therapy remains a substantial unmet medical need. [This is especially true after the dismal failure of NUVO’s Alfimeprase.]

Acute peripheral arterial occlusive disease (aPAO) is a condition caused by a sudden reduction in blood flow to the extremities due to progressive clot accumulation around an atherosclerotic plaque in the diseased artery. More than 100,000 cases of aPAO are reported annually in the United States and the disease is a significant cause of nerve and muscle damage and, in severe cases, amputation or death. Although no drugs are currently approved for the treatment of aPAO, patients are typically treated with a combination of the use of catheters, the delivery of plasminogen activators, such as tPA, to the site of the clot, and surgery. Plasminogen activators have been relatively unsuccessful in dissolution of the long, older and more compacted blood clots associated with aPAO. In addition, treatment of aPAO with plasminogen activators often require intensive care stays of 24 to 36 hours and may result in bleeding complications at sites remote from the clot.

Research suggests that intact, full-length recombinant human plasmin is ideal for the treatment of blood clots, as it combines the potential for superior clot dissolution with substantial safety advantages. The five kringle domains of natural plasmin enable a high affinity and specificity for binding to the fibrin component of blood clots. Researchers believe that plasmin's high affinity to fibrin may result in a therapy that is more effective than other direct thrombolytics in development such as alfimeprase and truncated forms of plasmin, each of which lack the five kringle domains of full-length plasmin. Additionally, as a native protein, plasmin is regulated by a number of inhibitors within the body that exist in high quantities and serve to rapidly inactivate any plasmin that circulates beyond the immediate site of the clot. This safety mechanism may decrease the risk of bleeding complications associated with the therapeutic administration of plasminogen activators and alfimeprase. The combination of plasmin's high affinity to fibrin and the presence of high level of circulating plasmin inhibitors provides protection from bleeding complications and may result in a therapy with a higher therapeutic index than other direct thrombolytics. [That’s the hope, anyway.]

Presentation at Society of Thrombosis and Haemostasis Research

In a presentation entitled "Recombinant Plasmin from Lemna Minor - Purification, Characterization and In Vitro Comparison to Human-Plasma Derived Plasmin," researchers presented data demonstrating that BLX-155, recombinant plasmin produced using the LEX System, is indistinguishable from human plasma-derived plasmin in characterization and activity. These results are significant, due to the fact that the production of full-length recombinant human plasmin at commercially viable levels has only been reported using the LEX System. The limitations of existing production systems have resulted in the production of truncated versions of plasmin that lack the full five kringle domains of native plasmin and therefore lack the natural affinity for fibrin. As a result of these limitations full-length plasmin previously could only be derived from human donor plasma, but this source is limited and carries the potential for transmitting human pathogens. The development of BLX-155 using the LEX System allows exploitation of the natural binding, efficacy and safety advantages of natural plasmin without the limitations or risks associated with truncated plasmin, plasma-derived plasmin, plasminogen activators, or alfimeprase.

"We are excited with the results presented at this conference, which once again confirm the capability of the LEX System to produce hard-to-make proteins and to provide key advantages over existing production systems," said Mr. Jan Turek, Biolex's Chief Executive Officer. "We expect to file an IND to commence a Phase 1 clinical study of BLX-155 at the end of this year. The advancement of this product into clinical trials is in line with our strategy to identify and commercialize proprietary products that rely upon known mechanisms of action to provide a reduced risk profile while targeting large, proven pharmaceutical markets."

About Biolex Therapeutics

Biolex Therapeutics is developing and commercializing therapeutic proteins based on its proprietary LEX System(SM), an expression system that enables the production, development and commercialization of hard-to-make proteins and the optimization of monoclonal antibodies. The Company is developing a proprietary pipeline of products that rely upon known mechanisms of action to provide a reduced risk profile while targeting large, proven pharmaceutical markets. Biolex's lead candidate, Locteron™, is in Phase 2 clinical trials as a best-in-class controlled-release interferon alfa for the treatment of hepatitis C. The Company's second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up clots in certain diseases such as acute peripheral arterial disease, catheter occlusion and deep vein thrombosis. In addition, the unique capabilities of the LEX System have led to collaborations with Centocor, Medarex and other leading pharmaceutical/biotech companies. Biolex is a venture-capital-backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex's web site at www.biolex.com.
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[DewDiligence]

