PHARMA NEWSLETTER September 2011

Avanir sues Impax on Nuedexta

01 September 2011

Avanir Pharmaceuticals, Avanir Holding and Center for Neurologic Study have sued Impax Laboratories in the District of Delaware over patents listed in connection with Nuedexta (dextromethorphan hydrobromide and quinidine sulfate 20mg / 10mg) capsules.

Nuedexta is indicated for the treatment of pseudobulbar affect (PBA).

Impax has submitted a new drug application (ANDA) containing a paragraph IV certification for a generic version of Nuedexta with the US Food & Drug Administration (FDA).

Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the product

Theratechnologies submits tesamorelin MAA in Brazil

01 September 2011

Theratechnologies' commercial partner, an affiliate of Sanofi, has submitted a marketing authorization application (MAA) to register tesamorelin in Brazil with the National Health Surveillance Agency (ANVISA), a division of its Ministry of Health.

Tesamorelin is intended as a treatment for excess abdominal fat in HIV-infected patients with lipodystrophy.

Earlier in December 2010, Theratechnologies has given license to an affiliate of Sanofi to commercialize for tesamorelin in Latin America, Africa and the Middle East.

Theratechnologies president and CEO John-Michel Huss said this is the first regulatory application for tesamorelin in Latin America.

Roche Tarceva gets EC nod

01 September 2011

Roche has received the European Commission (EC) approval for Tarceva (erlotinib) to use in patients suffering from a genetically distinct type of non-small cell lung cancer (NSCLC) in Europe.
The approval allows Roche to use Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.
In previous studies, Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival - PFS) compared to chemotherapy.
Roche Global Product Development head and chief medical officer Hal Barron said the European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment.

FDA approves Lupin Tramadol HCl ER Tablets ANDA

01 September 2011

The US Food and Drug Administration (FDA) has approved Lupin Pharmaceuticals' Tramadol Hydrochloride Extended-Release Tablets' (Tramadol HCl ER) 100, 200 and 300 mg abbreviated new drug application (ANDA).
Tramadol HCl ER is a centrally acting synthetic analgesic in an extended release formulation.
Tramadol HCl ER is generic equivalent to Ultram ER Tablets of Ortho-McNeil-Janssen Pharmaceuticals which are used to manage moderate to moderately severe chronic pain in adults who need to be treated around the clock for their pain for an extended period of time.

Dr Reddy's resolves patent dispute with Pfizer over Lipitor Tablets

01 September 2011

Indian drug maker Dr Reddy's Laboratories has settled its patent litigation case against Pfizer over Lipitor Tablets, 10mg, 20mg, 40mg, and 80mg.
Lipitor, known generically as Atorvastatin Calcium tablets, are a type of cholesterol-lowering medicine called a statin, which block an enzyme in the liver that the body uses to make cholesterol.
Lipitor can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as age, smoking, high blood pressure, low HDL, or family history of early heart disease.
Pfizer has filed the lawsuit against the Indian drug maker in December 2009 for blocking generic copies of Lipitor which infringe Pfizer's patent for the tablets to be expire in 2017.


Vivus gets FDA acceptance to review ED drug NDA

02 September 2011

The US Food and Drug Administration (FDA) has accepted to review US based Vivus' new drug application (NDA) of its experimental drug avanafil as a treatment for erectile dysfunction (ED).

The results from Phase 3 trials demonstrated improvement in erectile function in comparison to placebo.

The avanafil development program included over 1,350 patients and avanafil was shown to be well tolerated and effective in treating patients with general ED and diabetics with ED.

Vivus has licensed Avanafil from Mitsubishi Tanabe Pharma.

Vivus president Peter Tam said if approved, avanafil could be a valuable treatment alternative for the 18 million men in the US that suffer from ED.

Suven NCEs receive patents in Australia, New Zealand

05 September 2011

India-based Suven Life Science has received three patents from Australia and one patent from New Zealand covering new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases.
The issued patents cover the class of selective 5-HT compounds of Suven that are being developed to treat cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia.
Suven CEO Venkat Jasti said they are very pleased by the grant of these patents to Suven for their pipeline of molecules in CNS arena that are being developed for cognitive disorders.

