PHARMA NEWSLETTER OCT. 2011

Tianyin completes environmental assessment at JCM

03 October 2011

China-based Tianyin Pharmaceutical has completed the manufacturing environmental assessment (EA) at its 250-ton Jiangchuan Macrolide Facility (JCM).

The EA will assess plant operation, macrolide branded generics and active pharmaceutical ingredients (API) production.

The company should abide by regulatory guidelines in terms of surface and ground water environmental quality status, ambient air quality status, API production industrial ingredients recycling, disposal and management, exhaust emissions, waste water pre-treatment recycling and management, noise environmental impact and assessment.

The JCM project is said to have met the national industrial policy and environmental protection guidelines for clean production process using technologies.

FDA approves Sagent Clindamycin Injection

03 October 2011

Sagent Pharmaceuticals' Clindamycin Injection, USP, an antibiotic which helps treat bacterial infections has received approval by the US FDA.

Clindamycin treats serious infections caused by susceptible anaerobic bacteria, besides treating infections due to susceptible strains of streptococci, pneumococci, and staphylococci.

The latex-free injection which is expected to be launched in early 2012 will be available in three single-dose vial sizes.

Clindamycin features the company's PreventIV MeasuresSM packaging and labeling designed to aid in the reduction of medication errors.

Vegenics files cancer drug IND to FDA

03 October 2011

Vegenics, a subsidiary of Circadian Technologies, has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) to initiate clinical studies of VGX-100.

VGX-100 is a human antibody that acts against the human VEGF-C protein and is used to treat glioblastoma and metastatic colorectal cancers.

Circadian is also developing VGX-100 for a number of other cancer indications, as well as an agent to treat front-of the-eye diseases.

The data from the preclinical studies have shown that when combined with Avastin and chemotherapy, VGX-100 reduces tumour growth and tumour spread as well as improve tumour inhibition, over and above that of Avastin and/or chemotherapy alone.

Recent studies have also shown that during Avastin treatment VEGF-C acts as a key mediator of disease progression, and when combination therapy of Avastin and VGX-100 are administered it improves treatment outcomes in cancer patients.

Circadian Technologies CEO Robert Klupacs said the company expects to start its first in man Phase I studies as soon as possible after FDA review.

Neuralstem earns patent allowance for neuronal growth compounds

05 October 2011

Neuralstem has received patent allowance for 'Compositions to Effect Neuronal Growth,' the compounds that effect neuronal growth.
The patent includes both structure and method claims for inducing neurogenesis and the growth of new neurons, both in-vitro and in-vivo.
Neuralstem announces Notice of Allowance for two additional neurogenic compound patents.
The company's first neurogenic patented compound, NSI-189 is currently in a Phase I FDA-approved safety trial in major depressive disorder.
The Phase Ib portion of the trial, in depressed patients, is likely to begin this fall

Ventana secures FDA approval for H. pylori antibody

05 October 2011

Ventana Medical Systems has secured 510(k) clearance from the Food and Drug Administration (FDA) for its H. pylori antibody.
The Ventana H. pylori antibody is used in the detection of Helicobacter pylori, a bacterium which causes chronic gastritis, ulcers and stomach cancer.
The antibody helps in accurate patient diagnosis as the high contrast staining of the organisms, using immunohistochemical (IHC) staining allows pathologists to view more bacteria than can be detected with special stains.
Ventana staff pathologist Dr. June Clements said the H. pylori IHC test is an improvement to what is currently available for the diagnosis of H. pylori in tissue.
"The clean background and clear staining make identifying the organisms easier and faster. This, along with the specificity, provides the pathologist more confidence in the diagnosis," Clements added.

BioAlliance submits European registration dossier for Sitavir

05 October 2011

BioAlliance Pharma has submitted its Sitavir (acyclovir Lauriad) European registration dossier through a European decentralized procedure.
Sitavir is a mucoadhesive buccal tablet used to treat recurrent orofacial herpes in immunocompetent patients presenting more than 4 episodes a year.
The drug delivers high concentrations of the active ingredient in the sites of the herpes infection like mucosa and lips.
The European registration dossier is based on the results of the pivotal phase III clinical trial conducted in 775 patients.
BioAlliance CEO Judith Greciet said the submission of Sitavir registration dossier represents a highly significant step for the company.
"With an overall sales potential estimated between €150 and €200 millions, Sitavir® is becoming a valuable asset to future strategic partnerships," Greciet added.

Ridaforolimus receives FDA approval as NDA filing

05 October 2011

The US Food and Drug Administration (FDA) has accepted filing and review of the New Drug Application (NDA) for ridaforolimus, by Merck and Ariad Pharmaceuticals.
Ridaforolimus is an investigational oral mTOR inhibitor to treat metastatic soft-tissue or bone sarcomas in patients who responded to chemotherapy.
The European Medicines Agency had earlier accepted the marketing authorization application for ridaforolimus.
Merck is known for the development and worldwide commercialization of ridaforolimus in oncology.

