Cerenis Reports Two Positive Phase II Studies for HDL Mimetic CER-001 at EAS

Cerenis Therapeutics, the biopharmaceutical company, today announced that two of its Phase II studies, SAMBA and MODE (Modifying Orphan Disease Evaluation), with CER-001, an engineered human apoA-I-containing pre-β HDL mimetic, met their primary clinical endpoints in patients with Familial Primary Hypoalphalipoproteinemia (FPHA) and Homozygous Familial Hypercholesterolemia (HoFH), respectively.

“These data indicate that HDL therapy is complementary to LDL-c-lowering treatment and may represent a new therapy for addressing the unmet medical need in FH patients.”

Data are being presented at the Late Breaker Session at the European Atherosclerosis Society (EAS) Meetings in Madrid, Spain on June 2, 2014.

SAMBA clinical trial:
Proof-of-Mechanism data will be presented at the EAS from the SAMBA Phase II efficacy and safety trial in patients with Familial Primary Hypoalphalipoproteinemia (FPHA), a rare syndrome of severe HDL deficiency caused by mutations in the genes responsible for HDL synthesis /maturation and characterized by accelerated atherosclerosis.
This pharmacokinetic/pharmacodynamic trial, conducted by Principal Investigator, Erik S.G. Stroes, MD, PhD of the Department of Vascular Medicine at the Academic Medical Center (AMC) in Amsterdam, The Netherlands, Lotensin (Benazepril) with free prescription enrolled 7 FPHA patients in an open-label single-arm active-treatment study and assessed the efficacy of infused CER-001 engineered human apoA-I-containing pre-β HDL particles in reconstituting the endogenous Reverse Lipid Transport in individuals who have defects in the natural HDL pathway and facilitate elimination of cholesterol from the body.
The data from patients receiving CER-001 treatment on top of optimized standard of care LDL-c-lowering therapy showed that CER-001 performed the four steps of the Reverse Lipid Transport pathway: CER-001 increased cholesterol mobilization and esterification in the HDL fraction, and one month of treatment with 9 doses of CER-001 resulted in a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI). CER-001 was well-tolerated.
Specific data from the study will be presented on Monday June 2, 2014 at 3:45pm in Madrid.
Dr. Stroes commented, "The results of this study support the future use of CER-001 for chronic administration aiming to reduce the elevated cardiovascular risk in low HDL patients with a high unmet clinical need."
MODE clinical trial:
Cerenis also reported that data from the MODE (Modifying Orphan Drug Evaluation) trial, a Phase II efficacy and safety study in patients with Homozygous Familial Hypercholesterolemia (HoFH), About Female Viagra (Sildenafil Citrate) with free prescription a rare disease of markedly elevated LDL-cholesterol (bad cholesterol) levels caused by genetic defects in the LDL-receptor pathway and characterized by premature atherosclerosis. Data will also be presented as a late-breaking clinical trial at the EAS.
The open-label single-arm active-treatment study in 23 patients with homozygous FH met the prespecified primary clinical endpoint in the modified Intention to Treat population, demonstrating a statistically significant reduction in carotid artery Mean Vessel Wall Area, as measured by Magnetic Resonance Imaging (3T-MRI), after 6-months of bi-weekly CER-001 treatment on top of optimized LDL-c-lowering therapy, including apheresis. CER-001 was well-tolerated.
Specific data from the study will be presented on Monday June 2, 2014 at 4:00pm in Madrid.
Dr. Kees Hovingh, the Principal Investigator of the MODE study, commented, Buy Diamox (Acetazolamide) with free prescription "These data indicate that HDL therapy is complementary to LDL-c-lowering treatment and may represent a new therapy for addressing the unmet medical need in FH patients."
John F. Paolini, MD, PhD, FACC, Chief Medical Officer of Cerenis, said, “CER-001 has been shown to offer an important benefit for patients suffering from accelerated cardiovascular disease caused by genetic defects at both ends of the spectrum of cholesterol homeostasis. The demonstrated safety profile observed in all studies performed thus far supports the use of CER-001 for chronic treatment in both these rare patient populations.”
Jean-Louis Dasseux, PhD, MBA, and CEO of Cerenis, concluded: “In all preclinical and clinical studies to date, CER-001 has been shown to perform the functions of natural HDL and the steps of the Reverse Lipid Transport Pathway leading to elimination of cholesterol from the body with a high degree of potency. The clinical benefit observed in these genetically challenged patients is further evidence supporting HDL therapy in the broader treatment of atherosclerosis. We are committed to continuing the development of CER-001 in these important rare disease clinical indications.”