Biolex Reports Phase-2a Results of Locteron in HCV

[Locteron is a controlled-release IFN that is intended to compete with Pegasys and Peg-Intron, the two IFN mainstays of HCV therapy, and with Albuferon, the albumin-modified IFN from HGSI and NVS that is currently in phase-3. Locteron is made using Biolex’s transgenic-plant technology. The data presented here look pretty good for the 320 and 480mcg cohorts; data from the 640mcg cohort will be reported later.]

http://biz.yahoo.com/iw/070726/0282755.html

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Thursday July 26, 1:45 am ET

PITTSBORO, NC--(MARKET WIRE)--Jul 26, 2007 -- Biolex Therapeutics today announced successful initial results from the SELECT-1 Phase 2a clinical trial of Locteron(TM), the first controlled-release interferon alfa being developed for the treatment of chronic hepatitis C. In the 12-week Phase 2a trial, the combination of the highest dose of Locteron evaluated and the antiviral drug ribavirin achieved an early virologic response (EVR) in 100% of the hepatitis C patients treated. Importantly, the study results also indicated that patients receiving Locteron experienced side effects that were less frequent and less severe than those previously reported in clinical trials for the currently marketed pegylated interferons and for albumin-fused interferon (Albuferon(TM)) currently under development. Biolex is co-developing Locteron with its partner OctoPlus N.V.

SELECT-1 (Safety and Efficacy of Locteron: European Clinical Trial-1) was designed to evaluate a range of up to four doses of Locteron administered once every two weeks in combination with ribavirin in a total of 32 treatment-naïve hepatitis C patients with the genotype-1 variant of the virus. The SELECT-1 protocol calls for patients to be treated for 12 weeks with the Locteron/ribavirin combination, and the repeat-dose study will assess viral response, safety and tolerability for each dose cohort. Under the protocol, dosing was commenced in January 2007 for the first three eight-patient cohorts of the study, the 160, 320 and 480 microgram (µg) doses, and dosing of the 640 µg cohort was to be triggered based on an assessment of safety and tolerability for the first three dose cohorts. As a result of a favorable safety and tolerability review for the first three dose cohorts, dosing of patients in the 640 µg cohort commenced in May 2007 and results are expected to be available in the fourth quarter of 2007.

"We are very pleased with the results from SELECT-1 as they support our original hypothesis for Locteron, that a controlled-release interferon alfa has the potential to provide a high level of efficacy while resulting in an improvement in side effects and patient tolerability," said Mr. Jan Turek, Biolex President and Chief Executive Officer. "Even in advance of completion of the highest-dose cohort in the study, SELECT-1 has highlighted two doses that appear to provide a combination of efficacy and improved tolerability. We believe that the need for improved patient tolerability will become even greater with the emergence of new antiviral products. These emerging antiviral products are associated with additional side effects, further adding to the potential for Locteron to be the interferon of choice for future combination therapy as a result of its potential for improved patient tolerability."

SELECT-1 Antiviral Results

The study has been completed for the 160, 320 and 480 µg dose cohorts of the study. The 12-week antiviral results for the two Locteron doses that were most effective, the 320 and 480 µg doses, compare favorably with results previously reported in clinical trials for the currently marketed pegylated interferon alfa products and for Albuferon. At the conclusion of the study, 12 weeks of treatment, the results for the 160, 320 and 480 µg dose cohorts were as follows:

-- A dose response was observed in the study, with patients treated with the 320 and 480 µg doses of Locteron demonstrating a greater reduction in hepatitis C virus than the patients treated with the 160 µg dose at all measurement times. Average viral reduction after 12 weeks of treatment for the 320 and 480 µg doses was 4.5 and 4.2 logs, respectively, compared to 1.8 logs in the lowest dose of 160 µg.

-- After 12 weeks of treatment, plasma hepatitis C RNA was reduced to undetectable levels ( < 28 IU/ml) in 63% (5/8) and 63% (5/8) of the patients in the 320 and 480 µg dose cohorts, respectively, compared to 13% (1/8) of the patients in the lowest-dose group of 160 µg.