Novartis pancreatic NET drug gets EC nod

05 September 2011

Swiss drug maker Novartis has received the European Commission (EC) approval for Afinitor (everolimus) tablets to treat adults patients with unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumors (NET) of pancreatic origin with progressive disease.
The approval was backed by the results of RAD001 In Advanced Neuroendocrine Tumors (RADIANT-3) Phase III trial which demonstrated that the treatment with Afinitor more than doubled the time without tumor growth and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET.
The results of the trial showed consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups, including patients who had not received prior chemotherapy.
Novartis Oncology president Herve Hoppenot said they remain committed to the development of everolimus and to further researching the role of mTOR inhibition in multiple tumor types to address significant unmet medical needs for patients.

Rexahn receives US patent to treat sexual dysfunction

06 September 2011

Rexahn Pharmaceuticals, a US based developer of cancer, CNS disorders, sexual dysfunction therapeutics, has received a US patent no. 7,998,991 for CNS-based treatment of sexual dysfunction.
The new patent entitled, 'Neurotherapeutic treatment for sexual dysfunction,' includes a method to treat erectile dysfunction and premature ejaculation in males, as well as enhancing libido in females.
Currently, the company has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel.
Rexahn president Rick Soni said the company is making progress in the development of Zoraxel, currently in Phase II trials for erectile dysfunction.

Janssen-Cilag prostate cancer drug gets EC approval

07 September 2011

Janssen-Cilag has received marketing authorization for Zytiga (abiraterone acetate) from the European Commission as a treatment for metastatic castration-resistant prostate cancer (mCRPC).
The results from a placebo-controlled, randomised, multicenter Phase 3 study treatment with abiraterone acetate in conjunction with prednisone or prednisolone resulted in a 35.4% reduction in the risk of death and an improvement of 3.9 months in median overall survival, compared to placebo and prednisone or prednisolone.
In the trial, the patients were randomized 2:1 to receive abiraterone acetate 1,000mg daily plus prednisone or prednisolone 5mg twice daily or placebo in combination with prednisone or prednisolone 5 mg twice daily (control arm)


Santen sirolimus gets EC orphan drug status

08 September 2011

Santen has received orphan drug status for sirolimus (DE-109) from the European Commission (EC) as a treatment for chronic non-infectious uveitis.
Sirolimus is currently being evaluated in a Phase III study entitled 'study assessing double-masked uveitis treatment' (Sakura) to evaluate the safety and efficacy of different doses of sirolimus.
The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) in June.
Santen, the US subsidiary of Japan-based global ophthalmic pharmaceutical company Santen Pharmaceutical, develops and markets ophthalmic products worldwide.

Novartis  everolimus tablets wins EC approval

09 September 2011

Novartis has received the European Commission (EC) approval for its Votubia (everolimus) tablets to treat subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC).
Everolimus treats patients aged 3 years and older who require therapeutic intervention but are not amenable to surgery.
Everolimus targets mTOR, a protein that acts as a regulator of tumor cell division, blood vessel growth and cell metabolism.
The EC approval follows Committee for Medicinal Products for Human Use (CHMP) positive opinion based on a open-label, prospective, single-arm, Phase II study of 28 patients showing SEGA tumor reduction in patients with TSC.

An additional placebo-controlled phase III study examining the patient population met its primary endpoint of SEGA response rate.

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J&JPRD AF drug gets FDA Advisory Committee recommendation

09 September 2011

Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has received recommendation from the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration (FDA) for the approval of rivaroxaban as a preventive measure for stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
The recommendation is based on the results from a double-blind Rocket AF Phase 3 trial which showed that once-daily rivaroxaban had a 21% relative risk reduction in stroke and non-CNS systemic embolism while on-treatment compared to warfarin, with low and comparable bleeding rates
The committee voted 9-2 in favor of rivaroxaban in patients with AF who are at risk of stroke and systemic embolism.
J&JPRD Cardiovascular and Metabolism Global Therapeutic Area head peter DiBattiste said they look forward to working with the FDA to help make this important therapy available in the US.

FDA approves Jubilant generic Protonix drug

08 September 2011

The US Food and Drug Administration (FDA)  has approved Jubilant Life Sciences' Pantoprazole Sodium Delayed Release Tablets 20mg & 40mg.
Pantoprazole Sodium Delayed Release Tablets 20mg & 40mg are the generic version of Protonix of Wyeth.
Pantoprazole Sodium tablets are indicated for the short-term treatment of erosive esophagitis linked with gastro esophageal reflux disease, maintenance of healing of erosive esophagitis and pathological hypersecretory conditions including Zollinger-Ellison Syndrome.
The drug will be marketed by the company's US subsidiary Jubilant Cadista Pharmaceuticals under its own label.

