ViroPharm entered into an agreement with Meritage

ViroPharma has entered into an exclusive option to acquire Meritage Pharma with an initial $7.5M upfront payment. The company has also agreed to fund Meritage up to an additional $12.5M for the development and exclusive rights to acquire Meritage once certain clinical and regulatory milestones have been achieved.

Meritage will utilize the initial funding to conduct additional phase 2 clinical trials to assess oral budesonide suspension for the treatment of eosinophilic esophagitis. Once the phase 2 trial data have been presented and Meritage and the FDA have agreed on the clinical endpoint for the phase 3 programs, ViroPharm will have options to acquire Meritage with $69.9M in addition to other milestone payments (clinical and regulatory achievement for the initial indication).

Meritage is a private company located in San Diego, CA.  The company's oral budesonide suspension has been given orphan drug status as of June 2011 for the treatment of patients with eosinophilic esophagitis. The company has completed an initial phase 2 dose-ranging trial in pediatric patients diagnosed with eosinophilic esophagitis (PEER study). The result shown that patients taking oral budesonide suspensions experienced a significant reduction of esophageal eosinophilia.  However, the results of the clinical endpoints were confounded by the use of a multi-symptom assessment tool and high response in the placebo group. In the PEER study, the company use the 6-domain symptom scoring tool to assess heartburn, abdominal pain, nocturnal awakening, nausea, early satiety and dysphagia/food impaction to assess clinical endpoint. However, the scoring tool was not sensitive enough to separate the responses between the oral budesonide suspension group and the placebo group.

Budesonide is an anti-inflammatory corticosteroid that has been approved in the US. The company's new formulation is designed to cover the esophagus and increases the effect of the drug in the esophagus. The company has filed patent application for oral budesonide suspension. If approved, the agent can be protected until 2028.

FDA Clearance - Mobile MIM Radiology App Version 3.0

The MIM Software received the FDA clearance for version 3.0 of its Mobile MIM medical imaging mobile app for radiologist and oncologist.

The last version Mobile MIM app was the first ever approved radiology app for 4 types of imaging modalities: X-ray, CT, PET, MRI and SPECT. The 3.0 version is now approved for viewing diagnostic X-ray and ultrasound  as well as radiation oncology treatment plan review and approval.

MIM Mobile is designed to use on Iphone and Ipad.

Demo of the app is available on YouTube

Company Info:
MIM Software Inc.
-  was originally called MIMvista Corp. as of July 23, 2010

-  provides practical imaging solutions for radiologists and oncologists.
-  is the leading third party PET/CT software package.
- develops software in the fields of Radiology/Nuclear Medicine, Neuroimaging, Cardiac Imaging, and Radiation Oncology.

Momenta signed a collaboration agreement with Baxter

Momenta has signed a collaboration agreement with Baxter to develop and commercialize follow-on biologic products for a variety of diseases including cancer, autoimmune disorders and other chronic conditions.

Momenta will receive an upfront cash payment of $33M from Baxter. Momenta and Baxter will collaborate up to six follow-on biologic compounds. Momenta is eligible to receive additional milestone payment in the next several years as the compounds developed under the collaboration achieve certain technical, development and regulatory milestones.

Poniard terminated planned merger agreement with Allozyne

Sometimes plans just don't go through...

Poniard Pharmaceuticals announced that the company has terminated its planned merger agreement with Allozyne because the combined companies' stocks are not qualified to be listed on the NASDAQ which is one of the conditions under the agreement.

For more information about the planned merger, please visit here

Poniard Pharmaceuticals is a biopharmaceutical company that utilizes its resources to develop and commercialize innovative oncology products.

The company's main product is picoplatin which is a new and differentiated platinum-based chemotherapeutic agent. The agent is currently being investigated for multiple cancer indications when used in combination with other agents.

Anacor Pharmaceuticals completed enrollment of the second phase III trial evaluating tavaborole

Anacor pharmaceuticals announced that it has completed the enrollment of the second phase III trial evaluating the company's tavaborole for the treatment of onychomycosis. The trial is conducted as agreed under a Special Protocol Assessment with the FDA.

The trial enrolled approximately 600 patients who were randomized into either 4% tavaborole (AN2690) or placebo in a two to one ratio. Patients will be given tavaborole or placebo once a day topically for 48 weeks.