About Cerenis Therapeutics
Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of novel HDL therapies for the treatment of cardiovascular and metabolic diseases. Acnederm with free Rx HDL is the primary facilitator of the reverse lipid transport, or RLT, pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body. Cerenis is developing a portfolio of HDL therapies, including HDL mimetics for the rapid regression of atherosclerotic plaque in high-risk patients, and drugs which increase HDL for patients with low HDL. Cerenis is well-positioned to become the leader in the HDL therapeutic market with a broad portfolio of programs in development.
Since its inception in 2005, the company raised €117 M in equity with top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and the FSI (Fund for Strategic Investment). €10,7M was also provided by OSEO, the French agency for innovation, to support the development of CER-001.
About CER-001
CER-001 is an engineered complex of recombinant human apoA-I, the major structural protein of HDL, and charged phospholipids. It has been designed to mimic the structure and function of natural, nascent HDL, also known as pre-beta HDL. Its mechanism of action is to increase apoA-I and the number of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to transport them to the liver for elimination through a process called Reverse Lipid Transport.
Familial Primary Hypoalphalipoproteinemia (FPHA)
Hypoalphalipoproteinemia (“low HDL”), as a general term, has historically been defined clinically as an HDL-cholesterol (HDL-C) less than 40 mg/dL (1.0 mmol/L) in men, and less than 50 mg/dL (1.3 mmol/L) in women. Medical Questions and Answers A number of etiologies, often metabolic, can underlie a reduced circulating level of cholesterol in the HDL fraction, for example diabetes, Metabolic Syndrome, obesity, and lack of physical activity (thus called secondary hypoalphalipoproteinemia). In a very small percentage of the population, particularly amongst the patients with the very lowest HDL-C values, there are patients who have a genetic defect (thus called primary hypoalphalipoproteinemia) affecting either the constituent components of the pre-β particle, the process of pre-β particle synthesis, the steps leading to maturation into an alpha HDL particle, or the rates of catabolism – any of which alone or in combination can then result in an inherited condition of very low circulating HDL particle number.
Familial Primary Hypoalphalipoproteinemia (FPHA) includes patients with a range of individual mutations across the key genes involved in HDL particle production or maturation (apoA-I, ABCA1, LCAT) which are individually extremely rare (prevalence less than one in one million births in the homozygous form) but in both homozygous and heterozygous forms can act in an autosomal dominant manner to cause low apoA-I levels and low HDL particle numbers through either decreased production or increased clearance and premature destruction of HDL particles and ultimately result in accelerated atherosclerosis from a single final common pathophysiology of impaired Reverse Lipid Transport (RLT) and accumulation of cholesterol throughout the body, in particular, the vasculature. FPHA patients are at high risk of cardiovascular disease as a consequence of having inherited a virtually absent endogenous RLT system. Because of the specific characteristics and very limited available therapeutic approaches, FPHA remains an unmet medical need and a life-threatening condition.
Familial Hypercholesterolemia (FH)
Familial hypercholesterolemia (FH) is characterized by high cholesterol levels, specifically very high low-density lipoprotein (LDL) levels and early cardiovascular disease. Many patients have mutations in the LDLR gene that encodes the LDL receptor protein, which normally removes LDL from the circulation, or apolipoprotein B (ApoB), which is the part of LDL that binds with the receptor; mutations in other genes are rare. In homozygous familial hypercholesterolemia (HoFH), serum LDL-C levels may be elevated six-fold. Patients develop severe aortic stenosis and coronary heart disease by age 20 and normally do not respond adequately to drug or diet modification therapy. Although the existing therapies, including statins, cholesterol absorption inhibitors, and LDL apheresis, can significantly reduce circulating LDL-C, nevertheless, LDL-C still remains higher than that recommended by current treatment guidelines, and these patients continue to have cardiovascular events of MI, stroke, and death at an elevated rate. The prevalence of homozygous FH is approximately one in one million births.

