The FDA approved Juvisync of Merck

The FDA has approved a new combination therapy containing sitagliptin and simvastatin for the treatment of type 2 diabetes and high cholesterol.  The new combination therapy is to be marketed as Juvisync by MDS InternationalGmbH Clonmel, Co. 

Sitagliptin is a dipeptidyl peptidase 4 inhibitor.  The agent has been approved and marketed as Januvia for the treatment of type 2 diabetes.  Simvastatin has been approved and marketed as Zocor.  Simvastatin is an HMG-CoA reductase inhibitor that works to reduce the production of cholesterol. 

Juvisync is to be made available in the following strengths (sitagliptin/simvastatin): 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg. 

MDS announced that it is to develop a fixed dose combination tablet containing 50 mg of sitagliptin and 10 mg, 20 mg, and 40 mg of simvastatin. 

Simvastatin 80 mg has recently received warning due to its risk of developing muscle toxicity.  As a result, the combination of sitagliptin with 80 mg dose will not be made available. 

The most common side effects that patients experienced while taking Juvisync is: upper respiratory tract infection, stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea. 

Merck announced that the price of Juvisync will be similar to Januvia alone.  It expects to have the product available in the market in the near future.

Watson received lawsuit from Pfizer

Watson announced that after filing an abbreviated new drug application with the FDA seeking the marketing authorization to manufacuture and market Embeda (R), a combination product of morphine sulfate and naltrexone hydrochloride extended-release capsules, the company has received a lawsuit filed by King Pharmaceuticals, part of Pfizer.

The suit was filed to prevent

Teva to release its third quarter financial earnings.

Teva announced that it is to release the financial results of its third quarter on November 2, 2011.  The company will also host a conference call and live webcast on the same day at 8:30 am Eastern Time.

Interested parties can participate in the conference call by either using the live webcast or dialing in.

The live webcast will be available at www.tevapharm.com

In order to call in, interested parties can use the following instruction:

• US and Canada: 1-877-407-0784
• International: 1-

LeGoo of PluroMed has been approved by the FDA

LeGoo of PluroMed has been approved by the US FDA to stop the blood flow during blood vessel surgery in order to join blood vessels without clamps or elastic loops.  However, the blood vessels have to be below the neck and are less than 4mm in diameter.  LeGoo is not approved for used in vessels supplying blood to the brain.

LeGoo is a temperature sensitive gel and often stays in liquid form at room temperature and becomes solid at higher temperature.  Once a gel plug is formed, it can stop the blood flow for up to 15 minutes.

Merck and ARIAD announced the acceptance of the NDA submitted for ridaforolimus

Merck announced that the US FDA has accepted a new drug application filed for ridaforolimus which is an investigational mTOR inhibitor for the treatment of metastatic soft-tissue or bone sarcomas in patients who have favorable response to chemotherapy.


In addition, the marketing authorization application filed with the European Medicines Agency has been accepted. 

Discovered by ARIAD who

The FDA accepts filing of NDA for mechlorethamine gels of Yaupon

Yaupon Pharmaceuticals announced that the new drug application submitted for the company's proprietary gel formulation of mechlorethamine hydrochloride for the treatment of early stage mycosis fungoides, the most common type of cutaneous T-cell lymphomas.

Included in application are the data from a pivotal, multi-center clinical trial evaluating mechlorethamine gel in patients with early stage mycosis fungoides.  The study

UltraGenyx's UX001 received orphan drug status designation from the US FDA

Ultragenyx announced that the FDA has granted the company's UX001 SA-ER orphan drug status for the treatment of hereditary inclusion body myopathy.

UX001 SA-ER is an extended release formulation of sialic aci and is currently being studied in the phase 1 pharmacokinetic and safety trial which was initiated in August 2011.  The company hopes to have data released later this year. The phase I trial plans to enroll 24 patients with Hereditary Inclusion Body Myopathys at two centers located in New York and Los Angeles.  Four doses of UX001 will be tested in each group of six subjects who will also undergo repeat dosing at three dose levels over 7 days.

Ultragenyx is a privately held developmental stage biotechnology company that is committed to develop and bring life-enhancing therapeutics to patients with rare and ultra-rare genetic diseases.

