PharmaPodia

Rexahn's isoquinolamine was granted European patent

2012-09-26T11:30:00.001-04:00

Rexahn announced that the European Patent Office has granted the company's novel anti-cancer isoquinolinamine compounds patent No. 2099765 entitled "5,6, or 7-substituted-3-arylisoquinolinamine derivatives as antitumor agents."

Isoquinolinamine compounds have been awarded patents in other countries (the US, Mexico, China).

Non-clinical studies found that the compounds have potent anti-tumor properties in several cancer cell lines such as breast, prostate, colon, ovary, kidney, pancreas, glioblastoma and melanoma.

Boehringer Ingelheim completed recruitmen of the two INPULSIS (TM) trials

2012-09-26T04:30:00.000-04:00

Boehringer Ingelheim announced that it has completed recruitment of two pivotal phase III studies evaluating nintedanib in patients with idiopathic pulmonary fibrosis (IPF). The INPULSIS (TM) phase III trials assess the clinical outcomes in IPF patients treated with nintedanib. The two trials are currently ongoing in 23 countries in Europe, Americas, Asia and Australia.

About the two Phase III sister tials:

Double-blind, randomized, placebo-controlled
Treatment duration: 52 weeks
Dose: 150 mg twice daily
Primary endpoint: the annual rate of decline in FVC expressed in mL over 52 weeks.
Several of the secondary endpoints: change from baseline in health-related quality of life, time to first acute exacerbation, respiratory mortality, overall survival, on-treatment survival, time to death on lung transplant.

IPF is classified as rare disease by the EMA and US National Institutes of Health with the prevalence of 14 to 43 cases per 10,000.
About nintedanib: It is a small molecule tyrosine kinase inhibitor which targets growth factor receptors which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis such as the vascular endothelial growth factor receptor, fibroblast growth factor receptor, and platelet-derived growth factor receptor. The agent has received orphan drug designation from the US FDA in June 2011 and from the Ministry of Health, Labour and Welfare of Japan in September 2011.

Several updates from Eisai

2012-09-26T00:30:00.000-04:00

Happy fall!! :) Hope everyone is doing well. It's been extremely busy but all is good. Hopefully I will be able to write more often so here are just some short update in the past few days or so...

Enjoy!

Eisai is on a roll with its press release:
On the same day, the company released three articles:

The company has announced that it has opened a new solid dose global manufacturing line for antepileptic agency Fycompa at its production plant in Hatfield, UK. The company has received a license (marketing authorization type II variation: addition of manufacturing site from the European regulatory authorities for solid dose manufacturing of the antiepileptic agent Fycompa (R) (perampanel), a first-in-class AMPA receptor antagonist discovered and developed by Eisai.
The company has entered into an option agreement with Santen Pharmaceuticals allowing Santen rights for evaluation and first negotiation for Eisai-owned ophthalmic compounds. Under the term of the agreement, Santen will have rights to evaluate the feasibility of developing compounds disclosed by Eisai for use in ophthalmology within a certain period as well as rights of first negotiation for a license agreement concerning any selected compound. As part of the agreement, Eisai will receive an upfront payment from Santen.
Eisai has also announced that it will launch Chocola BB(R) Hyper, a nutritional supplement drink for the relief of extreme fatigue and exhaustion starting Monday, October 1. The supplement will have 13 different active ingredients that can be found below. Per the company, the supplement can be used for nutritional support, physical revitalization, and enhancement of weak constitution. It is only recommended for adults (15 years and older) and costs approximately 399 yen per bottle.

Vitamin B₂ phosphoric acid ester	15 mg	Liquid guarana extract	0.15 mL
Vitamin B₆	10 mg	(Guarana equivalent	150 mg)
Vitamin B₁ nitrate	10 mg	Dried ginseng extract	41.4 mg
Royal jelly tincture	300 mg	(Ginseng equivalent	600 mg)
(Royal jelly equivalent	300 mg)	Ligustrum lucidum extract	62.5 mg
Taurine	1,200 mg	(Ligustrum lucidum equivalent	250 mg)
Glycine	50 mg	Nicotinamide	40 mg
L-arginine chloride	150 mg	Caffeine hydrate	45 mg
L-lycine chloride	100 mg

delafloxacin of Rib-X Pharmaceuticals has been designated as a qualified infectious disease product

2012-09-18T08:23:00.000-04:00

Rib-X Pharmaceuticals announced that the company's delafloxacin has received the FDA designation as a Qualified Infectious Disease Product for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia (CABP). This comes with incentives as the FDA has rolled out the new Generating Antibiotic Incentives Now (GAIN) program recently under the FDA Safety and Innovation Act (FDASIA). The drug will have an additional five years of market exclusivity, priority review and eligibility for fast-track status.