Ultragenyx UX001 receives orphan drug designation

05 October 2011

Ultragenyx Pharmaceutical has received the orphan drug designation for UX001 for the treatment of hereditary inclusion body myopathy (HIBM) from FDA Office of Orphan Products Development.
UX001 is an extended release formulation of sialic acid intended as a substrate replacement therapy for HIBM which is caused due to sialic acid deficiency.
The company initiated the first pharmacokinetic and safety trial of UX001 in humans in August 2011.
The data is expected to release later this year.
Ultragenyx CEO Emil D Kakkis said the FDA's decision to grant UX001 orphan drug designation is an important milestone for the HIBM clinical program and underscores the urgency of the need for a safe and effective treatment for this rare and debilitating neuromuscular disease.

FDA apporves Cialis to treat erectile dysfunction

07 October 2011

The US Food and Drug Administration (FDA) has approved Cialis (tadalafil) tablets by Eli Lilly and Company for once daily use to treat men who have erectile dysfunction and symptoms of benign prostatic hyperplasia (ED+BPH).
Cialis inhibits an enzyme, phosphodiesterase type 5 (PDE5), producing vascular relaxation and increased blood flow.
Cialis was assessed in a clinical trial program of three placebo-controlled efficacy and safety studies, comprising 1,989 men.
One study was specific to men with both ED and BPH, while two of these studies were carried out in men with only BPH .
In the ED+BPH study, Cialis 5 mg for once daily use demonstrated an improved score on International Index of Erectile Function-Erectile Function Domain (IIEF-EF), and the International Prostate Symptom Score (IPSS

 FDA approves combination therapy Juvisync

Oct 7 2011

The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.
About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.
Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.
“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients.  Dose selection should factor in what other drugs the patient is taking.”
Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Watson, Amphastar receive TRO on Enoxaparin

10 October 2011

The US District Court for Massachusetts has granted a request by Momenta Pharmaceuticals and Sandoz for a temporary restraining order (TRO) to stop Watson and Amphastar from selling Amphastar's Enoxaparin Sodium Injection product.
The injection product is a generic equivalent to Sanofi-aventis Lovenox.
Enoxaparin is a low molecular weight heparin for treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction
The temporary restraining order expires on 21 October.
Watson expects to launch the product during the fourth quarter of 2011 if the plaintiffs' request for a preliminary injunction is denied, the company said.

Combivent respimat for COPD receives FDA approval

10 October 2011

The US Food and Drug Administration (FDA) has approved Boehringer's Combivent respimat, an inhalation spray for the treatment of chronic obstructive pulmonary disease (COPD).
Combivent respimat, which is a propellant-free inhaler product uses a slow-moving mist to deliver the same active ingredients of Combivent Inhalation Aerosol in a metered dose inhaler (Combivent MDI).
Combivent MDI and Combivent respimat are short-acting bronchodilator products that offer two different medicines in a single inhaler.
The efficacy of the spray was studied in a 12-week, randomized, double-blind, placebo and active-controlled clinical trial.
The data demonstrated that Combivent respimat was clinically comparable to Combivent MDI, in terms of FEV1, which is the maximal amount of air that can be forcefully exhaled in one second.

Merck Juvisync for Type 2 Diabetes receives FDA approval

10 October 2011

The US Food and Drug Administration (FDA) has approved Juvisync (sitagliptin and simvastatin) by Merck for treatment of type 2 diabetes and lowering cholesterol.
Juvisync combines Januvia (sitagliptin), the glucose-lowering medication with the cholesterol-lowering medication Zocor (simvastatin).
According to the company, Juvisync is said to provide blood sugar-lowering benefits of a DPP-4 inhibitor and the cholesterol-lowering benefits of simvastatin, with a dose of single tablet in a day.
The approval by FDA is followed by clinical bioequivalence studies in healthy subjects who showed administration of Juvisync is equivalent to co-administration of corresponding doses of the two individual

Oxycodone by Indian firm receives tentative FDA approval

10 October 2011

Indian manufacturer of drugs, Taj Pharmaceuticals has secured tentative approval from the US FDA for Abbreviated New Drug Application (ANDA), to make and sell Drug Oxycodone Tablets 5 to 30 mg in the UK and European Market.
Oxycodone is a narcotic pain-reliever and cough suppressant similar to morphine, codeine, and hydrocodone.
The drug does not eliminate the sensation of pain but provides comfort by increasing tolerance to pain, besides causing sedation and respiratory depression.
Generally, the starting dose using immediate release oxycodone tablets is 5 to 30 mg every 4 hours.

Banner submits ANDA for Targretin

11 October 2011

US-based Banner Pharmacaps has submitted its Abbreviated New Drug Application (ANDA) for Bexarotene 75 mg soft gelatin capsules to be reviewed by the US Food and Drug Administration (FDA).

