“Pro-Pharmaceuticals continues to make progress toward its goal to commercialize DAVANAT,” said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. “We plan to initiate a Phase III clinical trial for late stage colorectal cancer patients as soon as we raise sufficient funds. In addition, the Company is actively engaged in discussions with potential partners to distribute DAVANAT internationally.”

For the fourth quarter of 2009, the Company reported a net loss applicable to common stock of $1.3 million, or ($0.03) per share, basic and diluted, compared with a net loss of $0.9 million or ($0.02) per share for the same period in 2008. For the full year 2009, the Company reported a net loss applicable to common stock of $9.4 million, or ($0.20) per share, basic and diluted, with non-cash expenses of approximately $5.1 million, compared with a net loss of $3.4 million, or $(0.07) per share in 2008. The full year 2009 results included $1.4 million of non-cash expense related to the change in the fair value of warrants compared with $2.1 million of non-cash income in 2008. The full year 2009 results include a $2.0 million non-cash expense related to dividends and accretion on the preferred stock compared with $0.2 million in 2008.

Research and development expense for the fourth quarter of 2009 was $0.2 million, compared with $0.3 million for the same period in 2008. The decrease was due primarily to overall lower activity in clinical and pre-clinical programs as a result of cost containment measures. Research and development expense for the full year 2009, was $1.1 million, compared with $1.8 million in 2008. The decrease was due primarily to overall lower activity as a result of cost containment measures and decreased salaries and stock-based compensation. Also, during the full year 2008, the Company incurred costs related to the filing of the DAVANAT Drug Master File with the FDA which were not incurred during 2009.

General and administrative expense for the fourth quarter of 2009 was $0.9 million, compared with $0.8 million for the same period in 2008. General and administrative expense for the full year 2009 was $5.0 million as compared to $3.6 million for 2008. The increase is due primarily to increased business development efforts, increased stock-based compensation, and the recognition of severance obligations related to the departure of our former Chief Executive Officer.

About DAVANAT

DAVANAT, the Company’s lead product candidate, is a polysaccharide polymer that targets Galectin receptors on cancer cells. Peer-reviewed studies have demonstrated that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis, tumor metastasis and give the tumor the ability to evade the immune system. To date, DAVANAT has been administered to approximately 100 cancer patients. Data from a Phase II trial for end-stage colorectal cancer patients showed that DAVANAT in combination with 5-FU extended median survival to 6.7 months compared to 4.6 months for best standard of care as determined by the patients’ physicians. Clinical trial results also showed that patients experienced fewer serious adverse side effects of the chemotherapy and required less hospitalization, resulting in an improved quality of life.

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Cash Position

Cash at January 3, 2010 totaled $3.8 million, a $7.8 million decrease compared to $11.6 million at December 28, 2008. Last month, GTC obtained an aggregate of $7 million of new funding from LFB Biotechnologies (LFB) in the form of a 4%, 36-month term loan with a single payment of principal and interest at maturity. With this new funding from LFB and anticipated receipts from existing partnering agreements, GTC projects that its cash resources will be sufficient to support its operations to the end of the second quarter of 2010, exclusive of future cash proceeds from potential new partnering agreements.

Significant product development events for 2009 and outlook for 2010

Factor VIIa

GTC, together with its collaboration partner LFB, has established the transgenic rabbit production system for its rhFVIIa program and initiated the production of clinical lots to support the IND filing and subsequent clinical program. Following discussions with the FDA, GTC plans to file an IND in April, with the objective of initiating a Phase I study in the 2nd quarter of 2010. This is planned to be a safety, pharmacokinetic and pharmacodynamic study in comparison with NovoSeven, in normal healthy volunteers. On the basis of current plans, GTC expects to have results from this study in the fourth quarter of 2010.

Alpha-Fetoprotein (AFP)

GTC in-licensed the AFP program in the middle of 2009. GTC has established a herd of transgenic goats that produce this product in significant quantities. Animal model tests are currently being conducted that are considered to be predictive for efficacy in autoimmune diseases such as myasthenia gravis and multiple sclerosis. GTC’s plan is to initiate a Phase II study in myasthenia gravis in the second half of 2010 once a partnering arrangement has been obtained.

ATryn

Following approval of ATryn by the FDA, Lundbeck, Inc. (Lundbeck), formerly Ovation Pharmaceuticals, Inc., launched ATryn in the USA in May 2009. Lundbeck continues its commercialization of ATryn in the hereditary deficiency indication. In addition, GTC is collaborating with Lundbeck to develop a protocol for a pivotal study of patients with acquired antithrombin deficiency who are undergoing cardiac surgery. GTC aims to initiate a clinical trial in this indication in the second half of 2010.

In Europe, GTC is seeking to establish an alternative partnering arrangement for the commercialization and further development of ATryn following the termination of GTC’s contract with LEO Pharma (LEO). At this time there is no final decision in the LEO arbitration proceedings which GTC initiated with the International Chamber of Commerce.

Monoclonal Antibodies and Follow-on Biologics

GTC, together with its collaboration partner LFB, has established transgenic goat production systems for the production of TG20, a monoclonal antibody that targets CD20. TG20, which is not identical to Rituximab (Rituxan), has demonstrated in in-vitro studies that it has an approximately 10-fold greater antibody dependent cell-mediated cytotoxicity (ADCC) than Rituximab. This may translate into improved efficacy or reduced dosage in hematologic malignancies. GTC is seeking a partner to support its share of the commercialization and clinical development of TG20.

