Entinostat of Syndax received UK Patent

The UK Intellectual Property Office has issue the UK patent covering the polymorph representing a preferred stable form of entinostat of Syndax Pharmaceuticals with “key .laims covering the polymorph form B and the manufacturing process by which it is derived”.

Syndax Pharmaceuticals filed the patent application as the Patent Cooperation Treaty (PCT) which will provide platform for additional worldwide filings in the following countries Japan, China, India, South Africa and Brazil.  Syndax has filed patent application for entinostat in the Us, Europe, Argentina, Venezuela, Taiwain, Kuwait and Saudi Arabia. 

Entinostat is an oral highly selective class I Histone deacetylase (HDAC) inhibitor.  It has very long half life which will allow it to be dose once a week or once every other week.  It’s currently being studied in phase II clinical trials listed below

• Add-on therapy to aromatase inhibitors in advanced breast cancer
• Add-on therapy to erlotinib in metastatic lung cancer
• Add-on therapy with azacitidine in non-small-cell lung cancer and advanced colorectal cancer (under CRADA w/ the NCI)
• Monotherapy in Hodgkin’s lymphoma.

Source - Syndax

Cubist announced its third quarter financial result

Cubist announced its third quarter financial result with an increase of 13% in total net revenue (an increase of 18.6 M compared to the same quarter of last year).   The company net income (GAAP basis) recorded a 31.2 M, an increase of 5.8 M from the same quarter of last year.  At the end of its third quarter on September 30, 2010, the company had 605.1 M in cash, cash equivalents and investments.  Source - Cubist

Atypical Thigh Fracture Warning issued to Bisphosphonate Medications

• The FDA warned patients and healthcare providers about the increase risk of atypical thigh bone (femoral) fracture associated with the use of bisphosphonate, a class of medications used to prevent and treat osteoporosis. 

• Bisphosphonate inhibits osteoclast-mediated bone resorption.  Osteoclast is a specific cell type that could break down bone in order to release minerals into the blood stream.  Under normal condition, it works together with osteoblast to balance the breaking and building of the bone.  By inhibiting its activity continuously, the medication will be able to stop the bone from being broken down.  Hence, it is thought this can preserve bone density.

• While it has been shown to reduce of certain fractures in patients with osteoporosis, the rate of atypical thigh bone (femoral) fracture has been seen to increase in patients taking bisphosphonate long term (over five years). 

• The FDA indicates that change in label will affect the bisphosphonate medications that have been approved to treat osteoporosis (both oral and injectable).

• Oral medications: Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, newly approved Atelvia, as well as its generic products.

• Injectable Medications: Reclast and Boniva

• Label changes will not be applicable to bisphosphonate medications that were approved for the treatment of Paget’s disease or cancer/hypercalcemia: 
• Didronel, Zometa, Skelid, and their respective generic products.

• Patients who have questions about their medications should consult with their primary healthcare providers for further guidance.  Stopping medication abruptly without primary healthcare provider recommendation is not recommended.

 Source - FDA

Auxilium starts phase III trial using Xiaflex as treatment of Peyronie's Disease

Auxilium initiates the phase III clinical studies using Xiaflex® or collagenase clostridium histolyticum kit as the treatment of Peyronie’s Disease.   Auxilium will conduct four clinical studies called IMPRESS – The Investigation for Maximal Peyronie’s Reduction Efficacy and Safety Studies.  

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The project will involve:

•  Two randomized, double-blind, placebo-controlled phase III studies.  These two studies will be conducted at 70 sites in the US and Australia.  The company plans to enroll 600 patients. The company expects to complete patient enrollment fin the first quarter of 2011 and top-line results will be available in the first half of 2012.
•  One open label study is expected to enroll 250 patients at 30 sites in the US, EU and New Zealand
• One pharmacokinetic study is expected to enroll 16 patients.

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Xiaflex or collagenase clostridium histolyticum has been approved in the US as the treatment of adult patients with Dupuytren’s contracture with a palpable cord.  It is a proteinase that can hydrolyze collagen in its native triple helical conformation under physiological conditions and will lead to the disruption of collage deposits.  

Peyronie's Disease is characterized by the harden penis due to plaque formation.  Currently, the progression of the disease is not well understood.  Patients are often faced with limited treatment options:  radiation therapy, surgery, or therapeutic medications (very limited and unsure about efficacy)

Source - Auxilium 

Lundbeck to market Asenapine (Sycrest) in countries outside of the US, China and Japan

• Lundbeck will have exclusive rights to Sycrest (asenapine) in all markets outside of the US, China and Japan under the newly signed exclusive commercialization agreement with Merck.   Lundbeck is to pay Merck an undisclosed upfront payment as well as product supply payments.  Expected European launch date is in 2011. 

•  Asenapine has been approved in Europe for the treatment of moderate to severe manic episodes associated with bipolar 1 disorders in adult.  Asenapine is an atypical antipsychotic medication.  

• Merck is currently marketing asenapine under the brand name Saphris  in the US for the treatment of acute manic or mixed episodes associated with bipolar 1 disorder with or without psychotic features in adults. 