Bexarotene capsules are used to treat cutaneous T-cell lymphoma (CTCL skin cancer) and are a generic version of Targretin.

Following FDA approval, the company expects to qualify for 180 days of generic marketing exclusivity.

Banner president and CEO Roger Gordon said the ANDA filing of Bexarotene would be an important milestone in the growth of the company's Rx portfolio.

Prolor receives NOA for CTP-modified interferons

11 October 2011

The US Patent and Trademark Office (USPTO) has sent a notice of allowance (NOA) regarding a patent application covering Prolor Biotech's CTP-modified interferons.
The company applies its patented Carboxyl Terminal Peptide (CTP) technology and its Reversible Pegylation technology to develop longer-acting, proprietary versions of already approved therapeutic proteins.
The CTP technology is applicable to all proteins and the Reversible Pegylation technology is well-suited for use with peptides and small molecule therapeutics.
Interferons like alfa and beta are proteins produced in response to the presence of tumor cells or pathogens and are used to treat hepatitis B and C virus infections, multiple sclerosis and hematological malignancies, such as leukemia and lymphomas.
Prolor president Shai Novik said once issued, these allowances should strengthen the intellectual property portfolio that they are creating around their CTP technology.

FDA approves Edgemont 60 mg depression drug

12 October 2011

The US Food and Drug Administration (FDA) has approved Edgemont Pharmaceuticals' new drug application (NDA) for Fluoxetine Tablets 60 mg.
Edgemont's Fluoxetine 60 mg tablet is a single pill which is used to treat major depressive disorder, obsessive compulsive disorder in adults and pediatrics, and bulimia nervosa and panic disorder in adults.
The tablets also have a functional score to allow for a convenient half-tablet 30 mg dosing option.
Edgemont president and CEO Douglas Saltel said by reducing the number of pills per dose from three pills to one, they are hopeful that their Fluoxetine 60 mg tablets may help patients be more therapy compliant.
"This is an especially important goal for the higher milligram dose patients that may be having trouble controlling their symptoms of depression," Saltel said.

Helix BioPharma submits Clinical Hold Response for Alpha-2b trial

13 October 2011

Helix BioPharma has filed IND clinical hold response with FDA for its planned topical interferon Alpha-2b phase II/III efficacy trial.
Alpha-2b incorporates the company's Biphasix drug delivery technology and provides a better means of delivering interferon-alpha-2b therapeutically to human papillomavirus (HPV) infected tissues.
FDA will take 30 days to review the process and make a decision if an applicant can proceed with its proposed clinical trial.
Following FDA approval, the company said it will require additional funding as well as strategic partner support to commence the pending US Phase II/III trial.

Rexahn secures US patent for anti-cancer drug

13 October 2011

Rexahn Pharmaceuticals has received US patent from United States Patent & Trademark Office for arylisoquinolinamine derivatives which are anti-cancer in nature.
The patent specifically covers the company's RX-8243 which is currently in pre-clinical development.
According to the company, RX-8243 has demonstrated potent anti-tumor properties in many cancer cell lines, besides paclitaxel-resistant human colorectal xenograft models.
The drug candidate also showed cytotoxic effect when combined with other cancer drugs against human cancer cells.
Rexahn president Rick Soni said the US patent marks an important step in the development of RX-8243.

DermSafe hand sanitizing lotion receives DRP Seal of Approval

13 October 2011

Skinvisible, a provider of dermatological and medical products, has received the 'Seal of Approval' from the Dermatology Review Panel (DRP) for its DermSafe Hand Sanitizing Lotion.
DRP tested Skinvisible's scientific data and validated the claims which said DermSafe is alcohol-free, offers protection from harmful bacteria, resists wash-off besides providing a moisture barrier for the hands.
The DRP Seal of Approval helps consumers and medical professionals easily identify products that are in compliance with the approval standards of the panel.
Alto Pharmaceuticals markets the sanitizing lotion in Canada.

Galenica submits Injectafer NDA to US FDA

14 October 2011

Galenica's US partner Luitpold Pharmaceuticals has submitted a New Drug Application (NDA) with the US FDA for Injectafer used to treat iron deficiency anaemia.
Injectafer is a non-dextran intravenous iron (i.v.) replacement therapy containing ferric carboxymaltose as its active pharmaceutical ingredient.
The NDA includes the data from two randomized controlled clinical trials which assessed the cardiovascular risk profile of Injectafer.
Of the two large scale, multi-center, randomized clinical trials, one trial compares Injectafer to Venofer (iron sucrose injection) in patients with iron deficiency anaemia and chronic kidney disease.
The second study compares Injectafer to either oral or intravenous (i.v.) iron (standard of care therapy) in patients with iron deficiency anaemia of various etiologies.

