Ortho-McNeil Neurologics issued another recall

how many more times Ortho-McNeil-Janssen (of J&J) is going to recall their products?

Adding to a long list of products, the troubled division is recalling another two products due to odor and TBA trace.  While the recall might not affect supply and its revenue (at this point at least), the polished image that J&J has carried for so many years is starting to disappear.

Patients/consumers are advised

KV Pharmaceuticals sold its generic unit

I always find it’s interesting when I mentioned the name of company in recent post and immediately a news release comes out. 

Just talked about KV Pharmaceuticals and its move in the case of Makena, today KV Pharmaceuticals announced that it has entered into a definitive agreement sell its generics subsidiary Nesher Pharmaceuticals to Zydus Pharmaceuticals for an approximately $60M in cash. 

The company plans to have the transaction completed in the second quarter of KV 2012’s fiscal year.

Based on Nesher Pharmaceuticals webite, the company is currently marketing potassium chloride extended-release capsules 8 mgEq and 10 mEq.

Watson is to launch generic Seasonique after the Court denied Duramed's request

Watson announced that the US District Court for the District of Nevada has denied Duramed’s request to prevent the launch of generic Seasonique® that Watson plans to launch.

Watson announced that it’s currently evaluating plans to initiate the launch of the contraceptive product.

Seasonique is a contraceptive product containing the following ingredients: levonorgestrel/ethinyl estradiol (0.15 mg/0.03 mg) and ethinyl estradiol (0.01 mg).

The brand Seasonique is marketed by Teva Women’s Health. Watson filed the ANDA for Seasonique in 2008.

The FDA panel unanimously recommended the approval of Eylea

So it's official!

The FDA panel met today to decide on the effectiveness and safety of Regeneron's Eylea (love it!) and agreed unanimously that it is.  With the FDA panel backing of its approval, Eylea (VEGF-Trap-Eye) is now set to wait for the decision from the FDA which will happen on August 20, 2011.

Although the FDA is not required to follow the Panel's recommendation, it usually does.  With the data

Watson is to launch generic nabumetone

Watson announced that the FDA has approved the generic nabumetone tablets 500 mg and 750 mg.  The company plans to launch the product soon.

As of April 30, 2011, the annual sale of nabumetone was $58M. 

Nabumetone is a non-steroidal anti-inflammatory drug that has been approved for the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.

The FDA accepted the sBLA for Menveo

Novartis announced that the US FDA has accepted the supplemental biologics license application (sBLA) to expand the use of Menveo (meningococcal vaccine) in infants and toddlers from 2 months of age.

The vaccine has been approved in the US in individuals whose ages range from 2 to 55.

The sBLA was submitted with data collected from pivotal trials involving over 6,000 infants and toddlers around the world.  The study showed that after the completing four doses of Menveo which were given at months 2, 4, 6, and 12-16 months of age, The correlated

SCT: Trading of Regeneron stock has been halted

As predicted, Trading of Regeneron common stock has been halted today due to the advisory committee meeting to discuss the LA of Eylea (VEGF Trap-Eye).  I like the name Eylea by the way (much much better the Trap-eye which has been used repeatedly over and over)

Let's wait and seewhat's going to happen...

Tioga Pharmaceuticals received key US patent for asimadoline

Tioga Pharmaceuticals announced that the US FDA has issued Key US Patent for asimadoline for its use in the treatment of diarrhea-predominant irritable bowel syndrome.  

The patent expiry is June 2028.

Asimadoline is currently being evaluated in the phase 3 trial under a special protocol assessment with the US FDA.   The molecule has also been granted

Takeda filed lawsuit against 18 Japanese companies

Just days after the FDA and the French Agency announced that Actos is linked to bladder cancer (with the French Agency has decided to pull Actos from the shelf), Takeda (Actos marketer) has filed a patent lawsuit against Generic companies in Japan (18 defendants companies).

Well, approximately 27 companies have filed the generic applications which have been approved in Japan.  Of the 27 companies, nine have agreed to settle the patent disputes.  Takeda has filed the lawsuit against the other 18.

Takeda the patents mentioned in the lawsuit cover the use of Actos or pioglitazone in combination with other antidiabetic products.

I think the decision to pull the drug from the market is a bit over-reacting.  A proper warning might be good.  But with the amount of diabetes medication available on the market, Actos is likely to lose ground very quickly.  If you have been reading the news (whether it's on the internet or on TV), you might have come across this news.  Now imagine a person who is currently taking Actos, he/she probably thinks about switching it immediately. Who would want to put themselves of risk of having bladder cancer?

So overall, it's not good news for Takeda who is now going to get involved in a patent lawsuit for a drug that is about to lose its market share significantly (not due to generic) due to its therapeutic effects.

Abbott received FDA approval for the lowest dose of Creon

Abbott announced that the FDA has approved the infant-specific dosage of Creon or pancrelipase which has an FDA-approved medication for exocrine pancreatic insufficiency due to cystic fibrosis. The new Creon dosage will be available as 3000-units capsule which will become the lowest available Creon in the market.