GTC has established production animals which express Trastuzumab (Herceptin) in their milk, and this protein is currently being characterized. GTC is also developing transgenic animals for the production of Adalimumab (Humira), and, together with our collaboration partner AgResearch in New Zealand, transgenic animals for the production of Cetuximab (Erbitux). For each of these products we will be seeking partners to support further clinical development and commercialization.

This portfolio of product candidates addresses markets with total annual sales currently in excess of $16 billion. For our product candidates addressing oncology indications, the natural glycosylation of the transgenic production system may provide advantages in ADCC. GTC plans to characterize each of these proteins as they become available and to initiate non-clinical studies in support of future partnering activities.

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Corporate Highlights:

– On January 15, 2009 Javelin entered into an exclusive European marketing partnership for Dyloject with Therabel N.V., worth up to $71.0 million, including $7 million upfront, future milestone payments and royalties on sales.

– On June 15, 2009 Javelin announced that a study showed Dyloject was well tolerated in patients with impaired renal and hepatic function.

– On June 23, 2009 Javelin announced that it had completed a large open label safety study of Dyloject.

– On December 2, 2009, Javelin submitted its NDA for Dyloject and was successfully accepted for filing with the US FDA on February 2, 2010. Dyloject has received a PDUFA date of October 3, 2010.

– On December 18, 2009, Javelin entered into a definitive merger agreement with Myriad Pharmaceuticals, Inc. (Nasdaq: MYRX). Additional information relating to the transaction can be found by accessing the registration statement on Form S-4 (File No. 333-164890) filed by Myriad Pharmaceuticals, Inc. with the SEC.

Financial Highlights for the Year Ended December 31, 2009:

– Ended the year with $0.77 million in cash, and cash equivalents.

– Total revenues for the year ended December 31, 2009 were $3.8 million compared to $1.1 million for the same period a year ago. For the three months ended December 31, 2009 total revenues were $.3 million compared to $.5 million in 2008.

– Partner revenue was $3.6 million in 2009 as a result of our January 2009, EU marketing partnership with Therabel. There were no partner revenues in 2008. Partner revenue was $.3 million in the quarter 2009. There were no partner revenues in the fourth quarter of 2008.

– Product revenues for the year ended December 31, 2009 were $.188 million and $1.1 million for the same period in 2008. For the three months ended December 31, 2009 there were no product revenues compared to $.5 million for the same period in 2008.

– Net loss decreased to approximately $37.6 million, or $0.62 per share, for the 12 months ended December 31, 2009, from $43.5 million, or $0.77 per share, for the same period in 2008. Net loss decreased to approximately $8.1 million, or $0.13 per share, in the fourth quarter of 2009, from $13.8 million, or $0.23 per share, in the fourth quarter of 2008.

– Javelin incurred approximately $41 million in total operating expenses for the full year ending December 31, 2009 compared to $45 million in the prior year. For the three months ended December 31, 2009 operating expenses were $8.4 million compared to $14 million for the same period in 2008.

– Cost of product revenues for the year ended December 31, 2009 was approximately $3.0 million compared to $.85 million for the same period in 2008. For the three months ended December 31, 2009 cost of product revenues were $.08 million compared to $.4 million for the same period a year ago.

– Research and development expenses decreased to $24.5 million for the year ended December 31, 2009 from $26.8 million for the same period in 2008. For the three months ended December 31, 2009, research and development expenses were $3.2 as compared to $9.8 million for the same period a year ago.

– Reported non-cash stock based compensation expense for the year ended December 31, 2009 was approximately $5.4 million, or $0.09 per share impact on operations, compared to $3.3 million, or $0.06 per share impact on operations for 2008.

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In Therapeutics:

* For its internal programs, the strategy of the Company is to bring drug candidates through proof-of-concept studies, and then partner the programs to accelerate product development. The milestone payments received will allow ExonHit to finance the development of other drug candidates and advance its diagnostics programs.
* ExonHit is looking for additional research collaborations to further leverage its discovery capabilities and expand its sources of financing and revenues.
* Starting in 2010, the company will focus its internal therapeutic activities on cancer projects to take advantage of shorter development timelines and earlier partnering opportunities than for neurodegenerative diseases. Work in neurodegeneration will continue with partners as demonstrated by the February 23, 2010 announcement that proprietary ExonHit lead compounds from an internal neuro-related program were being included into the Allergan collaboration.

In Diagnostics:

* ExonHit intends to become recognized as a player in molecular diagnostics which is a particularly attractive market with more rapid development timelines than for therapeutics.
* To strengthen its commercial portfolio, generate revenues rapidly and hence, reach break-even faster, the Company announced it is planning to acquire a revenue-generating US-based diagnostics company specializing in molecular diagnostics with a focus in oncology and/or neurodegeneration.

2010 will be a year of change for ExonHit. Assuming completion of the planned diagnostic acquisition in the US in the second half of 2010, the new global entity will have a commercial product portfolio and an increased presence in the United States.

2009 consolidated financial results

* Income Statement

Consolidated revenues amounted to € 4.9 million, an increase of 16% compared to the € 4.2 million achieved in 2008. These increased revenues mainly relate to the collaboration with Allergan under which more activities were performed in 2009, combined with a stronger dollar against the euro, all payments from Allergan being made in US dollars.

Research and Development expenses decreased by 9% to € 9.0 million in 2009 compared to € 9.9 million in 2008. The reduction is linked to a € 0.8 million loan that was forgiven by OSEO, a French government organization dedicated to financing innovative R&D projects. Excluding this loan, R&D expenses remained stable compared to 2008.