About delafloxacin:

"Delafloxacin is being developed for use as an effective and
convenient first-line antibiotic primarily in hospitals prior to the availability of a specific diagnosis. Delafloxacin has the potential to offer broad spectrum coverage as a monotherapy, including for methicillin-resistant Staphylococcus aureus (MRSA), with both intravenous (IV) and oral formulations. With the exception of Zyvox^® (linezolid), all other currently approved treatments for MRSA offer only IV delivery. In addition to strong Gram-positive potency, delafloxacin has shown excellent in vitro activity against susceptible Gram-negative bacteria."

"Delafloxacin has been in four Phase 2 trials where it has shown promising results for the treatment of lung infections, including pneumonia and bronchitis, and skin infections. Rib-X is developing both IV and oral formulations of delafloxacin to enable patients who begin IV treatment in the hospital setting to transition to oral dosing for home-based care, offering the potential to increase patient convenience, lower the overall cost of treatment and reduce the length of hospital stays."

AtoBio's AB103 granted Fast Track Designation

2012-09-14T01:01:00.000-04:00

AtoBio announced that the FDA has granted the company's AB103 Fast Track Designation for the treatment of necrotizing soft tissue infections (NSTI). AB103 was given Orphan Drug Designation in Oct 2011 for the same indication.

AB103 is a peptide acting as a CD28 modulator that works to regulate the host's inflammatory response, improving the host's ability to effectively fight the infection. It is currently being studied in phase II trial evaluating the safety and pharmacokinetic profile of different doses of AB103 administered to patients diagnosed with NSTI that are scheduled for an urgent surgical intervention as part of their standard of care. The company has completed enrolling patients for the trial and expects to have the results completed by December 2012.

Pfizer and Hisun launched joint venture

2012-09-13T13:51:00.002-04:00

As previously announced, Pfizer and Hisun have launched Hisun-Pfizer Pharmaceuticals, a joint venture between the two companies, to provide high-quality and affordable Branded generic medicines for patients in China and global markets. The establishment of the joint venture marks an important milestone in strengthening the ability of both companies to reach more patients with high-quality and low-cost medicines.

The companies signed the memorandum of understanding to establish the joint venture during the Zhejiang Provincial Government Delegation's visit to the US in June 2011. The Framework Agreement was signed at the Sino-US Economic & Trade Cooperation Forum held in LA. The venture has a registered capital of $259 with Hisun holds approximately 51% of the share and Pfizer holds 49%. The registration facilities and production plants will be in Fuyang, Zhejiang province and the Management Center as well as the R&D Center will be in Shanghai and Hangzhou respectively.

Eisai launched Fycompa in Europe

2012-09-13T06:00:00.000-04:00

Eisai announced that it has launched Fycompa (perampanel), an AMPA receptor antagonist, in Europe (the UK) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalized seizures, in patients aged 12 years and older. Eisai has submitted a New Drug Application to the US FDA in December 2011. The NDA was originally submitted May 2011 but the FDA issued a Refusal to file letter in July 2011 requesting reformatting and reanalyses of some datasets in the dossier.

The company also plans to launch the product in other European Union member states such as Germany, Austria, and Denmark.

Perampanel is a highly selective, non-competitive AMPA-type glutamate receptor antagonist discovered and developed by Eisai. The compound reduces
neuronal hyperexcitation associated with seizures by targeting glutamate activity at the post-synaptic AMPA receptors. The agent was evaluated in three global pivotal Phase III randomized, double-blind, placebo-controlled, dose-escalation studies examining 1,480 epilepsy patients with partial-onset seizures. The results showed consistent "excellent efficacy across all studies". The most commonly reported adverse events were dizziness, headache, somnolence, irritability, fatigue, falls and ataxia.

Eisai is currently conducting a phase III trial in Japan evaluating perampanel for the same approved indication. It is also conducting a global phase III study evaluating the agent as a potential treatment for generalized epilepsy.

