ViroPharma's New Drug Submission has been granted priority review status

ViroPharma announced that the new drug submission for Cinryze submitted to Health Canada has been granted priority review status.

Upon receiving the priority review status, ViroPharma is required to submit the complete NDS to the Agency with 60 days. The company plans to submit the complete NDS by the end of the quarter. The decision is set to be made by the end of 2012.

ViroPharm is seeking to market Cinryze for

Sobi entered into a global licensing agreement with O4CP

Sobi announced that it has entered into a global licensing agreement with Only for Children Pharmaceuticals (O4CP) regarding bumetanide reformulated for the treatment of diuresis and seizures in neonates.

O4CP will be in charge of manufacturing and filing regulatory application for bumetanide.  Sobi will be responsible for the commercialization of the product worldwide.  Sobi will

Novartis to restructure its US operation

Novartis announced restructuring program in the US ahead of the patent expiration of Diovan and the results of the ALTITUDE study evaluating Rasilez/Tekturna for the treatment of hypertension in high risk populations.

The company will reduce 1,960 positions in the US. This will cost the company approximately $160M in the first quarter of 2012. However, the move is said to save the company approximately $450M by 2013.

Diovan (valstartan) is expected to lose its

CSL Behring initiates the phase II/III pivotal study evaluating recombinant fusion protein linking coagulation factor IX with recombinant albumin

CSL Behring announced that the company has initiate the phase II/III pivotal study evaluating the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin.

The prospective, open-label study plans to enroll 60 male subjects whose ages range from 12 to 62 and have been diagnosed with hemophilia B. The estimated primary completion date is September 2013. Currently, the company has established trial sites in Austria, Bulgaria, France, Germany, Italy, Spain and Israel. Additional sites will be open in the US, Japan, and Russia.

The study primary outcome measures are

• change in frequency of spontaneous bleeding events between on-demand and prophylaxis treatment
• number of subjects developing inhibitors against factor IX

The study will also measure other secondary outcomes that are not listed here.

Valeant acquired rights to market Fleming's products

As of December 22, 2011, Valeant has acquired rights to market the following Fleming's brands: Ocean, Nephrocaps, Magonate and ProBarimin QT. Valeant Pharmaceuticals North America will become the distributor of these products. Based on the company's information, after the sales, the only product that will be marketed by Fleming will be ThyroShield.

Fleming also offers contract manufacturing services and is looking

Kedem initiates the development of sublingual Gleevec

Kedem Pharmaceuticals announced initiation the development of sublingual Gleevec, a tyrosine kinase inhibitor that has been approved for the treatments of several conditions including chronic myeloid leukemia in patients with Philadelphia Chromosome and gastrointestinal stromal tumor.

Gleevec is currently available in 100 mg and 400 mg tablets and marketed by Novartis.

Kedem Pharmaceuticals will utilize the company's sublingual and orodispersable technology to develop the sublingual formulation for Gleevec. The company claims that its technology will allow the drug to disintegrate in less than 20 second.

The company is currently developing sublingual formulations for the following medications:

• sildefanil 
• propranolol
• naproxen
• sumatriptan
• fentanyl
• zopiclone
• corticoid/steroid

OctoPlus entered into a feasibility agreement utilizing the company's PolyActive Technology

OctoPlus signed a feasibility agreement with a leading US-based pharmaceutical company to develop a controlled release formulation of a therapeutic compound that can be locally delivered into joints.

The company will utilizes its proprietary drug delivery technology PolyActive to develop the controlled release formulation for this product. The project can

Oramed filed a provisional application for its combination product for the treatment of type 2 diabetes

Oramed Pharmaceuticals announced that the company has filed a provisional patent application for a combination therapy of ORMD-0801 and exenatide oral formulation with the US Patent and Trademark Ofice.

ORMD-0801 is an orally available insulin capsule that has been shown to have favorable effect in the phase II trial evaluating its efficacy in the treatment of type II diabetes. ORMD-0901 (oral exenatide formulation) is a glucagon-like peptide-1 analog. Exanetide

Merrimack initiated trial evaluating MM-151

Adimab announced that Merrimack has initiated the phase 1 trial evaluating the company's MM-151.

MM-151 is an oligoclonal therapeutic containing three human monoclonal antibodies that have been designed to bind to different epitopes of the epidermal growth factor receptor.

Adimab and Merrimack entered into a a collaboration in 2009. Based on the press release published by the company, it looks like the agreement was signed in December of 2009. Under the terms of the agreement, Merrimack will have rights to commercialize the antibodies generated from the collaboration. Adimab will be eligible to receive milestone payments and licensing fees. Adimab also received upfront payments after the collaboration was signed.

A new PDUFA date has been set for lorcaserin of Arena and Eisai

Arena announced that the company's resubmission NDA for lorcaserin for weight management has been accepted for review y the US FDA.

The resubmission was classified as a complete, class

Omthera announced positive results of the pharmacokinetics study comparing Epanova to Lovaza

Omthera released positive results from the pharmacokinetics study comparing the bioavailability of Epanova to Lovaza in 52 subjects who were given the medications in combination with low fat diets for 14 days. The results showed that higher plasma EPA and DHA levels were observed in patients taking Epanova compared to Lovaza.