Marketing and Sales expenses amounted to € 1.2 million, an increase of 8% as compared to € 1.1 million in 2008, mainly driven by expenses for market studies.

General and Administrative costs decreased by 6% to € 4.3 million in 2009, compared to € 4.6 million for the same period in 2008. This decrease is linked to lower salary expenses subsequent to the CFO leaving the company, partially offset by an increase in legal fees.

As a result, the group’s operating expenses decreased by 7% to € 14.6 million in 2009 compared to € 15.6 million in 2008. In 2009, 62% of these expenses were allocated to R&D compared to 63% for the same period in 2008.

Consequently, the company posted an operating loss of € 9.7 million for 2009, a decrease of 15% compared to € 11.4 million for 2008.

Financing income decreased to € 0.34 million in 2009 from € 0.38 million in 2008. While financing costs decreased by 47%, following the conversion of convertible bonds and the ensuing reduction in interest payments, revenues also decreased by 22% due to lower cash reserves and lower interest rates in 2009 compared to 2008.

The estimated research tax credit amounted to € 1.6 million in 2009, compared to € 2.1 million in 2008. This decrease is essentially due to the deduction of the forgiven OSEO loan.

As a consequence, ExonHit recorded a consolidated net loss of € 7.7 million in 2009, compared to € 8.9 million in 2008.

* Balance sheet

On December 31, 2009, the cash position of the Company amounted to € 30.2 million, compared to € 21.1 million at the end of 2008. ExonHit cash is only invested in high quality funds which liquidity is reasonably guaranteed.

Three financings took place in 2009, namely the conversion of more than half of outstanding convertible bonds, the partial exercise of 08/09 warrants, and the December 2009 capital increase; in addition free shares were granted in 2009 and stock-options were exercised during the second half of 2009. As a result, total shareholder’s equity increased to € 25.5 million on December 31, 2009 against € 9.7 million on December 31, 2008.

Product Update

* Therapeutics

Following the review of its internal therapeutic portfolio, ExonHit decided to focus on oncology and to only pursue additional neuro-related programs with partners. As a result, further development of the EHT 207 program in epilepsy and the EHT 206 program in Alzheimer’s disease are being discontinued; however development of the EHT 206 sister program EHT 101 in cancer is maintained. ExonHit will refocus resources towards the new EHT 107 program, whose current lead has demonstrated broad low to sub-nanomolar activity across a panel of more than 70 cancer cell lines and is entering in vivo preclinical testing.

EHT 0202, ExonHit’s lead candidate in Alzheimer’s disease and potentially first in a new class of disease modifying therapies, which stimulate the α-secretase pathway, has successfully completed Phase 2a testing. The clinical results communicated in September 2009 showed that EHT 0202 is safe and generally well tolerated in patients and that it could potentially enhance cognition in patients suffering from Alzheimer’s disease. Discussions are ongoing to find a partner in 2H 2010.

EHT/AGN 0001, the lead compound from the most advanced program in the Allergan collaboration, as well as EHT/AGN 0002 and its associated back-up compounds were out licensed by Allergan to Bristol-Myers Squibb in March 2010. ExonHit continues its collaboration with Allergan dedicated to the identification, development and commercialization of drugs for the treatment of ophthalmology, pain and neurodegenerative diseases.

* Diagnostics

AclarusDx Alzheimer’s test is a blood-based biomarker identifying patients suffering from Alzheimer’s disease (AD). This test is designed to discriminate AD patients from healthy individuals and is intended to be used in association with standard methods of assessment.

As first market entry, it was launched in December 2009 as a “research use only” product, to improve patient selection for clinical trials, thus targeting pharmaceutical companies and leading academic centers performing clinical research.

ExonHit is anticipating a CE marking in Q4 2010, and is preparing the launch of AclarusDx in the clinical in vitro diagnostic (IVD) market with laboratory partners for a European launch in Q1 2011. Regarding US marketing approval, discussions have been initiated with the FDA to define the exact regulatory pathway to meet IVD requirements.

EHT Dx14, a novel breast cancer diagnostic biomarker developed using ExonHit’s SpliceArray platform, was licensed from Institut Gustave Roussy in May 2009. This test is intended to facilitate the reading of samples obtained by fine-needle aspiration (FNA) after a suspicious mass is discovered during mammography. Current methods are core needle biopsy or exploratory surgery. Performing EHT Dx14 could reduce the use of these invasive procedures and would shorten time to result. The molecular signature has been confirmed in a pilot study and ExonHit is proceeding with a large cohort for full validation. ExonHit plans to launch the test as a “research use only” product for oncology centers in Q3 2010.

The collaboration with bioMérieux to develop blood-based biomarkers for the detection of prostate cancer is ongoing. Collaborations on breast and colon cancer programs were discontinued. The technology was demonstrated to be robust and reproducible, however the clinical results did not reach the performance criteria set for the programs.

IP/Legal update

The lawsuit between ExonHit and Jivan Biologics Inc (Jivan) has been resolved by Consent Judgment entered by the Court against Jivan for infringement of ExonHit’s US Patent 6,881,571 (‘571 Patent). Jivan has been held to infringe the ‘571 Patent and is enjoined from further infringement. ExonHit agreed to release Jivan from claims for damages for Jivan’s infringing devices sold prior to the Consent Judgment.

License agreements have been signed with Sigma Aldrich and Tocris allowing both companies to commercialize EHT 1864 for research use only, ExonHit’s proprietary and widely tested Rac 1/Rac 1b inhibitor.