FDA provides definitive guidance to develop EpiCept Ceplene

12 September 2011

The US Food and Drug Administration (FDA) has provided a definitive guidance regarding clinical development of EpiCept's  Ceplene (histamine dihydrochloride).

Ceplene is administered with interleukin-2 (IL-2) for the remission maintenance and prevention of relapse of patients with acute myeloid leukemia (AML) in first complete remission.

The FDA indicated that the patients in the IL-2 monotherapy group receive the same IL-2 dosing regimen as those patients receiving Ceplene/IL-2 in combination.

The primary endpoint of the trial is indicated on overall survival benefit of Ceplene/IL-2 vs. IL-2 monotherapy.

Leukemia-free survival (LFS) can be a secondary endpoint provided that bone marrow samples are collected at pre-specified and regular intervals during the course of the trial.

EpiCept president and CEO Jack Talley said they will incorporate the FDA's feedback in the design of a new pivotal clinical study with appropriate treatment arms and endpoints, such that, assuming a positive trial result, only one new pivotal study will be sufficient to support the submission of a new drug application.

FDA issues complete response letter to Janssen Biotech arthritis drug sBLA

12 September 2011

The US Food and Drug Administration (FDA) has issued a complete response letter to Janssen Biotech’s Simponi (golimumab) supplemental biologics license application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis.

Simponi is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.

The drug is available either through the Simponi SmartJect autoinjector or a prefilled syringe.

The sBLA included data from a Phase 3 trial evaluating the effect of Simponi in inhibiting the progression of structural damage and maintaining improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis.

Janssen Biotech intends to request an end-of-review meeting with the FDA to thoroughly understand the details of the complete response letter and discuss what future steps may be necessary to achieve the intended approval.

Avedro VibeX gets FDA orphan drug status

13 September 2011

Avedro, a US based pharmaceutical and medical device company, has received the US Food and Drug Administration (FDA) orphan drug status for VibeX (0.1.% riboflavin ophthalmic solution) to be used with its KXL System (UVA irradiation) for Corneal Cross-linking as a treatment for Keratoconus.
Avedro's KXL, VibeX and Keraflex are CE marked and are commercially available outside of the US.
Currently, the company has filed an additional application for orphan drug designation for cross-linking for the treatment of corneal ectasia following refractive surgery.
Avedro CEO David Muller said this orphan drug designation, along with the encouraging clinical results from our Phase III keratoconus study, is another important step in bringing this technology to patients in the US.
"We look forward to working with FDA as we progress towards an NDA submission in the very near future," Muller said.

Genentech files BCC drug NDA with FDA

13 September 2011

Genentech has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its experimental drug vismodegib as a treatment for the patients with advanced basal cell carcinoma (BCC) for whom surgery is inappropriate.
The filing of the NDA is backed by the results from a multicenter, two-cohort, single-arm, open-label Phase II Erivance BCC study that investigated vismodegib in patients with advanced BCC.
The results of the trial demonstrated that vismodegib substantially shrank tumors or healed visible lesions (overall response rate, or ORR) in 43% of patients with locally advanced BCC (laBCC) and 30% of patients with metastatic BCC (mBCC).
Genentech is developing vismodegib under a collaboration agreement with Curis.

Mallinckrodt to submit OA drug sNDA

15 September 2011

Mallinckrodt, a US market partner of Nuvo Research, is set to submit the supplementary new drug application (sNDA) regulatory approval for Pennsaid Viscous Solution, a higher viscosity formulation of Pennsaid (diclofenac sodium topical solution) to treat osteoarthritis (OA) of the knee..
As per the agreement held during 2009, Pennsaid Viscous Solution is being handled by Nuvo's licensee - Covidien and it has assumed all responsibility for managing, executing and paying for all development activities.
Covidien said that the data obtained through its recently completed clinical study can be used to support the sNDA.
Pennsaid Viscous Solution is under development for the treatment of the signs and symptoms of OA of the knee via twice-daily administration with a 2% diclofenac concentration.