Currently, Creon is available in delayed-release capsules containing

APP Pharmaceuticals expands injectable product line with site expansion

APP Pharmaceuticals announced that it has invested $38M to expand its Grand Island, NY Manufacturing facility.  The expansion is going to enlarge the manufacturing site by 13,000 square feet.  It will also add an additional six productions lines specifically for generic injectable products.  In return for its investment, the Empire State Development is set to provide approximately 1.18M in Excelsior Jobs Program tax credits over five year period to the company.

The project is expected to be completed in two years.  The company plans to add another 90 employees for the expansion plan.  The site is currently employ 580 people.

APP Pharmaceutical is a pharmaceutical company that develops, manufactures, and markets injectable pharmaceutical products in the following therapeutic areas: oncology, anti-infective, anesthetic/analgesic and critical care markets.  APP Pharmaceutical was acquired in September 2008 by Fresenius Kabi Pharmaceutical Holding Inc.

Regeneron ahead of the decision

Just a short update... it's possible that Regeneron shares might not be traded this Friday because the Dermatologic and Ophthalmic drugs Advisory Committee is going to meet to discuss the Biologics License Application for VEGF Trap-Eye (I still don't think it's a great name for a medication) for the treatment of neovascular form of age-related macular degeneration.  in the past, several companies have halted the trading of their stocks based on the regulatory meeting.  For some companies

The FDA approved Nulojix of BMS

Bristol-Myers Squibb announced that the FDA has approved Nulojix or belatecept for the prevention of acute rejection in adult patients who underwent kidney transplant. The medication is approved under a condition that it is to be used with other immunosuppressants specifically basiliximab, mycophenolate, and corticosteroid. 

Nulojix is a T-cell co-stimulation blocker.  If you are not familiar with immunology, T-cell plays an important role in our immune system.  It has key role in the defense mechanism.  In patients undergoing transplantation, to prevent the body from rejecting the organ, often time, we have to give immunosuppressant to suppress the immune system (make it weaker so that it can’t form an attack against the transplant organ).  Organ rejection has not been a common issue since the emerging of the immunosuppressant.

The approval came from the results of the two open-label, randomized, multicenter, controlled phase 3 studies in over 1,200 patients.  The studies evaluating two dose regimens of Nulojix in addition to cyclosporine showed that the regimen was safe and effective for the prevention of acute organ rejection.

Common adverse reactions observed in patients in the trials were: anemia, constipation, kidney or bladder infection, and swollen legs, ankles, or feet.  Patients taking Nulojix is advised to stay away frm the sun due to an increase risk of skin cancer.  Patients are also advised to not take any live vaccines due to risk of infections.

Strength and formulations: 250 mg Lyophilized powder per vial. Each vial is accompanied with a 12 mL syringe.

ImmunoGen received $2M in milestone payments from Bayer

ImmunoGen announcd that it has received a milestone payment of $2M from Bayer after Bayer announced that it has submitted the Investigational New Drug Application for BAY 94-9343 which is currently being development as potential cancer treatment.

BAY 94-9343 is developed using the Targeted Antibody Payload Technology developed by

Lundbeck is to submit MAA for nalmefene to the EMA

Lundbeck announced that it has completed the clinical phase III program evaluating nalmefene as potential treatment of alcohol dependence.  The company intends to submit the European Marketing Authorization by the end of 2011.

The program included three phase III studies that were conducted in Europe in approximately 2,000 individuals with alcohol dependence.  All subjects was enrolled in a medical compliance encouragement program.  The most frequently observed adverse events in the phase III program

SCT: Azellon is to initiate the phase I trial using stem cells in the UK

Angel Biotechnology announced that Azellon is to start the phase I trial evaluating the use of stem cells in the treatment of patients with meniscal tears in the UK.  The UK regulatory agency has just approved the initiation of the phase I trial.

Angel Biotechnology is a contract manufacturer that has signed a contract agreement with Azellon to manufacture autologous cell therapy for Azellon's Phase I studies.   Angel Biotechnology is responsible for the development and GMP manufacturing services for the product in phase I trials.

Angel Biotechnology has its

Boehringer Ingelheim and Lilly announced launch of Tradjenta in the US

Boehringer and Lilly announced that Tradjenta or linagliptin tablets, approved recently for the treatment of type 2 diabetes but has also been the topic of the lawsuit that Amylin filed against Lilly, is now readily available at ll US pharmacies.  The product is available in 5 mg tablet and is manufactured by Boehringer Ingelheim.

The listed wholesale acquisition price for Tradjenta is $6.77 per tablet (not

The FDA announced that it has approved Inform Dual ISH, a test measuring the number of copies of the HER2 gene in tumor cells.  The test is now approved to be used by health care profressional to determine if women with breast cancers are HER-2 positive and therefore, candidates for Herceptin (or trastuzumab) treatment.