COTI-2 for cancer treatment secures US patent

14 October 2011

Critical Outcome Technologies (COTI) has received US patent for its oncology drug candidate, COTI-2, by United States Patent and Trademark Office (USPTO).
The compound has been discovered by the company's Artificial Intelligence drug discovery process, CHEMSAS.
The specific cellular targeting, low toxicity, and efficacy of the drug candidate help in treatment of cancers that over express Akt/Akt2.
COTI CEO Wayne Danter said the US patent provides validation of CHEMSAS, and its ability to discover novel small molecules.
"This patent provides protection for COTI-2 until 2030 and is a valuable asset to us in the advancement of our licensing initiatives," Danter added.

Noven registers lawsuit in US District Court against Watson

14 October 2011

Noven Pharmaceuticals has registered a patent infringement lawsuit against Watson Pharmaceuticals in the US District Court of New Jersey for infringement of certain patents of Noven.
The lawsuit was registered for submission of an abbreviated new drug application (ANDA) to the
US Food and Drug Administration's (FDA) prior to the expiration of Noven's patents in 2018 for approval of a generic version of its Daytrana (methylphenidate transdermal system).
Noven is engaged in the research and development of prescription pharmaceutical products.
Noven mainly focuses on three areas including transdermal drug delivery and related manufacturing, the Novogyne joint venture, and Noven Therapeutics, Noven's specialty pharmaceutical unit.

Insmed receives FDA notification over Arikace in NTM treatment

17 October 2011

Insmed, a biopharmaceutical company, has received notification from the US FDA on the continuation of the clinical hold previously placed on phase 3 clinical trial for Arikace (liposomal amikacin for inhalation) to treat non-tuberculous mycobacterial (NTM) lung disease.
The clinical holds placed on the trial were based on an initial review by FDA of the interim results of a long-term rat inhalation carcinogenicity study reported to the agency.
FDA had requested additional information on Arikace and data from the rat study as it had insufficient information to assess the risks of Arikace in NTM patients in the planned phase 3 clinical trial.
The agency has called for a phase 2 clinical trial in adult NTM patients intended to provide proof-of-concept efficacy and safety data for Arikace before the company can proceed with a phase 3 clinical trial.

Ferriprox receives FDA approval to treat iron overload

17 October 2011

The US Food and Drug Administration approved of deferiprone (Ferriprox Tablets, ApoPharma), as an oral iron chelator to treat patients with transfusional iron overload due to thalassemia syndromes.
The approval followed previously conducted trials enrolling patients with transfusional iron overload and evidence of inadequate iron removal despite previous treatment with deferoxamine.
The standard of care to treat transfusional iron overload is chelation therapy, where chemical agents that are used to remove heavy metals from the body.
Ferriprox is intended for use when chelation therapy is inadequate.

Watson files ANDA for Atelvia with FDA

18 October 2011

Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has filed Abbreviated New Drug Application (ANDA) with the US FDA, seeking approval to market Risedronate Sodium Delayed-release Tablets (Atelvia), 35 mg to treat postmenopausal osteoporosis.
Warner Chilcott (US) and Warner Chilcott Company had filed suit against Watson seeking to prevent Watson from commercializing its product.
The lawsuit which was filed under the provisions of the Hatch-Waxman Act resulted in a stay of final FDA approval of Watson's ANDA.
Following the approval of ANDA for the drug, the company hopes to be entitled to 180 days of generic market exclusivity.

FDA approves Oxford BioMedica UshStat for Usher syndrome

18 October 2011

Oxford BioMedica has received approval by the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the Phase I/IIa clinical development of UshStat, to treat Usher syndrome type 1B.
UshStat was developed using LentiVector platform technology, which is a gene delivery system, with applications in product development and discovery research.
The open label, dose escalation Phase I/IIa study will enrol around 18 patients with Usher syndrome type 1B at the Oregon Health and Science University's Casey Eye Institute, Portland, Oregon.
The trial, which is likely to begin by the end of 2011, will assess three dose levels for safety, tolerability and aspects of biological activity.

Perrigo files NDA for generic version of Patanase nasal spray

19 October 2011

Perrigo Company has filed an Abbreviated New Drug Application (ANDA) with the US FDA for the generic version of Patanase nasal spray and has notified Alcon Laboratories which manufactures the spray.
Alcon Labs had filed a lawsuit against Perrigo on 14 October 2011 alleging patent infringement.
Patanase (olopatadine hydrochloride) nasal spray helps provide relief from the symptoms of seasonal allergic rhinitis.

Perrigo chairman and CEO Joseph C Papa said the filing marks their investment in new products and expansion of product portfolio.