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Financial Results

As of December 31, 2009, cash, cash equivalents and investments totaled $40.2 million compared to $55.6 million at December 31, 2008. Additionally, in December 2009 the Company earned a milestone payment of €3.0 million from Merck KGaA and recognized this milestone payment as revenue in 2009. The Company received $4.1 million in payment of this milestone in the first quarter of 2010 which is not included in December 31, 2009 cash.

Fourth Quarter Results

Net income for the three months ended December 31, 2009 was $3.9 million, or $0.17 per diluted share, compared to net income of $0.4 million, or $0.01 per diluted share, for the same period in 2008.

Total revenues for the three months ended December 31, 2009 were $10.2 million compared to $6.3 million for the same period in 2008.

Research and development expenses for the three months ended December 31, 2009 totaled $4.4 million compared to $4.3 million for the same period in 2008.

General and administrative expenses for the three months ended December 31, 2009 totaled $2.1 million compared to $1.8 million for the same period in 2008.

Full Year Results

Net income for the year ended December 31, 2009, was $7.5 million, or $0.31 per diluted share, compared to net income of $1.5 million, or $0.06 per diluted share, for 2008.

Total revenues for the year ended December 31, 2009 were $34.5 million compared to $26.5 million for 2008.

Research and development expenses for the year ended December 31, 2009 totaled $18.6 million compared to $16.2 million for 2008.

General and administrative expenses for the year ended December 31, 2009 totaled $8.6 million compared to $9.8 million for 2008.

Clinical and Preclinical Programs

EMD 1201081 (IMO-2055), a TLR9 Agonist, in Cancer Treatment (Collaboration with Merck KGaA)

* Phase 2 Clinical Trial of EMD 1201081 in Squamous Cell Carcinoma of the Head and Neck

In December 2009, Merck KGaA initiated a Phase 2 clinical trial of EMD 1201081, also known as IMO-2055, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The Company achieved a milestone under its agreement with Merck KGaA related to this trial initiation and received a milestone payment of €3.0 million (approximately $4.1 million) from Merck KGaA in the first quarter of 2010.

* Phase 1b Clinical Trial of EMD 1201081 in Combination with Tarceva® and Avastin in Non-small Cell Lung Cancer (NSCLC)

In September 2009, the Company presented preliminary data from a Phase 1b clinical trial evaluating EMD 1201081 in combination with Tarceva and Avastin in patients with NSCLC that had progressed during previous therapy. EMD 1201081 was well tolerated at dosages up to 0.48 mg/kg/week in combination with Tarceva plus Avastin. Eight of 16 patients in the dose-escalation portion of the trial remained on treatment at least 18 weeks. Of the 13 patients evaluable for disease status, three had a partial response and eight experienced stable disease.

Subsequent to the preliminary data presented in September 2009, Merck KGaA recruited patients for an expanded cohort at the anticipated recommended phase 2 dose level for EMD 1201081 in combination with Tarceva and Avastin.

* Phase 1b Clinical Trial of EMD 1201081 in Combination with Erbitux and Chemotherapy in Colorectal Cancer (CRC)

In January 2009, dosing of patients was initiated in a Phase 1b clinical trial evaluating EMD 1201081 in combination with Erbitux and chemotherapy in patients with CRC that had progressed during previous therapy. EMD 1201081 is being evaluated at three escalating dose levels in combination with standard dose regimens of Erbitux and chemotherapy to evaluate the safety of the combination and to determine the recommended dosage of IMO-2055 for potential use in a subsequent Phase 2 clinical trial.

As of March 2010, Merck KGaA has assumed responsibility for all current and future clinical trials in the development of EMD 1201081 for the treatment of cancer, excluding vaccines.

IMO-2125, a TLR9 Agonist, in Chronic Hepatitis C Virus (HCV) Infection

* Phase 1 Clinical Trial with IMO-2125 Monotherapy in Null Responder Patients with Chronic HCV Infection

In December 2009, the Company announced interim results from a Phase 1 clinical trial of IMO-2125 in null responder HCV patients treated through the first four cohorts of the trial. The Company defines null responder HCV patients as patients who have failed to achieve a 2 log10 reduction in viral load during previous 12 to 24 weeks of treatment with pegylated recombinant interferon-alpha plus ribavirin. IMO-2125 was well tolerated by all patients in the four cohorts at dosages of 0.04, 0.08, 0.16, and 0.32 mg/kg/week. IMO-2125-treated patients showed dose-dependent increases in natural interferon-alpha and other antiviral proteins. In addition, an increasing percentage of patients, ranging from 40% at the 0.08 mg/kg/week dose level to 75% at the 0.32 mg/kg/week dose level, achieved a maximum reduction in viral load of 1 log10 or more at least once during the four-week treatment period. In contrast, none of the patients who received placebo treatment or IMO-2125 at the 0.04-mg/kg/week dose level achieved a maximum reduction in viral load of 1 log10 or greater at any time during the four-week treatment period. The Company plans to present detailed interim results of the trial at a scientific meeting in the second quarter of 2010.

Based on the interim data, the Company extended the trial and is currently recruiting patients in a fifth cohort at 0.48 mg/kg/week.