The Mayo Clinic to manufacuture and distribute Choline C 11 injection

2012-09-13T02:00:00.000-04:00

The FDA has approved the Mayo Clinic PET Radiochemistry's Choline C 11 injection , a Position Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.
The agent can be injected in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer.

The product will be produced in specialized facility, in this case will be the Mayo Clinic PET Radiochemistry Facility located in Rochester, Minn and needs to be used in patients shortly after its production.

The safety and effectiveness of Choline C 11 injection were studied in a systematic review of four independent studies examining a total of 98 patients with elevated PSA levels but not sign of recurrent prostate cancer on conventional imaging. After being injected with Choline C 11, abnormalities were detected on the PET scans. Approximately half of the patients who had abnormal scans in each study had recurrent prostate cancer which was later confirmed by tissue sampling of the abnormal areas.

No side effects to Choline C 11 injection was noted aside from an uncommon, mild skin reaction at the injection site.

Mylan's Brand Generic Reference goes mobile

2012-09-12T05:10:00.000-04:00

With everything is at the fingertip nowadays, access to database has moved from desktop to laptop to touchscreen...(I wonder whether what can be used to make it something"top")

Mylan who has been printing and provided Generic Brand Reference in the past years has now moved to the touchscreen world. The company announces it has launched the first ever app of its Generic Brand Reference (R) guide (a note here, this is not the first generic brand app ever, it's just the first app ever of the company's Generic Brand Reference which is available in print for free). The application will be available in the following platforms: iPhone(R), iPod(R) touch and iPad(R) - where are the apps for my android platforms. Complaint aside, the reference is intended to provide an easy-to-use cross-reference guide for brand and generic product names. It also will include clinical support tools (which I should really checkout) including laboratory reference values, an interactive medical abbreviations converter, and functional calculators for common systems for weights and measures.

I was re-reading its press release to see what the app is called but I couldn't find the exact app name.

..now if I can get a hold on an ipad, iphone, ipod products, I can test out to see how useful the apps will be.

Eisai to launch positively-charged gel in Japan

2012-09-12T01:57:00.000-04:00

Eisai just keeps on launching products (maybe for the flu season?)

On the same day, the company said it is to launch Crystal Veil (R) alpha Nasal gel to help block viruses from entering the body through the nose on Tuesday, September 18. The gel contains no medicinal product but it is positively-charged to help prevent virus particles from entering through the nose. The product is classified as miscellaneous goods.

The main ingredient of the product is the positively charged water-soluble polymer.

To use the product, consumer can applies a single drop of gel about the size of a sesame seed around the nostrils.

The suggested retail price is 1,980 yen (>$20) (maybe I should pick this up next time while I'm there...?)

Eisai to launch new anti-microbial mask spray in Japan

2012-09-11T23:50:00.001-04:00

wow how long has it been? I've been so busy lately but here is some interesting update! :)

Anyone who has been to Japan, China or Hong Kong or some other Asian countries will probably notice the masks that many people wear on the street, on the train, at the workplace etc. Well the mask is used as a protection barrier to prevent certain airborne-transmitted disease.

Eisai has just announced that the company has launched the new mask spray Crystal Veil(R) Bokin 24 (which is classified as miscellaneous goods) on Tuesday, September 18 in Japan.

The mask contains a long-acting antimicrobial agent Etak(R) and several other ingredients like water and ethanol. The spray can be sprayed onto the mask prior to use in order to make it difficult for viruses and bacteria to adhere to the mask surface for a long period of time. The company said the effect can last approximately 24 hours.

Etak(R) was developed by Professor Hiroki Nikawa of the Department of Oral Health Engineering at Hiroshima University's Graduate School of Biomedical Sciences. It contains anti-microbial agent (which the company has not disclosed) and adhesive substances.

The company's suggested retail price is 1,381 yen.

The FDA approved Xtandi

2012-09-04T08:30:00.001-04:00

The FDA announced that it has approved Xtandi (enzalutamide) for the treatment of late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. The approval occurred three months ahead of the PDUFA date of Nov 22, 2012. The company intends to have Xtandi available to patients in the US in Mid-September 2012. The European Medicines Agency has accepted the Marketing Authorization Application for review.

The recommended dose is 160 mg (four 40 mg capsules) administered once daily orally. The medication can be taken with or without food and does not require concomitant steroid use.