• Recently, on September 7, 2010, the FDA has granted additional indications that allow Saphris to be used to treat schizophrenia in adults as monotherapy for the acute treatment of manic or mixed episode associated with bipolar I disorders in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Source - Lundbeck

Lundbeck and Genmab signed a research collaboration agreement

Lundbeck and Genmab signed a research collaboration agreement to create and develop human antibody therapeutics for Central Nervous System disorders.

Under the agreement, Genmab will receive 7.5 Million Euro as the upfront payment and Genmab will develop antibodies to target certain areas that Lundbeck specifies.  Lundbeck will have access to Genmab's antibody pipeline as well as some of the technology platforms from this project.

In addition, it can also select antibodies to move into clinical development and will be responsible for single digit milestone payment as well as development cost.  Genmab will also have the option to move its compound to clinical development and will be responsible for single digit milestone payment to Lundbeck and development cost. 

Source - Lundbeck

Vivitrol - Naltrexone Intramuscular Injection gained additional indication to treat and prevent relapse in opioid-dependent patients

Vivitrol, an extended-release formulated naltrexone intramuscular injection, developed by Alkermes has been given additional indication by the FDA to treat and prevent relapse in opioid-dependent patients who have undergone detoxification treatment.  Vivitrol can be administered once a month by the physician as an intramuscular injection.

Naltrexone is an opioid receptor antagonist and has highest affinity for the mu opioid receptor.  It blocks others opioid from accessing the opioid receptors.  Drugs that can been blocked by naltrexone are morphine, heroin and others.

Vivitrol was originally approved to treat alcohol dependence in 2006.

In addition, the FDA has issued a boxed warning to the active ingredient in Vivitrol - Naltrexone - indicating possible hepatocellular injury (Liver injury) when naltrexone is given at high dose.  Hence, patients with acute hepatitis (acute liver injury) or liver failure, and active liver disease are contraindicated.  At recommended dose, the risk of developing liver injury or toxicity is low.

Symptoms of acute liver injuries should be relayed to the patients:

• stomach area pain lasting more than a few days
• dark urine
• yellow of the whites of your eyes (sign of jaundice)
• tiredness.  

Tell physicians immediately if patients experienced these symptoms and other severe adverse events indicated in the packaged insert.
Source
Source - Alkermes

B Braun Launched Cefepime Duplex System

B. Braun Duplex System of 1g and 2g cefepime injection USP and Dextrose Injecion USP is now available for purchase. 

Cefepime is a bactericidal agent that can inhibits bacterial cell wall synthesis.  It can act against gram-positive and gram-negative bacteria.  It is highly resistant to organism to organism that produces beta-lactamase and can penetrate gram-negative’s cell wall rapidly. 

It has been approved to be used to treat various bacterial infections: pneumonia, empiric therapy for febrile neutropenic patients, uncomplicated and complicated urinary tract infection (including pyelonephritis), uncomplicated skin and skin structure infections, complicated intra-abdominal infections.

Duplex Drug Delivery System developed by B Braun is a pre-filled, ready to use, PVC-free, DEHP-free and latex-free IV containers containing accurate drug and diluents doses.  It is developed  to ease the administration of antibiotic in order to enforce compliance and ensure patient safety.

Source

The EU approved Vimovo of AstraZeneca and Pozen!

 

• Vimovo of AstraZeneca and Pozen received approval to be used as the treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID drug-associated gastric and/or duodenal ulcers in 23 countries across the European Union.  Following the approval, each state will now pursue pricing, reimbursement as well as national approvals.

• Earlier in 2010, Vimovo was approved in the US as the treatment of OA, RA, AS, and to decrease the risk of developing gastric ulcers in patients having risk of developing NSAID-associated gastric ulcers.

• Vimovo is a fixed dose combination of 500 mg naproxen and 20 mg esomeprazole.  In this combination, naproxen is enteric coated and omeprazole is formulated in immediate-release formulation.  Naproxen is a pain-relieving Nonsteroidal anti-inflammatory drug (NSAID).  Esomeprazole is a proton pump inhibitor and is often used to reduce gastric acid in patients experiencing Gastric Esophageal Reflux (GERD). 

• The EU Concerned Member States that formed the DCP include: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

 Source
 

Pfizer to acquire King Pharmaceutical with 3.6 B

Pfizer announced on October 12, 2010 that it is to acquire King Pharmaceuticals with a 3.6 Billion in cash or $14.25 per share (a 40% premium of King's closing price on Oct 11).  The companies to complete the transaction in a late fourth-quarter 2010 or first-quarter 2011.

Acquisition of King Pharmaceutical will diversify Pfzier's portfolio.  King Pharmaceuticals specializes in pain treatment (new formulation to decrease abuse and misuse potential), Meridian Auto-injector for emergency drug delivery such as EpiPen, and animal health. 