* Phase 1 Clinical Trial with IMO-2125 in Combination with Ribavirin in Treatment-naïve Patients with Chronic HCV Infection

In October 2009, the Company announced initiation of a Phase 1 clinical trial to assess the safety of IMO-2125 in combination with ribavirin in treatment-naïve patients with chronic HCV infection. A total of 15 patients are planned for the first cohort, with 12 randomized to receive IMO-2125 and ribavirin and three randomized to receive placebo and ribavirin. Starting with the second cohort, 12 patients will be randomized to receive IMO-2125 and ribavirin and six patients will be randomized to receive pegylated recombinant alfa-2a interferon and ribavirin as the control. The primary objective of the trial is to assess the safety and tolerability of IMO-2125 in combination with ribavirin. In addition, the Company plans to monitor the effect of treatment on HCV RNA levels.

IMO-3100, a Dual Antagonist of TLR7 and TLR9, in Autoimmune and Inflammatory Diseases

* Phase 1 Clinical Trial with IMO-3100

In January 2010, the Company initiated a single-dose, dose-escalation Phase 1 clinical trial of IMO-3100 in healthy subjects. In this trial, IMO-3100 is being administered by subcutaneous injection to healthy subjects, with the primary objective being the evaluation of safety and tolerability. Secondary objectives are to characterize the pharmacokinetic profile of IMO-3100 and to assess the pharmacodynamic mechanism of action through measurement of the ex vivo response of peripheral blood mononuclear cells to TLR7 and TLR9 agonists. The trial is being conducted at a single U.S. site.

The Company plans to use the results from this rising single-dose trial to select dosages for an anticipated follow-up trial in healthy subjects, the purpose of which would be to characterize safety, pharmacokinetics, and ex vivo pharmacodynamic mechanism of action with weekly subcutaneous administration for four weeks. The Company intends to identify an initial autoimmune disease indication for further clinical development of IMO-3100 by the end of 2010.

IMO-2134, a TLR9 Agonist, for Respiratory Diseases

During our collaboration with Novartis, IMO-2134 was identified as a lead compound for development in asthma and allergy indications and Novartis initiated a Phase 1 clinical trial of IMO-2134, also known as QAX935. Upon the termination of the research collaboration and option agreement in February 2010, the Company regained all rights to IMO-2134. The Company is currently evaluating the next steps in developing IMO-2134 for respiratory diseases.

TLR7, 8 and 9 Agonists as Vaccine Adjuvants (Collaboration with Merck & Co., Inc.)

In December 2006, the Company and Merck & Co. Inc. entered into an exclusive license and research collaboration agreement to research, develop and commercialize vaccine products containing the Company’s TLR7, 8, and 9 agonists in the fields of oncology, infectious diseases and Alzheimer’s disease. As part of the agreement, the two companies engaged in a two-year research collaboration to generate novel agonists targeting TLR7 and TLR8 incorporating both Merck and Idera chemistry for use in the licensed fields. In November 2009, Merck extended the research collaboration with the Company for a fourth year to December 2010. Under the terms of the agreement, Merck is funding the research and development activities, including our research and development activities under the collaboration.

TLR7 and TLR8 Agonists

The Company has created synthetic stabilized immune modulatory RNA (SIMRA) compounds that mimic viral RNA and induce immune responses by functioning as agonists of TLR7 and TLR8. The Company is continuing to study selected dual TLR7 and TLR8 agonists in preclinical models of hematological cancers and has observed antitumor activity of a dual agonist of TLR7 and TLR8 as monotherapy and in combination with selected targeted drugs currently approved for cancer treatment.

TLR Antisense

The Company has identified antisense compounds targeted to human TLRs 2, 3, 4, 5, 6, 7, 8, and 9 and to the TLR-associated signaling protein MyD88. The Company is studying these compounds for potential applications in autoimmune and inflammatory diseases.

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Emergent BioSolutions Inc. (NYSE: EBS) announced its financial results for the full year ended December 31, 2009.

For the full year 2009, total revenues were $234.8 million as compared to $178.6 million in 2008, and net income was $31.1 million, or $1.02 per share, as compared to $20.7 million, or $0.69 per share, in 2008. The 2009 performance was primarily driven by sales of BioThrax (Anthrax Vaccine Adsorbed), the company’s FDA licensed vaccine for the prevention of anthrax disease, including $34.0 million related to the approval of four-year expiry dating for BioThrax.

For the fourth quarter 2009, total revenues were $53.8 million as compared to $35.8 million in 2008, and net income was $4.2 million, or $0.14 per share, as compared to net income of $1.5 million, or $0.05 per share in 2008.

2009 Key Operational Accomplishments

* Received FDA approval extending shelf life of BioThrax to 4 years, triggering a $34.0 million payment from HHS;
* Received FDA approval to amend the BioThrax license, providing for an intramuscular route of administration and a reduction in the dosing schedule to five doses over 18 months—an initiative supported and funded by the U.S. Centers for Disease Control and Prevention (CDC);
* Received market authorization for BioThrax in India;
* Commenced what we expect will be the only clinical trial of the company’s polyclonal anthrax immune globulin (AIG) candidate for treating anthrax disease;
* Obtained Fast Track designation and Orphan Drug status from FDA and Orphan Drug status from EMEA for the company’s AIG candidate;
* Secured a NIAID grant to fund development of a third-generation anthrax vaccine candidate, valued at $4.9 million over a two-year period;
* Initiated a Phase IIb field efficacy trial in South Africa for the Company’s advanced TB vaccine candidate, largely funded by The Aeras Global TB Vaccine Foundation and the Wellcome Trust;
* Completed a Phase IIb clinical trial of TyphellaTM which demonstrated additional safety and immunogenicity of this typhoid vaccine product candidate in healthy subjects in the U.S.;
* Purchased a 56,000 square foot manufacturing facility in Baltimore, MD., which houses five independent manufacturing suites flexibly designed to support the production of both clinical and commercial materials for the Company’s growing product pipeline, for a total purchase price of $8.2 million;
* Purchased a 48,000 square foot product development facility in Gaithersburg, MD., that the Company previously leased, for a total purchase price of $6.4 million;
* Resumed scale-up of BioThrax in the Company’s large-scale manufacturing facility (Building 55) in Lansing, MI.; and
* Submitted a proposal to HHS, in response to a request, for funding the completion of the manufacturing scale-up of BioThrax in Building 55.