Swissmedic accepts Eisai epilepsy drug for review

15 September 2011

Swissmedic, the Swiss Agency for Therapeutic Products, has accepted to review Eisai's perampanel as a treatment for partial-onset seizures in patients with epilepsy.
Perampanel is a highly selective, non-competitive a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptor antagonist that has demonstrated anti-epileptic effects in Phase II and III studies.
The clinical development plan for perampanel consisted of three global Phase III studies: Studies 306, 305 and 304 in which a total of 1,480 patients participated.
The goal of study 306 was to identify the minimal effective dose and included four treatment arms (placebo, 2mg, 4mg, and 8mg).
Studies 304 and 305 included three arms (placebo, 8mg, and 12mg) and were to evaluate a more extended dose range.
Eisai Europe EU Epilepsy Business Unit head Bettina Bauer said the acceptance by Swissmedic to review perampanel for use in Switzerland is a positive step forward in the approval process.

Lupin Announces Launch of Generic KEPPRA XR Tablets

September 15, 2011

Lupin Pharmaceuticals, Inc. announced today that the FDA has granted final approval for the company's Abbreviated New Drug Application (ANDA) to market a generic version of UCB's KEPPRA XR tablets. Commercial shipment of the product has commenced.
Lupin's levetiracetam 500 mg and 750 mg extended-release tablets are the AB-rated generic equivalent of KEPPRA XR, an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients >/= 16 years of age with epilepsy. KEPPRA XR tablets had annual sales of approximately $161 million for the twelve months ended June 2011 based on IMS Health sales data.

Vivus to resubmit Qnexa NDA

16 September 2011

US based Vivus is planning to resubmit Qnexa new drug application (NDA) for the treatment of obesity under an agreement with the Endocrine and Metabolic Division of the Food and Drug Administration (FDA).
With this plan, the company expects to seek approval for an initial indication that includes obese men and women of non-child bearing potential.
The company intends to refile the NDA by the end of October 2011, prior to completion of the Fortress study.
Vivus president Peter Tam said the planned October resubmission will also allow for an early 2012 Advisory Committee meeting and a second quarter 2012 PDUFA date.
"If the Fortress results are favorable, we expect to file for the full indication in late 2012," Tam said.

BTG glucarpidase BLA gets FDA acceptance for review

20 September 2011

UK based BTG has received the US Food and Drug Administration (FDA) acceptance for reviewing biologics license application (BLA) of glucarpidase.
Glucarpidase is an investigational product which is indicated for the rapid and sustained reduction of toxic methotrexate levels due to impaired renal function.
Additionally, the agency has granted priority review status for glucarpidase BLA.

Matrix HIV/AIDS drug receives tentative approval from FDA

21 September 2011

The US Food and Drug Administration (FDA) has granted tentative approval for Matrix Laboratories' new drug application (NDA) of Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300mg/300mg, co-packaged with Nevirapine Tablets, 200mg.
Matrix's Lamivudine / Tenofovir Disoproxil Fumarate Tablets, 300mg/300mg are generic equivalent to
Epivir of GlaxoSmithKline, Viread of Gilead Sciences and Viramune of Boehringer Ingelheim.
According to the Mylan's subsidiary Matrix, this co-pack of ARV products is indicated for pregnant women suffering from HIV/AIDS in certain countries where Lamivudine, Tenofovir Disoproxil Fumarate and Nevirapine are approved for use during pregnancy.
Mylan president Heather Bresch said the approval of Lamivudine / Tenofovir Disoproxil Fumarate Tablets co-packaged with Nevirapine Tablets is an important product developed by Matrix for the treatment of HIV/AIDS.

Tibotec HCV drug gets EC nod

21 September 2011

Tibotec Virco-Virology has received the European Commission (EC) approval for Incivo (telaprevir) in combination with peginterferon alfa and ribavirin, as a treatment for agenotype-1 chronic hepatitis C virus (HCV) in adults.
The earlier studies, which included previously untreated genotype-1 chronic HCV patients and the patients who failed previous treatment, showed improvements in cure rates when treated with telaprevir in combination with peginterferon alfa and ribavirin as compared to standard treatment with peginterferon alfa and ribavirin alone.
The EC's decision was based on results of three Phase 3 studies, Advance, Realize and Illuminate.1,2 ,3 Advance and Realize which investigated the efficacy and safety of telaprevir in combination with peginterferon alfa and ribavirin compared with the previous standard treatment (peginterferon alfa and ribavirin alone).
The results of the trials demonstrated that treatment with a telaprevir based regimen increased cure rates for genotype-1 chronic HCV compared to the previous standard treatment in previously untreated patients and patients who relapsed during previous treatment.