The study primary efficacy endpoint is

Lundbeck divests its business to Akorn

It's the season of giving but also a season of selling...
Lundbeck announced that it has entered into an agreement with Akorn to divest several of its products in the US. The company said it will focus its resources to develop new products for the treatment of central nervous system disorders. The company has plans to launch several products in the future:

• Onfi for the treatment of Lennox-Gastaut syndrome
• aripiprazole depot formulation for the treatment of schizophrenia
• Lu AA21004 for the treatment of major depressive disorder

The following products are included in the agreement:

• Nembutal (pentobarbital sodium injection)
• Cogentin (benztropine mesylate injection)
• Intravenous sodium diuril (chlorothiazide sodium)

The company originally acquired these three products through its acquisition of Ovation Pharmaceuticals. 

Under the terms of the agreement signed with Akorn, Akorn has acquired and retains rights and responsibilities for the manufacturing, distribution and sales of the three products.

In addition, Akorn is required to make an upfront payment to Lundbeck after the agreement was signed. Lundbeck is also eligible to receive milestone payment after three years. Lundbeck is not eligible to receive royalties on any future sales of Nembutal.

Actavis to launch MoxDuoIR

Actavis Group announced that the the company's US subsidiary Actavis Inc has entered into a bind letter of intent with QRxPharma Limited. Under the agreement, Actavis will commercialize MoxDuoIR in the US.  QRxPharma retains rights to market MoxDuoIR outside the US.

MoxDuoIR is a combination product of morphine and oxycodone in a 3 to 2 ratio. Actavis plans to launch the product in the third quarter of 2012.

In addition, the agreement gives Actavis options to marketing and sales rights of QRxharma's Dual-Opioid, MoxDuoCR in addition to MoxDuo IV formulation.  However in order for Actavis to exercise the MoxDuoCR option, Actavis needs to achieve a certain sale milestones for MoxDuoIR.

The FDA approved Edarbyclor of Takeda

Takeda announced that the FDA has approved the company's combination product Edarbyclor for the treatment of hypertension.

The fixed-dose combination contains azilsartan chlorthalidone. Edarbyclor comes into two flavors:

• 40 mg of azilsartan and 12.5 mg of chlorthalidone
• 40 mg of azilsartan and 25 mg of chlorthalidone

The approval came after the FDA reviewed results of the clinical trials evaluating the combination products for the treatment of hypertension. Takeda has

Impax submitted the NDA for IPX066

Impax Pharmaceuticals announced that it has submitted the New Drug application for IPX066 to the US FDA for the treatment of idiopathic Parkinson's disease.

The NDA includes data from three controlled phase III trials in addition to two open label extensions studies evaluating IPX066 for the treatment of early and advanced Parkinson.

The company is currently developing IPX066 in collaboration with GSk. The agreement was signed in December of last year.

The companies have recently announced positive results of the phase III ASCEND-PD trial.

About IPX066:

IPX066 in fact is the combination of carbidopa-levodopa but is formulated in the extended release capsule formulation with the thoughts that by introducing the extended-release component will help maintaining the consistent plasma concentration of levodopa.

Chocolate PTA Balloon Catheter (TriReme Medical Inc.) got FDA 510(K) clearance

TriReme Medical, Inc. ("TriReme") announced that it has received FDA 510(K) clearance to market its Chocolate PTA balloon catheter ("Chocolate") for the treatment of occluded peripheral arteries.

Chocolate was developed in collaboration with Quattro Vascular Pte Ltd, a TriReme's subsidiary, in Singapore.

Chocolate's novel design is based on the constraining structure over a semi-compliant balloon allowing the formation of small modules ("pillow"), which minimizes shear stress and allows for uniform inflation and rapid deflation. Once in the desired location, the pillow can expand locally to facilitate plaque modification to restore blood flow but lower the strain and trauma induced on the vessel wall.

Dr. Jihad Mustapha, Director of Endovascular Interventions and Research at Metro Health Hospital in Wyoming, Michigan was thrilled to be first physician to use Chocolate on patients suffered from Critical Limb Ischemia and major amputations. He also said that the results were outstanding without the most feared complications of dissections and elastic recoil.

"Chocolate will provide substantial clinical benefits to patients suffering from peripheral vascular disease, both above and below the knee.", said Eitan Konstantino, PhD, President and CEO of TriReme.
 Company Info:
TriReme Medical, Inc.
- located in Pleasanton, California,
- a privately held medical device company
- a leading developer of innovative devices for the treatment of complex vascular disease

Mylan received WHO Prequalification for its "Second-line-in-a-box"

Mylan announced that WHO has approved the company's three antiretroviral therapies to be used in the
treatment of HIV/AIDS under the World Health Organization Prequalification of Medicines Programme. The three antiviral therapies consist of 4 medications and are considered as "second-line-in-a-box".