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For the fourth quarter ended December 31, 2009, Natus reported revenue of $51.6 million, compared to $43.4 million reported in the comparable quarter of the previous year. Net income was $4.3 million, or $0.15 per diluted share, for the fourth quarter of 2009, compared with net income of $6.3 million, or $0.22 per diluted share, for the fourth quarter of 2008.

For the year ended December 31, 2009, Natus reported revenue of $166.5 million, compared to $161.8 million reported in 2008. Net income was $11.1 million, or $0.39 per diluted share for the year ended December 31, 2009, compared to net income of $17.5 million, or $0.66 per diluted share in 2008.

The results for the full year 2009 include $550,000 of direct acquisition costs associated with the Company’s acquisitions of Hawaii Medical and Alpine Biomed in July and September 2009, respectively. Excluding these direct costs, which were reported as a component of general and administrative expense, non-GAAP earnings were $11.5 million, or $0.40 per diluted share.

As of December 31, 2009 the Company had cash, cash equivalents, and short-term investments of $33.5 million, stockholders’ equity of approximately $243 million, and working capital of approximately $76 million.

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Operating expenses for the year ended December 31, 2008 include a $1.2 million non-cash charge resulting from the modification of equity awards and $2.5 million of expenses related to the spin-off from Bentley Pharmaceuticals on June 30, 2008.

Fourth-Quarter Highlights

For the fourth quarter of 2009 compared to the fourth quarter of 2008:

* Revenues increased 23% to $5.2 million from $4.2 million.
* Operating expenses increased 45% to $5.8 million from $4.0 million.
* Net loss was $498,000, or $0.20 per share, compared to net income of $292,000, or $0.12 per share.

The growth in revenues for the fourth quarter of 2009 was due to increased royalties on sales of Testim. This growth is due to a reported 13.2% increase in prescriptions for Testim during the fourth quarter of 2009 compared to the same period in 2008.

General and administrative expenses for the fourth quarter of 2009 increased $1.1 million compared to the fourth quarter of 2008 due to $1.2 million in costs relating to the Upsher-Smith litigation. Research and development expenses for the fourth quarter of 2009 increased $627,000 compared to the fourth quarter of 2008 largely due to a $489,000 increase in expenses related to the Nasulin clinical program. Research and development expenses are expected to vary from period to period, primarily due to the number, size and recruitment levels of clinical trials in any given reporting period.

Year-to-Date Highlights

For the year ended December 31, 2009 compared to the comparable period in 2008:

* Revenues increased 20% to $18.7 million from $15.6 million.
* Operating expenses increased 16% to $21.9 million from $18.8 million.
* Net loss increased to $3.0 million, or $1.21 per share, from $2.9 million, or $1.25 per share.

The increase in revenues for the twelve months ended December 31, 2009 was due to increased royalties on sales of Testim. For the year ended December 31, 2009, Testim prescriptions were reported to have grown 14.9% compared to the same period in 2008. General and administrative expenses increased $2.4 million in the year ended December 31, 2009 compared to the same period in 2008. The increase was primarily due to increased litigation costs of $2.8 million partially offset by a $674,000 decrease in non-cash share-based compensation expense. Research and development expenses increased $3.2 million during the year ended December 31, 2009 compared to 2008 due to a $3.7 million increase in clinical trial expenses, primarily related to the Nasulin clinical program, which were partially offset by lower non-cash share-based compensation expense of $494,000.

On June 30, 2008, CPEX had approximately 2,274,000 common shares outstanding after the spin-off. The same number of shares is being used for the basic and diluted loss per share computation for all periods presented prior to June 30, 2008 because no CPEX equity awards were outstanding prior to the spin-off.

As of December 31, 2009, CPEX had unrestricted cash of approximately $13.7 million, working capital of $16.6 million and no debt.

Business Update

Ongoing Clinical Trials: CPEX’s intranasal insulin product candidate for the treatment of hyperglycemia in patients with Type 1 and Type 2 diabetes, Nasulin, is continuing in clinical trials evaluating the efficacy and safety profile of the product. CPEX has completed enrollment in its Phase 2a study designed to assess the efficacy and safety of Nasulin versus placebo over a 6-week treatment period. This study was conducted at multiple sites in the U.S. and randomized 94 patients. Data analysis is ongoing and preliminary results are expected this month. Earlier clinical studies of Nasulin indicated that CPEX’s intranasal insulin candidate achieved a faster time to peak plasma insulin levels when compared to other approved rapid-acting insulin therapies, thereby more closely mimicking the natural response of the pancreas to meals.