Mylan, Roche resolve cancer drug patent dispute

22 September 2011

Mylan has signed a licensing and settlement deal with Hoffman La Roche to resolve the patent dispute on Xeloda Tablets, 150mg and 500mg, USP, generically known as Capecitabine Tablets.
Xeloda Tablets, 150mg and 500mg, USP are indicated as a treatment of metastatic breast and colorectal cancers.
Pursuant to the agreement, the litigation was dismissed on 21 September 2011. Further, the terms  of the agreement were not disclosed

ImmunoGen files NHL drug IND with FDA

23 September 2011

US based ImmunoGen has filed an investigational new drug application (IND) for IMGN529 with the US Food and Drug Administration (FDA).
Developed by ImmunoGen, IMGN529 is indicated as a treatment for B-cell malignancies including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
ImmunoGen president and CEO Daniel Junius said they expect IMGN529 to be the first compound in the clinic for NHL that provides Rituxan-like antibody activity along with targeted cell-killing using a potent small molecule.

Gilead HIV drug gets EMA positive opinion

23 September 2011

Gilead Sciences has received positive opinion from the European Medicines Agency (EMA) for its marketing authorization application (MAA) of Eviplera as a treatment for HIV-1 infection in antiretroviral-naive adults with a viral load less than or equal to 100,000 HIV-1 RNA copies/ml.
Single-tablet regimen, Eviplera, combines Gilead's Truvada (emtricitabine and tenofovir disoproxil (as fumarate)) with Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine (as hydrochloride)).
The submission of the application was backed by the results from two Phase 3 trials, (Echo and Thrive), which was conducted by Tibotec to investigate the safety and efficacy of rilpivirine compared to efavirenz in treatment-naive HIV-1 infected adults.
A bioequivalence study conducted by Gilead demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate.

Japan approves AstraZeneca Faslodex 500mg

26 September 2011

AstraZeneca has received regulatory approval for its Faslodex (fulvestrant) 500mg in Japan.
Faslodex is an oestrogen receptor antagonist, which can bind, block and degrade the oestrogen receptor, thereby helping in the treatment of hormone receptor-positive metastatic breast cancer which has recurred after an endocrine therapy in postmenopausal women.
Faslodex also disrupts oestrogen signalling, causing down-regulation of the oestrogen receptors in the tumour, which prevents the spread of the cancer.
The results of the Phase III Confirm study led to the approval of Faslodex 500mg in Europe in March 2010 and the US in September 2010.
AstraZeneca Global Commercial Organisation executive vice president Tony Zook said metastatic breast cancer treatment primarily aims to prevent disease progression besides maintaining quality of life and Faslodex 500mg will provide better control over the disease.

Janssen Biotech Remicade UC drug gets FDA nod

26 September 2011

Janssen Biotech has obtained the US Food and Drug Administration (FDA) approval for Remicade (infliximab) as a treatment for moderately to severely active ulcerative colitis (UC) in pediatric patients.
The FDA approval is based on the results of different studies evaluating Remicade in adults with ulcerative colitis plus additional data from a Phase 3 trial investigating the efficacy and safety of Remicade in the treatment of pediatric patients with moderately to severely active UC.
The Phase 3 trial was a randomized, multicenter, open-label trial and was designed to evaluate the efficacy of a 3-dose Remicade regimen inducing clinical response in pediatric patients with moderately to severely active UC.
The treatment with Remicade 5mg/kg induced clinical response in 73% of patients at week 8 and showed a safety profile consistent with previous clinical trials conducted in an adult population.