The four medications are:

• 300 mg atazanavir capsule, 100 mg

Phage Pharmaceuticals filed an investigational new drug application for FGF-1

Phage Pharmaceuticals announced that it has filed an investigational new drug application for FGF-1 to the US FDA seeking to test the agent in the phase I trial for the repair of tympanic membrane perforation. The company currently has active and open INDs with the FDA for FGF-1 and its human growth hormone

FGF-1 is an acidic fibroblast growth factor that belongs to a family of heparin-binding growth factors. In order to maintain its stability, the FGF-1 needs to by to heparin. FGF-1 will interact with fibroblast growth factor receptors in order to stimulate cell growth.

The agent is currently being manufactured at Phage' facilities. It has completed the phase 1 trial for the treatment of diabetic wounds.

SFDA approved Devon Medical Products to market ViewSite(TM) Brain Access System (VBAS) in China

Devon Medical Products received approval from the State Food & Drug Administration (SFDA) to market the ViewSite(TM) Brain Access System (VBAS) neurosurgery device in the People's Republic of China. 

VBAS is a brain access and retraction device, it allows surgeons to reach target areas in the brain, such as tumors and hemorrhages, with higher precision. With its navigation functions,  the surrounding tissue will be better visualized, allowing the surgeons to perform reposition the retractor fewer times during the operation. VBAS allows higher accuracy and less tissue trauma during the intra-operation and potentially faster recovery for patients 

According to Dr. Benneth, the president of Devon Medical Products, this will allow "surgeons and patients who will be able to benefit from the VBAS device in China as they have in the United States."

VBAS is made in the United States by Vycor Medical, Inc., a medical device company specializing in products for neurosurgery. Devon Medical Products is co-partnered with PKUcare BeiYi Pharmaceutical Co. Ltd., to distribute VBAS in China.

Company Info:

Devon Medical Products, www.devonmedicalproducts.com 

- is part of the Devon International Group, specialized in healthcare, IT, and international business industries and headquartered in King of Prussia, Pennsylvania.

- is a global medical device designer, manufacturer, and distributor that provides the medical community with innovative, safe, and cost-effective medical products. 

- has cultivated an exclusive line of medical devices for advance healthcare treatments and maximize safety for healthcare workers and patients worldwide. 

- has office is in China and other countries staffed with bilingual engineers, product developers, and regulatory experts.

Vycor Medical VYCO -1.20% ,  www.vycormedical.com

- is a medical device company specializing in products for brain and spinal surgery. 

- is an ISO certified manufacturer.

PKUcare BeiYi Pharmaceutical Co. Ltd. 

- is a specialized pharmaceutical logistics company providing medicine, chemical raw medicine, drug preparation services, and medical instruments. 

- is a subsidiary of the PKU International HealthCare Group, which was established in 2003 to leverage the rich resources of the Founder Group as well as the medical science department of PKU. 

Raptor signed a collaborative and research agreement with the NIDDK

Raptor Pharmaceuticals announced that it has signed a collaborative research and development agreement with the National Institute of Diabetes and Digestive and Kidney Diseases which is part of the National Institute of Health. Under the agreement, Raptor will conduct a phase 2b clinical trial evaluating the safety and efficacy of RP104 for the treatment of non-alcoholic steatohepatitis (NASH) in children. The company plans to initiate the trial in the first calendar quarter of 2012. The company estimates the cost of conducting the trial will be within $14 to 16M. Raptor will contribute $6M toward the cost of the trial and will also provide clinical trial materials as well as drug manufacturing/quality support. The trial material and support are estimated to be approximately $1M.

The trial will enroll approximately 160 pediatric patients at 10 centers in the NIDDK-sponsored NASH Clinical Research Network in the US. Study subjects will be randomized into either the RP104 group or the placebo group and will receive treatment for 52 weeks. The primary objective will be measured by changes in the NAFLD Activity Score. The trial will also measure alanine transaminase, aspartate transaminase, safety and tolerability as secondary endpoints.

RP104 is a delayed release tablet formulation of cysteamine bitartrate delayed-release tablet.