Catabasis initiates phase 1 trial evaluating CAT-1004

Catabasis Pharmaceuticals announced that it has initiated the phase 1 trial evaluating CAT-1004 which is a novel conjugate of the essential omega-3 fatty acid docosahexaenoic and salicylate for the treatment of inflammatory and metabolic disease.

The phase 1 trial is a single center, randomized, double-blind placebo-controlled ascending dose study that evaluates the safety, tolerability and pharmacokinetic profile of CAT-1004.  The company hopes to enroll ^) subjects who will receive a single dose of CAT-1004  or placebo via oral administration.

The Medicines Company launched Cleviprex injectable emulsion

The Medicines Company announced the launch of Cleviprex or clevidipine injectable emulsion which was approved by the US FDA in June 2011. The new formulation allows longer infusion time which was originally at 4 hour. 

Clevidipine is a dihydropyridine calcium channel

The FDA set the PDUFA date for Intermezzo

Transcept announced that the FDA has set November 27, 2011 as the PDUFA date for the company's resubmission NDA of Intermezzo and classified the resubmission as Class 1 response.

Transcept resubmitted the NDA of Intermezzo in September.

About Zolpidem:


Intermezzo is a zolpidem tartrate sublingual tablet. If approved, it will be the first prescription for the stated indication. Zolpidem is available in other dosage forms.

Zolpidem is not a benzodiazepine but binds to GABA receptor to induce the effect of benzodiazepine which often works to induce sedation.

It's a schedule IV substance

Inspiration Pharmaceuticals expanded its partnership with Ipsen

Inspiration Pharmaceuticals expanded its partnership with Ipsen to prepare for the commercial launch of Inspiration's Hemophilia pipeline in Europe.  The partnership will create a European hemophilia commercial organization in Europe.  The companies will hire and train a highly specialized commercial team in order to work in Europe for all hemophilia drugs commercialized by Inspiration.

Inspiration currently has two products in late clinical testing:

• IB1001: an intravenous recombinant factor IX for the treatment and prevention of individuals with hemophilia B
• OBI-1: an IV porcine recombinant factor VIII for the treatment of bleeding individuals with acquired hemophilia A and congenital hemophilia A who have developed FVIII inhibitors. 

Of these two products, Inspiration plans to file a marketing authorization application with the European Medicines Agency by the end of the year for IB1001.

About the expanded agreement:

• The original agreement was signed in Jan 2010 under which Inspiration in-licensed OBI-1 from Ipsen in addition to receiving $259M in milestone-based funding from Ipsen to support the development of Inspiration's two lead development programs.
• By sub-licensing OBI-1 to Inspiration, Ipsen received $50 M in convertible notes in addition to 27.5% royalty on future of OBI-1 sales.
• Of the $259M funding to Inspiration: Ipsen made an upfront investment of $85M in exchange for the shares of a new class of preferred stock which made up of 20% if Inspiration's fully-dilated equity.  Ipsen is also entitled to appoint one member (of the 7( to the Board of Directors of Inspiration.  The other $174M will be paid to Inspiration once the company successfuly develops IB1001 and OBI-1. 
• 
  
• The expanded agreement will create a hemophilia business that acts as the exclusive commercial agent for Inspiration products sold in the EU, Russia, and other European Countries.  Inspiration will book all sales in the business unit.  Ipsen will book all related sales and marketing expenses which will be rebilled to Inspiration and recorded in the company's Other revenues. 

Sangamo discontinued the development of SB-509

While it's important to post positive news, it's also equally important to see which one did not make it to the market.  Everyone often told me...of one drug that gets to market, millions have to be discarded.  Often time, we just don't hear about them but sometimes without these failures, success can't be attained. 

Sangamo announced that it has discontinued the development of SB-509 for the treatment  of diabetic neuropathy due to disappointing results of the phase IIb trial evaluating the compound in 170 subjects.

The phase 2b trial is a double-blind, repeat-dosing, placebo controlled study that is designed to finalize the dosing, schedule, and primary as well as secondary endpoints for the expected pivotal phase 3 trials.  Compared to placebo, SB-509 did not significantly improve sural nerve conduction velocity which is the study's primary end point at day 180.  In addition, the study also did not meet the prespecified secondary endpoints which were measured by neuropathy impairment score in the lower limb or intraepidermal nerve fiber density.