The safety and efficacy of Xtandi were evaluated in 1,188 patients with metastatic castration-resistant prostate cancer who had received prior treatment
with docetaxel. The results showed that patients taking Xtandi had a median overall survival of 18.4 months and patients taking placebo had a median survival of 13.6 months.

The most commonly observed side effects were weakness, fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory tract infection, dizziness, spinal cord compression and cauda equina syndrome, muscal weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure. Approximately 1% of patients receiving Xtandi had seizure.

Xtandi will be marketed by both Medivation and Astellas who have agreed to conduct an open-label safety study in patients who are at high risk for seizure with the FDA. The companies have agreed to supply the data from this study in 2019.

Xtandi is an androgen receptor inhibitor. It has been shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with the DNA. The medication's major metabolite, N=desmethyl enzalutamide, had been shown to have similar activity to XTANDI in in vitro experments. The prescribing information for Xtandi can be accessed here

Janssen-Cilag Internationsl submitted a marketing authorization application for bedaquiline to the European Medicine Agency

2012-08-31T12:50:00.001-04:00

Janssen-Cilag International NV (Janssen) announced that it has submitted a marketing authorization application for bedaquiline (TMC207) as an oral treatment to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.The company has already submitted a new drug application to the US FDA for review in June 2012.

Included in the application is the 24-week data from the phase II clinical development program that includes an open-label study and a controlled, randomized trial. Both evaluated the safety and efficacy of bedaquiline against placebo for the treatment of pulmonary MDR-TB in combination with background therapy in adult patients.

The company plans to conduct a phase III trial called TMC207-C210 evaluating TMC20 in combination with an intensive nine-month background regimen against an intensive nine-month background regimen with placebo. The company plans to have the recruitment started in the fourth quarter of 2012.

The drug works by targeting adenosine triphosphate synthase which is essential in the generation of energy.

Forest and Ironwood's Linzess got a nod of approval from the US FDA

2012-08-31T10:25:00.000-04:00

Forest and Ironwood Pharmaceuticals announced that the US FDA has approved Linzess (linaclotide) for the treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). The company intends to make the medication available in the fourth quarter of 2012. Linzess can be taken once daily for patient with chronic abdominal pain and constipation associated with IBS-C and constipation and hard stools associated with CIC. The recommended dose for patients with IBS-C is 290 mcg and for CIC patients is 145 mcg.

Linaclotide is a first-in-class guanylate cyclase-C (GC-C) agonist that acts locally in the intestine with minimal systemic exposure. When evaluated in a placebo-controlled phase III clinical trials involving 2,800 adults, in IBS-C patients treated with Linzess, significantly
reduction in abdominal pain was observed and in both IBS-C and CIC patients, significant increased in bowel movement frequency was observed. When patients were crossed over to either the placebo group or the Linzess group, the symptoms were either reversed or improved respectively.

The most commonly observed adverse reactions were diarrhea, abdominal pain, flatulence, and abdominal distension.

"LINZESS binds to the GC-C receptor locally in the intestine, with no measurable blood plasma concentrations, resulting in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevations in intracellular cGMP are believed to stimulate secretion of intestinal fluid and accelerate gastrointestinal transit resulting in increased frequency of bowel movements. Elevations in extracellular cGMP are believed to decrease activity of pain-sensing nerves, which is thought to be responsible for a reduction in intestinal pain, according to nonclinical models.

An issued composition of matter patent for linaclotide provides protection to 2025 in the United States. Ironwood and Forest will co-promote LINZESS in the United States. Ironwood has out-licensed linaclotide to Almirall, S.A. for European development and commercialization and to Astellas Pharma Inc. for development and commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan, and Thailand."

Novartis announces results of the SPARK trial and anticipates EU and Japan submissions by the end of the year

2012-08-30T14:46:00.001-04:00

Novartis announces results of the company's Phase III trial evaluating QVA149 for the management of chronic obstructive pulmonary disease and plans to seek approval in EU and Japan by the end of the year. The company also plans to submit the NDA to the US FDA in 2014.

