Rexahn's isoquinolamine was granted European patent

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

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

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:

1. 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.
2. 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. 
3. 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

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

AtoBio's AB103 granted Fast Track Designation

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

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

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

The Mayo Clinic to manufacuture and distribute Choline C 11 injection

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

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

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...?)