4SC HL drug resminostat gets orphan drug status from FDA

26 September 2011

4SC, a German-based developer of targeted small-molecule drugs, has received orphan drug status for its oncology drug resminostat as a treatment for Hodgkin's lymphoma (HL) from the US Food and Drug Administration (FDA).
The results from a Phase II Saphire study investigating resminostat as a third-line treatment in relapsed/refractory HL patients, showed a 33.3% overall response rate and 54.5% of patients achieving a clinical benefit from the treatment with resminostat.
4SC CEO Ulrich Dauer said the combined final data set of the Saphire study in HL and the Shelter study in HCC, which is anticipated by the end of this year, should encourage them to discuss their plans for a pivotal development programme for resminostat with regulatory authorities and potential partners in the near future.

FDA approves Lannett Loxapine Capsules

28 September 2011

The US Food and Drug Administration (FDA)  has approved Lannett's abbreviated new drug application (ANDA) of Loxapine Capsules, 5mg, 10mg, 25mg and 50mg.
Lannett's Loxapine Capsules, 5mg, 10mg, 25mg and 50mg are the generic version of Watson Pharmaceuticals' Loxitane Capsules, 5mg, 10mg, 25mg and 50mg.
The company expects to start supplying the product soon. Lannett president and CEO Arthur Bedrosian said they have now received five product approvals from the FDA over the last three months.

Novartis files Vectura NVA237 with EMA for marketing authorization

28 September 2011

Vectura Group, which develops inhaled therapies for respiratory diseases, has announced that Novartis has filed NVA237 (glycopyrronium bromide) for marketing authorisation with the European Medicines Agency (EMA) under the brand-name Seebri Breezhaler.
Following the move, Vectura will receive a payment of $5m.

Novartis has presented new NVA237 Phase III data at the European Respiratory Society (ERS) congress.
The Glow1 and Glow3 studies in chronic obstructive pulmonary disease (COPD) patients show that NVA237 (glycopyrronium bromide) increased patients' lung function compared to placebo.
The findings of Glow1 study revealed that NVA237 50 mcg once-daily produced a significant improvement in lung function of 108 mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in patients with moderate-to-severe COPD compared to placebo.
The Glow3 study evaluated the effects of NVA237 50 mcg once-daily on exercise endurance in moderate-to-severe COPD patients and showed 21% improvement in exercise endurance versus placebo at the end of the study.

Transcept Pharma refiles Intermezzo NDA

28 September 2011

Transcept Pharmaceuticals has informed regarding the refiling of the new drug application (NDA) of Intermezzo (zolpidem tartrate sublingual tablet) with the US Food and Drug Administration (FDA).
Intermezzo is indicated for the treatment of insomnia or sleeping disorders.
The refiling of the application follows a meeting between Transcept and the FDA, to discuss the issues raised by the FDA in July 2011 Complete Response Letter.

Frutarom gets new patent for FenuLife

28 September 2011

Frutarom has received a patent EP 2026763 B1, to treat heartburn and gastroesophageal reflux disease (GERD) with FenuLife.
The company claims FenuLife is a completely natural fenugreek fiber that can act as a prophylactic treatment for heartburn and reflux symptoms.
In addition to the prophylactic function, the patent also claims that products using FenuLife can serve to reduce temporary acid reflux symptoms due to pregnancy.
In a study the efficacy of FenuLife in diminishing heartburn severity for subjects with frequent occurrences was scientifically proven.
The study results suggested that it was similarly effective as the positive control, the commonly used OTC antacid Ranitidine.

Chelsea files Northera NDA with FDA

29 September 2011

Chelsea Therapeutics has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) to market Northera (droxidopa).
Northera is indicated as a treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
The NDA filing is backed by the combined safety and efficacy data from Chelsea's two completed Phase III efficacy studies in NOH (Studies 301 and 302).
Chelsea president and CEO Simon Pedder said they believe the clinical data generated by their Phase III program clearly demonstrates that Northera is safe and effective for the treatment of symptomatic NOH.

Health Canada approves Valeant Pharma colesevelam

29 September 2011

The Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals' New Drug Submission of colesevelam hydrochloride (colesevelam).
Colesevelam, an orally administered, bile-acid sequestrant showed efficacy in reducing LDL-C lipoproteins and drug-interaction and tolerability profile comparable to placebo.
Valeant chairman and CEO Michael Pearson said clinical trials have shown reduced cardiovascular events with the use of bile acid sequestrants, either as monotherapy or in combination with other agents.
"Compared with conventional bile acid sequestrants, colesevelam has enhanced specificity, greater affinity, and higher capacity for binding bile acids, due to its polymer structure engineered for bile acid sequestration," Pearson said

Onyx Pharma files carfilzomib NDA

29 September 2011

Onyx Pharmaceuticals has submitted the new drug application (NDA) with the US Food and Drug Administration (FDA) for carfilzomib as a treatment for the patients with relapsed and refractory multiple myeloma.
Additionally, Onyx has requested priority review of the application, which reduces the time the FDA takes to review a new drug application.
Onyx Research and Development and Technical Operations executive vice president Ted Love said they believe the efficacy and safety data within the NDA submission provide a compelling basis for accelerated approval of carfilzomib in the relapsed and refractory treatment setting.