Fraunhofer USA Center for Molecular Biotechnology Begins Clinical Trial of New Malaria Vaccine Approach

Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announced today that clearance was obtained from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND), Fraunhofer’s plant-derived malaria transmission-blocking vaccine (TBV), which targets the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety and immunogenicity study.

“Entering this clinical trial is an important milestone”

Antibodies directed at Pfs25 can block transmission of the malaria parasite from mosquitoes to humans by preventing the parasite from developing in the mosquito. Elavil (Amitriptyline) pills In preclinical models, purified plant-derived virus-like particles containing Pfs25, in combination with the adjuvant Alhydrogel®, have been shown to induce antibodies that effectively block infection of mosquitoes that have fed on an infectious blood meal. Buy Eldepryl (Selegiline) If these results can be reproduced in humans, the vaccine approach may provide a strategy to interrupt malaria transmission and thereby contribute to reduction of the P. falciparum disease burden.
“Entering this clinical trial is an important milestone,” said Dr. Yusibov, Executive Director of FhCMB. Buy Ziac (Biosoprolol, Hydrochlorothiazide) “We have moved targets from molecular engineering all the way through to pilot scale manufacturing in plants under good manufacturing practices and evaluation in a Phase 1 clinical trial.”
Development of this malaria TBV is an effort to improve global health by supporting the development of critical platform technologies for delivering vaccines to malaria-endemic countries. Vitamins As part of the planned collaboration strategy, FhCMB, the PATH Malaria Vaccine Initiative (MVI) and Accelovance entered into an agreement to conduct a Phase 1 clinical trial.
“We are excited to see this promising new vaccine approach advance to clinical testing,” says Ashley J. Birkett, PhD, Director of MVI. “Vaccines that can induce immunity to break the cycle malaria parasite transmission between humans and mosquitoes have the potential important interventions to accelerate future elimination and eradication efforts.”
This Phase 1 clinical trial was initiated in early November and is being conducted by Accelovance.
About Fraunhofer
Fraunhofer USA is a subsidiary of Fraunhofer-Gesellschaft, a world leading applied R&D organization with 66 institutes and independent research units throughout Germany. Cardio & Blood Medications Customers Review Fraunhofer USA’s nine centers perform applied research under contract to government and industry.
Fraunhofer USA Center for Molecular Biotechnology is developing a safe, rapid and economical alternative for vaccine production. The Center conducts research in the area of plant biotechnology, utilizing new, cutting edge approaches to assist the diagnosis, prevention and treatment of human and animal diseases. With its GMP production facility, the Center provides the full complement of capabilities from target expression through Phase 1 and 2 clinical product development.

GSK’s MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Melanoma Misses First Co-Primary Endpoint

Agenus Inc. today announced that GlaxoSmithKline’s (NYSE:GSK) DERMA study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic (CI) trial, which contains Agenus’QS-21 Stimulon^® adjuvant, a component of GSK’s novel adjuvant system AS15, did not meet its first co-primary endpoint. Buy Benzac (Benzoyl Peroxide) pills online without prescription In an independent analysis, the study did not significantly extend the disease-free survival (DFS)^iv period when compared to placebo in the overall MAGE-A3 positive trial population.

“In the near future, we expect to report results of several other QS-21 Stimulon adjuvant containing programs.”