Source

Atelvia of Warner Chilcott is now approved to be used as treatment of postmenopausal osteoporosis in the US

The FDA has approved the Atelvia (TM) or risedronate sodium delayed-release tablet of Warner Chilcott for the treatment of postmenopausal osteoporosis in the US.  Atelvia belongs to a therapeutic class called bisphosphonate.  The company plans to initiate the commercial launch of Atelvia in early 2011. 

Several other available bisphosphonates are:

• Alendronate (Fosamax)
• Elodronate (Bonefos or Clasteon)
• Etidronate (Didronel)
• Ibandonate (Boniva)
• Pamidronate (Aredia)
• Tiludronate (Skelid)
• Zoledronic acid (Reclast or Zometa)

Source

Top of the line data of the phase II study using brentuximab vedotin of Seatlle Genetics and Milennium showed positive result

Top of the line data of the phase II trial using Brentuximab Vedotin (SGN-35) for the treatment of Relapsed or Refractory systemic anaplastic large cell lymphoma (ALCL) showed that an objective response was achieved in eighty-six percent of participants.  The single-arm phase II trial is run to assess the efficacy and safety of brentuximab vedotin in relapse or refractory ACLC.  The study primary endpoint is overall objective response rate. 

Brentuximab is currently under the joint-development of Seattle Genetics and Millennium (now a Takeda Company). Under the signed agreement, Seattle Genetics has the US and Canadian commercialization rights, while Take Group has commercialization rights to the rest of the world.   


Brentuximab is an ADC that has anti-CD30 monoclonal antibody attached to a potent, synthetic drug payload, monomethyl auristatin (MMAE) by an enzyme cleavable linker.  The development of brentuximab utilized proprietary technology of Seattle Genetics.  Brentuximab is also in other phase III and II trials for other indications.

Source

Restructuring of the Sanofi-Aventis US Pharmaceutical Operation will eliminate 25% work force (1,700 positions)

Sanofi-Aventis plans to restructure its US Pharmaceutical Operations with an estimated of 25% work force reduction (1,700 positions).  The US Pharmaceuticals will focus on: Diabetes, Atrial Fibrillation and Oncology. Sanofi-Aventis US employs 13,000 people with 6,900 employees in the Pharmaceutical Operation.

The company plans to finalize the decision by Mid-December.

Source

Complete response letter from the FDA indicates needed additional clinical trials for JZP-6

The FDA issued a complete response letter in regard to JZP-6 or sodium oxybate of Jazz Pharmaceuticals.  Jazz Pharmaceuticals filed the NDA for JZP-6 for the treatment of fibromyalgia. The letter indicated additional clinical studies are needed for the approval of JZP-6. 

A meeting with the FDA has been requested in order to discuss the contents of the complete response letter. 

An investor conference call and live audio website will be at at 8:30 AM EST. 
Call number:

• US:866-700-6067 
• Outside of US:  617-213-8834
• Passcode: 43104766

Source

Stratatech received 3.95M funding to start the phase IIb trial of StrataGraft from AFIRM

Stratatech announced that the Defense Department's Armed Forces Institute of Regenerative Medicine (AFIRM) has agreed to fund the phase IIb trial using StrataGraft tissue of Stratatech to evaluate its efficacy in the healing of excised, deep, partial-thickness burns with 3.95 million. The trial is expected to commence in the first half of 2011.

StrataGraft(R) is a second-generation human skin tissue substitute developed using StrataTech's proprietary NIKS human keratinocytes.  Keratinocytes were originally discovered at the University of Wisconsin. 

Stratatech Corporation
505 S. Rosa Road
Suite 169
Madison, WI 53719

 

Source 

 

Interim result of the phase II trastuzumab-DM1 of ImmunoGen showed positive development

The interim result of the phase II clinical trial comparing the use of trastuzumab-DM1 in addition to docetaxel as the first-line treatment of HER2+ metastatic breast cancer and standard first-line therapy (Herceptin and chemotherapy) showed positive development.  The trastuzumab-DM1 treatment group had the objective response rate of 47.8% ( a 7.3% higher than the Herceptin group). 

ImmunoGen announced the final progression-free survival results will be available in the second quarter 2011.

Trastuzumab is originally developed by Genetech (now part of Roche).  The compound uses ImmunoGene's TAP technology DM1, a DM1 cancer cell-killing agent.  Trastuzumab is currently being studied in multiple clinical trials in various phases.

Source

Watson settled agreement with Endo with plan to launch generic Opana(R) ER

Watson has reached a settlement agreement with Endo in regards to Endo's Opana(R) ER or oxymorphone ER products.  Watson filed an Abbreviated New Drug Application (ANDA) with the FDA to market generic Oxymorphone ER 5, 7.5, 10, 15, 20, 30 and 40 mg strengths.  Endo filed a lawsuit right after.  Now that the settlement has been reached, Watson plans to introduce generic Opana(R) ER to the market in 2012.  Tentative launch day will be September 15, 2012.

Oxymorphone is a pure opioid agonist that is selective for mu receptor.  At high dose, it can interact other opioid receptors.  It is approved to relieve moderate to severe acute pain. Source