Par Pharma gains rights to Teva Pharma products

19 October 2011

Par Pharmaceutical, a manufacturer of generic drugs and niche pharmaceuticals, has gained rights to Teva Pharmaceuticals' three products.
As per the agreement, Par will own the abbreviated new drug application (ANDA) of fentanyl citrate lozenges, a generic version of Actiq.
It will also own ANDA of cyclobenzaprine ER capsules, the generic version of Amrix, as well as the US rights to market modafinil tablets, the generic version of Provigil.
Par is currently shipping all strengths of fentanyl citrate lozenges to the trade that were previously available from Teva.
Cyclobenzaprine ER capsules and modafinil tablets were not previously marketed by Teva and are not yet available.

Insight Pharmaceuticals recalls nasal decongestant over bacterial contamination

20 October 2011

Insight Pharmaceuticals has issued a voluntary recall of one lot of Nostrilla Nasal Decongestant nasal spray as it has the potential to be contaminated with bacteria Burkholderia cepacia.
Internal investigations revealed the presence of a microbial contaminant that exceeds the product specifications which may subsequently result in a subpar product.
The product bearing the UPC Code, 6373673005, was distributed in the US through retail outlets and pharmacies.
Burkholderia cepacia can cause serious infection in individuals with a weak immune system or chronic lung condition.
The company, however, said that no illnesses have been reported.

US FDA grants approval to use BYETTA with insulin glargine

20 October 2011

  The US Food and Drug Administration (FDA) has approved the use of BYETTA (exenatide) injection by Amylin Pharmaceuticals, as an add-on therapy to insulin glargine for adults with type 2 diabetes.
BYETTA is a glucagon-like peptide-1 (GLP-1) receptor agonist which shows similar effects as the human incretin hormone GLP-1, according to Eli Lilly and Company .
A study conducted to evaluate the efficacy of the product demonstrated that patients who received BYETTA in addition to insulin glargine showed better reduction in A1C (a measure of average blood sugar over three months) as compared to those treated with insulin glargine alone.
The primary endpoint was reduction in A1C and the secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health, hypoglycemia and patient-reported outcomes.

Nutra Pharma wins patent for MS drug

20 October 2011

Nutra Pharma's subsidiary, ReceptoPharm, has received patent for its Multiple Sclerosis (MS) drug from the United States Patent and Trademark Office (USPTO).

The patent, 'Modified anticholinergic neurotoxins as modulators of the autoimmune reaction' describes a composition of matter and method of its use to treat multiple sclerosis in humans.
The composition is a modified anticholinergic alpha-neurotoxin.
Nutra Pharma CEO Rik J Deitsch said such patents are key to the continuing development of their pipeline and provide the value for eventual commercialization of the technology or out-licensing of the drugs.
"We currently own or license twelve patents that protect a broad range of drug and medical device technologies," Deitsch added.

 Vertex files cystic fibrosis drug NDA with FDA

  20 October 2011

Vertex Pharmaceuticals has submitted a new drug application (NDA) for priority review to the US Food and Drug Administration (FDA) for approval of Kalydeco to treat cystic fibrosis (CF).
Kalydeco was studied among people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The NDA includes Phase 3 pivotal studies results which showed sustained improvements in lung function and other measures of disease in people with CF.
The company said if the NDA is granted, the FDA's review time would get shortened from 10 to 6 months.
Vertex also plans to submit a marketing authorization application (MAA) for Kalydeco with the European Medicines Agency (EMA) and if granted will shorten the review time from 210 days to 150 days following the start of the review.
Vertex has also submitted requests to the FDA and EMA to use the trade name KALYDECO (ivacaftor) for VX-770.
Vertex Global Research and Development CSO and executive vice president Peter Mueller said they look forward to working with US and European regulatory agencies to make Kalydeco available as quickly as possible.

Prasco selected as Eli Lilly authorized generics partner for Zyprexa

20 October 2011

Privately-held US drugmaker Prasco Laboratories says it has signed a marketing and distribution agreement with Eli Lilly  (NYSE: LLY) to market the authorized generic version of the drug major’s blockbuster schizophrenia and bi-polar disorder agent Zyprexa (olanzapine) tablets and Zyprexa Zydis (olanzapine) orally disintegrating tablets, in the US, where it loses patent protection on October 23.

Prasco will begin distribution of both products on the first ANDA entrant into the market. Prasco will market all six strengths of Olanzapine Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg. Olanzapine Orally Disintegrating Tablets will be available in 5mg, 10mg, 15mg, and 20mg strengths.

Zyprexa, which lost exclusivity in Europe last month, generated third-quarter 2011 sales of $1.18 million for Lilly, of which $563 million came from the USA. The financial terms of the agreement with Prasco were not disclosed.

Prasco says it is established as the “Authorized Generics” company, having brought more authorized copy drugs to market than any other firm by offering generic products that are identical to the brand product. "Prasco partnerships with brand companies offer alternatives for consumers and pharmacists that are specific and measurable. This is especially true with the olanzapine launch through our new Lilly relationship," said the firm’s chief executive Thomas Arington.