In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the study until the second co-primary endpoint is assessed. This co-primary endpoint is based on predefined criterion that was agreed upon by regulatory authorities. This analysis, which is based on gene signature, is designed to prospectively identify patients who may have the capability to be more immunologically responsive and therefore can potentially benefit from treatment. Buy Betagan (Levobunolol) tabs online without prescription If further analysis shows that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. GSK anticipates that these data will be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.
“We continue to believe that cancer immunotherapeutics have the potential to deliver significant benefits to patients and we look forward to the analysis of gene signature data,” said Garo H. Armen, Ph.D., chairman and CEO of Agenus Inc. Buy Timoptic (Timolol) without prescription “In the near future, we expect to report results of several other QS-21 Stimulon adjuvant containing programs.”
QS-21 Stimulon adjuvant is key component of many vaccines currently in clinical development. Agenus expects to report Phase 2 data for HerpV, Agenus’QS-21 Stimulon containing investigational therapeutic vaccine for genital herpes, during the fourth quarter of 2013. GSK is expected to announce Phase 3 results from MAGRIT, the MAGE-A3 non-small cell lung cancer (NSCLC) clinical trial during the first half of 2014. Buy Vitamins online In addition, GSK is expected to provide an update to the RTS,S program for the prevention of malaria.
About MAGE-A3 and GSK’s Cancer Immunotherapeutics (CIs)
MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, NSCLC, head and neck cancer, and bladder cancer, with no expression in normal cells^v.
GSK's CIs represent a class of novel investigational compounds that are based on tumor antigens presented to the patient's immune system as recombinant proteins in combination with a GSK novel adjuvant system. future Pharmaceuticals CIs are designed to trigger a specific immune response against tumor cells expressing these proteins, rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner and eventually eliminate them.
This approach primarily aims at reducing the risk of tumor recurrence following surgery. The highly targeted mode of action of GSK CIs against specific cancer antigens expressed by tumor cells may allow selection of patients eligible for the treatment depending on the expression of the tumor antigens. All Best Rx : Buy drugs online This may help oncologists to select patient populations most likely to respond to the treatment.
GSK’s MAGE-A3 CI contains a purified recombinant MAGE-A3 protein combined with GSK's novel AS15 adjuvant system. It was developed with the goal of inducing strong and sustained immune responses. AS15 is composed of the QS-21 Stimulon adjuvant, monophosphoryl lipid A (MPL), and CpG7909, a TLR-9 agonist, in a liposomal formulation.
Adjuvants are substances, which when used in combination with antigens in vaccines, enhance the immune response.
About Agenus’ QS-21 Stimulon^® Adjuvant
Agenus’ flagship adjuvant, QS-21 Stimulon adjuvant, is a saponin extracted from the bark of the Quillaja saponaria tree, also known as the soap bark tree or Soapbark, an evergreen tree native to warm temperate central Chile. FDA Approved Rx : Online Pharmacy Agenus’ QS-21 Stimulon has become a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. QS-21 Stimulon has been widely studied and approximately 50,000 patients have received vaccines containing the adjuvant. QS-21 Stimulon is being studied in 21 vaccine indications, which include GSK’s Phase 3 vaccine programs for RTS,S for malaria, MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma and HZ/su for shingles. Drugs Rx Guide : Buy drugs online In addition, Janssen’s QS-21 Stimulon adjuvant-containing vaccine candidate is in Phase 2 trials for the treatment of Alzheimer’s disease, and Agenus’ HerpV, a therapeutic vaccine for the treatment of genital herpes, is in a Phase 2 trial with data expected during the fourth quarter 2013. Agenus is generally entitled to receive milestone payments as QS-21 Stimulon containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.
About GSK’s DERMA Program
The GSK DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic, when compared to placebo, in MAGE-A3 positive patients (those whose tumor shows expression of the MAGE-A3 gene) with Stages IIIB/C surgically resected melanoma. The MAGE-A3 antigen is expressed in approximately 65% of tumors in Stage III melanoma patients.
The DERMA trial randomized 1,345 patients and is being conducted in 33 countries. In accordance with the study protocol, patients were given up to 13 injections into the muscle of the upper arm or thigh, over a period of 27 months.
About Melanoma
Melanoma is the most aggressive form of all skin cancers and its incidence is rising at a rate exceeding all other cancers. Worldwide, it is believed that approximately 160,000 people will be diagnosed with melanoma each year. If detected in its earliest stages and treated properly, melanoma is curable, however, melanoma is more likely than other skin tumors to spread to other parts of the body. Patients with stage IIB-C and stage III (locoregional lymph-node involvement) melanoma have a high risk of relapse following surgery (60% and 75% risk of recurrence, respectively). There are limited options for patients with advanced melanoma disease, highlighting that this type of melanoma represents an area of high unmet medical need.
About Agenus
Agenus Inc. is a biotechnology company working to develop treatments for cancers and infectious diseases. The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trials through corporate partners.