Epanova is a patent protected, novel, ultra-pure mixture of free fatty acid forms of eicosapentaenoic acid and docosahexaenoic acid. The company has conducted

Shire acquired US rights to Resolor (prucalopride)

Shire announced that the company has entered into an agreement with Janssen Pharmaceutica NV to obtain exclusive rights to develop and market Resolor (prucalopride) in the US for the treatment of chronic sontipation.

Resolor (prucalopride) was developed by Janssen Pharmaceutica NV. Movetis, which was acquired by Shire in 2010, obtained rights to market the product in Europe.

Resolor is a prokinetic and has been approved in 33 countries for the symptomatic treatment of chronic constipation in women who have failed laxative

Sinovac initiated the phase III trial evaluating EV71 vaccine

Sinovac of China has initiated the phase III trial evaluating its EV71 vaccine against hand, foot and mouth disease. The expected completion date will be in the first half of 2013.

The company has also anticipated the completion of the manufacturing facility for the EV71 vaccine and obtaining a GMP (good manufacturing practice) in 2013.

The phase III trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy of EV71 in up to 10,000 healthy volunteers

Cubist and Hydra Biosciences plan to initiate the phase 1 trial of CB-625

Cubist Pharmaceuticals and Hydra Biosciences announced plan to initiate the phase 1 trial evaluating CB-625, discovered under the collaboration between the two companies, forthe treatment of acute pain, in the first quarter of 2012.

The phase 1 trial will be designed as an open-label, dose-escalation study evaluating the safety and pharmacokinetics of CB-625 in healthy volunteers.

The initiation of the phase 1 trial will trigger a

Mylan confirmed lawsuit filed by Takeda, Watson and Andrx Labs

Mylan confirmed that the company has been sued by Takeda Pharmaceutical Company, Watson Pharmaceuticals and Andrx Labs in association with the filing of an Abbreviated New Drug Application (ANDA) with the US FDA for Actoplus Met(R) XR, a combination of pioglitazone and extended-release metformin. The suit was filed in the US District Court for the Southern District of New York.

Mylan believes that it is the first company to file the ANDA containing a Paragraph IV certification for all strengths. It also expects to have 180-days of marketing exclusivity following the

BioCryst announced positive results of the ongoing phase 2b study evaluating BCX4208

BioCryst released positive results from the ongoing phase 2B study evaluating BCX4208 for the treatment of gout. 

The company conducted a 12-week study evaluating the use of BCX4208 given in addition to allopurinol for the treatment of gout in 279 subjects. The trial was extended and 160 of these subjects were enrolled and given the medication to study the long-term effects of the investigational product. All subjects remained blinded to the study drug.  

Patients were treated with either BCX4208 (

Recall products from Novartis

What will you do when you open a bottle and find that two pills don’t look alike? Well, due to a malfunction manufacturing facility in Lincoln, Nebraska (which has been shut down for the time being), Novartis Consumer Health Inc is recalling several over-the-counter products in the US. The company estimates the recall will cost the company 120M that will be taken in the fourth quarter of 2011.

The following products are affected in this recall:

• Excedrin and NoDoz products having expiry dates of December 20, 2014 or earlier
• Bufferin and Gas-X Prevention products having expiry dates of December 20, 2013 or earlier

The company said products might have stray

NovaBay entered into an agreement with Pioneer Pharma

NovaBay Pharmaceuticals entered into a strategic marketing agreement with Pioneer Pharma for NeutroPhase in China in this territory.

NeutroPhase is an anti-infective Aganocide compounds and has been approved by the US FDA as a wound cleanser to promote healing and improve clinical outcomes for patients with chronic non-healing wounds, including Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

NovaBay is currently seeking additional

Bristol-Myers Squibb to acquired Inhibitex

Bristol-Myers Squibb announced that the company and Inhibitex have entered into a definitive agreement allowing BMS to acquire Inhibitex for $26 per share in cash. The acquisition is estimated to be at $2.5B and has gotten approvals from the boards of directors of both companies.

Inhibitex is a clinical-stage pharmaceutical company.  The company has several products in clinical trials.

INX-189, a nucleotide polymerase inhibitor,

Endo Pharmaceuticals signed an agreement with BioDelivery Sciences International

Endo Pharmaceuticals and BioDelivery Sciences International have entered into an international license and development agreement for the development and commercialization of BEMA buprenorphine.

BEMA is a mucoadhesive technology developed by BioDelivery Sciences International. BEMA buprenorphine is currently being investigated in the phase III trial for the treatment of moderate to serve chronic pain.

Under the terms of the agreement, BioDelivery Sciences International will receive $30M from Endo Pharmaceuticals.  BioDelivery Sciences International will

CBP501 of CanBas Co. has been granted orphan drug designation

CanBas Co. of Japan has announced that the company's CBP501 has been granted orphan drug designation for its use in combination with cisplatin and pemetrexed for treatment of patients with mesothelioma.

CBP501 is currently being investigated in late phase II development for the first-line treatment for patients with advanced malignant pleural mesothelioma who are ineligible for curative surgery.  The company expects to have the trial completed by the first half

Fact or Fiction #3

Remember not too long ago, Regeneron entered into a partial settlement with Genentech and the whole issue has created a big commotion in the industry because Eylea is projected to be a blockbuster drug for the years to come.

Information regarding the lawsuit was not specific and information was not readily available. The patent and law issues surrounding it is not simple to understand either.

Mandour & Associates Intellectual Property Law wrote an article "Genentech Files Patent Infringement Lawsuit Against Regeneron" on December 28, 2011.  In the article, the company said