Taj Pharma receives FDA approval to manufacture Papaverine

21 October 2011

Taj Pharmaceuticals of India has received tentative approval from the US FDA to manufacture and sell Drug Papaverine capsules 150 mg to market in European Market.
Papaverine, an opium alkaloid is used to treat visceral spasm, vasospasm, and erectile dysfunction, besides being used as a smooth muscle relaxant in microsurgery.
The FDA held Papaverine in its priority review for new molecular entity (NME) for more than 3 years.
Taj Pharmaceuticals makes pharmaceutical formulations and API for India and other countries.

Amarantus gets US patent for apoptosis drug

21 October 2011

Amarantus BioSciences has got notice of allowance (NOA) for its US patent application on discovery of mesencephalic astrocyte-derived neurotrophic factor (MANF).
MANF is a potent neurotrophic factor which is used to treat apoptosis-related diseases including Parkinson's disease.
Amarantus claims to protect its compositions of matter and methods of use for MANF, and other related compounds in the patent.
Amarantus BioSciences CEO Martin Cleary said the new patent will further protect its intellectual property as the company expands its pipeline of first-in-class therapeutics to address a number of indications.
The company said MANF is currently in pre-clinical development.

Newron gets back safinamide global rights from Merck Serono

24 October 2011

Newron Pharmaceuticals, which specializes in development of novel CNS and pain therapies, has regained global rights to safinamide from Merck Serono, a subsidiary of Merck KGaA.
Newron will now re-assess all the opportunities for safinamide including re-partnering the compound at some stage.
Newron can also pursue marketing of this new chemical entity for Parkinson's disease in selected territories.
According to the agreement signed in 2006, Merck Serono has confirmed that it will meet its contractual and ethical commitments concerning the ongoing clinical development program for safinamide until April 2012.
Merck said the move has been made on strategic considerations and re-prioritization of its R&D pipeline, and is not based on any new efficacy or safety findings with safinamide.

Cephalon returns Lupuzor rights to ImmuPharma

24 October 2011

ImmuPharma, which focuses on discovery and development of pharmaceuticals has regained rights to Lupuzor from Cephalon, following its acquisition by Teva Pharmaceutical Industries.
ImmuPharma and Cephalon had signed an option agreement in 2008,when the ImmuPharma designed and funded Phase IIb study was ongoing.
ImmuPharma was paid $15m by Cephalon before the results of the phase IIb study for the exclusive option to enter into the worldwide license.
Following positive results of the ImmuPharma phase IIb study in early 2009, Cephalon exercised its option by paying a further $30m for an exclusive worldwide license, which was a part of an agreement worth $500m.
Cephalon took over the responsibilities and costs for the development and commercialisation of Lupuzor, after the completion of the license agreement.
Ferring Euflexxa receives FDA approval

24 October 2011

Labeling supplement for Euflexxa (1% sodium hyaluronate) by Ferring Pharmaceuticals has been approved by the US FDA, which has shown 26-week efficacy data from the Flexx trial and 52-week safety data to demonstrate the safety of repeated injection cycles.
Euflexxa is a bioengineered, non-avian product which provides relief from osteoarthritis knee pain, especially when simple pain medications such as acetaminophen or from exercise and physical therapy do not provide enough relief.
The 26-week multicenter, randomized, double-blind Flexx trial which enrolled 588 patients assessed the safety and efficacy of Euflexxa to treat osteoarthritis of the knee as compared to saline.
The study showed that patients treated with Euflexxa had a decrease in osteoarthritis knee pain versus saline control injections treated patients.

Watson testosterone transdermal delivery system wins FDA approval

24 October 2011

The US Food and Drug Administration (FDA) has approved Watson Pharmaceuticals' Androderm (testosterone transdermal system) 2 mg and 4 mg formulation, which is likely to be launched in November 2011.
Androderm,a once daily skin patch, called a transdermal delivery system, is a testosterone replacement therapy in males with a deficiency or absence of endogenous testosterone. It delivers consistent, controlled concentrations of testosterone through the skin.
The new testosterone patch which comes in smaller size and lower-dose provides 20% reduction in the active ingredient from the original strength in a smaller patch size.
The approval occured following a trial that demonstrated 97% of the subjects achieved testosterone concentrations within the normal range after 28 days of daily therapy.



FDA approves Boca Glycopyrrolate Tablet ANDA

24 October 2011

The US Food and Drug Administration (FDA) has approved Boca Pharmacal's Glycopyrrolate Tablets' USP, 1 mg and 2 mg abbreviated new drug application (ANDA).
Glycopyrrolate tablets are used as adjunctive therapy to treat peptic ulcers.
Glycopyrrolate Tablets USP, 1 mg and 2 mg are generic equivalent to Robinul Tablets, 1 mg and Robinul Forte Tablets, 2 mg, distributed by Shionogi Pharma.