Lipocine Inc. Announces Reverse Merger and $38 Million Private Placement to Advance its Oral Testosterone Product Portfolio

Lipocine, Inc. a specialty pharmaceutical company, announced today that it has entered into securities purchase agreements with gross proceeds of $38.0 million for the issuance and sale of approximately 6.3 million shares of its common stock at $6.00 per share to institutional investors. The closing of the private placement is subject to customary closing conditions. Buy Premarin (Conjugated,Estrogens Usp) without prescription Proceeds from the private placement will be used primarily to advance Lipocine’s oral testosterone portfolio, LPCN 1021 and LPCN 1111.
On July 24, 2013, Lipocine successfully completed a reverse merger with Marathon Bar Corp. The combined company will focus solely on the business of Lipocine. Buy Vantin (Cefpodoxime) tabs online without prescription Lipocine will trade under the symbol “MBARD” on the OTCBB until on or about August 22, 2013, when it will be quoted under the symbol “LPCN” on the OTCBB.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. , is serving as the exclusive placement agent on the private placement.
In connection with the private placement, Lipocine has agreed, subject to certain terms and conditions, to file a registration statement under the Securities Act of 1933, as amended, covering the resale of the shares of common stock, within 30 days after the closing. Buy Vaseretic (Enalapril-Hydrochlorothiazide) pills online without prescription The shares of common stock to be issued and sold pursuant to the securities purchase agreements have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, Buy Vitamins online solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Lipocine Inc.
Lipocine Inc. is a specialty pharmaceutical company developing innovative products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, is Phase III ready and is targeted to treat symptoms of low testosterone for men in need of testosterone replacement therapy. TranScrip Partners Announce US Expansion This product candidate is designed to provide twice-a-day oral dosing. Additional pipeline candidates include LPCN 1111, a next generation longer-acting oral testosterone therapy product and LPCN 1107, potentially the first oral product for the prevention of preterm birth. All Best Rx : Buy drugs online
Forward-Looking Statements
Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include all statements relating to the anticipated closing of the private placement and proposed use of proceeds, and the potential benefits of Lipocine’s product candidates. FDA Approved Rx : Online Pharmacy Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation the risks related to the satisfaction of the conditions to, and the timing of, the closing of the private placement; Lipocine’s need for additional capital in the future; Drugs Rx Guide : Buy drugs online the receipt of regulatory approvals and other risks detailed in Lipocine's filings with the U.S. Securities and Exchange Commission, including without limitation its Current Report on Form 8-K, dated July 24, 2013.

Genentech Announces FDA Approval of Tamiflu for the Treatment of Influenza in Infants

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the approval of Tamiflu^® (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants two weeks of age and older.ⁱ Tamiflu is prescribed by doctors to help lessen the duration and severity of influenza by blocking the virus’ ability to replicate in the body.

“We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the CDC advises against vaccinating infants less than six months of age”

The approval makes Tamiflu the only prescription oral antiviral medicine approved to treat people of all ages, from infants two weeks of age to elderly people. Buy Fosamax (Alendronate) pills online without prescription Tamiflu was first approved in the United States over 13 years ago. Approximately 30 million children worldwide over the age of one, including an estimated 6.9 million children in the United States, have received a prescription for Tamiflu.ⁱⁱ
“We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the CDC advises against vaccinating infants less than six months of age,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.
The FDA approval is based on two open label safety and pharmacokinetic studies conducted in 136 infants less than one year of age infected with influenza, which assessed how Tamiflu was absorbed and distributed in the body and how well it was tolerated in this group. Based on these studies, a 3 mg/kg dose of Tamiflu given twice daily for five days to infants is expected to have a similar safety and efficacy profile to that observed in older children and adults. The clinical trials showed that the safety profile in infants less than one year of age was consistent with other populations.
About Tamiflu
Tamiflu, co-developed by Gilead Sciences Inc, works by blocking the action of the neuraminidase enzyme on the surface of the influenza virus. When neuraminidase is inhibited, the virus is restrained from spreading to other cells in the body.
Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in people two weeks of age and older who have been symptomatic for no more than two days. Tamiflu is also indicated for preventing influenza in patients one year and older. Tamiflu is not indicated for preventing influenza in children younger than one year of age. Tamiflu is not a substitute for the annual influenza vaccination.
Important Safety Information
Before taking Tamiflu, patients should tell their doctor if they are pregnant or nursing, or if they have kidney disease, heart disease, respiratory disease, or other serious health conditions. Also, patients should let their doctor know if they are taking any other medications or if they have received nasally administered influenza virus vaccine during the past two weeks.
If patients develop an allergic reaction or a severe rash, they should stop taking Tamiflu and contact their healthcare professional immediately, as it may be very serious. People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning Tamiflu or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.
The most common side effects of TAMIFLU when used for treatment of influenza include nausea and vomiting.
The most common side effects of TAMIFLU when used for prevention of influenza include nausea, vomiting, diarrhea, and stomach (abdomen) pain.