QVA149 is a combination of indacaterol maleate/glycopyrronium bromide currently being investigated in the phase III trial as a potential medication for the management of COPD. SPARK was a phase III, 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study enrolling 2,224 patients with severe to very severe COPD. Patients were randomized to either
the QVA149 group where QVA149 was given once daily or the glycopyrronium 50 mcg or an open-label tiotropium 18 mcg. The results showed significantly lower number of all COPD exacerbations were observed in patients treated with QVA149 compared to either glycopyrronium 50 mcg and tiotropium 18 mcg. For moderate-to-severe COPD exacerbations, QVA149 showed significant reduction in the number of exacerbation compared to glycopyrronium 50 mcg. However, the reduction was not significant when it was compared to tiotropium.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate (a long-acting beta2-adrenergic agonist) and glycopyrronium bromide ( a long-acting muscarinic antagonist). The product is currently being investigated in the phase III IGNITE clinical trial program evaluating its effect for the treatment of COPD. The IGNITE clinical trial program consists of 10 studies with 5 studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have been completed and 3 studies (BLAZE, ARISE, BEACON) are expected to be completed by the end of the year.

Ariad submitted an MAA for ponatinib to the EMA

2012-08-30T11:07:00.001-04:00

Ariad Pharmaceuticals announced that it has submitted a marketing authorization application for ponatinib to the European Medicines Agency for use as treatment in adult patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The application was granted for accelerated assessment. The company has submitted a new drug application for ponatinib with the US FDA on July 30, 2012.

The company has announced the results of the ongoing PACE trial of ponatinib at the annual meeting of the American Society of Clinical Oncology. The results showed that 54% of patients who had chronic-phase CML and were resistant or intolerant to prior tyrosine kinase inhibitor achieved a major cytogenetic response (MCyR) and 30% of these same patients achieved a major molecular response.

Ponatinib is an investigational BCR-ABL inhibitor that has been shown to selectively inhibit certain other tyrosine kinases in preclinical studies, including FLT3, RET, KIT and the members of the FGFR and PDGFR families of kinases.

Teva received approval to market tbo-filgrastim

2012-08-30T08:44:00.002-04:00

Teva announced that the FDA has approved the company's tbo-filgrastim (XM01 filgrastim) for the treatment of chemotherapy-induced neutropenia. Tbo-filgrastim is a short-acting recombination form of granulocyte colony-stimulating factor.Tbo-filgrastim works to increase the production of neutrophil
through the stimulation of bone marrow. It can be administered 24 hours after chemotherapy administration. The product will be supplied as single use, preservative-free, prefilled syringe in doses of 300 mcg/0.5 ml and 480 mcg/0.8 ml. The product is to be given subcutaneously.

Its efficacy was evaluated in a clinical study of 348 adult patients who had advanced breast cancer and received treatment with the anti-cancer drugs doxorubicin and docetaxel. Patients were randomized assigned into either the tbo-filgrastim group, the placebo group or a non-US-approved filgrastim product. The results showed that patients in the tbo-filgrastim treated group had a significantly shorter neutropenic recovery time compared to patients in the placebo group (1.1 days vs 3.8 days).

Its safety data have also been evaluated in 680 adult patients with breast cancer, lung cancer, or non-Hodgkin's lymphoma who received high-dose of chemotherapy.

The most commonly observed side effect was bone pain.

The company plan to launch the product as early as November 2013 in accordance to the settlement that was reached with Amgen.

Hospira purchased manufacturing facility in India

2012-08-29T10:10:00.001-04:00

Hospira announced that the company has entered into an agreement with Orchid Chemicals and Pharmaceuticals to acquire an active pharmaceutical ingredient (API) manufacturing facility for an approximately $200M. The facility is the US FDA approved-facility and Hospira expects that the acquisition will reduce the company's cost, support continuity of supply of key antibiotic products and pave the way for future API devleopment. Orchid will retain its cephalosporin API facilities and business will continue to provide Hospira with this associated API.

Previously, the company has purchase Orchid's generic injectable finished-dosage form pharmaceutical business. This acquisition will allow the company to vertically integrate into a certain critical beta-lactam antibiotics APIs (penems and penicillins).

The facility was constructed in 2000 and has 50,000 square meters of space.

Novartis received approval to market Jakavi in the EU

2012-08-29T01:10:00.000-04:00

Novartis announced that the European Commission has approved Jakavi (ruxolitinib for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The recommended starting dose for Jakavi is 15 mg twice daily for patients with a platelet count between 100,000cubic millimeters (mm³) and 200,000 mm³,and 20 mg twice daily for patients with a platelet count of >200,000 mm³. Doses may be titrated based on safety and efficacy.