HER-2 gene has been found to be excessively expressed in breast cancer cells and the gene is located on chromosome 17 of the cells. Patients' cancer cells will be stained and chromosome 17 will appear red while copies of HER2 gene will have the color black.

The approval came from the studies involving samples from 510 patients with breas

Watson confirmed patent challenge from Alcon regarding Pataday

Watson announced that it has filed an abbreviated new drug application with the US FDA to seek the approval of the generic Pataday or olopatadine hydrochloride ophthalmic solution 0.2% currently marketed by Alcon for the treatment of ocular itching associated with allergic conjunctivitis.

It has also confirmed that Alcon Research, Alcon Pharmaceuticals and Kyowa Hakko Kirin have filed a lawsuit against Watson in the US District Court for the Southern District of Indiana on Jun 9, 2011 to prevent

AVEO plans to propose public offerings

AVEO Pharmaceuticals announced its plan to propose public offering of its common stock utilizing J.P. Morgan Securities LLC and Jefferies & company as joint book-running managers and underwriters for the proposed offering.  Canacoord Genuity Inc will be acting as co-lead manager.

AVEO plans to give the underwriters a 30-day options to purchase up to an additional 15% of the amount sold to cover-allotments.


About AVEO:

• AVEO is a pharmaceutical company developing medicines focusing

The FDA extended the PDUFA date for Exparel

_{Delay in progress…}

_{The FDA announced that it has extended the PDUFA target date for EXPAREL of Pacira Pharmaceuticals by three months making the decision date to be October 28, 2011.} 

_{Pacira has recently submitted additional information to the FDA who viewed the amendment as a major addition to the already received document.} 

_{Exparel is an investigational product utilizing DepoFoam(R), Pacira’s proprietary,}

Gilead received subpoena from the US Department of Justice

Is Gilead in trouble?  Once the leader in viral medication, the company has yet to release its next blockbuster viral drug while its rivals have simultaneously (okie not at the same time but almost!) launched their newly approved hepatitis C medications (with good efficacy profiles).  I'm talking about Vertex and Merck. Vertex has launched Invicek and Merck has launched Victrelis.  So what happened to Gilead?

The company recently announced that the US Attorney's Office for the Northern District of California has issued a subpoena (trouble ahead?).  The company is requested to submit documents related to the manufacture, quality and distribution practices

Takeda responded to the decision made by the French regulatoryauthorities to withdraw pioglitazone

Avandia (rosiglitazone) was the talk in town last year due to its adverse event profiles. Ever since, the compound has been a subject of discussion among many professions.  This year, Actos or pioglitazone is the subject of the day. (Avandia and Actos beloong to the same therapeutic class: thiazolidines)

The French regulatory authorities (AFSSAPS - very long!) has informed the subsidiary of Takeda, Laboratoires Takeda that it intends to suspend the use of pioglitazone

Cel-Sci initiates the phase III trial using Multikine in Hungary

Cel-Sci announced that it has initiated the phase III trial evaluating the company's Multikine(R) as potential treatment in patients with head and neck cancer in Hungary.

The company has recently initiated the phase III trial in Poland and received approval to initiate the trial in Taiwan.

The trial is currently ongoing at twelve clinical sites located in the US, Canada, Poland and India.

About the trial

NeoStem announced approval of additional production line from SFDA

NeoStem announced that the State Food & Drug has approved a new production line of its subsidiary Suzhou Erye Pharmaceutical which will be responsible for the production of over 20 finished pharmaceutical products and 80% of these are on the National Insurance Drug List.   With the new addition of the production line, NeoStem expects to ease up the constraint capacity associated with its previously operating facility.

NeoStem is a development and manufacturing of cell-based therapies in the US.  The company has three distinct business units: US adult stem cells, China Adult Stem Cells and China Pharmaceutical.

In 2010, Erye brought in $70M in sales and generated $10M in earnings.  The subsidiary had over $18M in sales in the first quarter 2011.

The company acquired Suzhou Erye in Oct 2009.  As of Jan 7, 2011, Eyre has 526 full-time employees and 309 part-time employees.

Vertex signed licensing agreement with Alios biopharma

Vertex announced that it has entered into an exclusive agreement with Alios BioPharma to add two nucleotide drug candidates into its hepatitis C portfolio.  Vertex recently received FDA approval for its telaprevir which is now on the market as Incivek!

Under the agreement, Vertex will have worldwide rights to ALS-2200 and ALS-2158 discovered by Alios.  In addition, it will also have option to select additional compounds

Valeant and GSK for US FDA Approval for Potiga (ezogabine)

Valeant and GSK announced that the US FDA has approved their Potiga™ or ezogabine for its use as an adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

The product has been approved in the EU and marketed as Trobalt™ on March 28^th, 2011.

The company plans to have the product available in all US pharmacies by the end of the year.

The approval of Ezogabine came from the results