Boca Pharmacal CEO Robert Edwards said they are continuing to file new ANDAs, and will keep doing so in their ongoing effort to provide generic products to their customers and patients.

Prezista receives FDA approval for label update

24 October 2011

Janssen Therapeutics has received approval from the US Food and Drug Administration (FDA) for the label update of its Prezista (darunavir)tablets to include 192-week data from the Artemis study in HIV patients.
Artemis (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects), an international, randomized, controlled, open-label, non-inferiority, Phase 3 trial compared the efficacy and safety of Prezista/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients.
The 192 week trial demonstrated that 70% of patients in the Prezista/r arm reached an undetectable viral load as compared to 61% of patients in the lopinavir/r arm.
Virologic failure was 12% in the Prezista/r arm and 15% in the lopinavir/r arm.
Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Janssen Therapeutics.

FDA approves ANDA for Lannett Diethylpropion HCl tablets

25 October 2011

The US FDA has approved Lannett Company's Abbreviated New Drug Application (ANDA) for Diethylpropion HCl Extended Release Tablets, 75 mg.
Diethylpropion HCl, like many anti-obesity drugs, is primarily sold to bariatric clinics, the company said.
Lannett president and CEO Arthur P Bedrosian said the approval would add to their line of anti-obesity medications.
"Our pipeline remains deep, with a number of ANDAs currently pending at the FDA, several of which we expect to be approved over the next couple of quarters," Bedrosian added.

Ironwood, Forest announce FDA approval for Linaclotide NDA

25 October 2011

Ironwood Pharmaceuticals and Forest Laboratories have announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for linaclotide to treat irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).
Linaclotide, an investigational drug, is an agonist of the guanylate cyclase type-C (GC-C) receptor located on the luminal surface of the intestine.
The NDA for linaclotide was submitted for the treatment of IBS-C and CC following efficacy and safety results from a Phase 3 program.
The program, which included four double-blind placebo-controlled trials and two open-label long term safety studies, enrolled over 2,800 patients received a once-daily dose of either linaclotide or placebo.

Atox Bio secures orphan drug designation for AB103

26 October 2011

Atox Bio has received orphan drug designation by FDA, for AB103 to treat necrotizing soft tissue infections (NSTI).

AB103 is a short peptide acting as a CD28 modulator which regulates the inflammatory response in the host.
The drug candidate is said to have completed a phase 1 study and expects to go into a phase 2 proof of concept study to assess its clinical benefit.
Atox Bio CEO Dan Teleman said orphan drug designation for AB103 marks an important milestone for their clinical program.
"We look forward to continue working cooperatively with the agency to advance this potentially important new therapy through the clinical testing and regulatory process" Teleman added.

EC approves extended use of Prevenar 13 for adults

27 October 2011

The European Commission (EC) has approved Pfizer's pneumococcal polysaccharide conjugate vaccine - Prevenar 13 - as an extended use drug for adults aged 50 and older to treat invasive pneumococcal disease caused by Streptococcus pneumoniae.
The approval of Prevenar 13 was based on the review of clinical immunogenicity and safety data involving more than 6,000 adults aged 50 years and older.
Prevenar 13 uses company-pioneered conjugation technology and prevents invasive pneumococcal disease caused by the 13 serotypes contained in the vaccine and is for a single dose.

FDA approves Mylan Morphine Sulfate ER Tablets ANDA

27 October 2011

The US Food and Drug Administration (FDA) has approved Mylan's Morphine Sulfate Extended-release (ER) Tablets' abbreviated new drug application (ANDA).
Mylan's Morphine Sulfate ER tablets are available in different doses including 5 mg, 30 mg, 60 mg, 100 mg and 200 mg.
Morphine Sulfate ER Tablets, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg are generic equivalent to Purdue Pharma's MS Contin, an opioid analgesic for moderate to severe pain management.

Gilead submits NDA for Quad Tablet

28 October 2011

Gilead Sciences has submitted a New Drug Application (NDA) to the US FDA for marketing approval of the Quad, a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate to treat HIV-1 infection in adults.
Following approval, the Quad will be the only once-daily, single-tablet regimen containing an integrase inhibitor.
The submission of NDA was done on the back of positive data from two Phase 3 studies in which the Quad met its primary objective of non-inferiority.
Gilead Sciences Research and Development executive vice president and chief scientific officer Norbert Bischofberger said the Quad could evolve as a new treatment option for HIV and the company has reached an important milestone soon after the unblinding of the second Phase 3 study.