The decision was made based on positive findings from the COMFORT (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) clinical trial program.

The COMFORT clinical trial program include the two pivotal Phase III trials - COMFORT I and COMFORT II. In COMFORT I, 41.9% of Jakavi-treated patients achieved at least 35% reduction in spleen volume at 24 weeks from baseline compared
to 0.7% of placebo-treated patients. The results were statistically significant.The most frequently reported grade 3 or higher adverse events were hematologic.The most common non-hematologic adverse events of any grade reported for patients receiving Jakavi were fatigue, diarrhea, peripheral edema and ecchymosis. The trial was conducted by Incyte with whom Novartis has a worldwide collaboration and license agreement for INC424.

In COMFORT II, a significantly higher number of patients received Jakavi had 35% or greater in spleen size reduction when compared to patients receive best available therapy at 48 weeks. Patients taking Jakavi had an increase in frequency of anemia and thrombocytopenia when compared to the best-available-therapy group. The most frequently reported serious adverse event was anemia for both group.

Myelofibrosis is a life-threatening blood cancer with a poor prognosis and limited treatment options. Studies show that patients with myelofibrosis have a decreased life expectancy, with a median survival of 5.7 years. Although allogeneic stem cell transplantation may cure myelofibrosis, the procedure is associated with significant morbidity and transplant-related mortality and is available to less than 5% of patients who are young and fit enough to undergo the procedure.

Jakavi^® (INC424, ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.

Novartis licensed INC424 (ruxolitinib) from Incyte for development and potential commercialization outside the US. Incyte has retained rights for the development and commercialization of INC424 (ruxolitinib) in the US. Both the European Commission and the US Food and Drug Administration (FDA) granted INC424 (ruxolitinib) orphan drug status for myelofibrosis. Incyte received FDA approval for INC424 (ruxolitinib) in November 2011 under the name Jakafi^® for the treatment of patients with intermediate or high-risk myelofibrosis.As part of the Novartis clinical development program, Jakavi is also being investigated in clinical trials for the treatment of polycythemia vera.

Jakavi is a registered trademark of Novartis AG in countries outside the United States.

Formerly known as "Quad", Stribild of Gilead is now approved in the US

2012-08-28T08:55:00.001-04:00

Gilead announced that the company has received the US FDA approval to market Stribild, a complete once-daily single tablet regimen for the treatment of Naive Adults with HIV-1 Infection.

Stribild is a combination product containing the following active ingredients: elvitegravir 50 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir disoproxil fumarate 300 mg. The combination was formerly known as the Quad.

The FDA approved the product based on information provided in the 48-week data from two pivotal phase 3 studies in which the combination was shown to be non-inferior to Atripla (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) and to Truvada (emtricitabine/tenofovir combination) in combinationg with ritonavir-boosted atazanavir.

Elvitegravir is an integrase inhibitor. that works by interfering with HIV replication by blocking the ability of the virus to integrate into the genetic material of human
cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir on June 27, 2012.

Cobicistat is a pharmacoenhancing or “boosting” agent that enables elvitegravir once-daily dosing and has no anti-viral activity. It is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A). Gilead submitted an NDA to FDA for cobicistat on June 28, 2012.

Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established.

Patient Assistance Programs
Gilead’s U.S. Advancing Access^® program provides assistance to patients in the United States who do not have insurance or who need financial assistance to pay for their medications, including Stribild. Patients may contact Advancing Access at 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. (Eastern Time) to see if they are eligible for the program.

For patients with private insurance, Gilead’s co-pay coupon program provides assistance with out-of-pocket expenses for Gilead’s HIV medications, including Stribild, starting at the first dollar. Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Stribild for patients who receive medications through these programs.

Boehringer Ingelheim will present new data on tiotropium at the Annual Congress of the European Respiratory Society

2012-08-28T01:41:00.000-04:00

Boehringer Ingelheim announced they results of the first phase III trial evaluating tiotropium via the Respimat inhaler in asthma and the new phase II trial data evaluating the combination of tiotropium and olodaterol via Respimat in COPD patients will be presented at the Annual Congress of the European Respiratory Society in Vienna, Austria in September.