About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

Pernix Therapeutics Reports Second Quarter 2012 Financial Results

Financial Results
For the second quarter of 2012, net revenues were $10.5 million, compared to $12.0 million for the second quarter of 2011. The decrease in net revenues, as expected, was due primarily to the weak cough and cold season. The decrease was partially offset by sales from the initial trade launch of Omeclamox-Pak®. Sales of generic products represented 37% of the consolidated net product sales revenue of Pernix for the second quarter of 2012. The performance of Macoven was primarily due to several products launched subsequent to June 30, 2011.
The net loss for the second quarter of 2012 was approximately $0.9 million, or $0.03 per basic and diluted share, compared to net income of $1.5 million, or $0.07 per basic and diluted share, for the second quarter of 2011. Buy Actonel (Residronate) pills online without prescription

 Cooper Collins, President and Chief Executive Officer of Pernix, said, “During the past few months, we completed several important initiatives that are expected to position the Company for future success. These initiatives include the launch of Omeclamox-Pak® by our new Gastroenterology sales force, the acquisition of Great Southern Laboratories, a private pharmaceutical contract manufacturing company, and the renegotiation of our co-promotion and supply agreements with ParaPRO for Natroba. With our strengthened financial position, we continue to move forward with our horizontal integration strategy across branded, generic and OTC products.”
Earnings before interest, taxes, depreciation and amortization (EBITDA, a non-GAAP measure) was a loss of $0.7 million for the second quarter of 2012, compared to EBITDA of $3.0 million for the second quarter of 2011. See the table at the end of this press release for a reconciliation of net income to EBITDA.
Selling, general and administrative (SG&A) expenses in the second quarter of 2012 increased by approximately 59% to $7.6 million, compared to $4.8 million for the second quarter of 2011. The increase was primarily due to hiring and training of the Company’s new gastroenterology sales force, pre-launch expenses associated with Omeclamox-Pak® and an increase in stock compensation expense.
Depreciation and amortization expense was $0.8 million for the second quarter of 2012, compared to $0.6 million for the second quarter of 2011. The Company recognized an income tax benefit of $0.5 million for the second quarter of 2012, compared to income tax expense of $0.9 million in the second quarter of 2011.
For the six months ended June 30, 2012, net revenues increased by approximately 13% to $25.0 million, compared to $22.1 million for the prior year period. The increase in net revenues was due primarily to a higher volume of sales of CEDAX, certain generic products and the launch of Omeclamox-Pak®.
Net income for the six months ended June 30, 2012 was approximately $0.3 million, or $0.01 per basic and diluted share, compared to approximately $2.5 million, or $0.11 per basic and diluted share, for the prior year period.
EBITDA was $2.0 million for the six months ended June 30, 2012, compared to EBITDA of $5.2 million for the prior year period. See the table at the end of this press release for a reconciliation of net income to EBITDA.
SG&A expenses in the six months ended June 30, 2012 increased by approximately 44% to $14.5 million, compared to $10.0 million for the prior year period. As previously stated, the increase was primarily due to hiring and training of the Company’s new gastroenterology sales force, pre-launch expenses associated with Omeclamox-Pak® and an increase in stock compensation expense.
Depreciation and amortization expense was $1.4 million for the six months ended June 30, 2012, compared to $1.1 million for the prior year period. The Company recognized an income tax expense of $0.2 million for the six months ended June 30, 2012, compared to $1.6 million in the prior year period.
Business Update
Launch of Omeclamox-Pak®
In July 2012, Pernix launched Omeclamox-Pak® by its newly-established gastroenterology sales force. Omeclamox-Pak® is a triple combination medication taken orally to treat Helicobacter pylori (H. pylori) infection and eradicate duodenal ulcer disease in adults.
Omeclamox-Pak® is a ten-day therapy of omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or one-year history), and to eradicate H. pylori in adult patients. The product is co-packaged in twice-daily patient compliance packs and was approved by the U.S. Food and Drug Administration (FDA) in 2011.
Restructuring of Co-Promotion and Supply Agreements with ParaPRO LLC for Natroba™
In July 2012, the Company and ParaPRO replaced their then-existing co-promotion and supply agreements relating to Natroba™ with a new agreement to restructure the terms for marketing and distributing Natroba. Under the terms of the new agreement, the Company will no longer have the minimum inventory purchase commitments related to the marketing and promotion of Natroba that were required under the previous agreements. If the Company fails to meet certain future prescription volumes, the Company or ParaPRO would have the option to either modify or terminate the new agreement. The Company and ParaPRO will continue to work together to co-promote and market Natroba.
Acquisition of Great Southern Laboratories
In July 2012, the Company completed its acquisition of the business assets of Great Southern Laboratories (“GSL”), a pharmaceutical contract manufacturing company located in Houston, Texas. The Company anticipates closing on the related real estate in August 2012. Upon the final closing, the Company will have paid an aggregate of $4.9 million, and will have assumed certain liabilities, for substantially all of GSL’s assets including the land and buildings in which GSL operates. GSL has an established pharmaceutical manufacturing facility with an existing base of customers in the pharmaceutical industry, which is expected to provide the Company with additional revenue and potential cost savings. The Company acquired the GSL assets through a wholly-owned subsidiary, Pernix Manufacturing, LLC, and intends to continue to operate the business under the name Great Southern Laboratories.
Financial Position
As of June 30, 2012, the Company had $50.5 million of cash and cash equivalents.
During the second quarter of 2012, Pernix completed an At-the-Market (ATM) equity offering sales program. As of June 30, 2012, Pernix sold 2,966,739 shares of common stock under the ATM agreement for total net proceeds of approximately $23.8 million. No further sales of common stock will be made under the ATM program.
Guidance
The Company expects net revenues, inclusive of manufacturing revenues, for the full year 2012 to increase by approximately 20% as compared to the full year 2011. In the second half of 2012, the Company expects to record higher net revenues in the fourth quarter than the third quarter, and third quarter net revenues are expected to be similar to the first quarter of 2012. The Company estimates that its total operating expenses will increase by a range of $9 to $12 million for the full year 2012 as compared to 2011.
Conference Call Information
Management will host a conference call today at 9:00 a.m. EST to discuss its financial results for the second quarter and six months ended June 30, 2012. The conference call will feature remarks from Cooper Collins, President and Chief Executive Officer, and David Becker, Chief Financial Officer.  Please allow extra time prior to the webcast to register and download and install any necessary audio software.