Alexza submits Adasuve MAA to EMA

28 October 2011

Alexza Pharmaceuticals has submitted Adasuve marketing authorization application (MAA) to the European Medicines Agency (EMA).
Adasuve utilizes the company's proprietary oral inhalation technology - Staccato system - which provides systemic delivery of a thermally-generated aerosol of loxapine.
The MAA seeks approval for the rapid control of agitation in adult patients with schizophrenia or with bipolar disorder.
Alexza Research and Development senior vice president James Cassella said in addition to information from the US NDA, their Adasuve MAA submission contains additional analysis of the primary efficacy data, and a comprehensive comparison of Staccato loxapine and other injectable drugs used to treat agitation.
NuPathe Zelrix Patch receives FDA rejection

28 October 2011

The New Drug Application (NDA) filed by NuPathe for its transdermal sumatriptan migraine patch (Zelrix), has been rejected by the FDA over chemical make-up and manufacturing issues.
According to FDA, the data provided by the company was insufficient regarding migrane indication, painmedicinenews.com reported.
NuPathe conducted a Phase III trial testing the efficacy of the transdermal patch, which showed that 70% of subjects reported no nausea, a common adverse event seen with oral triptans.
The company said it will provide additional information to the FDA.

Meda files Dymista MAA in Europe

28 October 2011

Meda has registered a marketing authorization application (MAA) of its Dymista in Europe.
The MAA includes the efficacy and safety data of several studies involving over 4,000 patients, and also includes a long-term safety study with more than 600 patients.
Dymista is formulated with azelastine hydrochloride and fluticasone propionate and is used as a nasal spray formulation to treat moderate to severe allergic rhinitis and rhinoconjuctivitis.

Avanir submits Nuedexta MAA to EMA

31 October 2011

Avanir Pharmaceuticals has submitted marketing authorization application to the European Medicines Agency (EMA) for Nuedexta used to treat pseudobulbar affect (PBA).
The MAA includes Nuedexta phase 3 studies clinical data of in patients with PBA and also includes data from the company's longer-term safety studies.
Nuedexta comprises dextromethorphan hydrobromide (20 mg), an ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.
NUEDEXTA acts on sigma-1 and NMDA receptors in the brain and treats PBA.

US court grants plea to prevent sale of Enoxaparin by Watson, Amphastar

31 October 2011

Watson has announced that the US court has granted preliminary injunction preventing Watson and Amphastar from selling Amphastar's Enoxaparin Sodium Injection, as requested by Momenta Pharmaceuticals and Sandoz.
Enoxaparin, a generic equivalent to Sanofi-aventis' Lovenox is a low molecular weight heparin used to treat deep vein thrombosis and prophylaxis in unstable angina and non-Q-wave myocardial infarction.
The US FDA has approved Amphastar's Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection in the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL,100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths.
The sole right to distribute Amphastar's Enoxaparin in the US retail pharmacy channel is held by Watson.

EC grants approval for Alimta in NSCLC treatment

31 October 2011

The European Commission (EC) has granted approval to Eli Lilly and Company for the use of Alimta (pemetrexed for injection) as a single agent for continuation maintenance therapy to treat advanced nonsquamous non-small cell lung cancer (NSCLC).
Clinical trial data which demonstrated an improvement in progression-free survival for NSCLC patients treated first with Alimta plus cisplatin and then with Alimta alone, led to the approval.
Continuation maintenance therapy with Alimta will help in treatment of a particular type of NSCLC, called nonsquamous, and in patients who have shown a positive response or disease stabilization after treatment with first-line Alimta plus cisplatin, the company said.
Lilly Oncology senior medical director Allen Melemed said the approval marks a significant step in the advancement of lung cancer treatment.
"With ALIMTA continuation maintenance therapy, patients with lung cancer who have already benefited from first-line treatment will now have the option to continue treatment with ALIMTA, with the goal of a better clinical outcome," Melemed added

FDA approves Pacira post surgical pain management product

31 October 2011

The US Food and Drug Administration (FDA) has approved Pacira Pharmaceuticals' Exparel for post surgical pain management.
Exparel is a multivesicular liposomal combined therapy product including bupivacaine with a delivery technology - DepoFoam.
Exparel with DepoFoam delivers bupivacaine for an extended period of time, providing analgesia for up to 72 hours.
University of California surgery associate professor Sonia Ramamoorthy said Exparel, a single dose administration, non-opioid therapy, has the potential to reduce or delay the use of opioids following inpatient and outpatient surgical procedures.

Vegenics receives FDA IND clearance for VGX-100 drug trial

31 October 2011

Vegenics, a subsidary of Circadian Technologies, has secured FDA approval for its Investigational New Drug (IND) application to commence clinical trials with VGX-100 drug, used to treat cancer patients with solid tumors.
VGX-100 is a human antibody that acts against the human VEGF-C protein.
VGX-100 when combined with Avastin and chemotherapy, demonstrated reduced tumour growth and tumour spread, and improved tumour inhibition, in animal models.
The Phase I study will evaluate VGX-100 in patients with a variety of late stage cancers.
Circadian Technologies CEO Robert Klupacs said the company expects to start clinical trials before the end of 2011, with results to be available in the second half of 2012.