Horizon Pharma submits NDA for Rheumatoid Arthritis drug

29 September 2011

Horizon Pharma has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Lodotra, for the treatment of Rheumatoid Arthritis.
Lodotra, which is currently approved for marketing in 16 European countries is a modified (delayed)-release formulation of low-dose prednisone.
Circadian Administration of Prednisone in RA (CAPRA-2), 12-week, double-blind, placebo-controlled Phase 3 trial involving 350 RA patients, led to the NDA submission.
Results from CAPRA-2 showed that an improvement in American College of Rheumatology 20 (ACR20) response criteria for patients who were treated with Lodotra compared to the placebo group.
In addition, an improvement in ACR50 response compared to placebo and an improvement in the more stringent ACR70 response criteria, was also noted.

Allon receives US patent for preclinical compound

29 September 2011

Allon Therapeutics has received US patent for covering the composition of matter of preclinical compound AL-408, the D-isomer of NAP (davunetide).
AL-408 has been proven to have potent neuroprotective effects in a number of in vitro and in vivo models of neurotoxicity, the data from pre-clinical studies says.
In an animal model of fetal alcohol syndrome, AL-408 showed better survival and cognitive performance besides neuroprotective activity in a preclinical model of amyotrophic lateral sclerosis
Allon vice president of Commercial Research Dr. Alistair Stewart said the technology platform of neuroprotective peptides derived from naturally occurring brain proteins shows broad neuroprotective effects in a variety of diseases and conditions.
"AL-408 has shown some interesting early-stage research results in areas outside of neurodegenerative diseases, further diversifying and adding value to our product pipeline," Stewart added.

Phytopharm Cogane receives Orphan Drug status by EC

30 September 2011

The European Commission (EC) has awarded Orphan Drug status to Cogane (PYM50028) by Phytopharm, for the treatment of amyotrophic lateral sclerosis (ALS).
Cogane demonstrated positive results in preclinical in vitro and in vivo models of ALS.
There is an ongoing study of Cogane in the genetic 'gold standard' in vivo model of ALS, which is supported by the UK-based Motor Neurone Disease Association.
Results from the study are expected to be announced in Q4 2011.
Cogane received Orphan Drug status by the United States Food & Drug Administration (US FDA) in July 2011.

AstraZeneca files patent infringement litigation with Handa

30 September 2011

AstraZeneca has entered into a settlement agreement with Handa Pharmaceuticals over its US SEROQUEL XR (quetiapine fumarate) extended-release tablets patent infringement litigation.
AstraZeneca has filed a lawsuit against Handa for submitting an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR to the US Food and Drug Administration.
As per the agreement, Handa accepts that the patents asserted by AstraZeneca in the US patent litigation are valid and enforceable.
Handa received a licence from AstraZeneca to enter the US market with generic SEROQUEL XR on 1 November 2016.
SEROQUEL XR is an extended-release tablet formulation of quetiapine fumarate, used as an add-on treatment to an antidepressant for patients with major depressive disorder (MDD).

Ironwood submits MAA for linaclotide

30 September 2011

Ironwood Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide used to treat irritable bowel syndrome with constipation (IBS-C).
Linaclotide is a guanylate cyclase type-C (GC-C) agonist.
The company provided its efficacy and safety data from a Phase 3 program comprising two double-blind placebo-controlled trials.
Over 1,600 patients with IBS-C received a once-daily dose of either linaclotide or placebo and demonstrated improvements in abdominal and bowel symptoms for linaclotide treatment as compared to placebo treatment.
The study also revealed that diarrhea was the most commonly reported adverse event and led to study discontinuation in 5% of linaclotide-treated patients compared to fewer than 1% of patients receiving placebo.