Patent Infringement Lawsuit Update: CPEX and Auxilium Pharmaceuticals, Inc. continue to vigorously pursue their lawsuit against Upsher-Smith for infringement of CPEX’s patent that covers Testim. In August 2009, the U.S. Food and Drug Administration (FDA) responded to a Citizen Petition filed by Auxilium. The FDA agreed with some of the statements made in the Citizen Petition regarding the testing required for generic versions of Testim, while disagreeing with other statements. While the FDA did not comment upon any particular filing, the agency stated that: “The practical effect of this determination is that any application for a testosterone gel product that has different penetration enhancers than the reference listed drug cannot be submitted as an ANDA [(i.e., an abbreviated new drug application)] and, instead, will have to be submitted as an NDA under section 505(b) of the Act.” (FDA’s August 26, 2009, Response to Auxilium’s Citizen Petition)

Partnering Update: Serenity Pharmaceuticals, CPEX’s licensing and development partner, continues to recruit patients in multiple Phase 3 clinical trials of their undisclosed urology drug, which is delivered using CPEX’s intranasal technology for the treatment of nocturia. These randomized, double blind, placebo controlled studies are being conducted at multiple sites in the United States.

New Chief Scientific Officer: On February 1, 2010, CPEX announced the appointment of Nils Bergenhem, Ph.D. as its Chief Scientific Officer. Prior to joining CPEX, Dr. Bergenhem served as Chief Scientific Officer at Escoublac, Inc., the first biotechnology company in the Biogen Idec Innovations Incubator, where he was responsible for development and execution of the research plan for human osteocalcin in metabolic disease, Type 2 diabetes and obesity. Dr. Bergenhem succeeds Fred Feldman, Ph.D., who is retiring after a 35 year career in research and drug development.

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Human Genome Sciences, Inc. (Nasdaq: HGSI) announced financial results for the quarter and full year ended December 31, 2009, and provided highlights of recent key developments.

FINANCIAL RESULTS

HGS reported increased revenues of $275.7 million for the year ended December 31, 2009, compared with revenues of $48.4 million for 2008. Revenues for 2009 included $180.2 million recognized from sales and deliveries to the U.S. Strategic National Stockpile under the raxibacumab contract with the U.S. Government, $54.2 million recognized from the ZALBIN agreement with Novartis, $24.4 million recognized from manufacturing and development services other than raxibacumab, and $4.7 million recognized from the BENLYSTA agreement with GSK.

The Company reported net income for 2009 of $5.7 million ($0.04 per share), compared with a net loss of $268.9 million ($1.99 per share) for 2008. The improvement in net income for 2009 was due primarily to increased revenues, lower research and development and general and administrative expenses, and a gain on extinguishment of debt.

Cash increased by $818.7 million during 2009 primarily as a result of the successful public offerings of HGSI common stock completed in August and December 2009. As of December 31, 2009, cash and investments totaled $1.2 billion, of which $1.1 billion was unrestricted and available for operations. This compares with cash and investments totaling $372.9 million as of December 31, 2008, of which $303.6 million was unrestricted and available for operations.

Net cash flow for 2009 totaled $29.7 million, compared with net cash burn of $244.8 million for 2008; this does not include the effect of the public offerings of HGSI common stock and the repurchase of $106.2 million principal amount of outstanding long-term debt. The improvement primarily reflected increased revenues and lower research and development and general and administrative expenses.

For the fourth quarter ended December 31, 2009, HGS reported revenues of $53.0 million, compared with revenues of $12.9 million for the same period in 2008. Fourth quarter 2009 revenues included $27.6 million recognized from the ZALBIN agreement with Novartis, $17.7 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile, $5.3 million recognized from manufacturing and development services other than raxibacumab, and $1.0 million recognized from the BENLYSTA agreement with GSK.

The Company’s net loss for the quarter ended December 31, 2009 decreased to $9.7 million ($0.06 per share), compared with a net loss of $61.9 million ($0.46 per share) for the fourth quarter of 2008. The decrease in net loss was due primarily to higher revenues and lower research and development and general and administrative expenses.

HIGHLIGHTS OF RECENT PROGRESS

BENLYSTA: On Track for Second Quarter 2010 Submission of U.S. and European Marketing Applications; Potential U.S. Approval Fourth Quarter 2010

BENLYSTA (belimumab) met the primary efficacy endpoints in BLISS-52 and BLISS-76, the largest late-stage clinical trials ever conducted in lupus patients. The results of these pivotal Phase 3 studies were reported in July and November 2009. HGS and GSK expect to submit marketing applications for BENLYSTA to regulatory authorities in the United States and Europe in the second quarter of 2010, and it has the potential to receive regulatory approval in the U.S. in the fourth quarter of 2010. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006.

The Phase 3 data showed that BENLYSTA plus standard of care achieved a clinically and statistically significant improvement in patient response rate, compared with placebo plus standard of care. BLISS study results also showed that belimumab was generally well tolerated, with rates of overall adverse events and discontinuations due to adverse events comparable between belimumab and placebo treatment groups.

ZALBIN: Marketing Applications Filed in United States and Europe in Fourth Quarter 2009; Potential U.S. Approval Fourth Quarter 2010

In the fourth quarter of 2009, HGS submitted a Biologics License Application (BLA) to FDA for ZALBIN (albinterferon alfa-2b) in the United States, and Novartis submitted a Marketing Authorization Application (MAA) under the brand name JOULFERON to the EMEA in Europe. In February 2010, HGS received confirmation that the BLA submission was accepted by the FDA for filing with a Prescription Drug User Fee Act (PDUFA) target date of October 4, 2010. Albinterferon alfa-2b is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006.