The company will also present a new analysis of the four year UPLIFT (TM) data at the same conference. The study evaluated the effect of tiotropium in low risk patients based on the newly defined patient groups in the updated report of the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

In addition, the company has already initiated the evaluation of the combination of tiotropium and olodaterol fix-dose combination in the TOviTO(TM) phase III clinical trial programme.

About tiotropium:

Tiotropium is a long-acting inhaled anticholinergic bronchodilator and was the first inhaled maintenance treatment to provide significant and sustained improvements in lung function in COPD with once-daily dosing. Tiotropium works by opening narrowed airways and helping to keep them open for 24 hours.

About olodaterol:

Olodaterol is a once-daily, long-acting beta₂-agonist (LABA) that Boehringer Ingelheim has designed and developed as an ideal partner to tiotropium for patients with COPD. To date, olodaterol’s efficacy as a once-daily bronchodilator has been shown in clinical studies, with a significant increase in lung function for at least 24 hours in patients with COPD.

Roche to submit an MAA to the EMA following positive results of the phase III EMILIA

2012-08-27T11:36:00.000-04:00

Roche releases new data from the phase III EMILIA study evaluating trastuzumab emtansine against the combination of lapatinib and Xeloda (capecitabine) for the treatment of HER2-positive metastatic breast cancer in patients who are HER2+ mBC and had previously received Herceptin (trastuzumab) and taxane chemotherapy. The results showed that trastuzumab significantly improved overall survival and progression-free survival of patients with Her2+ mBC.

Genentech, a member of the Roche Group, has submitted a new drug application for trastuzumab in the US. Roche plans to submit the marketing authorization
application for trastuzumab in the EMA shortly.

Trastuzumab is an antibody-drug conjugate that contains the antibody trastuzumab and chemotherapy DM1. Both of which are attached by a stable linker. The antibody-drug conjugate works by targeting HER2 and delivering the chemotherapy DM1 directly inside the HER2-positive cancer cells.

EMILIA study:

It is an international, phase III, randomized, open-label study comparing trastuzumab emtansine alone to lapatinib in combination with Xeloda in 981 patients with HER2+ locally advanced or metastatic breast cancer who had previously been treated with Herceptin and a taxane-based chemothreapy.

Gevokizumab received US orphan drug designation

2012-08-27T08:21:00.000-04:00

Xoma announced that the company's gevokizumab has received orphan drug designation from the US for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.

Gevokizumab (XOMA 052) is a potent monoclonal antibody with unique allosteric modulating properties and has potential to treat patients with a wide variety of inflammatory diseases and other diseases. The antibody binds strongly to interleukin-1 beta which is a pro-inflammatory cytokine that has been shown to be involved in Behcet's and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases.

Watson to start shipping generic Lidoderm in September

2012-08-24T11:05:00.000-04:00

Watson announced that the US FDA has approved the company's ANDA for lidocaine topical patch 5%. Lidocaine topical patch 5% is currently marketed as Lidoderm by Endo Pharmaceuticals for the relief of pain associated with post-herpetic neuralgia. Watson and Endo and Teikoku Seiyaku Co. have entered into an agreement to settle all outstanding patent litigation related to Watson's generic version of Lidoderm. Under the agreement, Watson will start shipment of generic Lidoderm
on September 13, 2012. The company will be entitled to 180 days of marketing exclusivity under the Hatch-Waxman rules.

Based on IMS data, the total US sales of Lidoderm was estimated to be 1.2B in the twelve months ending June 30, 2012.

Lidocaine is an amide-type local anesthetic agent that can stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses.

BMS halts the development of BMS-986094 due to patient death

2012-08-24T08:46:00.000-04:00

Bristol-Myers Squibb announced that it has discontinued the development of BMS-986094 for the treatment of hepatitis C

BMS-986094, formerly known as INX-189, is a nucleotide polymerase inhibitor that is currently being developed in the phase II clinical studies for the treatment of hepatitis C. The FDA has placed a clinical hold on the development of the compound which has also affected the development of Idenix's IDX184 and tanked Idenix shares.

The phase II trial was initially suspended on August 1, 2012 due to a heart failure case which now has resulted in death. As of now, nine patients have been hospitalized and two remained hospitalized. The company has yet to establish a definitive relation between the compound and kidney and heart toxicity. However, for the interest of the patients, it has decided to halt the development of BMS-986094.