SB-509  which is an injectable plasmid encoding a zinc finger DNA-binding protein transcription factor is designed to upregulate the expression of the gene encoding for vascular endothelial growth factor. 

The company said it will focus on the development of ZFP(R) therapeutisc for HIV and monogenic diseases.

Sangamo currently has the following compounds in the pipeline

• SB-728 for HIV/AIDs: phase 1
• SB-313 for glioblastoma: preclinical
• Other compounds for hemophilia, rare disease, other indications.

Sanofi acquires acne vaccine and treatment from UCSD

Sanofi Pasteur announced that it has acquired exclusive, worldwide license of an acne vaccine and treatment from a research and development collaboration with the University of California, San Diego targeting Propionibacterium acnes factors in inflammation.

The company did not disclose any financial

PPD to go private after acquisition

PPD announced that it is to go private after the company signed a definitive agreement to be acquired by  The Carlyle group and Hellman& Friedman for $3.9 billion. 

Under the terms of the agreement, Carlely and Hellman & Friedman will pay $33.25 per share in cash which represents a 29.6% premium of  PPD's closing price on September 30, 2011.

The companies hope to have the transaction complete by the fourth quarter of 2011.

PPD is a global contract research organization that has presence globally. The company is based in Wilmington, NC.

Momenta filed lawsuit against Amphastar Pharmaceuticals, Watson Pharmaceuticals and International Medical Systems

Momenta Pharmaceuticals released a statement saying that it has filed for preliminary injunction against pharmaceuticals, Waston Pharmaceuticals and International Medical Systems in regard to the company enoxaparin sodium product in the US. 

The company claimed in the lawsuit filed with the US District Court of the District of Massachusetts that two Momenta patents were infringed.  The two US Patent No: 7,790,466 (methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures), and the US Patent No 7,575,886 (methods of analyzing enoxaparin for the presence of a certain structure signature).

Momenta collaborated with Sandoz (the generics business of Novartis) to develop the generic version of Lovenox which was approved in July 2010 and has been available on the market since.

About Lovenox or enoxaparin

• Enoxaparin is a low molecular

BioTie Therapeies to acquire Newron

Biotie Therapies announced that it has signed an agreement to acquire Newron for 45M EUR to create a biopharmaceutical company focusing on the development therapeutics for the Central Nervous System.

After the acquisition completed, the company will have two clinical candidates, nalmefene for the treatment of alcohol dependence and safinamide for the treatment of Parkinson's disease, which are both in late phase III development.

Nalmefene, of Biotie, is an orally available medication

Johnson & Johnson acquired full ownership of JNJ & Merck Joint Venture

McNeil PPC and its affiliate McNeil MMP (both of Johnson & Johnson) have acquired full ownership of the Johnson&Johnson and Merck Consumer Pharmaceuticals Co. Joint Venture which will be renamed McNeil Consumer Pharmaceuticals. The company said it will continue to market products under PEPCID(R), MYLANTA9R), and MYLICON(R) brands.

In addition, Johnson and Johnson has acquired

Sagent received approval to market clindamycin injection

Sagent Pharmaceuticals announced thatthe US FDA has approved the Abbreviated New Drug Application that the company submitted for clindamycin injection USP.

The company's clindamycin injection is latex-free and will be available in three single-dose vial sizes in pharmacy bulk packaging.

Clindamycin is an antibioteic that has been approved for the treatment of serious infections caused by susceptible anaerobic bacteria. It is also been approved for use in serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.

Faslodex is now approved in Japan

AstraZeneca announced that the Japanese Ministry of Health has approved the company's Faslodex or fulvestrant for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer which has recurred or progressed following prior endocrine therapy.

The decision was made based on the results

AstraZeneca settled litigations with Handa Pharamceuticals

AstraZeneca has settled the patentlitigation with Handa Pharmaceuticals following the filing of the abbreviated new drug application for Seroquel XR or quetiapine fumarate extended release tablets.

Under the settlement, Handa now has license to market generic Seroquel XR in the US tarting November 1, 2016 or earlier depending on certain circumstances. Based on the company's website, Seroquel XR is protected by patents and other exclusivity rights dating from March 2012 to November 17.

Both companies will file a proposed Consent Judgment