Impax Laboratories initiated the phase IIb trial evaluating IPX159

Impax Laboratories announced that it has initiated the phase IIb trial evaluating IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

The phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study. The trial plans to enroll 120 adults patients who will be randomized to receive either IPX159 or placebo. Study subjects will be treated for up to 11 weeks. The study primary endpoint will be measured by the International Restless Legs Syndrome Study Group Rating Scale.

The company plans to have the results ready by mid-2013.

IPX159 is a small molecule with an established pharmacological and safety profile that has been formulated as an oral controlled-release formulation.

Pacira announced publication of the phase III trial evaluating Exparel

Pacira Pharmaceuticals announced that the results of the pivotal trial evaluating Exparel (bupivacaine liposome injectable suspension) has been published in the Journal of Diseases of the Colon & Rectum.

Exparel has been approved in the US for administration into the surgical site to produce postsurgical analgesia. 

The phase III trial was a multi-center, randomized, double-blind, placebo-controlled study evaluating the magnitude and duration of postsurgical analgesia produced by a single dose of Exparel in patients undergoing a two- or three-column excisional hemorrhoidectomy under general anesthesia using the Milligan-Morgan technique. Opioids were allowed as rescue pain relief in both the placebo and Exparel group. 

The results showed that administration of Exparel significantly reduced pain when compared to placebo at three time points over 72 hours when compared to placebo.

Patients treated with Exparel also significantly had a significantly longer the median time to first opioid use when compared to placebo group (14.3 hours vs 1.2 hours, p < 0.0001)

Patients treated with Exparel also consumed significantly less amount of opioids when compared to placebo.

Significantly more patients in the Exparel group reported satisfied or extremely satisfied with their postsurgical analgesia at 72 hours when it was compared to the placebo group.

Silenor plans to reduce workforce and hires financial advisor

Somaxon announced that it has hired Stifel Nicolaus Weisel as a strategic advisor to help the company in identifying and evaluating strategies for the company in order to increase its stockholder value.

The company’s President and CEO Richard W. Pascoe mentioned possible sales of one or more of the company’s assets related to Silenor and possible partnering and collaboration relating to the US or ex-US prescription or over-the-counter rights to Silenor.

In order to minimize the company’s cash burn rate, it also

Isis Initiates the phase 1 trial evaluating ISIS-SMNRx in spinal muscular atrophy patients

Isis Pharmaceuticals announced that it has initiated the phase I trial evaluating the company's ISIS-SMNRx for the treatment of spinal muscular atrophy.

The company also reported that the US FDA has given ISIS-SMNRx an orphan drug designation and fast track status.

The phase I trial is an open-label, single-dose, dose-escalation study aiming to evaluate the safety, tolerability and pharmacokinetic profile of ISIS-SMNRx in children

Sanofi completed sales of its Dermik Dermatology Unit to Valeant

After launching a hostile takeover of Ista Pharmaceuticals, Valeant completed its acquisition of Dermik Dermatology Unit of Sanofi.  The agreement was signed in July 2011 and Valeant is said to pay Sanofi approximately $422.5M in cash. Sanofi said it will use the cash to grow the company's business in North America.

Dermik Dermatology of Sanofi has products in aesthetic and therapeutic business in the US and Canada. The Unit also has marketed aesthetic products around the world.  Coming with Dermik is its manufacturing site in Canada. Several products of Dermik Dermatology are: Benzaclin, Carac and Sulptra.

The company estimates that sales of Dermik products will be more than $200M in the year of 2011. Dermik recorded sales of 206M in the year of 2010 in the US.

Mylan launched generic version of Toprol XL

Mylan announced that it has launched generic version of Toprol XL tablets. Toprol XL is the brand name of metoprolol succinate extended-release tablets. The company's generic version will come in the following strengths: 25 mg, 50 mg, 100 mg and 200 mg.

Metoprolol succinate extended-release tablets have been approved for the treatment of hypertension. The brand Toprol XL is currently being marketed by AstraZeneca.

The sales of metoprolol succinate extended release in the 12 months ending Sept 30, 2011 were estimated to be $1.78B.

Metoprolol is a beta-blocker that works decrease hypertension or high blood pressure.

Boehringer Ingelheim expands its operation in Shanghai

It's become more common to hear about company's effort to expand its presence in China these days. After Icon acquired a BeijingWits Medical Consulting to increase its presence in China, Boehringer Ingelheim has increased its supply center in China.

The company will spend approximately 70M Euro to increase the