-- The percentage of patients who achieved early virologic response (EVR), defined as at least a two-log reduction in hepatitis C virus after 12 weeks of treatment, was 88% (7/8) and 100% (8/8) in the 320 and 480 µg dose cohorts, respectively, compared to 38% (3/8) of the patients in the lowest-dose group of 160 µg. Achievement of EVR has been broadly established to be a pre-requisite for long-term response.

SELECT-1 Safety and Tolerability Results

The following Locteron side effect and patient tolerability results were observed during the 12 weeks of treatment for the 160, 320 and 480 µg dose cohorts:

-- Locteron was safe and well tolerated.
-- There were no serious adverse events.
-- The vast majority (over 90%) of the adverse events that were experienced were rated as mild.
-- Dose reductions were limited to one patient each in the 320 and 480 µg dose cohorts with none in the 160 µg dose cohort.
-- No patients discontinued treatment.

The majority of the side effects experienced by patients treated with Locteron in the SELECT-1 study in the 160, 320 and 480 µg dose cohorts appear to be less frequent and less severe than the side effects reported in previous clinical trials for pegylated interferons and Albuferon. For example, only one patient in the SELECT-1 study receiving Locteron experienced an adverse event rated as severe, indicating an improvement over previously reported results in clinical trials for Pegasys® and Albuferon as illustrated in Figure 1.

Although many of the side effects experienced by patients in the SELECT-1 trial and clinical trials for other interferon products are subjective in nature, the occurrence of fever is an objective point of comparison and is a marker for the family of adverse events characterized as flu-like symptoms and. Fever, characterized by a temperature reading of at least 38 degreesC, occurred in only one (4%) of the Locteron patients in SELECT-1, notably lower than other interferon products.

Furthermore, the rates of other side effects previously reported in clinical trials for pegylated interferons and Albuferon, such as chills, diarrhea, dizziness, headache, irritability, and nausea, also appeared to be lower in patients treated with Locteron in SELECT-1. All other side effects experienced by patients treated with Locteron in SECLECT-1 were predominantly mild and appeared as a group to be comparable with other interferon products.

Locteron Overview

Locteron combines BLX-883, a recombinant interferon alfa produced by Biolex in its patented LEX System(SM), with PolyActive(TM), an advanced controlled-release drug delivery technology developed by OctoPlus. Locteron is the first controlled-release interferon alfa under clinical development for the treatment of hepatitis C and is designed to improve patient care through a more favorable side-effect profile and more convenient patient dosing. Locteron is configured to allow dosing once every two weeks, an improvement in patient convenience compared to currently marketed pegylated interferon alfa products that require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alfa to patients over the duration of two weeks. This controlled-release mechanism is designed to cover inter-dose troughs while reducing the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with currently marketed pegylated interferons and with Albuferon.

Biolex and OctoPlus plan to commence SELECT-2, a Phase 2b trial of Locteron in 2008 after assessment of the final results from the SELECT-1 Phase 2a trial, expected to occur in the fourth quarter of 2007. The 12-week results of the Phase 2b trial will be used as the basis for dose selection for the commencement of the Phase 3 development program.

About Biolex Therapeutics

Biolex Therapeutics is developing and commercializing therapeutic proteins based on its proprietary LEX System(SM), an expression system that enables the commercially viable production of hard-to-make proteins and the optimization of monoclonal antibodies. The Company is developing a proprietary pipeline of biologic product candidates that have known mechanisms of action and have the potential to provide a reduced risk profile while targeting large, proven pharmaceutical markets. Biolex's lead candidate, Locteron(TM), under joint development with OctoPlus N.V., is in Phase 2 clinical development as a controlled-release interferon alfa for the treatment of hepatitis C. The Company's second product candidate, BLX-155, is a direct-acting thrombolytic, designed to break up blood clots in patients with diseases or conditions such as acute peripheral arterial disease, deep vein thrombosis and hemodialysis graft thrombosis. In addition, the potential capabilities of the LEX System has led to collaborations with Centocor, Medarex, Genmab and other leading pharmaceutical and biotech companies. Biolex is a venture capital-backed company located in the Research Triangle region of North Carolina, United States. For additional information, please visit Biolex's web site at www.biolex.com.
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