The regulatory submissions include the results of two pivotal Phase 3 clinical trials, known as ACHIEVE 1 and ACHIEVE 2/3, showing that 900-mcg ZALBIN dosed every two weeks met its primary endpoint of non-inferiority to Pegasys (peginterferon alfa-2a) dosed once each week. Patients also received oral ribavirin. In both studies, ZALBIN, with half the injections, achieved sustained virologic response comparable to that achieved by Pegasys. The rates of serious and/or severe adverse events were also comparable in these studies. ACHIEVE 1 was conducted in patients infected with genotype 1 virus, and ACHIEVE 2/3 was conducted in patients with genotypes 2 or 3 virus. The two studies treated a total of 2,255 patients.

Raxibacumab: $180 Million in Revenue Recognized in 2009 from Deliveries to U.S. Strategic National Stockpile; First Delivery under Second Order Completed November 2009; Approximately 15,000 Doses to Be Delivered to Stockpile in 2010

In the first half of 2009, HGS achieved its first product sales and recognized $162.5 million in revenue by delivering 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile. In July 2009, the U.S. Government exercised its option to purchase 45,000 additional doses to be delivered over a three-year period. HGS expects to receive approximately $142 million from the second award as deliveries are completed, including $17.7 million recognized as revenue from delivery of approximately 5,600 doses in fourth quarter 2009. The Company expects to deliver approximately 15,000 doses to the Stockpile in 2010.

HGS submitted a BLA to FDA for raxibacumab for the treatment of inhalation anthrax in May 2009, received a Complete Response Letter in November 2009, and is working closely with the FDA to obtain approval. HGS will receive $20 million from the U.S. Government upon FDA licensure of raxibacumab. Raxibacumab is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS).

GSK Pipeline: Phase 3 Trials Ongoing for Darapladib in Cardiovascular Disease and Syncria in Type 2 Diabetes

In December 2009, GSK announced the initiation of its second pivotal Phase 3 trial to evaluate whether darapladib can reduce the risk of adverse cardiovascular events such as a heart attack or stroke. During the year, GSK completed enrollment of its first Phase 3 trial of darapladib ahead of schedule. With more than 27,000 patients enrolled in the two trials, the Phase 3 clinical program for darapladib is among the largest ever conducted to evaluate the safety and efficacy of any cardiovascular medication. Darapladib was discovered by GSK based on HGS technology. HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.

HGS received a $9.0 million milestone payment during the first quarter of 2009, following GSK’s initiation of a Phase 3 program to evaluate the efficacy, safety and tolerability of Syncria (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Six Phase 3 trials of Syncria are currently ongoing. Syncria was created by HGS using its proprietary albumin-fusion technology, and the product was licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183 million – including $33 million received to date – in addition to single-digit royalties on worldwide sales if Syncria is commercialized.

Oncology Program: Therapeutic Opportunities across Broad Range of Cancers

Three randomized Phase 2 chemotherapy combination trials are currently underway to evaluate the potential of mapatumumab (HGS-ETR1) in the treatment of advanced multiple myeloma, non-small cell lung cancer, and hepatocellular cancer. Results are expected in first quarter 2010 for non-small cell lung cancer and mid-2010 for multiple myeloma. Mapatumumab, a human monoclonal antibody to TRAIL receptor 1, is the most advanced of any product in development that targets the TRAIL apoptosis pathway.

In November 2009, HGS and Aegera Therapeutics announced the initiation of a Phase 1 trial of the Company’s lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced lymphoid tumors. HGS1029 as monotherapy is also being studied in an ongoing Phase 1 study initiated in 2008 in patients with advanced solid tumors. HGS plans to continue the study of HGS1029 both alone and in combination with other anti-cancer agents, including mapatumumab.

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Business Highlights

* AMAG reported fourth quarter 2009 Feraheme net product revenues of $12.8 million, including $1.3 million of the $11.5 million in previously deferred product revenues.
* To date, more than 1,300 providers have purchased Feraheme (ferumoxytol) Injection; collectively, these providers purchased approximately 240,000 grams of all forms of IV iron over the past 52 weeks1.
* Of the providers that have purchased Feraheme to date, more than 1,100 are treating non-dialysis dependent chronic kidney disease patients and more than 60 percent have purchased on a repeat basis.
* AMAG estimates that more than half of Feraheme provider demand in 2009 was outside of the dialysis setting.

As of December 31, 2009, the Company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $129.5 million. In January 2010, AMAG successfully completed a follow-on offering of 3.6 million shares of common stock, with net proceeds to the Company of approximately $165.6 million. Revenues for the quarter ended December 31, 2009 were $13.1 million as compared to revenues of $0.6 million for the same period in 2008. Revenues for the year ended December 31, 2009 were $17.2 million as compared to $1.9 million for the same period in 2008. The increases in revenues in 2009 over the comparable 2008 periods were attributable to Feraheme product sales following its approval and subsequent launch in July 2009.

Total operating costs and expenses for the quarter ended December 31, 2009 were $33.3 million as compared to $23.8 million for the same period in 2008. Total operating costs and expenses for the year ended December 31, 2009 were $115.1 million as compared to $81.5 million for the same period in 2008. The increases in operating costs and expenses in 2009 over the comparable 2008 periods were primarily due to increased selling, general and administrative expenses associated with the commercialization of Feraheme.

The Company reported a net loss of $18.4 million, or a loss of $1.07 per basic and diluted share, for the quarter ended December 31, 2009, as compared to a net loss of $21.8 million, or a loss of $1.28 per basic and diluted share, for the same period in 2008. Net loss for the year ended December 31, 2009 was $93.4 million, or a loss of $5.46 per basic and diluted share, as compared to a net loss of $71.6 million, or a loss of $4.22 per basic and diluted share for the same period in 2008.

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