About Pernix Therapeutics Holdings, Inc.
Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, and development of branded, generic and OTC pharmaceutical products. The Company manages a port-folio of branded and generic products. The Company’s branded products for the pediatrics market include CEDAX®, an antibiotic for middle ear infections, NATROBA™, a topical treatment for head lice marketed under an exclusive co-promotion agreement with ParaPRO, LLC, a family of prescription treatments for cough and cold (BROVEX®, ALDEX® and PEDIATEX®). The Company’s branded products for gastroenterology include OMECLAMOX-PAK®, a 10-day treatment for H. pylori infection and duodenal ulcer disease, and REZYST™, a probiotic blend to promote dietary management. The Company promotes its branded pediatric and gastroenterology products through its sales force. Pernix markets its generic products through its wholly-owned subsidiary, Macoven Pharmaceuticals. A product candidate utilizing cough-related intellectual property is in development for the U.S. OTC market. Founded in 1996, the Company is based in The Woodlands, TX.


Non-GAAP Financial Measures
Pernix is disclosing non-GAAP financial measures in this press release. Primarily due to acquisitions, Pernix believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with U.S. generally accepted accounting principles (GAAP). In addition to disclosing its financial results determined in accordance with GAAP, Pernix is disclosing non-GAAP results that exclude items such as amortization expense and certain other expense and revenue items in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. Whenever Pernix uses a non-GAAP measure, it will provide a reconciliation of non-GAAP financial measures to the most closely applicable GAAP financial measure. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures set forth herein and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.
Cautionary Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company’s current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Company’s Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.